Published in December 2013
© all rights reserved
Compiled and Published by :
Medical Department
Beximco Pharmaceuticals Ltd.
Design and Graphics by Medical Department
Printed by Shuktara Printers Ltd.
bexinfo: Therapeutic Guide electronic PDF copy can be accessed at www.beximco-pharma.com

Beximco Pharmaceuticals Ltd. (Beximco Pharma) is a leading manufacturer of finished formulations and active pharmaceutical ingredients (APIs) in Bangladesh.
Incorporated in the late 70s, Beximco Pharma began its journey as a distributor, importing products from global
Multinational Companies (MNCs) like Bayer, Germany and Upjohn Inc., USA, which were later manufactured under licensing arrangements. Today, Beximco Pharma is the largest exporter of pharmaceuticals in the country winning National Export Trophy (Gold) a record four times. Company’s state-of-the-art manufacturing facilities are certified by the regulatory authorities of
Australia, European Union, Gulf nations, and Brazil, among others and it has visible and growing presence across regional markets of Asia, Africa and Central
America. Beximco Pharma has also entered the highly regulated pharma markets of US and EU and it has the unique distinction as the only Bangladeshi company to get listed on AIM of London Stock Exchange. The company is consistently building upon its portfolio and currently producing more than 300 generics in over 500 different strengths and dosage forms.

Operational Headquarter
19, Dhanmondi R/A, Road No. 7
Dhaka 1205, Bangladesh
Phone : +880-2-8619151, +880-2-8619091
Website : www.beximco-pharma.com
Corporate Headquarter
17, Dhanmondi, Road No. 2
Dhaka 1205, Bangladesh
Factory
Tongi Unit
126 Kathaldia, Tongi, Gazipur
Kaliakoir Unit
Plot no. 1070/1083, Mouchak, Kaliakoir
Gazipur

C
B
I

bexinfo: T
HERAPEUTIC
G
UIDE
B
RAND
N
AME
A NALGESICS & A NTIPYRETICS
Lucidol Capsule / Suppository
Napa Tablet / Syrup / Suspension /
Suppository / Pediatric Drops
Napa IV Infusion
NapaDol Tablet
Napa Extend Tablet
Napa Extra Tablet
Napa Soft Tablet
G
ENERIC
N
AME
Tramadol Hydrochloride
Paracetamol
Paracetamol
Paracetamol + Tramadol Hydrochloride
Paracetamol BP 665 mg
Paracetamol + Caffeine
Paracetamol + DL-Methionine
A NTI -A LLERGIC D RUGS
Aerovil Syrup
Atrizin Tablet/ Syrup/ Pediatric drops
Axodin Tablet/Suspension
Bexidal Tablet
Curin Tablet
Momento Tablet/Syrup
Olopan Nasal Spray
Pedeamin Syrup
Pretin Tablet
Pretin D Tablet
Promezin Syrup
Pheniramine Maleate
Cetrizine Hydrochloride
Fexofenadine
Mebhydrolin Napadisylate
Levocetirizine Dihydrochloride
Desloratadine
Olopatadine
Diphenhydramine Hydrochloride
Loratadine
Loratadine +
Pseudoephedrine Hydrochloride
Promethazine Hydrochloride
37
37
38
40
40
41
42
43
44
45
47
27
28
30
31
31
32
33
A NTI -C ANCER D RUGS
Tamona Tablet
A NTI -I NFECTIVE
A NTI -A MEBIC
Filmet Tablet / Suspension
Filmet IV Infusion
Nitaxide Tablet / Suspension
Xynor Tablet
Tamoxifen 51
Metronidazole / Metronidazole Benzoate
Metronidazole
Nitazoxanide
Ornidazole
55
56
57
58 xi

bexinfo: T
HERAPEUTIC
G
UIDE
B
RAND
N
AME
A
NTI
- I
NFECTIVE
G
ENERIC
N
AME
A NTI -B ACTERIAL
Arixon Injection
Arlin Tablet / Suspension / Infusion
Azithrocin Capsule / Tablet /
Suspension / Injection
Clobex Capsule / Syrup
Etrocin Tablet / Suspension
Evo Tablet / Oral Solution
Evo IV Infusion
Flubex Capsule / Syrup / DS Syrup
Intracef Capsules / Suspension /
Pediatric Drops / Injection
Isofloxin Tablet
Maxidime Injection
Megadox Capsule
Megatrim DS Tablet /
Megatrim Suspension
Neofloxin Tablet / Suspension
Neofloxin IV Infusion
Sparlin Tablet
Tetracef Injection
Triocim Capsule / Suspension
Turbocef Tablet / Injection
Tycil Capsule / Suspension /
Pediatric Drops
Tyclav Tablet
Vercef Suspension / Pediatric Drops
A
NTIBIOTIC
S
OLUTION
Tobasol Respirator Solution
Ceftriaxone
Linezolid
Azithromycin
Cloxacillin
Erythromycin Ethylsuccinate
Levofloxacin
Levofloxacin
Flucloxacillin
Cefradine
Pefloxacin Mesylate
Ceftazidime
Doxycycline Hydrochloride
Trimethoprim + Sulfamethoxazole
Ciprofloxacin Hydrochloride
Ciprofloxacin Hydrochloride
Sparfloxacin
Cefepime
Cefixime
Cefuroxime
Amoxicillin
Amoxicillin + Clavulanic Acid
Cefpodoxime
A
NTI
-P
ARASITIC
Alphin DS Tablet
Ivera 6 Tablet
Melphin Suspension
Tobramycin
A NTI -F UNGALS
Fungistin Suspension
Omastin Capsule / Suspension / Infusion
Omastin Duo Capsule / Cream
Terbex Cream / Tablet
Nystatin
Fluconazole
Fluconazole +Clotrimazole
Terbinafine Hydrochloride
Albendazole
Ivermectin
Pyrantel Pamoate
91
92
92
94
95
96
97
98
64
65
66
68
68
69
72
73
75
76
77
80
81
82
84
85
86
60
61
62
88
89 xii

bexinfo: T
HERAPEUTIC
G
UIDE
B
RAND
N
AME
A NTI - I NFECTIVE
A NTI -V IRALS
Oseflu Capsule
Ovalac Tablet
Anti-HIV
Avifanz Tablet
Avifix Tablet
Avilam Tablet
Diavix Tablet
Triovix Tablet
C ARDIOVASCULAR D RUGS
A
NTI
-A
NGINALS
Monate Tablet
Metazine MR Tablet
Nitrosol Spray
Pacet Tablet
A NTI -H EMORRHAGIC
Tranexil Injection
A
NTI
-H
YPERTENSIVES
Amdocal Tablet
Amdocal Plus Tablet
Amdova Tablet
Bizoran Tablet
Cardopril Tablet
Dilapress Tablet
Enaril 5 Tablet
Indelix SR Tablet
Labeta Tablet
Lonet Tablet
Metoprol XL Tablet
Olmesan Tablet
Olmesan Plus Tablet
Primace Capsule / Tablet
Prosan Tablet
Prosan HZ Tablet
G
ENERIC
N
AME
Oseltamivir
Valacyclovir
Efavirenz
Nelfinavir
Lamivudine
Lamivudine + Zidovudine
Lamivudine + Zidovudine + Nevirapine
Isosorbide Mononitrate
Trimetazidine Hydrochloride
Glyceryl Trinitrate
Amiodarone Hydrochloride
Tranexamic Acid 117
Amlodipine Besylate
Amlodipine Besylate + Atenolol
Amlodipine Besilate + Atorvastatin Calcium
Amlodipine + Olmesartan
Captopril
Carvedilol
Enalapril Maleate
Indapamide
Labetalol Hydrochloride
Atenolol
Metoprolol Succinate
Olmesartan Medoxomil
Olmesartan Medoxomil + Hydrochlorothiazide
Ramipril
Losartan Potassium
Losartan Potassium +Hydrochlorothiazide
130
132
133
135
135
124
126
127
128
129
119
119
120
122
123
123
99
100
101
104
106
107
108
113
114
114
115 xiii

bexinfo: T
HERAPEUTIC
G
UIDE
B
RAND
N
AME
G
ENERIC
N
AME
C ARDIOVASCULAR D RUGS
A
NTI
-T
HROMBOTIC
Cleven
Odrel Tablet
Odrel Plus Tablet
Prasuva Tablet
D IURETICS
Resitone Tablet
Resitone Plus Tablet
Thalin Tablet
L IPID L OWERING A GENT
Atova Tablet
Ezeta Tablet
Lofat Capsule
Rosutin Tablet
V ASODILATORS
Cerivin Tablet
Vasolax Tablet
Zocil Tablet
Enoxaparin Sodium
Clopidogrel
Clopidogrel + Aspirin
Prasugrel
Furosemide + Spironolactone
Furosemide + Spironolactone
Chlorthalidone
Atorvastatin Calcium
Ezetimibe
Fenofibrate
Rosuvastatin
137
139
140
141
142
143
143
145
146
148
149
Vinpocetine
Pentoxifylline
Cilostazol
151
152
153
C OUGH AND C OLD P REPARATION
C
OUGH
S
UPPRESSANT
Dextromethorphan Syrup Dextromethorphan Hydrobromide 157
C OUGH E XPECTORANTS
Mucosol Syrup / Pediatric Drops
NoKOF Capsule / Syrup / DS Syrup
Prudex Syrup
Spulyt Tablet / Syrup
Tripec Syrup
Ambroxol Hydrochloride
Carbocisteine
Dextromethorphan + Pseudoephedrine +
Triprolidine
Bromhexin Hydrochloride
Guaifenesin + Pseudoephedrine
Hydrochloride + Triprolidine
158
159
160
161
162 xiv

bexinfo: T
HERAPEUTIC
G
UIDE
B
RAND
N
AME
E NDOCRINE & M ETABOLITES
G
ENERIC
N
AME
A
NTI
-D
IABETICS
CoDiaglit Tablet
Diactin Tablet
Diaglit Tablet
Diapro Tablet
Diapro 30 MR Tablet
Diaryl Tablet
Glipita Tablet
Glipita M Tablet
Informet Tablet / Informet LA Tablet
Premil Tablet
Pioglitazone Hydrochloride +
Metformin Hydrochloride
Glipizide
Pioglitazone Hydrochloride
Gliclazide
Gliclazide
Glimepiride
Sitagliptin Phosphate
Sitagliptin Phosphate +
Metformin Hydrochloride
Metformin Hydrochloride
Repaglinide
O
VULATORY
S
TIMULANT
Fertil Tablet Clomiphene Citrate
175
177
179
165
166
168
169
170
170
172
174
G ASTRO -I NTESTINAL D RUGS
A
NTACIDS
& A
NTI
F
LATULENT
Antacid Max Tablet
Digecid Plus Tablet / Suspension
Flatameal DS Suspension
Lactameal Tablet / Suspension
Aluminum Hydroxide +
Magnesium Hydroxide + Simethicone
Magaldrate + Semithicone
Aluminum Hydroxide Gel +
Magnesium Hydroxide + Simethicone
Aluminum Hydroxide Gel +
Magnesium Hydroxide
A NTI -C OLIC & A NTI -F LATULENT
Neodrop Pediatric Drops Simethicone
A NTI -E METIC
Onsat Tablet /Syrup
Onsat Injection
A
NTI
-S
PASMODIC
Emonium Tablet
Emonium Injection
Loverin Tablet / Syrup
Rostil Tablet
Spanil Tablet
Taverin Tablet
Ondansetron Hydrochloride
Ondansetron Hydrochloride
Tiemonium Methylsulphate
Tiemonium Methylsulphate
Dicycloverine Hydrochloride
Mebeverine Hydrochloride
Hyoscine Butylbromide
Drotaverine Hydrochloride
186
187
188
191
191
192
193
194
194
183
183
184
185 xv

bexinfo: T
HERAPEUTIC
G
UIDE
B
RAND
N
AME
G
ASTRO
-I
NTESTINAL
D
RUGS
A NTI -U LCERANTS
Acifix Tablet
Gastalfet Tablet
Misopa Tablet
Neoceptin R Tablet/ Syrup
Neoceptin R Injection
Neo Kit Tablet / Capsule
Opton Tablet / IV Injection
Pantobex Tablet / IV Injection
Proceptin Capsule / IV Injection
Protolan Capsule
Viscocid Tablet / Suspension
Yamadin Tablet
D IGESTIVE E NZYME
Zymet Tablet
G
ASTROPROKINETIC
Deflux Tablet / Suspension /
Pediatric Drop
L AXATIVES
Serelose Solution
M USCULOSKELETAL D RUGS
C HONDROPROTECTIVES
Feburic Tablet
Jointec Max Tablet
M USCLE R ELAXANT
Lospan Tablet
Relentus Tablet
Tolmus Tablet
G
ENERIC
N
AME
Rabeprazole Sodium
Sucralfate
Prostaglandin
Ranitidine Hydrochloride
Ranitidine Hydrochloride
Clarithromycin + Omeprazole +
Metronidazole
Esomeprazole
Pantoprazole
Omeprazole
Lansoprazole
Sodium Alginate + Potassium Bicarbonate
Famotidine
196
197
198
199
200
201
202
203
204
206
207
208
Pancreatin
Domperidone Maleate
Lactulose Solution
Febuxostat
Diacerein and Glucosamine
Baclofen
Tizanidine hydrochloride
Tolperisone Hydrochloride
209
210
212
215
216
217
218
219 xvi

bexinfo: T
HERAPEUTIC
G
UIDE
B
RAND
N
AME
M
USCULOSKELETAL
D
RUGS
G
ENERIC
N
AME
N ON -S TEROIDAL A NTI -I NFLAMMATORY D RUGS (NSAID S )
Cox B Capsule Celecoxib
Dexifen Tablet / Suspension
Dinovo Tablet
Dexibuprofen
NSAIDs + Esomeprazole Magnesium
Mefenamic Acid Fenamic Capsule / Tablet /
Suspension
Mobicam Tablet
Nuprafen Tablet
Reumafen Tablet / Suspension
Tenoxicam
Naproxen
Ibuprofen
Ribox Tablet
Tolmic Tablet
Ultrafen Tablet / Suppository
Ultrafen IM Injection
Ultrafen Plus Tablet
Ultrafen Extra IM Injection
Voligel Gel
Xidolac Tablet
Xidolac IM / IV Injection
Xynofen-100 SR Capsule
Zolfin Tablet
Etoricoxib
Tolfenamic Acid
Diclofenac Sodium
Diclofenac Sodium
Diclofenac Sodium + Misoprostol
Diclofenac Sodium +
Lidocaine Hydrochloride
Diclofenac Sodium
Ketorolac Tromethamine
Ketorolac Tromethamine
Ketoprofen
Aceclofenac
N
EUROLOGICAL
D
RUGS
A NTI -D EPRESSANTS
Apresin Tablet
Atralin Tablet
Frenxit Tablet
Melev 20 Tablet
Modipran Capsule
Seropam Tablet
A
NTI
-E
METICS
Vomec Tablet
Vomec Plus Tablet
A
NTI
-E
PILEPTICS
Epilep Tablet / CR Tablet
A NTI -M IGRAINE
Avidro Tablet
Flurium Tablet
Fluphenazine Hydrochloride +
Nortriptyline Hydrochloride
Sertraline Hydrochloride
Flupentixol and Melitracen
Paroxetine Hydrochloride
Fluoxetine hydrochloride
Escitalopram Oxalate
Meclizine Hydrochloride
Meclizine Hydrochloride +
Pyridoxine Hydrochloride
Carbamazepine
Pizotifen Malate
Flunarizine Dihydrochloride
251
252
253
255
256
245
245
246
247
248
249
221
222
223
225
226
227
228
229
231
232
233
234
235
237
237
238
240
241 xvii

bexinfo: T
HERAPEUTIC
G
UIDE
B
RAND
N
AME
N EUROLOGICAL D RUGS
A NTI -P ARKINSONISM
Repitol Tablet
G
ENERIC
N
AME
Ropinirole
A NTI -P SYCHOTIC
Pericam Tablet
L
OCAL
A
NESTHETIC
Nerkein Injection
Olanzapine
Bupivacaine Hydrochloride
N EUROPATHIC P AIN M ANAGEMENT
Nervalin Capsule Pregabalin
N
EUROPROTECTIVE
Citicol IM / IV Injection
T RANQUILIZER
Keolax Tablet
Nightus Tablet
Xetril Tablet
Zolax Tablet
V
ITAMIN
Neurocare Tablet
Citicolin
Clobazam
Bromazepam
Clonazepam
Alprazolam
Thiamine Mononitrate + Pyridoxine
Hydrochloride + Cyanocobalamin
258
260
262
264
266
267
268
268
270
271 xviii

bexinfo: T
HERAPEUTIC
G
UIDE
B
RAND
N
AME
N
UTRITIONAL
S
UPPLEMENT
G
ENERIC
N
AME
Aristocal Tablet
Aristocal D Tablet
Aristocal M Tablet
Aristoferon Syrup
Aristoplex Syrup
Aristovit B Tablet
Aristovit B Injection
Aristovit M Tablet
Aristovit X Tablet
Ascobex Tablet
Avitron V Tablet
Bextram Tablet
Bextram Gold Tablet
Bextram Silver Tablet
Bextram KIDZ Syrup
Bextram Teen Hm Tablet
Bextram Teen Hr Tablet
Calorate Tablet
Calorate Kit Tablet
Carnitab Tablet
Carocet Tablet
Formula E Tablet
Hemofix Tablet
Hemofix FZ Tablet
Momvit Plus Tablet
Neurocare Tablet
Nutrimin Solution
Nutrimin D Solution
Pregvit Capsule
Tynisol Drop
Veniron Injection
Vitonic Syrup
Vivis Capsule
Zedex DS Syrup
Calcium Carbonate
Calcium + Vitamin D
Calcium + Vitamin D + 5 minerals
Ferrous Sulphate
Vitamin B Complex
B Vitamins
Vitamin B Complex
11 Vitamins + 5 Minerals + Iron
Vitamins + Antioxidants + Minerals
Ascorbic Acid + Sodium Ascorbate
Vitamin B
1 or Thiamine Hydrochloride
Vitamins + Anti-oxidants + Minerals + Micronutrients
14 Vitamins +18 Minerals (Iron, Folic acid and Zinc)
Vitamins and Minerals
Eight Essential Vitamins + Cod liver oil
Multivitamin + Mineral supplement
Multivitamin + Mineral supplement
Calcium Orotate
Ibandronic Acid + Calcium Orotate
Levocarnitine
Beta Carotene + Vitamin C + Vitamin E
Vitamin E
Ascorbic Acid + Iron
Iron+ Folic acid + Zinc
Multivitamin + Multimineral
Thiamine Mononitrate + Pyridoxine Hydrochloride +
Cyanocobalamin
Crystalline Amino Acids +
D-Sorbitol with electrolytes
Amino Acids IV Infusion + 10% Glucose with electrolytes
Iron+ Folic Acid + Vitamin B-complex + Vitamin C
Vitamin A + Vitamin C + Vitamin D +
Thiamine + Riboflavin + Pyridoxine +
Niacinamide + Dexpanthenol
Iron Sucrose
Iron+ Some B Vitamins + Zinc
Ascorbic Acid (Vitamin C) + Vitamin E + Zinc +
Copper + Lutein
Zinc Sulfate
300
302
304
305
306
307
308
309
286
287
288
289
290
282
282
283
284
285
275
275
276
277
278
278
279
280
281
293
294
295
297
297
298
299 xix

bexinfo: T
HERAPEUTIC
G
UIDE
B
RAND
N
AME
O
PHTHALMIC
D
RUGS
G
ENERIC
N
AME
Alastine Eye Drops
Chlormet Eye Drops
Cinarex Eye Drops
Cinarex D Eye Drops
Contra Eye Drops
Evo Eye Drops
Evo TS Eye Drops
Glucovis Eye Drops
Hyprosol Eye Drops
Hypersol 5 Eye Drops
Inflavis Eye/Ear Drops
Intramol Eye Drops
Mydrate Eye Drops
Neofloxin Eye / Ear Drops
Neofloxin D Eye / Ear Drops
Ocutrex Eye/Ear Drops
Olopan Eye Drops
Olopan DS Eye Drops
Opanac Eye Drops
Rubalon Eye Drops
Saloride Eye Drops
Tearex Eye Drops
Tearon Eye Drops
Tofen Eye Drops
Vivis Capsule
Xalanol Eye Drop
Xalaprost Eye Drops
Xegal Eye Drops
Xidolac Eye Drops
Epinastine Hydrochloride
Dexamethasone Phosphate + Chloramphenicol
Tobramycin
Dexamethasone +Tobramycin
Lomefloxacin
Levofloxacin
Levofloxacin
Betaxolol
Hypromellose
Sodium Chloride
Dexamethasone Phosphate
Timolol
Cyclopentolate Hydrochloride
Ciprofloxacin
Dexamethasone +Ciprofloxacin
Chloramphenicol
Olopatadine
Olopatadine
Nepafenac
Fluorometholone
Sodium Chloride
Povidone
Polyethylene Glycol + Propylene Glycol
Ketotifen
Ascorbic Acid (Vitamin C) + Vitamin E + Zinc +
Copper + Lutein
Latanoprost + Timolol
Latanoprost
Gatifloxacin
Ketorolac Tromethamine
337
338
338
340
327
328
329
330
331
322
322
324
325
326
313
314
315
315
317
318
319
320
321
332
333
334
334
335
336 xx

bexinfo: T
HERAPEUTIC
G
UIDE
B
RAND
N
AME
R ESPIRATORY D RUGS
G
ENERIC
N
AME
A
NTIBIOTIC
S
OLUTION
Tobasol Respirator Solution
A STHMA M ANAGEMENT
Bexitrol Inhaler
Bexitrol-F Inhaler
Bexitrol-F Bexicap Capsule
Ipramid Inhaler
Iprasol Inhaler
Monocast Tablet
Symbion Inhaler
Symbion Bexicap Capsule
Tioriva Bexicap Capsule
Prophylaxis
Aeronid Inhaler
Cesonide Inhaler
Decomit Inhaler
Tofen Tablet / Syrup
Zukast Tablet
Tobramycin
B
RONCHODILATORS
Azmasol Tablet
Azmasol Inhaler
Azmasol Respiration Solution
Bronkolax Tablet / Syrup
Bricasol Respirator Solution
Forterol Respirator Solution
Ipramid Respirator Solution
Iprasol Respirator Solution
Larnox LA Tablet
Mucomist Respirator Solution
Respira Tablet / Syrup
Salbutamol Sulphate
Salbutamol Sulphate
Salbutamol Sulphate
Salbutamol Sulphate
Terbutaline Sulfate
Arformoterol Tartrate
Ipratropium Bromide
Ipratropium Bromide
Aminophylline
Acetylcysteine
Levosalbutamol Sulphate
N ASAL P REPARATIONS
Decomit Nasal Spray
Nasomet Nasal Spray
Nazolin Nasal Spray
Perinase Nasal Spray
Beclomethasone dipropionate
Mometasone Furoate
Oxymetazoline Hydrochloride
Fluticasone Propionate
343
Salmeterol Xinafoate
Salmeterol + Fluticasone Propionate
Salmeterol Xinafoate + Fluticasone Propionate
Ipratropium Bromide
Salbutamol Sulphate + Ipratropium Bromide
Montelukast Sodium
Formoterol Fumarate Dihydrate + Budesonide
Formoterol Fumarate Dihydrate + Budesonide
Tiotropium Bromide
344
345
346
348
349
350
352
354
355
Budesonide
Ciclesonide
Beclometasone Dipropionate
Ketotifen
Zafirlukast
356
358
358
359
360
376
377
378
379
367
368
369
370
371
362
363
364
365
366
374 xxi

bexinfo: T
HERAPEUTIC
G
UIDE
B
RAND
N
AME
T OPICAL P REPARATIONS
A
NTI
-A
CNE
Cosmotrin Cream
G
ENERIC
N
AME
Tretinoin
A NTIBIOTICS
Burnsil Cream
Furasep Cream
Gentosep Cream
Silver Sulfadiazine
Nitrofurazone
Gentamicin Sulphate
A NTIBIOTIC , A NTI -F UNGAL & A NTI -I NFLAMMATORY
Exovate N Cream Clobetasol Propionate + Nystatin +
Neomycin
A NTIBIOTIC & A NTI -I NFLAMMATORY
Fusidic Plus Ointment Sodium Fusidate +
Hydrocortisone Acetate
A
NTI
-F
UNGALS
Neosten Cream
Neosten VT Tablet
Tenafin Cream
Clotrimazole 0 .1%
Clotrimazole
Butenafine Hydrochloride
A
NTI
-F
UNGALS
& A
NTI
-I
NFLAMMATORY
Ecotrim Cream Econazole + Triamcinolone
Neosten HC Cream Clotrimazole + Hydrocortisone
A NTI -I NFLAMMATORY
Atolimus Ointment
Exovate Cream / Ointment
Tacrolimus
Clobetasol Propionate
A NTI -P SORIATIC
Soritene Cream
A
NTI
-S
CABIES
Noscab Cream
Tazarotene 15%
Permethrin 5%
383
384
385
385
387
389
390
391
391
393
394
395
395
397
398 xxii

bexinfo: T
HERAPEUTIC
G
UIDE
B
RAND
N
AME
T OPICAL P REPARATIONS
E MOLLIENT
Eukrim Cream
G
ENERIC
N
AME
Urea 10%
H EMORRHOID & F ISSURE
Anustat Ointment
M
USCULOSKELETAL
IcyKool / IcyKool Max Cream
Cinchocaine + Hydrocortisone +
Neomycin + Esculin
Methyl Salicylate + Menthol
N ON S TEROIDAL A NTI I NFLAMMATORY D RUG (NSAID)
Voligel Gel Diclofenac Sodium
S
KIN
C
ARE
Q-Rash Ointment
Recur Tablet
U
ROLOGICAL
D
RUGS
Zinc Oxide 40%
Finasteride
Tadalafil
Sildenafil Citrate
Oxybutynin Chloride
Adafil Tablet
Enegra Tablet
Uricon Tablet
A
NTI
-BPH A
GENT
Prosfin Tablet
Uroflo Capsule
D
IAGNOSTIC
D
YE
Lopidam Injection
Finasteride
Tamsulosin Hydrochloride
Lopamidol
399
400
401
402
403
403
407
408
409
411
412
413 xxiii

A
& A

bexinfo: T
HERAPEUTIC
G
UIDE
®
Capsule / Suppository
Lucidol, a preparation of Tramadol Hydrochloride, is a centrally acting analgesic.
Tramadol is a synthetic analogue of codeine.
Indications: Lucidol is indicated for the management of moderate to moderately severe pain.
Dosage and Administration : Capsule: Adults: Lucidol 50 mg to 100 mg can be administered as needed for relief of painful conditions every four to six hours, not to exceed 400 mg per day. For moderate pain, Lucidol 50 mg may be adequate as the initial dose, and for more severe pain, Lucidol 100 mg is usually more effective as the initial dose.
Children: Not recommended for children under 16 years of age.
Use in the Elderly: Daily doses in excess of 300 mg are not recommended in patients over 75 years.
Individualization of Dose: The recommended dose for patients with cirrhosis is 50 mg every 12 hours. Patients receiving chronic carbamazepine dose up to 800 mg daily may require up to twice the recommended dose of Lucidol.
Lucidol Suppository: 100 mg up to 4 times daily.
Side Effects: Most common side effects are malaise, vasodilatation, anxiety, confusion, coordination disturbance, euphoria, nervousness, sleep disorder, abdominal pain, anorexia, flatulence, hypertonia, skin rash, visual disturbance, urinary retention, urinary frequency and menopausal symptoms.
Drug Interactions: Patients treated with MAO inhibitors within 14 days prior to the administration of the opioid pethidine have experienced life-threatening interactions affecting the central nervous system as well as the respiratory and circulatory centers.
Lucidol may potentiate the CNS depressant effects of other centrally acting drugs
(including alcohol) when administered concomitantly with such drugs. Lucidol may increase the potential for SSRIs, TCAs, anti-psychotics and other seizure threshold lowering drugs to cause convulsions. Isolated cases of serotonergic syndrome have been reported with the therapeutic use of Lucidol in combination with other serotonergic agents such as selective SSRIs. Administration of Lucidol together with carbamazepine results in markedly decreased serum concentrations of Tramadol which may reduce analgesic effectiveness and shorten the duration of action. Caution should be exercised during concomitant treatment with Lucidol and coumarin derivatives (e.g., warfarin) due to reports of increased INR and ecchymosis in some patients. The combination of mixed agonists / antagonists (e.g., buprenorphine, nalbuphine, pentazocine) and Tramadol is not recommended because it is theoretically possible that the analgesic effect of a pure agonist is attenuated under these circumstances. There is no interaction with food.
27

bexinfo: T
HERAPEUTIC
G
UIDE
Warning & Precautions: The recommended dose of Lucidol should not be exceeded. It should be administered cautiously in patients at risk for respiratory depression. When large doses of Tramadol are administered with anesthetic medications or alcohol, respiratory depression may result. It should be used with caution in patients with increased intracranial pressure or head injury. Pupillary changes (miosis) from Tramadol may obscure the existence, extent, or course of intracranial pathology. This is not recommended for patients who are dependent on opioids. Patients who have recently taken substantial amounts of opioids may experience withdrawal symptoms. In patients with creatinine clearances of less than 30 ml/min, reduction of doses is recommended.
Use in Pregnancy and Lactation: Tramadol should not be used in pregnancy prior to or during labor unless the potential benefits outweigh the risks. Chronic use during pregnancy may lead to physical dependence and post-partum withdrawal symptoms in the newborn. It is not recommended for obstetrical preoperative medication or for postdelivery analgesia in nursing mothers.
Overdosage & Contraindications: Serious potential consequences of over dosage are respiratory depression and seizure. In treating an overdose, primary attention should be given to maintaining adequate ventilation along with general supportive treatment.
Hemodialysis is not expected to be helpful in an overdose because it removes less than
7% of the administered dose in a 4-hour dialysis period. Lucidol should not be administered to patients who have previously demonstrated hypersensitivity to Tramadol, any other component of this product, or opioids. It is also contraindicated in cases of acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic drugs.
Commercial Pack: Lucidol ® Capsule: Box containing 30 capsules in 3X10's blister strips.
Each capsule contains Tramadol Hydrochloride BP 50 mg.
Lucidol ® Suppository: Box containing 5 suppositories in blister strip. Each suppository contains Tramadol Hydrochloride BP 100 mg.
®
Tablet / Syrup / Suspension / Suppository / Pediatric drops
Napa is a fast acting and safe analgesic with marked antipyretic property. It is especially suitable for patients who, for any reason, can not tolerate aspirin or other analgesics.
Indications: All conditions requiring relief from pain and fever such as neuritis, neuralgia, headache, earache, toothache, pain due to rheumatic disorder, cold, influenza, dysmenorrhea, post-vaccination pain & fever of children etc. Napa suppositories are used for rapid symptomatic management of pain and fever.
Dosage and Administration: Tablets : Adults : 1-2 tablets 3-4 times daily; Syrup /
Suspension: Adults : 4-8 Measuring spoonful 3-4 times daily; Children : 6-12 years: 2-
4 measuring spoonful 3-4 times daily, 1-5 years : 1-2 Measuring spoonful 3-4 times daily,
28

bexinfo: T
HERAPEUTIC
G
UIDE
Up to 1 year: ½ -1 Measuring spoonful 3-4 times daily.
Pediatric drops: Neonates &
Children: 0-3 months : 0.5 ml, 4-11 months : 1ml, 12-23 months: 1.5 ml, 2-3 years: 2 ml,
4-5 years: 3ml four times daily or as directed by physicians. Suppositories: Children: 1-
5 years: 125-250 mg, 6-12 years: 250-500 mg, up to 4 times daily.
Side Effects: Side effects of paracetamol are usually mild, though hematological reactions including thrombocytopenia, leukopenia, pancytopenia, neutropenia, and agranulocytosis have been reported. Pancreatitis, skin rashes, and other allergic reactions occur occasionally.
Warning & Precaution: Napa should be given with caution to patients with impaired kidney or liver function. It should be given with care to patients taking other drugs that affect the liver or should not be taken after alcohol consumption, because of risk of hepatotoxicity.
Use in Pregnancy & Lactation: Pregnant or nursing mother should seek the advice of a health professional before using this product.
Overdosage & Contraindications: Symptoms of Paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 40 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may also occur. It is contraindicated in patients with severe renal function impairment and hepatic disease (Viral Hepatitis).
Commercial Pack: Napa ® Tablet: Box containing 50 blister strips of 10 tablets, each containing 500 mg Paracetamol BP.
Napa ® Syrup: Bottle containing 100 ml, 60 ml & 50 ml syrup, each 5 ml containing 120 mg Paracetamol BP.
Napa ® Suspension: Bottle containing 60 ml & 50 ml suspension, each 5 ml containing
120 mg Paracetamol BP.
Napa ® Pediatric Drops: Bottle containing 15 ml drops, each ml containing 80 mg
Paracetamol BP.
Napa ® 125 Suppository: Box containing 4 foils of 5 suppositories (4x5's), each suppository containing 125 mg Paracetamol BP.
Napa ® 250 Suppository: Box containing 4 foils of 5 suppositories (4x5's), each suppository containing 250 mg Paracetamol BP.
Napa ® 500 Suppository: Box containing 4 foils of 5 suppositories (4x5's), each suppository containing 500 mg Paracetamol.
29

bexinfo: T
HERAPEUTIC
G
UIDE
®
I/V Infusion
Napa I/V is a preparation of Paracetamol IV injection which is a sterile, clear, colorless, non pyrogenic, isotonic formulation of Paracetamol intended for intravenous infusion.
Paracetamol is a non-salicylate antipyretic and non-opioid analgesic agent.
Indications: Napa IV is indicated for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fever.
Dosage and Administration: Adults and adolescents weighing 50 kg and over: The recommended dosage of Paracetamol IV is 1000 mg every 6 hours or 650 mg every 4 hours, with a maximum single dose of Paracetamol IV of 1000 mg, a minimum dosing interval of 4 hours, and a maximum daily dose of Paracetamol of 4000 mg per day.
Adults and adolescents weighing under 50 kg: The recommended dosage of Paracetamol
IV is 15 mg / kg every 6 hours or 12.5 mg / kg every 4 hours, with a maximum single dose of Paracetamol IV of 15 mg / kg, a minimum dosing interval of 4 hours, and a maximum daily dose of Paracetamol of 75 mg / kg per day.
Children ≥ 2 to 12 years of age: the recommended dosage of Paracetamol IV is 15 mg / kg every 6 hours or 12.5 mg / kg every 4 hours, with a maximum single dose of
Paracetamol IV of 15 mg / kg, a minimum dosing interval of 4 hours, and a maximum daily dose of Paracetamol of 75 mg / kg per day.
Side Effects: As described previously. See page No. 29
Drug Interactions: As described previously. See page No. 29
Warning & Precautions: Paracetamol IV should be discontinued immediately if symptoms associated with allergy or hypersensitivity occurs. It should not to be used in patients with Paracetamol allergy.
Use in Pregnancy and Lactation: Pregnancy Category C. Paracetamol IV should be given to a pregnant woman only if clearly needed. This is secreted in human milk in small quantities after oral administration.
Overdosage & Contraindications: As described previously. See page No. 29
Commercial Pack: Napa ® IV: Supplied in a 100 ml glass bottle containing 1000 mg
Paracetamol (10 mg/ml).
30

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablet
NapaDol is a preparation of combination of Paracetamol and Tramadol Hydrochloride.
Indications: For the symptomatic treatment of moderate to severe pain.
Dosage and Administration: Adults: For the management of pain, the recommended dose is 1 or 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 tablets per day. The dosing interval should not be less than six hours.
Children: NapaDol is not recommended in patients under 18 years of age.
Side Effects: The most commonly reported side effects are nausea, dizziness and somnolence.
Use in Pregnancy and Lactation: Since it is a fixed combination of active ingredients including Tramadol Hydrochloride, it should not be used during pregnancy & lactation.
Contraindications: Hypersensitivity to Tramadol Hydrochloride, paracetamol or to any of the excipients of the medicinal product and acute intoxication with alcohol, hypnotic drugs, centrally-acting analgesics, opioids or psychotropic drugs. It should not be administered to patients who are receiving monoamine oxidase inhibitors or within two weeks of their withdrawal, patient with severe hepatic impairment or patient of epilepsy not controlled by treatment.
Commercial Pack: NapaDol ® Tablet: Box containing 30 tablets in 3x10’s blister strips.
Each film coated tablet contains Paracetamol BP 325 mg & Tramadol Hydrochloride BP
37.5 mg.
®
Extended Release Tablet
Napa Extend is an extended release tablet contains Paracetamol BP 665 mg
Indications: It is effective for the relief of persistent pain associated with osteoarthritis and muscle aches and backache. Napa Extend extended release tablet also provides effective, temporary relief of pain and discomfort associated with headache, tension headache, period pain, toothache, pain after dental procedures and cold & flu. It reduces fever.
Dosage and Administration: Adults and children over 12 years: Two tablets, swallowed whole, every 6 to 8 hours (maximum of 6 tablets in any 24 hours). The tablets must not be crushed.
31

bexinfo: T
HERAPEUTIC
G
UIDE
Napa Extend extended release tablets are to be administered orally, with or without food.
Side Effects: Usually rare, although dyspepsia, nausea, allergic and hematological reactions can occur.
Contraindications: Hypersensitivity to Paracetamol or to any of the excipients.
Commercial Pack: Napa ® Extend Tablet: Box containing 120 extended release tablets in 12X10’s blister strips. Each extended release tablet contains Paracetamol BP 665 mg.
®
Tablet
Napa Extra is a specially formulated tablet for fast effective pain relief. This tablet contains
Paracetamol and caffeine, which acts to further help the effectiveness of Paracetamol. It is suitable for asthmatics who are sensitive to aspirin and NSAIDs.
Indications: Fever, headache, migraine, backache, Joint and muscle pain, dysmenorrhea, osteoarthritic pain, toothache, pain following dental procedures/ tooth extraction, pain after vaccination, sore throat, discomfort from colds and flu.
Dosage & Administration: Adults: 1-2 tablets 3-4 times daily.
Children: Not recommended in children under 12 years of age
Side Effects: Side effects of paracetamol are usually mild, though hematological reactions including thrombocytopenia, leukopenia, pancytopenia, neutropenia and agranulocytosis have been reported. Pancreatitis, skin rashes and other allergic reaction occur occasionally.
Warning & Precautions: Paracetamol should be given with care to patients with impaired kidney or liver function. Paracetamol should be given with care to patients taking other drugs that affect the liver and should not be taken with any other paracetamol containing products. Avoid drinking too much coffee or tea when taking these tablets.
Use in Pregnancy & Lactation: Pregnancy Category B. In case of lactating mother paracetamol is excreted into milk in small amounts, so usual amounts are safe.
Contraindications: Contraindicated in patients with severe renal function impairment and hepatic disease.
Commercial Pack: Napa ® Extra Tablet: Box containing 20 blister strips of 10 tablets, each containing Paracetamol BP 500mg and Caffeine BP 65mg.
32

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablet
Napa Soft is a combination of Paracetamol (an analgesic and antipyretic) and DL-
Methionine (its antidote); this mixture is called co-methiamol.
Indication: Napa Soft is indicated for the treatment of pain and fever in patients with the risk of liver toxicity.
Dosage and Administration: Adult: 2 tablets every 4 hours; maximum 8 tablets daily.
Child: Not recommended for children under 12 years of age.
Side Effects: Side effects of recommended doses (up to 8 tablets a day in adults) are rare, but some of the side effects such as blood disorders, skin rashes are known to be associated with Napa Soft.
Warning & Precautions: This should be used with caution in patients with decreased kidney function .In cases of overdose, immediate advice should be sought from a physician. Alcohol increases the risk of liver damage that can occur if an overdose of paracetamol is taken. The hazards of paracetamol overdose are greater in persistent heavy drinkers and in people with alcoholic liver disease. So, Napa Soft should be used with caution in alcoholism.
Contraindications: Napa Soft is contraindicated in known sensitivity or allergy to any ingredient of this product and in liver disease.
Commercial Pack: Napa ® Soft Tablet: Box containing 50 tablets in 5X10's blister strips.
Each film coated tablet contains Paracetamol BP 500 mg and DL-Methionine BP 100mg.
33

A
-A
D

bexinfo: T
HERAPEUTIC
G
UIDE
®
Syrup
Aerovil contains Pheniramine, a competitive H
1 histamine receptor antagonist. Like other alkylamine antihistamines it is also antagonist of muscarinic cholinergic receptors and possesses local anesthetic properties.
Indications: Pheniramine is indicated in hay fever and perennial rhinitis, vasomotor rhinitis, mild uncomplicated allergic skin reactions like dermatitis, eczema, urticaria, angioedema, pruritis, and vertigo. It has also been used for its antiemetic properties in the prevention and control of motion sickness.
Dosage and Administration: Children: Syrup is particularly preferable for children.
1-3 years: ½ a measuring spoonful (7.5 mg) 2-3 times daily.
4-12 years: 1 measuring spoonful (15 mg) 2-3 times daily.
Adult: Adults and children over 12 years: 1-2 measuring spoonful (15-30 mg) 2-3 times daily.
Side Effects: The most common side effect is sedation that varies from slight drowsiness to deep sleep. Inability to concentrate, lassitude, dizziness, muscular weakness and incoordination may also occur. Other side effects are headache, dry mouth, constipation, blurred vision, etc.
Warning and Precautions: If drowsiness, patients should not drive or operate machinery requiring alertness. Alcohol and certain other CNS depressants can potentiate the sedative effects of antihistaminic and patient should be warned of these effects.
Contraindications: Pheniramine is contraindicated with known hypersensitivity to
Pheniramine. Also contraindicated in new born and premature infants.
Commercial Pack: Aerovil ® Syrup: Bottle containing 100 ml syrup. Each 5 ml contains
Pheniramine Maleate BP 15 mg.
®
Tablet / Syrup / Pediatric drops
Atrizin is a preparation of Cetirizine Hydrochloride BP. Cetirizine is a piperazine derivative and a potent functional antagonist of histamine H antihistamine.
1 receptors. Atrizin is a long acting
Indications: Atrizin is indicated for the prevention and symptomatic relief of allergic manifestations, such as Seasonal allergic rhinitis, Perennial allergic rhinitis,Chronic idiopathic urticarial.
37

bexinfo: T
HERAPEUTIC
G
UIDE
Dosage and Administration: Adults and children over 12 years: 10 mg (1 tablet) once daily.
Atrizin syrup: Adult & Children over 6 yrs: 10 mg (2 teaspoonful) daily.
Child 2-6 years: 5 mg (1 teaspoonful) daily or 2.5 mg (½ teaspoonful) twice daily.
Atrizin Pediatric Drops: Infants 6 months to 23 months: 2.5 mg (1 ml) as a single dose, if needed 5 mg (2 ml) in two divided doses; 2-5 years: 5 mg (2 ml) as a single dose or
2.5mg (1 ml) twice a day. 6-11 years: 10 mg (4 ml) as a single or two divided doses or as recommended by the physician.
The maximum recommended dose is 20 mg daily. Cetirizine is safe for use in the elderly patients. Less frequent dosing is advised in patients with reduced creatinine clearance.
Contraindication: Cetirizine is contraindicated in patients who have shown hypersensitivity or idiosyncrasy to it or its parent compound - Hydroxyzine.
Side Effects: The most common adverse reaction is somnolence. Fatigue, dry mouth, pharyngitis, dizziness, and headache are also reported.
Drug Interaction: Concomitant administration with alcohol or diazepam does not impair psychomotor performance any more than the impairment of performance produced by alcohol alone.
Commercial Pack: Atrizin ® Tablet: Box containing 15 blister strips of 10 film coated tablets, each tablet contains Cetirizine Hydrochloride BP 10 mg.
Atrizin ® Syrup: Amber glass bottle containing 60 ml syrup. Each 5 ml syrup contains
Cetirizine Hydrochloride BP 5 mg.
Atrizin ® Pediatric Drops: Bottle containing 15 ml pediatric drops. Each ml contains
Cetirizine Hydrochloride BP 2.5 mg.
®
Tablet / Suspension
Axodin is a preparation of Fexofenadine , a non-sedating antihistamine with selective peripheral H
1 receptor antagonist activity.
Indications: Seasonal Allergic Rhinitis: Fexofenadine is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 2 years of age and older.
Chronic Idiopathic Urticaria: Fexofenadine is indicated for treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older.
38

bexinfo: T
HERAPEUTIC
G
UIDE
Dosage and Administration: For Tablet: Seasonal Allergic Rhinitis and Chronic
Idiopathic Urticaria: Adults and Children 12 Years and older: The recommended dose is
60 mg twice daily or 180 mg once daily with water. A dose of 60 mg once daily is recommended as the starting dose in patients with decreased renal function.
Children 6 to 11 Years: The recommended dose is 30 mg twice daily with water. A dose of 30 mg once daily is recommended as the starting dose in pediatric patients with decreased renal function.
For Oral Suspension: Seasonal Allergic Rhinitis: Children 2 to 11 Years: The recommended dose of oral suspension is 30 mg twice daily. A dose of 30 mg (5 ml) once daily is recommended as the starting dose in pediatric patients with decreased renal function.
Chronic Idiopathic Urticaria: Children 6 months to 11 years: The recommended dose of oral suspension is 30 mg (5 ml) twice daily for patients 2 to 11 years of age and 15 mg
(2.5 ml) twice daily for patients 6 months to less than 2 years of age. For pediatric patients with decreased renal function, the recommended starting doses of oral suspension are
30 mg (5 ml) once daily for patients 2 to 11 years of age and 15 mg (2.5 ml) once daily for patients 6 months to less than 2 years of age.
Side Effects: Common: Headache. Uncommon: Fatigue, drowsiness, nausea, tachycardia, palpitations, dry mouth, nose and / or throat, dyspepsia and gastrointestinal disturbances (including diarrhea). Rare: Taste disturbances, anaphylactic reactions, dyspnea, chest tightness, increased hair loss / hair thinning, photosensitivity, dysmenorrhea, menstrual disorders.
Contraindication: This is contraindicated in patients with known hypersensitivity to any of it’s ingredients.
Use in Pregnancy and Lactation: Fexofenadine should be used in pregnancy only if the potential benefit outweighs the potential risk to the fetus. Fexofenadine was found to cross into human breast milk. Therefore, this is not recommended for lactating mothers.
Drug Interaction: Fexofinadine should not be taken in time (15 minutes) with aluminium and magnesium containing antacids. Fruit juices such as grapefruit, orange, and apple may reduce the bioavailability and exposure of Fexofenadine.
Commercial Pack: Axodin ® 60 Tablet: Box containing 50 tablets in 5 x 10's blister strips.
Each tablet contains Fexofenadine Hydrochloride USP 60 mg.
Axodin ® 120 Tablet: Box containing 30 tablets in 3 x 10's blister strips. Each tablet contains Fexofenadine Hydrochloride USP 120 mg.
Axodin ® 180 Tablet: Box containing 30 tablets in 3 x 10's blister strips. Each tablet contains Fexofenadine Hydrochloride USP 180 mg.
Axodin ® Suspension: Bottle containing 50 ml suspension. Each 5 ml contains
Fexofenadine Hydrochloride USP 30 mg.
39

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablet
Each tablet contains Mebhydrolin 50 mg as Mebhydrolin Napadisylate BPC.
Indications: Allergic diseases or symptoms, such as urticaria, pruritus of various origin, eczema, drug rash, allergic conjunctivitis, dermatitis of nutritional origin, hay fever, vasomotor rhinitis, allergic asthma.
Dosage and Administration: Unless otherwise prescribed, the following doses are recommended:
Adults and children over 10 years 2-6 tablets daily
Children from 5-10 years 2-4 tablets daily
Children from 2-5 years 1-3 tablets daily
Children upto 2 years 1-2 tablets daily
Side Effects: Lassitude, dizziness, hypotension, muscular weakness, and incoordination, nausea, vomiting, diarrhea or constipation and epigastric pain may occur. Other side effects include headache, blurred vision, tinnitus, depression, irritability, allergic reaction especially of the skin, nightmares, anorexia, difficulty in micturition, dryness of the mouth, tightness of the chest, and tingling, heaviness and weakness of the hands.
Drug Interaction: The effects of atropine and tricyclic antidepressants may be enhanced by Mebhydrolin.
Warning and Precautions: Caution is required while driving or operating heavy machinery.
Commercial Pack: Bexidal ® Tablet: Box containing 20 aluminium strips of 10 tablets.
Each tablet contains Mebhydrolin 50 mg as Mebhydrolin Napadisylate BPC.
®
Tablet
Curin tablet is a preparation of Levocetirizine Dihydrochloride. Levocetirizine is the active
(levo) isomer of Cetirizine. It is a new highly effective and well-tolerated non-sedating antihistamine with potent antiallergic properties. It has a two-fold higher affinity for H
1 receptors than Cetirizine.
-
Indications: Curin is indicated in the treatment of symptoms associated with allergic conditions such as seasonal allergic rhinitis, perennial allergic rhinitis and chronic idiopathic urticaria.
Dosage and Administration: Adults & children over 6 years of age: One Curin tablet once daily.
40

bexinfo: T
HERAPEUTIC
G
UIDE
Patients with renal impairment: The recommended dose in patients with moderate renal impairment is one Curin (Levocetirizine Dihydrochloride) tablet every two days. In those with severe renal impairment, the dose interval should be increased to every three days.
Patients with end-stage renal disease should not be given Levocetirizine.
Side Effects: Generally Levocetirizine is well tolerated. However, a few side effects like headache, dry mouth, fatigue and skin rash have been reported rarely.
Contraindications: This is contraindicated in patients who are hypersensitive to this medication or to any of its ingredients.
Use in Pregnancy and Lactation: The safety of Levocetirizine in pregnancy has not been established. Therefore, it should be used with caution during pregnancy and only if the potential benefits to the mother outweigh any risks to the fetus. This passes into breast milk. So, it should be used with caution in nursing mothers and only if the expected benefit to the mother is greater than the positive risk to the nursing infant.
Pediatric Use: Not recommended for use in children less than 6 years of age.
Commercial Pack: Curin ® Tablet: Each box contains 10 blister strips of 10 tablets. Each film coated tablet contains Levocetirizine Dihydrochloride INN 5 mg.
Momento ®
Tablet / Syrup
This is a preparation of Desloratadine which is a potent, rapidly effective, long-acting, non-sedative antihistamine with selective H
1 receptor histamine antagonist activity.
Indications: Seasonal Allergic Rhinitis: Momento is indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis in patients 2 years of age and older.
Perennial Allergic Rhinitis: Momento is indicated for the relief of the nasal and non-nasal symptoms of perennial allergic rhinitis in patients 6 months of age and older.
Chronic Idiopathic Urticaria: Momento is indicated for the symptomatic relief of pruritus, reduction in the number of hives, and size of hives, in patients with chronic idiopathic urticaria 6 months of age and older.
Dosage and Administration: Adults and children 12 years of age and over: One 5 mg tablet or 2 teaspoonfuls (10 ml) once daily.
Children 6 to 11 years of age: ½ tablet or syrup 1 teaspoonful (2.5 mg in 5 ml) once daily.
Children 12 months to 5 years of age: Syrup ½ teaspoonful (2.5 ml) once daily.
Children 6 to 11 months of age: Syrup 2 ml (1.0 mg) once daily.
The age appropriate dose of Momento Syrup should be administered with a commercially available measuring spoon that is calibrated to deliver 2 ml and 2.5 ml (½ teaspoon).
41

bexinfo: T
HERAPEUTIC
G
UIDE
In patients with liver or renal impairment, a starting dose of one tablet every other day is recommended .
Side Effects: Commonly reported adverse effects are dry mouth, fatigue, myalgia, and somnolence. Less common side effects may include headache, nausea, dizziness, dyspepsia, pharyngitis etc.
Contraindications: Momento is contraindicated in patients who are hypersensitive to this medication or to any of its ingredients, or to Loratadine.
Warning and Precautions: Pregnancy Category C and Lactation: Desloratadine should be used during pregnancy only if clearly needed. Desloratadine passes into breast milk, therefore a decision should be made whether to discontinue nursing or to discontinue
Momento, taking into account the importance of the drug to the mother.
Pediatric Use: The safety of Momento syrup has been established in 246 pediatric subjects aged 6 months to 11 years in three placebo-controlled clinical studies. The effectiveness of this syrup in these age groups is supported by evidence from adequate and well-controlled studies of Momento tablets in adults. The safety and effectiveness of
Momento tablets or Momento syrup have not been demonstrated in pediatric patients less than 6 months of age.
Geriatric Use: In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Drug Interactions: Concomitant administration of Erythromycin, Ketoconazole,
Azithromycin, Fluoxetine, and Cimetidine with Desloratadine increased the plasma concentration of Desloratadine. But there were no clinically relevant changes in the safety profile of Desloratadine.
Commercial Pack: Momento ® Tablet: Each Box contains 10 blister strips of 10 tablets.
Each tablet contains Desloratadine INN 5 mg.
Momento ® Syrup: 60 ml syrup in amber glass bottle, each 5 ml contains Desloratadine INN
2.5 mg.
®
Nasal Spray
Olopan contains Olopatadine , an antihistamine with selective H activity.Its principal effects are mediated via inhibition of H
1
1
-receptor antagonist receptors.
Indications: Seasonal Allergic Rhinitis: Olopan Nasal Spray is an H
1
-receptor antagonist indicated for the relief of the symptoms of seasonal allergic rhinitis in adults and children
6 years of age and older.
42

bexinfo: T
HERAPEUTIC
G
UIDE
Dosage and Administration: Adults and Adolescents 12 years of age and older:
The recommended dosage is two sprays per nostril twice daily.
Children 6 to 11 years of age: The recommended dosage is one spray per nostril twice daily.
Priming: Before initial use, prime Olopan Nasal Spray by releasing 5 sprays or until a fine mist appears. When Olopan Nasal Spray has not been used for more than 7 days, re-prime by releasing 2 sprays. Avoid spraying Olopan Nasal Spray into the eyes.
Use in Pregnancy and Lactation: Pregnancy Category C: Olopatadine Nasal Spray should be used in pregnant women only if the potential benefit to the mother justifies the potential risk to the embryo or fetus.
Nursing Mothers: Olopatadine Nasal Spray should be used by nursing mothers only if the potential benefit to the patient outweighs the potential risks to the infant.
Side Effects: Common side effects of Olopatadine nasal spray include bitter taste, headaches, nosebleeds, throat pain.
Drug Interactions: Drug interactions with inhibitors of liver enzymes are not anticipated because Olopatadine is eliminated predominantly by renal excretion. Drug interactions involving P450 inhibition and plasma protein binding are also not expected.
Contraindications: Hypersensitivity to any of the ingredients of this preparation.
Commercial Pack: Olopan ® Nasal Spray: Each bottle contains 120-metered doses, each actuation delivers Olopatadine Hydrochloride USP equivalent to Olopatadine
600mcg.
®
Syrup
Pedeamin is a preparation of Diphenhydramine hydrochloride BP.
Indication: Diphenhydramine is indicated for the treatment of followings: Seasonal, perennial, vasomotor rhinitis, urticaria, angioneurotic edema, anaphylaxis, pruiritic conditions, premedication, emesis, motion sickness, miscellaneous include meniere’s disease and parkinsonism.
Dosage and Administration: Adult: Most allergic conditions are controlled in adult 25 -
50 mg three times a day with a further 50 mg at night.
Children: 1 to 5 years of age: 5 mg i.e., 2.5 ml of elixir 4 times a day
More than 6 years of age: 10 mg i.e. 5 ml of elixir 4 times a day.
43

bexinfo: T
HERAPEUTIC
G
UIDE
Contraindications: This is contraindicated in any patients in whom drowsiness is undesirable e.g. drivers, machine operators, concomitant consumption of alcohol or CNS depressants will potentiate drowsiness, patients with known hypersensitivity to
Diphenhydramine.
Use in pregnancy and lactation: Diphenhydramine cross the placenta.There has been a suggestion that Diphenhydramine ingestion during pregnancy is associated with a higher incidence of cleft palate. As for all drugs care should be taken when prescribing
Diphenhydramine during pregnancy and lactation.
Side Effects: Sedation, dizziness, tinnitus, fatigue, ataxia, blurred vision, diplopia, euphoria, and epigastric discomfort.
Drug Interactions: Diphenhydramine administration significantly reduces the absorption of the antituberculous agent PAS from the gastrointestinal tract.
Commercial Pack: Pedeamin ® Syrup: Amber glass bottle containing 100 ml syrup. Each
5ml contains 10 mg Diphenhydramine hydrochloride B.P.
®
Tablet
Pretin tablet contains 10 mg of Loratadine USP. This is a potent, rapidly effective and long-acting non-sedative, histamine H
1 receptor antagonist, with anti-allergic properties.
Indications: Pretin is indicated for Seasonal allergic rhinitis , perennial allergic rhinitis, sneezing, rhinorrhea & itching,ocular itching and burning, chronic urticaria & other allergic dermatologic disorders.
Dosage and Administration: Adult and children above 12 years of age: 10 mg (1 Pretin tablet) once a day.
Children: 6 - 12 yrs : 10 mg (1 Pretin tablet) once a day.
2 - 5 yrs : 5 mg (½ Pretin tablet) once a day.
Safety and efficacy of Loratadine in children below 2 years of age have not yet been established.
Contraindications: Loratadine is contraindicated in patients who have hypersensitivity or idiosyncrasy to its component.
Side Effects: Commonly reported adverse effects are headache, dry mouth, fatigue, and somnolence. Less common side effects may include nervousness, wheezing, hyperkinesia, dysphonia, dizziness, dyspepsia, pharyngitis etc.
Warning and Precautions: Neonates: The drug is not normally used in neonates.
44

bexinfo: T
HERAPEUTIC
G
UIDE
Lactating mothers: Loratadine is also excreted in breast milk. So lactating mothers are advised not to take the drug. Children: The safety and efficacy of loratadine in children below 2 years of age have not yet been established. Pregnant women: This should be used only if the potential benefit justifies the potential risk to the fetus.
Drug Interactions: There are no reports of potentially hazardous interactions with other drugs to date. Psychomotor performance studies show that unlike other H
1
-receptor antagonists, loratadine does not potentiate the effect of alcohol when administered concomitantly with it.
Commercial Pack: Pretin ® Tablet: Box containing 10 blister strips of 10 tablets. Each tablet contains Loratadine USP 10 mg.
®
Tablet
Pretin D extended release tablet is a preparation of Loratadine INN for immediate release and Pseudoephedrine Hydrochloride BP. Loratadine is selective peripheral histamin H receptor antagonist. Pseudoephedrine is an orally active sympathomimetic amine, which
1 exerts a decongestant action on the nasal mucosa.
Indications: Pretin D is indicated for the relief of symptoms of seasonal and perennial allergic rhinitis. This should be administered when both the antihistaminic properties of
Loratadine and the nasal decongestant activity of Pseudoephedrine are desired in patients 12 years of age and older. Pretin D tablet also temporarily relieves runny nose, sneezing, itchy, watery eyes, nasal congestion, itching of the nose or throat due to allergic rhinitis or other upper respiratory allergies, symptoms of common cold, and nasal congestion & sinus pressure associated with sinusitis.
Dosage and Administration: In adults and children 12 years of age and over, the recommended dose of Pretin D tablet is once daily. It is best recommended to be taken in the morning.
Side Effects: Commonly reported adverse effects are dry mouth, somnolence, insomnia, pharyngitis, dizziness, coughing, fatigue, nausea, nervousness, anorexia, dysmenorrhea and headache. Other less common side effects may include; increased sweating, thirst, back pain, chest pain, malaise, palpitations, hypertension, tachycardia, abdominal distension, altered taste, flatulence, myalgia, dry throat, agitation, micturation frequency etc.
Contraindications: Pretin D tablet is contraindicated in patients who are hypersensitive to this medication or to any of its ingredients. This product, due to its Pseudoephedrine component, is contraindicated in patients with narrow-angle glaucoma or urinary retention, and in patients receiving monoamine oxidase (MAO) inhibitor therapy or within fourteen days of stopping such treatment. It is also contraindicated in patients with severe hypertension, severe coronary artery disease, and in those who have shown
45

bexinfo: T
HERAPEUTIC
G
UIDE hypersensitivity or idiosyncrasy to its components, to adrenergic agents, or to other drugs of similar chemical structures.
Warning and Precautions: Loratadine / Pseudoephedrine combination tablets should be used with caution in patients with hypertension, diabetes mellitus, ischemic heart disease, increased intraocular pressure, hyperthyroidism, renal impairment, or prostatic hypertrophy. Central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension may be produced by sympathomimetic amines.
Use in Patients Approximately 60 Years of Age and Older: The safety and efficacy in patients greater than 60 years old have not been investigated in placebo-controlled clinical trials. The elderly are more likely to have adverse reactions to sympathomimetic amines
Pregnancy Category B: No evidence of risk in humans is reported.
Nursing Mothers: It is not known if this combination product is excreted in human milk.
However, both Loratadine and Pseudoephedrine when administered alone passes into breast milk, therefore a decision should be made whether to discontinue nursing or to discontinue Pretin D, taking into account the importance of the drug to the mother.
Pediatric Use: Safety and effectiveness in children below the age of 12 years have not been established.
Drug Interaction: Pretin D tablet is contraindicated in patients taking monoamine oxidase inhibitors and for 2 weeks after stopping use of an MAO inhibitor. The antihypertensive effects of β -adrenergic blocking agents, methyldopa, reserpine, and veratrum alkaloids may be reduced by sympathomimetics. Increased ectopic pacemaker activity can occur when Pseudoephedrine is used concomitantly with digitalis. Concomitant administration of erythromycin, ketoconazole, and Cimetidine increased the plasma concentration of both Loratadine and descarboethoxyloratadine. But there were no clinically relevant changes in the safety profile of Loratadine.
Overdose: In the event of overdosage, general symptomatic and supportive measures should be instituted promptly and maintained for as long as necessary. Treatment of overdosage would reasonably consist of emesis (ipecac syrup), except in patients with impaired consciousness, followed by the administration of activated charcoal to absorb any remaining drug. If vomiting is unsuccessful, or contraindicated, gastric lavage should be performed with normal saline. Saline cathartics may also be of value for rapid dilution of bowel contents.
Commercial Pack: Pretin ® D Tablet: Box containing 50 tablets in 5 x 10’s blister strips.
Each tablet contains Loratadine USP 10 mg and Pseudoephedrine Hydrochloride BP
240mg.
46

bexinfo: T
HERAPEUTIC
G
UIDE
®
Syrup
This is a preparation of Promethazine Hydrochloride. Promethazine Hydrochloride is a first generation H
1 receptor antagonist.
Indications: Allergic conditions, nasal allergy & congestion, urticaria, Hay fever, angioneurotic edema, drug reaction or hypersensitivity, sedation , nausea & vomiting, sedative and drying effects in anesthesia and obstetrics, symptomatic relief of cough and cold (Specially in children), bronchial asthma.
Dosage and Administration: Adults (including elderly): 25 mg at night increased to 25 mg twice daily if necessary or 10-20 mg 2-3 times daily.
Children: Under 2 years it is not recommended. 2-5 yrs: 5-15 mg daily in 1-2 divided doses, 5-10 yrs: 10-25 mg daily in 1-2 divided doses.
Side Effects: Drowsiness, dryness of mouth & skin, gastro-intestinal disturbances.
Warning and Precautions: Promethazine Hydrochloride may cause drowsiness. If affected, patients should be advised not to drive or operate machinery. Alcohol and certain other CNS depressants can potentiate the sedative effects of this antihistamine and patient should be warned of these effects.
Contraindications: This is contraindicated in patients with hypersensitivity to the drug and patients with ventilatory impairment.
Commercial Pack: Promezin ® Syrup: Bottle containing 60 ml and 100 ml syrup. Each
5 ml syrup contains Promethazine Hydrochloride BP 5 mg.
47

A
‐C
D

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablet
This is a preparation of Tamoxifen, a non-steroidal, triphenylene based drug and displays a complex spectrum of estrogen antagonist and estrogen agonist-like pharmacological effects in different tissues.
Indications: It is indicated for the treatment of breast cancer.
Dosage and Administration: Adults (including elderly): The dosage range is 20 to 40 mg daily, given either in divided doses twice daily or as a single dose once daily.
Side Effects: Hot flushes, vaginal bleeding, vaginal discharge, pruritus vulvae, gastrointestinal intolerance, headache, light-headedness and occasionally fluid retention, alopecia, skin rashes including isolated reports of erythema multiforme are the common side effects. Stevens-Johnson syndrome and bullous pemphigoid and rare hypersensitivity reactions, including angioedema have been reported. A small number of patients with bony metastases have developed hypercalcemia on initiation of therapy. Leucopenia sometimes in association with anemia and/or thrombocytopenia, increased incidence of thromboembolic events including deep vein thrombosis and pulmonary embolism during
Tamoxifen therapy have been reported. A number of cases of visual disturbances including infrequent reports of corneal changes, retinopathy, increased incidence of cataracts have been found. Uterine fibroids, endometrial changes including hyperplasia and polyps, cystic ovarian swellings have occasionally been observed in premenopausal women receiving
Tamoxifen. There is evidence that Tamoxifen has been associated with changes in liver enzyme levels and on rare occasions with a spectrum of more severe liver abnormalities, including fatty liver, cholestasis and hepatitis. Rarely, elevation of serum triglyceride levels, in some cases with pancreatitis, may be associated with the use of Tamoxifen.
Drug Interactions: When Tamoxifen is used in combination with coumarin type anticoagulants, a significant increase in anticoagulant effect may occur. Where such coadministration is initiated, careful monitoring of the patient is recommended. When
Tamoxifen is used in combination with cytotoxic agents, there is an increased risk of thromboembolic events occurring.
Warning & Precautions: Menstruation is suppressed in a proportion of premenopausal women receiving Tamoxifen. An increased incidence of endometrial cancer has seen reported in association with Tamoxifen treatment. A number of second primary tumors, occurring at sites other than the endometrium and the opposite breast, have been reported in clinical trials, following the treatment of breast cancer patients with Tamoxifen.
Women should be advised not to become pregnant while taking Tamoxifen.
Use in Pregnancy and Lactation: Not recommended in pregnancy and lactation.
51

bexinfo: T
HERAPEUTIC
G
UIDE
Contraindications: Contraindicated in patients who have hypersensitivity to Tamoxifen or any other ingredients of this product.
Commercial Pack: Tamona ® 10 Tablet and Tamona ® 20 Tablet : Box containing 30 tablets in 3 x 10’s Alu Alu form packs. Each tablet contains Tamoxifen Citrate BP equivalent to 10 mg of Tamoxifen and Tamoxifen Citrate BP equivalent to 20 mg of
Tamoxifen respectively.
52

A
‐I

bexinfo: T
HERAPEUTIC
G
UIDE
A
NTI
- A
MEBIC
®
Tablets / Suspension
Filmet is the brand of Metronidazole film coated tablets and lemon flavoured suspension.
Filmet has antiprotozoal action and is effective against T. vaginalis, Entamoeba histolytica,
Giardia intestinalis and anerobic bacteria.
Indications: Urogenital trichomoniasis in the female and male, intestinal and extraintestinal amebiasis, Giardiasis, anerobic bacterial infections, non-specific vaginitis and anerobically-infected ulcers and pressure sores
Dosage and Administration:
Indications
Amebic dysentery
Durations in days
Adult & Children over 10 years
Children
7-10 years
5-10 or 2 800mg tid
2g once daily
400mg tid
Asymptomatic amebiasis
Hepatic & extraintestinal amebiasis
Giardiasis
5-10
5-10 or 2
3
400-800mg tid
400-800mg tid
2-2.4g once daily
Children
3-7 years
200mg qid
200-400mg tid 100-200mg qid
200-400mg tid 100-200mg tid
Trichomoniasis consort treatments recommended
Vincent’s infection
Anerobic infection
7 or 2 or 1
3
7
Children
1-3 years
200mg tid
100-200mg tid
100-200mg tid
2 g once daily 1 g once daily 600mg once daily
100mg bid
500mg once daily
50mg tid
200 mg tid
800mg morning &
1.2 g evening
2g single dose
100mg tid
100mg tid 200mg tid or
400mg bid
400mg tid
100mg tid 50mg tid
Non-specific vaginitis
Leg ulcer and pressure sore
7 400mg tid
1
7
2g single dose
400mg tid
7.5 mg / kg body weight in divided doses
55

bexinfo: T
HERAPEUTIC
G
UIDE
Side Effects: Side effects of Metronidazole include gastrointestinal discomfort, nausea, coated tongue, dryness of mouth and unpleasant metallic or bitter taste, headache, pruritus and skin rashes and less frequently, vertigo, depression, insomnia, drowsiness, urethral discomfort, and darkening of the urine. Occasionally there may be temporary moderate leukopenia. Peripheral neuropathy has been reported in patients on prolonged therapy.
Warning & Precautions: Regular clinical and laboratory monitoring are advised if administration of Filmet for more than 10 days is considered. It should not be used in patients with blood dyscrasia. Caution is advised in patients with active disease of the central nervous system other than brain abscess and in patients with hepatic encephalopathy. When given in conjunction with alcohol, Metronidazole may provoke a disulphiram like effect.
Use in Pregnancy & Lactation: Filmet should not be given in the first three months of pregnancy. It should be given during lactation only when the physicians consider it essential.
Contraindication: This is contraindicated in patients with prior history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.
Commercial Pack: Filmet ® 200 Tablet: 20 blister strips of 10 film coated tablets, each tablet contains 200 mg Metronidazole BP.
Filmet ® 400 Tablet: 10 blister strips of 10 film coated tablets & 25 blister strips of 10 film coated tablets, each tablet contains 400 mg Metronidazole BP.
Filmet ® DS Tablet: 10 blister strips of 10 film coated tablets, each tablet contains 800 mg
Metronidazole BP.
Filmet ® Suspension: 60 ml suspension in amber glass bottle, each 5 ml contains
Metronidazole Benzoate BP 320 mg equivalent to 200 mg Metronidazole.
®
IV Infusion
Filmet is a sterile, pyrogen free, isotonic formulation for intravenous administration in susceptible life threatening infections. Filmet has antiprotozoal action and is effective against T. vaginalis, Entamoeba histolytica, Giardia intestinalis and anerobic bacteria.
Indications: Filmet is indicated:
• In the prevention of post operative infections due to anerobic bacteria.
• In the treatment of intra abdominal infections - appendicitis, cholecystitis, peritonitis, liver abscess and post operative wound infections.
• Gynecological and obstetrical infections- puerperal sepsis, pelvic cellulitis, pelvic peritonitis.
56

bexinfo: T
HERAPEUTIC
G
UIDE
• Respiratory infections - necrotizing pneumonia, empyema, lung abscess.
• Central Nervous System infections - meningitis, brain abscess.
• Miscellaneous infections - septicemia, bacteremia, osteomyelitis, gas gangrene.
Dosage & Administration: Filmet may be diluted with appropriate volumes of normal saline, dextrose-saline, dextrose 5% w/v or potassium chloride (20 and 40 mmol)
Infusion for prophylaxis and treatment of anerobic infections
Adult Children
Dose per kg body weight
100 ml (500 mg) 1.5 ml (7.5 mg)
Duration
Infusion rate
Immediately before, during or after operation, 8 hourly.
Treatment for 7 days should be satisfactory for most patients but depending on clinical and bacteriological assessments, the physician may decide to prolong the treatment
Should be infused at an approximate rate of 5 ml/minute
Side Effects: Described as previously. See page No. 56
Warning & Precautions: Described as previously. See page No. 56
Use in pregnancy & Lactation: Described as previously. See page No. 56
Contraindications: Described as previously. See page No. 56
Commercial Pack: Filmet ® IV Infusion: Filmet IV Infusion is available in 100 ml polyethylene bottle containing 500 mg Metronidazole USP.
®
Tablet / Suspension
This is a preparation of Nitazoxanide, a synthetic antiprotozoal and anthelmintic agent for oral administration.
Indications:
• Protozoal diarrhea caused by Cryptospordium parvum, Giardia straia (lamblia / intestinalis) and E. histolytica.
• Diarrhea caused by Rota virus.
• Wide range of helminth / worm infections; Helminthiasis.
• Diarrhea caused by Giardia strains that are resistant to other drugs.
• Fascioliasis (infection caused by fluke / parasite)
Dosage and Administration: Age 1-3 years: 5 ml of Nitaxide Suspension (100 mg
Nitazoxanide) every 12 hours for 3 days.
57

bexinfo: T
HERAPEUTIC
G
UIDE
Age 4-11 years: 10 ml of Nitaxide Suspension (200 mg Nitazoxanide) every 12 hours for
3 days.
Age ≥ 12 years: Nitaxide Tablet or 25 ml of Nitaxide Suspension (500 mg Nitazoxanide) every 12 hours for 3 days.
Nitaxide should be taken with food.
Side Effects: Abdominal discomfort, diarrhea, nausea and headache.
Contraindications: Nitazoxanide is contraindicated in patients with a prior hypersensitivity to Nitazoxanide.
Commercial Pack: Nitaxide ® Suspension: Available in 30 ml and 60 ml bottle. Each 5 ml contains Nitazoxanide INN 100 mg.
Nitaxide ® Tablet: Box containing 20 tablets in 2 x 10’s blister strips. Each tablet contains
Nitazoxanide INN 500 mg.
®
Tablet
Xynor contains Ornidazole, which is a 5-nitroimidazole derivative. It is an antimicrobial agent.
Indications: Xynor is indicated for amebiasis (intestinal and hepatic), giardiasis, trichomoniasis, bacterial vaginosis and treatment of susceptible anerobic infections.
Dosage and Administration:
Amebiasis
Amebic dysentery
Giardiasis
Trichomoniasis
Bacterial vaginosis
Anerobic bacterial infections
Adult
500 mg twice daily for 5-10 days
1.5 g once daily for 3 days
1.5 g once daily for 1-2 days
Children
25 mg/kg once daily for 5-10 days
40 mg/kg for 2 days
40 mg/kg once daily for 3 days
1.5 g once or 500 mg twice daily for 5 days. Sexual partner should be treated simultaneously.
25 mg/kg as a single dose
1.5 g once or 500 mg once daily for
5-7 days
500 mg twice daily for 5-10 days 10 mg/kg twice daily for 5-10 days
Side Effects: The most frequently encountered side effect is dizziness, alone or in combination with other adverse reactions. The other side effects occurring to a lesser
58

bexinfo: T
HERAPEUTIC
G
UIDE extent are nausea, pyrosis, intestinal spasms and metallic taste. Vertigo, fatigue and other discomfort such as loose stools, insomnia, skin rash and headache have also been reported.
Drug Interactions: Like other imidazole’s, Ornidazole has a mild potential to cause disulphiram like reactions. Concomitant administration of oral anticoagulants may increase the risk of hemorrhage due to diminished hepatic metabolism. Ornidazole has been reported to decrease the clearance of 5-fluorouracil.
Warning & Precautions: This should be used with great care in patients with blood dyscrasia or with active disease of the central nervous system. Dosage should be reduced in patients with severe liver disease.
Use in Pregnancy & Lactation: This is not recommended for use in pregnant woman unless the benefits of treatment outweigh the risk to the unborn baby. Lactation is not recommended while taking Ornidazole.
Contraindications: This is contraindicated in patients hypersensitive to Ornidazole and other Imidazoles.
Commercial Pack: Xynor ® Tablet: Box containing 30 tablets in 3 x 10's blister strips.
Each film coated tablet contains Ornidazole INN 500 mg.
59

bexinfo: T
HERAPEUTIC
G
UIDE
A
NTI
-B
ACTERIAL
®
Injection
This is a preparation of Ceftriaxone, a third generation Cephalosporin which is highly stable to most β-lactamases, both Penicillinases and Cephalosporinases of Gram-positive and Gram-negative bacteria. The action of Arixon is bactericidal which inhibits the cell wall synthesis.
Indications: It is indicated for the treatment of sepsis, meningitis, abdominal infections
(peritonitis, infections of the biliary and gastro-intestinal tracts), infections of the bones, joints, soft tissue, skin and/or wounds infections, urinary tract infections, respiratory tract infections, particularly pneumonia, ear, nose and throat infections and genital infections including gonorrhea.
Dosage & Administration: Adults and children over 12 years: The usual dosage is 1 to
2 gm of Arixon administered once daily in 24 hours. In severe cases infections caused by moderately sensitive organisms, the dose may be increased to 4 gm once daily.
Neonates, infants and children up to 12 years: For Neonates (up to 2 weeks) a daily dose of 20-50 mg/kg body weight, not to exceed 50 mg/kg on account of the immaturity of the infants is advised. For children with body weight of 50 kg or more, the usual adult dose should be used.
Elderly: The dosage recommended for adults require no modification in case of geriatric patients.
The duration of therapy varies according to the course of the diseases. As with antibiotic therapy in general administration, Arixon should be continued for a minimum of 48-72 hours after the patient has become afebrile or evidence of bacterial eradication has been obtained. For the treatment of gonorrhea, a single intramuscular dose of 250 mg Arixon is recommended.
Side Effects: Diarrhea, nausea, vomiting, stomatitis and glossitis.
Warning & Precautions: As with other Cephalosporins anaphylactic shock cannot be rubbed out even if a thorough patient history is taken. Anaphylactic shock requires immediate counter measures.
Use in Pregnancy and Lactation: Arixon is of pregnancy category B.
Commercial Pack: Arixon ® 250 mg IM Injection: Each box containing one vial of
Ceftriaxone Sodium USP equivalent to Ceftriaxone 250 mg and one ampoule of 2 ml
Lignocaine Injection BP 1%.
60

bexinfo: T
HERAPEUTIC
G
UIDE
Arixon ® 500 mg IM Injection: Each box containing one vial of Ceftriaxone Sodium USP equivalent to Ceftriaxone 500 mg and one ampoule of 2 ml Lignocaine Injection BP 1%.
Arixon ® 1 gm IM Injection: Each box containing one vial of Ceftriaxone Sodium USP equivalent to Ceftriaxone 1 gm and one ampoule of 3.5 ml Lignocaine Injection BP 1%.
Arixon ® 250 mg IV Injection: Each box containing one vial of Ceftriaxone Sodium USP equivalent to Ceftriaxone 250 mg and one ampoule of 5 ml Water for Injection BP.
Arixon ® 500 mg IV Injection: Each box containing one vial of Ceftriaxone Sodium USP equivalent to Ceftriaxone 500 mg and one ampoule of 5 ml Water for Injection BP.
Arixon ® 1 gm IV Injection: Each box containing one vial of Ceftriaxone Sodium USP equivalent to Ceftriaxone 1 gm and one ampoule of 10 ml Water for Injection BP.
Arixon ® 2 gm IV Injection: Each box containing one vial of Ceftriaxone Sodium USP equivalent to Ceftriaxone 2 gm and one ampoule of 20 ml Water for Injection BP.
®
Tablet / Suspension / IV Infusion
This is a preparation of Linezolid, which is a synthetic antibacterial agent of the oxazolidinone class.
Indications: Vancomycin Resistant Enterococcus faecium infections, including cases with concurrent bacteremia, nosocomial pneumonia, community-acquired pneumonia including cases with concurrent bacteremia, and uncomplicated skin and skin structure infections combination therapy may be clinically indicated if the documented or presumptive pathogens include Gram-negative organisms.
Dosage and Administration: • Vancomycin - resistant Enterococcus faecium infections, including concurrent bacteremia, recommended dose is 600mg 12 hourly for 14 to 28 days.
• Nosocomial pneumonia, complicated skin and skin structure infections, and community acquired pneumonia, including concurrent bacteremia, recommended dose is 600mg 12 hourly for 14 days.
• Uncomplicated skin and skin structure infections, recommended dose is 400mg 12 hourly for 10 to 14 days.
Side Effects: Most of the adverse events are mild to moderate in intensity. Adverse events include diarrhea, headache, nausea, oral moniliasis, vaginal moniliasis, hypertension, dyspepsia, localized abdominal pain, pruritus, and tongue discoloration.
Drug Interactions: Linezolid is a reversible, nonselective inhibitor of monoamine oxidase. Therefore, Linezolid has the potential for interaction with adrenergic and serotonergic agents.
61

bexinfo: T
HERAPEUTIC
G
UIDE
Use in Pregnancy & Lactation: Linezolid should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when
Linezolid is administered to a lactating woman.
Overdosage & Contraindications: In the event of overdosage, supportive care is advised with maintenance of glomerular filtration. Hemodialysis may facilitate more rapid elimination of Linezolid. It is contraindicated for patients who have known hypersensitivity to Linezolid or any of the other product components.
Commercial Pack: Arlin ® 400 Tablet: Box containing 20 tablets in 2 x 10’s blister strips.
Each film-coated tablet contains Linezolid INN 400 mg.
Arlin ® 600 Tablet: Box containing 20 tablets in 2 x 10’s blister strips. Each film-coated tablet contains Linezolid INN 600 mg.
Arlin ® Powder for Suspension: Dry Powder in amber glass bottle for reconstitution into
100 ml suspension. After reconstitution each 5 ml contains Linezolid INN 100 mg.
Arlin ® IV Infusion: Supplied in 300 ml glass bottle containing 600 mg (2 mg/ml) Linezolid
INN.
®
Capsule / Tablet / Suspension / IV Injection
Azithrocin contains Azithromycin USP. It is an azalide antibiotic active against Grampositive and Gram-negative organisms. Azithromycin interferes with ribosome function in susceptible bacteria by inhibiting the translocation of peptides.
Indications: Azithrocin is indicated for infections caused by susceptible organisms, in upper respiratory tract infections, lower respiratory tract infections, skin and soft tissue infections, otitis media, uncomplicated genital infections due to Chlamydia trachomatis.
Dosage and Administration: Adult: Azithrocin should be given as 500 mg once-daily orally for 3 days or as an alternative, given over 5 days with 500 mg on day 1, then 250 mg on days 2-5. For sexually transmitted diseases caused by Chlamydia trachomatis in adults, the dose is 1 g given as a single dose.
Elderly: Normal adult dose is recommended for elderly patients.
Children: For children over 6 months recommended dose is 10 mg/kg once daily for 3 days; or if body weight is 15-25 kg: 200 mg once daily for 3 days, body weight is 26-35 kg: 300 mg once daily for 3 day, body weight is 36-45 kg: 400 mg once daily for 3 days.
As common with many other antibiotics, Azithrocin should be taken at least 1 hour before or 2 hours after meal and antacid.
62

bexinfo: T
HERAPEUTIC
G
UIDE
Azithrocin 500 IV Injection:
Pneumonia: The recommended dose of Azithromycin for injection for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is 500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of
500 mg, administered as two 250-mg tablets to complete a 7 to 10-day course of therapy.
Pelvic inflammatory disease : The recommended dose of Azythrocin 500 IV is 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7-day course of therapy.
Side Effects: Azithromycin is well tolerated with a low incidence of side effects. Majority of the side effects were mild to moderate in nature and of gastro-intestinal in origin with nausea, abdominal discomfort, vomiting, flatulence and diarrhea. Allergic reactions such as rash have been occurred and there have also been rare reports of serious hypersensitivity reactions. Reversible elevations in liver transaminases have been seen with a frequency similar to the comparative macrolides and penicillins used in clinical trials. Transient mild reductions in neutrophil counts have occasionally been observed in clinical trials, although a causal relationship to Azithromycin has not been established.
Drug Interaction: Azithromycin absorption is reduced in presence of food and antacid.
So, Azithromycin should be administered 1 hour before or 2 hours after taking food or antacid. In patients receiving ergot alkaloids Azithromycin should be avoided concurrently because of the possibility of ergotism. However, no cases of such interaction have been reported. Macrolides have been known to increase the plasma concentration of Digoxin and Cyclosporine.
Warning & Precaution: No dose adjustment is needed in patients with renal impairment.
Use in Pregnancy and Lactation: Azithromycin should only be used in pregnant and lactating women only if adequate alternatives are not available.
Overdosage & Contraindications: Typical symptoms of overdosage with macrolide antibiotics include hearing loss, severe nausea, vomiting and diarrhea. Gastric lavage and general supportive measures are indicated. Azithromycin is contraindicated in patients hypersensitive to Azithromycin or any other macrolide antibiotic, patient with hepatic diseases and co-administration of ergot derivatives with Azithromycin.
Commercial Pack: Azithrocin ® Capsule: Box containing 1 x 10's blister strip, each capsule contains Azithromycin USP equivalent to 250 mg anhydrous Azithromycin.
Azithrocin ® 500 Tablet: Box containing 3 x 3's Alu-Alu form packs. Each film coated tablet contains Azithromycin USP equivalent to 500 mg anhydrous Azithromycin.
63

bexinfo: T
HERAPEUTIC
G
UIDE
Azithrocin ® Powder for Suspension: Dry powder in glass bottle for reconstitution into 15 ml, 30 ml & 50 ml of suspension. After reconstitution each 5 ml contains Azithromycin
USP equivalent to 200 mg anhydrous Azithromycin.
Azithrocin ® IV Injection: Each commercial box containing one vial of lyophilized
Azithromycin 500 mg, 250 ml 0.9% Sodium Chloride BP Infusion (Saloride IV Infusion) and an infusion set.
®
Capsule / Syrup
Clobex contains Cloxacillin, a β-lactamase resistant antibacterial agent with bactericidal activity against most Gram-positive organism and Neisseria spp. It is also effective against β-lactamase producing Gram-negative organisms when given with ampicillin.
Indications: Clobex is indicated for the treatment of –
• Skin and Soft tissue infections: Boils, Abscess, Carbuncles, Furunculosis, Cellulitis,
Infected wounds, Infected burns, Otitis media and externa, Protection of skin grafts and skin infections like ulcer, eczema acne, etc.
• Respiratory tract infections: Pneumonia, Lung abscess, Empyema, Sinusitis,
Pharyngitis, Tonsillitis and Peritonsillar abscess.
• Other infections caused by sensitive organisms: Osteomyelitis, Enteritis, Endocarditis,
Urinary tract infections, Meningitis and Septicemia.
Dosage and Administration: Adult: Usual dose is 500 mg 6 hourly daily. Children (2-10 years): 250 mg 6 hourly daily. Children (upto 2 years): 125 mg (1 measuring spoonful of
Clobex Syrup) 6 hourly daily. Dose may be doubled in severe infection and should be taken at least 30 minutes before food
Side Effects: Common side effects are skin rash, transient diarrhea, nausea, heartburn, pruritus and disturbance of blood electrolytes. Rarely anaphylactic shock.
Warning & Precaution: It should be given with caution to patients with known history of allergy.
Contraindication: It should not be given to patients known to be sensitive to Penicillin.
Commercial Pack: Clobex ® Capsule: Box containing 10 aluminium strips of 10 capsules, each capsule contains Cloxacillin Sodium BP equivalent to 500 mg Cloxacillin.
Clobex ® Syrup: Dry Powder in glass bottle for reconstitution of 100 ml syrup, each 5 ml reconstituted syrup contains Cloxacillin Sodium BP equivalent to 125 mg Cloxacillin.
64

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablet / Suspension
This is a preparation of Erythromycin Ethylsuccinate. Enteric-coated Etrocin tablet is a preparation of Erythromycin USP.
Its range of antimicrobial action is similar to that of penicillin. It is active against most
Gram-positive and some Gram-negative bacteria including Neisseria species,
Haemophilus influenzae and Bordetella pertussis , against spirochete and some rickettsiae and chlamydia. Micoplasma pneumoniae is very sensitive to Erythromycin.
Legionella pneumophila is reported to be sensitive to Erythromycin.
Indications: Etrocin is highly effective in the treatment of a great variety of clinical infections caused by Erythromycin sensitive organisms. Upper Respiratory Tract infections: Tonsillitis, peritonsillar abscess, pharyngitis, laryngitis, sinusitis, secondary infections in cold and influenza. Lower Respiratory Tract infections: Tracheitis, acute & chronic bronchitis, pneumonia (lobar pneumonia, broncho-pneumonia, primary atypical pneumonia), bronchiectasis, legionnaires’ disease. Ear infections: Otitis media and otitis externa, mastoiditis. Oral infections: Gingivitis, Vincent’s angina. Eye infection:
Blepharitis. Skin & soft tissue infections: Boils and carbuncles, paronychia, abscesses, pustular acne, impetigo, cellulitis, erysipelas. Gastro-intestinal infections: Cholecystitis, staphylococcal enterocolitis. Prophylaxis: Pre- and post-operative trauma, burns, rheumatic fever. Other infections: Osteomyelitis, urethritis, gonorrhea, syphilis, lymphogranuloma venereum, diphtheria, prostatitis, scarlet fever.
Dosage and Administration: In case of suspension, optimum blood levels are obtained, when doses are given on an empty stomach. Etrocin tablet can be given before, during or after meal. Adults & children over 8 years: 250-500 mg every 6 hours or 0.5 -1 g every
12 hours. This may be increased up to 4 gm per day according to the severity of infection.
Elderly: Same as for adults. Children: The usual regimen is 30-50 mg/kg/day in divided doses or as directed by the physician. For more severe infections this dosage may be doubled. If administration on a twice daily schedule is desirable, one half of the total daily dose may be given every 12 hours, one hour before meal.
Amebic dysentery: Adult: 250-500 mg four times daily for 10 to 14 days. Children: 30-
50 mg/kg/day in divided doses for 10-14 days. Pertussis: Although optimum dosage and duration of treatment have not been established, doses of Erythromycin utilized in reported clinical studies were 40-50 mg/kg/day given in divided doses for 5-14 days.
Streptococcal infections: In the treatment of group A β-hemolytic streptococcal infections, therapeutic dosage of Erythromycin should be administered for at least 10 days.
Prophylaxis: In continuous prophylaxis of streptococcal infections in persons with a history of rheumatic heart disease, the dosage is 250 mg twice daily. When Etrocin is used prior to surgery to prevent endocarditis caused by α-hemolytic streptococci, a recommended schedule for children- 20mg/kg 1.5-2 hours pre-operatively and 10 mg/kg every six hours for eight doses post-operatively. For adults the dose is 1 g, 1.5-2 hours pre-operatively and 500 mg every six hours for eight doses post-operatively.
65

bexinfo: T
HERAPEUTIC
G
UIDE
Side Effects: The most frequent side effects are gastro-intestinal (e.g. abdominal cramping and discomfort) and dose related. Nausea, vomiting and diarrhea occur infrequently with usual oral doses. Mild allergic reactions such as urticaria and other skin rashes, have occurred. Serious allergic reactions, including anaphylaxis have been reported.
Warning & Precautions: Since Erythromycin is metabolized principally by the liver, caution should be exercised in administering the antibiotic to patient with impaired hepatic function. There have been reports of hepatic dysfunction with or without jaundice occurring in patients taking oral Erythromycin. The use of Erythromycin in patients who are receiving concomitant high doses of theophylline may be associated with an increase in serum theophylline and potential theophylline toxicity. If symptoms of toxicity develop, the dose of theophylline should be reduced.
Use in Pregnancy & Lactation: Caution should be exercised when prescribing for the pregnant women. Erythromycin is readily excreted in breast milk.
Contraindications: It is contraindicated in patients hypersensitive to Erythromycin.
Commercial Pack: Etrocin ® 250 Tablet: Box containing 50 enteric-coated tablets in 5
X10's blister strips, each tablet contains 250 mg Erythromycin USP.
Etrocin ® 500 Tablet: Box containing 100 enteric-coated tablets in 10 X10's blister strips, each tablet contains 500 mg Erythromycin USP.
Etrocin ® Suspension: Bottle containing dry powder for 100 ml suspension. After reconstitution each 5 ml contains Erythromycin Ethylsuccinate USP equivalent to 125 mg
Erythromycin.
®
Tablet / Oral Solution
This is a preparation of Levofloxacin, a synthetic, broad-spectrum antibacterial agent.
Chemically Levofloxacin is a chiral fluorinated carboxyquinolone.
Indications: Evo is indicated in acute maxillary sinusitis, community acquired pneumonia, complicated urinary tract infections, acute pyelonephritis and uncomplicated & complicated skin and skin structure infections.
Dosage and Administration: Acute sinusitis: 500 mg once daily for 10-14 days.
Exacerbation of chronic bronchitis: 500 mg once daily for 7 days. Community acquired pneumonia: 500 mg once daily for 7-14 days or 750 mg once daily for 5 days. Nosocomial pneumonia: 750 mg once daily for 7-14 days. Uncomplicated urinary tract infections: 250 mg once daily for 3 days. Complicated urinary tract infections and acute pyelonephritis:
250 mg once daily for 10 days or 750 mg once daily for 5 days. Uncomplicated skin and
66

bexinfo: T
HERAPEUTIC
G
UIDE skin structure infections: 500 mg once daily for 7-10 days. Complicated skin and skin structure infections: 750 mg once daily for 7-14 days. Chronic bacterial prostatitis: 500 mg once daily for 28 days
Children: Not recommended for children.
Side Effects: Levofloxacin is generally well tolerated. However, a few side effects include- nausea, vomiting, diarrhea, abdominal pain, flatulence and rare occurrence of photo toxicity (0.1%). Very rarely include tremors, depression, anxiety, confusion etc.
Drug Interactions: Antacids, Iron and multivitamin preparation with Zinc reduce absorption of Levofloxacin. NSAIDS may increase the risk of CNS stimulation and convulsive seizures. Warfarin may increase the risk of bleeding.
Warning & Precautions: While taking Levofloxacin adequate amount of water should be taken to avoid risk of crystalluria. Dose adjustment should be done in presence of renal insufficiency & hepatic insufficiency.
Use in Pregnancy & Lactation: It is not recommended for use during pregnancy or nursing.
Contraindication: This is contraindicated in patients with a history of hypersensitivity to
Levofloxacin, quinolone antimicrobial agents, or any other components of this product.
Commercial Pack: Evo ® 250 Tablet: Box containing 30 tablets in 3x10’s blister strips.
Each film coated tablet contains Levofloxacin Hemihydrate USP equivalent to
Levofloxacin 250 mg.
Evo ® 500 Tablet: Box containing 20 tablets in 2x10’s blister strips. Each film coated tablet contains Levofloxacin Hemihydrate USP equivalent to Levofloxacin 500 mg.
Evo ® 750 Tablet: Box containing 10 tablets in 1x10’s blister strip. Each film coated tablet contains Levofloxacin Hemihydrate USP equivalent to Levofloxacin 750 mg.
Evo ® Oral Solution: Bottle contains 100 ml oral solution. Each 5 ml contains Levofloxacin
Hemihydrate USP equivalent to Levofloxacin 125mg.
67

bexinfo: T
HERAPEUTIC
G
UIDE
®
IV Infusion
This is a preparation of Levofloxacin, a synthetic, broad-spectrum antibacterial agent.
Chemically Levofloxacin is a chiral fluorinated carboxyquinolone.
Indications: Described as previously. See page No. 66
Dosage & Administration: Levofloxacin solution for infusion is administered by slow intravenous infusion once or twice daily. The dosage depends on the type and severity of the infection and the sensitivity of the presumed causative pathogen. It is usually possible to switch from initial intravenous treatment to the oral route after a few days
(Levofloxacin 250 or 500 mg tablets), according to the condition of the patient.
Duration of treatment: As with antibiotic therapy in general, administration of Levofloxacin
(solution for infusion) should be continued for a minimum of 48 to 72 hours after the patient has become a febrile or evidence of bacterial eradication has been obtained. The infusion time must be at least 30 minutes for 250 mg or 60 minutes for 500 mg
Levofloxacin solution for infusion.
Side Effects: As described previously. See page No. 67
Drug Interactions: As described previously. See page No. 67
Warning & Precautions: As described previously. See page No. 67
Use in Pregnancy & Lactation: Not recommended in pregnancy and lactation.
Contraindication: As described previously. See page No. 67
Commercial Pack: Evo ® IV Infusion: Evo is available in 100 ml polyethylene bottle containing 500 mg (5 mg/ml) Levofloxacin USP.
®
Capsule / Syrup / DS Syrup
This is a preparation of Flucloxacillin, which acts in similar way to Penicillin by inhibiting bacterial cell wall synthesis.
Indications: Flubex is indicated for the treatment of infections due to Gram-positive organisms, including infections caused by β- lactamase producing Staphylococci. Typical indications include respiratory tract infections, skin and soft tissue infections and other infections caused by Flucloxacillin-sensitive organisms like osteomyelitis, enteritis, endocarditis, urinary tract infection, meningitis, septicemia. It is also indicated for use as a prophylactic agent during major surgical procedures where appropriate; for example, cardiothoracic and orthopedic surgery.
68

bexinfo: T
HERAPEUTIC
G
UIDE
Dosage and Administration: Doses should be administered half hour before meals.
Adult dosage (including elderly patients): 250 mg four times daily. Dose may be increased in severe infections. In osteomyelitis, endocarditis – up to 8 g daily, in divided doses six to eight hourly.
Children (2-10 years) - half of adult dose; Under 2 years - one fourth of adult dose.
Side Effects: Side effects, as with other penicillins, are uncommon and mainly of a mild and transitory nature. These include gastrointestinal upsets (e.g. nausea, diarrhea), hepatitis and cholestatic. If skin rash occur, treatment should be discontinued.
Use in Pregnancy & Lactation: The use of Flucloxacillin in pregnancy should be reserved for cases considered essential by the clinician.
Contraindications: Flucloxacillin is contraindicated for those who have hypersensitivity to penicillins.
Commercial Pack: Flubex ® 250 Capsule: Box containing 5 aluminium strips of 10 capsules. Each capsule contains Flucloxacillin Sodium BP equivalent to Flucloxacillin
250 mg.
Flubex ® 500 Capsule: Box containing 3 aluminium strips of 10 capsules, each capsule contains Flucloxacillin Sodium BP equivalent to Flucloxacillin 500 mg.
Flubex ® Powder for Syrup: Dry powder in amber glass bottle for reconstitution into 100 ml syrup. After reconstitution, each 5 ml contains Flucloxacillin Sodium BP equivalent to
Flucloxacillin 125 mg.
Flubex ® DS Powder for Syrup: Dry powder in amber glass bottle for reconstitution into
100 ml syrup. After reconstitution, each 5 ml contains Flucloxacillin Sodium BP equivalent to Flucloxacillin 250 mg.
®
Capsules / Suspension / Pediatric Drops / Injection
This is a preparation of Cefradine which is a first generation cephalosporin antibiotic that works in a similar way to penicillin by inhibiting bacterial cell wall synthesis.
Indications: Intracef is a broad spectrum bactericidal antibiotic active against both Grampositive and Gram-negative bacteria. It is also highly active against most strains of penicillinase producing staphylococci. Intracef is indicated for the treatment of the following infections: The upper and lower respiratory tract infections: Pharyngitis, sinusitis, otitis media, tonsillitis, laryngo-tracheo-bronchitis, acute and chronic bronchitis, lobar and chronic bronchopneumonia, Gastrointestinal infections, Urinary tract infections: Cystitis,
69

bexinfo: T
HERAPEUTIC
G
UIDE urethritis, pyelonephritis, Skin and soft tissue infections: Abscess, cellulitis, furunculosis and impetigo, prophylaxis for surgical procedures associated with high risk of disastrous consequences of infection and immediately prior to surgery and continued during the postoperative period.
Dosage and Administration: Intracef may be given regardless of meals.
Adults: For urinary tract infections the usual dose is 500 mg four times daily or 1 gm twice daily; severe or chronic infections may require larger dose. Prolonged intensive therapy is needed for complications such as prostatitis and epididymitis. For respiratory tract infections and skin and soft tissue infections the usual dose is 250 mg or 500 mg four times daily or 500 mg or 1gm twice daily depending on the severity and site of infection.
For otitis media daily dose from 75 to 100 mg/kg body weight in divided doses every 6 to
12 hours are recommended. Maximum dose 4 gm per day.
Children: The usual dose is from 25 to 50 mg/kg/day total, given in two or four equally divided doses.
Elderly: There are no specific dosage recommendations or precautions for use in the elderly except as with other drugs to monitor those patients with impaired renal or hepatic function.
Dose in renal impairment: A modified dosage schedule is necessary. In adults, the initial loading dose is 750 mg of Intracef and the maintenance dose is 500 mg at the time intervals listed below:
Creatinine Clearance Time Interval
More than 20 ml/min
15-19 ml/min
10-14 ml/min
5-9 ml/min
Less than 5 ml/min
6-12 hours
12-24 hours
24-40 hours
40-50 hours
50-70 hours
Further modification of the dosage schedule may be necessary in children.
For Injection:
Adults: The usual dose of Intracef for injection is 2 to 4 gm daily in four equally divided doses intramuscularly or intravenously (e.g; 500 mg to 1 gm four times daily). A dosage of 500 mg four times a day is adequate in uncomplicated pneumonia, furunculosis with cellulitis, and most urinary tract infections. In severe infections, the dose may be increased by giving injections every four hours or by increasing the dose. The maximum dose should not exceed 8 gm per day.
The recommended dose for surgical prophylaxis is either a single 2 gm dose given 1 hour before surgery or a regimen of 1gm given one hour before surgery followed by a second dose 4 hours later. Additional doses of 1 gm may be given every 4 hours until vital signs are stabilized.
70

bexinfo: T
HERAPEUTIC
G
UIDE
Infants and Children: The usual dose range is 50 to 100mg/kg/day in equally divided doses four times a day and should be regulated by age, mass of the patient, and severity of the infection being treated.
Elderly: There are no specific dosage recommendations or precautions for use in the elderly except as with other drugs to monitor those patients with impaired renal or hepatic function.
Dosage in renal impairment: A modified dosage schedule is necessary in patients with decreased renal function. Each patient should be considered individually; the following modified dosage schedule is recommended as a guideline, based on the creatinine clearance (ml/min/1.73m
2 ). In adults, the initial loading dose is 750 mg of Intracef
(Cephradine) and the maintenance dose is 500 mg at the time intervals listed below :
Creatinine Clearance Dose Time Interval
More than 20ml/min
5-20 ml/min
Less than 5ml/min
500mg
250mg
250mg
6 hours
6 hours
12 hours
Further modification of the dosage schedule may be necessary in children.
Side Effects: Rarely Cefradine may induce hypersensitivity reaction, nausea, vomiting, diarrhea, glossitis, heartburn, dizziness, abdominal pain, candidal overgrowth, vaginitis, urticaria, skin rashes, joint pain and edema. As with other cephalosporins, mild transient eosinophilia, leucopenia and neutropenia, rarely positive direct Coombs test and pseudomembranous colitis have been reported.
Drug Interactions: The Cephalosporins are potentially nephrotoxic (particularly
Cephaloridine) and may enhance the nephrotoxicity of aminoglycoside antibiotics such as Gentamicin and Tobramycin. One should be cautious about the use of any cephalosporin with Furosemide and Ethacrynic acid.
Warnings & Precautions: There is evidence of partial cross-allergenicity between penicillins and the cephalosporins. Therefore Cefradine should be used with caution in patients with known hypersensitivity to penicillins
Use in Pregnancy and Lactation: No teratogenicity has been demonstrated in animals, but safety in pregnancy has not been established. Cefradine is excreted in breast milk and should be used with caution in lactating mothers.
Contraindications: Patients with known hypersensitivity to Cephalosporin antibiotics.
Commercial Pack: Intracef ® 250 Capsule: Box containing 8 x 6’s Alu-Alu form packs.
Each capsule contains Cefradine BP 250 mg.
Intracef ® 500 Capsule: Box containing 6 x 6’s Alu-Alu form packs. Each capsule contains
Cefradine BP 500 mg.
71

bexinfo: T
HERAPEUTIC
G
UIDE
Intracef ® Powder for Suspension: Each amber glass bottle contains Cefradine dry powder for oral suspension. After reconstitution, the total volume of suspension will be 100 ml and each 5 ml contains Cefradine BP 125 mg.
Intracef ® DS Powder for Suspension: Each amber glass bottle contains Cefradine dry powder for oral suspension. After reconstitution, the total volume of suspension will be
100 ml and each 5 ml contains Cefradine BP 250 mg.
Intracef ® Powder for Pediatric Drops: Each amber glass bottle contains Cefradine dry powder for pediatric drops. After reconstitution, the total volume of drops will be 15 ml and each 1.25 ml contains Cefradine BP 125 mg.
Intracef ® 250 Injection: Each box contains 10 combipacks. Each combipack contains 1 vial of Cephradine with Arginine equivalent to Cephradine USP 250 mg and 1 ampoule of 5 ml water for Injection BP.
Intracef ® 500 Injection: Each box contains 10 combipacks. Each combipack contains 1 vial of Cephradine with Arginine equivalent to Cephradine USP 500 mg and 1 ampoule of 5 ml water for Injection BP.
Intracef ® 1gm Injection: Each box contains 1 combipack. Each combipack contains 1 vial of Cephradine with Arginine equivalent to Cephradine USP 1 gm and 1 ampoule of
10 ml water for Injection BP.
®
Tablet
This is a preparation of Pefloxacin Mesylate BP.
Indication: Isofloxin is indicated for the treatment of single infections or mixed infections caused by two or more susceptible organisms. It can also be used for infections caused by organisms resistant to other antibiotics including Aminoglycosides, Penicillins and
Cephalosporins.
Isofloxin is indicated for the treatment of the following infections caused by sensitive bacteria: Severe systemic infections, urinary tract infections, Respiratory tract infections,
Gastro-intestinal infections, Infections of the biliary system, Skin and soft tissue infection,
Eye, ear, nose and throat infections, Intra abdominal infections, Bone and joint infections and Pelvic infections. It is also indicated in gonorrhea including urethral, rectal and pharyngeal gonorrhea caused by β-lactamase producing organisms or organisms moderately sensitive to Penicillin.
Dosage and Administration: The usual dose is 400 mg twice daily orally in most infections and should be taken with meals.
Side Effects: Gastrointestinal: Nausea, diarrhea, vomiting, dyspepsia, abdominal pain.
72

bexinfo: T
HERAPEUTIC
G
UIDE
Central nervous system (CNS): Dizziness, headache, tiredness, confusion, convulsions.
Hypersensitivity reactions: Skin rashes, pruritus and possible systemic reactions. The other reactions have also been reported joint pain, mild photosensitivity and thrombocytopenia (at doses of 1600 mg daily).
Drug Interactions: Antacids may interfere with absorption of Pefloxacin resulting in serum and urine levels lower than desired, so concurrent administration of these agents with Pefloxacin should be avoided.
Warning & Precautions: Avoid exposure to sunlight and ultraviolet radiation during treatment with Pefloxacin because of the risk of photosensitivity reactions. Dosage readjustment is required in severe hepatic insufficiency.
Use in Pregnancy & Lactation: Not recommended in pregnancy and lactation.
Overdosage & Contraindications: Pefloxacin is contraindicated in patients who have shown hypersensitivity to Pefloxacin or other quinolones. It is also contraindicated in children and growing adolescents except where the benefits of treatment exceed the risks, and in patients with glucose-6-phosphate dehydrogenase deficiency.
Commercial Pack: Isofloxin ® Tablet: Box containing 5 aluminium strips of 10 film coated tablets. Each tablet contains Pefloxacin Mesylate BP equivalent to Pefloxacin 400 mg.
®
IV / IM Injection
This is a preparation of Ceftazidime, a semisynthetic, broad-spectrum, β-lactamase antibiotic for parenteral administration. It is bactericidal in action exerting its effect by inhibition of enzymes responsible for cell-wall synthesis.
Indications: Maxidim Injection is indicated for lower respiratory tract Infections including pneumonia, skin and skin structure infections, complicated and uncomplicated urinary tract infections, bacterial septicemia, bone and joint Infections, gynecologic infections including endometritis, pelvic cellulitis, and other infections of the female genital tract caused by E. coli , intra abdominal Infections, CNS Infections including meningitis etc.
Dosage & Administration: Adults: The usual adult dosage is 1 gm administered intravenously or intramuscularly every 8 to 12 hours. a) Uncomplicated urinary tract infections: 250 mg 12 hourly, b) Bone and joint infections: 2 gm IV 8hrly, c) Complicated urinary tract infections: 500 mg 8-12 hourly, d) Uncomplicated pneumonia, mild skin and skin structure infections: 500mg-1 gm 8hrly, e) Serious gynecologic and intra-abdominal infections: 2 gm IV 8hrly, f) Meningitis: 2 gm IV 8hrly, g) Very severe life-threatening infection especially in immunocompromised patients, Lung infections caused by
Pseudomonas spp.: 2 gm IV 8 hrly, h) In patients with cystic fibrosis with normal renal function: 30-50 mg/kg IV 8 hrly to a maximum of 6 gms per day.
73

bexinfo: T
HERAPEUTIC
G
UIDE
Neonates (0-4 weeks): 30 mg/kg IV 12hrly.
Infants and children (1 month-12 years): 30-50 mg/kg IV 8hrly to a maximum of 6 gms per day.
Impaired Renal Function: Ceftazidime is excreted by the kidneys, therefore, in patients with impaired renal function (glomerular filtration rate [GFR] <50 mL/min), it is recommended that the dosage of Ceftazidime be reduced. An estimate of GFR should be made to determine the appropriate maintenance dosage.
Administration: Maxidim may be given IV or deep IM injection into a large muscle mass.
Intra-arterial administration should be avoided. For IV/IM administration, Maxidim should be reconstituted with the supplied sterile water for Injection.
Side Effects: The most common side effects are diarrhea, nausea, vomiting, abdominal pain, headache, dizziness, paraesthesia, pruritus, rash, and fever. Angioedema and anaphylaxis have been reported very rarely.
Warning & Precautions: The total daily dosage should be reduced when Ceftazidime is administered to patients with renal insufficiency. It should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
Use in Pregnancy & Lactation: This drug should be used during pregnancy only if clearly needed. In case of lactating woman a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Overdosage & Contraindications: Ceftazidime overdosage has occurred in patients with renal failure. Reactions include seizure, encephalopathy, neuromuscular excitability, and coma. Supportive treatment should be given in these cases. It is contraindicated in patients with hypersensitivity to Ceftazidime or the cephalosporin group of antibiotics.
Commercial Pack: Maxidim ® 250 mg IV/IM Injection: Pack of 1 vial containing Sterile mixture of Ceftazidime Pentahydrate and Sodium Carbonate USP equivalent to
Ceftazidime 250 mg accompanied by an ampoule of 5 ml Water for Injection BP.
Maxidim ® 500 mg IV/IM Injection: Pack of 1 vial containing Sterile mixture of Ceftazidime
Pentahydrate and Sodium Carbonate USP equivalent to Ceftazidime 500 mg accompanied by an ampoule of 5 ml Water for Injection BP.
Maxidim ® 1 gm IV/IM Injection: Pack of 1 vial containing Sterile mixture of Ceftazidime
Pentahydrate and Sodium Carbonate USP equivalent to Ceftazidime 1 gm accompanied by an ampoule of 10 ml Water for Injection BP.
74

bexinfo: T
HERAPEUTIC
G
UIDE
®
Capsule
This is a preparation of Doxycycline Hydrochloride BP, a semisynthetic tetracycline antibiotic with a broad spectrum activity. It is primarily a bacteriostatic antibiotic. It has a similar spectrum of activity to other tetracyclines but in particular is more active against
S. aureus and Nocardia. Certain gram-negative strains of E.coli
, Proteus mirabilis and
Klebsiella, which are often resistant to Tetracycline, may be sensitive to doxycycline. In addition, 70-90% of the various anerobes are sensitive to Doxycycline and Bacteroides fragilis is more likely to be sensitive to Doxycycline than to other tetracyclines.
Indications: Megadox is indicated in the following infections: Pneumonia & other respiratory tract infections caused by Klebsiella, Pneumococci & Mycoplasma pneumonia, gastrointestinal infections, genito-urinary tract infections, soft tissue infections, ophthalmic infections (trachoma) caused by Chlamydia trachomatis, acne, prophylaxis of Plasmodium falciparum malaria and miscellaneous group of infections:
Prostatitis, Psittacosis, Trigonitis, Louse borne typhus, Plague etc.
Dosage & Administration: Adults: Usual dose is 200mg on first day, then 100 mg daily for 7-10 days. a) Severe infections (including refractory urinary tract infections): 200 mg daily for 10days, b)Acne: 100 mg daily, c) Uncomplicated genital chlamydia, nongonococcal urethritis: 100 mg twice daily for 7-21 days (14-21 days in pelvic inflammatory disease).
Elderly: No specific precautions are necessary in the elderly.
Side Effects: Diarrhea have been reported infrequently, others are anorexia, nausea, vomiting, glossitis, dysphagia, enterocolitis. Hypersensitivity reactions e.g., urticaria, angioneurotic edema, anaphylactic purpura, pericarditis and exacerbation of systemic lupus erythematosus may occur. Hemolytic anemia, thrombocytopenia, neutropenia and eosinophilia have also been reported. On rare occasions, anaphylaxis may occur.
Use in Pregnancy & Lactation: Not recommended in pregnancy & lactation.
Contraindications: It is contraindicated in patients with known hypersensitivity to any of the tetracyclines, and children under 12 years of age.
Commercial Pack: Megadox ® Capsule: Box containing 10 blister strips of 10 capsules, each capsule contains Doxycycline Hydrochloride BP equivalent to 100 mg Doxycycline.
75

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablet
®
Suspension
This is a broad spectrum antibacterial drug containing Trimethoprim BP and
Sulfamethoxazole BP in a 1:5 fixed combination. Megatrim exerts its bactericidal action by the sequential blockade of two bacterial enzyme systems in the biosynthesis of Folinic acid in the micro-organisms. The synergy thus produced accounts for the high degree of bactericidal activity.
Indications: Megatrim is bactericidal in vitro to a wide range of Gram-positive and Gramnegative organisms. Indications include: a) Respiratory tract infections: Acute and chronic bronchitis (treatment and prophylaxis), bronchiectasis, lung abscess, lobar and broncho-pneumonia, Pneumocystis carinii pneumonitis, sinusitis and otitis media.
b) Genito-urinary tract infections: Urethritis, acute and chronic cystitis, pyelitis, pyelonephritis and prostatitis, gonorrhea. c) Gastro-intestinal tract: Infections, caused by S. typhi and S. paratyphi , including chronic carrier state. d) Others: Infections, caused by a wide range of organisms confirmed to be susceptible to Megatrim. Such infections include acute and chronic osteomyelitis, acute brucellosis, skin infections including pyoderma, abscesses and wound infections, septicemia, bacillary dysentery and cholera (as an adjuvant to fluid and electrolyte replacement), nocardiosis and mycetoma.
Dosage & Administration: Duration of therapy: In acute infections, apart from gonorrhea, Megatrim DS should be given for at least 5 days or until the patient has been symptom free for 2 days. Treatment for prostatitis and acute brucellosis should be maintained for a period of at least 4 weeks, whilst nocardiosis and mycetoma, dosage guideline requires long-term therapy.
Side Effects: Crystalluria, allergic reactions, hemolysis, thrombocytopenia, neutropenia, agranulocytosis, have been reported rarely. Other side effects, less serious in nature are malaise, headache, nausea, vomiting. These are normally transient and do not require withdrawal of treatment.
Warning & Precautions: Prolonged full dose treatment with Sulfamethoxazole-
Trimethoprim combination is associated with the risk of macrocytic anemia due to the drug's interference in the conversion of Folic acid into Folinic acid. Care should be taken when giving this combination to diabetic patients receiving sulphonylurea drug for possible potentiation of action of sulphonylurea.
Use in Pregnancy & Lactation: It should be avoided during pregnancy and lactation,
76

bexinfo: T
HERAPEUTIC
G
UIDE because sulphonamides pass the placenta and are excreted in the breast milk and may cause kernicterus.
Contraindications: It is contraindicated in known hypersensitivity to Trimethoprim or
Sulphonamides, in patients with documented megaloblastic anemia due to folate deficiency and in patients showing marked liver parenchymal damage, blood dyscrasia, severe renal insufficiency, glucose 6-phosphate dehydrogenase deficiency.
Commercial Pack: Megatrim ® DS Tablet: Box containing 15 blister strips of 10 tablets.
Each tablet contains 160mg Trimethoprim BP and 800mg Sulphamethoxazole BP.
Megatrim ® Suspension: 60 ml suspension in amber glass bottle. Each 5ml of Suspension contains 40mg Trimethoprim BP and 200mg Sulphamethoxazole BP.
®
Tablet / Suspension
The active ingredient of Neofloxin is Ciprofloxacin Hydrochloride USP. Ciprofloxacin, a fluoroquinolone, is an extremely broad spectrum antimicrobial agent and acts by inhibiting a subunit of DNA gyrase which is essential in the reproduction of bacterial DNA. This mode of action differs from that of Penicillins, Cephalosporins, Aminoglycosides and
Tetracyclines and therefore, organisms resistant to these antibiotics are generally sensitive to Ciprofloxacin.
Indications: Neofloxin is indicated for the treatment of single infection or mixed infections caused by two or more susceptible organisms. It can also be used for infections caused by organisms resistant to other antibiotics including Aminoglycosides, Penicillins and
Cephalosporins. The extensive tissue penetration of Ciprofloxacin combined with its enhanced antibacterial activity (including antipseudomonal activity), enables Ciprofloxacin to be used alone (pending sensitivity results) or in combination with an Aminoglycoside or with β-lactam antibiotics for instance when severe neutropenia is present or with an antibiotic active against anaerobes where the presence of Bacteroides fragilis is suspected.
Neofloxin is indicated for the treatment of the following infections caused by sensitive bacteria:
Severe systemic infections: Septicemia, bacteremia, peritonitis, infections in immunosuppressed patients with hematological or solid tumors and in patients in intensive care unit with specific problems such as infected burns.
Respiratory tract infections: Lobar and bronchopneumonia, acute, and chronic bronchitis, acute exacerbation of cystic fibrosis, bronchiectasis, empyema.
Urinary tract infections: Uncomplicated and complicated urethritis, cystitis, pyelonephritis, prostatitis, epididymitis.
77

bexinfo: T
HERAPEUTIC
G
UIDE
Skin and soft tissue infections: Infected ulcers, wound infections, abscesses, cellulitis, otitis externa, erysipelas, infected burns.
Gastro-intestinal infections: Enteric fever, infective diarrhea.
Infection of the biliary tract: Cholangitis, cholecystitis, empyema of the gall bladder.
Intra-abdominal infections: Peritonitis, intra abdominal abscesses.
Bone and joint infections: Osteomyelitis, septic arthritis.
Pelvic infections: Salpingitis, endometritis, pelvic inflammatory diseases.
Eye, ear, nose and throat infections: Otitis media, sinusitis, mastoiditis, tonsillitis.
Genito-urinary infections: Gonorrhea (urethral, rectal and pharyngeal) caused by βlactamase producing organisms or organisms moderately sensitive to penicillin.
Dosage and Administration: The duration of treatment depends upon the severity of infections, clinical response and bacteriological findings. For acute infections the usual treatment period is 5-10 days with Neofloxin tablet, generally the treatment should be continued for 3 days after the sign and symptoms of the infection have disappeared.
Adults: The dosage range for adults is 100-750 mg twice daily.
a. In infections of the lower and upper urinary tract: 250-500 mg twice daily.
b. In respiratory tract infections: 250-750 mg twice daily for both upper and lower respiratory tract infections. c. For the treatment of known Streptococcal infection, the recommended dosage: 750 mg twice daily. d. In gonorrhea: a single dose of 250 or 500 mg. e. In the majority other infections: 500-750 mg twice daily should be administered. f. Cystic fibrosis: In adults with pseudomonal infections of lower respiratory tract, the normal dose is 750 mg twice daily. As the pharmacokinetics of Ciprofloxacin remain unchanged in patients with cystic fibrosis, the low body weight of these patients would be fallen into consideration when determining dosage.
Elderly: No dosage adjustment is necessary.
Adolescents and children: The dosage should be 7.5-15 mg/kg/day depending upon the severity of infection, administered in two divided doses.
Dosage Adjustment: Impaired renal function- Dosage adjustment is not usually required except in patients with severe renal impairment (serum creatinine >265 µmol/l or creatinine clearance <20 ml/minute). If adjustment is necessary, this may be achieved by reducing the total daily dose by half, although monitoring of drug serum levels provide the most reliable basis for dose adjustment.
78

bexinfo: T
HERAPEUTIC
G
UIDE
Side Effects: Gastrointestinal: Nausea, diarrhea, vomiting, dyspepsia, abdominal pain.
Central nervous system: Dizziness, headache, tiredness, confusion, convulsions.
Hypersensitivity reactions: Skin rashes, pruritus and possible systemic reactions. The following other reactions: Joint pain, mild photosensitivity and transient increase in liver enzymes (particularly in patients with previous liver damage), serum bilirubin, urea or creatinine levels.
Drug Interactions: Concurrent administration of Ciprofloxacin with Theophylline may lead to elevated plasma concentrations of Theophylline and prolongation of its elimination half-life, which may result in increased risk of theophylline related adverse reactions.
Therefore dosage adjustments is required. Antacids containing Magnesium Hydroxide or Aluminium Hydroxide may interfere with the absorption of Ciprofloxacin, so minimum
2 hours interval should be maintained in using those drugs concomitantly. Probenecid interferes with renal tubular secretion of Ciprofloxacin and produces an increase in the level of Ciprofloxacin in serum.
Warning and Precautions: Ciprofloxacin should be used with caution in patients with a history of convulsive disorders. Crystalluria related to the use of Ciprofloxacin has been observed only rarely. It may be taken with or without meals, preferably two hours after a meal. Patients should be advised to drink adequate water.
Use in Pregnancy and Lactation: Not recommended in pregnancy and lactation.
Contraindication: This is contraindicated in patients who have shown hypersensitivity to Ciprofloxacin or other Quinolones.
Commercial Pack: Neofloxin ® 250 Tablet: Box containing 5 blister strips of 10 film coated tablets, each tablet contains Ciprofloxacin Hydrochloride USP equivalent to Ciprofloxacin
250 mg.
Neofloxin ® 500 Tablet: Box containing 2 blister strips of 10 film coated tablets and 5 blister strips of 10 film coated tablets, each tablet contains Ciprofloxacin Hydrochloride
USP equivalent to Ciprofloxacin 500 mg.
Neofloxin ® 750 Tablet: Box containing 3 blister strips of 10 film coated tablets, each tablet contains Ciprofloxacin Hydrochloride USP equivalent to Ciprofloxacin 750 mg.
Neofloxin ® XR-1000 Tablet: Box containing 1 blister strip of 10 extended release tablets, each tablet contains Ciprofloxacin Hydrochloride USP equivalent to Ciprofloxacin
1000mg.
Neofloxin ® Granules for Suspension: Box containing a glass bottle of Ciprofloxacin granules. After reconstitution, each 5 ml contains Ciprofloxacin Hydrochloride USP equivalent to Ciprofloxacin 250mg.
Neofloxin ® Granules: Box containing 14 sachets of granules. Each sachet contains
Ciprofloxacin Hydrochloride USP equivalent to Ciprofloxacin 250 mg.
79

bexinfo: T
HERAPEUTIC
G
UIDE
®
IV Infusion
This is supplied as clear, almost colorless to pale yellow solution containing Ciprofloxacin
Hydrochloride. Ciprofloxacin is a synthetic, 4-Quinolone derivative with bactericidal activity against a wide range of gram-negative and gram-positive organisms including strains resistant to Penicillins, Cephalosporins and / or aminoglycosides.
Indications: a. Respiratory Tract Infections: Pneumonia, bronchopneumonia, infected pleurisy, empyema, lung abscess, infected bronchiectasis, acute exacerbation of chronic bronchitis and lung infections in patients with cystic fibrosis. b. Ear, Nose and Throat Infections: Otitis media, sinusitis, mastoiditis. c. Gastrointestinal Tract Infections: Enteric fever, infective diarrhea. d. Intra-abdominal Infections: Peritonitis, intra-abdominal abscess, cholangitis, cholecystitis, empyema of gall bladder.
e. Skin and Soft Tissue Infections: Infected ulcers, wound infections, abscesses, cellulitis, otitis externa, infected burns. f. Bone and Joint Infections: Acute and chronic osteomyelitis, septic arthritis. g. Urinary Tract Infections: Acute and chronic pyelonephritis, prostatitis, cystitis, epididymitis and chronic, complicated or recurrent UTI. h. Gonorrhea including urethral, rectal and pharyngeal gonococcal infections even those caused by resistant gonococci. i. Gynecological Infections: Salpingitis, endometritis, pelvic inflammatory disease. j. Eye infections-Bacterial conjunctivitis. k. Severe Systemic Infections: Septicemia, bacteremia and infections in immunecompromised patients.
Neofloxin is also indicated for prophylaxis against infection in elective uppergastrointestinal surgery and endoscopic procedures where there is an increased risk of infection.
Dosage & Administration: The dosage of Neofloxin is determined by the severity and type of infection, the sensitivity of the causative organism(s) and the age, weight, and renal function of the patient. The usual intravenous dose is 100 to 400mg twice daily. a. Upper and Lower UTI: 100mg (50ml) every 12 hourly, duration depends upon the severity of infection, usually 5-7 days. b. Lower RTI: 200mg (100ml) every 12 hourly for 5-7 days, the infusion should be done over 30-60 minutes. c. Other Infections: 200mg (100ml) every 12 hourly for at least 3 days, after the signs and symptoms of the infection have disappeared. d. Gonorrhea: 100mg (50ml) as a single dose.
Children: Ciprofloxacin is usually not recommended for use in children. However, if the benefits of Ciprofloxacin therapy are considered to outweigh the potential risk, the dosage should be 5-10mg/kg/day in 2 divided doses, depending on the severity of infection.
80

bexinfo: T
HERAPEUTIC
G
UIDE
This infusion is compatible with sodium chloride 0.9% solution, Ringer's solution, glucose
5% and 10% solutions, glucose/saline and fructose 10% solution. Unless compatibility is proven, the infusion should always be administered separately.
Side Effects: Described as previously. See page No. 79
Drug Interactions: Described as previously. See page No. 79
Warning & Precautions: Described as previously. See page No. 79
Contraindications: Described as previously. See page No. 79
Commercial Pack: Neofloxin ® IV Infusion: Neofloxin is available in 100ml polyethylene bottle containing 200 mg Ciprofloxacin USP.
®
Tablet
This is a preparation of Sparfloxacin, a synthetic, broad-spectrum antibacterial agent from the fluoroquinolone family.
Indications: a. Upper & lower respiratory tract infections: Sinusitis, acute exacerbation of chronic bronchitis, community acquired and hospital acquired pneumonia. b. Urinary tract infections including gonococcal and non-gonococcal urethritis c. Cancroid and other sexually transmitted diseases d. Skin and soft tissue infections e. Prophylactic use in different urological and ophthalmic operations.
Dosage and Administration: The recommended daily adult dose is two tablets (400 mg) on first day as a loading dose, followed by one tablet (200 mg) daily as a maintenance dose. Duration of maintenance treatment is 5 to 10 days. It can be taken with or without food.
Side Effects: Side effects are mild and transient, these are allergic reactions, photosensitization, headache & sleep disturbance, gastrointestinal disorders including nausea, vomiting, diarrhea at the start of treatment.
Drug Interaction: On concomitant use with Quinidine, Sotalol, Erythromycin, Astemizole,
Terfenadine, Vinca alkaloids there is increased risk of arrhythmia. Salts, oxides & hydroxides of magnesium, aluminium & calcium decrease absorption of Sparfloxacin.
Warning & Precautions: Sparfloxacin should be used with caution in renal disease, gastric ulcers, and in concomitant use of NSAIDs. In renal failure of third degree severity
(creatinine clearance <30 ml/min) dosage modification is recommended- 400 mg on 1st
81

bexinfo: T
HERAPEUTIC
G
UIDE day, 200 mg on 2nd & 3rd day followed by 200 mg every 48 hours. Because fluoroquinolones have been associated with tendon rupture, Sparfloxacin should be discontinued at the first sign of tendon pain. Exposure to UV radiation during treatment should be avoided. Not recommended for children below 12 years of age.
Use in Pregnancy and Lactation: Sparfloxacin should be administered in pregnant women
& lactating mother only if the potential maternal benefits justify the risks to the fetus/neonate.
Contraindications: Hypersensitivity to fluoroquinolones including Sparfloxacin or others, patients with known QTc prolongation or in those with pre-arrhythmic conditions (e.g., hypokalemia, significant bradycardia, congestive heart failure, atrial fibrillation or other cardiac disease).
Commercial Pack: Sparlin ® Tablet: Box containing 1 blister strip of 10 tablets, each tablet contains Sparfloxacin INN 200 mg.
®
IV / IM Injection
This is a preparation of Cefepime, a fourth generation broad-spectrum cephalosporin antibiotic. It acts by inhibition of bacterial cell wall synthesis. Cefepime is highly resistant to hydrolysis by most β-lactamases and exhibits rapid penetration into Gram-negative bacterial cells.
Indications: Tetracef Injection is indicated in the treatment of the following infections:
Pneumonia (moderate to severe), uncomplicated and complicated urinary tract infections
(including pyelonephritis), uncomplicated skin and skin structure infections, complicated intra-abdominal infections and empiric Therapy for febrile neutropenic patients.
Dosage and Administration: Adults: a. Moderate to Severe Pneumonia due to S. pneumoniae, P. aeruginosa, K.
pneumoniae , or Enterobacter species: 1-2 gm IV for every 12 hours for 10 days. b. Empiric therapy for febrile neutropenic patients: 2 gm IV for every 8 hours for 7 days. c. Mild to Moderate Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E. coli, K. pneumoniae , or P. mirabilis : 0.5-1 g IV/IM for every
12 hours for 7-10 days. d. Severe Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E. coli or K. pneumoniae : 2 gm IV for every 12 hours for 10 days. e. Moderate to Severe Uncomplicated Skin and Skin Structure Infections due to S.
aureus or S. pyogenes : 2 gm IV for every 12 hours for 10 days. f. Complicated Intra-abdominal Infections (used in combination with Metronidazole) caused by E. coli, viridans group streptococci, P. aeruginosa, K. pneumoniae,
Enterobacter species, or B. fragilis : 2 gm IV for every 12 hours for 7-10 days.
82

bexinfo: T
HERAPEUTIC
G
UIDE
Children (2 months up to 16 years): The usual recommended dosage in pediatric patients up to 40 kg in weight for uncomplicated and complicated urinary tract infections (including pyelonephritis), uncomplicated skin and skin structure infections, and pneumonia is 50 mg per kg per dose, administered every 12 hours (50 mg per kg per dose, every 8 hours for febrile neutropenic patients).
Side Effects: Generally Cefepime is well tolerated, however, few side-effects including rash, pruritus, urticaria, fever, headache, nausea, vomiting, diarrhea, dizziness, oral moniliasis.
Warning & Precautions: In patients with impaired renal function (creatinine clearance
<60 ml/min), the dose of Cefepime should be adjusted. It should be prescribed with caution in individuals with a history of gastrointestinal diseases, particularly colitis.
Use in Pregnancy & Lactation: Cefepime should be used during pregnancy only if clearly needed. Caution should be exercised when Cefepime is administered to a nursing woman.
Overdosage & Contraindications: Patients who receive an overdose should be carefully observed and given supportive treatment. Symptoms of overdose include encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, seizures, and neuromuscular excitability. Cefepime is contraindicated in patients who have shown hypersensitivity reactions to the
Cephalosporin class of antibiotics, penicillins or other β -lactam antibiotics & any component of the formulation.
Commercial Pack: Tetracef ® 500 mg IM/IV Injection: Pack of 1 vial containing Sterile
Cefepime Hydrochloride USP equivalent to Cefepime 500 mg premixed with L-Arginine accompanied by one ampoule of 5 ml water for injection BP, a 5 ml disposable syringe, an alcohol pad & a first aid band.
Tetracef ® 1 gm IM/IV Injection: Pack of 1 vial containing Sterile Cefepime Hydrochloride
USP equivalent to Cefepime 1 gm premixed with L-Arginine accompanied by one ampoule of 10 ml water for Injection BP, a 10 ml disposable syringe, an alcohol pad & a first aid band.
Tetracef ® 2 gm IV Injection: Pack of 1 vial containing Sterile Cefepime Hydrochloride
USP equivalent to Cefepime 2 gm premixed with L-Arginine accompanied by one ampoule of 10 ml water for Injection BP, a 10 ml disposable syringe, an alcohol pad, a butterfly needle & a first aid band.
83

bexinfo: T
HERAPEUTIC
G
UIDE
®
Capsule / Suspension
This is a preparation of Cefixime, a broad spectrum antibiotic of third generation for oral administration. It is a bactericidal antibiotic which interfere with the synthesis of the bacterial cell wall, and is stable to hydrolysis by many β-lactamases.
Indications: Enteric fever, upper and lower respiratory tract infections, urinary tract infections, gonococcal urethritis, acute otitis media.
Dosage and Administration:
Adult dose: 400mg daily as a single dose or in two divided doses for 7 to 14 days, according to the severity of infection.
Children dose: 8 mg/kg daily as a single dose or in two divided doses for 7 to 14 days according to the severity of infection or age.
½ -1 year
1-4 years
5-10 years
11-12 years
Above 12 years
: 75 mg
: 100 mg
: 200 mg
: 300 mg
: Adult dose
Side Effects: Cefixime is generally well tolerated, common side effects are diarrhea, changes in the color of stool, nausea, abdominal pain, dyspepsia, headache, dizziness, elevation of serum amylase.
Warning & Precautions: This drug should be prescribed with caution in individuals with a history of gastrointestinal diseases, particularly colitis. Dosage adjustment is only necessary in severe renal failure.
Contraindications: Patients with known hypersensitivity to Cephalosporin group of drugs.
Commercial Pack: Triocim ® 200 Capsule: Box containing 16 capsules in 4 x 4’s Alu-
Alu form packs. Each capsule contains Cefixime USP equivalent to anhydrous Cefixime
200mg.
Triocim ® 400 Capsule: Box containing 6 capsules in 1 x 6’s Alu-Alu form pack. Each capsule contains Cefixime USP equivalent to anhydrous Cefixime 400mg.
Triocim ® Powder for Suspension: Bottle containing dry powder for preparation of 30 ml
& 50 ml suspension. After reconstitution, each 5 ml contains Cefixime USP equivalent to anhydrous Cefixime 100mg.
Triocim ® DS Powder for Suspension: Bottle containing dry powder for preparation of 50 ml suspension. After reconstitution, each 5 ml contains Cefixime USP equivalent to anhydrous Cefixime 200mg.
84

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablet / Injection
This is a preparation of Cefuroxime, a broad spectrum antibiotic of second generation. It is an effective antibacterial agent, which has broad-spectrum bactericidal activity against a wide range of common pathogens, including β-lactamase producing strains.
Indications: Turbocef is indicated in the treatment of upper respiratory tract infections
(otitis media, sinusitis, tonsillitis and pharyngitis), lower respiratory tract infections (acute bronchitis, acute exacerbations of chronic bronchitis and pneumonia), skin and soft tissue infections (furunculosis, pyoderma and impetigo), urinary tract infections (pyelonephritis, urethritis and cystitis), acute uncomplicated gonococcal urethritis, and cervicitis, early
Lyme disease & subsequent prevention of late Lyme disease.
Dosage & Administration:
Adults: Mild to moderate lower respiratory tract infections: 250 mg 12hourly. Severe lower respiratory tract infections: 500 mg 12 hourly should be given. Urinary tract infections: A dose of 125 mg 12 hourly is usually adequate, Pyelonephritis: 250 mg 12 hourly. The usual duration of dose 5-10 days, average 7 days. A single dose of one gm is recommended for the treatment of uncomplicated gonorrhea. Lyme disease in adults and children over the age of 12 years: The recommended dose is 500 mg 12hourly for 20 days.
Children: The usual dose is 125 mg 12hourly or 10 mg/kg 12 hourly to a maximum of
250 mg daily. Otitis media: In children less than 2 years of age: The usual dosage is 125 mg 12 hourly or 10 mg/kg 12hourly to a maximum of 250 mg daily. In children over 2 years of age: 250 mg 12hourly or 15 mg/kg 12hourly to a maximum of 500 mg daily.
There is no experience in children under three months of age. The usual course of therapy is seven days. Cefuroxime should be taken after food for optimum absorption.
Parental Dosage: Adults: 750 mg to 1.5 g IM or IV every 8 hourly, usually 5 to 10 days.
Preoperative prophylaxis: For clean contaminated or potentially contaminated surgical procedures, administer 1.5 g IV prior to surgery (30 min to 1 hour before). Thereafter,
750 mg IV or IM every 8 hours should be given when the procedure is prolonged.
Infants and Children (>3 months): 50 to 100 mg/kg/day in equally divided doses every 6 to 8 hours. 100 mg/kg/day for more severe or serious infections. Bone & joint infections:
150 mg/kg/day in equally divided doses every 8 hours. Bacterial meningitis: Initially 200 to 240 mg/kg/day IV in divided doses every 6 to 8 hours.
Side Effects: It has been associated with nausea and vomiting in a small number of patients.
Drug Interactions: No potentially hazardous interactions have been reported.
Warning & Precaution: Prolonged use of Cefuroxime may result in the overgrowth of non-susceptible organisms (e.g. Candida, Enterococci, C. difficile ), which may require interruption of treatment.
85

bexinfo: T
HERAPEUTIC
G
UIDE
Use in Pregnancy & Lactation: Cefuroxime has been safely used in pregnancy, caution should be exercised when administered to a nursing mother.
Overdosage & Contraindications: Excessively large doses of all Cephalosporins can cause cerebral irritation and may cause convulsions. This complication is unlikely to occur in routine practice unless the patient is in renal failure. Hemodialysis or peritoneal dialysis can remove Cefuroxime. Cefuroxime is contraindicated in patients with known allergy to
Cephalosporins.
Commercial Pack: Turbocef ® 250 Tablet: Box containing 14 tablets in 2 x 7’s Alu-Alu blister packs. Each tablet contains Cefuroxime Axetil USP equivalent to 250 mg
Cefuroxime.
Turbocef ® 500 Tablet: Box containing 7 tablets in 1 x 7’s Alu-Alu blister pack. Each tablet contains Cefuroxime Axetil USP equivalent to 500 mg Cefuroxime.
Turbocef ® 750 IM/IV Injection: Pack of 1 vial containing Cefuroxime 750 mg as
Cefuroxime Sodium USP accompanied by a solvent ampoule of 10 ml Water for Injection
BP, a 10 ml disposable syringe & an alcohol pad.
Turbocef ® 1.5 gm IV Injection: Pack of 1 vial containing Cefuroxime 1.5 gm as
Cefuroxime Sodium USP accompanied by two solvent ampoules (2x10 ml) of water for
Injection BP, a 20 ml disposable syringe, a first aid band, a butterfly needle & an alcohol pad.
®
Capsule / Suspension / Pediatric Drops
Tycil contains Amoxicillin as trihydrate BP. It is a broad-spectrum, bactericidal antibiotic similar to Ampicillin in the spectrum of activity but is better absorbed when taken orally and produces a higher blood level.
Indications: Infections of the respiratory tract & ear, infections of the biliary and G.I. tract, infections of the genito-urinary tract, skin and soft tissue infections, prophylaxis of endocarditis, pre and post operative prophylaxis and treatment of septicemia, osteomyelitis etc.
Dosage and Administration: Adult dosage (including elderly patients): a. Standard dosage: 250 mg three times daily, increasing up to 500 mg three times daily for more severe infections. b. Severe or recurrent purulent infection of the respiratory tract: A dosage of 3 g twice daily is recommended in appropriate cases (Maximum recommended oral dosage- 6 gm daily in divided doses). c. Uncomplicated acute urinary tract infection: A single dose of 3 gm.
d. Gonorrhea: A single dose of 3 gm, often with 1 gm probenecid in the treatment of uncomplicated gonorrhea in areas where the pathogen is sensitive to amoxicillin. e. Prophylaxis of endocarditis in susceptible patients: A single dose of 3 gm about 1 hour before procedures such as dental extraction.
86

bexinfo: T
HERAPEUTIC
G
UIDE
Children dosage: a. Children up to 10 years of age may be given the equivalent of 125 to 250 mg three times daily; under 20 kg body weight a dose of 20 to 40 mg per kg daily has been suggested. b. Children weighing 20 kg or more should be given doses according to the recommended dosage for adults. c. In prophylaxis of endocarditis, children may be given half of the adult dose, i.e., 1.5g
about 1 hour before procedures such as dental extraction.
Side Effects: Side effects, as with other penicillins are rare and usually of mild and transient in nature. Skin rashes and diarrhea have occasionally been observed.
Warning & Precautions: In presence of gastrointestinal diseases such as diarrhea and vomiting, absorption of oral preparation is doubtful. Like all broad-spectrum antibiotics, superinfection may occur in association with amoxicillin. In such cases treatment with amoxicillin should be discontinued and appropriate therapy to combat superinfection should be instituted.
Contraindications: It is contraindicated in patients with known hypersensitivity to
Penicillins.
Commercial Pack: Tycil ® 250 Capsule: Box containing 10 blister strips of 10 capsules, each capsule contains Amoxicillin Trihydrate BP equivalent to 250 mg Amoxicillin.
Tycil ® 500 Capsule: Box containing 5 blister strips of 10 capsules, each capsule contains
Amoxicillin Trihydrate BP equivalent to 500 mg Amoxicillin.
Tycil ® Suspension: Dry powder in amber glass bottle for reconstitution into 100 ml suspension. After reconstitution, each 5 ml contains Amoxicillin Trihydrate BP equivalent to 125 mg Amoxicillin.
Tycil ® DS Suspension: Dry powder in amber glass bottle for reconstitution into 100 ml suspension. After reconstitution, each 5 ml contains Amoxicillin Trihydrate BP equivalent to 250 mg Amoxicillin.
Tycil ® Pediatric Drops: Dry powder in amber glass bottle for reconstitution into 15 ml suspension. After reconstitution, each 1.25 ml contains Amoxicillin Trihydrate BP equivalent to 125 mg Amoxicillin.
87

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablet
Tyclav is an antibacterial combination consisting of the antibiotic Amoxicillin and the βlactamase inhibitor Clavulanic Acid. Amoxicillin has a broad spectrum of bactericidal activity against many Gram-positive & Gram-negative microorganisms. Clavulanic acid possesses the ability to inactivate a wide range of β-lactamase enzymes commonly found in microorganisms resistant to penicillins and cephalosporins. Thus Clavulanic acid in combination of Amoxicillin and Clavulanic acid protects Amoxicillin from degradation by
β-lactamase enzymes and effectively extends the antibiotic spectrum.
Indications: Upper respiratory tract infections, lower respiratory tract infections, urinary tract infections, skin and soft tissue infections, bone and joint infections, other infections including septic abortion, puerperal sepsis, intra-abdominal sepsis, etc.
Dosage and Administrations: Adults and children over 12 years: The usual adult dose is one Tyclav 625 Tablet every 12 hours or one Tyclav 375 Tablet every 8 hours. For more severe infections and infections of the respiratory tract, the dose should be one Tyclav
1gm Tablet every 12 hours or one Tyclav 625 Tablet every 8 hours.
Side Effects: Diarrhea, pseudomembranous colitis, indigestion, nausea, vomiting and candidiasis have been reported. If gastrointestinal side effects occur with oral therapy, that may be reduced by taking Tyclav at the start of meals. Hepatitis and cholestatic jaundice have been reported rarely but are usually reversible. Rarely erythema multiforme, Stevens-Johnson Syndrome and exfoliative dermatitis have been reported.
In common with other β-lactam antibiotics angioedema and anaphylaxis have also been reported.
Drug Interactions: In common with other broad-spectrum antibiotics, Tyclav may reduce the efficacy of oral contraceptives. Concomitant use of allopurinol during treatment with
Amoxicillin can increase the likelihood of allergic skin reactions.
Warning & Precautions: This should be used with care in patients on anti-coagulation therapy or with severe hepatic dysfunction. In patients with moderate or severe renal impairment, dosage should be adjusted. During the administration of high dose of
Amoxicillin adequate fluid intake and urinary output should be maintained to minimize the possibility of crystalluria.
Use in Pregnancy and Lactation: In pregnancy it is not recommended unless considered essential by the physician. During lactation, trace quantities of Amoxicillin can be detected in breast milk.
Overdosage & Contraindications: Overdoses are unlikely to occur, if encountered gastrointestinal symptoms and disturbance of the fluid and electrolyte balances may be evident. This may be removed from the circulation by hemodialysis. Contraindicated in patients with history of Penicillin hypersensitivity. Attention should be paid to possible cross sensitivity with other β-lactam antibiotics, and also contraindicated for patients with previous history of Amoxicillin or Penicillin associated cholestatic jaundice.
88

bexinfo: T
HERAPEUTIC
G
UIDE
Commercial Packs: Tyclav ® 375 Tablet: Each box contains 18 tablets in 3X6's Alu-Alu form packs. Each film coated tablet contains Amoxicillin Trihydrate BP equivalent to
250mg Amoxicillin and Clavulanate Potassium USP equivalent to Clavulanic Acid 125mg.
Tyclav ® 625 Tablet: Each box contains 18 tablets in 3X6's Alu-Alu form packs. Each film coated tablet contains Amoxicillin Trihydrate BP equivalent to 500 mg Amoxicillin and
Clavulanate Potassium USP equivalent to Clavulanic Acid 125 mg.
Tyclav ® 1gm Tablet: Each box contains 12 tablets in 3X4's Aluminium strips. Each film coated tablet contains Amoxicillin Trihydrate BP equivalent to 875 mg Amoxicillin and
Clavulanate Potassium USP equivalent to Clavulanic Acid 125 mg.
®
Suspension / Pediatric Drops
This is a preparation of Cefpodoxime, an orally administered extended spectrum, semisynthetic 3rd generation antibiotic of cephalosporins group. It is a bactericidal drug that acts by inhibition of bacterial cell wall synthesis.
Indications: a. Lower respiratory tract infections: Acute community acquired pneumonia, acute bacterial exacerbation of chronic bronchitis.
b. Upper respiratory tract infections: Acute otitis media, acute maxillary sinusitis, pharyngitis, tonsillitis. c. Sexually transmitted diseases: Acute uncomplicated urethral & cervical gonorrhea, acute ano-rectal infection in woman caused by N. gonorrhoeae . d. Uncomplicated urinary tract infection: Cystitis, Pyuria. e. Skin & soft tissue infections: Furuncle cellulitis, subcutaneous abscess, infectious atheroma & periproctic abscess.
Dosage and Administration: Adults (Including children of aged 13 years and older): a. Acute community acquired pneumonia: 400mg daily or 200 mg 12 hrly for 14 days. b. Acute bacterial exacerbation of chronic bronchitis: 400 mg daily or 200mg 12 hrly for
10 days c. Uncomplicated gonorrhea (men-women): 200mg single dose d. Rectal gonococcal infection in women: 200mg single dose e. Skin & soft tissue infection: 400 mg daily or 200 mg 12 hourly for 7 to 14 days f. Pharyngitis or tonsillitis: 200 mg daily or 100 mg 12 hourly for 5 to 10 days g. Uncomplicated urinary tract infections: 200mg daily or 100 mg 12 hourly for 7 days h. Acute maxillary sinusitis: 400 mg daily or 200 mg 12 hourly for 10 days.
Children: a. 15 days- 6 months: 4mg/kg every 12hours b. 6 months- 2 years: 40mgs every 12hours c. 3-8 years: 80mg every 12hours d. Over 9 years: 100mg every 12hours
89

bexinfo: T
HERAPEUTIC
G
UIDE
Side Effects: The side effects include diarrhea, nausea, skin & vaginal fungal infection, abdominal pain, headache, chest pain, myalgia, dyspepsia, dizziness, vertigo, cough etc.
Drug Interactions: Antacids: Concomitant administration of high doses of Antacids
(Sodium Bicarbonate and Aluminum Hydroxide) or H
2 blockers reduces peak plasma level of the drug. Probenecid: Renal excretion of Cefpodoxime was inhibited by
Probenecid and resulted in an approximately 31% increase in AUC. Nephrotoxic drugs:
Close monitoring of renal function is advised when Cefpodoxime is administered concomitantly with compounds of known nephrotoxic potential.
Warning & Precautions: For patients with severe renal impairment (Creatinine clearance
<30 ml/min) the dosing intervals should be increased to 24 hours. Dose adjustment is not necessary in patients with liver cirrhosis. In patients with transient or persistent reduction in urinary output due to renal insufficiency, the total daily dose of Cefpodoxime should be reduced.
Use in Pregnancy and Lactation: The drug should be used during pregnancy only if clearly needed. A decision should be made whether to discontinue breast-feeding or to discontinue the drug.
Overdosage & Contraindications: Overdosage may cause toxic reaction including nausea, vomiting, epigastric distress, diarrhea. It is contraindicated in patients with a known allergy to Cefpodoxime or to the cephalosporin group of antibiotics.
Commercial Pack: Vercef ® Suspension: Bottle containing dry powder for preparation of
100 ml & 50 ml suspension. After reconstitution each 5 ml contains Cefpodoxime Proxetil
USP equivalent to Cefpodoxime 40 mg.
Vercef ® DS Suspension: Bottle containing dry powder for preparation of 50 ml suspension. After reconstitution each 5 ml contains Cefpodoxime Proxetil USP equivalent to Cefpodoxime 80 mg.
Vercef ® Pediatric Drops: Bottle containing dry powder for preparation of 15 ml suspension. After reconstitution each ml contains Cefpodoxime Proxetil USP equivalent to Cefpodoxime 20 mg.
90

bexinfo: T
HERAPEUTIC
G
UIDE
A
NTIBIOTIC
S
OLUTION
®
Respirator Solution
Tobasol Respirator Solution is an aqueous solution of Tobramycin. Tobramycin is an aminoglycoside antibiotic and acts primarily by disrupting protein synthesis, leading to altered cell membrane permeability, and eventual cell death.
Indications: Tobasol Respirator Solution is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa.
Safety and efficacy have not been demonstrated in patients below the age of 6 years, patients with a forced expiratory volume <25% or >75% predicted, or patients colonized with Burkholderia cepacia.
Dosage and Administration: The recommended dosage for, both adult and pediatric patients, 6 years of age and older, is one single-use ampoule (300 mg) administered b.i.d
for 28 days. Dosage is not adjusted by weight. The doses should be taken as close to 12 hours apart as possible; they should not be taken less than 6 hours apart. In case of multi-medications, the recommended order is: bronchodilator first, followed by chest physiotherapy, then other inhaled medications and finally Tobasol. Tobasol is to be taken twice a day in repeated cycles of 28 days on drug, followed by 28 days off drug.
Side Effects: Inhaled Tobramycin is generally well-tolerated. Voice alterations and tinnitus are more common in the on-drug periods. However all the episodes are transient and resolved without discontinuation of the regimen. Others like dizziness and increase in serum creatinine were similar to those occurring with placebo.
Contraindications: Tobasol is contraindicated in patients with a known hypersensitivity to any aminoglycoside.
Warnings and Precautions: Tobasol Respirator Solution must only be used by inhalation from a nebulizer and must not be injected or swallowed. It should be used with care in patients with known or suspected renal, auditory, vestibular, or neuromuscular dysfunction. Patients receiving concomitant aminoglycoside therapy should be monitored as clinically appropriate. It must be used with caution in patients with ototoxicity and nephrotoxicity. Discuss the use of Tobramycin with your doctor if you have kidney problems or changes in hearing. If you are a nursing mother, pregnant or want to become pregnant, ask your doctor about the possibility of Tobramycin causing any harm.
Commercial Pack: Tobasol ® Respirator Solution: Box containing 1 x 5 ampoules of 5 ml. Each 5 ml ampoule contains Tobramycin USP 300 mg.
91

bexinfo: T
HERAPEUTIC
G
UIDE
A
NTI
-F
UNGALS
®
Suspension
Fungistin oral suspension is banana flavoured, ready to use suspension containing
100,000 units of Nystatin BP per ml. It is an antifungal antibiotic which is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast like fungi.
Indications: It is indicated for the prevention and treatment of candidal infection of the oral cavity, esophagus and intestinal tract caused by Candida albicans (monilia). It provides effective prophylaxis against oral candidiasis in those born of mothers with vaginal candidiasis.
Dosage and Administration: Adults: 1-6 ml four times daily. For the treatment of denture sores, and oral infections, in adults caused by C. albicans , 1-2 ml of the suspension should be dropped into the mouth four times daily, it should be kept in contact with the affected area as long as possible for greater effect. Older people with intestinal candidiasis may be given 5 ml of the suspension four times a day.
Children & Infants: 1-6 ml four times daily in children& 1-2 ml four times daily in infants
.In intestinal and oral candidiasis (thrush) in infants and children: 1-2 ml should be dropped into the mouth four times a day.
Prophylaxis: For oral candidiasis in the newborn the suggested dose is 1 ml once daily.
Administration should be continued for 48 hours after clinical cure to prevent relapse.
Side Effects: Nausea, vomiting and diarrhea have occasionally been reported with doses of Nystatin exceeding 4 to 5 million units daily. No systemic effects or allergic reactions have been associated with its oral use.
Contraindications: There are no known contraindications to the use of Nystatin except hypersensitivity to the drug.
Commercial Pack: Fungistin ® Oral Suspension: 12 ml suspension in amber glass bottle with graduated dropper, each ml contains 100,000 units of Nystatin BP.
®
Capsule / Suspension / IV Infusion
This is a preparation of Fluconazole, a triazole antifungal agent. It is a potent and selective inhibitor of fungal cytochrome P-450 dependent enzymes necessary for the synthesis of ergosterol.
Indications: Vaginal candidiasis, oropharyngeal candidiasis, esophageal candidiasis, systemic candidiasis and cryptococcal infections, Tinea corporis / Tinea cruris / Tinea
92

bexinfo: T
HERAPEUTIC
G
UIDE pedis / other Tinea, Kerion, Pityriasis versicolor , Onchomycosis. Other indications include:
Fungal urinary tract infections, disseminated candidiasis, prophylaxis for fungal infection in neutropenic cancer patients, and in acute treatment of other systemic fungal infections such as coccidioidomycosis and histoplasmosis.
Dosage & Administration: Recommended dosage are given below, and this regimen is recommended from early infection to severe infections. Immunocompromised patients usually require maintenance therapy to prevent relapse.
• 150 mg as a single dose or 200 mg in 1st day followed by 100 mg daily for 14 days.
• 200 mg in 1st day followed by 100 mg daily for 14-30 days.
• 400mg in 1st day followed by 200mg daily for 28 days or longer based on clinical response
• 150mg weekly for 4-6 weeks
• 50mg daily for 20 days
• 400mg as a single dose
• 150 mg weekly for 12 months
Child over 1 year:
• In Superficial Candidiasis 1-2 mg/kg daily
• In Systemic Candidiasis & Cryptococcal infection 3-6 mg/kg daily
In serious life threatening infections upto 12 mg/kg daily has been given to children aged
5-13 years (Maximum 400 mg daily)
Side Effects: Therapy with Fluconazole is well tolerated. The most common adverse events include nausea, abdominal pain, vomiting and diarrhea, headache and skin rash.
Drug Interactions: Cyclosporine, Phenytoin, Anticoagulants, Oral hypoglycemics,
Rifampicin and Oral contraceptives.
Warning & Precautions: In renal impairment no adjustment in single dose therapy is required. In multiple dose therapy of patients with renal impairment, normal doses should be given on days 1 and 2 of treatment and there after the dosage intervals should be modified as follows:
Creatinine clearance (ml/min)
>41
21-40
10-20
Patients receiving regular dialysis
Dosage interval (hours)
24
48
72
One dose after every dialysis session
Use in Children: In pediatric use doses of 3-6 mg/kg (maximum 12mg/kg) daily have been used without any report of serious adverse reactions.
Fluconazole is not predictable hepatotoxic drug in man.
93

bexinfo: T
HERAPEUTIC
G
UIDE
Use in Pregnancy & Lactation: Fluconazole should be used in pregnancy only if the potential benefit justifies the possible risk to the fetus. The use of Fluconazole in nursing mother is not recommended.
Contraindications: Fluconazole should not be used in patients with known hypersensitivity to Fluconazole or to related triazole compounds.
Commercial Pack: Omastin ® 50 Capsule: Box containing 50 capsules in 5x10’s Alu-Alu form packs. Each capsule contains Fluconazole USP 50 mg.
Omastin ® 150 Capsule: Box containing 20 capsules in 2x10’s Alu-Alu form packs. Each capsule contains Fluconazole USP 150 mg.
Omastin ® Powder for Suspension: Dry powder in glass bottle for reconstitution into 35 ml of suspension. After reconstitution, each 5 ml contains Fluconazole USP 50 mg.
Omastin ® IV Infusion: Supplied in a 100 ml polyethylene bottle containing 200 mg (2 mg/ml) Fluconazole USP.
®
Capsule / Cream
This is a preparation of Fluconazole oral preparation and Clotrimazole tropical preparation.
Indications: The Omastin is used to treat thrush. The thrush relief cream is used to relieve the external itching and soreness of vaginal thrush. Thrush relief cream should be applied thinly and evenly onto the irritated area of the skin outside the vagina, two or three times daily until symptoms are relieved.
Omastin Duo is not recommended for children.
Side Effects: The Omastin 150 mg oral capsule may cause mild side effects such as nausea, headache, stomach pain, indigestion or diarrhea. Thrush relief cream Neosten may cause mild burning, stinging or irritation immediately after application.
Drug Interactions: Phenytoin, warfarin and oral hypoglycemics may interact with
Omastin duo.
Warning & Precautions: It should be used in caution in patient with liver or kidney disease, diabetic patient, patient with a history of irregular vaginal bleeding, etc.
Use in Pregnancy: Not recommended in pregnancy.
Commercial Pack: Omastin ® Duo: Each pack contains a single Omastin 150 mg oral capsule and a 20 gm tube of Neosten thrush relief cream. The capsule contains
Fluoconazole USP 150 mg and the cream contains Clotrimazole BP 10 mg/gm.
94

bexinfo: T
HERAPEUTIC
G
UIDE
®
Cream / Tablet
This is a preparation of Terbinafine Hydrochloride. Terbinafine is an allylamine with a range of antifungal activity.
Indication: Terbex Cream: Terbex cream is indicated for the treatment of interdigital tinea pedis (Athlete’s foot), tinea cruris (jock itch) or tinea corporis (ring worm) due to susceptible organisms and planter tinea pedis (mocasin type) due to Trychophyton sp.
Terbex Tablet: Terbex tablet is indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes and also by non-dermatophyte fungi.
Dosage and Administration: Topical application of Terbex cream to affected areas once or twice daily for 1-2 weeks may be adequate for fungal infections of the skin but certain infections may require oral Terbex tablet therapy.
Usual duration of treatment of Terbex cream in Tinea corporis, and Tinea cruris: 1-2 weeks. In Tinea pedis : 2-4 weeks (One week of treatment will normally suffice if the cream is applied twice daily.) In cutaneous candidiasis:1-2 weeks and inPityriasis (tinea) versicolor : 2 weeks
To prevent relapses in fungal infection, treatment should be continued for adequate length of time.
Oral administration of Terbex tablet is essential for hair or nail infections. The usual oral dose is 1 Terbex tablet (250 mg) daily for 2 to 12 weeks depending upon the infection.
Finger nail onychomycosis: 1 Terbex tablet (250 mg) once daily for 6 weeks. Toe nail
Onychomycosis: 1 Terbex tablet (250 mg) once daily for 12 weeks.
Side Effects: The side effects include gastrointestinal disturbances (diarrhea, dyspepsia, and abdominal pain), rashes etc. Rarely, cases of symptomatic hepato biliary dysfunction including cholestatic hepatitis have been reported. Besides, there have been isolated reports of serious skin reactions.
Warning & Precautions: Experience with topical Terbinafine Hydrochloride cream in children is limited and its use cannot therefore be recommended. In adult cases, if progressive skin rash occurs after administration of Terbex tablet, treatment should be discontinued.
Contraindications: Hypersensitivity to Terbinafine or any of the ingredients in the preparation.
Commercial Pack: Terbex ® Cream: Tubes containing 5 g and 10 g cream, each gm contains Terbinafine Hydrochloride BP 10 mg.
Terbex ® Tablet: Box containing blister pack of 10 Terbex tablets, each tablet contains
Terbinafine Hydrochloride BP equivalent to 250 mg Terbinafine.
95

bexinfo: T
HERAPEUTIC
G
UIDE
A
NTI
-P
ARASITIC
®
Tablet
Alphin DS is a preparation of Albendazole, a broad spectrum anthelmintic.
Indications:
• Ascariasis, Trichuriasis, Strongyloidiasis and Hookworm infestations
• Enterobiasis, Capillariasis, Cysticercosis and Cutaneous larva migrans
• Hydatid disease
• During surgery as an adjunct therapy (either pre-or post-operatively)
Dosage and Administration: The usual dose for adults and children aged 2 years or over with ascariasis (roundworm), hookworm infestations, trichuriasis (whipworm) and cutaneous larva migrans is 400 mg as a single dose. In strongyloidiasis, 400 mg is given daily for 3 consecutive days. This may be repeated after 3 weeks if necessary. In enterobiasis (pinworm, threadworm), children aged 2 years or more have been given a single dose of 100 mg repeated after 7 days; the adult dose is 400 mg repeated after 7 days. In hydatid disease, the usual dose is 400 mg twice daily for adults. This is mostly given for 28 day cycles with a 2-week interval between cycles. The number of cycles ranges from 1 to 12, though 3 cycles may be sufficient for most cysts.
Side Effects: Gastrointestinal disturbances, headache and dizziness have been reported during treatment. Rash, fever and rarely alopecia may occur during treatment.
Drug Interactions: There is a theoretical risk of interaction with Theophylline, anticonvulsants, anticoagulants, oral contraceptives and oral hypoglycemics.
Warning & Precautions: Elevations in hepatic enzyme levels and reversible reduction in total white cell count have occasionally been reported. These changes appear to be more common during treatment of E. multilocularis .
Contraindications: Albendazole is absolutely contraindicated during pregnancy and hypersensitivity to the drug.
Commercial Pack: Alphin ® DS Tablet: Box containing 50 chewable tablets in 50X1's blister strips. Each chewable tablet contains Albendazole USP 400 mg.
96

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablet
This is a preparation of Ivermectin.
Indications: Strongyloidiasis of the intestinal tract, onchocerciasis etc.
Dosage and Administration: Strongyloidiasis: A single oral dose designed to provide approximately 200 mcg of Ivermectin / kg of body weight on an empty stomach with water.
Dosage Guidelines for Ivermectin for Strongyloidiasis
Body Weight (kg)
15-24
25-35
36-50
51-65
66-79
>80
Dose
3 mg
6 mg
9 mg
12 mg
15 mg
200 mcg / kg
Onchocerciasis: The recommended dosage of Ivermectin is a single oral dose designed to provide approximately 150 mcg of Ivermectin per kg of body weight on an empty stomach with water, the most commonly used dose interval is 12 months. For the treatment of individual patients, retreatment may be considered at intervals as short as
3 months.
Dosage Guidelines for Ivermectin for Onchocerciasis
Body Weight (kg) Dose
15-25
26-44
45-64
65-84
>85
3 mg
6 mg
9 mg
12 mg
150 mcg / kg
Side Effects: The common side effects are fatigue, abdominal pain, anorexia constipation, diarrhea, nausea, vomiting , dizziness, somnolence, vertigo, tremor, pruritus, urticaria, synovitis lymph node enlargement (axillary ,cervical, inguinal), skin involvement including edema, papular and pustular or frank urticarial rash , and fever, eyelid edema, anterior uveitis, conjunctivitis, limbitis, keratitis, and chorioretinitis or choroiditis.
Contraindications: Hypersensitive to any component of this product.
Commercial Pack: Ivera ® 6 Tablet: Box containing 1 blister strip of 10 tablets. Each tablet contains Ivermectin BP 6 mg.
97

bexinfo: T
HERAPEUTIC
G
UIDE
®
Suspension
Melphin contains Pyrantel Pamoate USP. It is an anti-helminthic.
Indications: Melphin is specifically indicated for the treatment of infestations caused by
Ascaris lumbricoides, Enterobius vermicularis, Ancylostoma duodenale / Necator americanus and Trichostrongylus.
Dosage and Administration: Melphin is given orally at anytime without regard to ingestion of food or beverages. A single dose of 11 mg/kg body weight, to a maximum of
1 g, should be given to treat infestations caused by the parasites mentioned above. In the case of Pinworm, it is often wise to repeat the dose after an interval of 2 weeks.
Side Effects: Melphin is well tolerated in recommended dosage. In large dosage, it may cause gastro-intestinal upset. Rare side effects include headache, dizziness and rash.
Warning & Precautions: Since Pyrantel Pamoate and Piperazine appear to be mutually antagonistic; Melphin should not be given together with Piperazine.
Overdosage and Contraindications: This is normally contraindicated in pregnancy. It is not recommended for children below 1 year of age.
Commercial Pack: Melphin ® Suspension: 10 ml suspension in amber glass bottle, each ml contains Pyrantel Pamoate USP equivalent to 50 mg Pyrantel.
98

bexinfo: T
HERAPEUTIC
G
UIDE
A
NTI
-V
IRALS
®
Capsule
This is a preparation of Oseltamivir, an ethyl ester prodrug requiring ester hydrolysis for conversion to the active form, Oseltamivir carboxylate.
Indications: Oseltamivir is indicated for prevention of flu (influenza) in adults and adolescents aged 13 years and over who have been in contact with someone diagnosed with flu; treatment of flu (influenza) in adults and in children over one year of age when the influenza virus is circulating in the community.
Dosage and Administration: Oseltamivir Phosphate may be taken with or without food.
However, when taken with food, tolerability may be enhanced in some patients.
Standard Dosage – Treatment of Influenza
Adults and Adolescents: The recommended oral dose of Oseltamivir for treatment of influenza in adults and adolescents 13 years and older is 75 mg twice daily for 5 days.
Treatment should begin within 2 days of onset of symptoms of influenza.
Standard Dosage – Prophylaxis of Influenza
The safety and efficacy of Oseltamivir for prophylaxis of influenza in pediatric patients younger than 13 years of age have not been established.
The recommended oral dose of Oseltamivir for prophylaxis of influenza in adults and adolescents 13 years and older following close contact with an infected individual is 75 mg once daily for at least 7 days. Therapy should begin within 2 days of exposure. The recommended dose for prophylaxis during a community outbreak of influenza is 75 mg once daily. Safety and efficacy have been demonstrated for up to 6 weeks. The duration of protection lasts for as long as dosing is continued.
Side Effect: The most frequently reported adverse events are nausea and vomiting.
These events generally of mild to moderate degree and usually are occurred on the first
2 days of administration. Additional adverse events occurring in <1% of patients receiving
Oseltamivir for treatment include unstable angina, anemia, pseudomembranous colitis, humerus fracture, pneumonia, pyrexia, and peritonsillar abscess.
Drug Interaction: Information derived from pharmacology and pharmacokinetic studies of Oseltamivir suggests that clinically significant drug interactions are unlikely. Coadministration with amoxicillin does not alter plasma levels of either compound.
Warning & Precautions: There is no evidence for efficacy of Oseltamivir Phosphate in any illness caused by agents other than influenza viruses Types A and B. Efficacy of
Oseltamivir Phosphate in patients who begin treatment after 40 hours of symptoms has
99

bexinfo: T
HERAPEUTIC
G
UIDE not been established. The safety and pharmacokinetics in patients with hepatic impairment have not been evaluated. Dose adjustment is recommended for patients with a serum creatinine clearance <30 mL/min. Oseflu is not indicated for either treatment or prophylaxis of influenza in pediatric patients younger than 1 year of age.
Use in Pregnancy & Lactation: Not recommended in pregnancy. Oseltamivir Phosphate should be used only if the potential benefit for the lactating mother justifies the potential risk to the breast-fed infant.
Contraindications: This is contraindicated in patients with known hypersensitivity to any of the components of the product.
Commercial Pack: Oseflu ® Capsule: Box containing 10 capsules in blister strip. Each capsule contains Oseltamivir Phosphate INN equivalent to Oseltamivir 75 mg.
®
Tablet
This is a preparation of Valacyclovir, is the hydrochloride salt of L-valyl ester of the antiviral drug Acyclovir.
Indications: Valacyclovir is indicated for the treatment of Herpes zoster (shingles), for the treatment or suppression of genital herpes in immuno-competent individual and for the suppression of recurrent genital herpes in HIV infected patients. Also indicated for the treatment of cold sores (Herpes labialis).
Dosage & Administration: Herpes zoster: The recommended dosage of Valacyclovir for the treatment of Herpes zoster is 1gm orally three times daily for 7 days.
Genital herpes: Initial episodes: The recommended dosage of Valacyclovir for the treatment of initial genital herpes is 1 gm twice daily for 10 days.
Suppressive therapy: The recommended dosage of Valacyclovir for chronic suppressive therapy of recurrent genital herpes is 1 gm once daily in patients with normal immune function.
Reduction of transmission: The recommended dosage of Valacyclovir for reduction of transmission of genital herpes in patients with a history of 9 or fewer recurrences per year is 500mg once daily for source partner.
Cold sores (Herpes labialis): The recommended dosage of Valacyclovir for the treatment of cold sores is 2gm twice daily for 1 day taken about 12 hours apart.
Patient with acute or chronic Renal Impairment: In patients with reduced renal function, reduction in dosage is recommended.
100

bexinfo: T
HERAPEUTIC
G
UIDE
Side Effects: The most frequently reported side effects are nausea, headache, vomiting, dizziness and abdominal pain.
Drug Interactions: No dosage adjustment is recommended when Valacyclovir is coadministrated with Digoxin, Antacids, Thiazide diuretics, Cimetidine or Probenecids in subjects with normal renal function.
Warning & Precautions: Caution should be exercised when administering Valacyclovir to patients receiving nephrotoxic drug. The safety and efficacy Valacyclovir have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV- infected patients. Safety and effectiveness of Valacyclovir in pre-pubertal pediatric patients have not been established. Elderly patients may require a dose reduction of Valacyclovir due to a low body weight or disorders (renal, CNS etc) associated with aging.
Use in Pregnancy & Lactation: Valacyclovir should be administered to a pregnant woman and nursing mother with caution and only when indicated.
Contraindications: Valacyclovir is contraindicated in patients with a known hypersensitivity or intolerance to Valacyclovir, Acyclovir or any component of the formulation.
Commercial Pack: Ovalac ® Tablet: Box containing 10 tablets. Each tablets contains
Valacyclovir Hydrochloride INN equivalent to 500mg Valacyclovir.
NTI
®
Tablet
This is the brand name for Efavirenz, a synthetic anti-retroviral agent, which is a nonnucleoside reverse transcriptase inhibitor.
Indications: Avifanz (Efavirenz) in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection.
Dosage and Administration: Adults: The recommended dosage of Avifanz is 600 mg orally, once daily, in combination with a protease inhibitor and or nucleoside analogue reverse transcriptase inhibitors (NRTIs). This should be taken on an empty stomach preferably at bed time. However, a high fat meal may increase the absorption of Avifanz and should be avoided.
In order to improve the tolerability of nervous system side effects, bedtime dosing is recommended during the first two to four weeks of therapy and in patients who continue to experience these symptoms.
101

bexinfo: T
HERAPEUTIC
G
UIDE
Pediatric Patients: The following table describes the recommended dose of Avifanz for pediatric patients 3 months of age or older and weighing between 10 and 40 Kg.
Pediatric Dose to be Administered Once Daily
Body Weight (Kg)
3.5 to < 5
5 to < 7
7.5 to < 15
15 to < 20
20 to < 25
25 to < 32.5
32.5 to < 40
At least 40
Avifanz Dose (mg)
100
150
200
250
300
350
400
600
Side Effects: CNS: Dizziness, impaired concentration, abnormal dreams and insomnia.
Dermatologic and Sensitivity Reactions: Rash, pruritus, sweating, allergic reaction, alopecia, eczema, falliculities, skin exfoliation or urticaria.
GI Effects: Nausea or diarrhea, vomiting, dyspepsia, abdominal pain, or flatulence.
Cardiovascular Effects: Elevation of total serum cholesterol, hot flushes, flushing, palpitations, tachycardia, or thrombophlebitis.
Warning and Precautions: Regular, periodic measurement plasma HIV-1 RNA levels and CD4+ T-cell counts is necessary to determine the risk of disease progression and to determine when to modify anti-retroviral agent regimens.
Patients should be advised that Efavirenz has not been shown to reduce the risk of transmission of HIV to others via sexual contact or blood contamination. Efavirenz should always be administered in conjunction with other anti-retroviral agent and should not be used alone in the treatment of HIV infection. Although Efavirenz used in combination with other anti-retroviral agents appears to be well tolerated, patients should be monitored closely for adverse effects during combination therapy.
The effect of Efavirenz therapy on subsequent therapy with other non-nucleoside reverse transcriptase inhibitors remains to be determined. Because cross-resistance occurs among non-nucleoside reverse transcriptase inhibitors, most clinicians suggest that individuals who experience disease progression while receiving one of the agents (e.g.,
Delavirdine, Efavirenz, Nevirapine) should not be switched to another agent in the class.
Because Efavirenz has been associated with adverse CNS effect patients should be advised that the drug may impair their ability to perform hazardous activities requiring mental alertness or physical coordination such as operating machinery or driving a motor vehicle. In addition, patients receiving Efavirenz should be informed that there is a potential for additive CNS effects if they use Efavirenz concomitantly with psychoactive drugs or alcohol.
102

bexinfo: T
HERAPEUTIC
G
UIDE
The drug should be used with caution in patents with hepatic impairment. Serum hepatic enzyme concentrations should be monitored during Efavirenz therapy in patients who have, or may have, Hepatitis B and / or C virus infection, in patients receiving concomitant ritonavir and in patients receiving concomitant therapy with hepatotoxic drug (s).
Because of the risk of fetal malformations, Efavirenz should not be used in women who are or may become pregnant unless no other therapeutic options exist.
Pediatric Precautions: Safely and efficacy of Efavirenz in neonates and children younger than 3 years of age or who weigh less than 13 kg have not been evaluated. Antihistamins may be used for the prevention of rash.
Contraindications: Efavirenz is contraindicated in patients with known hypersensitivity to the drug or any ingredient in formulation.
Commercial Pack: Avifanz ® Tablet: Each box contains 1 x 10’s tablets in blister strip.
Each tablet contains Efavirenz INN 600 mg.
103

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablet
Nelfinavir (as mesylate) a human immunodeficiency virus (HIV) protease inhibitor available as film coated tablet in 250 mg strength (as Nelfinavir free base).
Indications: Avifix is indicated for the treatment of HIV infection when antiretroviral therapy is warranted.
Dosage and Administration: Adults: The recommended dose is 1250 mg (five 250 mg tablets) twice daily or 750 mg (three 250 mg tablets) three times daily. Avifix should be taken with a meal. Antiviral activity is enhanced when Avifix is administered in combination with nucleoside analogues. Therefore, it is recommended that Avifix be used in combination with nucleoside analogues.
Pediatric Patients (2-13 years): The recommended oral dose of Avifix for pediatric patients
2 to 13 years of age is 45 - 55 mg / kg twice daily or 25 - 35 mg / kg thrice daily. The recommended pediatric dose of Avifix to be administered three times daily is described in following table:
Pediatric Dose to be Administered Three Times Daily
Body Weight
Kg
Number of Level
1 gm Scoops
Number of Level
Teaspoons
7 to < 8.5
8.5 to < 10.5
10.5 to < 12
12 to < 14
14 to < 16
16 to < 18
18 to < 23 greater than or equal to 23
6
7
4
5
8
9
10
15
2
2 ¼
2 ½
3 ¾
1
1 ¼
1 ½
1 ¾
Number of
Tablets
2
3
-
-
-
-
-
-
Side Effects: The most common adverse event among patients receiving Nelfinavir was diarrhea. Body as a whole: Abdominal pain, accidental injury, allergic reaction, asthenia, back pain, fever, headache, malaise, pain and redistribution / accumulation of body fat.
Digestive System: Anorexia, dyspepsia, epigastric pain, gastrointestinal bleeding, hepatitis, mouth ulceration, pancreatitis and vomiting. Hemic / Lympathic System:
Anemia, leukopenia and thrombocytopenia. Metabolic / Nutritional: Increase in alkaline phosphate, amylase, creating phosphokinase, lactic dehydrogenase, SGOT, SGPT and gamma glutamyl transpeptidase, hyperlipemia, hyperuricemia, hyperglycemia, hypoglycemia, dehydration and liver function tests abnormal. Musculoskeletal System:
104

bexinfo: T
HERAPEUTIC
G
UIDE arthralgia, arthritis, cramps, myalgia, myast henia and myopathy. Nervous System: anxiety, depression, dizziiness, emotional lability, hyperkinesia, insomnia, migraine, paresthesia, seizures, sleep disorder, somnolence and suicide ideation. Respiratory
System: dyspnea, pharyngitis, rhinitis and sinusitis. Skin / Appendages: Dermatitis, folliculits, fungal dermatitis, maculopapular rash, pruitus, sweating, and urticaria . Special
Senses: Acute iritis and eye disorder. Urogenital System: Kidney calculas, sexual dysfunction and urine abnormality.
Drug Interactions: Co-administration of drugs that inhibit CYP3A may increase Nelfinavir plasma concentration.
Drugs That Should Not Be Co-administered With Avifix are: Amiodarone, Quinidine,
Astemizole, Terfenadine, Ergot derivatives, Rifampin, Midazolam, Triazolam, Cisapride,
Carbamazepine and Ethinyl estradiol.
Drugs Which Require a Dose Reduction When Co-adminstered With Avifix: Rifabutin
Anti-HIV Protease Inhibitors: There are no safety and efficacy data available from the use of this combination with Indinavir, Ritonavir and Saquinavir.
Anti-HIV Reverse Transcriptase Inhibitors: Didanosine: It is recommended that didanosine be administered on an empty stomach; therefore, Nelfinavir should be administered (with food) one hour after or more than two hours before didanosine.
Zidovudine: Dose adjustment is not needed when Zidovudine is administered with Avifix.
Avifix can be co-administered with Lamivudine or stavudine.
Warning and Precautions: New onset diabetes mellitus, exacerbation of pre-existing diabetes mellitus and hyperglycemia have been reported during post-marketing surveillance in HIV-infected patients receiving protease inhibitor therapy. Some patients required either initiation or dose adjustments of insulin or oral hypoglycemic agents for treatment of these events. In some cases diabetic ketoacidosis has occurred.
Pregnancy Category B and Lactation: This can be used during pregnancy and breast feeding.
Pediatric: The safety, effectiveness and pharmacokinetics of Nelfinavir have not been evaluated in pediatric patients below the age of 2 years.
Contraindications: Avifix is contraindicated in patients with clinically significant hypersensitivity to any of its components. Co-administration of Avifanz is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentration are associated with serious life threatening events.
Commercial Pack: Avifix ® Tablet: Each box contains 1 x 10’s tablets in blister strip.
Each tablet contains Nelfinavir (as mesylate) 250 mg.
105

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablet
Avilam is a preparation of Lamivudine (formerly known as 3TC), a synthetic nucleoside analogue with activity against HIV.
Indications: Avilam in combination with other antiretroviral is indicated for the treatment of HIV infection.
Dosage and Administration: Adults and Adolescents (<16 years of age): The recommended oral dose of Avilam for adults and adolescents is 150 mg twice daily or
300 mg once daily administered in combination with other antiretroviral.
Pediatric Patients: The recommended oral dose of Avilam for pediatric patients 3 months to up to 16 years of age is 4 mg / kg twice daily (up to a maximum of 150 mg twice a day) administered in combination with Zidovudine.
Dose Adjustment: It is recommended that doses of Avilam be adjusted in accordance with renal function.
Adjustment of Dosage of Avilam in Accordance With Creatinine Clearance
Creatinine Clearance (mL / min) Recommended Dosage of Avilam
>50 150 mg twice daily or 300 mg once daily
30-49
15-29
150 mg once daily
150 mg first dose, then 100 mg once daily
5-14
<5
150 mg first dose, then 50 mg once daily
50 mg first dose, then 25 mg once daily
Warnings and Precautions: In pediatric patients with a history of pancreatitis or other significant risk factors for the development of pancreatitis, the combination of Lamivudine and Zidovudine should be used with extreme caution and only if there is no satisfactory alternative therapy. Treatment with Lamivudine should be stopped immediately if there are clinical signs, symptoms, or laboratory abnormalities suggestive of pancreatitis.
Treatment with Lamivudine should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or hepatotoxicity. Reduction of the dosage of Lamivudine is recommended for patients with impaired renal function.
Side Effects: The events identified during use of in clinical practice include alopecia, anaphylaxis, hyperglycemia, lactic acidosis and hepatic steatosis, peripheral neuropathy, pruritus, rash, urticaria, and weakness.
Contraindications: This is contraindicated in patients with previously demonstrated clinically significant hypersensitivity to any of the components of the product.
Commercial Pack: Avilam ® Tablet: Each box contains 1x10’s tablets in blister strip. Each tablet contains Lamivudine USP 150 mg.
106

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablet
Diavix tablets are combination tablets containing Lamivudine USP 150 mg and
Zidovudine USP 300 mg.
Indications: Diavix is indicated for the treatment of HIV infection.
Dosage and Administration: The recommended oral dose of Diavix for adults and adolescents is one tablet twice daily.
Pediatric patients: The recommended oral dosage of pediatric patients who weighted greater than or equal to 30 kg is 1 tablet twice daily.
Dose Adjustment: As it is a fixed-dose combination, Diavix should not be prescribed for patients requiring dosage adjustment such as patients with impaired hepatic function, those with reduced renal function (creatinine clearance <50 mL / min), those with low body weight (<50 kg or 110 lb), or those experiencing dose-limiting adverse events.
Contraindications: This is contraindicated in patients with previously demonstrated clinically significant hypersensitivity to any of the components of the product.
General: Reduction of doses of Lamivudine is recommended for patients with low body weight (less than 50 kg or 110 lb).
Warning and Precautions: Assess risk to patient and take action as needed in chronic hepatitis B, hepatomegaly with steatosis. lactic acidosis, liver function impairment, severe renal function impairment, peripheral neuropathy.
Side Effects: Body as a whole: Headache, malaise , fatigue, fever. Digestive: Nausea, diarrhea, vomiting, anorexia, abdominal pain, abdominal cramps, dyspepsia. Nervous system: Neuropathy, insomnia & other sleep disorders, dizziness, depressive disorders.
Respiratory: Nasal signs & symptoms, cough. Skin: Skin rashes. Musculoskeletal:
Musculoskeletal pain, myalgia, arthralgia.
The following events have been chosen for inclusion due to their seriousness, frequency of reporting, causal connection to Lamivudine and / or Zidovudine or a combination of these factors. Cardiovascular: Cardiomyopathy. Endocrine and Metabolic: Gynecomastia, hyperglycemia. Gastrointestinal: Oral mucosal pigmentation, stomatitis. Hemic and
Lymphatic: Aplastic anemia, anemia, lymphadenopathy, pure red cell aplasia, splenomegaly. Hepatic and Pancreatic: Lactic acidosis and hepatic steatosis, steatosis, pancreatitis, post-treatment exacerbation of hepatitis B. Hypersensitivity: Sensitization reactions (including anaphylaxis), urticaria. Musculoskeletal: Muscle weakness, CPK elevation, rhabdomyolysis. Nervous: Paresthesia, peripheral neuropathy, seizures.
Respiratory: Wheezing. Skin: Alopecia, erythema multiforme, Stevens-Johnson syndrome.
Commercial Pack: Diavix ® Tablet: Each box contains 1x10’s tablets in blister strip. Each tablet contains Lamivudine USP 150 mg and Zidovudine USP 300 mg.
107

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablet
A fixed dose combination of Lamivudine (150 mg), Zidovudine (300 mg) and Nevirapine
(200 mg) is recommended for Human Immunodeficiency Virus (HIV-1) infected patients who are able to tolerate standard doses of Lamivudine, Zidovudine and Nevirapine for at least 2 weeks prior to switching over to this fixed dose combination.
Indications: Triovix is recommended for Human Immunodeficiency Virus (HIV-1) infected patients weighted at least 25 kg.
Dosage and Administration: For treatment of HIV Infection.
Adult Dosage: One tablet twice daily. This fixed dose combination is not recommended for patients who have not been on initial lower dose of Nevirapine 200 mg once daily for
2 weeks and or have not tolerated this dose. After successful therapy with low dose
Nevirapine for two weeks, patients can be switched over to 200 mg b.i.d. dose provided they have not demonstrated any hypersensitivity reaction (rash, abnormal liver function tests) during their initial exposure to Nevirapine. Monitoring of patients for their liver function tests etc. is desirable prior to initiating therapy with Nevirapine and monitoring at frequent intervals once therapy with fixed dose combination is continued.
Dosage Adjustment: Lamivudine: For patients with low body weight (<50 kg) where dosage adjustment may be required, it preferable not to use this fixed dose combination.
Zidovudine: Because it is a fixed-dose combination, this should not be prescribed for patients requiring dosage adjustment such as those with reduced renal function
(creatinine clearance 50 ml / min) or those experiencing dose-limiting adverse events.
Nevirapine: For patients who experience severe rash or rash with constitutional complaints during the initial low dose Nevirapine phase of 14 days with once daily dose of 200 mg, neither, dose should be increased to twice daily nor they should receive triple fixed dose combination until the rash is resolved. Similarly for patients with abnormal liver function tests, Nevirapine therapy should be stopped till liver function return to normal and careful restart is advisable after extended observation. In event of recurrence,
Nevirapine therapy can not be restarted.
For patients where Nevirapine therapy has to be restarted after an interruption, someone daily dose of Nevirapine 200 mg for 14 days should be followed with twice daily dose in absence of any hypersensitivity reaction.
Side Effects: Lamivudine: Pancreatitis, Paresthesias, Peripheral neuropathy, cough, dizziness, fatigue, gastrointestinal problems, headache, insomnia, anemia, neutropenia, drug induced skin, rash, hair loss. Zidovudine: Headache ,malaise , fatigue, fever or chills, nausea, diaphoresis, dyspnea, fever, rash and taste perversion have been reported. Skin rashes, Myalgia has been reported in patients receiving Zidovudine. The major adverse effect is bone marrow toxicity resulting in severe anemia and / or neutropenia. Nevirapine:
Incidence more frequent: Skin rash, diarrhea, gastrointestinal problems, headache,
108

bexinfo: T
HERAPEUTIC
G
UIDE nausea, stomach pain; incidence less frequent: aphthous stomatitis, fever, hepatitis,
Stevens – Johnson syndrome.
Warning and Precautions: Assess risk to patient and take action as needed: Chronic
Hepatitis B, Hepatomegaly with steatosis, lactic acidosis, liver function impairment, severe renal function impairment, peripheral neuropathy.
Contraindications: History of hypersensitivity to Lamivudine, Zidovudine, Nevirapine and to any of excipients available in formulation. Not to be used as initial therapy because initial therapy requires 200 mg once daily of Nevirapine whereas fixed dose combination allows for 200mg twice daily of Nevirapine.
Commercial Pack: Triovix ® Tablet: Each box contains 1x10’s tablets in blister strip. Each tablet contains Lamivudine USP 150 mg, Zidovudine USP 300 mg & Nevirapine USP
200 mg respectively.
109

C
D

bexinfo: T
HERAPEUTIC
G
UIDE
A
NTI
-A
NGINALS
®
Tablet
Monate tablet contains Isosorbide Mononitrate BP 20 mg which is an organic nitrate. It is a vasodilator, active on both arteries and veins.
Indications: Monate tablets are indicated for prophylaxis of angina pectoris and as an adjunct to treatment of heart failure.
Dosage and Administration: Adults: The recommended dosage is from 20 to 120 mg
Isosorbide Mononitrate daily in divided doses. The majority of patients will require a dosage in the range of 40 to 60 mg daily in divided doses.
Elderly: There is no evidence to suggest an adjustment of dose. However, caution may be required.
Children: The safety and efficacy of Isosorbide Mononitrate in children has not been established.
Side Effects: Headache and feelings of dizziness, feelings of weakness, nausea or vomiting may occur occasionally. Side effects that have been associated with Isosorbide
Dinitrate (e.g. flushing, postural hypotension, dry rash, exfoliative dermatitis) may also occur.
Warning and Precautions: Isosorbide Mononitrate tablet is not indicated for the relief of an acute attack, sublingual or buccal glyceryl trinitrate tablets or spray should be used.
In the case of acute myocardial infarction, Isosorbide Mononitrate tablets should be continued only under strict medical supervision. Since a rebound phenomenon cannot be excluded, therapy with Isosorbide Mononitrate should be terminated gradually rather than stopping abruptly.
Use in Pregnancy and Lactation: Use in pregnancy and lactation is not recommended unless considered essential by the physician.
Drug Interactions: Orthostatic hypotension may occur with combined use of calcium channel blockers, antihypertensive agents, phenothiazines or tricyclic antidepressants.
Use of alcohol with Isosorbide Mononitrate may produce severe hypotension and collapse.
Contraindications: It is contraindicated in patients with a known hypersensitivity to
Isosorbide Mononitrate or Isosorbide Dinitrate. Also in cases of marked low blood pressure, shock and acute myocardial infarction with low left ventricular filling pressure.
Commercial Pack: Monate ® Tablet: Box containing 100 tablets in 10x10’s blister strips.
Each tablet contains Isosorbide Mononitrate BP 20 mg.
113

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablet
Metazine MR contains Trimetazidine Hydrochloride, an unique anti-anginal and antiischemic agent that exerts anti-ischemic effects without inducing hemodynamic changes and improves the status of ischemic myocardium
Indications: Trimetazidine Hydrochloride is indicated for
1. Ischemic heart disease (angina pectoris, sequelae of infarction)
2. Adjuvant symptomatic treatment of vertigo and tinnitus
3. Adjuvant treatment of the decline visual acuity and visual field disturbances, presumably of vascular origin.
Dosage and Administrations: One tablet at mealtimes in the morning and evening.
Side Effects: Trimetazidine Hydrochloride is safe and well tolerated. The most common side effects encountered are gastric discomfort, nausea, headache and vertigo. However, the side effects are mild and non-specific.
Contraindications: Trimetazidine Hydrochloride is contraindicated in patients who are hypersensitive to Trimetazidine.
High Risk Group: Use in Pregnancy: Prescription should be avoided during pregnancy.
Use in Nursing mother: Breast feeding should be discontinued if the use of Trimetazidine
Hydrochloride is considered essential.
Use in Children: Safety and efficacy have not been established with Trimetazidine
Hydrochloride use in children.
Drug Interactions: No drug interactions specially with β -blockers, calcium antagonists, nitrates, heparin, hypolipidemic agents or digitalis preparation have been reported.
Commercial Pack: Metazine ® MR Tablet: Box containing 30 tablets in 3X10’s Alu-Alu form packs. Each modified release tablet contains Trimetazidine Hydrochloride BP 35mg.
®
Spray
Nitrosol Aerosol is a metered dose spray containing Glyceryl Trinitrate BP.
Indications: Nitrosol Aerosol is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.
114

bexinfo: T
HERAPEUTIC
G
UIDE
Dosage and Administration: At the onset of an attack, one or two metered sprays should be administered under the tongue. No more than three metered sprays are recommended within a 15-minute period.
Contraindications: Nitroglycerin is contraindicated in patients who are allergic to it. It is also contraindicated in patients taking certain drugs for erectile dysfunction
(phosphodiesterase inhibitors): in Hypotensive Shock, Narrow-angle Glaucoma, Severe anemia, Cerebral hemorrhage and Brain trauma.
Side Effects: Transitional, mild burning sensation in the mouth. Pulsation in the head, facial flush, headache, dizziness, palpitation, sensation of heat, nausea, sweating. Mainly at overdosage, methemoglobinemia and cyanosis may occur.
Warning and Precautions: Severe hypotension, particularly with upright posture, may occur even with small doses of nitroglycerin. Paradoxical bradycardia and increased angina pectoris may accompany nitroglycerin-induced hypotension. Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy. Pregnancy: Pregnancy
Category C. Nursing mothers: It is not known whether nitroglycerin is excreted in human milk. Pediatric use: Safety and effectiveness have not been established.
Drug Interactions: It should be applied with precaution together with antihypertensive, tricyclic antidepressants (hypotension is enhanced).
Commercial Pack: Nitrosol ® Spray: Each pack contains one canister of Nitrosol. Each canister of Nitrosol contains minimum 200 doses. Each actuation delivers Glyceryl
Trinitrate BP 400 mcg.
®
Tablet
Pacet contains Amiodarone Hydrochloride BP which is used to correct abnormal rhythms of the heart (an antiarrhythmic medication).
Indication: Amiodarone is used for ventricular fibrillation, ventricular tachycardia, atrial fibrillation, and atrial flutter.
Dosage and Administration: Oral dose is 200 mg 3 times daily for 1 week reduced to
200 mg twice daily or the minimum required to control arrhythmia.
Side Effects: The most severe side effects are any symptoms of cough, fever, or painful breathing, reversible corneal microdeposits, impaired vision due to optic neuritis, peripheral neuropathy, bradycardia and conduction disturbances, phototoxicity and rarely persistent skin discoloration, hypothyroidism, hyperthyroidism, raised serum transaminases, jaundice, hepatitis and cirrhosis etc.
Warning and Precautions: Use in pregnancy and lactation: Pacet should not be administered during pregnancy and lactation.
115

bexinfo: T
HERAPEUTIC
G
UIDE
Drug Interactions: Amiodarone may interact with β - blockers, calcium-channel blockers, digoxin, flecainide, procainamide, quinidine, tricyclic antidepressants, warfarin and dextromethorphan.
Commercial pack: Pacet ® 100 Tablet and Pacet ® 200 Tablet: Each box containing 3 x
10’s tablets in blister strip. Each tablet contains Amiodarone Hydrochloride BP 100 mg and 200 mg respectively.
116

bexinfo: T
HERAPEUTIC
G
UIDE
A
NTI
- H
EMORRHAGIC
®
IV Injection
Tranexil is a preparation of Tranexamic acid, which is is antifibrinolytic agent.
Indication: Tranexil Injection is indicated in patients with hemophilia for short term use
(two to eight days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.
Dosage and Administration: Immediately before tooth extraction in patients with hemophilia, administer 10 mg per kg body weight of Tranexil intravenously together with replacement therapy. Following tooth extraction, intravenous therapy, at a dose of 10 mg per kg body weight three to four times daily, may be used for 2 to 8 days.
For patients with moderate to severe impaired renal function, the following dosages are recommended
Serum Creatinine (µmol / L) Tranexamic Acid IV Dosage
120 to 250 (1.36 to 2.83 mg / dL)
250 to 500 (2.83 to 5.66 mg / dL)
> 500 ( > 5.66 mg / dL)
10 mg / kg BID
10 mg / kg daily
10 mg / kg every 48 hours or 5 mg / kg every 24 hours
Side Effects: Gastrointestinal disturbances (nausea, vomiting, and diarrhea) may occur.
Giddiness and hypotension have been reported occasionally. Hypotension has been observed when intravenous injection is too rapid. Worldwide Postmarketing Reports:
Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, cerebral thrombosis, acute renal cortical necrosis, and central retinal artery and vein obstruction) have been rarely reported in patients receiving tranexamic acid for indications other than hemorrhage prevention in patients with hemophilia. However, due to the spontaneous nature of the reporting of medical events and the lack of controls, the actual incidence and causal relationship of drug and event cannot be determined.
Warning & Precautions: The dose of Tranexil Injection should be reduced in patients with renal insufficiency because of the risk of accumulation.
Ureteral obstruction due to clot formation in patients with upper urinary tract bleeding has been reported in patients treated with Tranexamic Acid.
Venous and arterial thrombosis or thromboembolism has been reported in patients treated with Tranexamic Acid. In addition, cases of central retinal artery and central retinal vein obstruction have been reported.
117

bexinfo: T
HERAPEUTIC
G
UIDE
Patients with a previous history of thromboembolic disease may be at increased risk for venous or arterial thrombosis.
Tranexil should not be administered concomitantly with Factor IX Complex concentrates or Anti-inhibitor Coagulant concentrates, as the risk of thrombosis may be increased.
Patients with disseminated intravascular coagulation (DIC), who require treatment with
Tranexil must be under strict supervision of a physician experienced in treating this disorder.
Use in Pregnancy and Lactation: Pregnancy Category B. Tranexamic acid is present in the mother's milk at a concentration of about a hundredth of the corresponding serum levels. Caution should be exercised when Tranexil is administered to a nursing woman.
Contraindications: Tranexil Injection is contraindicated:
• In patients with acquired defective color vision, since this prohibits measuring one endpoint that should be followed as a measure of toxicity.
• In patients with subarachnoid hemorrhage. Anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by Tranexilin such patients.
• In patients with active intravascular clotting.
• Hypersensitivity to this product.
Drug Interaction: Tranexamic Acid is known to interact with other drugs like Factor VIII.
These interactions are sometimes beneficial and sometimes may pose threats to life.
Always consult your physician for the change of dose regimen or an alternative drug of choice that may strictly be required.
Commercial Pack: Tranexil ® IV Injection: Box containing 1X5 ampoules of 5 ml in blister pack. Each 5 ml ampoule contains Tranexamic Acid BP 500 mg.
118

bexinfo: T
HERAPEUTIC
G
UIDE
A
NTI
-H
YPERTENSIVES
®
Tablet
Amdocal contains amlodipine, a dihydropyridine calcium antagonist, with a long duration of action.
Indications: Amdocal is indicated for the treatment of hypertension, stable angina, confirmed or suspected vasospastic angina.
Dosage and Administration: The usual initial oral dose is 5 mg once daily with a maximum dose of 10 mg once daily. Elderly individuals or patients with hepatic insufficiency may be started with 2.5 mg once daily dose.
Contraindication: Amlodipine is contraindicated in patients with known hypersensitivity to Amlodipine.
Warning and Precautions: Caution should be exercised when administering Amlodipine with any other peripheral vasodilator particularly in patients with severe aortic stenosis, with congestive heart failure and patients with hepatic impairment.
Side Effects: Peripheral edema, skin erythema, facial flushing and fatigue were reported.
Commercial Pack: Amdocal ® 5 Tablet and Amdocal ® 10 Tablet: Box containing 100 tablets in 10 x 10’s Alu-Alu form packs and 60 tablets in 6 x 10’s Alu-Alu form packs respectively. Each tablet contains Amlodipine Besilate BP equivalent to Amlodipine 5 mg and 10 mg respectively.
®
Tablet
Amdocal Plus contains Amlodipine Besylate, a dihydropyridine calcium antagonist and
Atenolol, a selective β1 blocker.
Indications: Hypertension not controlled by monotherapy, Angina pectoris & hypertension co existing diseases, Post M.I patients, Refractory angina pectoris where nitrate therapy has failed.
Dosage and Administration: The recommended dosage is one tablet of Amdocal Plus
50 or Amdocal Plus 25. Depending upon the therapeutic response, titration of the dosage is recommended. In elderly patients, it is advisable to initiate the therapy with ½ tablet of
Amdocal Plus 50.
119

bexinfo: T
HERAPEUTIC
G
UIDE
Contraindications: Amdocal Plus is contraindicated in patients with a known sensitivity to dihydropyridines and atenolol. It should not be used in cardiogenic shock, clinically significant aortic stenosis, unstable angina, severe bradycardia, second degree or third degree heart block, uncontrolled heart failure, hypotension, severe peripheral vascular disease (including intermittent claudication), sick sinus syndrome, cardiogenic shock, pheocromocytoma (without a concommitant α blocker), metabolic acidosis.
Side Effects: Amlodipine: Peripheral edema, skin erythema, facial flushing and fatigue
Atenolol: Pronounced fatigue and cold extremities, bradycardia, dizziness and gastrointestinal symptoms, sleep disturbances, depressions, paresthesia, impotence, exanthema, psoriasis exacerbations and arthropathies.
Warning and Precautions: Atenolol may mask the symptoms of hyperthyroidism and hypoglycaemia.
Use in Pregnancy & Lactation: Atenolol crosses the placenta. So it is contraindicated in pregnancy and lactation.
Commercial Pack: Amdocal ® Plus 25 Tablet and Amdocal ® Plus 50 Tablet: Box containing 30 tablets in 3 X 10’s Alu-Alu form packs and 60 tablets in 6 X 10’s Alu-Alu form packs respectively. Each tablet contains Amlodipine Besilate BP equivalent to
Amlodipine 5 mg and Atenolol BP 25 mg and Amlodipine Besilate BP equivalent to
Amlodipine 5 mg and Atenolol BP 50 mg respectively.
®
Tablet
It is a combination product containing Amlodipine Besilate BP equivalent to 5 mg
Amlodipine, a calcium channel blocker and Atorvastatin calcium INN equivalent to 10 mg
Atorvastatin, a statin (HMG-CoA reductase inhibitor).
Indications: Patients in whom treatment with Amlodipine and Atorvastatin is appropriate at the dose presented, which include hypertension, chronic stable angina, an adjunct to diet for hypercholesterolemia and in hypertensive patient with multiple risk factors for
CHD to reduce the risk of non fatal MI and non fatal stroke.
Amlodipine:
1. Hypertension
2. Coronary Artery Disease (CAD): a. Chronic Stable Angina b. Vasospastic Angina (Prinzmetal's or Variant Angina) c. Angiographically Documented CAD
120

bexinfo: T
HERAPEUTIC
G
UIDE
Atorvastatin:
Atorvastatin is indicated as an adjunct to diet to reduce elevated total cholesterol, LDLcholesterol, apolipoprotein B and triglyceride levels in patients with a. Primary hypercholesterolemia (heterozygous familial and non familial) b. Mixed dyslipidemia (Fredrickson types lla and llb) c. Patients with elevated serum triglyceride levels (fredrickson type iv) d. Patients with primary dysbetalipoproteinemia (Fredrickson type iii)
Dosage and Administration: Dosage of Amdova must be individualized on the basis of both effectiveness and tolerance for each individual component. Usual dose is one tablet once daily. Highest daily recommended dose of Amlodipine and Atorovastatin is 10 mg
& 80 mg respectively.
Side Effects: Amlodipine: Commonly reported side effects are headache, edema, nausea, vertigo, erythema, gum hyperplasia.
Atorvastatin: Adverse effects reported commonly include constipation, flatulence, dyspepsia, abdominal pain, headache, nausea, myalgia, diarrhea, asthenia and insomnia.
Contraindications: Amlodipine: Amlodipine is contraindicated in patients with known hypersensitivity to Amlodipine.
Atorvastatin: Contraindicated in hypersensitivity to any component of this medication.
Active liver disease or unexplained persistent elevations of serum transaminases exceeding three times the upper limit of normal.
Pregnancy / Lactation: Safety in pregnancy has not been established. Use of HMG-CoA reductase inhibitors during breast feeding is not recommended.
Pediatrics: Safety and efficacy of Atorvastatin have not been established in children.
Geriatrics: Efficacy and safety in older patients using recommended doses is similar to that seen in the general population.
Commercial Pack: Amdova ® Tablet: Box containing 30 tablets. Each tablet contains
Amlodipine Besilate BP equivalent to 5 mg Amlodipine and Atorvastatin calcium INN equivalent to 10 mg Atorvastatin.
121

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablet
Bizoran is a combination product containing Amlodipine 5mg, a calcium channel blocker and Olmesartan 10 mg, an angiotensin II receptor blocker.
Indications: Bizoran is indicated for the treatment of hypertension, alone or with other antihypertensive agents. This may also be used as initial therapy in patients who are likely to need multiple antihypertensive agents to achieve their blood pressure goals.
Dosage and Administration: Initial Therapy: The usual starting dose of Bizoran is one tablet (5 / 20 mg) once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum dose of two tablets of Bizoran (5 / 20 mg) once daily as needed to control blood pressure.
Side Effects: The most common side effects include peripheral edema, flushing, palpitations, dizziness. Other adverse reactions that occurred in placebo-controlled clinical trials are orthostatic hypotension, diarrhea, rash, abdominal pain, fatigue, back pain, pruritus, rhabdomyolysis.
Warning & Precautions: Caution should be exercised while using in following conditions:
Hypotension in volume- or Salt-depleted patients, vasodilatation, patients with severe obstructive coronary artery disease, patients with congestive heart failure, patients with impaired renal function, patients with hepatic impairment.
High Risk Group: Pregnant women: When pregnancy is detected, discontinue Bizoran as soon as possible.
Nursing Mothers: Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug,
Pediatric Use: The safety and effectiveness of Amlodipine & Olmesartan combination in pediatric patients have not been established.
Geriatric Use: Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Contraindications: Hypersensitivity to Olmesartan medoxomil or Amlodipine.
Commercial Pack: Bizoran ® Tablet: Box containing 30 tablets, in 3X10’s alu-alu form packs. Each tablet contains Amlodipine Besilate BP equivalent to 5 mg Amlodipine and
Olmesartan Medoxomil INN 20 mg.
122

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablet
Cardopril tablet contains 25 mg of Captopril, a inhibitor of angiotensin converting enzyme.
Indication: It is indicated in the treatment of hypertension and congestive heart failure.
Dosage and Administration: Hypertension: Captopril therapy should be used as an adjunct to thiazide therapy. Starting dose is 12.5 mg twice daily. The usual maintenance dose is 25 mg twice daily, which can be increased up to a maximum of 50 mg thrice daily.
Heart failure: In congestive heart failure, an initial dose of 6.25 mg to 12.5 mg is given under close medical supervision. The usual maintenance dose is 25 mg three times daily and should not exceed 50 mg thrice daily.
Warning and Precautions: Cardopril should be used with great caution in patients with impaired renal function particularly if renovascular disease is present or suspected and in patients with collagen vascular disorders such as systemic lupus erythematosus or scleroderma. Cardopril should not be used in patients with aortic stenosis or outflow tract obstruction. Cardopril should not be used in pregnancy and nursing mothers.
Side Effects: Side effects include neutropenia, anemia & thrombocytopenia, proteinuria, elevated blood urea and creatinine, elevated serum potassium and acidosis, skin rashes, weight loss, loss of taste, elevation of liver enzymes, hepatocellular injury and cholestatic jaundice, gastric irritation and abdominal pain.
Contraindication: A history of previous hypersensitivity to Captopril.
Drug Interaction: Diuretics, vasodilators, Non-steriodal anti-inflammatory agents, immunosuppressant, procainamide alopurinal.
Commercial Pack: Cardopril ® 25 Tablets and Cardopril ® 50 Tablets: Each box containing
10 blister strips of 10 tablets. Each tablet contains 25 mg of Captopril USP and 50 mg of
Captopril USP respectively.
®
Tablet
Dilapress contains Carvedilol which is a non-selective β -blocker and α
1
-blocker.
Indications: Dilapress is indicated for the treatment of essential hypertension and mild to moderate heart failure and angina pectoris.
Dosage and Administration: Essential Hypertension: Initially 12.5 mg once daily for 2 days. Thereafter the recommended dose is 25 mg once daily to a maximum 50 mg daily.
123

bexinfo: T
HERAPEUTIC
G
UIDE
Heart Failure: Initially 3.125 mg twice daily for 2 weeks, maximum 25 mg twice daily in patients less than 85 kg body weight and 50 mg twice daily in patients over 85 kg.
Angina Pectoris: Initially 12.5 mg twice daily for the first 2 days. Thereafter, the recommended dose is 25 mg twice daily.
Contraindication: Dilapress must not be used in patients with NYHA class IV (New York
Heart Association Class IV) decompensated heart failure requiring intravenous inotropic support, Asthma, Chronic obstructive pulmonary disease (COPD) with a bronchospastic component, 2nd or 3rd degree AV block, sick sinus syndrome (unless a permanent pacemaker is in place), cardiogenic shock or severe bradycardia. Therapy is not to be initiated in severe heart failure.
Side Effects: Dizziness, headache, fatigue, gastrointestinal disturbances, postural hypotension, peripheral edema, bradycardia, dry mouth, dry eyes, eye irritation or disturbed vision, impotence, disturbances of micturition, influenza- like symptoms, rarely angina, AV block, exacerbation of intermittent claudication or Raynaud's phenomenon, allergic skin reactions, nasal stuffiness, wheezing, depressed mood, sleep disturbances, paresthesia, heart failure, changes in liver enzymes, thrombocytopenia, leukopenia are also reported.
Warning and Precautions: Take precaution in hepatic impairment and in heart failure.
Before increasing dose ensure that the renal function and heart failure are not deteriorating.
Use in Pregnancy and Nursing Mothers: Carvedilol should not be used during pregnancy and lactation.
Drug Interactions: General anesthesia, class I anti-arrthythmic drugs or calcium antagonists.
Commercial Pack: Dilapress ® 6.25 Tablet, Dilapress ® 12.5 Tablet and Dilapress ® 25
Tablet: Each box containing 30 tablets in 3x10’s blister strips. Each tablet contains
Carvedilol BP 6.25 mg, Carvedilol BP 12.5 mg, and Carvedilol BP 25 mg respectively.
®
Tablet
Enaril is a Enalapril Maleate which is a long-acting angiotensin converting enzyme inhibitor.
Indications: Enaril is indicated for the treatment of all grades of essential hypertension, renovascular hypertension and heart failure.
Dosage and Administration: Essential and Renovascular Hypertension: Treatment should be initiated with 5 mg once a day.
124

bexinfo: T
HERAPEUTIC
G
UIDE
Heart failure: The recommended starting dose of Enaril is 2.5 mg once daily.
Use in the elderly (over 65 years): The starting dose should be 2.5 mg.
The usual maintenance dose is 10-20 mg once daily. In severe hypertension, the dosage may be increased incrementally to a maximum of 40 mg once daily.
Warning and Precautions: Hypotension: Symptomatic hypotension has been reported mainly in patients with severe heart failure.
Impaired renal function: Enalapril should be used with caution in patients with renal insufficiency.
Angioneurotic edema: Angioneurotic edema has been reported with ACE inhibitors, including Enalapril.
Cough: Cough has been reported with the use of ACE inhibitors.
Surgery / Anesthesia: In patients undergoing major surgery or during anesthesia with agents that produce hypotension.
Lactating mothers: Enalapril and Enalaprilat are excreted in breast milk ; caution should be exercised if Enalapril is given to lactating mothers.
Drug Interactions: β -blockers, methyldopa, calcium antagonists, diuretics, propranolol and lithium.
Side Effects: The commonly reported side effects are dizziness and headache. Other side effects occurring less frequently include orthostatic hypotension, nausea, rash, cough etc.
Cardiovascular: Myocardial infarction or cerebrovascular accident, possibly secondary to severe hypotension in high-risk patients. palpitation, rhythm disturbances.
Gastro-intestinal: Abdominal pain, dyspepsia, hepatitis, jaundice.
Nervous system: Confusion, nervousness, insomnia, somnolence.
Respiratory: Sore throat, hoarseness of voice.
Skin: Urticaria, pruritus.
Special senses: Blurred vision.
Renal: Oliguria, renal dysfunction, renal failure are reported in rare cases.
Contraindications: Enalapril is contraindicated in pregnancy. It is also contraindicated in patients who are hypersensitive to any component of this product and in patients with a history of angioneurotic edema relating to previous treatment with an ACE inhibitor.
Commercial Pack: Enaril ® 5 Tablet: Box containing 10 blister strips of 10 tablets. Each tablet contains 5 mg of Enalapril Maleate USP.
125

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablet
Indelix SR contains Indapamide which is an oral antihypertensive agent.
Indications: This is indicated in the treatment of essential hypertension. It is effective in treating hypertension in patients with renal function impairment, although its diuretic effect is reduced. It is also indicated for the treatment of salt and fluid retention associated with congestive heart failure.
Dosage and Administration: 1 tablet daily, preferably in the morning. In more severe cases, this can be combined with other categories of antihypertensive agents.
Warning and Precautions: The drug should be used cautiously in disturbed water/ electrolyte balance, diabetes, gout and kidney problems. Monitoring of potassium and uric acid serum levels is also recommended.
Use in Pregnancy and Lactation: Not recommended in pregnancy and lactation.
Use in Pediatric Patients: The safety and effectiveness in pediatric patients have not been established.
Contraindications: This drug must not be taken in the conditions: Known allergy to this drug or to sulphonamides, renal failure, severe liver disease, hypokalemia (abnormal decline in plasma potassium levels).
Side Effects: Side effects include dizziness, headache, anorexia, nausea, vomiting, constipation, diarrhea and postural hypotension. Electrolyte imbalances include hypochloremic alkalosis, hyponatremia, hypokalemia and hyperuricemia, hypersensitivity reactions which include skin rashes, cholestatic jaundice and blood dyscrasias including thrombocytopenia, leucopenia and aplastic anemia.
Drug Interaction: Other Antihypertensive: No adverse reactions occur in combination with other antihypertensive drugs.
Norepinephrine: Indapamide do not affect the effectiveness of norepinephrine.
Commercial Pack: Indelix ® SR Tablet: Box containing 30 tablets in 3X10’s blister strips.
Each sustained release tablet contains Indapamide USP 1.5 mg.
126

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablet
Labetalol is adrenergic receptor blocking agents that have both selective α
1-adrenergic and nonselective
β
-adrenergic receptor blocking actions in a single substance.
Indications: It is indicated in the management of hypertension and may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics.
Dosage and Administration: The recommended initial dosage is 100 mg twice daily whether used alone or added to a diuretic regimen. After 2 or 3 days, using standing blood pressure as an indicator, dosage may be titrated in increments of 100 mg b.i.d.
every 2 or 3 days. The usual maintenance dosage of labetalol HCl is between 200 and
400 mg twice daily.
Side Effects: Most adverse effects are mild and transient and occur early in the course of treatment. Fever, hypotension, bradycardia, heart block, paresthesia, most frequently described as scalp tingling, systemic lupus erythematosus, positive antinuclear factor, dry eyes, hepatic necrosis, hepatitis, cholestatic jaundice, elevated liver function tests.
muscle cramps, toxic myopathy, bronchospasm, rashes of various types etc.
Warning and Precautions: It should be used with caution in patients with impaired hepatic function since metabolism of the drug may be diminished.
Elderly Patients: The majority of elderly patients will require between 100 and 200 mg b.i.d.
Use in Pregnancy and Lactation: Pregnancy: Pregnancy Category C. Small amounts of labetalol (approximately 0.004% of the maternal dose) are excreted in human milk.
Caution should be exercised when administered to a nursing woman.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Contraindications: They are contraindicated in bronchial asthma, overt cardiac failure, greater-than-first-degree heart block, cardiogenic shock, severe bradycardia, other conditions associated with severe and prolonged hypotension, and in patients with a history of hypersensitivity to any component of the product.
Drug Interactions: Halogen, Nitroglyserin and Cimetidine.
Commercial Pack: Labeta ® 100 Tablet and Labeta ® 200 Tablet: Box containing 60 tablets in blister strips and 30 tablets in blister strips respectively. Each tablet contains
Labetalol Hydrochloride USP 100 mg and Labetalol Hydrochloride USP 200 mg respectively.
127

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablet
Lonet contains Atenolol, a synthetic β
1-selective (cardioselective) adrenoreceptor blocking agent
Indications: Acute Myocardial Infarction: Atenolol is indicated in the management of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality. Treatment can be initiated as soon as the patient's clinical condition allows.
Hypertension: Atenolol is indicated in the management of hypertension. It may be used alone or concomitantly with other antihypertensive agents, particularly with a thiazidetype diuretic.
Angina Pectoris due to Coronary Atherosclerosis: Atenolol is indicated for the long-term management of patients with angina pectoris.
Dosage and Administration: Hypertension: The initial dose of Atenolol is 50 mg daily.
The dosage can be increased to Atenolol 100 mg daily.
Angina Pectoris: The initial dose of Atenolol is 50 mg daily. The dosage can be increased to Atenolol 100 mg daily. Some patients may require a dosage of 200 mg once a day for optimal effect.
Dosage should be adjusted in elderly and renally-impaired patients.
Side Effects: Common adverse effects are bradycardia and hypotension. Some other side effects are agranulocytosis, fever, combined with aching and sore throat, laryngospasm and respiratory distress, reversible mental depression progressing to catatonia; an acute reversible syndrome characterized by disorientation of time and place, short-term memory loss, emotional lability with slightly clouded sensorium, and decreased performance on neuropsychometrics, mesenteric arterial thrombosis, ischemic colitis, erythematous rash, Raynaud's Phenomenon and dry eyes.
Drug Interactions: Catecholamine-depleting drugs (e.g., Reserpine) and Calcium channel blockers may have an additive effect when given with Atenolol. Clonidine and aspirin may have some drug reactions.
Warning and Precautions: General: Patients already on a
β
-blocker must be evaluated carefully before Atenolol is administered. Atenolol may aggravate peripheral arterial circulatory disorders.
Impaired Renal Function: Caution should be excised.
Use in Pregnancy & Lactation: Pregnancy Category D. Caution should be exercised when
Atenolol is administered to a nursing woman.
128

bexinfo: T
HERAPEUTIC
G
UIDE
Use in children: Safety and effectiveness in pediatric patients have not been established.
Overdose: Overdosage with Atenolol has been reported with patients surviving acute doses as high as 5 gm. One death was reported in a man who may have taken as much as 10 gm acutely.
The predominant symptoms reported following Atenolol overdose are lethargy, disorder of respiratory drive, wheezing, sinus pause and bradycardia. Additionally, common effects associated with overdosage of any β -adrenergic blocking agent and which might also be expected in Atenolol overdose are congestive heart failure, hypotension, bronchospasm and / or hypoglycemia. Treatment of overdose should be directed to the removal of any unabsorbed drug by induced emesis, gastric lavage, or administration of activated charcoal. Atenolol can be removed from the general circulation by hemodialysis. Other treatment modalities should be employed at the physician's discretion.
Contraindications: Atenolol is contraindicated in sinus bradycardia, heart block greater than first degree, cardiogenic shock, and overt cardiac failure.
Commercial Pack: Lonet ® 50 Tablet and Lonet ® 100 Tablet: Each box containing 100 tablets in 10 x 10’s blister strips. Each tablet contains Atenolol BP 50 mg. and Atenolol
BP 100 mg. respectively.
®
Tablet
Metoprol XL contains Metoprolol succinate which is an extended- release tablet.
Indications: Metoprol XL is indicated for the treatment of hypertension, angina pectoris, heart failure and treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin.
Dosage and Administration: Metoprol XL is an extended release tablet intended for once daily administration.
Hypertension: Pediatric Hypertensive Patients ≥ 6 Years of age: The recommended starting dose of Metoprol XL is 1.0 mg / kg once daily however, the maximum initial dose should not exceed 50 mg once daily. Doses above 2.0 mg / kg (or in excess of 200 mg) once daily have not been studied in pediatric patients.
Angina Pectoris: The usual initial dosage is 100 mg daily, given in a single dose. Dosages above 400 mg per day have not been studied.
Contraindication: Metoprolol is contraindicated in severe bradycardia, heart block greater than first degree, cardiogenic shock, decompensated cardiac failure, sick sinus syndrome (unless a permanent pacemaker is in place), and in patients who are hypersensitive to any component of this product.
129

bexinfo: T
HERAPEUTIC
G
UIDE
Side Effects: Hypertension, angina, tiredness, dizziness, depression, mental confusion, headache, somnolence, nightmares, insomnia, shortness of breath and bradycardia, cold extremities, palpitations, congestive heart failure, peripheral edema, syncope, chest pain, wheezing (bronchospasm) and dyspnea; nausea, dry mouth, gastric pain, constipation, flatulence, digestive tract disorders, heartburn, pruritus, peyronie's disease, musculoskeletal pain, blurred vision, decreased libido and tinnitus have also been reported.
Warning and Precautions: General: Metoprolol should be used with caution in patients with impaired hepatic function.
High Risk Group: Pregnancy Category C.
Nursing Mothers: Metoprolol is excreted in breast milk in very small quantities. Caution should be exercised when Metoprol XL is administered to a nursing woman.
Pediatric Use: Safety and effectiveness of Metoprolol have not been established in patients < 6 years of age.
Geriatric Use: There were no notable differences in efficacy or the rate of adverse events between older and younger patients.
Drug Interactions: Catecholamine-depleting drugs (eg, reserpine, monoamine oxidase
(MAO) inhibitors) may have an additive effect when given with β -blocking agents. Drugs that inhibit CYP2D6 such as quinidine, fluoxetine, paroxetine and propafenone are likely to increase metoprolol concentration. These increases in plasma concentration would decrease the cardioselectivity of metoprolol. Concomitant use of digitalis glycosides and
β -blockers can increase the risk of bradycardia. β -blockers may exacerbate the rebound hypertension which can follow the withdrawal of clonidine.
Commercial Pack: Metoprol XL ® 50 Tablet and Metoprol XL ® 100 Tablet: Each box contains 50 tablets in 5x10’s blister strips. Each Extended- Release tablet contains
Metoprolol Succinate USP 47.5 mg equivalent to Metoprolol Tartrate 50 mg. and
Metoprolol Succinate USP 95 mg equivalent to Metoprolol Tartrate 100 mg respectively.
®
Tablet
It is an angiotensin II receptor antagonist (AT1 subtype). Olmesartan Medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from gastrointestinal tract.
Indications: Olmesartan Medoxomil is indicated for the treatment of hypertension alone or in combination with other antihypertensive agents.
Dosage and Administration: Dosage must be individualized. The usual recommended
130

bexinfo: T
HERAPEUTIC
G
UIDE starting dose of Olmesartan Medoxomil 20 mg once daily when used as monotherapy in patients who are not volume-contracted. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose of Olmesartan Medoxomil may be increased to 40 mg.
Contraindications: Olmesartan Medoxomil is contraindicated in patients who are hypersensitive to any component of this product.
Side Effects: Back pain, bronchitis, creatine phosphokinase increased, diarrhea, headache, hematuria, hyperglycemia, hypertriglyceridemia, influenza-like symptoms, pharyngitis, rhinitis and sinusitis.
Warning & Precautions: Impaired Renal Function: As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals treated with Olmesartan Medoxomil. Treatment with angiotensin converting enzyme inhibitors and angiotensin receptor antagonists has been associated with oliguria and / or progressive azotemia and (rarely) with acute renal failure and / or death.
Pregnancy: Pregnancy Categories C (first trimester) and D (second and third trimesters).
Nursing Mothers: Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Geriatric Use: Of the total number of hypertensive patients receiving Olmesartan
Medoxomil in clinical studies, more than 20% were 65 years of age and over, while more than 5% were 75 years of age and older. No overall differences in effectiveness or safety were observed between elderly patients and younger patients
Drug Interactions: No significant drug interactions were reported in studies in which
Olmesartan Medoxomil was co-administered with digoxin or warfarin in healthy volunteers. The bioavailability of Olmesartan was not significantly altered by the coadministration of antacids [Al(OH)
3
/ Mg(OH)
2
]. Olmesartan Medoxomil is not metabolized by the cytochrome P450 system and has no effects on P450 enzymes; thus, interactions with drugs that inhibit, induce or are metabolized by those enzymes are not expected.
Commercial Pack: Olmesan ® 20 Tablet and Olmesan ® 40 Tablet: Each box containing
30 tablets. Each tablet contains Olmesartan Medoxomil INN 20 mg and Olmesartan
Medoxomil INN 40 mg respectively.
131

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablet
It is a combination of an angiotensin II receptor antagonist (AT1 subtype), olmesartan medoxomil, and hydrochlorothiazide .
Indications: It is indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy.
Dosage and Administration: Dosing should be individualized. The usual recommended starting dose is one tablet of Olmesan Plus (20 / 12.5) once daily. Depending on the blood pressure response, the dose may be titrated at intervals of 2-4 weeks to two tablets of
Olmesan Plus (40 / 25) once daily.
Patients with Renal Impairment: The usual regimens of therapy with Olmesan Plus may be followed provided the patient's creatinine clearance is >30 ml / min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so Olmesan Plus is not recommended.
Patients with Hepatic Impairment: No dosage adjustment is necessary with hepatic impairment.
Side Effects: The following adverse events were also reported at a rate of > 2%, but were as, or more, common in the placebo group: headache and urinary tract infection, chest pain, back pain, peripheral edema, vertigo, abdominal pain, dyspepsia, gastroenteritis, diarrhea, increased SGOT, increased GGT, increased SGPT, hyperlipemia, creatine phosphokinase increased, hyperglycemia, arthritis, arthralgia, myalgia, cough, rash.
Warning & Precautions: All patients receiving thiazide therapy should be observed for clinical signs of fluid or electrolyte imbalance: hyponatremia, hypochloremic alkalosis and hypokalemia. Serum and urine electrolyte determinations are important when the patient is vomiting excessively or receiving parenteral fluids. Warning signs or symptoms of fluid and electrolyte imbalance, irrespective of cause, include dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, confusion, seizures, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia and gastrointestinal disturbances such as nausea and vomiting. Hypokalemia may develop, especially with brisk diuresis, when severe cirrhosis is present, or after prolonged therapy.
High Risk Group: Pregnant women: Pregnancy Categories C (first trimester) and D
(second and third trimesters).
Nursing Mothers: Olmesartan and Thiazides is secreted at low concentration in the milk.
A decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
132

bexinfo: T
HERAPEUTIC
G
UIDE
Geriatric Use: Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant diseases or other drug therapy.
Drug Interaction: Alcohol, Barbiturates, or Narcotics causes potentiation of orthostatic hypotension may occur.
Contraindications: Patients who are hypersensitive to any component of this product.
Patients with anuria or hypersensitivity to other sulfonamide derived drugs; as this product contains Hydrochlorothiazide.
Commercial Pack: Olmesan Plus ® Tablet: Box containing 30 tablets. Each tablet contains Olmesartan Medoxomil INN 20 mg and Hydrochlorothiazide BP 12.5 mg.
®
Capsule / Tablet
Primace contains Ramipril which is an angiotensin converting enzyme (ACE) inhibitor.
Indications: It is indicated in mild to severe hypertension and also in congestive heart failure.
Contraindications: It is contraindicated in patients who are hypersensitive to any component of this product and in patients with a history of angioedema related to previous treatment with a ACE inhibitor.
Dosage and Administration: Dosage of Primace must be adjusted according to the patient tolerance and response.
Hypertension: The usual initial dose of Primace is 1.25 - 2.5 mg once daily. The usual maintenance dosage in adults is 2.5 - 20 mg daily given as a single dose or in 2 divided doses daily.
Congestive heart failure after myocardial infarction: Primace therapy may be initiated as early as 2 days after myocardial infarction. An initial dose of 2.5 mg twice daily is recommendedupto a maximum 5 mg twice daily.
Prevention of major cardiovascular events: In this case, the recommended dose is 2.5
mg once daily for the first week of therapy and 5 mg once daily for the following 3 weeks; dosage then may be increased, as tolerated, to a maintenance dosage of 10 mg once daily.
Dosage in renal impairment: For the patients with hypertension and renal impairment, the recommended initial dose is 1.25 mg Primace once daily up to a maximum of 5 mg daily. For the patients with heart failure and renal impairment, the recommended dose is
1.25 mg once daily.
133

bexinfo: T
HERAPEUTIC
G
UIDE
Warning and Precautions: Ramipril should be used with caution in patients with impaired renal function, hyperkalemia, hypotension, surgery / anesthesia and impaired hepatic function.
Use in pregnancy & lactation: Pregnancy should be excluded before start of treatment with Ramipril.
Side Effects: Dizziness, headache, fatigue and asthenia are commonly reported side effects. Other side effects occurring less frequently include symptomatic hypotension, cough, nausea, vomiting, diarrhea, rash, urticaria, oliguria, anxiety, amnesia etc.
Angioneurotic edema, anaphylactic reactions and hyperkalemia have also been reported rarely.
Commercial Pack: Primace ® 1.25 Capsule: Box containing 30 capsules in 3 x10’s blister strips. Each capsule contains Ramipril BP 1.25 mg.
Primace ® 2.5 Capsule: Box containing 30 capsules in 3 x10’s blister strips. Each capsule contains Ramipril BP 2.5 mg.
Primace ® 5 Capsule: Box containing 30 capsules in 3 x10’s blister strips. Each capsule contains Ramipril BP 5 mg.
Primace ® 10 Capsule: Box containing 30 capsules in 3 x10’s blister strips. Each capsule contains Ramipril BP 10 mg.
Primace ® 1.25 Tablet: Box containing 30 tablets in 3 x10’s alu-alu form packs. Each tablet contains Ramipril BP 1.25 mg.
Primace ® 2.5 Tablet: Box containing 30 tablets in 3 x10’s alu-alu form packs. Each tablet contains Ramipril BP 2.5 mg.
Primace ® 5 Tablet: Box containing 30 tablets in 3 x10’s alu-alu form packs. Each tablet contains Ramipril BP 5 mg.
Primace ® 10 Tablet: Box containing 30 tablets in 3 x10’s alu-alu form packs. Each tablet contains Ramipril BP 10 mg.
134

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablet
Prosan contains Losartan Potassium, an angiotensin-II receptor (type AT
1
) antagonist.
Indications: It is indicated for the treatment of hypertension alone or in combination with other antihypertensive agents.
Dosage and Administration: The usual starting dose is 50 mg once daily, with 25 mg used in patients with possible depletion of intravascular volume (e.g., patients treated with diuretics) and patients with a history of hepatic impairment. It can be administered once or twice daily with total daily doses ranging from 25 mg to 100 mg.
Contraindications: Losartan Potassium is contraindicated in patients who are hypersensitive to the active ingredient or any component of the drug.
Side Effects: Most common side effect is dizziness. Rarely, rash, swelling of the face, lips and / or tongue, and cough may be reported
Use in Special Population: Children: There are no data on the safety or efficacy of
Prosan in children.
Pregnant and lactating women: Prosan must be discontinued as soon as possible when pregnancy is detected. It should not be prescribed during lactation, as there is no information in human on the passage of Losartan into breast milk.
Elderly: In elderly patients up to 75 years of age, no dosage adjustment is necessary.
Commercial Pack: Prosan ® 25 Tablet and Prosan ® 50 Tablet: Each box containing 50 tablets in 5x10’s blister strips. Each film-coated tablet contains Losartan Potassium USP
25 mg and Losartan Potassium USP 50 mg respectively.
®
Tablet
Prosan HZ is a combination product of Losartan Potassium and Hydrochlorothiazide.
Indications: Prosan HZ is indicated for the treatment of hypertension after a patient has failed to achieve the desired effect with monotherapy.
Dosage and Administration: Dosing must be individualized. The usual starting dose of
Losartan is 50 mg once daily, Losartan can be administered once or twice daily at total daily doses of 25 to 100 mg. Hydrochlorothiazide is effective in doses of 12.5 to 50 mg once daily and can be given at doses of 12.5 to 25 mg as Prosan HZ.
135

bexinfo: T
HERAPEUTIC
G
UIDE
Contraindications: Prosan HZ is contraindicated in patients who are hypersensitive to any component of this product.
Side Effects: In clinical trials the overall incidence of adverse experiences reported with the combination was comparable to placebo.
Warning and Precautions: All patients receiving Prosan HZ should be observed for clinical signs of fluid or electrolyte imbalance. In diabetic patients dosage adjustments of insulin or oral hypoglycemic agents may be required.
Safety and effectiveness in pediatric patients have not been established.
Use in Patients with Renal Impairment: The usual regimens of therapy with Prosan HZ may be followed as long as the patient’s creatinine clearance is >30 mL / min. In patients with more severe renal impairment, Prosan HZ is not recommended.
Patients with Hepatic Impairment: Prosan HZ is not recommended for titration in patients with hepatic impairment because the appropriate 25 mg starting dose of losartan cannot be given.
Use in pregnancy and Lactation: Generally Prosan HZ should be discontinued in pregnancy and lactation.
Drug Interactions: Losartan: Cimetidine and Phenobarbital, Hydrochlirothiazide: Alcohol, barbiturates, or narcotics, antidiabetic drugs (oral agents and insulin), lithium and
NSAIDs.
Commercial Pack: Prosan ® HZ Tablet: Box containing 60 tablets in 6 x 10's Alu-Alu form packs. Each tablet contains Losartan potassium USP 50 mg and Hydrochlorothiazide BP
12.5mg.
Prosan ® HZ 100 / 25 Tablet: Box containing 30 tablets in 3 x 10’s Alu-Alu form packs.
Each tablet contains Losartan potassium USP 100 mg and Hydrochlorothiazide BP 25mg.
Prosan ® HZ 100 / 12.5 Tablet: Box containing 30 tablets in 3 x 10’s Alu-Alu form packs.
Each tablet contains Losartan potassium USP 100mg and Hydrochlorothiazide BP
12.5mg.
136

bexinfo: T
HERAPEUTIC
G
UIDE
A
NTI
-T
HROMBOTIC
®
Pre-filled syringe
Cleven is a READY-TO-USE sterile aqueous solution containing Enoxaparin sodium, a low molecular weight heparin with a high anti-Xa activity and with a low anti-Xa or antithrombin activity.
Indications: Cleven is indicated for-
• Treatment of venous thromboembolic disease presenting with deep vein thrombosis, pulmonary embolism or both.
• Treatment of unstable angina and non-Q-wave myocardial infarction, administered concurrently with aspirin.
• Treatment of acute ST-segment Elevation Myocardial Infarction (STEMI) including patients to be managed medically or with subsequent Percutaneous Coronary
Intervention (PCI) in conjunction with thrombolytic drugs (fibrin or non-fibrin specific).
• Prophylaxis of thromboembolic disorders of venous origin, in particular those which may be associated with orthopedic or general surgery.
• Prophylaxis of venous thromboembolism in medical patients bedridden due to acute illness.
• Prevention of thrombus formation in the extracorporeal circulation during hemodialysis.
Dosage and Administration: Adults: Prophylaxis of venous thromboembolism: In patients with a low to moderate risk of venous thromboembolism the recommended dosage is 20 mg (2,000 IU) once daily by sc injection for 7 to 10 days, or until the risk of thromboembolism has diminished. In patients undergoing surgery, the initial dose should be given approximately 2 hours pre-operatively. In patients with a higher risk, such as in orthopedic surgery, the dosage should be 40 mg (4,000 IU) daily by sc injection with the initial dose administered approximately 12 hours before surgery.
Prophylaxis of venous thromboembolism in medical patients: The recommended dose of Enoxaparin sodium is 40 mg (4,000 IU) once daily by sc injection, minimum of 6 days and continued until the return to full ambulation, for a maximum of 14 days.
Treatment of venous thromboembolism: Cleven should be administered sc as a single daily injection of 1.5 mg / kg (150 IU / kg), usually prescribed for at least 5 days and until adequate oral anticoagulation is established.
Treatment of unstable angina and non-Q-wave myocardial infarction: The recommended dose is 1 mg / kg 12 hourly by sc injection, administered concurrently with oral aspirin
(100 to 325 mg once daily), minimum of 2 days and continued until clinical stabilization.
The usual duration of treatment is 2 to 8 days.
Treatment of acute ST-segment elevation myocardial infarction: The recommended dose of Cleven is a single IV bolus of 30 mg and a 1mg / kg SC dose followed by 1 mg / kg
137

bexinfo: T
HERAPEUTIC
G
UIDE administered SC every 12 hourly (max 100mg for the first two doses only, followed by 1 mg / kg dosing for the remaining doses).
Prevention of extracorporeal thrombus formation during hemodialysis: A dose equivalent to 1 mg / kg (100 IU / kg) introduced into the arterial line at the beginning of a dialysis session is usually sufficient for a 4 hour session. If fibrin rings are found, such as after a longer than normal session, a further dose of 0.5 to 1 mg / kg (50 to 100 IU / kg) may be given. For patients at a high risk of hemorrhage the dose should be reduced to 0.5 mg / kg (50 IU / kg) for double vascular access or 0.75 mg / kg (75 IU / kg) for single vascular access.
Elderly: For treatment of acute ST-segment elevation myocardial infarction in elderly patients 75 years of age, do not use an initial IV bolus. Initiate dosing with 0.75 mg / kg
SC 12 hourly (maximum 75 mg for the first two doses only, followed by 0.75 mg / kg dosing for the remaining doses). For other indications, no dosage adjustments are necessary in the elderly, unless kidney function is impaired.
Side Effects: Hemorrhage, thrombocytopenia, elevations of serum aminotransferase, urticaria, pruritus, erythema, bluish marks at injection sites to skin rash at injection sites mat occur. Cases of neuraxial hematomas with the concurrent use of Enoxaparin and spinal / epidural anesthesia or spinal puncture have resulted in varying degrees of neurologic injuries. Although rare, cutaneous or systemic allergic reactions may occur.
Drug Interactions: It is recommended that agents which affect hemostasis such as systemic Salicylates, Acetylsalicylic acid, NSAIDs including ketorolac, Dextran, and
Clopidogrel, systemic Glucocorticoids, Thrombolytics and Anticoagulants should be discontinued prior to Enoxaparin therapy unless their use is essential. If the combination cannot be avoided, Enoxaparin should be used with careful clinical and laboratory monitoring.
Warnings & Precautions: Enoxaparin injection should not be administered by intramuscular route. It should be used with caution in conditions with increased potential for bleeding, such as impaired hemostasis, history of peptic ulcer, recent ischemic stroke, uncontrolled severe arterial hypertension, diabetic retinopathy, recent neuro or opthalmologic surgery and low weight patients (low-weight women (<45 kg) and lowweight men (<57 kg). It is recommended that the platelet count be measured befored the initiation of the treatment and regularly thereafter during treatment.
A dosage adjustment is required for patients with severe renal impairment.
Standard dosing
1 mg / kg SC twice daily
1.5 mg / kg SC once daily
30 mg-single IV bolus plus a
1 mg / kg SC dose followed by
1 mg / kg twice daily
Severe renal impairment
1 mg / kg SC once daily
1 mg / kg SC once daily
30 mg-single IV bolus plus a 1 mg / kg SC dose followed by
1 mg / kg once daily
138

bexinfo: T
HERAPEUTIC
G
UIDE
Dosage adjustments for prophylactic dosage ranges
Standard dosing
40 mg SC once daily
20 mg SC once daily
Severe renal impairment
20 mg SC once daily
20 mg SC once daily
The recommended dosage adjustments do not apply to the hemodialysis indication.
Although no dosage adjustments are recommended in patients with moderate renal impairment (creatinine clearance 30-50 ml / min) or mild renal impairment (creatinine clearance 50-80 ml / min), careful clinical monitoring is advised. It should be used in caution in case of hepatic impairment.
Contraindications: Hyper sensitivity to either Enoxaparin, Heparin or other low molecular weight Heparins, major clotting disorders like history of thrombocytopenia, active gastro-intestinal ulcer or organic lesion likely to bleed, recent hemorrhagic vascular cerebral stroke.
Commercial Pack: Cleven ® 20: Each box contains 1 pre-filled syringe containing 2000 anti-Xa IU is equivalent to 20 mg Enoxaparin Sodium USP (0.2 ml) in a blister pack.
Cleven ® 40: Each box contains 1 pre-filled syringe containing 4000 anti-Xa IU is equivalent to 40 mg Enoxaparin Sodium USP (0.4 ml) in a blister pack.
Cleven ® 60: Each box contains 1 pre-filled syringe containing 6000 anti-Xa IU is equivalent to 60 mg Enoxaparin Sodium USP (0.6 ml) in a blister pack.
Cleven ® 80: Each box contains 1 pre-filled syringe containing 8000 anti-Xa IU is equivalent to 80 mg Enoxaparin Sodium USP (0.8 ml) in a blister pack.
®
Tablet
Odrel is a preparation of Clopidogrel which is an inhibitor of ADP-induced platelet aggregation.
Indications: Odrel is indicated for the reduction of atherosclerotic events in patients with atherosclerosis documented by recent stroke, recent myocardial infarction or established peripheral arterial disease.
Dosage and Administration: The recommended dose of Odrel is 75 mg once daily with or without food. No dosage adjustment is necessary for elderly patients or patients with renal disease.
Contraindications: Odrel is contraindicated in patients with hypersensitivity to any component of the product and active pathological bleeding such as peptic ulcer or intracranial hemorrhage.
139

bexinfo: T
HERAPEUTIC
G
UIDE
Side Effects: The most common clinically important side effects are pruritus, purpura, diarrhea and rash. Infrequent events include intracranial hemorrhage (0.4%) and severe neutropenia (0.04%).
Warning and Precautions: Odrel should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery or other pathological conditions.
Drug Interactions: Concomitant administration of Odrel and NSAIDs, warfarin or heparin should be undertaken with caution. Odrel should be used with caution in hepatic impaired patients. Safety and effectiveness in the pediatric population have not been established.
Odrel should be used during pregnancy only if clearly needed.
Commercial Pack: Odrel ® Tablet: Box containing 30 tablets in 3x10’s Alu-Alu form packs. Each tablets contains Clopidogrel Bisulfate USP equivalent to 75 mg of
Clopidogrel.
®
Tablet
Odrel Plus is a fixed dose combination containing Clopidogrel and Aspirin.
Indications: Odrel Plus is indicated for the prevention of ischemic events, myocardial infarction, stroke and cardiovascular death in patients with acute coronary syndrome.
Dosage and Administration: The recommended dose is one tablet once daily.
Contraindications: Odrel Plus is contraindicated in patients with hypersensitivity to any component of the product or any NSAIDs and active pathological bleeding such as peptic ulcer or intracranial hemorrhage.
Warning and Precautions: Clopidogrel should be used with caution in-patients who may be at risk of increased bleeding from trauma, surgery or other pathological conditions.
Clopidogrel should be discontinued 7 days prior to surgery.
Odrel Plus should be avoided in patients with impaired hepatic and renal function & during the last three months of pregnancy and nursing mothers.
Safety and effectiveness of Odrel Plus in the pediatric population have not been established.
Side Effects: Adverse effects are gastro-intestinal disturbances and skin rashes, neutropenia, thrombotic thrombocytopenic purpura, nausea, dyspepsia, vomiting, irritation of the gastric mucosa with erosion, ulceration.
Commercial Pack: Odrel ® Plus Tablet: Each box contains 30 film coated tablets in 3 x
10’s Alu-Alu form packs. Each tablet contains Clopidogrel Bisulfate USP equivalent to 75 mg Clopidogrel and Aspirin USP 75 mg.
140

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablet
Prasuva contains Prasugrel which is a thienopyridine which inhibits ADP receptors.
Indication: It is indicated to reduce the rate of thrombotic cardiovascular (CV) events
(including stent thrombosis) in patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI) as follows:
Patients with unstable angina (UA) or non-ST-elevation myocardial infarction (NSTEMI).
Patients with ST-elevation myocardial infarction (STEMI) when managed with primary or delayed PCI.
Dosage and Administration: The recommended dose of prasugrel is a one-time 60 mg oral loading dose followed by a maintenance dose of 10 mg orally once daily, given with background aspirin therapy (75-325 mg daily).
Contraindications: Prasugrel is contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage and a history of prior transient ischemic attack (TIA) or stroke and with hypersensitivity (e.g., anaphylaxis) to prasugrel or any component of the product.
Side Effects: Unusual bleeding such as nosebleeds, bleeding gums, or any bleeding that will not stop, feeling very weak or dizzy, blood in urine or stools, chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feelings, sudden headache, confusion, problems with vision, speech, or balance.
Warning and Precautions: It increases the risk of bleeding. With the dosing regimens used in TRITON-TIMI 38, TIMI Major and TIMI Minor bleeding events were more common on Prasuva. Suspect bleeding in any patient who is hypotensive and has recently undergone coronary angiography, PCI, CABG, or other surgical procedures even if the patient does not have overt signs of bleeding. It should not be used in patients with active bleeding, prior TIA or stroke.
Use in Pregnancy and Lactation: Prasugrel has been assigned to pregnancy category B by the FDA. Caution should be used when administering prasugrel to nursing women.
Drug Interaction: Additive anticoagulant / antiplatelet effects may increase bleeding risk.
Concomitant therapy should be avoided. NSAID's should be avoided while taking
Prasugrel.
Commercial Pack: Prasuva ® 5 Tablet and Prasuva ® 10 Tablet: Box containing 30 tablets in 3X10's alu-alu form packs and 20 tablets in 2X10's alu-alu form packs respectively.
Each film coated tablet contains Prasugrel Hydrochloride INN equivalent to Prasugrel 5 mg. and Prasugrel Hydrochloride INN equivalent to Prasugrel 10 mg respectively.
141

bexinfo: T
HERAPEUTIC
G
UIDE
D
IURETICS
®
Tablet
Resitone is a combination diuretic containing Furosemide & Spironolactone.
Indications: Furosemide & Spironolactone is indicated for the treatment of congestive heart failure, essential hypertension, swelling due to excess fluid retention (edema), liver cirrhosis, with collection of fluid in the abdominal cavity (ascites), overproduction of aldosterone (hyperaldosteronism) and resistant edema associated with secondary hyperaldosteronism.
Dosage and Administration: Resitone: 1 to 4 tablets daily according to the patient's response.
Contraindications: Furosemide & Spironolactone is contraindicated in acute renal insufficiency, anuria, hyperkalemia and in patients with a history of hypersensitivity to
Furosemide or Spironolactone.
Side Effects: Adverse reactions that are known to be associated with Furosemide &
Spironolactone are fatigue, blood disorders, skin rashes, diarrhea, constipation, nausea, vomiting or abdominal pain, hyperglycemia, hypotension, abnormal enlargement of breasts in the male (gynecomastia), irregular menstrual cycle, disturbances in the levels of electrolytes in the blood, impotence.
Warning and Precautions: It is recommended that individuals taking this medicine have their fluid and salt (electrolyte) balance monitored regularly. Furosemide & Spironolactone should be used with caution in diabetes, enlarged prostate (prostatic hypertrophy), hypotension, low volume of circulating blood (hypovolemia).
Use in Pregnancy and Lactation: Furosemide & Spironolactone should be used with caution during pregnancy. It is recommended that mothers should avoid using this medicine while breastfeeding.
Drug Interactions: ACE inhibitors or potassium salts, cardiac glycosides such as digoxin, carbenoxolone, corticosteroids such as hydrocortisone, indomethacin and possibly other non-steroidal anti-inflammatory drugs (NSAIDs).
Commercial Pack: Resitone ® Tablet: Box containing 30 tablets in 3x10’s blister strips.
Each tablet contains Spironolactone BP 50 mg and Furosemide BP 20 mg.
142

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablet
Resitone Plus is a combination diuretic containing Furosemide & Spironolactone.
Indications: As previous like Resitone. See page No. 142
Dosage and Administration: Resitone Plus: For previously stabilized patients 1 to 2 tablets daily, orally.
Contraindications: As previous like Resitone. See page No. 142
Side Effects: As previous like Resitone. See page No. 142
Warning and Precautions: As previous like Resitone. See page No. 142
Commercial Pack: Resitone ® Plus Tablet: Box containing 30 tablets in 3x10's blister strips. Each tablet contains Spironolactone BP 50 mg and Furosemide BP 40 mg.
®
Tablet
Thalin contains Chlorthalidone, an antihypertensive / diuretic supplied as 25 mg tablets for oral use.
Indications: Chlorthalidone is indicated in the management of hypertension.
Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis and corticosteroid and estrogen therapy.
Dosage and Administration: Therapy should be initiated with the lowest possible dose and then titrated according to individual patient response. A single dose given in the morning with food is recommended; divided doses are unnecessary.
Dose: Edema, up to 50 mg daily.
Hypertension: 25 mg daily in the morning, increased to 50 mg daily if necessary.
Heart failure: 25-50 mg daily in the morning, increased if necessary to 100-200 mg daily
(reduce to lowest effective dose for maintenance).
Side Effects: Side-effects include mild gastro-intestinal disturbances, postural hypotension, altered plasma lipid concentrations, metabolic and electrolyte disturbances including hypokalaemia, hyponatremia, hypomagnesemia, hypercalcemia, hyperglycemia, hypochloremic alkalosis, hyperuricemia, and gout. Less common sideeffects include blood disorders such as agranulocytosis, leucopenia, and
143

bexinfo: T
HERAPEUTIC
G
UIDE thrombocytopenia, and impotence. Pancreatitis, intrahepatic cholestasis, cardiac arrhythmias, headache, dizziness, paresthesia, visual disturbances, and hypersensitivity reactions (including pneumonitis, pulmonary edema, photosensitivity, and severe skin reactions).
Contraindications: Anuria, known hypersensitivity to chlorthalidone or other sulfonamide derived drugs.
Warning: Chlorthalidone should be used with caution in severe renal disease. In patients with renal disease, chlorthalidone or related drugs may precipitate azotemia.
Chlorthalidone should be used with caution in patients with impaired hepatic function or progressive liver disease, because minor alterations of fluid and electrolyte balance may precipitate hepatic coma. Sensitivity reactions may occur in patients with a history of allergy or bronchial asthma.
Precautions: Thiazides and related diuretics can exacerbate diabetes, gout, and systemic lupus erythematosus. Electrolytes should be monitored, particularly with high doses, long-term use, or in renal impairment. Thiazides and related diuretics should also be used with caution in nephrotic syndrome, hyperaldosteronism, malnourishment, hepatic impairment, avoid if severe, renal impairment, pregnancy, and breast feeding.
Use in Pregnancy: Pregnancy category B.
Nursing Mothers: Thiazides are excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from chlorthalidone, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use: Safety and effectiveness of Chlorthalidone tablets in pediatric patients have not been established.
Geriatric Use: Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
Drug Interaction: Chlorthalidone may add to or potentiate the action of other antihypertensive drugs.Insulin requirements in diabetic patients may be increased, decreased or unchanged. Higher dosage of oral hypoglycemic agents may be required.
Chlorthalidone and related drugs may increase the responsiveness to tubocurarine.
Lithium renal clearance is reduced by chlorthalidone, increasing the risk of lithium toxicity.
Commercial Pack: Thalin ® Tablet: Box containing 60 tablets in 6 x 10's Alu-Alu form packs. Each tablet contains Chlorthalidone USP 25 mg.
144

bexinfo: T
HERAPEUTIC
G
UIDE
L
IPID
L
OWERING
A
GENT
®
Tablet
Atova is a preparation of Atorvastatin Calcium, which is a synthetic lipid-lowering agent.
It is an inhibitor of 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA).
Indications: Atova is indicated as an adjunct to diet to reduce elevated total cholesterol,
LDL- cholesterol, apolipoprotein B and triglyceride levels in patients with primary hypercholesterolemia (heterozygous familial and non familial) and mixed dyslipidemia
(Fredrickson Types lla and llb). This is indicated as adjunctive therapy to diet for the treatment of patients with elevated serum triglyceride levels (Fredrickson Type IV). This is indicated for the treatment of patients with primary dysbetalipoproteinemia (Fredrickson
Type III) who do not respond adequately to diet. This is also indicated to reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.
Dosage and Administration: Adults: The patient should be placed on a standard cholesterol-lowering diet before receiving Atova and should continue on this diet during treatment with Atova.
Hypercholesterolemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia
(Fredrickson Types IIa and IIb): The recommended starting dose of Atova is 10 mg daily.
The dosage range is 10 to 80 mg once daily.
Since the goal of treatment is to lower LDL-C, the LDL-C levels should be used to initiate and assess treatment response. Only if LDL-C levels are not available, total-C should be used to monitor therapy.
Homozygous Familial Hypercholesterolemia: The dosage of Atova in patients with homozygous FH is 10 to 80 mg daily. This should be used as an adjunct to other lipidlowering treatments (e.g. LDL apheresis) in these patients or if such treatments are unavoidable.
Side Effects: Generally well tolerated. Adverse effects reported commonly include constipation, flatulence, dyspepsia, abdominal pain, headache, nausea, myalgia, diarrhea, asthenia and insomnia. Dose related and reversible elevated serum ALT levels have been reported in approximately 1.3% of patients receiving Atorvastatin. Elevated serum CPK levels have been reported in some patients on Atorvastatin but only rarely have patients had concurrent muscle pain, tenderness or weakness.
Warning and Precautions: Rhabdomyolysis with acute renal failure secondary to myoglobinuria has been reported with other drugs in this class. Atorvastatin may cause an elevation in serum creatine phosphokinase levels. This should be considered in the
145

bexinfo: T
HERAPEUTIC
G
UIDE differential diagnosis of chest pain in patients on therapy with Atorvastatin. Uncomplicated myalgia has been reported in Atorvastatin-treated patients. Atorvastatin therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. The risk of myopathy during treatment with other drugs in this class is increased with concurrent administration of cyclosporin, fibric acid derivatives, erythromycin, niacin, or azole anti-fungals. Patients should be advised to report promptly any unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever.
Use in Pregnancy: Safety in pregnancy has not been established. An interval of 1 month should be allowed from stopping Atorvastatin treatment to conception in the event of planning a pregnancy.
Contraindications: This is contraindicated in hypersensitivity to any component of this medication, active liver disease or unexplained persistent elevations of serum transaminases exceeding three times the upper limit of normal.
Commercial Pack: Atova ® 10 Tablet: Box containing 30 tablets in 3X10’s Alu-Alu form packs. Each film coated tablet contains Atorvastatin Calcium USP equivalent to
Atorvastatin 10 mg.
Atova ® 20 Tablet: Box containing 20 tablets in 2X10’s Alu-Alu form packs. Each film coated tablet contains Atorvastatin Calcium USP equivalent to Atorvastatin 20 mg.
Atova ® 40 Tablet: Box containing 20 tablets in 2X10’s Alu-Alu form packs. Each film coated tablet contains Atorvastatin Calcium USP equivalent to Atorvastatin 40 mg.
®
Tablet
Each Ezeta tablet contains Ezetimibe INN. Ezetimibe is in a class of lipid-lowering compounds that selectively inhibits the intestinal absorption of cholesterol and related phytosterols.
Indications: As Monotherapy: Ezetimibe, administered alone, is indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C and Apo B in patients with primary (heterozygous familial and non-familial) hypercholesterolemia.
Combination therapy with HMG-CoA reductase inhibitors: Ezetimibe, administered in combination with an HMG-CoA reductase inhibitor, is indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C and Apo B in patients with primary
(heterozygous familial and non-familial) hypercholesterolemia and homozygous familial hypercholesterolemia (HoFH). The combination of Ezetimibe and atorvastatin or simvastatin, is indicated for the reduction of elevated total-C and LDL-C levels in patients with HoFH, as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.
146

bexinfo: T
HERAPEUTIC
G
UIDE
Homozygous Sitosterolemia: Ezetimibe is indicated as adjunctive therapy to diet for the reduction of elevated plasma sitosterol and campesterol levels in patients with homozygous familial sitosterolemia.
Dosage and Administration: The recommended dose of Ezetimibe is 10 mg once daily.
Ezetimibe can be administered with or without food.
Side Effects: Ezetimibe has been evaluated for safety in more than 4700 patients in clinical trials. Clinical studies of Ezetimibe (administered alone or with an HMG-CoA reductase inhibitor) demonstrated that Ezetimibe was generally well tolerated. The overall incidence of adverse events reported with Ezetimibe was similar to that reported with
Placebo, and the discontinuation rate due to adverse events was also similar for
Ezetimibe and Placebo.
Drug Interaction: Fibrates may increase cholesterol excretion into the bile, leading to cholelithiasis. In a preclinical study in animals, Ezetimibe increased cholesterol in the gallbladder bile. Co-administration of Ezetimibe with fibrates is not therefore recommended until use in patients is studied.
Warning and Precautions: Concurrent administration of Ezeta with a specific HMG-CoA reductase inhibitor should be in accordance with the product labeling for that HMG-CoA reductase inhibitor.
Use in Pregnancy and Lactation: Not recommended in pregnancy. In terms of giving
Ezetimibe to lactating mother, a decision should be made to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use: The safety and effectiveness of Ezetimibe in pediatric patients have not been established.
Contraindications: Hypersensitivity to any component of this medication. The combination of Ezetimibe with an HMG-CoA reductase inhibitor is contraindicated in patients with active liver disease or unexplained persistent elevations in serum transaminases.
Commercial Pack: Ezeta ® Tablet: Box containing 20 tablets in 2 x 10’s blister strips.
Each tablet contains Ezetimibe INN 10 mg.
147

bexinfo: T
HERAPEUTIC
G
UIDE
®
Capsule
Lofat is a preparation of Fenofibrate. It is a fibric acid derivative approved by the Food and Drug Administration in February of 1998 for the treatment of hyperlipidemia.
Indications: Lofat is indicated as an adjunct to diet for the treatment of adults with hypertriglyceridemia (types IV and V hyperlipidemia) who have not responded adequately to diet therapy and who are at risk for pancreatitis. This is also indicated in mixed hyperlipidemia (types II hyperlipidemia).
Dosage and Administration: Lofat capsule once daily is recommended as the dose for the treatment of primary hypercholesterolemia, hypertriglyceridemia or mixed hyperlipidemia.
Side Effects: In European trials the most common adverse events (occurring in 6% of patients) were gastrointestinal symptoms, muscle pain, skin problems, sweating and dizziness. Skin rashes (2%) were the most frequent events causing discontinuation of
Fenofibrate treatment.
Drug Interactions: Fenofibrate has been reported to potentiate the anticoagulant effects of Warfarin. Also Fenofibrate may increase the nephrotoxicity of cyclosporine. Due to a potential increase in the risk of rhabdomyolysis, cautions should be taken against the use of Fenofibrate with HMG-CoA reductase inhibitors unless the benefits outweigh the risks. However the use of low-dose statins with Fenofibrate appears to be well tolerated.
Warning and Precautions: Precautions of Fenofibrate include risk of pancreatitis and myopathy. Transient hematologic changes have been reported in some cases.
Thrombocytopenia and agranulocytosis have been reported rarely. The dose should be reduced in the presence of renal insufficiency. The safety and efficacy of the drug has not been established in pediatric patients.
Use in Pregnancy and Lactation: Not recommended for pregnant women and nursing mothers.
Contraindications: This is contraindicated in patients with hypersensitivity to
Fenofibrate, severe renal disease, or preexisting gallbladder disease. This is also contraindicated in patients with hepatic dysfunction, including biliary cirrhosis.
Commercial Pack: Lofat® Capsule: Box containing 30 capsules in 3 x 10’s blister strips.
Each capsule contains Fenofibrate BP 200 mg.
148

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablets
Rosutin is a preparation of Rosuvastatin calcium, which is a synthetic lipid-lowering agent for oral administration. It is an inhibitor of 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-
CoA).
Indications: Hyperlipidemia and Mixed Dyslipidemia: This is indicated as adjunctive therapy to diet to reduce elevated Total-C, LDL-C, Apo B, non HDL-C, and triglycerides and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia. Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and nonpharmacological interventions alone has been inadequate.
Pediatric Patients 10 to 17 years of age with Heterozygous Familial Hypercholesterolemia
(HeFH): Adjunct to diet to reduce Total-C, LDL-C and ApoB levels in adolescent boys and girls, who are at least one year post-menarche, 10-17 years of age with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present: LDL-C >190 mg / dL or >160 mg / dL and there is a positive family history of premature cardiovascular disease (CVD) or two or more other CVD risk factors.
Hypertriglyceridemia: This is indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia.
Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia): This is indicated as an adjunct to diet for the treatment of patients with primary dysbetalipoproteinemia (Type III
Hyperlipoproteinemia).
Homozygous Familial Hypercholesterolemia: This is indicated as adjunctive therapy to other lipid-lowering treatments (e.g., LDL apheresis) or alone if such treatments are unavailable to reduce LDL-C, Total-C, and ApoB in adult patients with homozygous familial hypercholesterolemia.
Slowing of the Progression of Atherosclerosis: This is indicated as adjunctive therapy to diet to slow the progression of atherosclerosis in adult patients as part of a treatment strategy to lower Total-C and LDL-C to target levels.
Primary Prevention of Cardiovascular Disease: In individuals without clinically evident coronary heart disease but with an increased risk of cardiovascular disease based on age ≥ 50 years old in men and ≥ 60 years old in women, hsCRP ≥ 2 mg / L, and the presence of at least one additional cardiovascular disease risk factor such as hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease. Rosutin is indicated to:
- Reduce the risk of stroke.
- Reduce the risk of myocardial infarction.
- Reduce the risk of arterial revascularization procedures.
149

bexinfo: T
HERAPEUTIC
G
UIDE
Dosage and Administration: The recommended starting dose is 5-10 mg once daily.
The dose may be increased if necessary at intervals of at least 4 weeks to 20 mg once daily. The dose may be increased after further 4 weeks to 40 mg once daily only in severe hypercholesterolemia with high cardiovascular risk and under specialist supervision. Dose in elderly patients: Initially 5 mg once daily. Patients of asian origin: Initially 5 mg once daily increased if necessary to max. 20 mg once daily.
Side Effects: Rhabdomyolysis with myoglobinuria and acute renal failure, myopathy
(including myositis), liver enzyme abnormalities, myalgia, abdominal pain, nausea, headache and asthenia.
Warning & Precautions: Rosuvastatin should be used with caution in pregnancy, lactation, and children. This may cause fetal harm when administered to pregnant women.
Because another drug in this class passes into breast milk it is advised not to nurse their infants while taking this drug.
Drug Interaction: Gemfibrozil, Lopinavir / Ritonavir, Cyclosporine, Coumarin, Niacin.
Contraindication: Patients with a known hypersensitivity to any component of this product, in active liver disease.
Commercial Pack: Rosutin ® 5 Tablet and Rosutin ® 10 Tablet: Box containing 30 tablets in 3x10's alu-alu form packs and 20 tablets in 2x10's alu-alu form packs respectively.
Each film coated tablet contains Rosuvastatin Calcium INN equivalent to 5 mg
Rosuvastatin and 10 mg Rosuvastatin respectively.
150

bexinfo: T
HERAPEUTIC
G
UIDE
V
ASODILATORS
®
Tablet
Cerivin is a preparation of Vinpocetine which increases cerebral metabolism.
Indications: All forms of acute and chronic cerebral circulatory insufficiency: TIA
(Transient Ischemic Attack), reversible ischemic neurological deficiency, progressive stroke, completed stroke, post-apoplectic conditions, multi-infarct dementia, cerebral arteriosclerosis, post traumatic condition, hypertensive encephalopathy etc.
For the reduction of psychic or neurological symptoms of cerebral insufficiency (e.g.
memory disturbances, dizziness, headache, aphasia, apraxia, locomotor disorders etc.).
Ophthalmology: It can be used for the treatment of vascular disorders of the choroid and retina due to arteriosclerosis, vasospasm, macular degeneration, arterial or venous thrombosis or embolism, and glaucoma secondary to the above mentioned disorders.
Otology: For the treatment of impaired hearing of vascular or toxic (iatrogenic) origin, presbyacusis, Meniere's disease, cochleovestibular neuritis, tinnitus and dizziness of labyrinth origin.
For the treatment of vasovegetative symptoms of climacteric syndrome.
Dosage and Administration: Cerivin is taken 1-2 tablets three times daily with meals.
The maintenance dose is 1 tablet three times daily over long periods.
Side Effects: Cerivin is well tolerated. In some cases transient fall of blood pressure and tachycardia may occur.
Contraindications: Cerivin is contraindicated in pregnancy and lactation.
Warning and Precautions: Individuals with a tendency to bleed should avoid vinpocetine.
Drug Interactions: Slight changes in prothrombin time have been noted in those adding vinpocetine to warfarin dosing. The changes appear minimal. There are no other interactions reported so far. Therefore, it can be applied in combinations.
Commercial Pack: Cerivin ® Tablet: Box containing 100 tablets in 10x10's blister strips.
Each tablet contains Vinpocetine INN 5 mg.
151

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablet
This is a preparation of Pentoxifylline.
Indications: In patients with intermittent claudication on the basis of chronic occlusive arterial disease of the limbs. This can improve function and symptoms. But it is not intended to replace more definitive therapy, such as vascular surgery, or removal of arterial obstructions when treating peripheral vascular disease.
Dosage and Administration: The usual dosage is one tablet (400mg) three times a day with or after meals, to be swallowed whole with some liquid.
Contraindications: Patients who have previously exhibited intolerance to this product or Methylxanthines such as Caffeine, Theophylline, and Theobromine. This should not be given to patients with recent or severe hemorrhage, e.g. massive retinal hemorrhage, cerebral hemorrhage, acute myocardial infarction or patients with peptic ulcer.
Warning and Precautions: This is not recommended in-patients with marked impairment of kidney or liver function. Patients with less severe impairment of these organs should be closely monitored during Vasolax therapy and may require lower doses. Patients with chronic occlusive arterial disease of the limbs frequently show other manifestations of arteriosclerotic disease. Vasolax has been used safely for treatment of peripheral arterial disease in-patients with concurrent coronary artery and cerebrovascular diseases, but there have been occasional reports of angina, hypotension, and arrhythmia. Controlled trails do not show that Vasolax causes such adverse effects more often than placebo, but, as it is a methylxanthine derivative, it is possible that some individuals will experience such responses. Careful monitoring is required in-patients with acute arrhythmias.
Use in pregnancy and lactation: Pregnancy category B: Should not be used in pregnancy unless clearly needed. Vasolax and its metabolites are excreted in human milk. A decision should therefore be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Side Effects: The most frequent types of side effects seen with Pentoxifylline were gastrointestinal upsets, including nausea, dyspepsia, vomiting, flatus / bloating, abdominal pain and diarrhea. However, the controlled release preparations of
Pentoxifylline resulted is much fewer GI side effects. Side effects related to CNS disturbances include dizziness, headache, and tremor.
Drug Interactions: Concomitant use with antihypertensive drugs, β− blockers, diuretics and other drugs with blood pressure lowering potential may increase their blood pressure lowering effects. An increase in the intensity and frequency of adverse events associated with Theophylline may result from concomitant use with Pentoxifylline.
Commercial Pack: Vasolax ® Tablet: Box containing 30 tablets in 3 x 10’s blister strips.
Each CR tablet contains Pentoxifylline BP 400 mg.
152

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablet
Zocil contains Cilostazol which is a Quinolinone derivative.
Indications: Zocil is indicated for the reduction of symptoms of intermittent claudication, as indicated by an increased walking distance.
Dosage and Administration: The recommended dosage of Zocil is 100 mg orally b.i.d., taken at least half an hour before or two hours after breakfast and dinner. A dose of 50 mg b.i.d. should be considered during coadministration of inhibitors of CYP3A4 (eg, ketoconazole, itraconazole, erythromycin and diltiazem) and during coadministration of inhibitors of CYP2C19 as omeprazole. Patients may respond as early as 2 to 4 weeks after the initiation of therapy but treatment for up to 12 weeks may be needed before a beneficial effect is experienced.
Side Effects: Most common side effects are headache, diarrhea, vomiting, rash, anorexia, face edema etc.
Contraindications: Zocil is contraindicated in patients with congestive heart failure of any severity and in patients with known or suspected hypersensitivity to any of its components.
Warning and Precautions: As grapefruit juice inhibits CYP3A4, avoid concurrent use with Cilostazol.
Pregnancy: Use during pregnancy only if the potential benefit justifies the potential risk in the fetus.
Nursing mothers: A decision should be made to discontinue nursing or to discontinue
Zocil.
Pediatric use: The safety and effectiveness of Zocil (Cilostazol) in pediatric patients have not been established.
Renal impairment : No dosage adjustment in patients with mild to moderate renal impairment.
Drug Interactions: Pharmacokinetic studies have demonstrated that omeprazole and erythromycin significantly increased the systemic exposure of Cilostazol and / or its major metabolites. Population pharmacokinetic studies showed higher concentrations of cilostazol among patients concurrently treated with diltiazem.
Commercial Pack: Zocil ® 50 Tablet and Zocil ® 100 Tablet: Box containing 30 tablets in
3x10’s blister strips and 20 tablets in 2x10’s blister strips respectively. Each tablet contains
Cilostazol USP 50 mg. and Cilostazol USP 100 mg respectively.
153

C
& C
P

bexinfo: T
HERAPEUTIC
G
UIDE
C
OUGH
S
UPPRESSANT
®
Syrup
Dextromethorphan Syrup is a cherry flavored liquid, containing Dextromethorphan
Hydrobromide BP. Dextromethorphan (d-3-methoxy-N-methylmorphinan) is the d-isomer of the codeine analogue of levorphanol. It has a depressant action on the cough centre of the brain.
Indication: As antitussive.
Dosage and Administration: Adults: 1-3 teaspoonful 1-4 times daily or as advised by physician.
Children: Should not be used for children
Side Effects: Occasionally, it may cause drowsiness, dizziness, excitation, mental confusion and gastrointestinal disturbance. Very high doses may produce respiratory depression. Abuse of Dextromethorphan has been reported in few cases, but there does not appear to be any evidence of dependence of the morphine type.
Warning & Precaution: Should be administered with caution to asthmatic patient.
Use in Pregnancy and Lactation: Pregnant women should not use this because of the risk of birth defects.
Overdosage & Contraindication: Contraindicated to patients who are hypersensitive to any of the ingredients of this product and liver disease.
Commercial Pack: Dextromethorphan ® Syrup: 100 ml syrup in glass bottle, each 5 ml contains 10 mg of Dextromethorphan Hydrobromide BP.
157

bexinfo: T
HERAPEUTIC
G
UIDE
C
OUGH
E
XPECTORANTS
®
Syrup / Pediatric Drops
Mucosol contains Ambroxol which is the active metabolite of Bromhexine, and it has been proven that this metabolite possesses a greater bronchosecretolytic effect than
Bromhexine. Ambroxol has anti-inflammatory properties owing to the inhibitory effect on the production of cellular cytokines and Arachidonic acid metabolites.
Indications: Productive cough, acute and chronic inflammatory disorders of respiratory tracts concomitant with formation of viscous and hardly separated expectoration, acute and chronic inflammatory disease of rhino pharyngeal tract (laryngitis, pharyngitis, sinusitis and rhinitis) associated with viscid mucus, asthmatic bronchitis, bronchial asthma with thick, hard expectoration, bronchiectasis and chronic pneumonia.
Dosage and Administration: Syrup: 2-5 years old: 2.5 ml (½ teaspoonful), 2-3 times a day, 5-10 years old: 5 ml (1 teaspoonful), 2-3 times a day and 10 years old & adults: 10 ml (2 teaspoonful), 3 times a day.
Pediatric drops: 0-6 months old : 0.5 ml, 2 times a day, 6-12 months old : 1 ml, 2 times a day and 1-2 years old : 1.25 ml, 2 times a day.
Ambroxol is to be given preferably after meal. It may be prescribed to patients suffering from diabetes mellitus.
Side Effects: Ambroxol is well tolerable, however, rarely allergic responses such as skin eruption, urticaria or angioneurotic edema may occur. When used for a long time, epigastric pain, stomach overfill feeling cannot be excluded.
Drug Interaction: Ambroxol should not be taken simultaneously with antitussives (e.g.,
Codeine) because phlegm, which has been liquefied by Ambroxol might not be expectorated.
Use in Pregnancy & Lactation: It is advised not to use it in pregnancy, especially during the first trimester. Safety during lactation has not been established yet.
Overdosage & Contraindications: First trimester of pregnancy, gastro-duodenal ulcer, hypersensitivity to any component of the preparation.
Commercial Pack: Mucosol ® Syrup: Bottle containing 100 ml syrup, each 5 ml contains
15 mg of Ambroxol Hydrochloride BP.
Mucosol ® Pediatric Drops: Bottle containing 15 ml drops, each ml contains 6 mg of
Ambroxol Hydrochloride BP.
158

bexinfo: T
HERAPEUTIC
G
UIDE
®
Capsule / Syrup / DS Syrup
This is a preparation of Carbocisteine. Carbocisteine loosens thick sputum effectively by reducing its viscosity and thereby helps to expectorate that mucus more easily from the respiratory tract.
Indications: It is indicated in expectoration of productive cough in the following diseases-
Acute bronchitis, chronic bronchitis, Bronchial asthma, Upper respiratory tract inflammation (pharyngitis, laryngitis), Cystic fibrosis, Bronchiectasis and Pulmonary tuberculosis. Also indicated in drainage in chronic sinusitis and pneumonia and drainage in otitis media in children.
Dosage and Administration: Adults (including elderly): Dosage is based upon an initial dose of 2250 mg daily in divided doses (750 mg 3 times daily) reducing to 1500 mg daily in divided doses (375 mg 4 times daily), when a satisfactory response has been obtained.
Children: Normal daily dose is 20 mg/kg body weight in divided doses. For 2-5 years :
62.5 – 125 mg 4 times daily and for 6-12 years : 250 mg 3 times daily
Side Effects: Gastrointestinal discomfort, nausea, diarrhea, gastrointestinal bleeding, palpitation, dizziness, headache, heartburn and skin rash may occur.
Warning & Precautions: No specific precaution is recommended but Carbocisteine should be used with caution in patients with a recent history of peptic ulcer and recurrent gastrointestinal bleeding.
Use in Pregnancy and Lactation: Although there are no reports of teratogenic effects with
Carbocisteine the drug is not recommended in the first trimester of pregnancy. No information available on the use of Carbocisteine during lactation.
Overdosage & Contraindications: Contraindicated in active peptic ulceration and in patients with hypersensitivity to the drug.
Commercial Pack: NoKOF ® Capsule: Each box contains 3 blister strips of 10 capsules.
Each capsule contains 375 mg of Carbocisteine BP.
NoKOF ® Syrup: Bottle containing 100 ml syrup. Each 5 ml contains 125 mg
Carbocisteine BP.
NoKOF ® DS Syrup: Bottle containing 100 ml syrup. Each 5 ml contains 250 mg
Carbocisteine BP.
159

bexinfo: T
HERAPEUTIC
G
UIDE
®
Syrup
This is a combined preparation of Dextromethorphan, Pseudoephedrine and Triprolidine.
Indications: It is an antitussive preparation indicated for the symptomatic relief of allergic rhinitis and upper respiratory tract disorders accompanied by unproductive cough which are benefited from a combination of an antitussive, a decongestant and an antihistamine.
Dosage & Administration: Adults & Children over 12 years: 2 teaspoonful three times daily.
Children: 6-12 years: 1 teaspoonful three times daily.
Children: 2-5 years: ½ teaspoonful three times daily or as recommended by the physician.
Side Effects: Side effects of Dextromethorphan appear to be rare, may include dizziness and gastro-intestinal disturbances. Side effects of pseudoephedrine include sympathetic hyperactivity such as fear, anxiety, restlessness, tremor, insomnia, confusion, and irritability. Triprolidine may cause sedation.
Drug Interactions: Decongestants, Tricyclic antidepressants, appetite suppressants, amphetamine or with MAO inhibitors. Because of its pseudoephedrine content, this may partially reverse the hypertensive action of drugs which interfere with sympathetic activity including methyldopa, α and β adrenergic blocking agents.
Warning& Precautions: It should be used with caution in patients taking antihypertensive agents, Tricyclic antidepressants or other Sympathomimetic agents.
Caution should be exercised in the presence of severe renal and hepatic impairment. It should not be used for persistent cough such as occurs with smoking, asthma or emphysema or where cough is accompanied by excessive secretions unless directed by a physician. If drowsiness occurs, do not drive or operate machinery.
Use in Pregnancy & Lactation: Not recommended in pregnancy. In case of lactation caution should be exercised by balancing the potential benefit of treatment to the mother against any possible hazards to the development of fetus.
Overdosage & Contraindications: Known hypersensitivity to Dextromethorphan,
Pseudoephedrine or Triprolidine, in patients with severe hypertension or severe coronary artery diseases and in persons who are taking or have taken MAO inhibitors within the preceding two weeks.
Commercial Pack: Prudex ® Syrup: Bottle containing 100 ml syrup.Each 5ml syrup contains Dextromethorphan Hydrobromide BP 10 mg, Pseudoephedrine Hydrochloride
BP 30 mg and Triprolidine Hydrochloride BP 1.25 mg.
160

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablet / Syrup
This is the preparation of Bromhexin Hydrochloride, a highly effective expectorant.
Indications: Spulyt is indicated in the treatment of respiratory disorders associated with productive cough. These include; tracheobronchitis, bronchitis with emphysema, bronchiectasis, bronchitis with bronchospasm, chronic inflammatory pulmonary conditions and pneumoconiosis.
Dosage & Administration: Spulyt Tablet: Adults and Children over 10 years: 8-16 mg 3 times daily. Children 5-10 years: 4 mg 3 times daily.
Spulyt Syrup: Adults: The recommended daily dose is 2 to 4 teaspoonful 3 times. Initially
4 teaspoonful 3 times daily and then as required. Children: Suggested dosage for children under 2 years is ¼ teaspoonful 3 times daily, for 2-5 years is ½ teaspoonful 3 times daily and for children aged 5-10 years: 1 teaspoonful 3 times daily.
Side Effects: A transient rise in serum aminotransferase values has been reported. Other side effects include headache, dizziness, sweating and skin rash. Gastrointestinal side effects may occur occasionally.
Warning & Precautions: Since mucolytic may disrupt the gastric mucosal barrier,
Bromhexin Hydrochloride should be used with caution in patients with a history of gastric ulceration. Care is also advisable in case of asthmatic patients. Clearance of Bromhexin
Hydrochloride or its metabolites may be reduced in patients with severe hepatic or renal impairment.
Use in Pregnancy & Lactation: It is safe for pregnancy. Not recommended for lactating mother unless the potential benefits to the patients are weighed against the possible risk of infant.
Overdosage & Contraindications: This is contraindicated in patients with known hypersensitivity or idiosyncratic reaction to Bromhexine Hydrochloride or any other ingredients in the product.
Commercial Pack: Spulyt ® Tablet: Each box contains 10 blister strips of 10 tablets. Each tablet contains Bromhexine Hydrochloride BP 8mg.
Spulyt ® Syrup: Bottle containing 100 ml syrup. Each 5ml contains Bromhexine
Hydrochloride BP 4mg.
161

bexinfo: T
HERAPEUTIC
G
UIDE
®
Syrup
Tripec a highly palatable orange flavored syrup, is a combination preparation of three active ingredients namely Guaifenesin, Pseudoephedrine Hydrochloride BP and
Triprolidine Hydrochloride BP. Guaifenesin reduces the viscosity of tenacious sputum and is used as an expectorant. Pseudoephedrine is a decongestant as well as a bronchodilator for the upper respiratory tract, which gives symptomatic relief of nasal congestion. Triprolidine is an antihistamine, it is used for the symptomatic relief of hypersensitivity reactions including rhinitis, conjunctivitis and urticaria.
Indications: Tripec is indicated for the symptomatic relief of upper respiratory tract disorders associated with common cold, allergy, viral infections, symptomatic treatment of productive cough and relieve symptoms of upper respiratory tract allergies e.g., sneezing, rhinrrhoea and pruritus of nose, eyes and throat.
Dosage and Administration: Adult and Children over 12 years: 2 teaspoonful thrice daily.
Children aged 6-12 years: 1 teaspoonful thrice daily.
Children aged 2-5 years: ½ teaspoonful thrice daily or as directed by the physician.
Side Effects: CNS depression or excitation, drowsiness, sleep disturbances, hallucinations, skin rashes with or without irritation, tachycardia, dryness of mouth, nose and throat have been reported.
Warnings and Precaution: Caution should also be exercised in hypertension, heart disease, diabetes, hyperthyroidism, elevated intra-ocular pressure, prostatic enlargement, severe renal and hepatic impairment. This preparation should not be used for persistent or chronic cough. If drowsiness happened patients should be advised not to drive or operate machinery. Concomitant administration of alcohol or other centrally acting sedatives should be avoided.
Use in Pregnancy & Lactation: This products have been in widespread use without any ill report during pregnancy. Not recommended in nursing women.
Overdosage & Contraindications: This is contraindicated in the cases of known hypersensitivity to any of its constituents, cardiovascular disease including hypertension, lower respiratory symptoms including asthma and monoamine oxidase (MAO) inhibitor therapy.
Commercial Pack: Tripec ® Syrup: Amber coloured glass bottle containing 100 ml highly palatable orange flavoured Syrup, each 5 ml of which contains Guaifenesin BP 100 mg,
Pseudoephedrine Hydrochloride BP 30 mg & Triprolidine Hydrochloride BP 1.25 mg.
162

E
& M

164

bexinfo: T
HERAPEUTIC
G
UIDE
A
NTI
D
IABETIC
®
Tablet
CoDiaglit is a combination of Pioglitazone Hydrochloride and Metformin Hydrochloride of which, Pioglitazone Hydrochloride is a member of the Thiazolidinedione class, and
Metformin Hydrochloride, a member of the Biguanide class.
Indication: Type II Diabetes mellitus who are already treated with a combination of
Pioglitazone and Metformin as separate tablets or whose diabetes is not adequately controlled with Metformin alone, or for those patients who have initially responded to
Pioglitazone alone and require additional glycemic control.
Dosage and Administration: CoDiaglit may be initiated at either the 15 mg/500 mg or
15 mg/850 mg tablet strength once or twice daily, and gradually titrated after assessing adequacy of therapeutic response.
The maximum recommended dose for Pioglitazone is 45 mg daily and Metformin is 2550 mg in adults.
Side Effects: Upper respiratory tract infection, diarrhea, combined edema/peripheral edema and headache.
Drug Interaction: Metformin-furosemide, Nifedipine, Cationic drugs, Thiazides, and other diuretics, Corticosteroids, Phenothiazines, Thyroid products, Estrogens, Oral contraceptives, Phenytoin, Nicotinic acid, Sympathomimetic, Calcium channel blocking drugs, and Isoniazid when such drugs are administered to a patient receiving combination of Pioglitazone and Metformin, the patient should be closely observed to maintain adequate glycemic control.
Warning & Precautions: Combination of Pioglitazone and Metformin should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because it may result in acute alteration of renal function.
Use in Pregnancy and Lactation: Combination of Pioglitazone and Metformin should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus.
Contraindications: Combination of Pioglitazone and Metformin is contraindicated in patients with:
• Renal disease or renal dysfunction [e.g., as suggested by serum creatinine levels >1.5
mg/dl (males), >1.4 mg/dl (females), or abnormal creatinine clearance] which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia.
165

bexinfo: T
HERAPEUTIC
G
UIDE
• Known hypersensitivity to Pioglitazone, Metformin or any other component of combination of Pioglitazone and Metformin.
• Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin.
Commercial Pack: CoDiaglit ® 500 Tablet and CoDiaglit ® 850 Tablet: Box containing 30 tablets in 3X10’s blister strips. Each tablet contains Pioglitazone Hydrochloride INN equivalent to Pioglitazone 15 mg and Metformin Hydrochloride BP 500 mg and
Pioglitazone Hydrochloride INN equivalent to Pioglitazone 15 mg and Metformin
Hydrochloride BP 850 mg respectively.
®
Tablet
This is a preparation of Glipizide, an oral blood glucose lowering drug of the Sulfonylurea class.
Indications: Diactin is indicated as an adjunct to diet for the control of hyperglycemia and its associated symptomatology in the treatment of non-insulin-dependent diabetes mellitus (NIDDM; type II) when diet modification has not been proved effective on its own.
In certain patients who are receiving insulin, the concurrent use of Glipizide would allow a reduction in the daily dose of insulin. During maintenance, if satisfactory lowering of blood glucose is no longer achieved, use of Glipizide should be discontinued.
Dosage & Administration: Like any other oral hypoglycemic agent, dosage of Diactin is not fixed and may be adjusted through periodic monitoring of blood glucose level. In general, Diactin should be given approximately 30 minutes before a meal to achieve the maximum reduction in postprandial hyperglycemia.
Initial Dose: The recommended starting dose is 5 mg, given before breakfast. Geriatric patients or those with liver disease may be started on 2.5 mg.
Dosage Adjustments: Dosage adjustment may be done at intervals of several days by an increment of 2.5-5 mg, as determined by blood glucose response. If response to a single dose is not satisfactory, dividing that dose might prove effective. The maximum recommended once daily dose is 15 mg. Doses above 15 mg should ordinarily be divided and given before meals of adequate caloric content. The maximum recommended total daily dose is 40 mg.
Maintenance: Some patients may be effectively controlled on a once daily regimen, while others show better response with divided dosing. Total daily doses above 30 mg have been safely given on 12 hourly to long term patients. Patients can usually be stabilized on a dosage ranging from 2.5 to 30 mg daily.
Patients receiving other oral hypoglycemic agents: As with other sulfonylurea, no
166

bexinfo: T
HERAPEUTIC
G
UIDE transition period is necessary while transferring patients to Glipizide. Patients should be observed carefully for any possible hypoglycemic effect due to overlapping of drug effects.
Side Effects: Hypoglycemia is the most common side effects. Others are nausea, diarrhea, constipation, gastralgia, cholestatic jaundice, erythema, morbilliform or maculopapular eruption, leucopenia, hemolytic anemia, dizziness, drowsiness and headache.
Drug Interactions: The hypoglycemic action of Sulfonylurea may be potentiated by
NSAIDs, Salicylates, Sulfonamides, Chloramphenicol, Probenecid, Coumarins,
Monoamine oxidase inhibitors (MAOIs), and β adrenergic blocking agents. Thiazides and other diuretics, Corticosteroids, Phenothiazines, Thyroid products, Estrogens, Oral contraceptives, Phenytoin, Nicotinic acid, Sympathomimetic, Calcium channel blocking drugs and Isoniazid tend to produce hyperglycemia. Diabetic control may be altered also in patients treated with Cyclophosphamide. A potential interaction between oral
Miconazole and oral Hypoglycemic agents leading to severe hypoglycemia has been reported.
Warning & Precautions: It should be used with caution in patients with impaired renal and/ or hepatic function. When a patient stabilized on any diabetic regimen is exposed to stress such as fever, trauma, infection or surgery, a loss of control may occur. At such times, it may be necessary to discontinue Glipizide and administer Insulin.
Use in Pregnancy and Lactation: Glipizide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not recommended during lactation.
Children: In children safety and effectiveness have not been established.
Overdosage & Contraindications: Overdosage of Glipizide can produce hypoglycemia.
Cases of hyponatremia and the syndrome of inappropriate antidiuretic hormone (SIADH) secretion have also been reported. This is contraindicated in patients with hypersensitivity to Glipizide or any component of the product, Juvenile onset diabetes, Severe or unstable
`brittle' diabetes, diabetes complicated by ketosis and acidosis, major surgery, severe sepsis or severe trauma and severe renal, hepatic or thyroid impairment, co-existent renal and hepatic disease.
Commercial Pack: Diactin ® Tablet: Box containing 10 aluminium strips of 10 tablets.
Each tablet contains Glipizide BP 5mg.
167

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablet
This is a preparation of Pioglitazone which is a member of the newest class of oral antidiabetic agent called Thiazolidinedione.
Indications: Diaglit is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type II diabetes (NIDDM). Diaglit is indicated for monotherapy and also indicated for use in combination with Sulfonylurea, Metformin or Insulin when diet and exercise plus the single agent does not result in adequate glycemic control.
Dosage and Administration: Diaglit can be taken once daily without regard to meals.
The management of antidiabetic therapy should be individualized. Diaglit monotherapy may be initiated at 15 mg or 30 mg once daily in patients not adequately controlled with diet & exercise alone. For patients who respond inadequately to the initial dose of
Pioglitazone, the dose can be increased up to 45 mg once daily. For patients not responding adequately to monotherapy, combination therapy should be considered. No placebo-controlled clinical studies of more than 30 mg once daily have been conducted in combination therapy.
Side Effects: Common side effects are upper respiratory tract infection, headache, sinusitis, myalgia, tooth disorder, and pharyngitis.
Drug Interactions: Administration of Thiazolidinedione with an oral contraceptive containing Ethinyl estradiol and Norethindrone reduces the plasma concentration of both hormones by approximately 30% which could result in loss of contraception.
Warning & Precautions: Pioglitazone exerts its antihyperglycemic effect only in the presence of Insulin. Therefore, it should not be used in Type-I diabetes or for the treatment of diabetic ketoacidosis. Pioglitazone should be used with caution in case of combination anti-diabetic therapy and hepatic insufficiency. Liver enzyme should be monitored regularly.
Use in Pregnancy and Lactation: Pioglitazone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It should not be administered to a lactating women.
Overdosage & Contraindications: Contraindicated in patients with known hypersensitivity to this product or any of its components.
Commercial Pack: Diaglit ® 15 Tablet and Diaglit ® 30 Tablet: Box containing 30 tablets in 3 x 10’s blister strips. Each tablet contains Pioglitazone Hydrochloride INN equivalent to Pioglitazone 15 mg and Pioglitazone Hydrochloride INN equivalent to Pioglitazone 30 mg respectively.
168

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablet
This is a preparation of Gliclazide, is a second generation Sulfonylurea that has hypoglycemic and potentially useful hemobiological properties.
Indications: Non-insulin dependent diabetes mellitus (type-II) when dietary modification has failed.
Dosage and Administration: Initially 40-80 mg daily, adjusted according to response, up to 160 mg as a single dose, with breakfast; higher doses divided; maximum 320 mg daily.
Side Effects: Gliclazide used in standard dose is less likely to cause hypoglycemia.
Hypoglycemia may be favored by concurrent conditions such as hepatic and renal disease, malnutrition, anorexia, senility, alcohol intoxication or adrenal and pituitary insufficiency. Other severe or irreversible adverse effects are gastrointestinal disturbances and dermatological reactions. Symptomatic adverse effects are headache, nausea, dizziness and skin reactions.
Drug Interactions: Following drugs may increase the hypoglycemic effect of Gliclazide-
Aspirin, NSAIDs, Phenylbutazone, Clofibrate, Sulfonamides and Coumarin anticoagulants, Cimetidine, Sulfonamides, Imidazole and the Monoamine Oxidase inhibitors (MAOI).
Warning & Precaution: Use of Gliclazide must be considered as treatment in addition to proper dietary regimen and not as substitute for diet. Patients over a period of time, may become progressively less responsive to therapy with oral hypoglycemic agents because of worsening of their diabetic state. If a loss of adequate blood glucose-lowering response to Gliclazide is detected, the drug should be discontinued. In patient of renal disease it may be wise to limit the maximum dose when the serum creatinine starts to rise. Patients receiving such drugs must be closely observed for both short and longterm complications. Periodic assessment of cardiovascular, ophthalmic, renal and hepatic status is advisable.
Children: There is little information about the use of Sulfonylureas in children.
Elderly: All sulfonylureas should be used with caution in the elderly.
Use in Pregnancy & Lactation: Not recommended in pregnancy and lactation.
Contraindications: Gliclazide, as other sulfonylurea, is contraindicated for use in definite hepatic disease.
Commercial Pack: Diapro ® Tablet: Box containing 50 tablets in 5 X 10’s blister strips.
Each tablet contains Gliclazide BP 80 mg.
169

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablet
Diapro contains Gliclazide which is a second generation sulfonylurea that has hypoglycemic and potentially useful hemobiological properties.
Indications: Non-Insulin dependent Diabetes mellitus (type-II) when dietary modification has failed.
Dosage and Administrations: Initially 40-80 mg daily, adjusted according to response; up to 160 mg as a single dose, with breakfast; higher doses divided; maximum 320 mg daily.
Switching from Gliclazide 80 mg tablets to Gliclazide 30 mg modified release tablets: 1 tablet of Gliclazide 80 mg is comparable to 1 tablet of Gliclazide 30 mg modified release tablet. Consequently the switch can be performed provided a careful blood monitoring.
Side Effects: As previously described. See page No. 169
Drug Interactions: As previously described. See page No. 169
Facts about Diapro ® MR:
• The innovative formulation of once daily Diapro MR is based on a hydrophilic matrix which extends on contact with gastric fluid to form a gel. By diffusion across this gel, short-acting active ingredient (Gliclazide) is released in a predictable and reproducible manner over 24- hour period.
• The release profile of the active glucose-lowering drug (Gliclazide) is perfectly matched to the normal rise and fall in blood glucose levels which occur in type-II diabetes patients over the course of a day, therefore Diapro MR is able to achieve an effective and sustained 24-hour glycemic control with a remarkable safety profile.
Commercial Pack: Diapro ® 30 MR Tablet: Box containing 30 tablets in 3X10’s blister strips. Each modified release tablet contains Gliclazide BP 30 mg.
®
Tablet
This is a preparation of Glimepiride BP, which is an oral blood-glucose-lowering drug of the Sulphonylurea class.
Indication: Non-Insulin dependent (type-II) diabetes, whenever blood sugar levels cannot be controlled adequately by diet, physical exercise and weight reduction. Diaryl is also indicated for use in combination with Insulin to lower blood glucose in patients whose hyperglycemia can not be controlled by diet and exercise or in conjunction with an oral hypoglycemic agent.
170

bexinfo: T
HERAPEUTIC
G
UIDE
Dosage and Administration: In principle, the dosage of Glimepiride is governed by the desired blood sugar level. The dosage of Glimepiride must be the lowest which is sufficient to achieve the desired metabolic control.
Initial dose and dose titration: The usual initial dose is 1 mg once daily. If necessary, the daily dose can be increased. Any increase can be based on regular blood sugar monitoring, and should be gradual, i.e., an intervals of one to two weeks and carried out stepwise as follows: 1 mg-2 mg-3 mg-4 mg-6 mg.
Dose range in patients with well controlled diabetes: Usual dose range in patients with well controlled diabetes is 1 to 4 mg daily.
Distribution of doses: Timing and distribution of doses are decided by the physician, in consideration of the patient’s current life style. Normally, a single daily dose is sufficient.
This should be taken immediately before a substantial breakfast or if none is taken or immediately before the first main meals. It is very important not to skip meals after taking the drug.
Secondary dosage adjustment: As the control of diabetes improves, sensitivity to insulin increases; therefore, Diaryl requirement may fall as treatment proceeds. To avoid hypoglycemia, timely dose reduction or cessation of Glimepiride therapy must be considered. A dose adjustment must also be considered whenever the patient’s weight or life style changes, or other factors arise which cause an increased susceptibility to hypo or hyperglycemia.
Changeover from other oral antidiabetics to Diaryl: When substituting Glimepiride for other such agents, the initial daily dose is 1 mg; this applies even in changeover from the maximum dose of other oral blood sugar lowering agents. Any dose increase should be in accordance with guideline given above in initial dose and dose titration.
It may be necessary to interrupt treatment to avoid additive effects which would increase the risk of hypoglycemia.
Side Effects: Hypoglycemia, temporary visual impairment, nausea, vomiting, diarrhea, abdominal pain, urticaria, fall in blood pressure.
Drug Interaction: Potentiation of the blood-sugar-lowering effect may occur with Insulin and other oral anti-diabetics, ACE inhibitors, Allopurinol, Anabolic steroids and Male sex hormones, Chloramphenicol, Coumarin derivatives, Fluoxetine, MAO inhibitors,
Miconazole, Para-amino salicylic acid, Pentoxifylline (high dose parenteral),
Phenylbutazone, Oxyphenbutazone, Quinolones, Salicylates, Sulphonamides,
Tetracyclines and β- blockers.
Weakening of the blood-sugar-lowering effect may occur with Acetazolamide,
Barbiturates, Corticosteroids, Diazoxide, Diuretics, Epinephrine and other sympathomimetic agents, laxative, Estrogens and Progestogens, Phenothiazines,
Phenytoin, Rifampicin and thyroid hormones.
171

bexinfo: T
HERAPEUTIC
G
UIDE
H2-receptors antagonists, Clonidine and Reserpine may lead to either potential or weakening of the blood-sugar-lowering effect. Both acute and chronic alcohol intake may potentiate or weaken the blood-sugar-lowering action of Glimepiride unpredictably.
Warning & Precaution: In the initial weeks of treatment, the risk of hypoglycemia may be increased and necessitates careful monitoring. If such risk is present it may be necessary to adjust the dosage of Glimepiride. Hypoglycemia can almost always be promptly controlled by immediate intake of carbohydrates.
Use in Pregnancy & Lactation: This must not be taken during pregnancy. Patients planning a pregnancy must inform their physician, and should be shifted to Insulin. Diaryl should not be taken by lactating women.
Overdosage & Contraindication: Glimepiride is not suitable for the treatment of insulin dependent (type-I) diabetes mellitus, or of diabetic pre-coma or coma. Diaryl must not be used in patients hypersensitive to Glimepiride, other Sulphonylurea.
Commercial Pack: Diaryl ® 1 Tablet: Box containing 30 tablets in 3 x 10’s blister strips.
Each tablet contains Glimepiride BP 1 mg.
Diaryl ® 2 Tablet: Box containing 30 tablets in 3 x 10’s blister strips. Each tablet contains
Glimepiride BP 2 mg.
Diaryl ® 3 Tablet: Box containing 30 tablets in 3 x 10’s blister strips. Each tablet contains
Glimepiride BP 3 mg.
®
Tablet
Glipita is a preparation of Sitagliptin Phosphate which is an orally-active, potent, and highly selective inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme for the treatment of type II diabetes.
Indications: Monotherapy: Glipita is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type II diabetes mellitus.
Combination with Metformin: It is indicated in patients with type II diabetes mellitus to improve glycemic control in combination with Metformin as initial therapy or when the single agent alone, with diet and exercise, does not provide adequate glycemic control.
Combination with a Sulfonylurea: Glipita is indicated in patients with type II diabetes mellitus to improve glycemic control in combination with a sulfonylurea when treatment with the single agent alone, with diet and exercise, does not provide adequate glycemic control.
Combination with a Thiazolidinedione: It is indicated in patients with type II diabetes
172

bexinfo: T
HERAPEUTIC
G
UIDE mellitus to improve glycemic control in combination with a thiazolidinedione when treatment with the single agent alone, with diet and exercise, does not provide adequate glycemic control.
Combination with Metformin and a Sulfonylurea: Glipita is indicated in patients with type
II diabetes mellitus to improve glycemic control in combination with Metformin and a sulfonylurea when dual therapy with these agents, with diet and exercise, does not provide adequate glycemic control.
Dosage and Administration: The recommended dose of Glipita is 100 mg once daily as Monotherapy or as combination therapy with Metformin, a sulfonylurea, a thiazolidinedione, or Metformin plus a sulfonylurea. It can be taken with or without food.
Elderly: No dosage adjustment is necessary for elderly patients.
Children: Not recommended under 18 years of age.
Side Effects: The most common side effects are upper respiratory tract infection, nasopharyngitis and headache. Hypoglycemia is also reported more commonly in patients treated with the combination of Sitagliptin and Sulfonylurea, with or without
Metformin.
Drug Interactions: Sitagliptin does not alter the pharmacokinetics of Metformin,
Glyburide, Simvastatin, Rosiglitazone, Warfarin, or Oral contraceptives. It causes a minimal effect on the pharmacokinetics of Digoxin.
Warnings & Precautions: Sitagliptin should not be used in patients with type I diabetes or for the treatment of diabetic ketoacidosis. Assessment of renal function is recommended prior to initiating Sitagliptin and dosage adjustment is recommended in patients with moderate or severe renal insufficiency and in patients with ESRD. When used with a Sulfonylurea, a lower dose of Sulfonylurea may be required to reduce the risk of hypoglycemia. There have been reports of serious allergic and hypersensitivity reactions such as anaphylaxis, angioedema, and exfoliative skin conditions including
Stevens-Johnson Syndrome in patients treated with Sitagliptin. In such cases, Sitagliptin should be immediately stopped and initiate alternative treatment for diabetes. No dosage adjustment is necessary for patients with mild to moderate hepatic insufficiency, but
Sitagliptin has not been studied in patients with severe hepatic insufficiency.
Use in Pregnancy and Lactation: This should be used during pregnancy only if clearly needed. Safety and effectiveness of Sitagliptin in nursing mother have not been established.
Contraindications: Patient hypersensitive reaction to Sitagliptin, such as anaphylaxis or angioedema.
Commercial Pack: Glipita ® 50 Tablet and Glipita ® 100 Tablet: Box containing 10 tablets in 1X10's alu-alu form pack. Each film coated tablet contains Sitagliptin Phosphate INN equivalent to 50 mg of Sitagliptin and Sitagliptin Phosphate INN equivalent to 100 mg of
Sitagliptin respectively.
173

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablet
Glipita M is a combination of Sitagliptin/Metformin HCl, two oral hypoglycemic drugs used in the management of type II diabetes
Indications: Glipita-M is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type II diabetes mellitus when treatment with both Sitagliptin and
Metformin is appropriate.
Dosage and Administration: The dosage of Glipita-M should be individualized on the basis of the patient's current regimen, effectiveness, and tolerability while not exceeding the maximum recommended daily dose of 100 mg Sitagliptin and 2000 mg metformin.
Glipita-M should generally be given twice daily with meals, with gradual dose escalation, to reduce the gastrointestinal (GI) side effects due to Metformin.
The recommended starting dose in patients not currently treated with Metformin is 50 mg
Sitagliptin/500 mg Metformin hydrochloride twice daily, with gradual dose escalation recommended to reduce gastrointestinal side effects associated with Metformin.
The starting dose in patients already treated with Metformin should provide Sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) and the dose of Metformin already being taken. For patients taking Metformin 850 mg twice daily, the recommended starting dose of Glipita-M is 50 mg Sitagliptin/1000 mg Metformin hydrochloride twice daily.
Co-administration of Glipita-M with an Insulin secretagogue (e.g., Sulfonylurea) or Insulin may require lower doses of the Insulin secretagogue or Insulin to reduce the risk of hypoglycemia.
Children: Not recommended in children below 18 years of age.
Elderly: It should be used with caution in elderly. Care should be taken in dose selection and regular monitoring of renal function.
Side Effects: Common side effects are diarrhea, upper respiratory tract infection, headache, nasopharyngitis and hypoglycemia, abdominal discomfort, indigestion, asthenia, and headache.
Drug Interactions: Amiloride, Digoxin, Morphine, Procainamide, Quinidine, Quinine,
Ranitidine, Triamterene, Trimethoprim, or Vancomycin-have the potential for interaction with Metformin by competing for common renal tubular transport systems. Certain drugs which include Thiazides and other diuretics, Corticosteroids, Phenothiazines, Thyroid products, Estrogens, Oral contraceptives, Phenytoin, Nicotinic acid, Sympathomimetics,
Calcium channel blocking drugs, and Isoniazid tend to produce hyperglycemia and may lead to loss of glycemic control.
Warnings and Precautions: Lactic acidosis is a rare, but serious, metabolic complication that can occur due to Metformin accumulation during treatment with Sitagliptin/Metformin
HCl combination, which is fatal in approximately 50% of cases. It may also occur in
174

bexinfo: T
HERAPEUTIC
G
UIDE association with a number of pathophysiologic conditions, including diabetes mellitus, and whenever there is significant tissue hypoperfusion and hypoxemia. There have been reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, in patients taking Sitagliptin/Metformin HCl combination. After initiation of
Sitagliptin/Metformin HCl combination, patients should be observed carefully for signs and symptoms of pancreatitis& if suspected Sitagliptin/Metformin HCl combination should promptly be discontinued and appropriate management should be initiated.
Sitagliptin/Metformin HCl combination should generally be avoided in patients with hepatic disease because of risk of lactic acidosis. The risk of Metformin accumulation and lactic acidosis increases with the degree of impairment of renal function. Thus, patients with serum creatinine levels above the upper limit of normal for their age should not receive Sitagliptin/Metformin HCl combination.
Use in Pregnancy and Lactation: Glipita-M should be used during pregnancy only if clearly needed. Safety and effectiveness of Glipita-M in lactating mother have not been established.
Overdosage & Contraindications: Glipita-M is contraindicated in patients with renal disease, acute myocardial infarction, septicemia, acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma, history of a serious hypersensitivity reaction to Sitagliptin/Metformin HCl combination or Sitagliptin such as anaphylaxis or angioedema. This combination drugs should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials.
Commercial Pack: Glipita ® M 50/500 Tablet: Box containing 10 tablets in 1X10's blister strip. Each film coated tablet contains Sitagliptin Phosphate INN equivalent to 50 mg of
Sitagliptin and Metformin Hydrochloride BP 500 mg.
Glipita ® M 50/1000 Tablet: Box containing 10 tablets in 1X10's blister strip. Each film coated tablet contains Sitagliptin Phosphate INN equivalent to 50 mg of Sitagliptin and
Metformin Hydrochloride BP 1000 mg.
®
®
Tablet
This is a preparation of Metformin Hydrochloride, a biguanide class of oral antidiabetic drugs.
Indications: Metformin Hydrochloride, as monotherapy, is indicated as an adjunct to diet to lower blood glucose in patients with non-insulin-dependent diabetes mellitus (NIDDM) whose hyperglycemia cannot be satisfactorily managed on diet alone. Metformin
Hydrochloride may be used concomitantly with a sulfonylurea alone do not result in adequate glycemic control.
175

bexinfo: T
HERAPEUTIC
G
UIDE
Dosage and Administration: Infomet 500: Initial dosage is 500 mg tablet 2-3 times daily with or after meals, gradually increased if necessary to 2 to 3 gm daily.
Informet 850: Initial dosage is 850 mg tablet once or twice daily with or after meals, gradually increased if necessary to 2 to 3 g daily.
Informet LA: The usual starting dose of Informet LA (Metformin Hydrochloride long acting) is 500 mg once daily with the evening meal. Dosage increase should be made in increments of 500 mg weekly, up to a maximum of 2 gm once daily with the evening meal.
If glycemic control is not achieved on Informet LA 2 gm once daily, a trial of Informet LA
1 gm twice daily should be considered.
Transfer from Other Antidiabetic Therapy: When transferring patients from standard oral hypoglycemic agents other than Chlorpropamide to Metformin Hydrochloride, no transition period is necessary. When transferring patients from Chlorpropamide, care should be exercised during the first two weeks because of the prolonged retention of
Chlorpropamide in the body, leading to overlapping drug effects and possible hypoglycemia.
Children: Safety and effectiveness in pediatric patients have not been established.
Elderly: Dosage adjustment should be based on a careful assessment of renal function in elderly patients.
Side Effects: Diarrhea, nausea, vomiting, abdominal bloating, flatulence, and anorexia are the most common reactions to Metformin Hydrochloride. Lactic acidosis also rarely occurs.
Drug Interactions: Nifedipine, Thiazide and other diuretics, Corticosteroids,
Phenothiazines, Thyroid products, Estrogens, Oral contraceptives, Phenytoin, Nicotinic acid, Sympathomimetics, Calcium channel blocking drugs, and Isoniazid.
Warning & Precautions: Metformin Hydrochloride therapy should be temporarily suspended for any surgical procedure (except minor procedures not associated with restricted intake of food and fluids) and should not be restarted until the patient's oral intake has resumed and renal function has been evaluated as normal. It should be used with caution in case of excessive alcohol intake and hepatic insufficiency. It should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function.
Use in Pregnancy & Lactation: Not recommended in pregnancy & lactation.
Overdosage & Contraindications: Metformin is contraindicated in patients with renal disease or renal dysfunction, congestive heart failure, known hypersensitivity, acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.
Hypoglycemia has not been seen even with ingestion of up to 85 gm of Metformin HCL, although lactic acidosis has occurred in such circumstances.
176

bexinfo: T
HERAPEUTIC
G
UIDE
Commercial Pack: Informet ® 500 Tablet: Box containing 100 tablets in 10x10’s blister strips. Each tablet contains Metformin Hydrochloride BP 500 mg.
Informet ® LA Tablet: Box containing 100 tablets in 10x10’s blister strips. Each long acting tablet contains Metformin Hydrochloride BP 500 mg.
Informet ® 850 Tablet: Box containing 60 tablets in 6x10’s blister strips. Each tablet contains Metformin Hydrochloride BP 850 mg.
®
Tablet
This is a preparation of Repaglinide which belongs to a new class of oral anit-diabetic drug called Meglitinide which stimulates Insulin release from β -cells of pancreas.
Indications: Premil is indicated as an adjunct to diet and exercise to lower the blood glucose level in patients with type II diabetes mellitus (NIDDM) whose hyperglycemia cannot be controlled by diet and exercise alone. It is also indicated for use in combination with metformin to lower blood glucose in patients whose hyperglycemia cannot be controlled by exercise, diet, and either Repaglinide or Metformin alone.
Dosage & Administration: Premil has to be taken just before or up to 30 minutes before the meal. Premil can be taken two, three or four times a day, depending on how many meals are taken. If a meal is missed, Premil should also be avoided. If an extra meal is eaten, an extra dose of Premil should be taken with that meal. If a dose of Premil is missed, it should not be taken between meals. Rather the usual dose should be taken before the next meal. The dose ranges from 0.5 to 4 mg before each meal. The starting dose of Repaglinide in patients with HbA1c <8% is 0.5 mg before each meal. In patients with HbA1c >8% the starting dose is 1 or 2 mg before each meal. The dose may be increased gradually up to 4 mg before each meal.
Side Effects: Common side effects include cold and flu-like symptoms, diarrhea, jointache, back pain and hypoglycemia.
Drug Interactions: Azole antifungals and Macrolides, Rifampicin, Phenobarbital,
Carbamazepine, Troglitazone, Cimetidine Digoxin, Theophylline, Warfarin, NSAIDs,
Salicylates, Sulfonamides, Chloramphenicol, Coumarins, Probenecid, Mono-amine oxidase (MAO) inhibitors, and β -adrenergic blockers.
Warning & Precautions: Proper patient selection, dosage, and instructions to the patients are important to avoid hypoglycemic episodes. Repaglinide should also be used in caution in renal and hepatic insufficiency.
Use in Pregnancy & Lactation: It should be used in pregnancy, only if clearly needed, caution should be exercised when it is administered to nursing women.
177

bexinfo: T
HERAPEUTIC
G
UIDE
Overdosage & Contraindication: Repaglinide is contraindicated in patients with diabetic ketoacidosis, with or without coma, in patients with type I diabetes and in patients with known hypersensitivity to the drug or its active ingredients.
Commercial Pack: Premil ® 0.5 Tablet: Box containing 30 tablets in 3 x 10’s blister strips.
Each tablet contains Repaglinide USP 0.5 mg.
Premil ® 1 Tablet: Box containing 30 tablets in 3 x 10’s blister strips. Each tablet contains
Repaglinide USP 1 mg.
Premil ® 2 Tablet: Box containing 30 tablets in 3 x 10’s blister strips. Each tablet contains
Repaglinide USP 2 mg.
178

bexinfo: T
HERAPEUTIC
G
UIDE
O
VULATORY
S
TIMULANT
®
Tablet
This is a preparation of Clomiphene Citrate, a selective estrogen receptor modulator
(SERM).
Indications: Fertil is indicated for the treatment of ovulatory failure in women desiring pregnancy whose partners are fertile and potent. It is also indicated in the treatment of menorrhagia caused by hyperplastic endometrium.
Dosage and Administration: The usual dose for the first course of Fertil is 50 mg (1 tablet) a day for 5 days in the early follicular phage of the cycle, following normal menstruation or a progestagen-induced withdrawal bleeding. Many regimens have been used, but most common begin either on day 2 or day 5. If this dose induces ovulation, but pregnancy does not occur, stimulation with Clomiphene Citrate is to be continued, but up to 6 stimulative courses. If the first course does not induce ovulation, the second course should be started with 100 mg a day (2 tablets of 50 mg taken in a single dose) for 5 days. If ovulation is not induced, 2 more stimulative courses of the same dose should be given. If the next three stimulative courses do not produce a successful result, the therapeutic trial is considered to be finished. If ovulation is induced, but pregnancy does not occur, maximum 6 courses with Fertil are recommended. However, if menstrual bleeding does not occur, the patient should be examined carefully for the possible pregnancy, and the next course of therapy should be delayed until the correct diagnosis has been determined.
Side Effects: Common side effects are dizziness, headache, nausea, vomiting, depression, fatigue, insomnia, vasomotor flushing, and allergic reaction.
Drug Interactions: There are no significant drug interactions with Clomiphene Citrate.
Warning & Precautions: Clomiphene Citrate is not to be used for longer maintenance therapy. If ovarian enlargement occurs, the next Fertil course is not to be given until the ovaries return to their pretreatment size and the dosage of the next course may be reduced. Fertil should be used with caution in alcoholic drinks & antidepressants. There is a minimal chance of multiple pregnancies.
Patient should be informed that blurring or other visual symptoms such as spots or flashes
(scintillating scotomata) may occasionally occur during therapy with Clomiphene Citrate.
These visual symptoms increase in incidence with increasing total dose or therapy duration and generally disappear within a few days or weeks after the drug is discontinued.
The ovarian hyperstimulation syndrome (OHSS) has been reported to occur in patients receiving Clomiphene Citrate therapy. Prolonged use of this preparation may increase the risk of a borderline or invasive ovarian tumor.
179

bexinfo: T
HERAPEUTIC
G
UIDE
Use in Pregnancy & Lactation: This should not be administered during pregnancy.
Caution should be exercised when it is administered to a nursing woman. In some patients, it may reduce lactation.
Contraindications: This is contraindicated during pregnancy, in patients with liver disease, ovarian cysts, bleeding of undetermined origin, and in patients with neoplasms of endometrium.
Commercial Pack: Fertil ® Tablet: Box containing 50 tablets in blister strip. Each tablet contains Clomiphene Citrate USP 50 mg.
180

G
D

bexinfo: T
HERAPEUTIC
G
UIDE
A
NTACIDS
& A
NTI
-
FLATULENT
®
Tablet
Antacid MAX is an antacid and antiflatulent containing a combination of Aluminum
Hydroxide, Magnesium Hydroxide and Simethicone.
Indications: This is indicated for dyspepsia, hyperacidity, gastric and duodenal ulcer, gastritis, relief of flatulence, abdominal distention and colic.
Dosage & Administration: 1-2 tablets of Antacid MAX after meals and at bed time or as directed by the physician.
Warning & Precautions: Drugs containing Aluminum Hydroxide should not be taken concomitantly with any form of Tetracycline, as the absorption of the later may be affected.
Aluminum Hydroxide may also reduce the absorption of Digoxin.
Commercial Pack: Antacid ® MAX Tablet: Box containing 20 blister strips of 10 tablets, each tablet contains 400 mg Dried Aluminum Hydroxide Gel USP, 400 mg Magnesium
Hydroxide BP and 30 mg Simethicone USP.
®
Tablet / Suspension
Digecid Plus contains Magaldrate and Simethicone. Magaldrate (magnesium aluminium compound i.e., Hydroxymagnesium Aluminate), which neutralizes gastric acid extraordinarily quickly without raising the pH above 3-5. It also decreases the activity of pepsin in gastric secretion. Besides this, Simethicone, another component, enables the gas bubble to coalesce and give relief from flatulence.
Indication: Magaldrate and Simethicone are indicated to relieve symptoms of dyspepsia, heartburn, acid indigestion, sour stomach, gastroesophageal reflux and hiatal hernia. It is also prescribed in hyperacidity associated with peptic ulcers, gastritis and esophagitis.
Magaldrate may be given to children if necessary. Also indicated for the relief of flatulence, abdominal distension and windy colic.
Dosage and Administration: Tablet: 1-3 tablet, after meals and at bed time or as directed by the physician.
Suspension: 2-4 teaspoonful after 20-60 minutes of meal and before sleep or on the basis of physician’s prescription.
Warning and Precautions: Care should be taken in decreased kidney function, hypophosphatemia and weak people.
183

bexinfo: T
HERAPEUTIC
G
UIDE
Use in Pregnancy and Lactation: Magaldrate may be used in pregnancy if indicated.
However one should avoid excessive dosage. This may pass into breast milk but has not been reported to cause problem in nursing babies.
Side Effects: GI side effects are uncommon. Occasionally, if excessive amount is consumed, diarrhea, constipation or regurgitation may occur.
Contraindications: Magaldrate is contraindicated in patients with known hypersensitivity to magnesium and aluminium. It is also contraindicated in patients with impaired renal functions.
Drug Interaction: It should not be used in patients taking any form of Tetracycline. The drug may cause reduced bio-availability or slower absorption of a number of drugs including propranolol, isoniazid, prednisolone and naproxen.
Commercial Pack: Digecid ® Plus Tablet: Each box contains 100 tablets in 10 x10’s blister strips. Each tablet contains Magaldrate USP 480 mg and Simethicone USP 20mg.
Digecid ® Plus Suspension: Bottle contains 200 ml of Magaldrate and Simethicone suspension. Each 5 ml contains Magaldrate USP 480 mg and Simethicone USP 20 mg.
®
Suspension
Flatameal DS is an antacid and antiflatulent combination containing Aluminum Hydroxide
Gel USP, Magnesium Hydroxide BP and Simethicone USP.
Indications: Flatameal DS is indicated for dyspepsia, hyperacidity, gastric and duodenal ulcer, gastritis; also indicated for the relief of flatulence, abdominal distention and windy colic.
Dosage & Administration: 1-2 teaspoonful of Flatameal-DS Suspension to be taken one hour after meals and at bed time or as directed by the physician.
Warning & Precautions: Drugs containing Aluminum Hydroxide should not be taken concomitantly with any form of Tetracycline, as the absorption of the later may be affected.
Aluminum Hydroxide may also reduce the absorption of Digoxin.
Commercial Pack: Flatameal ® DS Suspension: 200 ml suspension in glass bottle, each
5 ml contains dried Aluminum Hydroxide Gel USP equivalent to 200 mg Aluminum Oxide,
400mg Magnesium Hydroxide BP and 30 mg Simethicone USP.
184

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablet / Suspension
Lactameal is an antacid containing a combination of Aluminum Hydroxide and
Magnesium Hydroxide.
Indications: Hyperacidity, gastric and duodenal ulcer and gastritis.
Dosage and Administration: Two Lactameal tablets or 2 teaspoonful of Lactameal suspension one hour after meals and at bed time or as directed by the physician.
Commercial Pack: Lactameal ® Tablet: Box containing 20 blister strips of 10 tablets, each tablet contains 250 mg Dried Aluminum Hydroxide Gel USP and 400 mg
Magnesium Hydroxide BP.
Lactameal ® Suspension: 200 ml suspension in glass bottle, each 5 ml contains Aluminum
Hydroxide Gel USP equivalent to 175 mg Aluminum Oxide and 225 mg Magnesium
Hydroxide BP.
185

bexinfo: T
HERAPEUTIC
G
UIDE
A
NTI
-C
OLIC
& A
NTI
-F
LATULENT
®
Pediatric Drops
This is a preparation of Simethicone which is used as an antiflatulent to relieve symptoms commonly referred to gas including upper GI bloating, fullness or stuffed feeling.
Indications: a) Flatulence, abdominal distention, fullness, gas and windy colic etc. b)
Large bowel preparation: Addition of Neodrop to a polyethylene glycol bowel preparation produces symptomatic improvement prior to investigation in patients undergoing colonoscopy. c) Treatment of poisoning: as an antifoaming agent in the management of accidental ingestion of foaming detergents.
Dosage and Administration: The drug Take after meals and at bedtime. It can be given with infant’s feeds.
Children less than 2 years of age: 20 mg (0.3 ml Neodrop drops) 4 times daily up to 240 mg (3.6 ml Neodrop drops)/day.
Children: 2-12 years of age: 40 mg (0.6 ml Neodrop drops) 4 times daily.
Adults: 40-80 mg (0.6 ml-1.2 ml Neodrop drops) 4 times daily, up to 500 mg (7.5 ml
Neodrop drops/day).
Side Effects: Simethicone is physiologically inert and no adverse effect has been noted after oral ingestion.
Drug Interaction: The defoaming effect of Simethicone is reduced by antacids such as
Aluminum Hydroxide and Magnesium Carbonate.
Warning & Precautions: Doses should not be exceed more than 12 per day, except under the advice and supervision of a physician.
Use in Pregnancy & Lactation: No data are available to suggest any harmful effects.
Commercial Pack: Neodrop ® Pediatric Drops: Bottle containing 15 ml drops with a plastic dropper. Each ml drop contains Simethicone USP 67mg.
186

bexinfo: T
HERAPEUTIC
G
UIDE
A
NTI
-E
METIC
®
Tablet / Syrup
This is a preparation of Ondansetron Hydrochloride, which is a potent, highly selective
5HT
3 receptor-antagonist.
Indications: Onsat is indicated for the prevention and treatment of post-operative nausea and vomiting and for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy.
Dosage and Administration: For Tablet:
1. Postoperative nausea and vomiting: The recommended dosage is 16mg as two tablets 1 hour before induction of anesthesia.
2. Chemotherapy induced nausea and vomiting: a) For highly emetogenic cancer chemotherapy: The recommended adult oral dosage is three tablets administered 30 minutes before the start of chemotherapy. b) For moderately emetogenic cancer chemotherapy: One tablet twice daily. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose and tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy.
3. Radiotherapy induced nausea and vomiting: The recommended dosage is one tablet given thrice a day. For total body irradiation, one tablet should be administered 1 to
2 hours before each fraction of radiotherapy administered each day. For single high dose fraction radiotherapy to the abdomen, one tablet should be administered 1 to 2 hours before radiotherapy with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy. For daily fractionated radiotherapy in the abdomen, one tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given.
Pediatric use: For pediatric patients 4 to 11 years of age, the dosage is one half of a tablet given three times a day (every 8 hours).
Dosage adjustment for patients with impaired renal function: The dosage recommendation is the same as for the general population.
Dosage adjustment for patients with impaired hepatic function: In patients with severe hepatic impairment, a total daily dose of 8 mg should not be exceeded.
For Syrup: The usual dosage for adults is 8 mg (10 ml) twice daily for up to 5 days.
The usual dosage for children is 4 mg (5 ml) twice daily for up to 5 days.
187

bexinfo: T
HERAPEUTIC
G
UIDE
Side Effects: Frequently reported adverse events are headache, constipation and diarrhea. In chemotherapy induced nausea and vomiting, rash has occurred in approximately 1% of patients receiving Ondansetron. Rare cases of anaphylaxis bronchospasm, tachycardia, angina, hypokalemia shortness of breath have also been reported.
Drug Interactions: As Ondansetron is metabolized by hepatic cytochrome P-450 drug metabolizing enzymes reducers or inhibitors of these enzymes may change the clearance and hence the half life of Ondansetron. On the basis of available data no dosage adjustment of Ondansetron is recommended for patients taking these drugs.
Warnings & Precautions: Hypersensitivity reactions have been reported in patients who have exhibited hypersensitivity to other selective 5HT3 receptor antagonists. Onsat is not a drug that stimulates gastric or intestinal peristalsis. It should not be used instead of progressive ileus and/or gastric distension.
Use in Pregnancy & Lactation: Not recommended in pregnancy, caution should be exercised when Ondansetron is administered to a nursing mother.
Overdosage & Contraindications: Onsat is contraindicated in patients known to have hypersensitivity to the drug.
Commercial Pack: Onsat ® 8 Tablet: Each box contains 30 tablets in 3x10’s blister strips.
Each film coated tablet contains Ondansetron Hydrochloride USP equivalent to
Ondansetron 8 mg.
Onsat ® Syrup: Bottle containing 50 ml syrup. Each 5 ml contains Ondansetron
Hydrochloride USP equivalent to Ondansetron 4 mg.
®
IM / IV Injection
This is a preparation of Ondansetron Hydrochloride, which is a potent, highly selective
5HT3 receptor-antagonist.
Indications: Ondansetron is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy, and for the prevention and treatment of post-operative nausea and vomiting (PONV).
Dosage and Administration: Adults: Emetogenic chemotherapy and radiotherapy: For most patients receiving emetogenic chemotherapy or radiotherapy, onsat 8 mg should be administered as a slow intravenous or intramuscular injection immediately before treatment, followed by 8 mg orally twelve hourly.
Highly emetogenic chemotherapy: For patients receiving highly emetogenic chemotherapy, onsat can be given either by rectal, intravenous or intramuscular administration.
188

bexinfo: T
HERAPEUTIC
G
UIDE
Ondansetron has been shown to be equally effective in the following dose schedules over the first 24 hours of chemotherapy: A single dose of 8 mg by slow intravenous or intramuscular injection immediately before chemotherapy. A dose of 8 mg by slow intravenous or intramuscular injection immediately before chemotherapy, followed by two further intravenous or intramuscular doses of 8 mg two to four hours apart, or by a constant infusion of 1 mg/hour for up to 24 hours.
A single dose of 32 mg diluted in 50-100 ml of saline or other compatible infusion fluid and infused over not less than 15 minutes immediately before chemotherapy.
The selection of dose regimen should be determined by the severity of the emetogenic challenge.
Children: Ondansetron may be administered as a single intravenous dose of 5 mg/m2 immediately before chemotherapy, followed by 4 mg orally twelve hours later. 4 mg orally twice daily should be continued for up to 5 days after the end of chemotherapy.
Elderly: Ondansetron is well tolerated by patients over 65 years and no alteration of dosage, dosing frequency or route of administration are required.
Patients with Renal Impairment: No alteration of daily dosage or frequency of dosing or route of administration are required.
Patients with hepatic Impairment: In such patients a total daily dose of 8 mg should not be exceeded.
Post-operative nausea and vomiting (PONV): Adults: For the prevention of PONV ondansetron can be administered orally or by intravenous or intramuscular injection.
Ondansetron may be administered as a single dose of 4 mg given by intramuscular or slow intravenous injection at induction of anesthesia. For treatment of established PONV a single dose of 4 mg given by intramuscular or slow intravenous injection is recommended.
Children (aged 2 years and over): For prevention of PONV in pediatric patients having surgery performed under general anesthesia, onsat may be administered by slow intravenous injection at a dose of 0.1 mg / kg up to a maximum of 4 mg either prior to, at or after induction of anesthesia. For treatment of established PONV in pediatric patients, onsat may be administered by slow intravenous injection at a dose of 0.1 mg/kg up to a maximum of 4 mg.
Children (below 2 years): There is limited data on the use of ondansetron in the prevention and treatment of PONV in children below 2 years of age.
Side Effects: As described previously. See page No. 188
Drug Interactions: As described previously. See page No. 188
189

bexinfo: T
HERAPEUTIC
G
UIDE
Warning & Precautions: As described previously. See page No. 188
Overdosage & Contraindications: As described previously. See page No. 188
Commercial Pack: Onsat ® IM/IV Injection: Box containing 1 x 5 ampoules of 4 ml in blister pack. Each 4 ml ampoule contains Ondansetron Hydrochloride USP equivalent to
Ondansetron 8 mg.
190

bexinfo: T
HERAPEUTIC
G
UIDE
A
NTI
-S
PASMODIC
®
Tablet
This is a preparation of Tiemonium Methylsulfate. It is an antispasmodic. It reduces muscle spasms of the intestine, biliary system, bladder and uterus.
Indications: This drug is indicated for pain in gastrointestinal and biliary diseases, and in urology and gynecology.
Dosage and Administration: In adults the usual dose is 2 to 6 tablets per day.
Side Effects: In some people dry mouth with difficulty in swallowing and thirst, dilatation of pupils with loss of accommodation and sensitivity to light, increased intraocular pressure, flushing, dry skin, bradycardia followed by tachycardia, palpitations and arrhythmias, difficulty in micturition and constipation may occur.
Warning and Precautions: In order to avoid possible drug interactions, physician should know about any other drugs the patient is taking.
Use in Pregnancy and Lactation: Avoid taking this drug without medical advice during pregnancy or breast feeding.
Contraindications: Occasional retention of urine in excessive or overdoses. This drug should not be used in glaucoma and in difficulty to urinate (disorders of prostate or bladder).
Commercial Pack: Emonium ® Tablet: Box containing 50 tablets in 5 x 10’s blister strips.
Each tablet contains Tiemonium Methylsulfate INN 50 mg.
®
IM / IV Injection
This is a preparation of Tiemonium Methylsulphate, quaternary ammonium antimuscarinic agent with peripheral effect similar to those of atropine. Tiemonium strengthens calcium bonding with phospholipids and proteins thus stabilizing the cell membrane of the GI tract.
Indications: It reduces muscle spasms of the intestine, biliary system, uterus & urinary bladder. It is indicated for the pain in gastrointestinal & biliary disease in the urology and gynecology such as gastroenteritis, diarrhea, dysentery, biliary colic, enterocolitis, cholecystytis, colonopathyes, mild cystitis, & spasmodic dysmenorrhea.
191

bexinfo: T
HERAPEUTIC
G
UIDE
Dosage and Administration: Recommended injectable dose is one or two Tiemonium methylsulphate injection three times daily, through intravenous route slowly or intramuscular route.
Pediatric use: Safety and effectiveness of Tiemonium methylsulphate in pediatric patients have not been established.
Geriatric use: Efficacy and safety were maintained with increasing age.
Side Effects: Side effect with the use of Tiemonium methylsulphate is very rare.
Warning and Precautions: Caution should be taken in cases of chronic bronchitis, coronary insufficiency, ambient hyperthermia, renal insufficiency, hepatic insufficiency, pregnancy and lactation.
Use in Pregnancy & Lactation: Tiemonium methylsulphate may be used in pregnancy only if it is clearly needed by the assessment of risk benefit ratio. This may be used in lactating mother only if it is clearly needed by the assessment of risk benefit ratio.
Drug Interactions: Tiemonium methylsulphate should not be used with other drugs without prior consult of a registered physician to avoid possible drug interaction.
Contraindications: Contraindicated in glucoma or where acute pain of eyeball with vision disturbance, in patients with the disorder of prostate or urinary bladder.
Commercial Pack: Emonium ® IM/IV Injection: Box containing 1 x 5 ampoules of 2 ml in blister pack. Each 2 ml ampoule contains Tiemonium Methylsulphate INN 5 mg.
®
Tablet / Syrup
Loverin is a preparation of Dicycloverine Hydrochloride, a tertiary amine used to prevent gastrointestinal smooth muscle spasm.
Indications: Symptomatic relief of gastrointestinal disorders characterized by smooth muscle spasm.
Dosage and Administration: Adult: 10–20 mg 3 times daily.
Child: 6–24 months: 5–10 mg 3–4 times daily, 15 minutes before feeds.
Children 2–12 years: 10 mg 3 times daily.
Infant: Should not be given in infants under 6 months.
192

bexinfo: T
HERAPEUTIC
G
UIDE
Side Effects: The common side effects are constipation, transient bradycardia (followed by tachycardia, palpitations and arrhythmias), reduced bronchial secretions, urinary urgency and retention, dilatation of the pupils with loss of accommodation, photophobia, dry mouth, flushing and dryness of the skin. Confusion (particularly in the elderly), nausea, vomiting and giddiness occasionally may occur.
Drug Interactions: Concomitant use of drugs having antimuscarinic effects can increase side effects.
Use in Pregnancy and Lactation: Not recommended in pregnancy and lactation.
Overdosage & Contraindications: This is contraindicated in angle-closure glaucoma, myasthenia gravis, paralytic ileus, pyloric stenosis and prostatic enlargement.
Commercial Pack: Loverin ® Tablet: Box containing 50 tablets in 5X10’s blister strips.
Each tablet contains Dicycloverine Hydrochloride BP 10 mg.
Loverin ® Syrup: Available in 50 ml bottle. Each 5 ml contains Dicycloverine
Hydrochloride BP 10 mg.
®
Tablet
Rostil is a musculotropic antispasmodic agent available as film coated tablet, each containing Mebeverine Hydrochloride BP.
Indications: It is indicated for
• Symptomatic relief of Irritable bowel syndrome
• Other conditions includes :
- Chronic irritable colon
- Spastic constipation
- Mucous colitis
- Colicky abdominal pain and cramps
- Persistent non-specific diarrhea
Dosage & Administration: Adults (including elderly): One tablet three times a day, preferably 20 minutes before meals. After a period of several weeks when the desired effect has been obtained, the dosage may be gradually reduced.
Side Effects: There are no known life-threatening toxic effects of Rostil. There are a few reported cases of overdose with Mebeverine.
Warning & Precautions: This is not recommended for neonates, only recommended for children over 10 years.
Use in Pregnancy: No teratogenicity has been shown in animal experiments & there are no known teratogenic effects in human.
193

bexinfo: T
HERAPEUTIC
G
UIDE
Overdosage & Contraindications: Contraindications not known. In cases of overdose,
CNS excitability will occur. No specific antidote is known; gastric lavage & symptomatic treatment is recommended.
Commercial Pack: Rostil ® Tablet: Box containing 5 blister strips of 10 tablets, each tablet contains Mebeverine Hydrochloride BP 135 mg.
®
Tablet
This is an antispasmodic containing Hyoscine Butylbromide BP.
Indications: It is indicated for Spasm of the gastro-intestinal tract, Spasm of the genitourinary tract and spasmodic dysmenorrhea.
Dosage & Administration: Adult: 1-2 tablets 3-4 times daily.
Children: (6-12 years) 1 tablet 3 times daily.
Side Effects: Dryness of mouth and tachycardia have been reported infrequently during treatment with Hyoscine Butyl-bromide.
Warning & Precautions: Should be used with caution during 1st trimester of pregnancy.
Contraindication: This should not be given to patients suffering from glaucoma.
Commercial Pack: Spanil ® Tablets: Box containing 10 blister strips of 10 film coated tablets, each tablet contains 10 mg of Hyoscine Butylbromide BP.
®
Tablet
This is a preparation of Drotaverine Hydrochloride INN a potent synthetic antispasmodic which is readily absorbed from the intestine.
Indications: Taverin is indicated in the following conditions: a) Spastic conditions of the gastrointestinal tract, irritable bowel syndrome, biliary colic’s and spastic conditions of the biliary tract such as cholecystolithiasis, cholecystitis, cholangitis. b) Renal colics and spastic conditions of the urogenital tract: nephrolithiasis, ureterolithiasis, pyelitis, cystitis.
c) Spastic conditions of the uterus: dysmenorrhea, imminent abortion, uterine tetanus.
Owing to its freedom from cardio toxic and hypotensive effects as well as its specificity of cardiac adrenolytic action, Taverin is of outstanding value in the treatment of coronary insufficiency and angina pectoris.
Dosage & Administration: The average dose for adults is daily three-times 1 to 2 tablets.
Children should be given smaller doses according to age and body weight. Small children should receive once or twice daily ¼ - ½ tablet, older children ½ to 1 tablet daily. In peptic ulcer it is expedient to combine Taverin with Atropine or Atropine-like compounds.
194

bexinfo: T
HERAPEUTIC
G
UIDE
Side Effects: The common side effects are headache, dizziness, rhinitis, sinusitis, gastrointestinal upset, nausea, pharyngitis, edema and fatigue.
Warning & Precautions: As with most drugs, the use of Drotaverine Hydrochloride should be avoided during pregnancy & lactation unless essential.
Contraindications: Hypersensitivity to Drotaverine or any of the components of this product.
Commercial Pack: Taverin ® Tablet: Box containing 100 tablets in 10 x 10’s blister strips.
Each tablet contains Drotaverine Hydrochloride INN 40 mg.
195

bexinfo: T
HERAPEUTIC
G
UIDE
A
NTI
-U
LCERANTS
®
Tablet
Rabeprazole Sodium is an antiulcer drug which belongs to proton pump inhibitors.
Indications: Short-term treatment in healing and symptomatic relief of duodenal ulcers, erosive or ulcerative gastro-esophageal reflux disease (GERD), maintaining healing and reducing relapse rates of heartburn symptoms in patients with GERD, other symptoms associated with GERD, long-term treatment of pathological hyper secretory conditions including Zollinger-Ellison Syndrome and in combination with Amoxicillin and
Clarithromycin to eradicate H. pylori.
Dosage and Administration: Healing of Erosive or Ulcerative Gastro-esophageal Reflux
Disease (GERD): 20 mg to be taken once daily for four to eight weeks. For those patients who have not healed after 8 weeks of treatment, an additional 8-week course may be considered.
Maintenance of Healing of Erosive or Ulcerative Gastro-esophageal Reflux Disease: The recommended adult oral dose is 20 mg once daily.
Treatment of Symptomatic Gastro-esophageal Reflux Disease (GERD): The recommended adult oral dose is 20 mg once daily for 4 weeks. If symptoms do not resolve completely after 4 weeks, an additional course of treatment may be considered.
Healing of Duodenal Ulcers: The recommended adult oral dose is 20 mg once daily after the morning meal for a period up to four weeks. Most patients with duodenal ulcer heal within four weeks. A few patients may require additional therapy to achieve healing.
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
Rabeprazole sodium
Amoxicillin
Clarithromycin
20 mg
1000 mg
500 mg
Twice Daily for 7 Days
Twice Daily for 7 Days
Twice Daily for 7 Days
All three medications should be taken twice daily with the morning and evening meals.
Side Effects: The common side effects are-headache, diarrhea, abdominal pain, vomiting, constipation, dry mouth, increased or decreased appetite, muscle pain, drowsiness and dizziness.
Drug Interactions: No drug interaction is reported.
Warning & Precautions: The safety and effectiveness of Rabeprazole in pediatric patients have not been established.
196

bexinfo: T
HERAPEUTIC
G
UIDE
Use in Pregnancy and Lactation: This drug should be used during pregnancy only if clearly needed. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the benefit of the drug to the mother.
Contraindications: This is contraindicated in patients with known hypersensitivity to
Rabeprazole or to any component of the formulation.
Commercial Pack: Acifix ® 20 Tablet: Box containing 50 tablets in 5 x 10’s Alu -Alu form packs. Each enteric coated tablet contains Rabeprazole Sodium INN 20 mg.
®
Tablet
Gastalfet tablet contains 500 mg of Sucralfate, basic aluminum salt of sucrose octa sulphate.
Indications: For the treatment of duodenal ulcer, gastric ulcer and chronic gastritis.
Dosage and Administration: Adult: Usual dose 1 gm 4 times daily to be taken 1 hour before meals and at bed time. Maximum daily dose is 8 gms. Four to six weeks treatment is usually needed for ulcer healing but up to twelve weeks may be necessary in resistant cases. Antacids may be used as required for relief of pain, but should not be taken half an hour before or after Gastalfet.
Elderly: The lowest effective dose should be used.
Children: Safety and efficacy in children have not been established.
Side Effects: Mild side effect like constipation has been reported in some patients.
Drug Interactions: Tetracycline, Phenytoin, Cimetidine, Digoxin and Warfarin.
Warning & Precautions: The product should only be used with caution in patients with renal dysfunction.
Use in Pregnancy & Lactation: This should be used in pregnancy only if clearly needed.
Caution should be exercised when it is administered to nursing mothers.
Contraindications: There are no known contraindications.
Commercial Pack: Gastalfet ® Tablet: Box containing 10 blister strips of 10 tablets, each tablet contains Sucralfate USP 500 mg.
197

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablet
Misopa is a synthetic Prostaglandin E1 analogue that has gastric antisecretory and mucosal protective properties. The antisecretory activity of misoprostol is mediated through a class of high affinity E-type prostaglandin receptors on the surface of gastric parietal cells. Misoprostol achieves cytoprotection by stimulation of gastric mucus secretion, duodenal bicarbonate secretion and gastric mucosal blood flow.
Indications: Misopa tablet is indicated for reducing the risk of NSAIDs, aspirin–induced gastric ulcers in patients at high risk of complications from gastric ulcer, e.g., the elderly and patients with concomitant debilitating disease, and patients with a history of ulcer.
Dosage & Administration: The recommended adult oral dose of Misopa for reducing the risk of NSAID induced gastric ulcers - 20 mg 6 hourly daily with food and the last dose of the day should be at bedtime. If this dose cannot be tolerated, a dose of 10 mg can be used. In Renal impairment, the dosage can be reduced less than 20mg if necessary.
Side Effects: Gastrointestinal disorders had the highest reported incidence of adverse events for patients receiving this preparation. It can cause more abdominal pain, diarrhea and other GI symptoms. The incidence of diarrhea can be minimized by administering it with food and by avoiding co administration with magnesium-containing antacids.
Gynecological disorders such as spotting, cramps, postmenopausal bleeding menorrhagia, and dysmenorrhea have been reported.
Drug Interactions: There is no evidence of clinically significant interaction between
Misopa and cardiac, pulmonary and CNS drugs and NSAIDs. Bioavailability of
Misoprostol is decreased with high doses of antacid.
Warning & Precautions: Precaution should be taken in cerebrovascular and cardiovascular diseases.
Use in Pregnancy: Not recommended in pregnancy.
Contraindications: It is contraindicated in patients with a history of allergy to prostaglandins.
Commercial Pack: Misopa ® 200 Tablet: Box containing 3×10’s Alu-Alu form packs. Each tablet contains Misoprostol BP 200 microgram.
198

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablet / Syrup
The active ingredient of Neoceptin R is Ranitidine a histamine H2 receptor antagonist.
Indications: Neoceptin R is indicated for the treatment of duodenal ulcer, benign gastric ulcer, post-operative ulcer, reflux esophagitis, Zollinger-Ellison Syndrome and in other conditions where reduction of gastric acidity is beneficial.
Dosage and Administration: Duodenal and gastric ulcer: The usual dosage is 150 mg twice daily taken in the morning and evening or 300 mg as a single daily dose at night for
4 to 8 weeks.
Reflux esophagitis: 150 mg twice daily or 300 mg at bed time for up to 8 weeks.
Zollinger-Ellison Syndrome: 150 mg 3 times daily and increased if necessary up to 6 g daily in divided doses. Dosage should be continued as long as clinically indicated.
Episodic dyspepsia: 150 mg twice daily or 300 mg at bed time for up to 6 weeks.
Maintenance: 150 mg at night for preventing recurrences.
Child (Peptic ulcer): 2-4 mg/kg twice daily, maximum 300 mg daily.
Side Effects: Altered bowel habit, dizziness, rash, tiredness, reversible confusional states, headache, decreased blood counts, muscle or joint pain have rarely been reported.
Drug Interactions: Ranitidine at usual therapeutic doses does not potentiate the actions of drugs which are inactivated by inhibition of cytochrome P450-linked mixed function oxygenase system such as diazepam, lidocaine, phenytoin, propanolol and theophylline.
Due to the narrow therapeutic index, close monitoring of increased or decreased prothrombin time is recommended during concurrent treatment with ranitidine. High doses of ranitidine may reduce the excretion of procainamide and N-acetyl procainamide resulting in increased plasma level of these drugs.
Warning & Precaution: Ranitidine should be given in reduced dosage to patients with impaired renal and hepatic function.
Use in Pregnancy & Lactation: Neoceptin R should only be used during pregnancy if considered essential. Caution should be exercised when the drug is administered to a nursing mother.
Commercial Pack: Neoceptin ® R 150 Tablet: Box containing 150 tablets in 15 x 10’s
Alu-Alu form packs. Each tablet contains Ranitidine Hydrochloride USP equivalent to
Ranitidine 150 mg.
Neoceptin ® R Syrup: Bottle containing 100 ml sugar free syrup. Each 5 ml contains
Ranitidine Hydrochloride USP equivalent to Ranitidine 75 mg.
199

bexinfo: T
HERAPEUTIC
G
UIDE
®
IM / IV Injection
The active ingredient of Neoceptin R is Ranitidine, a histamine H2 receptor antagonist.
Indications: Adults: Neoceptin R Injection is indicated for the treatment of duodenal ulcer, benign gastric ulcer, post-operative ulcer, reflux esophagitis, Zollinger-Ellison Syndrome, the prophylaxis of gastrointestinal hemorrhage from stress ulceration, in the prophylaxis of recurrent hemorrhage in patients with bleeding peptic ulcers and before general anesthesia in patients considered to be at risk of acid aspiration (Mendel son’s
Syndrome), particularly obstetric patients during labor.
Children (6 months to 18 years): Neoceptin R Injection is indicated for the short term treatment of peptic ulcer and the treatment of gastro-esophageal reflux, including reflux esophagitis and symptomatic relief of gastro-esophageal reflux disease.
Dosage and Administration: Adults (including elderly) / Adolescents (12 years and over): Neoceptin R Injection may be given either as a slow (over 2 minutes) intravenous injection up to a maximum of 50 mg 6 - 8 hourly. In the prophylaxis of hemorrhage from stress ulceration or the prophylaxis of recurrent hemorrhage in patients bleeding from peptic ulceration, parenteral administration may be continued until oral feeding commences. In the prophylaxis of upper gastro-intestinal hemorrhage from stress ulceration a priming dose of 50 mg as a slow intravenous injection followed by a continuous intravenous infusion of 0.125 - 0.250 mg/kg/hour may be preferred. In patients considered to be at risk of developing acid aspiration syndrome, Neoceptin R Injection
50 mg may be given intramuscularly or by slow intravenous injection 45 to 60 minutes before induction of general anesthesia.
Children / Infants (6 months to 11 years): Neoceptin R injection should be given of 50 mg
6 to 8 hourly. It can be given in acute treatment of peptic ulcer disease and gastroesophageal reflux disease when oral therapy is not possible. The initial dose (2.0 mg/kg or 2.5 mg/kg, maximum 50 mg) may be administered as a slow intravenous infusion over
10 minutes, either with a syringe pump followed by a 3 ml flush with normal saline over
5 min, or following dilution with normal saline to 20 ml. Maintenance of pH > 4.0 can be achieved by intermittent infusion of 1.5 mg/kg every 6 h to 8 h. Alternatively treatment can be continuous, administering a loading dose of 0.45 mg/kg followed by a continuous infusion of 0.15 mg/kg/hour.
Prophylaxis of stress ulceration in seriously ill patients: The recommended dose for prophylaxis of stress ulceration is 1mg/kg (maximum 50 mg) 6-8hourly. Alternatively treatment can be continuous, administering 125 - 250 micrograms/kg/hour as continuous infusion.
Side Effects: Described as previously. See page No. 199
Drug Interactions: Described as previously. See page No. 199
200

bexinfo: T
HERAPEUTIC
G
UIDE
Warning & Precautions: Described as previously. See page No. 199
Overdosage & Contraindications: Described as previously. See page No.199
Commercial Pack: Neoceptin ® R IM/IV Injection: Box containing 2 x 5 ampoules of 2 ml in blister pack. Each 2 ml ampoule contains Ranitidine Hydrochloride USP equivalent to Ranitidine 50 mg.
®
Tablet / Capsule
The standard triple therapy regimens have proved to be effective for eradicating H. pylori.
Each Neo kit contains Clarithromycin USP, Omeprazole BP and Metronidazole BP
Indications: Neo Kit is indicated in the eradication of H. pylori in active chronic gastritis, duodenal and gastric ulcers.
Dosage and Administration: One Neo kit (2 tablets &1 capsule in one blister strip) twice daily (12 hourly) for 7 days.
Side Effects: The drugs of the Neo kit are well tolerated. Side effects may include nausea, vomiting, diarrhea and abdominal pain. Other side effects include unpleasant metallic or bitter taste, headache, drowsiness, vertigo, constipation, abdominal colic and flatulence.
Drug Interactions: Clarithromycin: Theophylline, digoxin and warfarin.
Omeprazole: Warfarin, ketoconazole.
Metronidazole: Warfarin.
Warning & Precautions: Caution should be exercised in patients with impaired hepatic and renal functions. It should not be used in patients with blood dyscrasia. Safety and effectiveness in children have not been established.
Use in Pregnancy and Lactation: Neo kit should be used with caution during pregnancy and lactation only if the potential benefit justifies the risk.
Contraindications: It is contraindicated in patients with known hypersensitivity to
Clarithromycin, Omeprazole and Metronidazole.
Commercial Pack: Neo Kit ® : Box containing 14 kits. Each kit contains one tablet of
Clarithromycin USP 500mg, one capsule of Omeprazole BP 20 mg & one tablet of
Metronidazole BP 400 mg.
201

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablet / IV Injection
This is a preparation of Esomeprazole, which is a S-isomer of Omeprazole. It is a specific inhibitor of the acid pump in the parietal cell.
Indications: Healing of erosive esophagitis, long-term management of esophagitis, symptomatic gastro-esophageal reflux disease (GERD) and H. pylori Eradication for treatment of duodenal ulcer (Triple therapy with Esomeprazole, Clarithromycin and
Amoxicillin).
Dosage and Administration: Opton Tablet: a) Healing of erosive esophagitis: 20 mg or
40 mg once daily for 4 to 8 Weeks. For those patients who have not healed after 4-8 weeks of treatment, an additional 4-8 weeks course of Esomeprazole may be considered.
b) Long-term management of esophagitis: 20 mg once daily. c) Symptomatic GERD: 20 mg once daily for 4 weeks. d) H. pylori eradication for treatment of duodenal ulcer: Triple therapy: 20 mg Esomeprazole once daily with 500 mg Clarithromycin twice daily, and 1 g Amoxicillin twice daily for 7-10 days.
Opton 40 IV Injection: a) The recommended adult dose in GERD with Erosive Esophagitis is either 20 or 40 mg Esomeprazole given once daily by intravenous injection (no less than 3 minutes) or intravenous infusion (10 to 30 minutes). b) Pediatric dose (1 to 11 years old): Short term treatment of symptomatic GERD: 10 mg once daily for up to 8 weeks. c) Healing of erosive esophagitis: Weight <20 kg: 10 mg once daily for up to 8 weeks. Weight ≥20 kg: 10 mg or 20 mg once daily for up to 8 weeks.
Side Effects: Opton is usually well tolerated in both short and long-term use. Common adverse effects are headache, diarrhea, nausea, flatulence, abdominal pain, constipation, and dry mouth.
Drug Interactions: Esomeprazole inhibits gastric acid secretion, therefore, it may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (eg, Ketoconazole, Iron salts and Digoxin).
Warning & Precautions: Safety and effectiveness of Esomeprazole in pediatric patients have not been established. No dosage adjustment is recommended for patients with mild to moderate hepatic insufficiency. However, in patients with severe hepatic insufficiency a dose of 20 mg once daily should not be exceeded.
Use in Pregnancy & Lactation: This drug should be used during pregnancy only if clearly needed. A decision should be made whether to discontinue the drug in lactating women.
Overdosage & Contraindications: Contraindicated in patients with known hypersensitivity to any component of the formulation. As in any case of overdose, treatment should be symptomatic and general supportive measures should be utilized.
Commercial Pack: Opton ® 20 Tablet: Box containing 60 tablets in 6 x 10’s Alu-Alu form pack. Each tablet contains Esomeprazole Magnesium USP equivalent to Esomeprazole
20 mg.
202

bexinfo: T
HERAPEUTIC
G
UIDE
Opton ® 40 Tablet: Box containing 30 tablets in 3 x 10’s Alu-Alu form pack. Each tablet contains Esomeprazole Magnesium USP equivalent to Esomeprazole 40 mg.
Opton ® 40 IV Injection: Each commercial box containing one vial of sterile lyophilized powder of Esomeprazole Sodium INN equivalent to Esomeprazole 40 mg, one ampoule of 0.9% Sodium Chloride BP 5 ml and one sterile disposable syringe (5 ml).
®
Tablet / IV Injection
This is a preparation of Pantoprazole, a novel substituted benzimidazole derivative.
Indications: Pantobex is indicated in Peptic ulcer diseases (PUD), Gastro-esophageal reflux diseases (GERD), treatment of ulcer resistant to H2 blocker, treatment of ulcer induced by NSAIDs, GI bleeding from stress or acid peptic diseases, eradication of H.
pylori, Zollinger-Ellison Syndrome, and prophylaxis for acid aspiration syndrome during induction of anesthesia.
Dosage and Administration: Pantobex Tablets: The usual recommended adult oral dose is 40 mg given once daily, preferably in the morning with or without food. The duration of therapy is ranging from 2-8 weeks. a) Duodenal ulcers: Pantoprazole 40 mg tablet once daily for 2-4 weeks. b) Gastric ulcer: Pantoprazole 40 mg tablet once daily for 4-8 weeks. c) Reflux esophagitis: Pantoprazole 40 mg tablet once daily for 4-8 weeks.
d) Ulcers induced by NSAIDs: Pantoprazole 40 mg tablet once daily. e) Maintenance therapy: Maintenance therapy should involve the lowest effective dose of the drug.
Pantoprazole both 20 mg & 40 mg doses are safe and effective in maintaining patients with healed reflux esophagitis and PUD in remission.
Pantobex40 I/V Injection: a) Treatment of GERD associated with a history of erosive esophagitis: The recommended adult dose is 40 mg Pantoprazole given once daily by intravenous infusion for 7 to 10 days. b)Pathological hyper secretion Associated with
Zollinger-Ellison Syndrome: The recommended adult dosage is 80 mg q12hour. The frequency of dosing can be adjusted to individual patient needs based on acid output measurements.
Side Effects: No potentially life-threatening effects have been reported with
Pantoprazole. Symptomatic side effects include headache, diarrhea, abdominal pain, dizziness, nausea, epigastric discomfort, flatulence, skin rash, pruritus etc. Peripheral edema has been occasionally reported in female patients.
Drug Interactions: There is no interaction with concomitantly administered antacids. No dosage adjustment is needed with combination use of the following drugs: Theophylline,
Caffeine, Diazepam, Digoxin, Ethanol, Metoprolol, Nifedipine or Warfarin.
Warning & Precautions: Patients should be cautious that Pantoprazole tablets should not be spilt, chewed or crushed.
203

bexinfo: T
HERAPEUTIC
G
UIDE
Use in Pregnancy and Lactation: Pantoprazole should be used during pregnancy or lactation only if the potential benefit justifies the potential risk to the fetus.
Contraindications: It is contraindicated in patients with known hypersensitivity to
Pantoprazole.
Commercial Pack: Pantobex ® 20 Tablet: Box containing 100 tablets in 10x10’s Alu-Alu form packs. Each tablet contains Pantoprazole Sodium USP equivalent to Pantoprazole
20 mg.
Pantobex ® 40 Tablet: Box containing 100 tablets in 10 x 10’s Alu-Alu form packs. Each tablet contains Pantoprazole Sodium USP equivalent to Pantoprazole 40 mg.
Pantobex ® 40 IV Injection: Each commercial box containing one vial of sterile lyophilized powder of Pantoprazole Sodium BP equivalent to Pantoprazole 40 mg, one ampoule of
0.9% Sodium Chloride Injection BP 10 ml for intravenous injection and one sterile disposable syringe (10 ml).
®
Capsule / IV Injection
Proceptin contains Omeprazole BP which belongs to a new class of anti-secretory compounds, the substituted benzimidazoles. It suppresses gastric acid secretion by specific inhibition of the H+ / K+ ATPase enzyme system at the secretory surface of the gastric parietal cell.
Indications: Omeprazole offers significant therapeutic gains in the treatment of acid related diseases like duodenal ulcer, gastric ulcer and erosive reflux esophagitis,
Zollinger-Ellison Syndrome.
Less clear-cut indications where benefit might be expected but where data are limited include:
• Prevention of stress ulceration
• Prevention of the acid aspiration syndrome
• Treatment of upper gastro-intestinal bleeding
Dosage and Administration: Proceptin Capsule: a) Duodenal Ulcer: 20 mg once daily for 4 weeks. In severe cases, 40 mg once daily for 4 weeks. b) Gastric Ulcer: 20 mg once daily for 8 weeks. In severe cases, 40 mg once daily for 8 weeks. d) Erosive Reflux esophagitis: 20 mg once daily for 4 weeks. For those not fully healed, to be continued for 4 more weeks. e) Refractory Reflux Esophagitis: 40 mg once daily for 8 weeks. f)
Zollinger-Ellison Syndrome: 60 mg once daily, adjusted individually and continued as long as necessary. Most patients will be effectively controlled with 20-120 mg daily.
Dosage above 80 mg should be divided and given twice daily. g) Long-term maintenance treatment with Omeprazole is not recommended.
204

bexinfo: T
HERAPEUTIC
G
UIDE
Proceptin IV Injection: a) Prophylaxis of acid aspiration: Omeprazole 40 mg to be given slowly (over a period of 5 minutes) as an intravenous injection, one hour before surgery.
b) Duodenal ulcer, gastric ulcer or reflux esophagitis: In patients with duodenal ulcer, gastric ulcer or reflux esophagitis where oral medication is inappropriate, Omeprazole IV
40 mg once daily is recommended. c) Zollinger-Ellison syndrome (ZES): In patients with
Zollinger-Ellison Syndrome the recommended initial dose of Omeprazole given intravenously is 60 mg daily. Higher daily doses may be required and the dose should be adjusted individually. When doses exceed 60 mg daily, the dose should be divided & given twice daily.
Children: Safety and effectiveness in children have not been established.
Side Effects: Side effects include nausea, diarrhea, constipation, flatulence, abdominal colic, paraesthesia, dizziness and headache. Skin rashes, leukopenia and transient elevation of hepatic amino-transferases have been observed occasionally.
Drug Interactions: Diazepam, Phenytoin and Warfarin.
Warning & Precautions: Symptomatic response to therapy with Omeprazole does not preclude the presence of gastric malignancy. In long term (2 years) studied in rats,
Omeprazole produced a dose related increase in gastric carcinoid tumors. In impaired renal or hepatic function adjustment is not required. Patients with severe liver disease should not require more than 20 mg Omeprazole daily.
Use in Pregnancy and Lactation: Omeprazole should not be given during pregnancy and lactation unless its use is considered essential.
Contraindications: Omeprazole is contraindicated in patients with known hypersensitivity to any component of the formulation.
Commercial Pack: Proceptin ® 20 Capsule: Box containing 100 capsules in 10x10’s Alu-
Alu form packs. Each capsule contains Omeprazole BP 20 mg as enteric coated pellets.
Proceptin ® 40 Capsule: Box containing 30 capsules in 6x5’s Alu-Alu form packs. Each capsule contains Omeprazole BP 40 mg as enteric coated pellets.
Proceptin ® 40 IV Injection: Each commercial box containing one vial of lyophilized
Omeprazole 40 mg, one ampoule of water for injection BP 10 ml and one sterile disposable syringe (10 ml).
205

bexinfo: T
HERAPEUTIC
G
UIDE
®
Capsule
This is a preparation of Lansoprazole, a proton pump inhibitor. It is an irreversible inhibitor of the parietal cell H+-K+ ATPase, which leads to profound inhibition of gastric acid secretion.
Indications: Duodenal ulcer, Gastric ulcer, Esophagitis/Ulceration, Zollinger-Ellison
Syndrome, resistant ulcers and esophagitis and eradication of H. pylori in the treatment of peptic ulcer (in combination with antibiotics).
Dosage and Administration: a) Benign gastric ulcer: 30 mg daily in the morning for 8 weeks. b) Duodenal ulcer: 30 mg daily in the morning for 4 weeks; maintenance 15 mg daily. c) NSAIDs-associated duodenal or gastric ulcer: 15-30 mg daily for 4 weeks, followed by a further 4 weeks if not fully healed. d) Zollinger–Ellison Syndrome (and other hyper secretory conditions): Initially 60 mg once daily adjusted according to response; daily doses of 120 mg or more is given in two divided doses. e) Gastro-esophageal reflux disease : 30 mg daily in the morning for 4 weeks, followed by a further 4 weeks if not fully healed; maintenance 15-30 mg daily. f) Acid-related dyspepsia: 15-30 mg daily in the morning for 2-4 weeks.
Side Effects: Long- term treatment with a proton pump inhibitor in patients with H. pylori infection may accelerate the development of atrophic gastritis. Dose dependent diarrhea or headache may occur.
Drug Interactions: Lansoprazole appears to be a selective inhibitor of the cytochrome
P450 monooxygenase system; there may be an effect on hepatic clearance, but there have been no reports to date of clinically relevant interactions. There is some uncertainty over the effect of Lansoprazole on the combined oral contraceptive pill.
Warning & Precautions: The drug is not recommended for use with neonates. The youngest person to have received Lansoprazole in clinical trials was 13 years old. No problems have been encountered in clinical use and there has been no increase in adverse drug reaction in the elderly.
Use in Pregnancy & Lactation: There is no relevant human data in pregnancy.
Contraindications: The use of this drug is contraindicated in patients with a history of hypersensitivity to any of the ingredients of Protolan capsule.
Commercial Pack: Protolan ® 30 Capsule: Box containing 30 capsules in 3 x 10’s blister strips. Each capsule contains Lansoprazole USP 30 mg as enteric coated granules.
206

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablet / Suspension
Viscocid is the combination of Sodium Alginate BP 500 mg & Potassium Bicarbonate BP
100 mg.
Indications: Gastro-esophageal reflux such as acid regurgitation, heartburn and indigestion following meals or during pregnancy or in patients with symptoms related to reflux esophagitis.
Dosage & Administration: Adults and children 12 years and over:
• One to two tablets after meals and at bedtime.
• For suspension: 5-10 ml after meals and at bedtime.
Children under 12 years: Should be given only on medical advice.
Elderly: No dose modifications necessary for this age group.
Side Effects: Urticaria, bronchospasm, anaphylactic reactions etc.
Warnings & Precautions: The Sodium content of a two-tablet dose is 103 mg (4.5mmol) and a Potassium content of 78 mg (2.0mmol). This should be taken into account when a highly restricted salt diet is recommended, e.g. in some cases of congestive cardiac failure and renal impairment or when taking drugs which can increase plasma Potassium levels. Each two-tablet dose contains 200 mg (2.0 mmol) of calcium carbonate. Care needs to be taken in treating patients with hypercalcemia, nephrocalcinosis and recurrent calcium containing renal calculi. Due to its aspartame content this product should not be given to patients with phenylketonuria. May cause central nervous depression in the presence of renal insufficiency and should not be used in patients with renal failure. There is a possibility of reduced efficacy in patients with very low levels of gastric acid. If symptoms do not improve after seven days, the clinical situation should be reviewed.
Use during Pregnancy and Lactation: Viscocid may be used during pregnancy and lactation.
Overdosage & Contraindications: In the event of over dosage, symptomatic treatment should be given. The patient may notice abdominal distension. This is contraindicated in patients with known or suspected hypersensitivity to the active substances or to any of the excipients.
Commercial Pack: Viscocid ® Chewable Tablet: Box containing 5_10's/10_10's /15_10's
/20_10's blister strips.
Viscocid ® Suspension: 200 ml suspension in glass bottle. Each 5 ml contains Sodium
Alginate BP 500 mg & Potassium Bicarbonate BP 100 mg.
207

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablet
This is a preparation of Famotidine, highly specific and potent competitive H2 receptor antagonist. It has a rapid onset and prolonged duration of action.
Indications: Short term treatment of active duodenal ulcer and benign gastric ulcer, maintenance therapy for prevention of relapses of duodenal ulceration, Gastroesophageal reflux disease and Zollinger-Ellison Syndrome.
Dosage and Administration: a) Duodenal ulcer: 40 mg at night for 4 to 8 weeks. b)
Benign gastric ulcer: 40 mg at night for 4 to 8 weeks. c) Maintenance therapy: 20 mg at night for preventing the recurrences of duodenal ulceration. d) Gastro-esophageal reflux disease: 20 mg twice daily for 6 to 12 weeks. e) Zollinger-Ellison Syndrome: The recommended starting dose is 20 mg every six hours. Dosage should then be adjusted to individual response. Doses up to 160 mg every six hours have been administered to some patients without significant adverse effects.
Side Effects: Yamadin is generally well tolerated, the side effects include dizziness, headache, constipation, diarrhea, dry mouth, nausea and/or vomiting, rash, abdominal discomfort, anorexia and fatigue.
Drug Interactions: This does not interact with the cytochrome P450 linked drug metabolizing enzyme system. So, no interactions have been found with warfarin, theophylline, phenytoin, diazepam, propranolol, aminopyrine or antipyrine.
Warning & Precautions: Dosage reduction should be considered or interval between doses should be prolonged if creatinine clearance falls to or below 30 ml/min.
Use in Pregnancy & Lactation: It should be prescribed in pregnancy only if clearly needed.
Nursing mothers should either stop nursing or stop taking the drug.
Contraindications: Hypersensitivity.
Commercial Pack: Yamadin ® 20 Tablet: Box containing 20 blister strips of 10 tablets.
Each round, film coated tablet contains 20 mg Famotidine USP.
Yamadin ® 40 Tablet: Box containing 10 blister strips of 10 tablets. Each round, film coated tablet contains 40 mg Famotidine USP.
208

bexinfo: T
HERAPEUTIC
G
UIDE
D
IGESTIVE
E
NZYME
®
Tablet
This is a preparation of Pancreatin containing enzyme protease, lipase and amylase activity. Each gm of pancreatin contains 1400 FIP units of protease activity, 20000 FIP units of lipase activity and 24000 FIP units of amylase activity.
Indications: Adults: In the conditions with deficient pancreatic exocrine function such as following pancreatectomy, following total gastrectomy and chronic pancreatitis.
Children : In children with reduced or absence of pancreatic exocrine secretion and Cystic fibrosis.
Dosage and Administration: 1-3 tablets daily with meal or as per direction of the physician.
Side Effects: Zymet may cause buccal and perianal soreness, particularly in infants.
Hypersensitivity reactions have been reported; these may be sneezing, lacrimation or skin rashes.
Warning and Precautions: Zymet should be used with caution in patients known to be allergic to animal protein.
Commercial Pack: Zymet ® Tablet: Box containing 100 tablets in 10 x 10’s blister strips, each sugar and enteric coated tablet contains Pancreatin BP 325 mg.
209

bexinfo: T
HERAPEUTIC
G
UIDE
G
ASTROPROKINETIC
®
Tablet / Suspension / Pediatric Drops
This is a preparation of Domperidone, which is a dopamine antagonist. As it does not enter the central nervous system, its effect is confined to the periphery and acts principally at the receptor in the chemoreceptor trigger zone.
Indications:
• Stimulation of gut motility in
- Non-ulcer dyspepsia
- Esophageal reflux, reflux esophagitis and gastritis
- Diabetic gastroparesis
- Functional dyspepsia
- Speeding barium transit in follow through radiological studies.
• Prevention and symptomatic relief of acute nausea and vomiting from any cause including cytotoxic therapy, radiotherapy and anti-parkinsonism therapy.
• In the prophylactic treatment of migraine.
Dosage and Administration: Domperidone should be taken 15-30 minutes before a meal. The recommended oral doses are
Adults: 10-20 mg every 4-8 hours daily.
Children: 0.2-0.4 mg/kg every 4-8 hours daily.
Side Effects: Deflux may produce hyperprolactinaemia, dry mouth, thirst, headache, nervousness, drowsiness, diarrhea, skin rash and itching. Extra-pyramidal reactions are seen in 0.05% of patients in clinical studies.
Drug Interactions: Bromocriptine, anti-muscarinic and opioid analgesics.
Warning and Precautions: This should be used with absolute caution in case of children because there may be an increased risk of extra-pyramidal reactions in young children because of an incompletely developed blood brain barrier.
Use in Pregnancy and Lactation: Not recommended in pregnancy. Animal studies have not demonstrated teratogenic effects on the fetus. Domperidone may precipitate galactorrhoea and improve post-natal lactation. It is secreted in breast milk but on very small quantities, insufficient to be considered harmful.
210

bexinfo: T
HERAPEUTIC
G
UIDE
Contraindications: Domperidone is contraindicated in patients who have hypersensitivity to this drug and in case of neonates.
Commercial Pack: Deflux ® Tablet: Box containing 15x10's blister strips. Each tablet contains Domperidone Maleate BP equivalent to 10 mg Domperidone.
Deflux ® Suspension: Bottle containing 100 ml of suspension. Each 5 ml contains
Domperidone BP 5 mg.
Deflux ® Pediatric Drops: Bottle containing 15 ml of drops. Each ml contains
Domperidone BP 5 mg.
211

bexinfo: T
HERAPEUTIC
G
UIDE
L
AXATIVES
®
Solution
Serelose is a brand of Lactulose, a hyperosmolar laxative - an effective treatment approach for constipation.
Indications: Constipation, hepatic encephalopathy etc.
Dosage & Administrations:
Adults (including elderly)
Children 5-10 years
Children under 5 years
Infant (under 1 year)
3 tea spoonful or 15 ml twice daily
2 tea spoonful or 10 ml twice daily
1 tea spoonful or 5ml twice daily
½ tea spoonful or 2.5 ml twice daily
(Pediatric dose should be given after breakfast)
Side Effects: Increased thirst, cramps, nausea, diarrhea, flatulence, irregular heartbeat, muscle cramps, dizziness, confusion, fatigue, weakness.
Warning and Precautions: It should be avoided if one is allergic to any hyperosmotic laxative, have symptoms of appendicitis, inflammatory bowel disease or intestinal blockage, have missed a bowel movement for only 1 or 2 days. Adverse reactions over age 60 years may be more frequent and severe than in younger persons. Lactulose oral solution could be used in infants and children only under medical supervision.
Use in Pregnancy and Lactation: In pregnancy no proven problems were detected. It has no side effects during breast feeding.
Commercial Pack: Serelose ® Solution: Each amber glass bottle contains 100 ml
Serelose solution. Each 5 ml contains Lactulose solution BP equivalent to 3.35 g
Lactulose.
212

M
D

bexinfo: T
HERAPEUTIC
G
UIDE
C
HONDROPROTECTIVES
®
Tablet
This is a preparation of Febuxostat which is a xanthine oxidase inhibitor. It acts on the root cause of gout which is serum uric acid level. Febuxostat inhibits xanthine oxidase from oxidising the xanthine and hypoxanthine to form uric acid.
Indications: This is indicated for the long-term management of Hyperuricemia in patients with gout. It is not recommended for use in the treatment of asymptomatic Hyperuricemia.
Dosage and Administration: The recommended starting dosage of Febuxostat is 40 mg once daily. For patients who do not achieve a serum uric acid concentration of less than 6 mg / dL after 2 weeks at the 40 mg dose, Febuxostat 80 mg once daily is recommended. Febuxostat can be administered without regard to food or antacid use.
Side Effects: Nausea and joint pain are some of the most commonly reported side effects.
Warning and Precautions: Pregnancy: Pregnancy Category C. Febuxostat should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers: Caution should be exercised when Febuxostat is administered to a nursing woman.
Pediatric Use: Safety and effectiveness in pediatric patients under 18 years of age have not been established.
Contraindications: Contraindicated in patients being treated with the xanthine oxidase substrates azathioprine, mercaptopurine, and theophylline. No dosage adjustment is necessary for patients with mild to moderate renal or hepatic impairment.
Commercial Pack: Feburic ® 40 Tablet and Feburic ® 80 Tablet: Each box containing 30 tablets in 3 x10’s blister strips. Each film coated tablet contains Febuxostat INN 40 mg and Febuxostat INN 80 mg respectively.
215

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablet
Jointec max is the combination of Diacerein and Glucosamine, two symptomatic slowacting drugs in Osteoarthritis.
Indication: This is primarily indicated in conditions like Osteoarthritis, rheumatoid arthritis, bone and joint injuries.
Dosage and Administration: Adult and Children aged 12 years and older: The usual dose of is 1 tablet twice daily (12 hourly) taken with food. In case of patients with CrCl less than 30 ml / min, the dose of Diacerein is to be reduced.
Warning and Precautions: Caution should be practised when administering Jointec Max in case of patients who are allergic to Glucosamine and / or Diacerein or to shellfish (e.g., shrimp, crab); who have diabetes, asthma, alcohol dependence, or liver disease. While taking this drug complete blood count, liver function, and urinalysis should be monitored regularly.
Side Effects: Diarrhea, constipation, epigastric pain, heartburn, nausea, vomiting, headache, skin rashes, drowsiness, intense yellow coloring of urine.
Drug Interactions: Decreased absorption of Diacerein with aluminium and / or magnesium hydroxide antacids. Increased risk of diarrhea with laxatives, antibiotics.
Avoid co-administration with fibres and phytic acids. Interactions between glucosamine and other prescription or over-the-counter medicines or herbal / health supplements have not been reported.
Contraindications: Diacerein is contraindicated in pregnancy, lactation and hypersensitivity to anthraquinone derivatives. Glucosamine should not be taken by pregnant women and nursing mothers due to a lack of scientific data regarding its effects on unborn babies and infants.
Commercial Pack: Jointec ® Max Tablet: Box containing 30 tablets in 3×10’s blister strips.
Each film coated tablet contains Diacerein INN 50 mg and Glucosamine Sulfate
Potassium Chloride USP equivalent to Glucosamine Sulfate 750 mg.
216

bexinfo: T
HERAPEUTIC
G
UIDE
M
USCLE
R
ELAXANT
®
Tablet
This is a preparation of Baclofen, a centrally acting skeletal muscle relaxant and an antispastic agent with a spinal site of action.
Indications: Baclofen is indicated for the signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity, spinal cord injuries and other spinal cord diseases.
Dosage and Administration: The determination of optimal dosage requires individual titration. The following dosage titration schedule is suggested: 5 mg t.i.d. for 3 days, 10 mg t.i.d. for 3 days, 15 mg t.i.d. for 3 days, 20 mg t.i.d. for 3 days. Thereafter additional increases may be necessary but the total daily dose should not exceed a maximum of
80 mg daily (20 mg q.i.d.). The lowest dose compatible with an optimal response is recommended.
Side Effects: Drowsiness, nausea, dizziness, light headedness, confusion, fatigue, muscular pain and weakness, and hypotension. Other side effects include euphoria, hallucinations, depression, headache, tinnitus, convulsions, paresthesias, slurred speech, dry mouth, taste alterations, vomiting, diarrhea or constipation, ataxia, tremors, insomnia, visual disturbances, skin rashes, urinary disturbances, respiratory or cardiovascular depression, blood sugar changes, alterations in liver function values, and a paradoxical increase in spasticity.
Contraindications: Contraindicated in patients with hypersensitivity to any component of this product.
Warning: Abrupt Drug Withdrawal: Hallucinations and seizures have occurred on abrupt withdrawal of Baclofen. Therefore, except for serious adverse reactions, the dose should be reduced slowly when the drug is discontinued.
Impaired Renal Function: Because Baclofen is primarily excreted unchanged through the kidneys, it should be given with caution, and it may be necessary to reduce the dosage.
Stroke: Baclofen has not significantly benefitted patients with stroke. These patients have also shown poor tolerability to the drug.
Precautions: Safe use of Baclofen in pediatric patients under age 12 has not been established. It is, therefore, not recommended for use in pediatric patients. Because of the possibility of sedation, patients should be cautioned regarding the operation of automobiles or other dangerous machinery, and activities made hazardous by decreased alertness. Patients should also be cautioned that the central nervous system effects of
Baclofen may be additive to those of alcohol and other CNS depressants.
217

bexinfo: T
HERAPEUTIC
G
UIDE
Use in Pregnancy and Lactation: This should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. This is excreted in breast milk.
However, evidence suggests that the quantities are so small that no undesirable effect on the infant would be expected.
Drug Interaction: Alcohol and other CNS depressants may exacerbate the CNS effects of baclofen and should be avoided, severe aggravation of hyperkinetic symptoms may possibly occur in patients taking lithium. There may be increased weakness if baclofen is given to patients taking a tricyclic antidepressant and there may be an increased hypotensive effect if it is given to patients receiving antihypertensive therapy. Ibuprofen and other drugs that produce renal insufficiency may reduce baclofen excretion leading to toxicity.
Commercial Pack: Lospan ® 10 Tablet and Lospan ® 25 Tablet: Each box containing 30 tablets in 3 x 10's blister strips. Each tablet contains Baclofen BP 10 mg and Baclofen
BP 25 mg respectively.
®
Tablet
Relentus is a preparation of Tizanidine hydrochloride which is a centrally acting skeletal muscle relaxant.
Indications: It is used in the symptomatic treatment of painful muscle spasm associated with musculoskeletal conditions and as an adjunct in the management of spasticity associated with multiple sclerosis or spinal cord disorders.
Dosage and Administration: The usual initial daily dose is 2 mg as a single dose. The daily dose may be increased thereafter according to response in steps of 2 mg at intervals of at least 3 to 4 days, usually up to 24 mg daily given in 3 to 4 divided doses. The maximum recommended dose is 36 mg daily.
Warning and Precautions: Patients with impaired kidney or liver function, when patients drive a vehicle or operate machinery.
Use in Children: Experience in children is limited and the use of Tizanidine in this patient group is not recommended.
Use in Elderly: Renal clearance in the elderly may in some cases be significantly decreased. Caution is therefore indicated when using in elderly patients.
Use in Pregnancy and Lactation: This should not be used during pregnancy unless the benefit clearly outweighs the risk. Women who are breast feeding should not take
Tizanidine.
218

bexinfo: T
HERAPEUTIC
G
UIDE
Side Effects: Drowsiness, fatigue, dizziness, dry mouth, nausea, gastrointestinal disturbances, hypotension, also reported bradycardia, insomnia, hallucinations and altered liver enzymes, rarely acute hepatitis.
Drug Interactions: Alcohol or other CNS depressants may enhance the CNS effects of
Tizanidine. There may be an additive hypotensive effect when Tizanidine is used in patients receiving antihypertensive therapy.
Contraindications: Tizanidine Hydrochloride is contraindicated to the patients who have known hypersensitivity to this drug and in case of severe hepatic impairment.
Commercial Pack: Relentus ® Tablet: Box containing 3 blister strips of 10 tablets & 5 blister strips of 10 tablets, each tablet contains Tizanidine Hydrochloride USP equivalent to 2 mg Tizanidine.
®
Tablet
Tolmus contains Tolperisone hydrochloride which is a centrally acting muscle relaxant that has been used for the symptomatic treatment of spasticity and muscle spasm. It effectively reduces muscular hypertonicity, improves peripheral blood flow by vasodilatation and reduces pain.
Indications: Treatment of painful musculoskeletal disorders with hypermyotonia and decreased motility, especially those resulting from spinal cord injuries, osteoporosis, arthritis, and spasticity. It has also been effective in lumboischial pain, neurolathyrism, knee arthritis, peripheral circulatory diseases, climacteric muscular and vascular complaints, trismus, myogenous headaches, rheumatic diseases accompanied by muscular hypertonia, spasms, pain, inflammatory symptoms and limited motion, and in the post-surgical treatment of traumatologic patients.
Dosage & Administration: Adult: 150-450 mg daily, administered in 2 or 3 divided doses.
The maximum dosage is 450 mg / day. Children: (from 3 months to 6 years): 1-2 mg / kg
/ day in 3 divided doses. Children: (from 6-14 years): 2-4 mg / kg / day in 3 divided doses.
Side Effects: Diarrhea, dizziness, drowsiness, dryness of the mouth, fall of blood pressure, fatigue, gastric complaints, headaches, hypersensitivity, itching, muscle pain, muscle weakness, rash, and somnolence.
Warning and Precaution: In case of children, the prescribed dose and duration of treatment should closely be observed.
Use in Pregnancy and Lactation: This should be used in pregnancy according to physician's advice. This should not be used during breast feeding.
219

bexinfo: T
HERAPEUTIC
G
UIDE
Drug Interactions: Concomitant use of Methocarbamol with Tolperisone Hydrochloride has been reported to cause disturbance of visual accommodation.
Contraindications: Hypersensitivity, Myasthenia Gravis and nursing mother.
Commercial Pack: Tolmus ® Tablet: Box contains 100 tablets in 10 x 10's alu-alu form packs. Each tablet contains Tolperisone Hydrochloride INN 50 mg.
220

N
ON
-S
TEROIDAL
A
NTI
-I
NFLAMMATORY
D
RUGS
(NSAID
S
) bexinfo: T
HERAPEUTIC
G
UIDE
®
Capsule
Cox B is a preparation of Celecoxib, a selective cyclooxygenase-2 (COX-2) inhibitor, and a Non-steroidal anti-inflammatory drug (NSAID). It exhibits anti-inflammatory, analgesic and antipyretic activities.
Indications: This is indicated for the relief of the signs and symptoms of osteoarthritis, for the relief of the signs and symptoms of rheumatoid arthritis, for the regression and prevention of colorectal adenomatous polyps in patients with familial adenomatous polyposis (FAP).
Dosage and Administration: Osteoarthritis: The recommended oral dose is 200 mg per day administered as a single dose or as 100 mg twice daily.
Rheumatoid arthritis: The recommended oral dose is 100 to 200 mg twice daily.
Familial adenomatous polyposis (FAP): Usual medical care for FAP patients should be continued while on Cox B. To reduce the number of adenomatous colorectal polyps in patients with FAP, the recommended oral dose is 400 mg (2 X 200 mg capsules) twice daily to be taken with food.
Contraindications: Contraindicated in patients with known hypersensitivity to Celecoxib.
This should not be given to patients who have demonstrated allergic-type reactions to sulfonamides (Celecoxib contains a sulfonamide side chain), patients who have demonstrated asthma, urticaria or allergic-type reactions after taking aspirin or other
NSAIDs.
Side Effects: Adverse events occurring in ≥ 2% of Cox B patients at recommended doses: Abdominal pain, diarrhea, dyspepsia, flatulence, nausea, back pain, peripheral edema, injury-accidental, dizziness, headache, insomnia, pharyngitis, rhinitis, sinusitis, upper respiratory tract infections, rash.
Warning and Precaution: Cox B, at doses upto 200 mg b.i.d, can be administered without regard to timing of meal. Higher doses (400 mg b.i.d) should be administered with food. Co-administration of Cox B with an aluminum and magnesium containing antacid should be avoided, because they may reduce the amount of this drug the body absorbs.
Drug Interactions: ACE inhibitors, furosemide, fluconazole, lithium, warfarin.
221

bexinfo: T
HERAPEUTIC
G
UIDE
Commercial Pack: Cox ® B 100 Capsule and Cox ® B 200 Capsule: Each box containing
50 capsules in 5x10’s blister strips. Each capsule contains Celecoxib INN 100 mg and
Celecoxib INN 200 mg respectively.
®
Tablet / Suspension
Dexifen is a preparation of Dexibuprofen. It possesses analgesic and anti-inflammatory properties like other Non steroidal anti-inflammatory agents.
Indications: Dexifen is indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis, for relief of mild to moderate pain, treatment of primary dysmenorrhea.
Dosage and Administration: The recommended dosage is 600 to 900 mg dexibuprofen daily, divided in up to three single doses. For the treatment of mild to moderate pain, initially single doses of 200 mg and daily doses of 600 mg are recommended. The maximum single dose is 400 mg dexibuprofen. The dose may be temporarily increased up to 1200 mg dexibuprofen per day in patients with acute conditions or exacerbations.
The maximum daily dose is 1200 mg. For dysmenorrhea a daily dose of 600 to 900 mg dexibuprofen, divided in up to three single doses, is recommended. The maximum single dose is 300 mg, the maximum daily dose is 900 mg.
Side Effects: The most frequent type of adverse reactions occurring with Dexifen are gastrointestinal in nature like dyspepsia, diarrhea, nausea, vomiting and abdominal pain.
Others include rash, fatigue or drowsiness, headache, dizziness, vertigo, peripheral edema and nephrotic syndrome. Bleeding time may be prolonged.
Warning and Precaution: Patients should be closely monitored for digestive disturbances, especially gastrointestinal bleeding, when taking dexibuprofen. As with other NSAIDs, allergic reactions, including anaphylactic / anaphylactoid reactions, can also occur without earlier exposure to the drug. In the treatment of patients with heart failure, hypertension, renal or hepatic disease, especially during concomitant diuretic treatment, the risk of fluid retention and a deterioration in renal function must be taken into account. If used in these patients, the dose of dexibuprofen should be kept as low as possible and renal function should be regularly monitored. Caution must be exercised in the treatment of elderly patients, who generally have a greater tendency to experience side effects to NSAIDs. Caution is required in patients suffering from, or with a previous history of, bronchial asthma since NSAIDs can cause bronchospasm in such patients.
Use in Pregnancy & Lactation: In pregnancy, no clinical data are available. Lactation:
Ibuprofen is slightly excreted in human milk. Breast-feeding is possible with Dexibuprofen if dosage is low and the treatment period is short.
Contraindication: Dexifen should not be used in patients who have previously exhibited hypersensitivity to the drug, or in individuals with the syndrome of nasal polyps,
222

bexinfo: T
HERAPEUTIC
G
UIDE angioedema, and bronchospastic reactivity to aspirin or other nonsteroidal antiinflammatory agents.
Drug Interactions: Anticoagulants, methotrexate, lithium, NSAIDs and salicylates, antihypertensives, β -blockers, thiazides, thiazide-related substances, loop diuretics and potassium-sparing diuretics.
Commercial Pack: Dexifen ® 200 Tablet: Box containing 100 tablets in 10 x 10’s blister strips. Each tablet contains Dexibuprofen INN 200 mg.
Dexifen ® 300 Tablet: Box containing 50 tablets in 5 x 10’s blister strips & 100 tablets in
10 x 10’s blister strips. Each tablet contains Dexibuprofen INN 300 mg.
Dexifen ® 400 Tablet: Box containing 50 tablets in 5 x 10’s blister strips & 100 tablets in
10 x 10’s blister strips. Each tablet contains Dexibuprofen INN 400 mg.
Dexifen ® Suspension: Each Bottle contains 100 ml suspension. Each 5 ml contains
Dexibuprofen INN 100 mg.
®
Tablet
The active ingredients of Dinovo are combination of naproxen which is an NSAIDs and esomeprazole magnesium which is a Proton Pump Inhibitor (PPI).
Indications: It is indicated for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAIDs associated gastric ulcers. This is not recommended for initial treatment of acute pain.
Dosage and Administration: Rheumatoid Arthritis, Osteoarthritis and Ankylosing
Spondylitis: The dosage is one tablet twice daily of Dinovo 375 mg naproxen and 20 mg of esomeprazole or 500 mg naproxen and 20 mg of esomeprazole. This is to be taken at least 30 minutes before meals.
Elderly Patients: It should be use in caution when high doses are required and some adjustment of dosage may be required.
Patients with moderate to severe Renal Impairment: Naproxen-containing products are not recommended for use in patients with moderate to severe or severe renal impairment
(creatinine clearance < 30 mL / min).
Hepatic Insufficiency: Monitor patients with mild to moderate hepatic impairment closely and consider a possible dose reduction based on the naproxen component of Dinovo.
This is not recommended in patients with severe hepatic impairment because esomeprazole doses should not exceed 20 mg daily in these patients.
Pediatric Patients: This is not recommended for use in children.
223

bexinfo: T
HERAPEUTIC
G
UIDE
Side Effects: Anaphylactoid reactions, angioneurotic edema, menstrual disorders, pyrexia, congestive heart failure, vasculitis, hypertension, pulmonary edema, gastrointestinal bleeding and / or perforation, hematemesis, pancreatitis, vomiting, colitis, exacerbation of inflammatory bowel disease, non peptic gastrointestinal ulceration, ulcerative stomatitis, esophagitis, peptic ulceration, jaundice, abnormal liver function tests, hepatitis , eosinophilia, leucopenia, melena, thrombocytopenia, agranulocytosis, granulocytopenia, hemolytic anemia, aplastic anemia etc.
Drug Interactions: Several studies conducted with naproxen and esomeprazole combination have shown no interaction between the two components.
Warning & Precaution: This can cause increase risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. Naproxen, which is a component of Dinovo, can lead to onset of new hypertension or worsening of preexisting hypertension. It can also cause fluid retention, edema, and peripheral edema have been observed in some patients taking NSAIDs and should be used with caution in patients with fluid retention or heart failure. NSAIDs, including naproxen, a component of Dinovo, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which can be fatal. While naproxen and esomeprazole combination has been shown to significantly decrease in the occurrence of gastric ulcers compared to naproxen alone, ulceration and associated complications can still occur. Long-term administration of
NSAIDs has resulted in renal papillary necrosis and other renal injury, so Naproxencontaining products are not recommended for use in patients with moderate to severe or severe renal impairment (Creatinine clearance < 30 mL / min). Patients with mild to moderate hepatic impairment should be closely monitored and consider a possible dose reduction based on the naproxen component of Dinovo. Dinovo is not recommended in patients with severe hepatic impairment because esomeprazole doses should not exceed
20 mg daily in these patients.
Use in Pregnancy and Lactation: Pregnancy Category C. In late pregnancy, this is contraindicated as with other NSAIDs, naproxen, a component of this drug, should be avoided because it may cause premature closure of the ductus arteriosus.
Contraindications: This is contraindicated in patients with known hypersensitivity to naproxen, esomeprazole magnesium, substituted benzimidazoles, or to any of the excipients. This is contraindicated in asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. This is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.
Commercial Pack: Dinovo ® 375 / 20 Tablet and Dinovo ® 500 / 20 Tablet: Each box containing 50 delayed release tablets in 5X10's blister strips.
224

bexinfo: T
HERAPEUTIC
G
UIDE
®
Capsule / Tablet / Suspension
Fenamic contains Mefenamic acid which is a member of the fenamate group of NSAIDs.
Indications: Fenamic is used in mild to moderate pain including headache, dental pain, postoperative and postpartum pain, dysmenorrhea, in musculoskeletal and joint disorder such as osteoarthritis and rheumatoid arthritis. in menorrhagia and in children with fever and Juvenile Idiopathic Arthritis.
Dosage and Administration: A 500 mg dose should be given preferably with food to adults up to three times (1.5 gm total) per day.
Infants over 6 months: 25 mg / kg of body weight daily in divided doses for not longer than 7 days.
Side Effects: In patients taking Fenamic or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1-10% of patients are gastrointestinal:
Abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gross bleeding / perforation, heartburn, nausea, GI ulcers (gastric / duodenal), vomiting, abnormal renal function, anemia, dizziness, edema, elevated liver enzymes, headaches, increased bleeding time, pruritus, rashes, tinnitus.
Warning and Precautions: Risk of GI Ulceration, bleeding, and perforation.
Use in Pregnancy & Lactation: In late pregnancy, as with other NSAIDs, Fenamic should be avoided because it may cause premature closure of the ductus arteriosus. There are no adequate and well-controlled studies in pregnant women. In case of lactating mother, decision should be made whether to discontinue nursing or to discontinue the drug.
Drug Interactions: Aspirin, Furosemide, Antacids, ACE inhibitors, Methotraxate and
Warfarin.
Contraindications: Fenamic is contraindicated in patients with known hypersensitivity to Mefenamic Acid. This should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Fenamic is contraindicated in patients with active ulceration or chronic inflammation of either the upper or lower gastrointestinal tract and should not be used in patients with preexisting renal disease.
Commercial Pack: Fenamic ® 250 Capsule: Each box contains 10 x 10’s capsules in blister strips. Each capsule contains Mefenamic Acid BP 250 mg.
Fenamic ® 500 Tablet: Each box contains 3 x 10’s tablets in blister strips. Each tablet contains Mefenamic Acid BP 500 mg.
Fenamic ® Suspension: Bottle containing 60 ml suspension. Each 5 ml contains
Mefenamic Acid BP 50 mg.
225

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablet
This is a preparation of Tenoxicam, an NSAID, with anti-inflammatory, analgesic, antipyretic properties and it also inhibits platelet aggregation.
Indications: This is indicated for the symptomatic treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute gout, and extra-articular inflammations such as tendinitis, bursitis and periarthritis of the shoulders or hips. It is also indicated in musculoskeletal & postoperative pain and in primary dysmenorrhea.
Dosage and Administraiton: For all indications (except primary dysmenorrhea, postoperative pain and acute gout) the usual recommended dose is 20 mg once daily.
Side Effects: Tenoxicam is well tolerated in the recommended doses. The usual side effects are mild and transient gastric, abdominal discomfort, dyspepsia, heartburn, nausea, dizziness, headache, itching, erythema, rash, urticaria, increase in BUN or creatinine, edema and palpitations. In isolated cases GI-perforation, asthma, angioedema and elevated blood pressure may occur.
Warning and Precautions: Caution should be exercised in patients have symptoms of gastrointestinal diseases. If peptic ulceration or gastrointestinal bleeding occurs,
Tenoxicam should be immediately withdrawn. It is necessary to adequately monitor the patient with increased risk of developing renal failure, impaired renal function in diabetics, hepatic cirrhosis and congestive heart failure. Patients having coagulation disorders or receiving therapy that interferes with hemostasis should, however, be carefully observed when treated with Tenoxicam. In women who have difficulty conceiving or are undergoing investigation of infertility, withdrawal of Tenoxicam should be considered.
Use in Pregnancy and Lactation: This should be used with caution during pregnancy and lactation.
Pediatric Patient: It is not recommended for patients under 16 years of age.
Contraindications: This should not be administered to patients with active peptic ulcer or active inflammatory diseases of the gastrointestinal tract, in patients who have shown hypersensitivity to the drug, in patients in whom acute asthmatic attacks, urticaria, rhinitis or other allergic manifestations are precipitated by ASA or other nonsteroidal antiinflammatory agents. Before anesthesia or surgery, Tenoxicam should not be given to elderly patients, to patients at risk of renal failure, or to patients with increased risk of bleeding, because of an increased risk of acute renal failure and possibility of impaired hemostasis. Tenoxicam is relatively contraindicated in patients with liver dysfunction.
Drug Interaction: Salicylates, methotrexate, potassium sparing diuretics, adrenergic blockers, ACE-inhibitors andantidiabetic drug (sulphonylurea group).
Commercial Pack: Mobicam ® Tablet: Box contains 30 tablets in 3x10’s blister strips.
Each tablet contains Tenoxicam BP 20 mg.
226

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablet
This contains Naproxen, a Non-steroidal anti-inflammatory agent, which is a preparation of d-2 (6-methoxy-2-naphthyl) propionic acid. This drug has analgesic, antiinflammatory and antipyretic properties. It is an inhibitor of prostaglandin synthetase.
Indications: This is indicated in mild to moderate pain such as dysmenorrhea, migraine and for the treatment of rheumatoid arthritis, osteoarthritis (degenerative arthritis), ankylosing spondylitis, Juvenile rheumatoid arthritis, acute gout, and acute musculoskeletal disorders.
Dosage and Administrations: Adults: For rheumatoid arthritis, osteoarthritis and ankylosing spondylitis, the usual dose is 500 mg to 1 g per day taken in two divided doses at 12 hour intervals. For mild to moderate pain such as primary dysmenorrhea, acute tendinitis and bursitis, the usual initial dose is 500 mg followed by 250 mg every 6 or 8 hours. The total daily dose should not exceed 1250 mg.
In acute gout an initial dose of 750 mg followed by 250 mg every 8 hours has been suggested until the attack subsides.
For Juvenile arthritis: A dose of 10 mg / kg body weight daily in 2 divided doses in children over 5 years of age has been recommended.
In the acute phase of the following cases a loading dose of 750 mg per day is recommended.
(a) In patients reporting severe night time pain and morning stiffness.
(b) In patients being switched to Nuprafen (Naproxen) from a high dose of another antirheumatic compound.
(c) In osteoarthrosis where pain is the predominant symptom.
Side Effects: Occasional skin rashes and angio-edema have been reported. Nausea, vomiting, abdominal discomfort, epigastric distress, headache, inability to concentrate, insomnia, tinnitus and vertigo. Thrombocytopenia, jaundice, aplastic anemia, hemolytic anemia, peptic ulceration, fatal hepatitis, hearing impairment, cognitive dysfunction, anaphylactic reactions to Naproxen and Naproxen sodium formulations and nephropathy may occur rarely.
Drug Interactions: Due to the high plasma protein binding of Naproxen, patients simultaneously receiving hydantoin, anti-coagulants or a highly protein bound sulphonamide should be observed for signs of overdosage of these drugs. Naproxen and other NSAIDs can reduce the antihypertensive effect of propranolol and other β -blockers.
Warning and Precautions: Pregnancy category C and Lactation: Because animal
227

bexinfo: T
HERAPEUTIC
G
UIDE reproduction studies are not always predictive of human response, the drug should not be used during pregnancy unless clearly needed. It should be used only if the potential benefits justify the potential risk of the fetus. The Naproxen anion has been found in the milk of lactating women. Because of the possible adverse effects of prostaglandin inhibiting drugs on neonates, use in nursing mother should be avoided.
Contraindications: The drug is contraindicated in patients who are allergic to naproxen or naproxen sodium. It is also contraindicated in patients in whom aspirin or other nonsteroidal antiinflammatory / analgesic drug induce the symptoms of asthma, rhinitis and nasal polyps.
Overdosage: Significant overdosage of the drug may be characterized by drowsiness, heartburn, indigestion, nausea or vomiting. No evidence of toxicity has been reported 5-
15 months after ingestion of the drug for three to seven days with doses upto 3 g / day.
Commercial Pack: Nuprafen ® 250 Tablet and Nuprafen ® 500 Tablet: Box containing 10 blister strips of 10 tablets and 5 blister strips of 10 tablets respectively. Each tablet contains 250 mg of Naproxen USP and 500 mg of Naproxen USP respectively.
®
Tablet / Suspension
Reumafen is a preparation of Ibuprofen, a Non-steroidal anti-inflammatory agent with analgesic and antipyretic properties.
Indications: Reumafen is indicated for the treatment of sign and symptoms of rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and other non-rheumatoid arthropathies, for the treatment of non-articular rheumatic conditions, such as frozen shoulder, bursitis, tendinitis, tenosynovitis and low back pain, dysmenorrhea, dental pain. for the treatment of cold & fever.
Dosage and Administration: For adult: For arthritic pain: The dosage range is from 0.9
to 2.4 g per day. The usual dose is 400 mg, 3-4 times per day, preferably after food. The dose may be raised to a maximum of 2.4 g daily depending on the severity of symptom at the time of initiating drug therapy or as patients fail to respond. After a satisfactory response has been achieved the patients dose should be reviewed and adjusted as required and tapered gradually.
For mild to moderate pain: 400 mg 6 hourly or as demanded by the condition.
For dysmenorrhea: 400 mg every 4 hours or as demanded by the condition.
For children: 20 mg per kg body weight daily in divided doses. In children weighing less than 30 kg the total daily dosage should not exceed 500 mg. 1-2 years: ½ tea spoonful
(2.5 ml) 3-4 times daily; 3-7 years: 1 tea spoonful (5 ml) 3-4 times daily; 8-12 years: 2 tea spoonful (10 ml) 3-4 times daily. This is not recommended for children under 1 year.
228

bexinfo: T
HERAPEUTIC
G
UIDE
Side Effects: Usually Ibuprofen has a low incidence of side effects. Peptic ulceration and gastrointestinal bleeding have occasionally been reported. Other side effects include headache, dizziness, nervousness, skin rash, pruritus, drowsiness, insomnia, blurred vision and other ocular reactions, hypersensitivity reaction, abnormal liver function test, impairment of renal function, agranulocytosis and thrombocytopenia.
Warning and Precautions: Ibuprofen should be given with caution to patients with bleeding disorders, cardiovascular diseases, peptic ulceration or a history of such ulceration and in those who are receiving coumarin anticoagulants and in patients with renal or hepatic impairment.
Pregnancy and Nursing Mother: Not recommended during pregnancy or for use in nursing mothers.
Contraindications: This should not be given to patients with hypersensitivity to lbuprofen and to individuals who show nasal polyps, angioedema, bronchospastic reactivity to aspirin or other NSAIDs. Ibuprofen is contraindicated in patients with active or previous peptic ulceration & gastro-intestinal ulceration or bleeding.
Overdosage: Gastric lavage, correction of blood electrolytes (if necessary). There is no specific antidote for Ibuprofen.
Commercial Pack: Reumafen ® 200 Tablet and Reumafen ® 400 Tablet: Each box containing 100 sugar coated tablets in 10 x 10’s blister strips. Each tablet contains
Ibuprofen BP 200 mg. and Ibuprofen BP 400 mg respectively.
Reumafen ® Suspension: Reumafen Suspension is available in 50 ml and 100 ml amber glass bottle. Each 5 ml contains Ibuprofen BP 100 mg.
®
Tablet
Ribox is a preparation of Etoricoxib, a COX-2 selective inhibitor which is 106.0 times more selective for COX-2 inhibition over COX-1.
Indication: For the symptomatic relief of osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis, and the pain and signs of inflammation associated with acute gouty arthritis.
Dosage and Administration: Osteoarthritis: The recommended dose is 30 mg once daily. In some patients with insufficient relief from symptoms, an increased dose of 60 mg once daily may increase efficacy.
Rheumatoid arthritis: The recommended dose is 90 mg once daily.
229

bexinfo: T
HERAPEUTIC
G
UIDE
Acute gouty arthritis: The recommended dose is 120 mg once daily. Etoricoxib 120 mg should be used only for the acute symptomatic period. In clinical trials for acute gouty arthritis, Etoricoxib was given for 8 days.
Ankylosing spondylitis: The recommended dose is 90 mg once daily.
Elderly: No dosage adjustment is necessary for elderly patients. As with other drugs, caution should be exercised in elderly patients.
Pediatric patients: Etoricoxib is contraindicated in children and adolescents under 16 years of age.
Contraindication: Etoricoxib is contraindicated to: Hypersensitivity to the active substance or to any of the excipients, active peptic ulceration or active gastro-intestinal
(GI) bleeding, patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic edema, urticaria, or allergic-type reactions after taking acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors, pregnancy and lactation, severe hepatic dysfunction (serum albumin <25 g / l or Child-Pugh score 10), estimated renal creatinine clearance <30 ml / min, children and adolescents under 16 years of age, inflammatory bowel disease, congestive heart failure (NYHA II-IV), blood pressure is persistently elevated above 140 / 90mmHg and has not been adequately controlled, established ischemic heart disease, peripheral arterial disease, and / or cerebrovascular disease.
Side Effects: Dry mouth, taste disturbance, mouth ulcers, flatulence, constipation, appetite and weight changes, chest pain, fatigue, paraesthesia, influenza-like syndrome
& myalgia.
Warning and Precautions: Upper gastrointestinal complications like perforations, ulcers or bleedings (PUBs) occurred in patients treated with Etoricoxib. COX-2 inhibitor, may be associated with a risk of thrombotic events (especially myocardial infarction and stroke), relative to placebo and some NSAIDs. Under conditions of compromised renal perfusion, administration of Etoricoxib may cause a reduction in prostaglandin formation and, secondarily, in renal blood flow, and thereby impair renal function. As with other medicinal products known to inhibit prostaglandin synthesis, fluid retention, edema and hypertension have been observed in patients taking Etoricoxib. Elevations of alanine aminotransferase (ALT) and / or aspartate aminotransferase (AST) have been reported in approximately 1% of patients in clinical trials treated for up to one year with Etoricoxib
30, 60 and 90 mg daily. Skin reactions, some of them fatal, including exfoliative dermatitis,
Stevens-Johnson Syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs and some selective COX-2 inhibitors during post-marketing.
Pregnancy and Lactation: Not recommended in pregnancy and lactation.
Drug Interaction: Oral anticoagulants, diuretics and ACE inhibitors, acetylsalicylic acid, cyclosporin and tacrolimus, lithium, methotrexate, oral contraceptives, prednisone /
230

bexinfo: T
HERAPEUTIC
G
UIDE prednisolone, digoxin, drugs metabolized by sulfotransferases (Ethinyl Estradiol), drugs metabolized by CYP isoenzymes, ketoconazole, rifampicin, and antacids have interaction with etoricoxib.
Commercial Pack: Ribox ® 60 Tablet: Box containing 30 tablets in 3 x 10's blister strips.
Each tablet contains Etoricoxib INN 60 mg.
Ribox ® 90 Tablet: Box containing 30 tablets in 3 x 10's blister strips. Each tablet contains
Etoricoxib INN 90 mg.
Ribox ® 120 Tablet: Box containing 20 tablets in 2 x 10's blister strips. Each tablet contains
Etoricoxib INN 120 mg.
®
Tablet
This is a preparation of Tolfenamic acid, an NSAID with anti-inflammatory, analgesic and antipyretic effects.
Indications: Acute migraine.
Dosage and Administration: For acute attacks: 200 mg when the first symptoms of migraine appear. The treatment can be repeated once after 1-2 hours if a satisfactory response is not obtained.
Use in Children: A pediatric dosage regimen has not yet been established.
Use in Elderly: Normal adult dose.
Use in Pregnancy and Lactation: As is the case with the use of other NSAIDs, tolfenamic acid should not be given in the last trimester, due to risks of premature closure of the ductus arteriosus and prolonged parturition. Tolfenamic acid is excreted to such a very small extent in mothers' milk that it should be without risk to the breast-fed baby.
Side Effects: Diarrhea, nausea, epigastric pain, vomiting, urticaria, allergic skin reactions etc.
Contraindications: Active peptic ulceration, significantly impaired kidney or liver function, in patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by aspirin or other NSAIDs and hypersensitivity to tolfenamic acid or any ingredients of this product.
Drug Interactions: Anticoagulants, Diuretics, Lithium.
Special Precautions for Use: As is the case with other NSAIDs, tolfenamic acid should be used with caution in patients with a history of gastrointestinal ulceration, or impaired liver or kidney function.
Commercial Pack: Tolmic ® Tablet: Box containing 30 tablets in 3x10’s blister strips.
Each tablet contains Tolfenamic Acid BP 200 mg.
231

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablet / Suppository
This is a preparation of Diclofenac Sodium, a Non-steroidal anti-inflammatory agent with marked analgesic, anti-inflammatory and antipyretic properties.
Indications: Rheumatoid arthritis, osteoarthritis, low back pain and other acute musculoskeletal disorders such as frozen shoulder, tendinitis, teno-synovitis, bursitis, sprain, strain and dislocation, ankylosing spondylitis, acute gout, pain in orthopedics, dental and other minor surgery.
Dosage and Administration: Adults: Enteric coated tablet: A total of 75-150 mg daily given in two or three divided doses.
Sustained release tablets: One tablet daily, taken whole with liquid, preferably during meal.
Suppositories: 75-150 mg daily in divided doses.
Children: Enteric coated tablet: 1-3 mg / kg per day in divided doses.
Sustained release tablets: Not recommended.
Suppositories: 1-3 mg / kg body weight in divided doses.
Side Effects: Epigastric pain, nausea and diarrhea, headache and slight dizziness may be complained by some patients. These are often transient, disappearing with continuation of medication. Occasionally skin rash, peripheral edema and abnormalities of serum transaminase have been reported.
Warning and Precautions: This should not be prescribed to pregnant women unless there is compelling reason for doing so. Patients with a history of peptic ulcer, hematemesis, melena, bleeding diathesis or with severe hepatic or renal insufficiency, should be kept under close surveillance. If abnormal liver function tests persist or worsen, clinical signs and symptoms consistent with liver disease develop or if other manifestations occur(eosinophilia, rash), Ultrafen should be discontinued. Use of this drug in patients with hepatic porphyria may trigger an attack.
Contraindications: Contraindicated in patients with previous hypersensitivity to
Diclofenac, asthmatic patients and in whom attacks of asthma, urticaria or acute rhinitis are precipitated by aspirin or other NSAIDs.
Commercial Pack: Ultrafen ® 25 Tablet: Box containing 20 blister strips of 10 enteric coated tablets, each tablet contains Diclofenac Sodium BP 25 mg.
Ultrafen ® 50 Tablet: Box containing 20 blister strips of 10 enteric coated tablets, each tablet contains Diclofenac Sodium BP 50 mg.
232

bexinfo: T
HERAPEUTIC
G
UIDE
Ultrafen ® 100 SR Tablet: Box containing 10 blister strips of 10 sustained release tablets, each tablet contains Diclofenac Sodium BP 100 mg.
Ultrafen ® 12.5 Suppository: Box containing 10 suppositories (2x5’s), each suppository contains Diclofenac Sodium BP 12.5 mg.
Ultrafen ® 50 Suppository: Box containing 10 suppositories (2x5’s), each suppository contains Diclofenac Sodium BP 50 mg.
®
IM Injection
This is a preparation of Diclofenac Sodium, a Non-steroidal anti-inflammatory agent with marked analgesic, anti-inflammatory and antipyretic properties.
Indications: Ultrafen injection is used to relief all grades of pain and inflammation in a wide range of conditions including: a. Arthritic conditions: Rheumatoid Arthritis, Osteoarthritis, Ankylosing spondylitis,
Acute gout.
b.
Acute musculoskeletal disorders such as periarthritis (e.g., frozen shoulder), tendinitis, tenosynovitis, bursitis.
c. Other painful conditions resulting from trauma including fracture, low back pain, sprains, strains, dislocations, orthopedic, dental and other minor surgeries.
Dosage and Administration: Adults: One ampoule once (or in severe cases, twice) daily by intramuscular injection.
Renal colic: One ampoule once daily intramuscularly. A further ampoule may be administered after 30 minutes, if necessary.
The recommended maximum daily dose of diclofenac is 150 mg , by any route.
Children: In Juvenile chronic arthritis, 1-3 mg of diclofenac / kg body wt. daily in divided doses.
Elderly patients: In elderly or debilitated patients, the lowest effective dosage is recommended, commensurate with age and physical status.
Contraindications: Diclofenac is contraindicated for those patients who are hypersensitive to diclofenac. In patients with active or suspected peptic ulcer or gastrointestinal bleeding or for those patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by aspirin or other NSAIDs possessing prostaglandin synthetase inhibiting activity, diclofenac is also contraindicated.
Side Effects: Side effects to diclofenac are usually mild and transient. However, if serious side effects occur, diclofenac should be discontinued.
233

bexinfo: T
HERAPEUTIC
G
UIDE
Gastrointestinal: Occasional: Epigastric pain, other gastro-intestinal disorders (e.g., nausea, vomiting, diarrhea, abdominal cramps, dyspepsia, flatulence, anorexia).
Warning and Precautions: Renal: Patients with severe hepatic, cardiac or renal insufficiency or the elderly should be kept under close surveillance, since the use of
NSAIDs may result in deterioration of renal function. The lowest effective dose should be used and renal function should be monitored.
Hepatic: If abnormal liver function tests persist or worsen, clinical signs or symptoms consistent with liver disease develop or if other manifestations occur (eosinophilia, rash), diclofenac should be discontinued.
Patients receiving long term treatment with NSAIDs should be monitored as a precautionary measure (e.g., renal, hepatic function and blood counts).
High risk group: Pregnancy & Lactation: Diclofenac should not be prescribed during pregnancy, unless there are compelling reasons for doing so. The lowest effective dosage should be used. This type of drug is not recommended during the last trimester of pregnancy. Very small quantities of diclofenac may be detected in breast milk, but no undesirable effects on the infant are to be expected.
Commercial Pack: Ultrafen ® IM Injection: Box containing 2 x 5 ampoules of 3 ml in blister pack. Each 3 ml ampoule contains Diclofenac Sodium BP 75 mg.
®
Tablet
It is a combination product containing Diclofenac Sodium, a Non-steroidal antiinflammatory drug (NSAID) with analgesic properties, and Misoprostol, a gastrointestinal mucosal protective prostaglandin E1 analog.
Indications: This combination is indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications.
Dosage and Administration: Osteoarthritis: The recommended dosage for maximal GI mucosal protection is Diclofenac Sodium 50 mg plus Misoprostol 200 mcg tid. For patients who experience intolerance, Diclofenac Sodium 75 mg plus Misoprostol 200mcg bid or Diclofenac Sodium 50 mg plus Misoprostol 200 mcg bid can be used.
Rheumatoid Arthritis: The recommended dosage is Diclofenac Sodium 50 mg plus
Misoprostol 200 mcg tid or qid. For patients who experience intolerance, Diclofenac
Sodium 75 mg plus Misoprostol 200 mcg bid or Diclofenac Sodium 50 mg plus
Misoprostol 200 mcg bid can be used.
Side Effects: The most common reported side effects are abdominal pain, diarrhea and
234

bexinfo: T
HERAPEUTIC
G
UIDE other GI symptoms. Diarrhea and abdominal pain developed early in the course of therapy, and were usually self-limited (resolved after 2 to 7 days).
Contraindication: Diclofenac Sodium and Misoprostol combination, because of the abortifacient property of the Misoprostol component, is contraindicated in women who are pregnant and hypersensitivity to this product.
Warning and Precautions: Patients with an underlying condition such as inflammatory bowel disease, or those in whom dehydration should be monitored carefully if Diclofenac
Sodium 50 mg plus Misoprostol 200 mcg is prescribed.
Commercial Pack: Ultrafen ® Plus 50 Tablet: Box containing 30 tablets in 3x10’s blister strips & 50 tablets in 5x10’s blister strips. Each tablet contains an enteric-coated core containing 50 mg Diclofenac Sodium BP surrounded by an outer mantle containing 200 mcg Misoprostol INN.
Ultrafen ® Plus 75 Tablet: Box containing 30 tablets in 3 x 10’s blister strips. Each tablet contains an enteric-coated core containing 75 mg Diclofenac Sodium BP surrounded by an outer mantle containing 200 mcg Misoprostol INN.
®
IM Injection
This is a preparation of Diclofenac Sodium & Lidocaine Hydrochloride.
Indications: Ultrafen Extra injection contains lidocaine, which acts as a local anaesthetic.
Therefore, the possibility of pain at the injection site, which is most likely to occur after intramuscular injection of normal diclofenac, is minimized if Ultrafen Extra injection is used. It is used to relief all grades of pain and inflammation in a wide range of conditions including: a. Arthritic conditions: Rheumatoid Arthritis, osteoarthritis, ankylosing spondylitis, acute gout.
b. Acute musculoskeletal disorders: Periarthritis (e.g., frozen shoulder), tendinitis, tenosynovitis, bursitis.
c. Other painful conditions resulting from trauma: Fracture, low back pain, sprains, strains, dislocations, orthopedic, dental and other minor surgery.
Dosage and Administration: Adults: One ampoule once (or in severe cases, twice) daily by intramuscular injection.
Renal colic: One ampoule once daily intramuscularly. A further ampoule may be administered after 30 minutes, if necessary.
The recommended maximum daily dose of Diclofenac is 150 mg , by any route.
235

bexinfo: T
HERAPEUTIC
G
UIDE
The recommended maximum daily dose of Lidocaine is 200 mg.
Children: In Juvenile chronic arthritis, 1-3 mg of diclofenac / kg body wt. daily in divided doses.
Elderly patients: In elderly or debilitated patients, the lowest effective dosage is recommended, commensurate with age and physical status.
Side Effects: Side effects to diclofenac are usually mild and transient. However, if serious side effects occur, diclofenac should be discontinued.
Gastrointestinal: Occasional: Epigastric pain, other gastro-intestinal disorders (e.g., nausea, vomiting, diarrhea, abdominal cramps, dyspepsia, flatulence, anorexia).
Contraindications: This contraindicated for those patients who are hypersensitive to diclofenac and lidocaine. In patients with active or suspected peptic ulcer or gastro intestinal bleeding, or for those patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by aspirin or other NSAIDs possessing prostaglandin synthetase inhibiting activity, diclofenac is also contraindicated. Because of the presence of lidocaine,
Ultrafen Extra injection is also contraindicated for those patients who are hypersensitive to local anesthetics of the amide type, although the incidence is very rare. In patients with Adams-Stokes syndrome or with severe degrees of SA, AV, or intraventricular heart block in the absence of an artificial pacemaker, and for those patients who are hypersensitive to any of the excipients used in the formulation (sodium metabisulphite, mannitol, benzyl alcohol, propylene glycol), this injection is also contraindicated.
Warning and Precautions: Renal: Patients with severe hepatic, cardiac or renal insufficiency or the elderly should be kept under close surveillance, since the use of
NSAIDs may result in deterioration of renal function. The lowest effective dose should be used and renal function monitored.
Hepatic: If abnormal liver function tests persist or worsen, clinical signs or symptoms consistent with liver disease develop or if other manifestations occur (eosinophilia, rash), diclofenac should be discontinued. Patients receiving long term treatment with NSAIDs should be monitored as a precautionary measure (e.g., renal, hepatic function and blood counts).
High risk group: Pregnancy & Lactation: Diclofenac should not be prescribed during pregnancy, unless there are compelling reasons for doing so. The lowest effective dosage should be used. This type of drugs are not recommended during the last trimester of pregnancy. Very small quantities of diclofenac may be detected in breast milk, but no undesirable effects on the infant are to be expected.
Commercial Pack: Ultrafen Extra ® IM Injection: Box containing 2 x 5 ampoules of 2 ml in blister pack. Each 2 ml ampoule contains Diclofenac Sodium BP 75 mg & Lidocaine
Hydrochloride BP 20 mg.
236

bexinfo: T
HERAPEUTIC
G
UIDE
®
Gel
This is a preparation of Diclofenac Diethylamine BP equivalent to Diclofenac Sodium 10 mg.
Indication: Indicated for the quick relief from pain, swelling and inflammation due to musculo-skeletal disorders such as sprains, strains, tendinitis, bursitis, hands, neck & shoulder pain, sciatica, muscle stiffness, joint pain, back ache and lumbago.
Dosages and Administration: A thin layer should be applied to the affected site three to four times daily with rubbing.
Side Effect: Usually well tolerated. Extremely low frequency of hypersensitivity reactions.
Warning and Precaution: For external use only. Avoid contact with the eyes. Stop use and ask a doctor if condition worsens or does not improve within 7 days. Keep out of the reach of children. If swallowed, get medical help or contact a poison control center right away.
Contraindication: Known hypersensitivity to any component of the preparation.
Commercial Pack: Voligel ® Gel: Each pack has a tube containing 30 gm gel. Each gm contains Diclofenac Diethylamine BP equivalent to Diclofenac Sodium 10 mg.
®
Tablet
Xidolac tablet contains Ketorolac Tromethamine USP 10 mg. Ketorolac Tromethamine is a drug of pyrrolo-pyrrole group of NSAID.
Indications: Ketorolac Tromethamine is indicated for the short term management of moderate to moderately severe acute pain that requires analgesia at the opiod level
(usually in a postoperative setting).
Dosage and Administration: 10 mg every 4-6 hours (Elderly: Every 6-8 hours) or 40 mg daily; maximum duration of treatment is 7 days.
Side Effects: It is generally well tolerated. However, side effects like dry mouth, excessive thirst, psychotic reactions, convulsion, myalgia, hyponatremia, hyperkalemia, raised blood urea and creatinine, renal failure, hypertension, bradycardia, chest pain, purpura, post operative hemorrhage, hematoma, liver function changes etc. may occur.
Contraindications: Ketorolac Tromethamine is contraindicated in patients with known hypersensitivity to NSAIDs and any of the components to Ketorolac Tromethamine.
237

bexinfo: T
HERAPEUTIC
G
UIDE
Moreover, the patient with the history of asthma, nasal polyp, angioedema, peptic ulcer and bleeding disorder are contraindicated for this drug.
Warning and Precautions: Precaution should be taken in the following conditions:
Elderly, allergic disorder, renal, cardiac & hepatic impairment, porphyria.
Patient with low body weight (<50kg): Reduced dose
Use in Pregnancy & Lactation: Ketorolac Tromethamine is contraindicated in pregnancy and lactation.
Use in Children: Not recommended for children below 16 years of age.
Drug Interactions: Warfarin, digoxin, heparin and salicylate.
Overdosage: Overdosage of Ketorolac Tromethamine may cause abdominal pain, peptic ulcers, which healed after discontinuation of dose. Metabolic acidosis has been reported following overdosage.
Commercial Pack: Xidolac ® Tablet: Box containing 20 tablets in 2 X 10’s blister strips.
Each tablet contains Ketorolac Tromethamine USP 10 mg.
®
IM / IV Injection
This is a preparation of Ketorolac Tromethamine, a drug of pyrrolo-pyrrole group of
NSAID.
Indications: Ketorolac Tromethamine is indicated for the short-term management of moderate to moderately severe acute pain that requires analgesia at the opioid level
(usually in a post-operative setting).
Dosage and Administration: Xidolac injection may be used as a single or multiple doses, on a regular or when necessary schedule for the management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. When administering Xidolac injection, the IV bolus must be given over no less than 15 seconds. The IM administration should be given slowly and deeply into the muscle. The analgesic effect begins within 30 minutes with maximum effect in 1 to 2 hours after dosing IV or IM. Duration of analgesic effect is usually 4 to 6 hours.
Single-Dose Treatment: The following regimen should be limited to single administration use only.
238

bexinfo: T
HERAPEUTIC
G
UIDE
Adult Patients:
IM Dosing: Patients <65 years of age: One dose of 60 mg. Patients >65 years of age, renally impaired and / or less than 50 kg of body weight: One dose of 30 mg.
IV Dosing: Patients <65 years of age: One dose of 30 mg. Patients >65 years of age, renally impaired and / or less than 50 kg of body weight: One dose of 15 mg.
Pediatric Patients (2 to 16 years of age):
IM Dosing: One dose of 1 mg / kg up to a maximum of 30 mg.
IV Dosing: One dose of 0.5 mg / kg up to a maximum of 15 mg.
Multiple-Dose Treatment (IV or IM): Patients <65 years of age: The recommended dose is 30 mg Xidolac injection every 6 hours. The maximum daily dose should not exceed
120 mg. Patients >65 years of age, renally impaired patients and patients less than 50 kg: The recommended dose is 15 mg Xidolac injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg. For breakthrough pain, do not increase the dose or the frequency of Ketorolac Tromethamine.
Conversion from Parenteral to Oral Therapy: Xidolac tablets may be used either as monotherapy or as follow-on therapy to parenteral Ketorolac. When Xidolac tablets are used as a follow-on therapy to parenteral Ketorolac, the total combined daily dose of ketorolac (oral + parenteral) should not exceed 120 mg in younger adult patients or 60 mg in elderly patients on the day the change of formulation is made. On subsequent days, oral dosing should not exceed the recommended daily maximum of 40 mg. Xidolac
IM should be replaced by Xidolac tablet as soon as feasible. The total duration of combined parenteral and oral treatment should not exceed 5 days.
Contraindications: Ketorolac Tromethamine is contraindicated in patients with known hypersensitivity to NSAIDs and any of the components to Ketorolac Tromethamine.
Moreover, the drug is contraindicated to patients with the history of asthma, nasal polyp, angioedema, peptic ulcer and bleeding disorders.
Side Effects: Same as Xidolac tablet. See page No. 237
Warning and Precautions: Precaution should be taken in the following conditions:
Elderly, allergic disorder ,renal, cardiac & hepatic impairment, porphyria
Patient with low body weight (<50kg): reduced dose
High risk group: Pregnancy & Lactation: Ketorolac Tromethamine is contraindicated in pregnancy and lactation.
Drug Interactions: Warfarin, digoxin, heparin and salicylate should be used carefully with Ketorolac Tromethamine.
239

bexinfo: T
HERAPEUTIC
G
UIDE
Commercial Pack: Xidolac ® 10 IM / IV Injection: Box containing 1 x 5 ampoules of 1 ml in blister pack. Each 1 ml ampoule contains Ketorolac Tromethamine USP 10 mg.
Xidolac ® 30 IM / IV Injection: Box containing 1 x 1 ampoule of 1 ml in blister pack. Each
1 ml ampoule contains Ketorolac Tromethamine USP 30 mg.
®
Capsule
Xynofen-100 SR is a preparation of Ketoprofen, a derivative of propionic acid which is widely used in the treatment of patients with rheumatic diseases. It is a potent NSAID and a strong inhibitor of prostaglandin synthetase.
Indications:
1. Rheumatic diseases: For anti-inflammatory and analgesic use in rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, gout.
2. Periarticular and musculoskeletal indications: For analgesia in bursitis, tendinitis, synovitis, tenosynovitis, lumbago.
3. Prophylaxis and treatment of migraine headache.
4. Surgical and traumatic uses: For analgesic action after sports injuries, orthopaedic manipulations, dental extractions, surgery.
5. Infectious diseases: For analgesic, anti-inflammatory and antipyretic purposes.
6. Gynecological uses: In dysmenorrhea, following IUCD insertion and for uterine relaxation and analgesia in the post-partum, non-nursing mother.
Dosage and Administration: Xynofen-100 SR is administered orally, in the dose of 100-
200 mg once daily, usually with food, depending on patient weight and on severity of symptoms.
Side Effects: Minor side effects are variable in severity and frequency, consisting mostly of gastrointestinal problems such as gastrointestinal discomfort, nausea, diarrhoea and occasionally bleeding and ulceration. Dyspepsia may be minimized by taking this drug with food or milk. Other minor side effects such as headache, dizziness, mild confusion, vertigo, drowsiness, edema, mood change and insomnia may occur less commonly.
Major side effects involving other organ systems such as hematological reactions, hepatic or renal damage, dermatological reactions, bronchospasm and anaphylaxis are exceedingly rare. In all cases of major side effects Xynofen-100 SR should be withdrawn at once.
Contraindications: Patients with rhinitis, nasal polyps and asthma associated with aspirin may show cross sensitivity with other NSAIDs including Ketoprofen. Patients with
240

bexinfo: T
HERAPEUTIC
G
UIDE active ulceration or chronic dyspepsia, severe renal insufficiency and hypersensitivity to any of the ingredients.
Warning and Precautions: Inhibition of renal prostaglandin synthesis by NSAIDs may interfere with renal function especially in the presence of existing renal disease.
Ketoprofen should therefore be used with caution in patients with renal impairment. To minimize gastric intolerance, Xynofen-100 SR capsule should always be taken with food.
Nursing mother: As with other drugs that are excreted in milk, it is not recommended for use in nursing mother.
Use in Pregnancy: The drug should not be used in pregnancy unless clearly needed.
Drug Interactions: Aspirin, digoxin, methotrexate, cyclosporine, diuretics, β -blockers and oral hypoglycemic agents.
Overdosage: In case of acute overdosage, it is recommended that stomach be emptied by vomiting or lavage. The use of oral activated charcoal may also be helpful.
Commercial Pack: Xynofen ® 100 SR Capsule: Box containing 50 capsules in 5 x 10's blister strips, each capsule contains Ketoprofen BP 100 mg as sustained release pellets.
®
Tablet
Zolfin contains Aceclofenac, which is a Non-steroidal agent with marked anti-inflammatory and analgesic properties. Aceclofenac is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandins.
Indications: Zolfin is indicated for the relief of pain and inflammation in both acute and chronic pain like osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, dental pain, gynecological pain, lower back pain etc.
Dosage and Administration: The recommended dose is 200 mg daily, taken as two separate 100 mg doses, one tablet in the morning and one in the evening.
Side Effects: The majority of side effects observed have been reversible and of a minor nature and include gastrointestinal disorders (dyspepsia, abdominal pain, nausea and diarrhea) and occasional occurrence of dizziness. Dermatological complaints including pruritus and rash and abnormal hepatic enzyme levels and raised serum creatinine have occasionally been reported.
Drug Interaction: Lithium, digoxin, diuretics, anticoagulants, antidiabetic agents, methotrexate, other NSAIDs and steroids, cyclosporin.
Contraindications: Zolfin should not be administered to patients with active or suspected peptic ulcer or gastrointestinal bleeding. Aceclofenac should not be given to patients with moderate to severe renal impairment and hypersensitivity to this product.
241

bexinfo: T
HERAPEUTIC
G
UIDE
Warning and Precautions: Renal: Patients with mild renal or cardiac impairment and the elderly should be kept under surveillance, since the use of NSAIDs may result in deterioration of renal function. The lowest effective dose should be used and renal function monitored regularly. Hepatic: If abnormal liver function tests persist or worsen, clinical signs or symptoms consistent with liver disease develop or if other manifestations occur (eosinophilia, rash), Aceclofenac should be discontinued. Use of Aceclofenac in patients with hepatic porphyria may trigger an attack. Hematological: Aceclofenac may reversibly inhibit platelet aggregation.
Use in Pregnancy & Lactation: Should not be prescribed during pregnancy and lactation, unless there are compelling reasons for doing so.
Commercial Pack: Zolfin ® Tablet: Box containing 150 tablets in 15 x 10’s Alu-Alu form packs. Each film coated tablet contains Aceclofenac BP 100 mg.
242

N
D

bexinfo: T
HERAPEUTIC
G
UIDE
A
NTI
-D
EPRESSANT
®
Tablet
This is a preparation of Fluphenazine Hydrochloride BP a tranquilizer of the phenothiazine type and Nortriptyline Hydrochloride BP a tricyclic antidepressant having less sedative action.
Indications: Mild to moderate mixed anxiety/depression, emotional disturbance, sleep disorder, gastric problems etc.
Dosage and Administration: Adults: One Apresin tablet 2 to 3 times daily.
Side Effects: Tardive dyskinesias have been reported in phenothiazine therapy; usually after prolonged courses. Blood dyscrasia, malignant neuroleptic syndrome, agranulocytosis and sudden death have been reported rarely.
Drug Interactions: Barbiturates, alcohol, and narcotic drugs.
Warning and Precautions: Precautions should be taken in patients with glaucoma, prostate enlargement, cardiac failure & myocardial infarction and in concurrent administration with CNS depressants. The drug may impair alertness and abilities to drive a car or operate machinery.
Use in Pregnancy and Lactation: Not recommended in pregnancy and lactation.
Overdosage & Contraindications: It is contraindicated in patients with history of gradual epilepsy or organic brain damage, blood dyscrasia, severe cardiac insufficiency, renal insufficiency or liver damage. It is also contraindicated in patients taking Mono amino oxidase (MAO) inhibitors, in younger children and hypersensitivity to any component of the preparation.
Commercial Pack: Apresin ® Tablet: Box containing 10 blister strips of 10 film coated tablets. Each tablet contains Fluphenazine Hydrochloride BP 0.5 mg and Nortriptyline 10 mg as Nortriptyline Hydrochloride BP.
®
Tablet
This is a preparation of Sertraline Hydrochloride INN, is a selective serotonin re-uptake inhibitor (SSRI) for oral administration. The mechanism of action of Sertraline is to be linked to its inhibition of CNS neuronal uptake of serotonin (5HT).
245

bexinfo: T
HERAPEUTIC
G
UIDE
Indications: Atralin is indicated for depressive illness, obsessive compulsive disorder, post traumatic stress disorder, panic disorders, social anxiety disorders, and premenstrual dysphoric disorder.
Dosage and Administration: The usual daily dose is 50 mg & can be increased to 100 mg. The maximum daily dose is 200 mg.
Side Effects: Generally well tolerated but tremor, dizziness, insomnia, fatigue, dry mouth and sexual problem may occur.
Drug Interactions: MAO inhibitors, Diazepam, Tolbutamide, or Cimetidine.
Warning and Precautions: Atralin should be used with caution in patients with impaired kidney or liver function. Safety and effectiveness in pediatric patients under 6 years have not been established.
Use in Pregnancy & Lactation: Sertraline is Pregnancy Category C. This should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Caution should be exercised when this is administered to a nursing women.
Overdosage & Contraindications: It is contraindicated to known hypersensitivity to any of the ingredients & patients with unstable epilepsy.
Commercial Pack: Atralin ® Tablet: Box containing 50 film coated tablets in 5x10’s blister strips. Each film coated tablet contains Sertraline Hydrochloride INN equivalent to
Sertraline 50 mg.
®
Tablet
Frenxit is a preparation of Flupentixol and Melitracen. Flupentixol is a neuroleptic with anxiolytic and antidepressant properties when given in small doses, and Melitracen is a bipolar thymoleptic with activating properties in low doses. In combination the compound renders a preparation with antidepressant, anxiolytic and activating properties.
Indications: Frenxit is indicated in patients with anxiety, depression apathy and in conditions like psychogenic depression, depressive neuroses, masked depression, psychosomatic affections accompanied by anxiety and apathy, menopausal depression, dysphoria and depression in alcoholics and drug addicts.
Dosage and Administration: Adults: Usually 2 tablets daily (morning and noon).
In severe cases the morning dose may be increased to 2 tablets. Maintenance dose is usually 1 tablet in the morning, second dose should not be taken after 4 pm.
Side Effects: In the recommended doses are rare but transient restlessness and insomnia may occur.
Drug Interactions: Flupentixol & Melitracen may enhance the response to alcohol, barbiturates and other CNS depressants. Simultaneous administration of MAO-inhibitors may cause hypertensive crisis.
246

bexinfo: T
HERAPEUTIC
G
UIDE
Warning and Precautions: If previously the patient has been treated with tranquilizers with sedative effects these should be withdrawn gradually.
Use in Pregnancy and Lactation: Flupentixol & Melitracen should preferably not be given during pregnancy and lactation.
Overdosage and Contraindications: The main contraindications are immediate recovery phase after myocardial infarction, defects in bundle-branch conduction, untreated narrow angle glaucoma, acute alcohol, barbiturate and opiate intoxications.
Flupentixol & Melitracen should not be given to patients who have received a MAOinhibitor within two weeks. Not recommended for excitable patients since its activating effect may lead to exaggeration of these characteristics.
Commercial Pack: Frenxit ® Tablet: Box containing 100 tablets in 10x10’s blister strips
& 150 tablets in 15x10’s blister strips. Each film coated tablet contains Flupentixol
Hydrochloride BP equivalent to 0.5 mg Flupentixol and Melitracen Hydrochloride INN equivalent to 10 mg Melitracen.
®
Tablet
This is a preparation of Paroxetine Hydrochloride, a potent selective serotonin reuptake inhibitor (SSRI).
Indications: Major depressive disorder, obsessive compulsive disorder, panic disorder, social anxiety disorder, generalized anxiety disorder & post-traumatic stress disorder.
Dosage &Administration: Usual initial dose is Melev 20 tablet as a single daily dose with or without food, usually in the morning.
Side Effects: The side effects are asthenia, sweating, nausea, decreased appetite, somnolence, dizziness, insomnia, tremor, nervousness, ejaculatory disturbance and other male genital disorders. Dry mouth, constipation, female genital disorders, impotence and infection may also occur.
Drug Interactions: Haloperidol / Amylobarbitone / Oxazepam, Alcohol, Drug metabolizing enzyme inducers / inhibitors, MAOIs, Lithium, Phenytoin / Anticonvulsants and Warfarin.
Warning & Precautions: Caution is advised when treating patients with cardiac conditions and in case of epilepsy and mania. Overall the incidence of seizures is <0.1% in patients treated with Paroxetine. Paroxetine should be discontinued in any patient who develops seizures. Paroxetine may impair performance of skilled tasks (e.g. driving).
Discontinuation of treatment should be gradual to reduce the risk of withdrawal symptoms
(i.e. decrease in the daily dose by 10 mg/day at weekly intervals).
Use in Pregnancy and Lactation: It should be used during pregnancy only if the potential
247

bexinfo: T
HERAPEUTIC
G
UIDE benefit justifies the potential risk to the fetus. Caution should be exercised when this drug is administered in a nursing mother.
Overdosage & Contraindications: It is contraindicated in patients with a hypersensitivity to Paroxetine. Concomitant use in patients taking either monoamine oxidase inhibitors
(MAOIs) or Thioridazine is contraindicated.
Commercial Pack: Melev ® 20 Tablet: Each box containing 30 tablets in 3x10’s blister strips. Each tablet contains Paroxetine Hydrochloride USP equivalent to 20 mg
Paroxetine.
®
Capsule
Modipran, a preparation of Fluoxetine hydrochloride BP, is a selective inhibitor of serotonin reuptake in presynaptic neurons and is used as an antidepressant with very long half life.
Indications: Depressive illness, obsessive compulsive disorder, panic disorder and bulimia nervosa.
Dosage & Administration: A dose of 20 mg/day administered in the morning and is recommended as the initial dose. A dose increase may be considered after several weeks if no clinical improvement is observed. Dosage above 20 mg/day, should be administered on a bid. schedule (i.e. morning and noon) and should not exceed a maximum dose of
80 mg/day. A lower or less frequent dosage should also be considered in patients, such as elderly, with concurrent disease or on multiple medication.
Elderly: A recommended maximum dose for elderly patients is 60 mg per day.
Children: Safety and effectiveness in children have not been established.
Side Effects: Gastrointestinal: Nausea, vomiting, dyspepsia, dry mouth, and diarrhea.
Neurological: Anxiety, nervousness, insomnia/drowsiness and fatigue.
Others: Excessive sweating, pruritus, skin rashes associated with liver, kidney and lung involvement. It has therefore been advised that Fluoxetine therapy should be discontinued in any patient who develops a skin rash.
Drug Interactions: There have been reports of serious, sometimes fatal reactions in patients receiving Fluoxetine in combination with Monoamine oxidase inhibitors (MAOIs).
Therefore, Modipran should not be used in combination with a MAOI, or within 14 days of discontinuing therapy with an MAOI.
Warning & Precautions: As Fluoxetine undergoes hepatic metabolism and renal
248

bexinfo: T
HERAPEUTIC
G
UIDE excretion, it should be used with caution and in reduced doses in patients with impaired hepatic or renal function. Because of its epileptogenic effect, it should be used with caution in patients with epilepsy or a history of such disorders. Fluoxetine may alter glycemic control and therefore caution is also warranted in diabetic subjects.
Use in Pregnancy & Lactation: Modipran should be used in pregnancy only if clearly needed. Caution should be exercised when it is administered to nursing mothers.
Overdosage & Contraindications: Contraindicated in patients known to be hypersensitive to it.
Commercial Pack: Modipran ® Capsule: Box containing 10 aluminium strips of 10 capsules. Each capsule contains Fluoxetine Hydrochloride BP equivalent to 20 mg
Fluoxetine.
®
Tablet
This is a preparation of Escitalopram Oxalate INN, which is a selective serotonin reuptake inhibitor (SSRI).
Indications: Acute & maintenance treatment of Major Depressive Disorder (MDD) in adult & adolescent aged 12-17 years and acute treatment of Generalized Anxiety
Disorder (GAD) in adults.
Dosage & Administration: Seropam should generally be administered once daily, morning or evening with or without food. Dosage guideline is as follows:
MDD: For adolescent (12-17 years) & adult, initial dose is 10 mg once daily and maximum dose is 20 mg once daily.
GAD: For adult, initial dose is 10 mg once daily is recommended. If the dose is increased to 20 mg, this should occur after a minimum of three weeks in adolescents & one week in adult. Safety & efficacy of Escitalopram has not been established in patients less than
18 years with GAD.
Children: It is not approved for using in patients less than 12 years.
Side Effects: Nausea, insomnia, ejaculation disorder, fatigue, drowsiness, increased sweating, decreased libido & anorgasmia (difficulty achieving orgasm).
Drug Interaction: Concomitant use of Escitalopram with SSRIs, SNRIs or tryptophan is not recommended. Caution is advised when co administered with other drugs that may affect the serotonergic neurotransmitter systems, such as tryptans, linezolid, lithium, tramadol.
249

bexinfo: T
HERAPEUTIC
G
UIDE
Use in pregnancy & lactation: This should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. Caution should be required when it is administered to a nursing woman.
Overdosage & Contraindications: It is contraindicated in patients who have hypersensitivity to the drug or any of the inactive ingredients. It should not be used with a MAOI or within 14 days of stopping a MAOI and should not be used concomitantly with
Pimozide.
Commercial Pack: Seropam ® 5 Tablet and Seropam ® 10 Tablet: Box containing 30 tablets in 3 x10’s blister strips. Each tablet contains Escitalopram Oxalate INN equivalent to Escitalopram 5 mg and Escitalopram 10mg respectively.
250

bexinfo: T
HERAPEUTIC
G
UIDE
A
NTI
-E
METICS
®
Tablet
This is a preparation of Meclizine Hydrochloride. Meclizine is an H1 receptor blocker of the piperazine side chain group.
Indications: Nausea, vomiting, motion sickness, vertigo.
Dosage and Administration: Adult & children over 12 years of age:
• Nausea and vomiting: 25-100 mg daily (single dose) or as directed by physician. Motion sickness: 25-50 mg, 1 hour before travel. The dose may be repeated every 24 hours as needed.
• Vertigo: 25-100 mg daily, in divided doses.
Children: Clinical studies establishing safety and efficacy in children have not been done.
Therefore, its use should be determined by physician.
Elderly: There is no specific information available. However older people may be especially sensitive to the anticholinergic effects of medicine.
Side Effects: Drowsiness, dry mouth, and on rare occasions, blurred vision have been reported.
Drug Interactions: Meclizine may increase the toxicity with CNS depressants, neuroleptics and anticholinergic. Alcohol, sedatives and tranquilizers can increase the drowsiness of the patient.
Warning & Precautions: Patients with asthma, bronchitis, emphysema, enlarged prostate, glaucoma or urinary tract blockage should take Meclizine with caution.
Use in Pregnancy & Lactation: Meclizine shows no risk of birth defects or abnormalities when administered during pregnancy. Although Meclizine may excrete into the milk, it causes no harm in nursing babies.
Overdosage & Contraindications: It is contraindicated in patients hypersensitive to
Meclizine or any of its excipeints.
Commercial Pack: Vomec ® Tablet: Box containing 50 tablets in5 x 10’s blister strips.
Each tablet contains Meclizine Hydrochloride USP 50 mg.
251

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablet
This is a preparation of Meclizine Hydrochloride and Pyridoxine Hydrochloride. Meclizine is an H1 histamine receptor blocker of the piperazine side chain group and Pyridoxine
(vitamin B6) is a vitamin B component having some antiemetic property.
Indications: Nausea, Vomiting, Motion sickness, vertigo, dizziness.
Dosage & Administration: a. Nausea & vomiting (including morning sickness in pregnancy): One tablet 1-2 times daily or as required. b. Motion Sickness: The initial dose is one or two tablet daily, it should be taken one hour to journey for protection against motion sickness. Therefore the dose may be repeated every 24 hours as indicated for the duration of the journey. c. Vertigo: One tablet two times daily or as required. d. Labyrinth & vestibular disturbances: The optimal dosage of meclizine is usually 25-
100 mg daily in divided doses, depending on the clinical response.
Drug Interaction: Meclizine may increase the toxicity with CNS depressants, neuroleptics and anticholinergic. Alcohol, sedatives and tranquilizers can increase the drowsiness of the patient.
Side Effects: Drowsiness, dry mouth, and on rare occasions, blurred vision have been reported.
Warning & Precautions: As Meclizine may impair mental alertness or physical coordination, patients should be warned. Due to its potential anticholinergic action, this drug should be used with caution in patients with asthma, glaucoma, or enlargement of the prostate gland.
Use in Pregnancy and Lactation: Meclizine shows no risk of birth defects or abnormalities when administered during pregnancy. Although Meclizine may excrete into the milk, it causes no harm in nursing babies. Pyridoxine itself is considered safe in pregnancy and has been used in pregnant women without any evidence of fetal harm.
Overdosage & Contraindications: Patients hypersensitive to Meclizine and/or
Pyridoxine or any of its excipeints.
Commercial Pack: Vomec ® Plus Tablet: Box containing 50 tablets in 5 x 10’s blister strips. Each tablet contains Meclizine Hydrochloride USP 25 mg & Pyridoxine
Hydrochloride USP 50 mg.
252

bexinfo: T
HERAPEUTIC
G
UIDE
A
NTI
-E
PILEPTICS
®
Tablet / CR Tablet
Epilep contains Carbamazepine which is an iminodibenzyl derivative with anticonvulsant properties and its structure is related to the tricyclic antidepressants.
Indications: Carbamazepine is indicated in all forms of epilepsy except myoclonic and absence seizures. It is also indicated in trigeminal neuralgia, mood disorder, aggression and diabetes insipidus.
Dosage and Administration: Epilepsy: Adults: 100-200 mg once or twice daily and this is then gradually increased by 200mg daily every week. The best response is often obtained with doses of 800-1200 mg daily.
Children: The dose in children is determined on the basis of body weight (10-20 mg/kg) and age.
Children up to 1 year of age: 100-300 daily in two to four divided doses.
Children up to 1 to 5 years of age: 200-400 mg daily in two to four divided doses.
Children up to 6 to 10 years of age: 400-600 mg daily in two to four divided doses
Children up to 11 to 15 years of age: 600-1000 mg daily in two to four divided doses.
Trigeminal Neuralgia: The initial dose is usually 200 mg daily. In some instances a dose of 1600 mg daily is necessary.
Mood Disorder: In patients unresponsive to lithium therapy, a starting dose of 400-600 mg daily.
Diabetes Insipidus: 200 mg two to three times daily. In children the dose should be determined according to body weight (10-20 mg/kg).
Side Effects: Aplastic anemia, agranulocytosis, fatal hepatitis, generalized erythematous skin rashes, dizziness, ataxia, headache, severe exfoliative dermatitis, transient leukopenia, thrombocytopenia, diplopia, drowsiness, nausea, Stevens Johnson
Syndrome, oliguria hematuria, proteinuria, vomiting, asthenia heart failure.
Warning & Precautions: Carbamazepine should be used with caution in cardiovascular disease, hepatic or renal disorders, changing treatment from Carbamazepine to another antiepileptic drug, hematological disorder, glaucoma etc.
253

bexinfo: T
HERAPEUTIC
G
UIDE
Use in Pregnancy & Lactation: There is definite evidence of risk to the human fetus, but this may be overweighed by the therapeutic benefit for the mother. Pregnancy decreased the plasma concentration of Carbamazepine. Therefore, it may be necessary to increase the dose of Epilep during pregnancy in order to maintain a satisfactory clinical response.
Breast-feeding is not contraindicated, however, the drug ingested by the breast fed infant is too small to cause adverse pharmacological effects.
Overdosage & Contraindications: Previous sensitivity to Carbamazepine or structurally related drugs, atrio-ventricular conduction abnormalities, history of previous bone marrow depression or of intermittent porphyria.
Commercial Packs: Epilep ® Tablet: Each box contains 5 x 10’s tablets in blister pack.
Each tablet contains Carbamazepine BP 200 mg.
Epilep CR ® Tablet: Each box contains 5 x 10’s tablets in blister pack. Each CR tablet contains Carbamazepine BP 200 mg.
254

bexinfo: T
HERAPEUTIC
G
UIDE
A
NTI
-M
IGRAINE
®
Tablet
This is a preparation of Pizotifen Malate, which is a tricyclic compound having antiserotoninergic and antihistaminergic effects together with weak anticholinergic action.
Indications: It is used as prophylactic treatment of vascular headaches of the migraine types, such as classic migraine, common migraine and cluster headache.
Dosage & Administration: Adult: Usually 1.5 mg daily, which may be taken as a single dose at night or in three divided doses. Dose should be adjusted to individual requirements. Up to a maximum of 4.5 mg daily and up to 3 mg may be given as a single dose daily.
Children: Up to 1.5 mg daily, usually in divided dose, and daily 1 mg as a single dose has been given at night using 0.5 mg tablet.
Duration of treatment: 3-6 months, minimum one month to observe the benefit.
Side Effects: Drowsiness is the most common side effect and also increased appetite, which may lead to increase in body weight. Other side effects are, dizziness, dry mouth, nausea, constipation, which are rare. In children CNS stimulation may occur.
Warning& Precautions: Patients should be cautioned about the possibility of drowsiness and informed of its significance in driving vehicles and operation of machineries. Pizotifen may enhance the central effects of sedative, hypnotic, antihistamine and alcohol. Dose adjustment may be required in patients with renal insufficiency.
Use in Pregnancy and Lactation: This should only be used during pregnancy under compelling circumstances and is not recommended to the nursing mother.
Overdosage &Contraindications: Pizotifen should not be administered in narrow-angle glaucoma or prostate hypertrophy. It should also not be given patients with hypersensitivity to this drug.
Commercial Pack: Avidro ® 0.5 Tablet: Box containing 10 x 10's tablets in blister strips.
Each tablet contains Pizotifen malate BP equivalent to Pizotifen 0.5 mg.
Avidro ® 1.5 Tablet: Box containing 5 x 10's tablets in blister strips. Each tablet contains
Pizotifen malate BP equivalent to Pizotifen 1.5 mg.
255

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablet
This is a preparation of Flunarizine Dihydrochloride, the difluorinated derivative of
Cinnarizine. Flunarizine is a selective calcium channel antagonist.
Indications: It is indicated for prophylaxis of classic (with aura) or common (without aura) migraine, symptomatic treatment of vestibular vertigo, dizziness, peripheral vascular disease (Intermittent claudication, Raynaud’s phenomenon, paresthesis, cold extremities, nocturnal cramp and trophic disorders owing to ischemia of limbs),refractory epilepsy resistant to conventional antiepileptic therapy and alternating hemiplegia of childhood.
Dosage and Administration: For migraine prophylaxis: Starting dose is 10 mg daily (at night) for patients less than 65 years and 5 mg for patients older than 65 years.
Maintenance treatment: If a patient’s response is satisfactory and if a maintenance treatment is needed, the dose should be decreased so that each week the patient has 5 days treatment at the same daily dose and 2 successive drug free days. Treatment should be interrupted after 6 months and re-initiated only if the patient relapses. The recommended maximum daily dose is 10 mg daily in adults and 5 mg daily in children.
For vertigo: The recommended maximum daily dose is 10 mg daily in adults & 5 mg daily in children (<40kg).
For epilepsy: An optimal therapeutic dosage in epileptic patients receiving other antiepileptic drugs is 15 to 20 mg daily in adults and 5 to 10 mg daily in children.
Side Effects: Flunarizine is well tolerated and seldom causes serious side effects. The common adverse effects are depression, drowsiness, sedation, anxiety, heart burn, nausea, emesis, dry mouth, gastralgia, weight gain, and/or increased appetite, asthenia, muscle aches, skin rash, and galactorrhea in female patients on oral contraceptives.
Drug Interactions: Oral contraceptives, hepatic enzyme inducers such as carbamazepine and phenytoin, calcium channel blocker and amiodarone. Excessive sedation can occur when alcohol, hypnotics or tranquilizers are taken simultaneously with flunarizine.
Warning & Precautions: Since sedation or drowsiness occur in some patients during treatment with flunarizine hydrochloride, patients should be cautioned against activities which require alertness or rapid, precise responses (e.g. operating machinery or a motor vehicle) until the response to the drug has been determined.
Use in Pregnancy and Lactation: It should not be administered to pregnant women unless the anticipated benefits outweigh the potential risks. Breast-feeding should be discouraged in women taking flunarizine.
256

bexinfo: T
HERAPEUTIC
G
UIDE
Overdosage & Contraindications: Acute overdosage has been reported and the observed symptoms were sedation, agitation and tachycardia. Treatment of acute overdosage consists of charcoal administration, induction of emesis or gastric lavage, and supportive measures. No specific antidote is known. It is contraindicated in hypersensitivity to flunarizine or structurally similar calcium channel blocker, patients with a history of depressive illness, patients with pre-existing symptoms of Parkinson’s disease or other extra pyramidal disorders and hepatic insufficiency.
Commercial Pack: Flurium ® 5 Tablet and Flurium ® 10 Tablet: Each box contains 3 blister strips of 10 tablets. Each tablet contains Flunarizine Dihydrochloride BP equivalent to
Flunarizine 5 mg and Flunarizine Dihydrochloride BP equivalent to Flunarizine 10 mg respectively.
257

bexinfo: T
HERAPEUTIC
G
UIDE
A
NTI
-P
ARKINSONISM
®
Tablet
This is a preparation of Ropinirole, a dopamine D2 receptor agonist which improves the symptoms & signs in Parkinson’s disease.
Indications: Ropinirole is used alone or with other medicines to treat Parkinson’s disease. It helps to improve muscle control and movement difficulties. Thus, is also used to treat a condition called Restless Legs Syndrome (RLS). This condition is an overwhelming feeling of wanting to move the legs to make them comfortable from unpleasant sensations in the legs.
Dosage and Administration: The recommended starting dose is 0.25 mg three times daily with or without food. Based on individual patient response, dosage should then be titrated with weekly increments as described in the table below. After week 4, if necessary, daily dosage may be increased by 1.5 mg per day on a weekly basis up to a dose of 9 mg per day, and then by up to 3 mg per day weekly to a total dose of 24 mg per day.
Ascending – Dose Schedule of Ropinirole: In first week: 0.25 mg three times daily, in 2nd week: 0.5 mg three times daily, in 3rd week: 0.75 mg three times daily and in 4th week:
1.0 mg three times daily. A total daily dose of 0.75mg, 1.5mg, 2.25 mg and 3.0 mg respectively. Dosage greater than 24 mg/day have not been tested in clinical trials.
Ropinirole should be discontinued gradually over a 7 day period. The frequency of administration should be reduced from three times daily to twice daily for 4 days. For the remaining 3 days, the frequency should be reduced to once daily prior to complete withdrawal of Ropinirole.
Side Effects : Common side effects are abdominal pain, swelling of the legs and ankles due to excess fluid retention (peripheral edema), confusion, difficulty performing voluntary movements, resulting in jerky or involuntary movements or muscle twitches (dyskinesia), false perceptions of things that are not really there (hallucinations), nausea and vomiting, sleepiness (somnolence), fainting (syncope), slower than normal heart beat
(bradycardia), profound drop in blood pressure (hypotension).
Drug Interactions: Ciprofloxacin, dopamine antagonists, such as neuroleptics
(phenothiazines, butyrophenones, thioxanthenes) or metoclopramide, may diminish the effectiveness of Ropinirole.
Warning & Precautions: If a patient develops significant daytime sleepiness or episodes of falling asleep during activities that require active participation (e.g. conversations, eating, etc.), Ropinirole should ordinarily be discontinued. If a decision is made to
258

bexinfo: T
HERAPEUTIC
G
UIDE continue Ropinirole, patients should be advised not to drive and to avoid other potentially dangerous activities. Safety and effectiveness of Ropinirole in the pediatric population have not been established.
Use in Pregnancy and Lactation: Pregnancy category C. It should be used during pregnancy only if the potential benefit outweighs the potential risk of the fetus. In case of nursing women a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Contraindications: Ropinirole is contraindicated for patients known to have hypersensitivity to the product.
Commercial Pack: Repitol ® 0.25 Tablet and Repitol ® 2 Tablet: Box containing 30 tablets in 3 x 10’s blister strips. Each tablet contains Ropinirole Hydrochloride INN equivalent to
Ropinirole 0.25 mg and Ropinirole Hydrochloride INN equivalent to Ropinirole 2 mg respectively.
259

bexinfo: T
HERAPEUTIC
G
UIDE
A
NTI
-P
SYCHOTIC
®
Tablet
This is a preparation of Olanzapine, which is an antipsychotic agent and has affinities for serotonin 5-HT2, 5-HT3, 5-HT6; dopamine D1- D5, cholinergic muscarinic receptors M
1
-
M5; α
1 adrenergic; and histamine H
1 receptors.
Indications: Acute and maintenance treatment of schizophrenia and related psychoses where positive symptoms (e.g. delusions, hallucinations, disordered thinking, hostility and suspiciousness) and/or negative symptoms (e.g. flattened affect, emotional and social withdrawal, poverty of speech) are prominent. Also indicated in acute mania or mixed episodes in bipolar disorder, with or without psychotic features and with or without a rapid cycling course.
Dosage and Administration: The recommended starting dose for Pericam is 10 mg/day, administered as a single daily dose without regard to meals. Daily dosage may subsequently be adjusted on the basis of individual clinical status within the range of 5-
20 mg daily. An increase to a dose greater than the routine therapeutic dose of 10 mg/day i.e. to a dose of 15 mg/day or greater is recommended only after appropriate clinical reassessment.
Drug Interaction: Drugs that induce CYP1A2 or glucuronyl transferases enzymes
(omeprazole, rifampicin), inhibitor of CYP1A2 (fluvoxamine), centrally acting drugs, and antihypertensive agents.
Side Effects: Somnolence and weight gain frequently occur. Less common side effects are- dizziness, asthenia, increased appetite, peripheral edema, orthostatic hypotension, and mild, transient anticholinergic effects including constipation and dry mouth; transient, asymptomatic elevations of hepatic transaminases, ALT, AST, Rare (0.1-1%):
Photosensitivity reaction and bradycardia.
Warning & Precaution: All antipsychotic medicines, including Olanzapine must be discontinued in patients with Neuroleptic Malignant Syndrome (NMS), or with unexplained high fever without additional clinical manifestations of NMS. Olanzapine should be used cautiously in patients who have a history of psoriatic hypertrophy, paralytic ileus or related conditions associated with seizures, in patients with low leukocyte and/or neutrophil counts, drug induced bone marrow depression/toxicity, hyper eosinophilic conditions, impaired hepatic function, and patients using hepatotoxic medicines, centrally acting drug and medicines known to increase QT interval, especially in elderly. Patients should be cautioned about operating hazardous machinery, including motor vehicles.
Use in Pregnancy and Lactation: Olanzapine should be used in pregnancy only if the potential benefits justify the potential risk to the fetus. Patients should not breast feed if they are taking Olanzapine.
260

bexinfo: T
HERAPEUTIC
G
UIDE
Contraindication: Known hypersensitivity to any ingredient of the product as well as in patients with known risk for narrow angle glaucoma.
Commercial Pack: Pericam ® 5 Tablet and Pericam ® 10 Tablet: Box containing 100 tablets in 10 x 10's blister strips. Each tablet contains Olanzapine INN 5 mg and
Olanzapine INN 10 mg respectively.
261

bexinfo: T
HERAPEUTIC
G
UIDE
L
OCAL
A
NESTHETICS
®
Injection
This is a preparation of Bupivacaine which is a long acting local anesthetic agent that belongs to amide group. It blocks the generation and the conduction of nerve impulses, by increasing the threshold for electrical excitation in the nerve, by slowing the propagation of the nerve impulse, and by reducing the rate of rise of the action potential.
Indication: Nerkein is used for pain management in the postoperative setting and other situations where therapeutic pain blockade is required. It is used for a number of different types of anesthesia including infiltration anesthesia (where it can be injected directly into the site where the procedure will occur), peripheral sympathetic nerve anesthesia, epidural anesthesia, surgical anesthesia, and obstetric anesthesia.
Dosage and Administration: The lowest dose required to provide effective anesthesia should be administered. The dose of Nerkein at any time should not exceed 2 mg/kg bodyweight. The normal recommended dose of plain bupivacaine injections for various anesthetic procedures in the average, healthy 70 kg adult patient are as follows:
Procedure Dose Range
Used (%)
Concentration
Required Volume (mL)
Infiltration
Peripheral nerve blocks ( minor)
Peripheral nerve blocks ( major)
Celiac Block
Epidural Block
Lumber
Caudal
Intercostal Block (per segment)
12.5-150 mg (0.25-.5) 5-30 ml to 5-60 ml
12.5-100 (0.25- 0.5)
50-150 mg (0.25-0.5)
100-125 mg (0.25)
75-100 mg (0.5)
75-125 mg (0.25)
10-25 mg ( 0.25)
5-20 ml to 5-30 ml
20-40 ml to 20-30 ml
40-50 ml
15-20 ml
15-40 ml
4-8 ml/seg
Hip Joint Block
Sciatic
Femoral
10-25 mg(0.5)
100-150 mg (0.5)
50-100 mg (0.5)
3-5 ml/seg
20-30 ml
10-20 ml
Obturator
Lateral cutaneous
Epidural/caudal (vaginal delivery etc)
50-100 mg (0.5)
12.5-25 mg (0.25)
15-60 mg (0.25-0.5)
10-20 ml
5-10 ml
6-12 ml
Epidural (cesarean section/ hysterectomy) 5-150 mg(0.5)⃰
Pudendal 12.5-50 mg (0.25-0.5)
15-30⃰
5-10 on each side
Postoperative Analgesia
Intermittent epidural
Continuous epidural
⃰ Given either as a single or incremental dose
20-40 mg (1-2/hrs) (0.5) 4-8 (1-2 / hrs)
18.75 mg/hr (0.125) 15 / hrs
262

bexinfo: T
HERAPEUTIC
G
UIDE
Side Effects: The common side effects are nausea, vomiting, tinnitus, numbness, nervousness, blurred vision, tremor, dizziness and disorientation.
Drug Interaction: Bupivacaine should be used with caution in patients receiving other local anesthetics or agents structurally related to amide-type local anesthetics, e.g. certain anti-arrhythmic, such as lidocaine and mexiletine, since the systemic toxic effects are additive.
Warning and Precaution: The lowest dosage that gives effective anesthesia should be used in order to avoid high plasma levels and serious systemic side effects. Injection of repeated doses of Bupivacaine Hydrochloride may cause significant increase in blood levels with each additional dose, due to accumulation of the drug or its metabolites or due to slow metabolic degradation. Debilitated, elderly patients and acutely ill patients should be given reduced doses commensurate with age and physical condition.
Use in Pregnancy and Lactation: Bupivacaine Hydrochloride should not be given in early pregnancy. Bupivacaine enters the mother's milk, but in such small quantities that there is no risk of affecting the child at therapeutic dose levels.
Labor and Delivery: Bupivacaine hydrochloride is contraindicated for obstetrical paracervical block anesthesia. Local anesthetics rapidly cross the placenta, and when used for epidural, caudal, or pudendal block anesthesia, can cause varying degrees of maternal, fetal, and neonatal toxicity. Adverse reactions in the parturient, fetus, and neonate involve alterations of the central nervous system, peripheral vascular tone, and cardiac function.
Overdosage & Contraindications: Bupivacaine is contraindicated in patients with a known hypersensitivity to it or to any local anesthetic agents of the amide type, in intravenous regional anesthesia (Bier block), in obstetrical paracervical block anesthesia and in all intravenous infusions. It is also contraindicated in the presence of inflammation and/or other infection at the proposed injection site, and in the presence of septicemia
Commercial Pack: Nerkein ® Injection: Each box contains 1 vial of 30 ml of Sterile
Solution for Injection. Each ml contains Bupivacaine Hydrochloride USP 5 mg.
263

bexinfo: T
HERAPEUTIC
G
UIDE
N
EUROPATHIC
P
AIN
M
ANAGEMENT
®
Capsule
This is a preparation of Pregabalin, which is a structural derivative of the inhibitory neurotransmitter Gamma-amino butyric acid (GABA). It binds with high affinity to the α-
2δ site (an auxiliary subunit of voltage-gated calcium channels) in central nervous system tissues.
Indications: Pregabalin is indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy, post herpetic neuralgia & spinal cord injury. It is also indicated as adjunctive therapy for adult patients with partial onset seizures. It can be used for the management of fibromyalgia.
Dosage and Administration: Neuropathic pain associated with diabetic peripheral neuropathy: The maximum recommended dose of Nervalin is 100 mg 3 times a day (300 mg/day) in patients with creatinine clearance of at least 60 mL/min. Dosing should begin at 50 mg three times a day and may be increased to 300 mg/day within 1 week based on efficacy and tolerability.
Neuropathic pain associated with post herpetic neuralgia: The recommended dose of
Nervalin is 75 to 150 mg two times a day or 50 to 100 mg three times a day (150 to 300 mg/day) in patients with creatinine clearance of at least 60 mL/min. Dosing should begin at 75 mg two times a day or 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability.
Adjunctive therapy for adult patients with partial onset seizures: The recommended dose of Nervalin for adults is 150 to 600 mg/day by 2 or 3 divided doses as adjunctive therapy in the treatment of partial onset seizures. In general, it is recommended that patients be started on a total daily dose not greater than 150 mg/day (75 mg two times a day or 50 mg three times a day). Based on individual patient response and tolerability, the dose may be increased to a maximum dose of 600 mg/day.
Management of Fibromyalgia: The recommended dose is 300 to 450 mg/day. Dosing should begin at 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient benefit with 300 mg/day may be further increased to
225 mg two times a day (450 mg/day).
Neuropathic pain associated with spinal cord injury: The recommended dose is 150 to
600 mg/day. The recommended starting dose is 75 mg two times a day (150 mg/day).
The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability.
264

bexinfo: T
HERAPEUTIC
G
UIDE
Side Effects: Common side effects are dizziness, somnolence, dry mouth, edema, weight gain, abnormal thinking and blurred vision.
Warning & Precautions: Abrupt or rapid discontinuation of Pregabalin may produce some symptoms including insomnia, nausea, headache and diarrhea. So it should be tapered gradually over a minimum of 1 week rather than discontinued abruptly. Pregabalin treatment may associate with creatine kinase elevations. It should be discontinued if myopathy is diagnosed or suspected or if markedly elevated creatine kinase levels occur.
The safety and efficacy of Pregabalin in pediatric patients have not been established.
Use in Pregnancy and Lactation: Pregnancy category C. So Pregabalin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It should be used in nursing women only if the benefits clearly overweigh the risks.
Overdosage & Contraindications: It is contraindicated in patients with known hypersensitivity to Pregabalin or any of its components.
Commercial Pack: Nervalin ® 50 Capsule and Nervalin ® 75 Capsule: Box containing 30 capsules in 3×10’s blister strips. Each capsule contains Pregabalin INN 50 mg and
Pregabalin INN 75 mg respectively.
265

bexinfo: T
HERAPEUTIC
G
UIDE
N
EUROPROTECTIVE
®
IM / IV Injection
This is a preparation of Citicoline, a natural substance that is a component of cell membranes. The substance, helps the brain tissues to repair or replace circuits needed for normal functions.
Indications: Cerebrovascular diseases: Ischemia due to stroke. Treatment of Citicoline within the first 24 hours after onset in patients with moderate to severe stroke increases the probability of complete recovery in 3 months.
Head Trauma of varying severity: Citicoline accelerated the recovery from post-traumatic coma and the recuperation of walking ability, achieved a better final functional result and reduced hospital stay.
Cognitive disorders of diverse etiology: Senile cognitive impairment which is secondary to degenerative diseases (e.g., Alzheimer's disease) and to chronic cerebral vascular disease. Citicoline improves scores on cognitive evaluation scales and slowed the progression of Alzheimer's disease.
Parkinson's disease: Citicol has also been shown to be effective as co-therapy for
Parkinson's disease. Beneficial neuroendocrine, neuroimmunodulatory, and neurophysiological effects have been described.
Dosage and Administration: 500 mg/4 ml Injection: 1 to 2 injections daily.
Side Effects: Citicol may exert a stimulating action of the parasympathetic system, as well as a fleeting and discrete hypotensive effect.
Drug Interactions: Citicol potentiates the effects of L-dopa.
Warning & Precautions: In case of persistent intracranial hemorrhage, the very slow administration (30 drops/minute) is recommended, the administration of larger doses could provoke an increase of the cerebral blood flow. Food, drugs, devices and cosmetics act prohibits dispensing without prescription.
Use in Pregnancy and Lactation: Citicol should be used in pregnancy and lactation only if the potential benefits justify the potential risks.
Contraindications: Contraindicated to patients with hypertonic of the parasympathetic.
Commercial Pack: Citicol ® IM / IV Injection: Box containing 1X5 ampoules of 4 ml in blister pack. Each 4 ml ampoule contains Citicoline Sodium INN equivalent to Citicoline
500mg.
266

bexinfo: T
HERAPEUTIC
G
UIDE
T
RANQUILIZER
®
Tablet
This is a preparation of Clobazam, which is an active ingredient of benzodiazepine derivative. Its actions and uses similar to those of diazepam.
Indications: Keolax is indicated for the relief of acute or chronic anxiety, tension and agitation. Physical symptoms associated with an underlying anxiety state, phobias and psychosomatic disorders may all respond to treatment with Clobazam. Keolax may be used together with antidepressants in the treatment of anxiety associated with depression, it is also used in the treatment of sleep disturbances with anxiety and may be used as adjunctive therapy in epilepsy.
Dosage and Administration: Adults: 20-30 mg daily in divided doses or as a single dose given at night. Doses of up to 60 mg daily have been used in the treatment of adult in patients with severe anxiety.
Elderly: Doses of 20 mg daily may be used in the elderly patients with anxiety.
Children: In children aged 3 years or over, doses should not exceed half the recommended adult dose.
Side Effects: Common side effects are drowsiness, dryness of mouth.
Warning & Precautions: Clobazam may potentiate the effect of central nervous system depressant drugs such as alcohol, analgesics, hypnotics and neuroleptics. The ability to drive or operate machinery may be impaired in individuals who are particularly hypersensitive to the effects of Clobazam or in patients taking high doses of the drug. It should be used in reduced doses in patients with impaired renal or hepatic function.
Use in Pregnancy & Lactation: There is a little information on the use of Clobazam in early pregnancy but no untoward effects have been found in animal studies. Clobazam has been detected in the breast milk of nursing mothers, but the effect on the neonate is not known.
Overdosage & Contraindications: Muscle weakness, ataxia, drowsiness and sedation may occur after ingestion of very high doses, the patient may lose consciousness. The treatment of overdosage is symptomatic, stomach should be emptied as soon as possible by gastric lavage and general supportive measures should be undertaken as necessary.
Clobazam should not be used in patients known to be hypersensitive to benzodiazepines.
Commercial Pack: Keolax ® Tablet: Box containing 100 tablets in 10 x 10’s blister strips.
Each tablet contains Clobazam BP 10mg.
267

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablet
This is a preparation of Bromazepam. Unlike other Benzodiazepines, it is a global anxiolytic with smooth and superior efficacy.
Indications: Nightus is indicated in anxiety with tension, in depression, restlessness and tension related insomnia, pseudo angina pectoris, tachycardia, hypertension, hyperventilation, Irritable bowel syndrome, ulcerative colitis, epigastric pain, spasm and psychogenic headache.
Dosage and Administration: Recommended dose is 1.5 mg -12 mg three times daily.
In severe cases 5 mg - 12 mg two to three times daily may be recommended. Dose should be reduced in half for elderly.
Side Effects: Drowsiness, light-headedness in the next day, confusion, ataxia and amnesia may occur.
Drug Interactions: Phenothiazines, barbiturates, MAO inhibitors and psychoactive drugs may potentiate the action of Bromazepam and should not be given concurrently.
Warning & Precautions: Bromazepam should be used with caution in respiratory diseases, muscle weakness, and history of alcohol or drug abuse.
Use in Pregnancy and Lactation: The administration of Bromazepam is rarely justified in women of child bearing potential. Not recommended in lactating mother.
Overdosage & Contraindications: Bromazepam is contraindicated in patients with known hypersensitivity to Benzodiazepines, in severe respiratory failure, myasthenia gravis and severe liver failure.
Commercial Pack: Nightus ® Tablet: Each box containing 100 tablets in 10 x 10’s blister strips. Each tablet contains Bromazepam BP 3 mg.
®
Tablet
This is a preparation of Clonazepam, which has broader spectrum of anxiolytic action, and extends beyond the suppression of panic disorders.
Indications: It is indicated in panic attack, epilepsy, status epilepticus, infantile spasm, absences, Lennox Gastaut Syndrome, Tonic-Clonic seizures, myoclonic seizures, partial seizures, drug induced dyskinesia, chloroform movements, fulgurant pain, and bipolar affective disorder.
268

bexinfo: T
HERAPEUTIC
G
UIDE
Dosage and Administration: Panic Disorder: Adults: The recommended initial dosage of Clonazepam is 0.25 mg twice daily, increment dose is 0.5-1 mg at interval of 3 days.
To reduce the inconvenience of somnolence administration of one dose at bedtime may be desirable.
Children: There is no clinical trial experience with Clonazepam in Panic disorder patients under 18 years of age.
Seizure Disorder: Adults: Initial dose is 1 mg/daily in divided dose (elderly 0.5 mg), not to exceed 1.5 mg/day. Increment dose is 0.5 mg at intervals of 3 days. Maintenance dose is 4.8 mg/day. Maximum dose: 20 mg/day should be administered with caution.
Children: Up to 1 year: 0.25 mg increased to 0.5-1 mg. 1-5 years: 0.25 mg increased to
1-3 mg at intervals of 3 days. Maintenance dose is 4-8 mg/day.
Side Effects: The common side effects are fatigue, drowsiness, muscular hypotonia, dizziness, light-headedness and ataxia. These effects are usually transient and generally disappear spontaneously although these can be partially prevented by increasing the dose slowly at the start of treatment.
Drug Interactions: Carbamazepine, Phenobarbitone or Phenytoin may accelerate the metabolism of Clonazepam. Intake of alcohol may affect the patient’s response to
Clonazepam. Clonazepam may be expected to have the sedative interactions associated with benzodiazepines in general.
Warning & Precautions: The dosage of Clonazepam must be carefully adjusted to individual requirements in elderly patients with preexisting disease of the respiratory system (chronic obstructive pulmonary disease), renal or hepatic diseases and in patients undergoing treatment with other centrally acting medications or anticonvulsant agents. It should be withdrawn slowly and abrupt discontinuance of the drug should be avoided.
Use in Pregnancy and Lactation: Clonazepam should only be administered to pregnant women if the potential benefit outweigh the risk to the fetus. Not recommended in lactation.
Overdosage & Contraindications: Contraindicated in patients with known hypersensitivity to benzodiazepines, acute pulmonary insufficiency and respiratory depression.
Commercial Pack: Xetril ® 0.5 Tablet and Xetril ® 2 Tablet: Each box contains 10 blister strips of 10 tablets. Each tablet contains Clonazepam USP 0.5 mg and Clonazepam USP
2 mg respectively.
269

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablet
This is a preparation of Alprazolam, which is a triazolo analog of the 1, 4 benzodiazepine class of central nervous system-active compounds.
Indication: It is indicated for the management of anxiety disorder, the short-term relief of symptoms of anxiety and panic disorder including agoraphobia.
Dosage and Administration: Treatment for patients with anxiety should be initiated with a dose of 0.25 mg to 0.5 mg given 3 times daily. The dose may be increased to achieve a maximum therapeutic effect, at intervals of 3 to 4 days, to a maximum daily dose of 4 mg, given in divided doses. In elderly patients, in patients with advanced liver disease or in patients with debilitating disease, the usual starting dose is 0.25 mg, given 2 or 3 times daily. This may be gradually increased if needed and tolerated. In all patients, dosage should be reduced gradually when discontinuing therapy or when decreasing the daily dosage.
Side Effects: Dependence may grow if Alprazolam is continued for long term. Other infrequently observed side effects are light-headedness, abnormal involuntary movement, headache, muscular twitching, fatigue and tiredness, irritability, memory impairment, nausea, vomiting, diarrhea, weight loss, and decreased appetite.
Drug Interactions: Alprazolam produce additive CNS depressant effects when coadministered with other psychotropic medications, anticonvulsants, antihistamines, ethanol and other drugs. Caution is recommended during administration of Fluoxetine,
Propoxyphene, oral Contraceptives with Alprazolam.
Warning & Precautions: Safety and effectiveness of Alprazolam in individuals below 18 years of age have not been established.
Use in Pregnancy and Lactation: Not recommended in pregnancy and lactation.
Overdosage & Contraindications: Alprazolam is contraindicated in patients with known hypersensitivity to this drug or other benzodiazepines.
Commercial Pack: Zolax ® 0.5 Tablet and Zolax ® 0.25 Tablet: Box containing 100 tablets in 10 x 10’s blister strips. Each tablet contains Alprazolam USP 0.5 mg and Alprazolam
USP 0.25 mg respectively.
270

bexinfo: T
HERAPEUTIC
G
UIDE
V
ITAMIN
®
Tablet
Each Neurocare tablet contains Thiamine mononitrate, Pyridoxine hydrochloride and
Cyanocobalamin. These vitamins play an essential role as co-enzyme in the metabolism of the nervous system. The combination of these 3 vitamins shows better effect than that of the individual component.
Indications: It is indicated in polyneuropathy of any origin such as diabetic, alcoholic or toxic neuropathies, neuritis, neuralgia, cervical syndrome, Shoulder-arm syndrome, lumbago, sciatica, Herpes Zoster, trigeminal neuralgia and supportive treatment in facial paresis.
Dosage and Administration: This tablet may be administered in a dosage of 1 to 3 tablets daily or as per the direction of physicians.
Side Effects: Allergic hypersensitivity reactions may occur.
Drug Interactions: Pyridoxine reduces the effects of levodopa. It also interacts with phenobarbital, isoniazide and oral contraceptive. Absorption of cyanocobalamin from gastrointestinal tract may be reduced by neomycin, aminosalicylic acid, and H2-receptor antagonists.
Warning and Precautions: Cyanocobalamin should not be given before a diagnosis has been fully established because of the possibility of masking symptoms of subacute degeneration of the spinal cord. Cyanocobalamin is not a suitable form of Vitamin B12 for the treatment of optic neuropathies associated with raised plasma concentrations of cyanocobalamin.
Use in Pregnancy & Lactation: Neurocare is safe for pregnant women. It is not known whether thiamine (vitamin B1) is excreted in breast milk or not, but may be taken cautiously during lactation. Vitamin B6 has no adverse effect during lactation. There is no known adverse effect on Vitamin B12 therapy also.
Contraindications: It should not be used in patients on Levodopa therapy and hypersensitivity to any of the above ingredients.
Commercial Pack: Neurocare ® Tablet: Box containing 30 tablets in 3 x10’s blister strips.
Each tablet contains Thiamine mononitrate USP 100 mg, Pyridoxine Hydrochloride USP
200 mg & Cyanocobalamin USP 200 mcg.
271

N
S

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablet
Aristocal contains Calcium Carbonate that is used as dietary calcium supplement and to sequester phosphorus in the intestine to reduce total body phosphate accumulation in chronic renal failure.
Indications: It is indicated for dietary calcium supplement when it is deficient, as a phosphate binder in chronic renal failure, as an adjunct therapy in the arrest or slowing down of bone demineralization in osteoporosis.
Dosage and Administration: Adults and Elderly: Dietary deficiency: 2 to 3 tablets daily.
As Phosphate binder: Dose as required by the individual patient depending on serum calcium and phosphate levels. Adjunct to osteoporosis therapy: 2 to 3 tablets daily.
Side Effects: Mild gastrointestinal disturbances (e.g. flatulence, abdominal pain, constipation) may occur. Hypercalcemia and alkalosis are rarely produced with large doses.
Warning and Precautions: In mild hypercalciuria or renal failure or stone formation in urinary tract, adequate checks must be kept on urinary calcium excretion. If necessary the dosage should be reduced or calcium therapy discontinued.
Use in pregnancy and lactation: Calcium containing drugs are used widely in pregnancy by way of oral calcium supplementation. Calcium Carbonate can be used in lactating women too.
Drug Interactions: Digoxin, Tetracycline preparations, Vitamin D therapy and
Ciprofloxacin.
Contraindications: Hypercalcemia and hyperparathyroidism, Renal calculi and nephrolithiasis, Zollinger-Ellision Syndrome and other causes of gastric acid hypersecretion.
Commercial Pack: Aristocal ® Tablet: Box containing 100 tablets in 10x10,s blister strips.
Each tablet contains Calcium Carbonate BP equivalent to 500 mg elemental Calcium.
®
Tablet
Aristocal D is a combined preparation of Calcium and Vitamin D (Cholecalciferol) specially designed to promote bone health.
Indications: It is indicated for prevention and treatment of osteoporosis, for the treatment of hypocalcemic states dietary supplementation, healthy bone formation and maintenance, to reduce phosphate absorption from the gut in patients with hyperphosphatemia, treatment of chronic renal failure.
275

bexinfo: T
HERAPEUTIC
G
UIDE
Dosage and Administration: One tablet twice daily with food or as directed by the physician.
Contraindications: Aristocal D is contraindicated in patients who have known hypersensitivity to any of the components of this preparation.
Warning and Precautions: Caution should be taken in patients with renal impairment, sarcoidosis, hypercalcemia and hypercalciuria.
Side Effects: Aristocal D is well tolerated. Mild gastrointestinal disturbances may occur.
Drug Interactions: Concurrent administration of Thiazide diuretics may increase the risk of hypercalcemia. Bran decreases the gastro-intestinal absorption of calcium, and may therefore decrease the efficacy of calcium supplements. Calcium salts reduce the absorption of a number of other drugs such as Biphosphonates, Fluoride, some
Fluoroquinolones and Tetracyclines.
Commercial Pack: Aristocal ® D Tablet: Box containing 50 tablets in 5 x 10’s blister strips.
Each tablet contains 500 mg Elemental Calcium (as Calcium Carbonate BP) and 200 IU
Vitamin D USP.
®
Chewable Tablet
This is a combined preparation of Calcium and Vitamin D and 5 minerals specially designed to promote bone health.
Indications: This is indicated for prevention and treatment of osteoporosis, for the treatment of hypocalcemic states, dietary supplementation, healthy bone formation and maintenance.
Contraindications: Known hypesensitivity, conditions associated with hypercalcemia and hypercalciuria.
Warning and Precautions: Renal impairment, sarcoidosis, concurrent administration of thiazide diuretics may increase the risk of hypercalcemia.
Use in Pregnancy & Lactation: Usually should be used considering the risk benefit ratio.
Dosage and Administration: One tablet twice daily with food or as directed by the physician.
Adverse Reactions: Well tolerated. Mild gastrointestinal disturbances.
Drug Interactions: Concurrent administration of thiazide diuretics may increase the risk of hypercalcemia.
276

bexinfo: T
HERAPEUTIC
G
UIDE
Commercial Pack: Aristocal ® M Tablet: 20’s, 30’s, 50’s & 100’s chewable tablets in
Blister strips & Bottle. Each chewable tablet contains Elemental Calcium USP (as Dibasic
Calcium Phosphate Anhydrous & Calcium Carbonate Heavy), Vitamin D USP (as Dry
Vitamin D3), Copper Ph Grade (as Cupric Oxide), Magnesium USP 40 mg (as
Magnesium Oxide Heavy), Manganese USP (as Manganese Sulfate) 1.8 mg, Zinc USP
(as Zinc Oxide) 7 mg and Boron USP (as Sodium Borate) 250 mcg.
®
Syrup
Aristoferon is a hematinic preparation of Ferrous Sulphate available as raspberry flavored syrup.
Indications: Aristoferon is indicated in the treatment and prevention of iron deficiency anemia and anemia of pregnancy where routine administration of iron is necessary.
Dosage and Administration: Adult: Initial therapeutic dose: 3-4½ teaspoonful daily in divided doses or as prescribed by the physician. Maintenance dose: 1½ teaspoonful daily, but if needed up to 1.8 gm (9 teaspoonful) daily can be given.
Children : Under 1 year : ¼ teaspoonful thrice daily or as directed by physician.
1-5 years : 1 teaspoonful thrice daily.
6-12 years : 1½ teaspoonful twice daily.
Special Instruction: 1. Mix with water or fruit juice to avoid temporary staining of teeth.
2. Do not mix with milk.
Side Effects: Therapeutic doses of iron may cause gastrointestinal symptoms like diarrhea, nausea and vomiting. Although iron is better absorbed between meals, side effects can be reduced by taking it with or immediately after food. Continuous administration may sometimes cause constipation. Iron containing liquid medication may cause temporary staining of teeth .
Warning and Precautions: It should be administered with caution when given to patients with iron storage or iron absorption disease, hemoglobinopathies or existing gastrointestinal disease.
Drug Interactions: Tetracycline, antacids and tea.
Contraindications: Iron therapy is contraindicated in hemachromatosis and hemosiderosis. It should not be given to patients receiving repeated blood transfusion or with anemia not produced by iron deficiency.
Commercial Pack: Aristoferon ® Syrup: Bottle containing 200 ml syrup. Each 5 ml syrup contains 200 mg of Ferrous Sulphate BP.
277

bexinfo: T
HERAPEUTIC
G
UIDE
®
Syrup
Aristoplex is a liquid preparation of Vitamin B Complex.
Indications: It is indicated for prevention and treatment of Vitamin B Complex deficiency states, manifested by glossitis, stomatitis, cheilosis, beriberi and polyneuritis, maintenance of normal growth and health during the early days of children, apathy and anorexia in elderly patients, prevention of vitamin deficiencies, particularly when depletion is suspected such as pregnancy and lactation, convalescence during debilitating illness, patients on restricted diets.
Dosage and Administration: Adults & Elderly: One to two 5 ml spoonful syrup three times a day.
Children: One 5 ml spoonful syrup three times a day. Infants: One 5 ml spoonful syrup daily.
Contraindication: Known hypersensitivity to any of the active constituents.
Warning and Precautions: Pyridoxine may reduce the therapeutic efficacy of levodopa.
Use in pregnancy and lactation: As with all medicines, careful considerations should be given before the administration of B Complex preparations during the first trimester of pregnancy. Vitamins are excreted in breast milk.
Commercial Pack: Aristoplex ® Syrup: Aristoplex syrup is available in 100 ml and 200 ml amber glass bottle. Each 5 ml Aristoplex syrup contains: Thiamine Hydrochloride
(Vitamin B
1
) BP 5mg, Riboflavin (Vitamin B
2
) USP 2mg, Pyridoxine Hydrochloride
(Vitamin B
6
) BP 2mg, Nicotinamide BP 20mg.
®
Tablet
Aristovit B is a sugar coated tablet containing different B vitamins.
Indications: Aristovit B is indicated in the treatment and prevention of Vitamin B deficiencies, particularly when depletion is suspected, such as in case of pregnancy and lactation, convalescence following debilitating illness and in restricted diet.
Dosage and Administration: One or two tablet three times daily.
Warning and Precautions: This should be given cautiously to patients taking Levodopa as Pyridoxine reduces the effect of Levodopa.
Overdosage and Contraindications: Contraindicated in case of hypersensitivity to any of the active ingredients of Aristovit B.
278

bexinfo: T
HERAPEUTIC
G
UIDE
Commercial Pack: Aristovit ® B Tablet: Bottle containing 45 sugar coated tablets. Each sugar coated tablet contains:
Nicotinamide (Vitamin B
3
)
Riboflavin (Vitamin B
2
)
USP 20 mg
Pyridoxine Hydrochloride (Vitamin B
6
) USP 2 mg
USP 2 mg
Thiamine Mononitrate (Vitamin B
1
) USP 5 mg
®
Injection
This injection is a sterile solution for intramuscular or slow intravenous injection comprised of vitamins which may be categorized as belonging to the vitamin B complex group.
Indications: In disorders requiring parenteral administration of vitamins, i.e. pre- and post-operative treatment, when requirements are increased as in fever, severe burns, increased metabolism, pregnancy, gastrointestinal disorders interfering with intake or absorption of vitamins, prolonged or wasting diseases, alcoholism and where other deficiencies exist.
Dosage and Administration: The solution for injection is applied parenterally intramuscularly or (rarely) intravenously in dose 1-2 ml daily or each second day, within
5-10 day.
Contraindications: Vitamin B complex should not be used in hypersensitivity to any of the vitamins, containing in the preparation, as well as in patients with 2nd or 3rd degree arterial hypertension.
Side Effects: Although the preparation is very well tolerated, in rare cases in predisposed patients itching, urticaria, and Quincke’s edema may appear.
Warning and Precautions: The usual precautions for parenteral administration should be observed. Do not inject if precipitation occurs. Inject slowly by the intravenous route.
High concentrations should be diluted using Normal Saline Injection when given intravenously.
High Risk Group: Pregnancy: Adequate and well-controlled studies have not been done in pregnant women. However, vitamin B12 is an essential vitamin and requirements are increased during pregnancy. Nursing Mothers: Vitamin B12 is known to be excreted in human milk.Vitamin B12 appears in the milk of nursing mothers in concentrations that approximate the mother's vitamin B12 blood level. Pediatric Use: Safety and effectiveness in pediatric patients has not been established.
279

bexinfo: T
HERAPEUTIC
G
UIDE
Commercial Pack: Aristovit ® B Injection: Each commercial box contains 1 vial of 10 ml of Aristovit-B Injection. Each 1 ml contains 25 mg of Thiamine hydrochloride USP, 2 mg of Riboflavin USP, 50 mg of Niacinamide USP, 5 mg Pyridoxine hydrochloride USP and
2.5 mg d-Panthenol USP.
®
Tablet
Aristovit-M is sugar coated multivitamin with mineral tablet. Each sugar coated tablet contains 11 vitamins, 5 minerals and Iron.
Indication: Deficiency state in acute and chronic disease. Conditions regarding specific support: pregnancy, lactation, and menopause, during treatment with antibiotics. The comprehensive formula of Aristovit-M assures liberal amounts of important vitamins, minerals and trace elements needed by the body during periods of increased energy requirements such as in disease and convalescence.
Dosage and Administrations: One tablet daily or as advised by the physician.
Overdosage and Contraindications: Supplemental vitamins and minerals should not be prescribed for patients with hemochromatosis or Wilson’s disease. Hypersensitivity to any of the active ingredients is a contraindication. Excessive doses of vitamin A and D can lead to hypervitaminosis. When multivitamin preparations are prescribed allowance must be made for vitamins from other sources. This is particularly important during the first trimester of pregnancy when large doses of vitamin A may be teratogenic. Iron and zinc chelate with tetracyclines and absorption of all three agents may be impaired.
Side Effects: Multivitamin preparations with ordinary doses of component are usually nontoxic.
Warning and Precautions: Aristovit-M may be used cautiously in patients being treated for Parkinson’s disease with a levodopa preparation. Pyridoxine acts as an antagonist of
Levodopa.
Commercial Pack: Aristovit ® M Tablet: Bottle containing 30 sugar coated tablets. Each tablet contains:
Vitamin A
Vitamin D
USP 1.5 mg
USP 10 mg
Thiamine Mononitrate (B
1
) USP 1.5
Riboflavin (B
2
) USP 1.7 mg
Ascorbic Acid USP 60 mg
Nicotinamide
Pyridoxine HCl (B
6
)
Folic Acid
USP 20 mg
USP 2 mg
USP 0.4 mg
280

bexinfo: T
HERAPEUTIC
G
UIDE
Calcium Pantothenate
Cyanocobalamin (B
12
)
Vitamin E
Ferrous Sulfate
USP 10.92 mg
USP 6 mg
NF 10.05 mg
USP 50 mg
Potassium Iodide
Potassium Sulfate
USP 196 mg
BP 11.14 mg
Manganese Sulfate Monohydrate USP 1 mg
Cupric Sulfate Pentrahydrate USP 2 mg
Zinc Sulfate USP 37.04 mg
®
Tablets
Aristovit-X is a special formulation comprising of important vitamins, anti-oxidants and minerals.
Indications: Aristovit-X is a once-daily tablet indicated for use to develop immune system, help prevent the well-known deficiency diseases such as scurvy, beriberi, pellagra and others, prevent certain types of cancer by blocking the formation of cancer causing substances in the body. It is also is capable of combating cardiovascular and immunological disorders. Aristovit-X helps strengthen immune system, keeping free from sickness and allowing a better, harder workout.
Dosage and Administrations: Aristovit-X may be administered once daily or as indicated by the physician.
Side Effects: Generally well tolerated.
Warning and Precautions: Excess vitamin A intake may be toxic and may increase the risk of birth defects. Pregnant women and women who may become pregnant should not exceed 5000 IU total per day of performed vitamin A (retinyl palmitate).
Contraindications: Aristovit-X is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Commercial Pack: Aristovit ® X (Super Antioxidant) Tablet: 30’s, 50’s and 100’s in blister strip and bottle. Each tablet contains:
Vitamin A
Vtamin E
Vitamin K
Vitamin C
6.00 mg
50.00 mg
25.00 mcg
200.00 mg
Manganese 3.00 mg
281

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablet
Ascobex tablet contains Ascorbic Acid USP 100 mg, Sodium Ascorbate USP 168.75 mg.
The combination is equivalent to 250 mg of Ascorbic Acid (Vitamin C).
Indications: Vitamin C deficiency disorders, pregnancy, lactation, post-operative or other wound healing state, infection, growing age, thyrotoxicosis and common cold. Being an antioxidant vitamin, it protects against cardiovascular diseases, atherosclerosis, malignancy and it has been found to delay the aging process. It has been found that in case of diabetes, there is an increase in requirement of vitamin C, Ascobex is also indicated in those conditions.
Dosage and Administrations: In scurvy : 4 tablets 2 to 3 times daily
In wound healing : 2-4 tablets 2 to 3 times daily
In other conditions : 1-2 tablets daily
Warning and Precautions: Should be given with caution to patients with hyperoxaluria.
Tolerance may be induced in patients taking higher doses.
Side Effects: Ascorbic acid does not seem to have any important adverse effects at dosages less than 4 gm / day. Larger dose may cause diarrhea or formation of renal calculi of calcium oxalate in patients with renal impairment. Ingestion of more than 600 mg daily have a diuretic action.
Commercial Pack: Ascobex ® Tablet: Box containing 200 tablets in 20 x 10’s aluminium strips. Each tablet contains Ascorbic Acid USP 100 mg, Sodium ascorbate USP 168.75
mg, the combination is equivalent to 250 mg of Ascorbic Acid (Vitamin C).
®
Tablet
Avitron V tablet contains Vitamin B1 or Thiamine hydrochloride USP.
Indications: This is indicated in the treatment of various manifestations of thiamine deficiency such as beriberi, ( wet or dry) and Wernick’s encephalopathy, neuritis associated with pregnancy and pellagra. Supplementary thiamine may be indicated prophylactically in conditions where there is low dietary intake or low gastrointestinal absorption of thiamine, and increased thiamine requirement periods e.g. active growth, heavy physical labor, pregnancy and lactation. In pathological conditions such as fever and hyperthyroidism and other conditions causing increased metabolism.
Dosage and Administration:
Mild chronic deficiency
Severe deficiency
: 10-25 mg daily
: 200-300 daily or as advised by the physician
282

bexinfo: T
HERAPEUTIC
G
UIDE
Side Effects: Vitamin B
1 does not have side effects when given orally. A feeling of warmth, pruritus, urticaria, weakness, sweating, nausea, restlessness etc. may occur.
Warning and Precautions: Pregnancy and Lactation: Thiamine is safe in pregnant women and during lactation.
Overdosage and Contraindications: This is contraindicated in patients with known hypersensitivity to it.
Commercial Pack: Avitron ® V Tablet: Box containing 25 blister strips of 10 tablets. Each tablet contains Thiamine Hydrochloride USP 100mg.
®
Tablet
Bextram is a special formulation comprising of important vitamins, anti-oxidants, minerals and micronutrients.
Indications: This is a once-daily tablet indicated for use to improve the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. This preparation can also be beneficial in improving the nutritional status of women prior to conception. Bextram maintains a healthy body and active lifestyle and keeps nutrition covered
Dosage and Administration: Bextram may be administered once daily or as indicated by the physician.
Side Effects: Generally well tolerated. Allergic sensitization has been reported following oral administration of folic acid.
Warning and Precautions: Long-term intake of high levels of vitamin A (excluding that sourced from β -carotene) may increase the risk of osteoporosis in postmenopausal women.
Use in pregnancy & lactation: This is recommended in pregnancy and lactation.
Drug interaction: No drug interactions have been reported.
Contraindications: This is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Commercial Pack: Bextram ® (Multivitamin and Minerals) Tablet: 30’s, 50’s and 100’s.
Each tablet contains:
Vitamin A 0.81 mg
Vtamin E
Vitamin K
Vitamin C
Thiamine Mononitrate
30.00 mg
65.00 mcg
120.00 mg
3.40 mg
283

bexinfo: T
HERAPEUTIC
G
UIDE
Riboflavin
Niacin
Pantothenic Acid
Pyridoxine Hydrochloride
3.40 mg
40.00 mg
20.00 mg
10.00 mg
®
Tablet
Inositol
Quercetin Dihydrate
50.00 mg
54.00 mcg
(High potency multivitamins and minerals formula)
Bextram Gold is a special formulation comprising of important Vitamins and Minerals.
Each tablet contains 14 vitamins, 18 minerals including Iron, Folic acid and Zinc.
Indications: Bextram Gold tablet maintains a healthy body and active lifestyle and keeps nutrition covered for all. Bextram Gold is a once-daily tablet indicated for use to improve the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and non-lactating mothers. This preparation can also be beneficial in improving the nutritional status of women prior to conception and geriatric patients.
Dosage and Administration: This may be administered once daily or as directed by the physician.
Side Effects: Generally well tolerated.
Drug Interactions: No clinically significant drug interactions have been reported.
Warning and Precautions: Long-term intake of high levels of vitamin A (excluding that sourced from β -carotene) may increase the risk of osteoporosis in postmenopausal women.
Overdosage and Contraindications: Contraindicated in patients with a known hypersensitivity to any of the ingredients.
284

bexinfo: T
HERAPEUTIC
G
UIDE
Commercial Pack: Bextram ® Gold Tablet: 15 and 30 tablets in HDPE container. Each film coated tablet contains:
Vitamin A 5000
Vitamin C 60
IU mg
Vitamin D 400 IU
Vitamin E 30 IU
Vitamin K 25 mg
Thiamine Mononitrate 1.5 mg
Riboflavin 1.7 mg
Niacin 20
Vitamin B6 2
Folic acid 400 mg mg mg
Vitamin B12 6 mg
Biotin 30 mg
Pantothenic acid 10 mg
Calcium 162 mg
Iron 18 mg
Phosphorus 109 mg
Iodine 150 mg
Magnesium 100 mg
Zinc 15 mg
Selenium 20
Copper 2
Manganese 2 mg mg mg
Chromium 120
Molybdenum 75
Chloride
Potassium
Boron
72
80
150
Nickel
Silicon
Tin
Vanadium
Lutein
5
2
10
10
250 mg mg mg mg mg mg mg mg mg mg
®
Tablet
Bextram Silver is a special formulation comprising of important Vitamins and Minerals.
Indications: This is a comprehensive multiple vitamin and mineral supplement specially formulated for the prevention and treatment of vitamin and mineral deficiencies for adults over 45 years of age. It is indicated for improving the nutritional status of elderly patients.
285

bexinfo: T
HERAPEUTIC
G
UIDE
Dosage and Administrations: One tablet once daily with food or as indicated by the physician.
Contraindications: This is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Side Effects: Allergic sensitization has been reported following oral administration of folic acid.
Warning and Precautions: Excess vitamin A intake may be toxic and increase the risk of birth defects. Pregnant women and women who may become pregnant should not exceed 5000 IU total per day of preformed vitamin A (Retinyl palmitate).
Use in Pregnancy and lactation: Recommended.
Drug Interactions: No drug interactions have been reported.
Commercial Pack: Bextram ® Silver Tablet: Each plastic bottle contains 30 tablets. Each tablet contains multivitamins and minerals. Each film-coated tablet contains: Vitamin A
5000 IU, Vitamin C 60 mg, Vitamin D 400 mg, Vitamin E45 IU, Vitamin K 10 mcg,
Thiamine1.5 mg, Riboflavin1.7 mg, Pyridoxine Hydrochloride 3 mg, Vitamin B12 25 mg,
Niacin 20 mg, Folic acid 400 mcg, Biotin 30mcg, Lutein 250 mcg, Pantothenic acid10 mg, Calcium 200 mg, Phosphorus 48 mg, Iodine150 mcg, Magnesium 100 mg, Zinc15 mg, Selenium 20 mcg, Copper 2 mg, Manganese, 2 mg, Chromium 150 mcg,
Molybdenum 75 mcg, Chloride 72 mg, Potassium 80 mg, Boron150 mcg, Nickel l5 mcg,
Silicon 2 mg, Vanadium 10 mcg.
®
Multivitamin Syrup
Bextram KIDZ syrup contains eight essential vitamins and cod liver oil that provides children with appropriate nutrients to support growth and healthy development of the children.
Indications: Bextram KIDZ syrup is indicated for the treatment and prevention of vitamin deficiencies associated with restricted diets, improper food intake and decreased absorption. It is also indicated in children with increased requirements for vitamins due to acute and chronic diseases, vitamin lacking symptom for growing child, lack of appetite in child, including patient under rehabilitating period.
Dosage and Administration: Bextram KIDZ Syrup: Infant (1-12 months): ½ teaspoonful
(2.5 ml) per day. Children (1-4 years): 1 teaspoonful (5 ml) per day. Children (4 years up): 1½ teaspoonful (7.5 ml) per day.
286

bexinfo: T
HERAPEUTIC
G
UIDE
Side Effects: Side effects have been reported with specific vitamins. Allergic rash and other idiosyncrasies are rarely reported.
Warning and Precautions: This medicine may accumulate in the body, which cause danger. Then, should not use over dosage.
Drug Interactions: No interactions have been reported.
Commercial Pack: Bextram ® KIDZ Syrup: Each bottle containing 100 ml multivitamin syrup with cod liver oil and a measuring spoon. Each 5 ml Bextram KIDZ Syrup contains
- Vitamin A (As Propionate) USP 2,000 IU, Vitamin D (As Cholecalciferol) USP 200 IU,
Vitamin C (As Ascorbic Acid) USP 17.50 mg, Vitamin B1 (As Thiamine Hydrochloride)
USP 0.70 mg, Vitamin B2 (As Riboflavin-5-Phosphate Sodium) USP 0.85 mg, Vitamin
B6 (As Pyridoxine Hydrochloride) USP 0.35 mg, Vitamin E (As α -Tocopherol Acetate)
USP 1.50 mg, Nicotinamide USP 9.00 mg and Cod Liver Oil BP 100 mg.
®
Tablet
This preparation is a comprehensive multivitamin and mineral supplement designed to help teen boys to meet their increased nutritional needs.
Indications: Complete Multivitamin for Teen Boys to Support: Healthy muscle function with magnesium; Healthy immune system with vitamins C and E, β -carotene, zinc, iron and selenium; Bone strength with calcium, vitamin D, and magnesium; Energy through the conversion of food to fuel with vitamins B6 and B12, thiamin, riboflavin, and niacin.
Dosage and Administration: Teens: One tablet daily, with food.
Contraindication: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Warning: Accidental overdose if an iron-containing product is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately. Do not use this product if safety seal bearing "Sealed for your protection" under cap is torn or missing.
Precaution: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemia where Vitamin B12 is deficient.
Adverse Reactions: Allergic sensitization has been reported following oral administration of folic acid.
Drug Interactions: No drug interactions have been reported.
Commercial Pack: Bextram ® Teen Hm Tablet: Each plastic bottle containing 30 tablets; each tablet contains 21 vitamins & minerals. Each tablet contains Ingredients contains:
287

bexinfo: T
HERAPEUTIC
G
UIDE
Vitamin A (20% as β -carotene) 2500 IU, Vitamin C 120 mg, Vitamin D 400 IU, Vitamin E
30 IU, Vitamin K 25 mcg, Thiamin (B
1
) 3.75 mg, Riboflavin (B
2
) 4.25 mg, Niacin 30 mg,
Vitamin B
6
5 mg, Folic Acid 400 mcg, Vitamin B
12
15 mcg, Biotin 300 mcg, Pantothenic
Acid 10 mg, Calcium (elemental) 200 mg, Iron 9 mg, Magnesium 100 mg, Zinc 15 mg,
Selenium 20 mcg, Copper 2 mg, Manganese 2 mg and Chromium 120 mcg.
®
Tablet
This preparation is a comprehensive multivitamin and mineral supplement designed to help teen girls to meet their increased nutritional needs.
Indications: Complete Multivitamin for teen girls to Support: Healthy skin function with
Vitamin A, C, Copper & Iron; Healthy immune system with vitamins A, C and E, zinc, iron and selenium; Bone strength with calcium, vitamin D, and magnesium; Energy through the conversion of food to fuel with vitamins B6 and B
12 thiamin, riboflavin, and niacin.
Dosage and Administration: For teen girls, one tablet daily with food.
Side Effects: Allergic sensitization has been reported following oral administration of folic acid.
Warning & Precautions: Accidental overdose if an iron-containing product is a leading cause of fatal poisoning in children less than 6 years. Keep this product out of reach of children. In case of accidental overdose, call a doctor immediately. Keep out of reach of children.
Drug Interaction: No drug interaction is reported.
Contraindications: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Commercial Pack: Bextram ® Teen Hr Tablet: 30 tablets in a white opaque bottle. Each tablet contains: Vitamin A (20% as
β
-carotene) 2500 IU, Vitamin C 120 mg, Vitamin D
800 IU, Vitamin E 30 IU, Vitamin K 25 mcg, Thiamin (B
1
) 2.3 mg, Riboflavin (B
2
) 2.6 mg,
Niacin 30 mg, Vitamin B
6
3 mg, Folic Acid 400 mcg, Vitamin B
12
9 mcg, Biotin 300 mcg,
Pantothenic Acid 10 mg, Calcium (elemental) 300 mg, Iron 18 mg, Magnesium 50 mg,
Zinc 15 mg, Selenium 20 mcg, Copper 2 mg, Manganese 2 mg and Chromium 120 mcg.
288

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablet
Calorate contains Calcium Orotate, a calcium supplement with a functional amino acid chelating ligand - orotic acid.
Indication: This medication is used to prevent or treat low blood calcium levels in people who do not get enough calcium from their diets. To fulfill the calcium deficiency or meet extra need of calcium, it may be used in conditions like osteomalacia, rickets, latent tetany, postmenopausal osteoporosis, senile osteoporosis, juvenile osteoporosis, drug
(phenytoin, phenobarbital, or prednisone) induced osteoporosis, pregnancy and lactation, premenstrual syndrome (PMS), hypoparathyroidism and hip joint plastic surgery.
Calcium Orotate acts against a number of inflammatory diseases like arthritis, psoriasis, lupus, spondylitis, various cardiovascular ailments, encephalitis, retinitis, phlebitis, colitis, and multiple sclerosis. This helps in controlling weight by suppressing the habit of frequent appetite of chronic overeaters. It is also beneficial in reducing the effects of mood swings and is proved to be quite effective in cognitive enhancement. It protects the heart by enhancing the efficiency of cardiac muscles. Recent studies on calcium orotate indicate its potential to minimize the risk of colon cancer.
Dosage & Administration: As an addition to the daily diet, 2-3 tablets are usually recommended with evening meal or as directed by physician. With the increase in the amount of Calcium, the percentage of absorption decreases. Absorption of calcium is the highest in doses less than or equal to 500 mg. So, taking more than 1,000 mg / day of
Calcium from supplements may be beneficial if the total amount is taken in divided doses in separate times during the day.
Warning and Precautions: Before taking Calcium, precaution is needed if the patient has any allergies, kidney disease, kidney stones, little or no stomach acid (achlorhydria), heart disease, disease of the pancreas, sarcoidosis, malabsorption syndrome.
Use in Pregnancy and Lactation: Women during pregnancy and lactation need more calcium. Pregnancy related high blood pressure is a common and serious risk for women and their babies, and taking supplemental forms of Calcium Orotate can help reduce this risk.
Drug Interaction: Calcium can decrease absorption of the following drugs when taken together: biphosphonates (e.g., alendronate), quinolone antibiotics (e.g., ciprofloxacin, levofloxacin), and tetracycline antibiotics (e.g., doxycycline, minocycline), levothyroxine, phenytoin (an anticonvulsant), and tiludronate disodium (to treat Paget's disease).
Thiazide-type diuretics can interact with calcium supplements, increasing the risks of hypercalcemia and hypercalciuria. Both aluminum and magnesium containing antacids increase urinary calcium excretion. Mineral oil and stimulant laxatives decrease calcium absorption. Glucocorticoids, such as prednisone, can cause calcium depletion and eventually osteoporosis when they are used for months. Oral contraceptives as well as
289

bexinfo: T
HERAPEUTIC
G
UIDE estrogen compounds reduce calcium. Anti-inflammatories such as NSAIDs, Aspirin,
Ibuprofen deplete calcium.
Side Effects: Bloating and swelling in the abdomen are common side effects of calcium orotate. Loss of appetite, upset stomach, constipation, nausea, vomiting, unusual weight loss, mood changes, bone / muscle pain, headache, increased thirst / urination, weakness, unusual tiredness, formation of kidney stones may occur infrequently.
Contraindications: This contraindicated in conditions like incomplete or infrequent bowel movements, kidney stone, kidney disease, sarcoidosis, increased activity of the parathyroid gland, high amount of Calcium in urine, high amount of Calcium in the blood, extreme loss of body water.
Commercial Pack: Calorate ® Tablet: Box containing 30 tablets in 3 x 10’s blister strips.
Each film coated tablet contains Calcium Orotate INN 400 mg.
®
Tablet
Calorate Kit contains Ibandronic Acid 150 mg and Calcium Orotate INN 400 mg.
Indication: This is indicated for the treatment and prevention of osteoporosis. It increases bone mineral density (BMD) and reduces the incidence of vertebral fractures.
Dosage and Administration: One tablet of Ibandronic Acid 150 mg once monthly on the same date each month is recommended. To maximize clinical benefit of Ibandronic acid, 02 tablets of Calorate (Calcium Orotate 400 mg) per day are usually recommended in divided dosage or as directed by physician.
Dosing Instructions :
• To maximize absorption and clinical benefit, Ibandronic Acid Tablet of Calorate Kit should be taken at least 60 minutes before the first food or drink (other than water) of the day or before taking any oral medication or supplementation, including calcium, antacids, or vitamins.
• To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, Ibandronic Acid tablet should be swallowed whole with a full glass of plain water (250 ml) while the patient is standing or sitting in an upright position. Patients should not lie down for 60 minutes after taking Ibandronic Acid tablet.
• Patients should not eat, drink anything except water, or take other medications for at least 60 minutes after taking Ibandronic Acid tablet.
• Plain water is the only drink that should be taken with Ibandronic Acid tablet. Note that some mineral waters may have a higher concentration of calcium and therefore should not be used.
290

bexinfo: T
HERAPEUTIC
G
UIDE
• Patients should not chew or suck the tablet because of a potential for oropharyngeal ulceration.
• Ibandronic Acid 150 mg tablet of Calorate Kit should be taken on the same date each month (i.e., the patient’s Ibandronic Acid day).
• The patient must not take two 150 mg tablets within the same week.
• If the once-monthly dose is missed, and the patient’s next scheduled Ibandronic acid day is more than 7 days away, the patient should be instructed to take one Ibandronic
Acid 150 mg tablet in the morning following the date that it is remembered. The patient should then return to taking one Ibandronic Acid 150 mg tablet every month in the morning of their chosen day, according to their original schedule.
• If the once-monthly dose is missed, and the patient’s next scheduled Ibandronic Acid day is only 1 to 7 days away, the patient must wait until the subsequent month’s scheduled Ibandronic Acid day to take their tablet. The patient should then return to taking one Ibandronic Acid 150 mg tablet every month in the morning of their chosen day, according to their original schedule.
Recommendations for Calcium Supplementation : Patients should receive supplemental calcium (already provided as Calorate 400 mg tablet) if dietary intake is inadequate.
Contraindication:
Ibandronic acid is contraindicated in conditions like:
• Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia
• Inability to stand or sit upright for at least 60 minutes
• Hypocalcemia
• Known hypersensitivity to any of its active excipients.
Calcium Orotate is contraindicated in conditions like:
• Incomplete or infrequent bowel movements
• Kidney stone, kidney disease,
• Sarcoidosis,
• Increased activity of the parathyroid gland,
• Extreme loss of body water.
Warning and Precautions:
Ibandronic acid
Upper Gastrointestinal Adverse Reactions : Ibandronic acid of Calorate Kit may cause local irritation of the upper gastrointestinal mucosa. Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when this is given to patients with active upper gastrointestinal problems (such as known
291

bexinfo: T
HERAPEUTIC
G
UIDE
Barrett’s esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis or ulcers). The risk of severe esophageal adverse experiences appears to be greater in patients who lie down after taking oral bisphosphonates and/or who fail to swallow it with the recommended full glass (6-8 oz) of water, and/or who continue to take oral bisphosphonates after developing symptoms suggestive of esophageal irritation.
Hypocalcemia and Mineral Metabolism: Adequate intake of calcium is important in all patients to prevent hypocalcemia.
Musculoskeletal pain: Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking Ibandronic acid. So, this should be discontinued if severe symptoms develop.
Jaw Osteonecrosis : Osteonecrosis, primarily in the jaw, has been reported in patients treated with bisphosphonates. Most cases have been in cancer patients undergoing dental procedures, but some have occurred in patients with postmenopausal osteoporosis or other diagnoses. Known risk factors for osteonecrosis include a diagnosis of cancer, concomitant therapies (e.g., chemotherapy, radiotherapy, corticosteroids), and co-morbid disorders (e.g., anemia, coagulopathy, infection, pre-existing dental disease).
Severe Renal Impairment : Ibandronic acid is not recommended for use in patients with severe renal impairment (creatinine clearance of <30 mL/min).
Use in Pregnancy and Lactation : Pregnancy Category of Ibandronic Acid: C. This should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus. Caution should be exercised when Ibandronic acid is administered to a nursing woman.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Calcium
Before taking Calcium, precaution is needed if the patient has any allergies. Precaution is needed before using this product in kidney disease, kidney stones, little or no stomach acid (achlorhydria), heart disease, disease of the pancreas, sarcoidosis (a certain lung disease), difficulty absorbing nutrition from food (malabsorption syndrome).
Drug Interactions: Ibandronic Acid
Calcium Supplements/Antacids : Products containing calcium and other multivalent cations (such as aluminum, magnesium, iron) are likely to interfere with absorption of
Ibandronic Acid.
Aspirin / Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) : Because aspirin, NSAIDs, and bisphosphonates are all associated with gastrointestinal irritation, caution should be exercised in the concomitant use of aspirin or NSAIDs with Ibandronic Acid.
292

H
2
Blockers : In healthy volunteers, co-administration with ranitidine resulted in a 20% increased bioavailability of ibandronate, which was not considered to be clinically relevant.
Calcium bexinfo: T
HERAPEUTIC
G
UIDE
Calcium can decrease absorption of the following drugs when taken together: biphosphonates (e.g., alendronate), quinolone antibiotics (e.g., ciprofloxacin, levofloxacin), and tetracycline antibiotics (e.g., doxycycline, minocycline), levothyroxine, phenytoin (an anticonvulsant), and tiludronate disodium (to treat Paget's disease).
Thiazide-type diuretics can interact with calcium supplements, increasing the risks of hypercalcemia and hypercalciuria. Both aluminium and magnesium containing antacids increase urinary calcium excretion. Mineral oil and stimulant laxatives decrease calcium absorption. Glucocorticoids, such as prednisone, can cause calcium depletion and eventually osteoporosis when they are used for months. Oral contraceptives as well as estrogen compounds reduce calcium. Anti inflammatories such as NSAIDs, Aspirin,
Ibuprofen deplete calcium. Corticosteroids deplete calcium.
Side Effects: Ibandronic Acid: Common side effects include hypertension, dyspepsia, nausea, diarrhea, abdominal pain, arthralgia, back pain, localized osteoarthritis, myalgia, muscle cramp, influenza, nasopharyngitis, bronchitis, urinary tract infection, upper respiratory tract infection, headache, dizziness, skin rash, insomnia etc.
Calcium Orotate: Bloating and swelling in the abdomen are common side effects of calcium orotate. Loss of appetite, upset stomach, constipation, nausea, vomiting, unusual weight loss, mood changes, bone/muscle pain, headache, increased thirst/urination, weakness, unusual tiredness, formation of kidney stones may occur infrequently.
Commercial Pack: Calorate ® Kit Tablet: Each box contains 1 tablet of Ibandronic Acid
INN 150 mg and 60 tablets of Calcium Orotate INN 400 mg in one calendar strip.
®
Tablet
Levocarnitine is a carrier molecule in the transport of long-chain fatty acids across the inner mitochondrial membrane.
Indications: Carnitab is indicated for the treatment of :
1. Primary carnitine deficiency syndromes
- Systemic carnitine deficiency
- Myopathic carnitine deficiency
2. Secondary carnitine deficiency or insufficiency states
- Genetically determined metabolic errors
(mainly organic acidurias )
- Chronic intermittent hemodialysis in end stage renal failure
- Cardiac and skeletal muscle ischemia
293

bexinfo: T
HERAPEUTIC
G
UIDE
Dosage and Administration: Adults: The recommended oral dosage for adults is 990 mg, two or three times a day using the 330 mg tablets, depending on clinical response.
Infants and children: The recommended oral dosage for infants and children is between
50 and 100 mg / kg / day in divided dose, with a maximum of 3 gm / day. Dosage should begin at 50 mg / kg / day. The exact dosage will depend on clinical response.
Monitoring should include periodic blood chemistries, vital signs, plasma carnitine concentrations and overall clinical condition.
Side Effects: Transient nausea and vomiting, abdominal cramps and diarrhea have been observed. Mild myasthenia has been described only in uremic patients receiving DLcarnitine. Decreasing the dosage often diminishes or eliminates drug related patient body odor or gastrointestinal symptoms when present. Tolerance should be monitored very closely during the first week of administration and after any dosage increment.
Warning and Precautions: The safety and efficacy of oral Levocarnitine has not been evaluated in patients with renal insufficiency. Chronic administration of high doses of oral
Levocarnitine in patients with severely compromised renal function or in ESRD patients on dialysis may result in accumulation of the potentially toxic metabolites, trimethylamine
(TMA) and trimethylamine-N-oxide (TMAO), since these metabolites are normally excreted in the urine.
Contraindications: There is no known disease or syndrome in which Levocarnitine administration is contraindicated
Commercial Pack: Carnitab ® Tablet: Box containing 3 aluminium strips of 10 tablets.
Each tablet contains Levocarnitine USP 330 mg.
®
Tablet
Carocet is a film coated tablet which contains a combination of three antioxidant vitamins.
Each tablet contains beta Carotene, vitamin C and vitamin E.
Indications: Antioxidant vitamins are used in a wide range of conditions in which free radical damage is playing a role. Antioxidant vitamin combination is used in the prevention of coronary heart diseases, certain types of cancer, aging as well as free radical damage caused by excessive exercise, illness, certain medications, air pollution, smoke, radiation and pesticides.
Dosage and Administration: Dosage varies according to individual’s need. The usual recommended dose is two tablets daily or as advised by the physician. The dose can be increased up to four tablets daily.
Side Effects: β -carotene is comparatively safe even at high and prolonged exposure.
294

bexinfo: T
HERAPEUTIC
G
UIDE
Individuals who routinely ingest large amounts of carotenoids can develop hypercarotenosis, which is characterized by a yellowish coloration of the skin and a very high concentration of carotenoids in the plasma. This benign condition, although resembling jaundice, gradually disappears upon correcting the excessive intake of carotenoids. Vitamin C is generally a safe drug for human use in normal doses. Larger doses may lead to gastrointestinal tract upset and renal stone formation. Vitamin E is considered safe even in large doses. Doses over 800 mg may cause diarrhea, abdominal pain or cramps, fatigue and reduced resistance to bacterial infection and transiently raised blood pressure.
Contraindications: There is no absolute contraindication. Antioxidant vitamins are comparatively safe.
Warning and Precautions: There are some evidences that β -carotene may cause harm to heavy smokers and alcoholics. Therefore, caution should be exercised in these cases.
Vitamin C should be given with caution to patients with hyperoxaluria. Vitamin E should be used with caution in patients taking anticoagulant drugs, because vitamin E may enhance the anticoagulant activity of these drugs.
Pregnancy and Lactation: β -carotene, vitamin C and vitamin E have not any teratogenic effects in humans. However, like any other drugs caution should be taken in prescribing to pregnant women.
Drug Interactions: Cholestyramine, colestipol, neomycin cause decreased absorption of beta-carotene. Circulating vitamin C levels have been shown to be reduced during the prolonged administration of certain drugs including oral contraceptives containing oestrogen, tetracycline and aspirin. The decrease in vitamin C level may be due to druginduced impaired absorption or increased utilization of the vitamin for drug metabolism.
Vitamin E may enhance the anticoagulant activity of anticoagulant drugs. High doses of vitamin E can impair intestinal absorption of vitamins A and K.
Commercial Pack: Carocet ® Tablet: Bottle containing 20 tablets. Each tablet contains
β−
Carotene USP 6 mg, Ascorbic Acid USP and Sodium Ascorbate USP equivalent to
Ascorbic Acid (Vitamin C) 200 mg and Vitamin E preparation USP equivalent to dlα -
Tocopheryl Acetate (Vitamin E) 50 mg.
®
Tablet
Formula E (vitamin E) is a crackable tablet with chocolate taste.
Indication: As a dietary supplement and for prophylactic use: To meet raised requirements (e.g. pregnancy and lactation period, high dietary intake of polyunsaturated fatty acids, etc). For prevention of vitamin E deficiency due to malabsorption syndromes caused by pancreatic, hepatobiliary and gastrointestinal disorders.
295

bexinfo: T
HERAPEUTIC
G
UIDE
Therapeutic use: Hemolytic anemia due to vitamin E deficiency (in premature infants),
Intermittent claudication.
Also vitamin E (Formula E) has been found to be effective in preventing and alleviating the symptoms of the following conditions:
In internal medicine: Thromboangiitis obliterans, varicose ulcers, myocardial insufficiency, fibrositis, dupuytren’s contracture, peyronie’s disease, male infertility, dyslipoproteinemia with low HDL cholesterol and high LDL cholesterol.
In gynecology and obstetrics: Habitual abortion, tendency to premature delivery, habitual stillbirth, threatened abortion, menopausal disorders, pruritus vulvae, kraurosis vulvae.
In dermatology: Lupus erythematosus, granuloma annulare, acrodermatosis, atrophicans progressiva, scleroderma.
Dosage and Administration: Dosage varies according to individual’s need.
The following dosages are recommended in different indications:
As a supplement or prophylactic use: Increased requirements: 100-300 mg daily.
Malabsorption syndromes: 100-300 mg daily.
Hemolytic anemia in premature infants: 100-200 mg / kg body weight.
Intermittent claudication: 300-600 mg daily.
Thromboangiitis obliterans, varicose ulcers, myocardial insufficiency: 300-600 mg daily.
Fibrositis, dupuytren’s contracture, peyronie’s disease, dyslipoproteinemia with low HDL cholesterol and high LDL cholesterol.: 200-300 mg daily.
Male infertility: 100-200 mg daily.
Habitual abortion, tendency to premature delivery, habitual stillbirth: 100 mg daily from the beginning of pregnancy as a prophylaxis, with hormone therapy if required.
Threatened abortion: 100 mg every 6 hours until the crisis is over.
Menopausal disorders, pruritus vulvae, kraurosis vulvae: 100-200 mg daily.
Lupus erythematosus, granuloma annulare, acrodermatosis, atrophicans progressiva, scleroderma: 100-300 mg daily.
Side Effects: Vitamin E is very well tolerated. As a rule, daily doses of upto 800 mg do not induce any adverse reactions. Only when a dose approaching 1 gm gives rise to transient gastrointestinal symptoms like nausea, flatulence, diarrhea, etc.
Overdosage and Contraindication: There is no absolute overdosage and contraindication.
296

bexinfo: T
HERAPEUTIC
G
UIDE
Warning and Precautions: Vitamin E may enhance the anticoagulant activity of anticoagulant drugs.
Drug Interactions: In animal studies very high doses of vitamin E were shown to limit the absorption of vitamins A and K.
Commercial Pack: Formula ® E Tablet: Bottle containing 15 tablets. Each tablet contains vitamin E USP (dlα tocopheryl acetate) 200 mg.
®
Tablet
This is a preparation of Ferrous ascorbate, a synthetic molecule of ascorbic acid and iron.
Indications: Indicated in the treatment of iron deficiency anemia.
Dosage and Administration: Adult & Elderly: One tablet a day before or after meal (food independent absorption) or as directed by the physician. In more severe cases, two tablets a day may be required as prescribed by the physician. Safety and effectiveness in pediatric patients have not been established.
Side Effects: The treatment of a neurotic patient was interrupted because of nausea and regurgitation. In pregnant women, the incidence of pyrosis and chronic constipation is slightly increased.
Warning and Precautions: Oral iron preparations may aggravate existing peptic ulcer, regional enteritis and ulcerative colitis. Iron compounds taken orally can impair the absorption of tetracycline antibiotics. Antacids given concomitantly with iron compounds decrease iron absorption.
Contraindications: Hemosiderosis, hemochromatosis, hemolytic anemia.
Commercial Pack: Hemofix ® Tablet: Box contains 30 tablets in 3x10’s alu-alu form packs. Each film coated tablet contains Ferrous Ascorbate INN equivalent to elemental
Iron 33 mg.
®
Tablet
It is an oral iron, folic acid and zinc preparation.
Indications: It is indicated for prophylaxis of iron deficiency especially when inadequate diet calls for supplementary zinc and iron during pregnancy and anemia.
297

bexinfo: T
HERAPEUTIC
G
UIDE
Dosage and Administration: Adult & Elderly: One tablet a day before or after meal (food independent absorption) or as directed by the physician. In more severe cases, two tablets a day may be required as prescribed by the physician. Safety and effectiveness in pediatric patients have not been established.
Side Effects: Epigastric pain, nausea, constipation, vomiting, diarrhea, heart burn, etc.
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
Drug Interactions: Tetracycline, Penicillamine and Antacid.
Overdosage: The clinical course of acute iron overdosage can be variable. Initial symptoms may include abdominal pain, nausea, vomiting, diarrhoea, tarry stools, melena, hematemesis, hypotension, tachycardia, metabolic acidosis, hyperglycemia, dehydration, drowsiness, pallor, cyanosis, lassitude, seizures, shock and coma.
Warning and Precautions: Care should be taken in patients who may develop iron overload, such as those with haemochromatosis, haemolytic anemia or red cell aplasia.
Failure to respond to treatment may indicate other causes of anemia and should be further investigated.
Use in Pregnancy: If pregnant, or planning to become pregnant or are currently breastfeeding please contact your physician, before taking or continuing the drug. Administration in first trimester of pregnancy should be avoided unless definite evidence of iron deficiency is observed. Prophylaxis of iron deficiency is justified during the remainder of pregnancy specifically when zinc supplementation is required.
Contraindications: It is contraindicated in patients with hemolytic anemia and in conditions with increased hypersensitivity to any of its components and increased body iron content.
Commercial Pack: Hemofix ® FZ Tablet: Box contains 30 tablets in 3x10’s Alu-Alu form packs. Each Film coated tablet contains Ferrous Ascorbate INN equivalent to elemental
Iron 48 mg, Folic Acid USP 0.5 mg & Zinc Sulfate Monohydrate USP equivalent to Zinc
22.5 mg.
®
Tablet
Momvit Plus tablet is specially formulated with 16 essential nutrients to provide multivitamin & multimineral support when planning conception, throughout pregnancy and while breast feeding.
Indications: This preparation is for pregnant and lactating mothers.
Dosage and Administration: Two tablets daily with a meal, or as professionally prescribed.
298

bexinfo: T
HERAPEUTIC
G
UIDE
Contraindications: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Warning and Precautions: The stated dose of folic acid should not be exceeded. Mother with a baby of neural tube defect should seek specific medical advice.
Side Effects: No clinically significant side effects or toxicity are reported with such kind of preparation.
Commercial Pack: Momvit ® Plus Tablet: Box containing 60 tablets in 6X10’s alu-alu form packs. Each tablet contains: Vitamin C (As Ascorbic Acid BP, 97%) 15 mg, Thiamine
Nitrate BP 500 mcg, Riboflavin BP 750 mcg, Nicotinamide BP 7.5 mg, Pyridoxine
Hydrochloride BP 750 mcg, Folic Acid BP 250 mcg, Calcium (As Calcium Hydrogen
Phosphate Anhydrous BP) 59 mg, Phosphorous (As Calcium Hydrogen Phosphate
Anhydrous BP) 45.6 mg, Magnesium (As Magnesium Oxide BP) 15 mg, Iron (As Ferrous
Fumarate BP) 5 mg, Zinc (As Zinc Sulphate Monohydrate BP) 8 mg, Iodine (As
Potassium Iodide BP) 125 mcg, Cyanocobalamin (As Cyanocobalamin BP, 1.0%) 1.5
mcg, Colecalciferol (As Dry Vitamin D3 1,00,000 IU / g BP) 0.00625 mg, Tocopheryl
Acetate (As Dry Vitamin E Acetate 50% BP) 5.20 mg, Betacarotene (As Betacarotene
BP, 20%) 3 mg
®
Tablet
Each Neurocare tablet contains Thiamine mononitrate, Pyridoxine hydrochloride and
Cyanocobalamin. These vitamins play an essential role as co-enzyme in the metabolism of the nervous system. The combination of these 3 vitamins shows better effect than that of the individual component.
Indications: It is indicated in polyneuropathy of any origin such as diabetic, alcoholic or toxic neuropathies, neuritis, neuralgia, cervical syndrome, Shoulder-arm syndrome, lumbago, sciatica, Herpes Zoster, trigeminal neuralgia and supportive treatment in facial paresis.
Dosage and Administration: This tablet may be administered in a dosage of 1 to 3 tablets daily or as per the direction of physicians.
Contraindications: It should not be used in patients on Levodopa therapy and hypersensitivity to any of the above ingredients.
Warning and Precautions: Cyanocobalamin should not be given before a diagnosis has been fully established because of the possibility of masking symptoms of subacute degeneration of the spinal cord. Cyanocobalamin is not a suitable form of Vitamin B12 for the treatment of optic neuropathies associated with raised plasma concentrations of cyanocobalamin.
299

bexinfo: T
HERAPEUTIC
G
UIDE
Use in Pregnancy & Lactation: Neurocare is safe for pregnant women. It is not known whether thiamine (vitamin B1) is excreted in breast milk or not, but may be taken cautiously during lactation. Vitamin B6 has no adverse effect during lactation. There is no known adverse effect on Vitamin B12 therapy also.
Side Effects: Allergic hypersensitivity reactions may occur.
Drug Interactions: Pyridoxine reduces the effects of levodopa. It also interacts with phenobarbital, isoniazide and oral contraceptive. Absorption of cyanocobalamin from gastrointestinal tract may be reduced by neomycin, aminosalicylic acid, and H2-receptor antagonists.
Commercial Pack: Neurocare ® Tablet: Box containing 30 tablets in 3 x10’s blister strips.
Each tablet contains Thiamine mononitrate USP 100 mg, Pyridoxine Hydrochloride USP
200 mg & Cyanocobalamin USP 200 mcg.
®
5 % Composite Amino Acid IV Infusion with
D-Sorbitol And Electrolytes
This is a sterile aqueous solution of crystalline Amino Acids and D-Sorbitol with electrolytes, which are necessary as the nitrogen, sources for parenteral nutrition.
Nitrogen is provided in the form of essential and non-essential amino acids. The solution is clear, colorless, having a pH lying in the range of 6.0 to 7.0.
Indications: Amino Acid is indicated as a source of amino acids for protein synthesis in patients needing intravenous nutrition. This is particularly suitable for patients with basal amino acid requirements, faster recovery in surgery, burns, renal insufficiency, hepatic insufficiency and effective management of cancer.
Dosage and Administration: Adults: The nitrogen requirement for maintenance of body protein mass depends on the patient's condition (nutritional state and degree of metabolic stress). The requirements are 0.10-0.15g nitrogen / kg / day (no or minor metabolic stress and normal nutritional state), 0.15-0.20g nitrogen / kg / day (moderate metabolic stress with or without malnutrition) and up to 0.20-0.25g nitrogen / kg / day (severe catabolism as in burns, sepsis and trauma). The dosage range 0.10-0.25g nitrogen / kg / day corresponds to 15-35 ml Nutrimin / kg / day. In obese patients, the dose should be based on the estimated ideal weight. Depending upon patients requirements, 1000-2000 ml .It
may be infused intravenously per 24 hours. It should be infused slowly, at rates 1.4-2.8
ml (30-60 drops) per minute.
Infants and Children: In children and infants, the rate of infusion is 28-35 ml / kg body weight per day is recommended, with a step wise increase in the rate of administration during the first week.
300

bexinfo: T
HERAPEUTIC
G
UIDE
Warning and Precautions: Hyperphenylaninemia has been noted in severely ill, premature infants. In these patients, monitoring of the phenylalanine levels is recommended and the infusion rate is adjusted as needed. Do not use if the solution is turbid or contains particles. Discard any unused portion.
Use in Pregnancy and Lactation: Successful and safe administration of amino acid solutions during pregnancy in the human has been reported.
Side Effects: Nausea Occurs rarely. Vomiting, flushing and sweating have been observed during infusion of Amino acid at rates exceeding the recommended maximal rare. Hypersensitivity reactions have been reported. As with all hypertonic infusion solution, thrombophlebitis may occur when peripheral veins are used. If given to severely ill, premature infants, hyperphenylalaninemia may occur.
Drug Interactions: At the recommended dosage the amino acid have no pharmacological effects and is not expected to interact with other medicaments.
Compatibility: Nutrimin containing amino acids should not be mixed with other preparations because of the increased risk of microbial contamination and incompatibility.
Contraindications: Contraindicated in patients with inborn errors of amino acids metabolism, irreversible liver damage and severe uremia when dialysis facilities are not available.
Commercial Pack: Nutrimin® : This is available in 500 ml glass bottle. Each 100 ml contains:
Essential Amino Acids
L-Isoleucine
L-Leucine
L-Lysine Hydrochloride
L-Methionine
L-Phenylalanine
L-Threonine
L-Tryptophan
L-Valine
L-Histidine
L-Tyrosine
Specification
USP
USP
USP
USP
USP
USP
USP
USP
USP
USP
Non Essential Amino Acids Specification
L-Arginine USP
L-Aspartic Acid
L-Glutamic Acid
L-Alanine
L-Cystine
Glycine(Aminoacetic Acid)
L-Proline
L-Serine
USP
BP
USP
BP
USP
USP
USP
Quantity
0.352 gm
0.490 gm
0.430 gm
0.225 gm
0.533 gm
0.250 gm
0.090 gm
0.360 gm
0.250 gm
0.025 gm
Quantity
0.500 gm
0.250 gm
0.075 gm
0.200 gm
0.010 gm
0.760 gm
0.100 gm
0.100 gm
301

bexinfo: T
HERAPEUTIC
G
UIDE
Carbohydrate
D-Sorbitol
Electrolytes
Sodium(Na+)
Potassium(K+)
Magnesium(Mg++)
Chloride(Cl-)
Acetate(CH3COO-)
Nitrogen content: 7.7 gm / L
Specification
BP
Quantity
40.78 mmol / L
25 mmol / L
2.5 mmol / L
53.54 mmol / L
25 mmol / L
Quantity
5.00 gm
®
7% Composite Amino Acid IV Infusion with
10% Glucose and Electrolytes
Nutrimin D is a sterile aqueous solution of Amino Acids IV Infusion and 10% Glucose with electrolytes, which are necessary as the nitrogen sources for parenteral nutrition. Nitrogen is provided in the form of essential and non-essential amino acids.
Indications: This is indicated as a source of amino acids, glucose and electrolytes in adult and pediatric patients needing IV nutrition. Nutrimin D is particularly suitable for patients with basal amino acid requirements.
Dosage and Administration: Adults: The requirements are 0.1-0.15 g nitrogen / kg body weight / day (no or minor metabolic stress and normal nutritional state), 0.15-0.2 g nitrogen / kg body weight / day (moderate metabolic stress with or without malnutrition) and up to 0.2-0.25 g nitrogen / kg body weight / day (severe catabolism as in burns, sepsis and trauma). The dosage range 0.1-0.25 g nitrogen / kg body weight / day corresponds to 11-27 mL Nutrimin D / kg body weight / day, respectively. Depending upon patient requirements, up to 1000-2000 mL of Nutrimin D may be infused IV per 24 hours.
Nutrimin D should be infused slowly, at a rate not exceeding 500 mL in 3 hours corresponding to approximately 2.8 mL / min (50 drops / min). In obese patients, the dose should be based on the estimated ideal weight.
In children and infants: A maximal rate of infusion of 30 mL Nutrimin D / kg body weight
/ day is recommended, with a stepwise increase in the rate of administration during the
1st week of treatment.
Contraindications: Patients with inborn errors of amino acid metabolism, severe liver dysfunction and in severe uremia when dialysis facilities are not available. Due to the content of glucose, Nutrimin D is contraindicated in patients with hyperosmolar nonketotic diabetic coma.
Warning and Precautions: IV infusion of amino acids is accompanied by increased urinary excretion of the trace elements copper and, in particular zinc, which should be
302

bexinfo: T
HERAPEUTIC
G
UIDE taken into account in the dosing of trace elements, particularly during long-term IV nutrition. Hyperphenylalaninemia has been noted in severely ill premature infants. In these patients, monitoring of the phenylalanine level is recommended and the infusion rate adjusted as needed. Nutrimin D should be used with caution in patients with diabetes mellitus, severe heart failure or with renal function in combination with fluid restrictions or oliguria / anuria of other origin. In patients with hyperglycemia, administration of exogenous insulin might be necessary.
Use in Pregnancy and Lactation: Successful and safe administration of amino acid solutions during pregnancy.
Side Effects: Nausea occurs rarely. Transient increases in liver tests during IV nutrition have been reported. Hypersensitivity reactions have been reported with amino acid solutions. As with all hypertonic infusion solutions, thrombophlebitis may occur when peripheral veins are used. Hyperphenylalaninemia may occur in severely ill, premature infants.
Drug Interactions: At the recommended dosage the amino acid have no pharmacological effects and is not expected to interact with other medicaments.
Overdosage: If Nutrimin D is administered at a higher rate than recommended, there is an augmented risk for nausea, vomiting and sweating. When peripheral veins are used thrombophlebitis may occur. Osmotic diuresis with dehydration may occur if the dosage recommendations are exceeded. There is also a risk of symptoms related to hyperglycemia. In case of symptoms due to overdose, the infusion should be slowed down or discontinued.
Commercial Pack: Nutrimin ® D: This is available in 500 ml glass bottle. Each 100 ml contains:
Essential Amino Acids:
Active ingredients
L-Isoleucine
L-Leucine
L-Lysine Hydrochloride
L-Methionine
L-Phenylalanine
L-Threonine
L-Tryptophan
L-Valine
L-Histidine
L-Tyrosine
Specification
USP
USP
USP
USP
USP
USP
USP
USP
USP
USP
Quantity
0.390 gm
0.530 gm
0.390 gm
0.190 gm
0.550 gm
0.300 gm
0.100 gm
0.430 gm
0.240 gm
0.050 gm
303

bexinfo: T
HERAPEUTIC
G
UIDE
Non Essential Amino Acids:
Active ingredients
L-Arginine
L-Aspartic Acid
L-Glutamic Acid
L-Alanine
L-Cysteine Hydrochloride
Glycine (Aminoacetic Acid)
L-Proline
L-Serine
Carbohydrate:
Active ingredients
Anhydrous Glucose (Dextrose)
Specification
USP
USP
BP
USP
BP
USP
USP
USP
Specification
BP
Electrolytes:
Active ingredients
Sodium (Na+)
Potassium (K+)
Calcium (Ca++)
Magnesium (Mg++)
Chloride (Cl-)
Nitrogen content: 9.4 g / L
Energy content: 2.7 MJ (650 kcal / L)
Quantity
50.00 mmol / L
20.00 mmol / L
2.5 mmol / L
1.5 mmol / L
51.26 mmol / L
Quantity
0.330 gm
0.410 gm
0.900 gm
0.300 gm
0.140 gm
0.210 gm
0.810 gm
0.750 gm
Quantity
10.00 gm
®
Capsule
Pregvit is a special preparation of Iron, Folic Acid, Vitamin B-complex and Vitamin-C.
Indications: Pregvit is indicated for the treatment and prophylaxis of iron, folic acid, vitamin B-complex and vitamin-C deficiency, or to meet extra need of these vitamins and minerals especially in pregnancy or when planning for pregnancy.
Dosage and Administration: Adult: One capsule daily. In more severe deficiency states,
2 capsules a day may be required or as directed by the physician.
Contraindications: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.Iron therapy is contraindicated in hemochromatosis and hemosiderosis, and in patients receiving repeated blood transfusion or with anemia not produced by iron deficiency.
Warning and Precautions: Care should be taken when given to patients with iron storage or iron absorption disease.
Use in Pregnancy & Lactation: Recommended.
304

bexinfo: T
HERAPEUTIC
G
UIDE
Side Effects: Generally well tolerated. However, a few gastrointestinal disorders and allergic reactions may be seen.
Drug Interactions: No drug interactions have been reported.
Overdose: Overdose of Iron is dangerous, particularly in children and requires immediate attention. Gastric lavage should be carried out in the early stages, vomiting may also be induced.
Commercial Pack: Pregvit ® Capsule: Each box contains 50 capsules in 5x10’s blister strips. Each capsule contains:
Dried Ferrous Sulphate
Folic Acid
BP
BP
Thiamine Mononitrate (vitamin B
1
) BP
Riboflavin (vitamin B
2
) BP
Pyridoxine Hydrochloride (vitamin B
6
) BP
Nicotinamide (vitamin B
3
) BP
Ascorbic Acid (vitamin C) BP
150 mg,
500 mcg,
2 mg,
2 mg,
1 mg,
10 mg,
50 mg.
®
Drops
Tynisol is a liquid preparation of multivitamin. Tynisol drops contain vitamin A, vitamin C, vitamin D, thiamine, riboflavin, pyridoxine, niacinamide and dexpanthenol.
Indication: For prevention and treatment of vitamin deficiency in children and infants.
Dosage and Administration: Below 1 year: 9-10 drops (0.3 ml).
1 year & above: 23-25 drops (1.0 ml) once daily or as advised by the physician.
Side Effects: Multivitamin preparations are usually devoid of side effects.
Overdosage and Contraindications: Supplemental vitamins should not be prescribed for patients with hemochromatosis or Wilson’s disease. It is contraindicated in patients with hypersensitivity to any of the ingredients. Excessive doses of vitamin A and D can lead to hypervitaminosis.When multivitamin preparations are prescribed allowance must be made for vitamins from other sources.
Commercial Pack: Tynisol ® Multivitamin Drops: Tynisol drops is available in 15 ml amber glass bottle. Each 0.6 ml contains:
Vitamin-A
Vitamin-D
Vitamin-C
Thiamine Hydrochloride
1.2 mg
10 mg
50 mg
1 mg
Riboflavin
Pyridoxine Hydrochloride
0.5 mg
1 mg
Niacinamide 5 mg
Dexpanthenol 3 mg
305

bexinfo: T
HERAPEUTIC
G
UIDE
®
Injection
This is an Iron Sucrose Injection USP which is a brown, sterile, aqueous, complex of
Polynuclear Iron (III) Hydroxide in Sucrose for Intravenous use. The drug product contains approximately 30% Sucrose w / v (300 mg / ml).
Indication: This is indicated for the treatment of Iron deficiency in the following indications: Where there is a clinical need for a rapid Iron supply In patients who can not tolerate oral Iron therapy or who are non-compliant In active Inflammatory bowel disease where oral Iron preparations are ineffective. Non-dialysis dependent-chronic kidney disease (NDD-CKD) patients receiving an erythropoietin Non-dialysis dependent-chronic kidney disease (NDD-CKD) patients not receiving an erythropoietin Hemodialysis dependent-chronic kidney disease (HDD-CKD) patients receiving an erythropoietin
Peritoneal dialysis dependent-chronic kidney disease (PDD-CKD) patients receiving an erythropoietin. It is also indicated in the treatment of Iron deficiency anemia in patients undergoing surgical procedures, patients donating blood, postpartum patients.
Dosages and Administration: Adults and Elderly: 5-10 ml Veniron (100-200 mg Iron) once to three times a week depending on the hemoglobin level. Children: There is limited data on children under study conditions. If there is a clinical need, it is recommended not to exceed 0.15 ml Veniron (3 mg Iron) per kg body weight once to three times per week depending on the haemoglobin level.
Side Effect: Hypotension, cramps / leg cramps, nausea, -headache, vomiting, and diarrhea. Some of these symptoms may be seen in patients with chronic renal failure or on hemodialysis not receiving intravenous iron. Body as a Whole: headache, fever, pain, asthenia, unwell, malaise, accidental injury. Cardiovascular Disorders, General: hypotension, chest pain, hypertension, hypervolemia. Gastrointestinal Disorders: nausea, vomiting, abdominal pain, elevated liver enzymes. Central and Peripheral Nervous
System: dizziness. Musculoskeletal System: cramps / leg cramps, musculoskeletal pain.
Respiratory System: dyspnea pneumonia, cough. Skin and appendages: pruritus, application site reaction. Hypersensitivity reactions: In safety studies, several patients experienced mild or moderate hypersensitivity reactions presenting with wheezing, dyspnea, hypotension, rashes, or pruritus. Anaphylactoid reactions including patients who experienced serious or life-threatening reactions (anaphylactic shock, loss of consciousness or collapse, bronchospasm with dyspnea, or convulsion) associated with
Iron Sucrose administration can occur. So, patients should be given a small test dose initially.
Contraindication: The use of Iron Sucrose is contraindicated in patients with evidence of Iron overload, in patients with known hypersensitivity to Iron Sucrose or any of its inactive components, and in patients with anemia not caused by Iron deficiency. It is also contraindicated in patients with history of allergic disorders including asthma, eczema and anaphylaxis, liver disease and infections.
306

bexinfo: T
HERAPEUTIC
G
UIDE
Warning and Precautions: General: Because body Iron excretion is limited and excess tissue Iron can be hazardous, caution should be exercised to withhold Iron administration in the presence of evidence of tissue Iron overload. Patients receiving Iron Sucrose require periodic monitoring of hematologic and haematinic parameters (hemoglobin, hematocrit, serum ferritin and transferrin saturation). Iron therapy should be withheld in patients with evidence of Iron overload. Transferrin saturation values increase rapidly after IV administration of Iron Sucrose; thus, serum Iron values may be reliably obtained
48 hours after IV dosing. Hypersensitivity Reactions: Serious hypersensitivity reactions have been rarely reported in patients receiving Iron Sucrose. Several cases of mild or moderate hypersensitivity reactions were observed in these studies. Hypotension:
Hypotension has been reported frequently in hemodialysis patients receiving intravenous
Iron. Hypotension following administration of Iron Sucrose may be related to rate of administration and total dose administered. Caution should be taken to administer Iron
Sucrose according to recommended guidelines.
Use in Pregnancy: Pregnancy Category-B. No adequate and well controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Use in Lactation: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Iron Sucrose is administered to a nursing woman.
Pediatric Use: Safety and effectiveness of Iron Sucrose in pediatric patients have not been established.
Geriatric Use: No overall differences in safety were observed between the elder subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Commercial Pack: Veniron ® Injection: Each pack contains one ampoule of Iron Sucrose
Injection USP (5 ml), 100 ml normal saline (0.9% NaCl), an infusion set, one sterile disposable syringe (5 ml), one alcohol prep.pad and one band aid.
®
Syrup
Vitonic is a preparation of iron, some B vitamins and zinc.
Indications: Treatment of iron deficiency anemia For prophylactic therapy of iron deficiency to cover the recommended daily dietary allowance Vitamins for the vitamin deficiency state. Zinc sulfate is for zinc deficiency treatment, treatment of recurrent respiratory tract infection, diarrhea, loss of appetite, and defective and delayed wound healing, night blindness, mental disturbness and many other afflictions.
Dosage and Administration: Adults: 5 ml to 10 ml 2-3 times daily.
Children: 1.25 ml to 2.5 ml 2-3 times daily.
307

bexinfo: T
HERAPEUTIC
G
UIDE
Side Effects: This is well tolerated. However, a few side effects of oral iron include gastrointestinal disturbness like nausea, vomiting, constipation or diarrhea, lethargy, respiratory distress, dyspepsia and abdominal pain. Occasionally, hypersensitivity reactions may occur.
Warning and Precautions: Caution should be taken in the conditions like
Hemocromatosis, Hemosiderosis and Hemolytic anemia. Accumulation of zinc may occur in case of renal failure.
Contraindications: It is contraindicated in condition where there is a risk of iron over load, e.g. Hemocromatosis, Thalasemias, Hemosiderosis Hypersensitivity to iron.
Drug Interactions: No interactions have been observed. Since the iron complex bound, ionic interaction with foodstuff components (Phytin, Oxalate, Tannin etc.) and concomitant administration of medicaments (Tetracyclines, Antacids) are unlikely to occur. Zinc may inhibit the absorption of Tetracycline if concomitantly used.
Commercial Pack: Vitonic ® Syrup: Bottle containing 50 ml, 100 ml and 200 ml syrup.
Each 5 ml syrup contains Iron (III) Hydroxide Polymaltose Complex INN equivalent to 50 mg elemental Iron, Thiamine Hydrochloride USP 5 mg, Riboflavin 5 / - Phosphate Sodium
USP equivalent to Riboflavin 2 mg, Pyridoxine Hydrochloride USP 2 mg, Niacinamide
USP 20 mg and Zinc Sulfate Monohydrate USP equivalent to elemental Zinc 10 mg.
®
Capsule
Vivis is a preparation of essential antioxidant vitamins, minerals and Lutein. A long term
Vitamin C supplement use (10+ years) and high serum Vitamin E concentrations have been associated with reduced risk of cataract. Lutein is a carotenoid specially concentrated in macula. This carotenoid could protect the macula from oxidative or light damage. One large study has found that high levels of dietary Lutein is associated with relatively lower risk of AMD (Age-Related Macular Degeneration). Zinc is an essential trace element involved in many enzyme systems. Copper plays important role in growth, skeletal integrity, and development of nervous system.
Indications: Vivis capsule is indicated for age-related eye disease. This is an advanced new antioxidant supplement formulated to provide nutritional support for the eye.
Dosage and Administration: One capsule, one or two times daily or as directed by the physician.
Side Effects: Large doses of Vitamin C are reported to cause diarrhea and other gastrointestinal disturbances. Large doses of Vitamin E may cause diarrhea, abdominal pain, and other gastrointestinal disturbances; fatigue and weakness have also been reported. Side effects of Zinc salt are abdominal pain and dyspepsia.
Contraindications: It is contraindicated in persons with a history of hypersensitivity to any of its ingredients.
308

bexinfo: T
HERAPEUTIC
G
UIDE
Warning and Precautions: Vitamin C should be given with care to patients with hyperoxaluria. In patients taking oral anticoagulants or estrogen, Vitamin E should be given carefully because it has been found to antagonize the effects of vitamin K leading to an increase in blood clotting time in these patient.
Drug Interactions: No drug interactions has been reported.
Commercial Pack: Vivis ® Capsule: Box containing 30 capsules in 3 x 10’s alu-alu form packs. Each capsule contains Ascorbic Acid (Vitamin C) USP 60 mg, Vitamin E USP 30 mg, Zinc (as Zinc Oxide USP) 15 mg, Copper (as Cupric Oxide Ph. Grade) 2 mg, Lutein
USP 6 mg.
®
Syrup
Zedex is a preparation of Zinc Sulfate. This is a source of Zinc which is an essential trace element and involved in a number of body enzyme systems. Zinc salts are used as supplements to correct Zinc deficiencies. The consequences of Zinc deficiency are malformations of the brain, eyes, bones, heart and other organs. Zinc is essential for the formation and function of the immune system. Systems influenced by Zinc include the reproductive, neurologic, immune, dermatologic and gastrointestinal system.
Indications: Zinc deficiency states; Growth retardation, RTI, alopecia, dermatitis, diarrhea, immunologic dysfunction, psychological disturbances, gonadopathy, impaired spermatogenesis, congenital malformations, acrodermatitis enteropathica.
Dosage and Administration: Children under 10 kg: 22.5 mg daily in divided doses.
Children within 10 to 30 kg: 22.5 mg 1 to 3 times daily after food.
Adults & children over 30 kg: 45 mg 1 to 3 times daily after food or as directed by the physician.
Side Effects: Abdominal pain & dyspepsia, copper deficiency and anemia. It can be converted to the corrosive Zinc Chloride, and it is this corrosive action that accounts for the acute toxicity of the soluble Zinc salts.
Drug Interaction: Zinc may inhibit the absorption of concurrently administered tetracyclines, therefore, an interval of at least 3 hours should be allowed while taking these products.
Contraindications: It is contraindicated in patients with hypersensitivity to Zinc.
Special Warnings and Precautions for Use: Accumulation of Zinc may occur in case of renal failure.
309

bexinfo: T
HERAPEUTIC
G
UIDE
Overdose: Zinc Sulfate is corrosive in overdosage. Symptoms are corrosion and inflammation of the mucous membrane of the mouth and stomach; ulceration of the stomach followed by perforation may occur. Gastric lavage and emesis should be avoided. Demulcents such as milk should be given. Chelating agents such as sodium edetate may be useful.
Commercial Pack: Zedex ® DS Syrup: 100 ml syrup in amber glass bottle. Each 5 ml contains Zinc Sulfate Monohydrate USP equivalent to 10 mg of elemental Zinc.
310

O
D

bexinfo: T
HERAPEUTIC
G
UIDE
®
Eye Drops
Epinastine Hydrochloride, an antihistamine and an inhibitor of histamine release from the mast cell for topical administration to the eyes.
Indications: Alastine ophthalmic solution is indicated for the prevention of itching associated with allergic conjunctivitis.
Dosage and Administration: The recommended dosage is one drop in each eye twice a day. Treatment should be continued throughout the period of exposure (i.e., until the pollen season is over or until exposure to the offending allergen is terminated), even when symptoms are absent.
Side Effects: Burning sensation in the eye, folliculosis, hyperemia and pruritus. The most frequently reported non-ocular adverse events were infection (cold symptoms and upper respiratory infections), headache, rhinitis, sinusitis, increased cough, and pharyngitis .
Contraindications: This is contraindicated in those patients who have shown hypersensitivity to Epinastine or to any of the other ingredients.
Warning and Precautions: For topical ophthalmic use only and not for injection or oral use. To preserve sterility, do not allow the dropper to touch the eye or any other surface.
High Risk Group: Pregnancy Category C: This ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers: Caution should be exercised when This is administered to a nursing woman.
Pediatric Use: Safety and effectiveness in pediatric patients below the age of 3 years have not been established.
Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.
Commercial Pack: Alastine ® Eye Drops: Plastic dropper bottle contains 5 ml sterile eye drops. Each ml contains Epinastine Hydrochloride BP 0.5 mg.
313

bexinfo: T
HERAPEUTIC
G
UIDE
®
Eye Drops
This is a preparation of Dexamethasone Phosphate and Chloramphenicol. It is used topically in the treatment of inflammatory conditions of the anterior segment of the eye.
Chloramphenicol is a broad spectrum bacteriostatic antibiotic which also covers against
Gram-negative and Gram-positive organisms.
Indications: Inflammatory ocular conditions for which a corticosteriod is indicated and where bacterial infection or a risk of bacterial ocular infection exists. For conditions such as anterior uveitis and corneal injury from chemical, radiation or thermal burns, penetration of foreign bodies, after cataract and corneal surgeries.
Dosage and Administration: 1 or 2 drops is instilled into the affected eyes every 3 or 4 hours, or more frequently as advisable by the physician.
Contraindications: It is contraindicated in fungal, viral, tuberculous and other infections of the eye and in glaucoma. It is also contraindicated in patients hypersensitive to any component of this product. The use of anti-infective and steroid is always contraindicated after uncomplicated removal of a corneal foreign body.
Side Effects: Blood dyscrasias, allergic sensitization , glaucoma, and infrequent optic nerve damage, posterior subcapsular cataract formation, and delayed wound healing, secondary infection may occur. Fungal infections of the cornea are particularly prone to develop with the long term use of steroids.
Warning and Precautions: Prolonged use of steroids containing product may result in posterior subcapsular cataract formation and glaucoma with optic nerve damage.
Intraocular pressure monitoring is needed. Bone marrow hypoplasia, including aplastic anemia has been reported following topical use of chloramphenicol. To preserve sterility, do not allow the dropper to touch the eye or any other surface.
Use in Pregnancy and Lactation: The product should not be used during pregnancy and lactation.
Drug Interactions: Dexamethasone: None relevant to topical use.
Chloramphenicol: Chloramphenicol should not be administered simultaneously with bactericidal substances (penicillins, cephalosporins, gentamicin, tetracyclines, polymyxin
B, or vancomycin) since bacteriostatic antibiotics may inhibit bactericidal antibiotics.
Furthermore Chloramphenicol should not be administered at the same time as systemic treatment with drugs which have an adverse effect on hematopoiesis, nor simultaneously with sulphonylureas, coumarin derivatives, hydantoins and methotrexate (precautionary measured).
Commercial Pack: Chlormet ® Eye Drops: Plastic dropper bottle contains 5 ml sterile eye drops. Each ml contains Dexamethasone Sodium Phosphate USP equivalent to
Dexamethasone Phosphate 1 mg and Chloramphenicol BP 5 mg.
314

bexinfo: T
HERAPEUTIC
G
UIDE
®
Eye Drops
This is a preparation of Tobramycin which is a water soluble aminoglycoside antibiotic active against a wide variety of ophthalmic infections.
Indications: This eye drop is indicated for the treatment of external infections of the eye and its appendages such as bacterial conjunctivitis, keratitis, corneal ulcer caused by susceptible bacteria.
Dosage and Administration: In mild to moderate infection, instill 1 drop 4-6 times daily into the conjunctival sac(s). In severe cases of infection, instill 1 drop hourly until improvement is obtained, then reduce the dose gradually. Duration of treatment is 5-15 days. Children: Clinical studies have shown Tobramycin ophthalmic preparation to be safe and effective for use in children.
Side Effects: The most frequent adverse reactions to Tobramycin are localized ocular toxicity and hypersensitivity, including lid itching and swelling and conjunctival erythema.
Contraindications: In patients with known hypersensitivity to any component of the product. Partial cross-allergenicity to other aminoglycosides has been established.
Warning and Precautions: As with other anti-infective, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If super-infection occurs, discontinue use and institute alternative therapy. Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis. The patient should not touch the dropper or tube opening to any surface, including eyes or hands.
Tobramycin ophthalmic may cause blurred vision.
Use in Pregnancy and Lactation: Tobramycin should be used during pregnancy only when potential benefits exceed the risks. Breast-feeding is possible with this drop considering the negligible amount of this substance possibly absorbed by the neonate.
Commercial Pack: Cinarex ® Eye Drops: Plastic dropper bottle contains 5 ml sterile eye drops. Each ml contains Tobramycin USP 3 mg.
®
Eye Drops
This is a preparation of Dexamethasone and Tobramycin. Dexamethasone is glucocorticoid which has an anti-inflammatory and anti-allergic action. It is used topically in the treatment of inflammatory conditions of the anterior segment of the eye. Tobramycin in the combination is included to provide antibacterial protection against susceptible bacteria.
315

bexinfo: T
HERAPEUTIC
G
UIDE
Indications: Eye: This combination eye drops are indicated for reduction of inflammation and prophylaxis of infection following cataract surgery, corneal surgery and any ocular inflammatory conditions where there is infection or chance of infection remains.
Dosage and Administration: Adults: One drop instilled into the conjunctival sac (s) every
4 to 6 hours while the patient is awake. During the initial 24 to 48 hours, the dosage may be increased to one drop every two hours while the patient is awake, for a maximum of
24 days. Frequency should be decreased gradually as warranted by improvement in clinical signs.
Use in the Elderly: Clinical studies have indicated dosage modifications are not required for use in the elderly.
Children: Safety and effectiveness in children have not been established.
Side Effects: Hypersensitivity and localised ocular toxicity, including lid itching and swelling, and conjunctival erythema,elevation of intraocular pressure (IOP), with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing.
Contraindication: Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella and other viral disease of the cornea and conjunctiva. Mycobacterial infections of the eye caused by Mycobacterium tuberculosis, Mycobacterium leprae , or
Mycobacterium avium . Fungal diseases of ocular structures. Untreated purulent infection of the eye.
Warning and Precaution: Prolonged use may result in overgrowth of nonsusceptible organisms including fungi; in ocular hypertension and / or glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision and posterior sub capsular cataract formation. Patients wearing contact lenses must not use the drops during the time the lenses are worn and hypersensitivity to any component of the medication.
Use in Pregnancy & Lactation: Safety for use during pregnancy and lactation in humans has not been established. So, this eye drops should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. A decision should be taken to discontinue nursing while using this combination eye drops.
Drug Interactions: No specific interaction studies were performed with this combination eye drops. In case of concomitant therapy with other topical ophthalmic medicines, an interval of 10 minutes should be allowed between successive applications.
Commercial Pack: Cinarex ® D Eye Drops: Plastic dropper bottle contains 5 ml sterile suspension. Each ml contains Dexamethasone USP 1 mg and Tobramycin USP 3 mg.
316

bexinfo: T
HERAPEUTIC
G
UIDE
®
Eye Drops
This is a preparation of Lomefloxacin, a difluorioniated quinolone derivative, which is effective against Gram positive and Gram negative bacteria. Lomefloxacin interferes with bacterial DNA related processes like transcription, DNA repair, recombination and transposition resulting in a rapid killing of prone bacteria.
Indications: This drug is indicated for bacterial infections, including conjunctivitis, blepharitis and blepharo-conjunctivitis which are due to Lomefloxacin susceptible germs.
Dosage and Administration: Adults and children (above 1 year of age): Apply 2-3 times daily 1 drop into the lower conjunctival sac. At the beginning of the treatment application should be more frequent, apply 5 drops within 20 minutes or 1 drop every hour during 6-
10 hours. Duration of the treatment: 7 to 9 days.
Contraindications: Hypersensitivity to the active ingredient, to excipients, or to quinolones. No adverse effects were noted in children included in clinical studies, although this data are limited.
Side Effects: Slight and transient burning immediately after instillation of the eye drops
, and photosensitization. Another side effects are allergic reactions, asthma, dyspnoea, urticaria, erythema, pruritus and hypersensitization.
Warning and Precautions: Long term treatment with antibiotic may enhance development of secondary fungal infections or may support growth of non-susceptible bacteria. Some isolated cases of phototoxicity have been reported after systemic but not after topical ophthalmic use of Lomefloxacin. Nevertheless, during treatment with
Lomefloxacin intensive exposure to sunlight or UV-radiation should be avoided. To preserve sterility, do not allow the dropper to touch the eye or any other surface.
Use in Pregnancy & Lactation: Clinical studies on the use of Lomefloxacin eye drops during human pregnancy or lactation are not available. So, the drug should only be used when the benefit outweighs the potential risk for the foetus or the infant.
Drug Interactions: No ophthalmic preparation containing heavy metals, such as zinc, should be used during 15 minutes preceding and following application of Lomefloxacin.
Bacteriostatic ophthalmic antibiotics should not be used concomitantly with Lomefloxacin eye drops.
Commercial Pack: Contra ® 0.3% Eye Drops: Plastic dropper bottle contains 5 ml sterile eye drops. Each ml contains Lomefloxacin Hydrochloride INN equivalent to Lomefloxacin
3 mg.
317

bexinfo: T
HERAPEUTIC
G
UIDE
®
Eye Drops
This is a preparation of Levofloxacin ophthalmic solution (0.5%) which is a fluoroquinolone antibacterial active against a broad spectrum of Gram-positive and Gramnegative ocular pathogens.
Indications: Levofloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis, keratitis, corneal ulcer, blepharitis, infective chalagion caused by susceptible strains of the following organisms: Aerobic Gram-positive and Gram-negative microorganisms.
Dosage and Administration: Instill one to two drops in the affected eye(s) every 2 hours in waking hours then can be reduced to one to two drops every 4 hours or as decided by the physician.
Side Effects: Transient decreased vision, fever, foreign body sensation, headache, transient ocular burning, ocular pain or discomfort, pharyngitis , photophobia , allergic reactions, lid edema, ocular dryness, and ocular itching.
Contraindications: This ophthalmic solution is contraindicated in patients with a history of hypersensitivity to levofloxacin, to other quinolones, or to any of the components in this medication.
Warning and Precautions: The solution should not be injected subconjunctivally. This should not be introduced directly into the anterior chamber of the eye. In patients receiving systemic quinolones, serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported, some following the first dose. If an allergic reaction to levofloxacin occurs, drug should be discontinued. Serious acute hypersensitivity reactions may require immediate emergency treatment. As with other anti-infectives, prolonged use may result in superinfection. In this case, drug should be discontinued. This should not be recommended for children under 1 year. Discontinuation of use immediately and consultations to the physician at the first sign of a rash or allergic reaction is advised. To preserve sterility, do not allow the dropper to touch the eye or any other surface.
Use in Pregnancy and Lactation: Levofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Levofloxacin is excreted in human milk. Caution should be exercised when it is administered to a nursing mother.
Pediatric Use: Safety and effectiveness in infants below the age of one year have not been established.
Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and other adult patients.
Drug Interactions: The systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine,
318

bexinfo: T
HERAPEUTIC
G
UIDE and enhance the effects of the oral anticoagulant warfarin and its derivatives, and has been associated with transient elevations in serum creatinine in patients receiving systemic cyclosporine concomitantly.
Commercial Pack: Evo ® 0.5% Eye Drops: Plastic dropper bottle contains 5 ml sterile eye drops. Each ml contains Levofloxacin Hemihydrate USP equivalent to Levofloxacin
5 mg.
®
Eye Drops
This is a preparation of Levofloxacin ophthalmic solution 1.5% which is a fluoroquinolone antibacterial active against a broad spectrum of Gram-positive and Gram-negative ocular pathogens.
Indications: It is indicated for the treatment of corneal ulcer caused by susceptible strains of the following bacteria:Gram-positive Bacteria, Corynebacterium species,
Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumonia, Viridans group streptococci, Gram-negative Bacteria, Pseudomonas aeruginosa, Serratia marcescens.
Dosage and Administration: Instill one to two drops in the affected eye(s) every 30 minutes to 2 hours in waking hours. This can be reduced to every 4 hours as directed by physician.
Side Effects: Headache and a taste disturbance. Following instillation, there may be blurred vision, diarrhea, dyspepsia, fever, infection, instillation site irritation, , nausea, ocular discomfort, and throat irritation. Other effects are chemosis, corneal erosion, corneal ulcer, diplopia, floaters, hyperemia, lid edema, and lid erythema.
Contraindications: This is contraindicated in patients with a history of hypersensitivity to levofloxacin, to other quinolones, or to any of the components in this medication.
Warning and Precautions: Same as Evo.
High risk group: Pregnancy Category C: Levofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers: Levofloxacin is excreted in human milk. Caution should be exercised when this drug is administered to a nursing mother.
Pediatric Use: Safety and effectiveness in children below the age of six years have not been established.
Drug Interactions: The systemic administration of some quinolones has been shown to
319

bexinfo: T
HERAPEUTIC
G
UIDE elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine, and enhance the effects of the oral anticoagulant warfarin and its derivatives, and has been associated with transient elevations in serum creatinine in patients receiving systemic cyclosporine concomitantly.
Commercial Pack: Evo ® TS Eye Drops: Plastic dropper bottle contains 5 ml sterile eye drops. Each ml contains Levofloxacin Hemihydrate USP equivalent to Levofloxacin 15mg.
®
Eye Drops
This is a preparation of Betaxolol hydrochloride ophthalmic solution which reduces elevated as well as normal intraocular pressure, whether or not accompanied by glaucoma.
Indications: In lowering intraocular pressure and in the treatment of ocular hypertension and chronic open-angle glaucoma. It may be used alone or in combination with other anti-glaucoma drugs.
Dosage and Administration: The recommended dose is one to two drops of Betaxolol
Hydrochloride Ophthalmic Solution in the affected eye(s) twice daily.
Side Effects: Discomfort, in rare instances decreased corneal sensitivity, erythema, itching sensation, corneal punctate staining, keratitis, anisocoria, edema, photophobia, blurred vision, foreign body sensation, dryness of the eyes, inflammation, discharge, ocular pain, decreased visual acuity, and crusty lashes, bradycardia, heart block and congestive failure, pulmonary distress characterized by dyspnea, bronchospasm, thickened bronchial secretions, asthma and respiratory failure.
Contraindications: Hypersensitivity to any component of this product, in patients with sinus bradycardia, greater than a first degree atrioventricular block, cardiogenic shock, or patients with overt cardiac failure.
Warning and Precautions: Caution should be used in treating patients with a history of cardiac failure or heart block. Treatment with Betaxolol Hydrochloride Ophthalmic Solution should be discontinued at the first signs of cardiac failure. This should be used cautiously in diabetes mellitus, thyrotoxicosis, muscle weakness, major surgery, pulmonary, risk from anaphylatic reaction, carcinogenesis, mutagenesis, impairment of fertility .
High Risk Group: Pregnancy and Lactation: Betaxolol Hydrochloride Ophthalmic
Solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether betaxolol HCl is excreted in human milk. So, caution should be exercised when Betaxolol Hydrochloride Ophthalmic Solution is administered to nursing women. To preserve sterility, do not allow the dropper to touch the eye or any other surface.
320

bexinfo: T
HERAPEUTIC
G
UIDE
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.
Drug Interactions: Close observation of the patient is recommended when a β -blocker is administered to patients receiving catecholamine-depleting drugs such as reserpine, because of possible additive effects and the production of hypotension and / or bradycardia. Caution should be exercised in patients using concomitant adrenergic psychotropic drugs. When Betaxolol Hydrochloride Ophthalmic Solution is used to reduce elevated intraocular pressure in angle-closure glaucoma, it should be used with a miotic and not alone.
Commercial Pack: Glucovis ® 0.25% Eye Drops: Plastic dropper bottle containing 5 ml sterile solution. Each ml contains: Betaxolol Hydrochloride BP equivalent to Betaxolol
2.5mg.
®
Eye Drops
This is a preparation of Hypromellose (Hydroxypropyl methylcellulose). It is used to relieve dryness and irritation caused by reduced tear flow.
Indications: Used topically to provide tear-like lubrication for the symptomatic relief of dry eyes and eye irritation associated with deficient tear production.
Dosage and Administration: Adults, children and the elderly: The dose depends on the need for lubrication. Usually one to two drops to both eyes (2-6 ) hourly or as prescribed by the physician.
Contraindications: Hypersensitivity to any component of the product. The product should not be used when soft contact lenses are worn.
Side Effects: May cause transient mild stinging or temporarily blurred vision.
Warning and Precautions: If irritation persists or worsens, or headache, eye pain, vision changes or continued redness occur, discontinue use and consult a physician. To preserve sterility do not allow the dropper to touch the eye or any other surface.
High risk group: Pregnancy & Lactation: There is insufficient evidence as to safety in pregnancy and this product should, therefore, only be used in pregnancy if it is considered essential by the physician.
Commercial Pack: Hyprosol ® 0.3% Eye Drops: Plastic dropper bottle contains 10 ml sterile eye drops. Each ml contains Hypromellose USP 3mg.
321

bexinfo: T
HERAPEUTIC
G
UIDE
®
Eye Drops
This is a preparation of 5% Sodium Chloride ophthalmic solution which is a sterile, hypertonic solution for ophthalmic use. It is used to reduce the edema or swelling of the cornea. This solution exerts its effect through using the tonicity difference.
Indications: This medication is used to reduce swelling of the cornea in certain eye conditions.
Dosage and Administration: Instill 1 or 2 drops in the affected eye(s) every 3 or 4 hours, or as directed by a physician.
Side Effects: Vision may be temporarily blurred or unstable for a period after applying the drops. Use caution if driving or performing duties requiring clear vision. Burning or irritation of the eye may occur when first applied. Notification to doctor is needed if the patient develop redness, pain, swelling in or around the eyes, vision problems, sensitivity to light, headache.
Contraindications: It is contraindicated in individuals with known hypersensitivity to any of the ingredients of this preparation.
Warning and Precautions: If the condition for which this was prescribed does not improve or becomes worse after a few days, stop using and consult your doctor. To preserve sterility, do not allow the dropper to touch the eye or any other surface.
Use in Pregnancy and Lactation: This should be used cautiously during pregnancy or while breast-feeding.
Commercial Pack: Hypersol ® 5 Eye Drops: Plastic dropper bottle contains 10 ml sterile eye drops. Each ml contains Sodium Chloride BP 50 mg.
®
Eye / Ear Drops
This is a preparation of Dexamethasone Phosphate. Sufficient absorption may occur after topical application to the skin and eye to produce systemic effects.
Indications: Eye: This is indicated for treatment of steroid responsive inflammatory conditions of the conjunctiva, cornea and anterior segment of the eye such as: anterior uveitis, iritis, cyclitis, allergic and vernal conjunctivitis, herpes zoster keratitis (stromal), superficial punctate keratitis and non-specific superficial keratitis. Also indicated for the treatment of corneal injury from chemical, radiation or thermal burns or following penetration by foreign bodies. Indicated for post-operative use to reduce inflammatory reactions and suppress graft reaction.
322

bexinfo: T
HERAPEUTIC
G
UIDE
Ear: Indicated in the steroid responsive inflammatory conditions of the external auditory meatus, such as allergic otitis externa, selected purulent and non-purulent infective otitis externa.
Dosage and Administration: Eye: The frequency of instillation of drops and the duration of treatment will vary depending upon the severity of the underlying condition and the response to treatment. Severe inflammations require one to two drops instilled into the eye every thirty to sixty minutes until a satisfactory response occurs. When a favourable response has been observed reduce the dosage towards one drop every four hours.
Ear: Instill two or three drops to the ear at two or three hour interval. The frequency of dosage and duration of the treatment may vary with the type of lesion and severity.
Contraindications: Herpes simplex and other viral diseases of the cornea and conjunctiva, fungal disease, ocular tuberculosis, untreated purulent infections and hypersensitivity to any component of the preparation. Patients with soft contact lenses should not use this preparation.
Side Effects: Topical steroid use may result in increased intraocular pressure. Intensive or prolonged use may lead to the formation of posterior subcapsular cataracts. In those diseases causing thinning of the cornea or sclera, perforation of the globe may occur.
Viral and fungal infections may be exacerbated by steroids. Transient stinging or burning may occur on instillation of the drops. Systemic side effects may occur with extensive use.
Warning and Precautions: Topical corticosteroids should never be given for an undiagnosed red eye as inappropriate use is potentially blinding. Because of the risk of
"steroid glaucoma" and cataract formation the intraocular pressure and the lens must be checked frequently during use of this preparation. To avoid the risk of enhancement of herpetic corneal disease, frequent slit-lamp examination is essential. Topical steroids may mask or enhance the activity of acute purulent eye infections. In such cases antibiotic therapy is mandatory. Topical corticosteroids are not effective in mustard gas keratitis or
Sjogren's keratoconjunctivitis. To preserve sterility, do not allow the dropper to touch the eye or any other surface.
High risk group: Pregnancy & Lactation: Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth retardation. There may therefore be a very small risk of such effects in the human pregnancy.
Commercial Pack: Inflavis ® Eye / Ear Drops: Plastic dropper bottle contains 5 ml sterile eye drops. Each ml contains Dexamethasone Sodium Phosphate USP equivalent to
Dexamethasone Phosphate 1 mg.
323

bexinfo: T
HERAPEUTIC
G
UIDE
®
Eye Drops
This is a preparation of Timolol Maleate BP equivalent to Timolol 5.0 mg which has the action of reducing elevated, as well as normal, intraocular pressure, whether or not accompanied by glaucoma.
Indications: In the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
Dosage and Administration: The dose is one drop of Timolol (either 0.25% or 0.5%) in the affected eye(s) once daily. Because in some patients the intraocular pressurelowering response to Timolol may require a few weeks to stabilize, evaluation should include a determination of intraocular pressure after approximately 4 weeks of treatment.
Side Effects: Local side-effects of eye drops include ocular stinging, burning, pain, itching, erythema, dry eyes and allergic reactions including anaphylaxis and blepharoconjunctivitis; occasionally corneal disorders have been reported.
Contraindications: Bronchial asthma or a history of bronchial asthma, severe chronic obstructive pulmonary disease , sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, cardiogenic shock, hypersensitivity to any component of this product.
Warning and Precautions: For topical ophthalmic use only. Not for injection or oral use.
Severe respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma, and, rarely death in association with cardiac failure, have been reported following systemic or ophthalmic administration of timolol maleate. These agents should be used with caution in patients with cerebrovascular insufficiency. To preserve sterility, do not allow the dropper to touch the eye or any other surface.
High risk group: Pregnancy Category C. and Nursing Mothers: Timolol maleate has been detected in human milk following oral and ophthalmic drug administration. Because of the potential for serious adverse reactions from Timolol in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Drug Interactions: Patients should not usually receive two topical ophthalmic β adrenergic blocking agents concurrently. Caution should be used in the co-administration of β -adrenergic blocking agents, such as Timolol and oral or intravenous calcium antagonists because of possible atrioventricular conduction disturbances, left ventricular failure, or hypotension. Masked symptoms of hypoglycemia in diabetic patients.
Commercial Pack: Intramol ® 0.5% Eye Drops: Dropper bottle containing 5 ml of sterile solution.
324

bexinfo: T
HERAPEUTIC
G
UIDE
®
Eye Drops
This is a preparation of Cyclopentolate Hydrochloride.When applied topically to the eyes, it causes a rapid, intense cycloplegic and mydriatic effect that is maximal in 15 to 60 minutes; recovery usually occurs within 24 hours. The cycloplegic and mydriatic effects are slower in onset and longer in duration in patients who have dark pigmented irises.
Indications: Cyclopentolate is used mainly to produce mydriasis and cycloplegia for diagnostic purposes.
Dosage and Administration: To produce mydriasis and cycloplegia for diagnostic purposes, in adults and children over 1 year: 1 drop instilled in the eye(s), followed by a second drop 5 minutes later, if necessary. Drops should be administered 40 to 50 minutes prior to the procedure. Complete recovery from mydriasis and cycloplegia should occur within 24 hours.
Side Effects: Blinding acute angle-closure glaucoma and raised intraocular pressure may occur during cyclopentolate therapy. Systemic effects, resulting from excessive absorption from mucosal surfaces or from ingestion of the drug, may include xerostomia, flushing, tachycardia and urinary retention. More severe systemic effects are tachypnea, scarlatiniform rash, delirium, psychosis, fever, stupor, coma, respiratory failure and death.
Contraindications: Cyclopentolate is contraindicated in patients with angle-closure glaucoma or in patients with shallow anterior chambers. Cyclopentolate should not be used in patients, especially children, who have previously experienced a severe systemic reaction to the drug, or in patients with hypersensitivity to any component of a cyclopentolate formulation.
Warning and Precautions: Cyclopentolate may cause increased intraocular pressure.
Angle-closure glaucoma may be induced by cyclopentolate in patients with higher susceptibility to increased intraocular pressure including the elderly and individuals with shallow anterior chambers. The drug should be discontinued and the physician consulted immediately if eye pain, blurring of vision, rapid pulse or dizziness occurs. Systemic absorption of topical cyclopentolate from the nasal mucosal surfaces may result in systemic adverse effects. To minimize systemic absorption, finger pressure should be applied to the lacrimal sac for 2 to 3 minutes following administration. Alternatively, the eyelids should be kept closed for 2 to 5 minutes following instillation. Patients with heavily pigmented irises may require larger doses. To preserve sterility, do not allow the dropper to touch the eye or any other surface.
High Risk Group: Children: Infants and young children and children with blond hair or blue eyes may be especially sensitive to the effects of cyclopentolate, increasing the chance of side effects during treatment. Use of cyclopentolate in children has been associated with psychotic reactions and behavioral disturbances.
325

bexinfo: T
HERAPEUTIC
G
UIDE
Drug Interactions: Cyclopentolate may affect the action of concomitantly administered drugs such as: Antihistamines, isoniazid, MAO inhibitors, phenothiazines, procainamide, disopyramide, propranolol, quinidine and tricyclic antidepressants. Anticholinergic agents, such as cyclopentolate, antagonize miosis and ciliary body contraction induced by cholinesterase inhibitors and cholinergic agonists.
Commercial Pack: Mydrate ® Eye Drops: Plastic dropper bottle contains 5 ml sterile eye drops. Each ml contains Cyclopentolate Hydrochloride USP 10 mg.
®
Eye / Ear Drops
This is a preparation of Ciprofloxacin which has bactericidal activities which results from an interference with DNA gyrase, an enzyme needed by the bacterium for the synthesis of DNA.
Indications: Eye: Ciprofloxacin eye drop is indicated for the treatment of corneal ulcers and superficial infections of the eye and adnexa caused by susceptible strains of bacteria.
Ear: Otitis externa, acute otitis media, chronic suppurative otitis media. Prophylaxis in otic surgeries such as mastoid surgery.
Dosage and Administration: Eye: Adults (including the Elderly):
Corneal Ulcers: Ciprofloxacin administered as 2 drops into the affected eye every 15 minutes for the first six hours and then 2 drops into the affected eye every 30 minutes for the remainder of the day. Eventually 2 drops in the affected eye hourly. Then one drop in the affected eye every 4 hours., the dosing or at the discretion of the attending physician.
Superficial Ocular Infection: The usual dose is one or two drops in the affected eye(s) four times a day. In severe infections, the dosage for the first two days may be one or two drops every two hours during waking hours.
For either indication a maximum duration of therapy of 21 days is recommended.
Children: The safety and efficacy of ciprofloxacin eye drops in children under the age of
1 year has not been established. The dosage in children above the age of 1 year is the same as for adults.
Ear: For all infections, 2-3 drops every 2-3 hours initially, reducing the frequency of the instillation with the control of infection. Treatment should be continued at least 7 days.
Contraindications: Hypersensitivity to any component of this medication. The use of ciprofloxacin is also contraindicated in patients with hypersensitivity to other quinolones.
Side Effects: Local burning and ocular discomfort, itching, foreign body sensation, lid margin crusting, crystals / scales, conjunctival hyperemia and bad taste following instillation. Additionally, corneal staining, keratopathy / keratitis, allergic reactions, lid edema, tearing, photophobia, corneal infiltrates, nausea and decreased vision .
326

bexinfo: T
HERAPEUTIC
G
UIDE
Warning and Precautions: As with other antibacterial preparations, prolonged use of ciprofloxacin may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated. Ciprofloxacin should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity reaction. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported. To preserve sterility, do not allow the dropper to touch the eye or any other surface.
High risk group: Pregnancy & Lactation: This should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. Orally administered ciprofloxacin is excreted in the human milk. Therefore, caution should be exercised when ciprofloxacin is administered to nursing mothers.
Drug Interactions: Systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, to interfere with the metabolism of caffeine, and to enhance the effect of the oral anticoagulant, warfarin, and its derivatives.
Transient elevation in serum creatinine has been reported in patients receiving cyclosporin concomitantly with systemic ciprofloxacin.
Overdose: A topical overdose of ciprofloxacin may be flushed from the eye(s) with warm tap water.
Commercial Pack: Neofloxin ® Eye / Ear Drops: Plastic dropper bottle contains 5 ml sterile eye drops. Each ml contains Ciprofloxacin Hydrochloride USP equivalent to
Ciprofloxacin 3 mg.
®
Eye / Ear Drops
This is a preparation of Dexamethasone and Ciprofloxacin. Dexamethasone is glucocorticoid which has an anti-inflammatory and anti-allergic action. On the other hand,
Ciprofloxacin has a very high in vitro activity against almost all Gram negative microorganisms including Pseudomonas aeruginosa . It is also effective against Gram positive bacteria, such as Staphylococci and Streptococci.
Indications: Eye: This combination eye drop is indicated for the treatment of steroid responsive inflammatory ocular conditions where bacterial infections or risk of bacterial infections co-exist. The combination can also be used for post-operative inflammation and any other ocular inflammation associated with infection.
Ear: It is indicated for the treatment of ear infections accompanied by inflammation such as otitis externa, otitis media and chronic suppurative otitis media etc. The combination can also be used for post-operative inflammation of ear.
Dosage and Administration: Eye: One or two drops to be instilled into conjunctival sac(s) every four to six hours. During the initial 24 to 48 hours, the dosage may be
327

bexinfo: T
HERAPEUTIC
G
UIDE increased to one to two drops every two hours. Frequency should be decreased gradually or warranted in clinical signs. Care should be taken not to discontinue therapy prematurely.
Ear: For all infections two to three drops every two to three hours initially. Frequency should be decreased gradually as warranted by improvement in clinical signs.
Side Effect: Transient ocular burning or discomfort, stinging, redness, itching, conjunctivitis / keratitis, periocular / facial edema, foreign body sensation, photophobia, blurred vision, tearing, dryness, and eye pain.
Contraindication: Known hypersensitivity to any ingredient of the product, Herpes simplex and other viral conditions, mycosis, glaucoma, newborn babies, fungal diseases of ocular or auricular structures.
Warning and Precaution: Prolonged use may result in overgrowth of nonsusceptible organisms including fungi; in ocular hypertension and / or glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision and posterior sub capsular cataract formation. Patients wearing contact lenses must not use the drops during the time the lenses are worn.
To preserve sterility, do not allow the dropper to touch the eye or any other surface.
High Risk Group: Pregnancy & Lactation: This combination should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when the combination is administered to a nursing woman.
Drug Interactions: Dexamethasone: None relevant to topical use.
Ciprofloxacin: Systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, to interfere with the metabolism of caffeine, and to enhance the effect of the oral anticoagulant, warfarin, and its derivatives. Transient elevation in serum creatinine has been reported in patients receiving cyclosporin concomitantly with systemic ciprofloxacin.
Commercial Pack: Neofloxin ® D Eye / Ear Drops: Plastic dropper bottle contains 5 ml sterile suspension. Each ml contains Dexamethasone USP 1 mg and Ciprofloxacin
Hydrochloride USP equivalent to Ciprofloxacin 3 mg.
®
Eye / Ear Drops
This is a preparation of Chloramphenicol which is a broad spectrum bacteriostatic antibiotic active against a wide variety of Gram-negative and Gram-positive organisms.
Indications: Eye: Chloramphenicol eye drops is indicated in surface bacterial infection involving conjunctiva or cornea. Sepsis caused by some species of Bacteroides may respond to chloramphenicol eye drops.
328

bexinfo: T
HERAPEUTIC
G
UIDE
Ear: Chloramphenicol can inhibit or destroy the bacteria present in ear canal.
Dosage and Administration: Eye: Adults, children aged 2 years and over and elderly: One drop instilled into the infected eye every 2 hours for the first 48 hours and 4 hourly thereafter used during waking hours only or as directed by the physician..
Ear: 2-3 drops into ear canal three to four times daily.
Contraindications: Contraindicated in a history of hypersensitivity to Chloramphenicol or to any other ingredient of the drops, patients who have experienced myelosuppression during previous exposure to Chloramphenicol, patients with a family history of blood dyscrasias.
Side Effects: Transient burning or stinging sensations, hypersensitivity reactions that may manifest as angioneurotic edema, anaphylaxis, urticaria, fever, and vesicular and maculopapular dermatitis. Bone marrow depression, including the idiosyncratic type of irreversible and fatal aplastic anemia that is recognised to occur with systemic therapy, has been reported in association with topical administration of Chloramphenicol.
Warning and Precautions: Chloramphenicol therapy is associated with a potential risk of aplastic anemia or other hematodyscrasias. A careful risk / benefit evaluation should therefore be made in each individual case. The product should only be used where alternative therapies are contraindicated. To preserve sterility, do not allow the dropper to touch the eye or any other surface.
High risk group: Pregnancy and Lactation: It is not recommended for use during pregnancy and lactation.
Drug Interactions: Chloramphenicol should not be administered simultaneously with bactericidal antibiotics. Furthermore Chloramphenicol should not be administered at the same time as systemic treatment with drugs which have an adverse effect on hematopoiesis, nor simultaneously with sulphonylureas, coumarin derivatives, hydantoins and methotrexate (precautionary measured).
Commercial Pack: Ocutrex ® Eye / Ear Drops: Plastic dropper bottle contains 10 ml sterile eye drops. Each ml contains Chloramphenicol BP 5 mg.
®
Eye Drops
This is a preparation of Olopatadine 1 mg / ml which is an inhibitor of the release of histamine from the mast cell and a relatively selective histamine H1 –antagonist that inhibits the in vivo and in vitro type 1 immediate hypersensitivity reaction including inhibition of histamine induced effects on human conjunctival epithelial cells.
329

bexinfo: T
HERAPEUTIC
G
UIDE
Indications: For the treatment of the signs and symptoms of allergic conjunctivitis.
Dosage and Administration: The recommended dose is one drop in each affected eye two times a day at an interval of 6 to 8 hours to be continued for weeks to months as decided by the physician.
Side Effect: Headache, asthenia, blurred vision, burning or stinging, cold syndrome, dry eye, foreign body sensation, hyperemia, hypersensitivity, keratitis, lid edema, nausea, pharyngitis, pruritus, rhinitis, sinusitis, and taste perversion.
Contraindication: In persons with a known hypersensitivity to olopatadine hydrochloride or any components of the drug.
Warning and Precautions: For topical ophthalmic use only. Not for injection or oral use.
Patients should be advised not to wear a contact lens if their eye is red. Olopatadine hydrochloride ophthalmic solution should not be used to treat contact lens related irritation. To preserve sterility, do not allow the dropper to touch the eye or any other surface.
High Risk Group: Pregnancy Category C: This drug should be used in pregnant women only if the potential benefit to the mother justifies the potential risk to the embryo or fetus.
Pediatric Use: Safety and effectiveness in pediatric patients below the age of 3 years have not been established.
Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.
Commercial Pack: Olopan ® 0.1% Eye Drops: Dropper bottle containing 5 ml of sterile solution. Each ml contains Olopatadine Hydrochloride INN equivalent to Olopatadine
1mg.
®
Eye Drops
This is a preparation of Olopatadine (2 mg / ml)which is an inhibitor of the release of histamine from the mast cell and a relatively selective histamine H1 –antagonist that inhibits the in vivo and in vitro type 1 immediate hypersensitivity reaction including inhibition of histamine induced effects on human conjunctival epithelial cells.
Indications: For the treatment of the signs and symptoms of allergic conjunctivitis.
Dosage and Administration: The recommended dose is one drop daily in each affected eye.
330

bexinfo: T
HERAPEUTIC
G
UIDE
Side Effects: Headache, asthenia, blurred vision, burning or stinging, cold syndrome, dry eye, foreign body sensation, hyperemia, hypersensitivity, keratitis, lid edema, nausea, pharyngitis, pruritus, rhinitis, sinusitis, and taste perversion.
Contraindications: In persons with a known hypersensitivity to olopatadine hydrochloride or any components of the drug.
Warning and Precautions: Same as Olopan.
High Risk Group: Pregnancy Category C: This drug should be used in pregnant women only if the potential benefit to the mother justifies the potential risk to the embryo or fetus.
Pediatric Use: Safety and effectiveness in pediatric patients below the age of 3 years have not been established.
Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.
Commercial Pack: Olopan ® DS Eye Drops: Plastic dropper bottle of 5 ml. Each ml contains Olopatadine Hydrochloride INN equivalent to Olopatadine 2 mg.
®
Eye Drops
This is a preparation of Nepafenac which is a Non-steroidal anti-inflammatory (NSAID) prodrug for ophthalmic use.
Indications: Nepafenac ophthalmic suspension is indicated for the treatment of pain and inflammation associated with cataract surgery.
Dosage and Administration: One drop of Nepafenac should be applied to the affected eye(s) three-times-daily beginning 1 day prior to cataract surgery, continued on the day of surgery and through the first 2 weeks of the postoperative period. Nepafenac may be administered in conjunction with other topical ophthalmic medications such as β -blockers, carbonic anhydrase inhibitors, alpha-agonists, cycloplegics and mydriatics.
Side Effects: Capsular opacity, transient blurred vision due to drop itself, discomfort, increased intraocular pressure and sticky sensation, conjunctival edema, corneal edema, dry eye, lid margin crusting, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, photophobia, tearing and vitreous detachment
Contraindications: Contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formula or to other NSAIDs.
Warning and Precautions: With some Non-steroidal anti-inflammatory drugs including
331

bexinfo: T
HERAPEUTIC
G
UIDE
Nepafenac, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ocularly applied nonsteroidal anti-inflammatory drugs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery. To preserve sterility, do not allow the dropper to touch the eye or any other surface.
High Risk Group: Use in Pregnancy and Lactation: Nepafenac should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Nepafenac ophthalmic suspension is administered to a nursing woman.
Pediatric Use: The safety and effectiveness of Nepafenac in pediatric patients below the age of 10 years have not been established.
Commercial Pack: Opanac ® Eye Drops: Plastic dropper bottle contains 3 ml sterile
Suspension. Each ml contains Nepafenac INN 1 mg.
®
Eye Drops
This is a preparation of Fluorometholone (1 mg / ml) , which is a sterile, topical antiinflammatory agent for ophthalmic use.
Indications: Rubalon ophthalmic suspension is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.
Dosage and Administration: Instill one drop into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosage may be increased to one application every four hours. Care should be taken not to discontinue therapy prematurely. If signs and symptoms fail to improve after two days, the patient should be re-evaluated. In chronic conditions, withdrawal of treatment should be carried out by gradually decreasing the frequency of applications.
Contraindications: Contraindicated in most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella and also in mycobacterial infection of the eye and fungal diseases of ocular structures, in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.
Side Effects: Adverse reactions include, in decreasing order of frequency, elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation and delayed wound healing.
Other adverse effects are allergic reactions, visual disturbance (blurry vision) and taste perversion.
332

bexinfo: T
HERAPEUTIC
G
UIDE
Warning and Precautions: Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, and in posterior subcapsular cataract formation.
Prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections. Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning, may lead to perforation. Acute purulent infections of the eye may be masked or activity enhanced by the presence of corticosteroid medication. Intraocular pressure should be monitored.
To preserve sterility, do not allow the dropper to touch the eye or any other surface.
High Risk Group: Use in Pregnancy and Lactation: Pregnancy Category C:
Fluorometholone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because of the potential for serious adverse reactions in nursing infants from Fluorometholone, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use: Safety and effectiveness in infants below the age of 2 years have not been established.
Commercial Pack: Rubalon ® Eye Drops: Plastic dropper bottle contains 5 ml sterile suspension. Each ml contains Fluorometholone USP 1.0 mg.
®
Eye Drops
This is a preparation of Sodium Chloride BP 0.9%. This is an ocular peri-operative drug.
Indications: Irrigation, including first-aid removal of harmful substances; intra-ocular or topical irrigation during surgical procedure. To dilute bronchodilator solutions for inhalation. Also for tracheal lavage.
Dosage: As required.
Contraindications: Known hypersensitivity to any ingredients in this product.
Warning and Precaution: For topical use only. Not for injection or oral use.
Commercial Pack: Saloride ® Eye Drops: Dropper bottle containing 10 ml of sterile solution. Each ml of drop contains Sodium Chloride BP 9.0 mg.
333

bexinfo: T
HERAPEUTIC
G
UIDE
®
Eye Drops
This is a preparation of Povidone . This eye drop functions as an artificial tear solution by the physico-chemical properties of its active ingredient.
Indications: A tear fluid substitute for the symptomatic treatment of dry eye conditions.
Dosage and Administration: Instill one drop four times daily into the conjunctival sac of the eye.
Side Effects: Mild transient burning or sticky sensation on occasion, and very rarely irritation or hypersensitivity reactions.
Contraindications: Known hypersensitivity to the active ingredients or the preservative.
The safety in pregnancy and lactation has not been established.
Warning and Precautions: No contact lenses should be worn during instillation. They can be reinserted after an interval of at least 30 minutes. Avoid driving motor vehicles or operating machines if vision becomes blurred immediately after instillation. Caution should be exercised in the use of benzalkonium chloride preserved topical medication over an extended period in patients with extensive ocular surface disease. To preserve sterility, do not allow the dropper to touch the eye or any other surface.
High Risk Group: There are no adequate and well controlled studies in pregnant women.
The drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Commercial Pack: Tearex ® 5% Eye Drops: Dropper bottle containing 10 ml of sterile solution. Each ml contains Povidone BP 50 mg.
®
Eye Drops
This is a preparation of Polyethylene Glycol and Propylene Glycol.
Indications: This combination eye drop is indicated for the temporary relief of burning and irritation due to dryness of the eye.
Dosage and Administration: The frequency of instillation of drops and the duration of treatment will vary depending upon the severity of the underlying condition and the response to treatment. Usually instill 1 or 2 drops in the affected eyes.
Side Effects: Allergic reaction: Itching or hives, swelling in face or hands, swelling or tingling in mouth or throat, chest tightness, trouble breathing, changes in vision. eye pain, redness, or irritation may occur.
334

bexinfo: T
HERAPEUTIC
G
UIDE
Contraindications: Contraindicated in hypersensitivity to any component of the preparation.
Warning and Precautions: If eye pain, changes in vision, continued redness or irritation of the eye occurs, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor. Do not use if product changes color or becomes cloudy or if you are sensitive to any ingredient in this product. To avoid contamination, do not touch tip of container to any surface.
Commercial Pack: Tearon ® Eye Drops: Plastic dropper bottle contains 10 ml sterile eye drops. Each ml contains Polyethylene Glycol 400 USNF 4 mg and Propylene Glycol BP
3mg.
®
Eye Drops
This is a preparation of Ketotifen. It is a relatively selective, non-competitive histamine antagonist (H1-receptor) and mast cell stabilizer.
Indications: Indicated for the temporary prevention of itching of the eye due to allergic conjunctivitis.
Dosage and Administration: The recommended dose is one drop in the affected eye(s) every 8 to 12 hours.
Side Effects: Transient burning or stinging, punctate corneal epithelial erosion, less commonly dry eye, subconjunctival hemorrhage, photophobia, headache, drowsiness, skin reactions, and dry mouth also reported.
Contraindications: Contraindicated in persons with a known hypersensitivity to any component of this product.
Warning and Precautions: For topical ophthalmic use only. Not for injection or oral use.
Patients who wear soft contact lenses and whose eyes are not red, should be instructed to wait at least ten minutes after instilling the drug before they insert their contact lenses.
To preserve sterility, do not allow the dropper to touch the eye or any other surface.
High risk group: Use in Pregnancy and Lactation: Pregnancy Category C. Caution should be exercised when ketotifen fumarate is administered to a nursing mother.
Pediatric Use: Safety and effectiveness in pediatric patients below the age of 3 years have not been established.
Commercial Pack: Tofen ® 0.025% Eye Drops: Dropper bottle containing 5 ml of sterile solution. Ketotifen Fumarate BP equivalent to Ketotifen 0.25mg.
335

bexinfo: T
HERAPEUTIC
G
UIDE
®
Capsule
Vivis is a preparation of essential antioxidant vitamins, minerals and Lutein. A long term
Vitamin C supplement use (10+ years) and high serum Vitamin E concentrations have been associated with reduced risk of cataract. Lutein is a carotenoid specially concentrated in macula. This carotenoid could protect the macula from oxidative or light damage. One large study has found that high levels of dietary Lutein is associated with relatively lower risk of AMD (Age-Related Macular Degeneration). Zinc is an essential trace element involved in many enzyme systems. Copper plays important role in growth, skeletal integrity, and development of nervous system.
Indications: Vivis capsule is indicated for age-related eye disease. This is an advanced new antioxidant supplement formulated to provide nutritional support for the eye.
Dosage and Administration: One capsule, one or two times daily or as directed by the physician.
Side Effects: Large doses of Vitamin C are reported to cause diarrhea and other gastrointestinal disturbances. Large doses of Vitamin E may cause diarrhea, abdominal pain, and other gastrointestinal disturbances; fatigue and weakness have also been reported. Side effects of Zinc salt are abdominal pain and dyspepsia.
Contraindications: It is contraindicated in persons with a history of hypersensitivity to any of its ingredients.
Warning and Precautions: Vitamin C should be given with care to patients with hyperoxaluria. In patients taking oral anticoagulants or estrogen, Vitamin E should be given carefully because it has been found to antagonize the effects of vitamin K leading to an increase in blood clotting time in these patient.
Drug Interactions: No drug interactions has been reported.
Commercial Pack: Vivis ® Capsule: Box containing 30 capsules in 3 x 10’s alu-alu form packs. Each capsule contains Ascorbic Acid (Vitamin C) USP 60 mg, Vitamin E USP 30 mg, Zinc (as Zinc Oxide USP) 15mg, Copper (as Cupric Oxide Ph. Grade) 2mg, Lutein
USP 6mg.
336

bexinfo: T
HERAPEUTIC
G
UIDE
®
Eye Drops
This medicine contains two active ingredients, Latanoprost and Timolol Maleate.
Indications: Open angle glaucoma, raised pressure in the eye (ocular hypertension).
Dosage and Administration: The usual dose is one drop into the affected eye, or eyes once daily.
Side Effects: Headache, skin rashes, inflammation of the lining of the eye, causing pain and redness (conjunctivitis), inflammation of the eyelids (blepharitis), disorders of the front layer of the eye (cornea), change in colour of the iris (the coloured part of the eye), darkening, thickening and lengthening of the eyelashes, red eye due to excess blood supply (hyperemia), pain in the eye and eye irritation including stinging, burning and itching may occur.
Contraindications: Contraindicated in allergy to any of the ingredients of the product, a history of asthma, chronic obstructive lung disease, or other breathing problems, certain heart conduction defect, irregular heart beat or heart failure, pregnancy and lactation.
Warning and Precautions: This medicine may mask the symptoms of low blood sugar such as increased heart rate, tremor and nausea. The color change is due to increased melanin content in the stromal melanocytes of the iris and not to an increase in number of melanocytes. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery in affected eyes, but the entire iris or parts of it may become more brownish. No further increase in brown iris pigment has been observed after discontinuation of treatment. This should be used with caution in patients with a history of herpetic keratitis, and should be avoided in cases of active herpes simplex keratitis and in patients with a history of recurrent herpetic keratitis specifically associated with prostaglandin analogues. Latanoprost may gradually change eyelashes and vellus hair in the treated eye and surrounding areas; these changes include increased length, thickness, pigmentation, number of lashes or hairs and misdirected growth of eyelashes.
Eyelash changes are reversible upon discontinuation of treatment. Thyroid hormone and blood sugar changes are to be monitored and doses and therapy modification is to be done as decided by the physician if any changes occurs.
High Risk Group: The safety and efficacy of this medicine have not been established in children and adolescents.
Drug Interactions: Precipitation occurs when eye drops containing thimerosal are mixed with latanoprost. Patients receiving a β -adrenergic blocking agent orally and Timolol should be observed for potential additive effects.
Commercial Pack: Xalanol ® Eye Drops: Plastic dropper bottle containing 2.5 ml sterile solution. Each ml contains Latanoprost INN 0.05 mg and Timolol Maleate BP equivalent to Timolol 5mg.
337

bexinfo: T
HERAPEUTIC
G
UIDE
®
Eye Drops
This is a preparation of Latanoprost which is a prostaglandin F2α analogue.
Indications: Indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Dosage and Administration: The recommended dosage is 1 drop (1.5 mcg) in the affected eye(s) once daily in the evening.
Side Effects: Eyelash changes (increased length, thickness, pigmentation, and number of lashes); eyelid skin darkening; intraocular inflammation (iritis / uveitis); iris pigmentation changes; and macular edema, including cystoid macular edema.
Warning and Precautions: For topical ophthalmic use only. Not for injection or oral use.
It should be used with caution in patients with a history of intraocular inflammation (iritis
/ uveitis) and should generally not be used in patients with active intraocular inflammation.
This drug should be used with caution in patients who do not have an intact posterior capsule or who have known risk factors for macular edema. To preserve sterility, do not allow the dropper to touch the eye or any other surface.
High Risk Group: Pregnancy Category C.
The drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Drug Interactions: In vitro studies have shown that precipitation occurs when eye drops containing thimerosal are mixed with latanoprost.
Contraindications: Known hypersensitivity to Latanoprost, Benzalkonium chloride or any other ingredients in this product.
Commercial Pack: Xalaprost ® Eye Drops: Plastic dropper bottle containing 2.5 ml sterile solution. Each ml contains Latanoprost INN 0.05 mg.
®
Eye Drops
This is a preparation of Gatifloxacin which is a 8-methoxyfluoroquinolone with a 3methylpiperazinyl substituent at C7.
Indications: This is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of Aerobic Gram-Positive Bacteria and Aerobic Gram-Negative
Bacteria.
Dosage and Administration: The recommended dosage regimen for the treatment of
338

bexinfo: T
HERAPEUTIC
G
UIDE bacterial conjunctivitis is: Instill one drop every two hours in the affected eye(s) while awake, up to 8 times daily. Subsequently, instill one drop up to four times daily while awake or as directed by the physician.
Contraindications: Contraindicated in patients with a history of hypersensitivity to gatifloxacin, to other quinolones, or to any of the components in this medication.
Side Effects: Conjunctival irritation, increased lacrimation, keratitis, papillary conjunctivitis, chemosis, conjunctival hemorrhage, dry eye, eye discharge, eye irritation, eye pain, eyelid edema, headache, red eye, reduced visual acuity and taste disturbance.
Warning and Precautions: As with other anti-infectives, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs discontinue use and institute alternative therapy. In patients receiving systemic quinolones, including gatifloxacin, serious and occasionally fatal hypersensitivity
(anaphylactic) reactions, some following the first dose, have been reported. If an allergic reaction to gatifloxacin occurs, discontinue the drug. Serious acute hypersensitivity reactions may require immediate emergency treatment. To preserve sterility, do not allow the dropper to touch the eye or any other surface.
High risk group: Pregnancy and Lactation: Pregnancy category C. This should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether this drug is excreted in human milk. So, caution should be exercised when Gatifloxacin is administered to a nursing woman.
Pediatric Use: Safety and effectiveness in infants below the age of one year have not been established.
Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.
Drug Interactions: Systemic administration of some Quinolones has been shown to elevate plasma concentrations of Theophylline, interfere with the metabolism of caffeine, and enhance the effects of the oral anticoagulant Warfarin and its derivatives, and has been associated with transient elevations in serum creatinine in patients receiving systemic Cyclosporine concomitantly.
Commercial Pack: Xegal ® Eye Drops: Plastic dropper bottle contains 5 ml sterile eye drops. Each ml contains Gatifloxacin INN 3 mg.
339

bexinfo: T
HERAPEUTIC
G
UIDE
®
Eye Drops
This is a preparation of Ketorolac Tromethamine which is a member of the pyrrolo-pyrrole group of non steroidal anti-inflammatory drugs (NSAIDs).
Indications: It is indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction, ocular itching due to seasonal allergic conjunctivitis.
Dosage and Administration: For the treatment of relief of ocular itching due to seasonal allergic conjunctivitis, one drop (0.25 mg) four times a day. For the treatment of postoperative inflammation in patients who have undergone cataract extraction, one drop should be applied to the affected eye(s) four times daily beginning 24 hours after cataract surgery and continuing through the first 2 weeks of the postoperative period.
Side Effects: Transient stinging and burning on instillation, allergic reactions, corneal edema, iritis, ocular inflammation, ocular irritation, superficial keratitis and superficial ocular infections. Corneal infiltrates, corneal ulcer, eye dryness, headaches, and visual disturbance (blurry vision).
Contraindications: Contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation.
Warning and Precautions: There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other Non-steroidal anti-inflammatory agents.
Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs. With some Non-steroidal anti-inflammatory drugs, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. All topical Non-steroidal anti-inflammatory drugs (NSAIDs) may slow or delay healing. To preserve sterility, do not allow the dropper to touch the eye or any other surface.
High Risk Group: Pregnancy and Lactation: Pregnancy Category C: The drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The use of drug during late pregnancy should be avoided. Caution should be exercised when ophthalmic solution is administered to a nursing woman.
Pediatric Use: Safety and efficacy in pediatric patients below the age of 3 years have not been established.
Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.
Commercial Pack: Xidolac ® 0.5% Eye Drops: Dropper bottle containing 5 ml of sterile solution. Each ml contains Ketorolac Tromethamine USP 5 mg.
340

R
D

bexinfo: T
HERAPEUTIC
G
UIDE
A
NTIBIOTIC
S
OLUTION
®
Respirator Solution
Tobasol Respirator Solution is an aqueous solution of Tobramycin. Tobramycin is an aminoglycoside antibiotic and acts primarily by disrupting protein synthesis, leading to altered cell membrane permeability, and eventual cell death.
Indications: Tobasol Respirator Solution is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa.
Safety and efficacy have not been demonstrated in patients below the age of 6 years, patients with a forced expiratory volume <25% or >75% predicted, or patients colonized with Burkholderia cepacia.
Dosage and Administration: The recommended dosage for, both adult and pediatric patients, 6 years of age and older, is one single-use ampoule (300 mg) administered b.i.d
for 28 days. Dosage is not adjusted by weight. The doses should be taken as close to 12 hours apart as possible; they should not be taken less than 6 hours apart. In case of multi-medications, the recommended order is: bronchodilator first, followed by chest physiotherapy, then other inhaled medications and finally Tobasol. Tobasol is to be taken twice a day in repeated cycles of 28 days on drug, followed by 28 days off drug.
Side Effects: Inhaled Tobramycin is generally well-tolerated. Voice alterations and tinnitus are more common in the on-drug periods. However all the episodes are transient and resolved without discontinuation of the regimen. Others like dizziness and increase in serum creatinine were similar to those occurring with placebo.
Contraindications: Tobasol is contraindicated in patients with a known hypersensitivity to any aminoglycoside.
Warnings and Precautions: Tobasol Respirator Solution must only be used by inhalation from a nebulizer and must not be injected or swallowed. It should be used with care in patients with known or suspected renal, auditory, vestibular, or neuromuscular dysfunction. Patients receiving concomitant aminoglycoside therapy should be monitored as clinically appropriate. It must be used with caution in patients with ototoxicity and nephrotoxicity. Discuss the use of Tobramycin with your doctor if you have kidney problems or changes in hearing. If you are a nursing mother, pregnant or want to become pregnant, ask your doctor about the possibility of Tobramycin causing any harm.
Commercial Pack: Tobasol ® Respirator Solution: Box containing 1 x 5 ampoules of 5 ml. Each 5 ml ampoule contains Tobramycin USP 300 mg.
343

bexinfo: T
HERAPEUTIC
G
UIDE
A
STHMA
M
ANAGEMENT
®
HFA Inhalation Aerosol
This is a preparation of Salmeterol Xinafoate BP which is a selective, long acting ß2agonist used in the treatment of asthma and other forms of diffuse airways obstruction.
Indication: This is indicated for the long term regular treatment of reversible airways obstruction (including nocturnal and exercise-induced asthma) and chronic bronchitis. In pediatric asthma, the use of Bexitrol (Salmeterol) may avoid exposure of children to theophylline or high-dose corticosteroids, with their attendant risks.
Dosage and Administration: The recommended dose is 50 mg (2 puffs) twice daily, although in severe disease the dose may be increased to 100 mg twice daily. The drug should not be used on an ‘as required’ basis, although on account of its efficacy in nocturnal and exercise induced asthma, single dose administration may be considered as a treatment option.
Side Effects: No severe irreversible adverse effect is known although systemic β
2agonist effects of salmeterol may last up to 12 hours. Hypokalemia, tremor and palpitations may all occur but only at doses of salmeterol exceeding that recommended.
Contraindications: Contraindicated in patients with thyrotoxicosis. Special caution should be exercised in patients with cardiac problems predisposing to arrythmias. The drug is ineffective in patients taking non-selective
β
-blocking drugs.
Warning and Precautions Bronchodilators should not be the only or the main treatment in patients with severe or unstable asthma. Severe asthma requires regular medical assessment, including lung function testing, as patients are at risk of severe attack or even death. Physicians should consider using oral corticosteroid therapy and / or the maximum recommended dose of inhaled corticosteroid in these patients. Increasing use of bronchodilators, in particular short acting inhaled β
2-agonist to relieve symptoms indicates deterioration of asthma control. Then salmeterol inhaler is not designed to relieve acute asthmatic symptoms, for which patients should be advised to have short acting bronchodilator rescue medication available. Potentially serious hypokalemia may result from β
2-agonist therapy, Particular caution is advised in acute severe asthma as this effect may be potentiated by concomitant treatment with xanthine derivatives, steroids, diuretics and hypoxia. Salmeterol should be administered with caution in patients with thyrotoxicosis.
Commercial Pack: Bexitrol ® Inhaler: Each canister contains 120 metered doses, each actuation contains Salmeterol Xinafoate BP equivalent to 25 mg Salmeterol.
344

®
HFA Inhalation Aerosol
This is a preparation of Salmeterol and Fluticasone Propionate .
bexinfo: T
HERAPEUTIC
G
UIDE
Indication: This is indicated in the regular treatment of asthma where use of a combination product (long-acting β
2-agonist and inhaled corticosteroid) is appropriate:
- Patients not adequately controlled with inhaled corticosteroids and "as needed" inhaled short-acting
β
2-agonist or
- Patients already adequately controlled on both inhaled corticosteroids and long-acting
β
2-agonist
Dosage and Administration: Adults and adolescents 12 years and older-
Two inhalations of 25 mg Salmeterol and 50 mg Fluticasone Propionate twice daily. or,
Two inhalations of 25 mg Salmeterol and 125 mg Fluticasone Propionate twice daily. or,
Two inhalations of 25 mg Salmeterol and 250 mg Fluticasone Propionate twice daily.
Contraindications: Contraindicated in patients with a history of hypersensitivity to any of the ingredients.
Warnings and Precautions: Consideration should be given to additional corticosteroid therapies, and to include antibiotics if an infection is present. Care should be taken for patients with active or quiescent pulmonary tuberculosis and thyrotoxicosis.
Pediatric Use: Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. The long-term effects of this reduction including the impact of final adult height are unknown.
Pregnancy and Lactation: Administration of drugs during pregnancy and lactation should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus or child.
Drug Interaction: Both non-selective and selective ß-blockers should be avoided in patients with asthma, unless there are compelling reasons for their use. Co-administering of known strong CYP3A4 inhibitors (e.g. ketoconazole, ritonavir), may increase systemic exposure to Fluticasone Propionate.
Side Effects: Salmeterol: Tremor, subjective palpitations and headache have been reported, but tend to be transient and reduce with regular therapy. Cardiac arrhythmia
(including atrial fibrillation, supraventricular tachycardia and extra systoles) may occur, usually in susceptible patients. There have been reports of arthralgia and hypersensitivity reactions, including rash, edema and angioedema. There have been reports of oropharyngeal irritation.
345

bexinfo: T
HERAPEUTIC
G
UIDE
Fluticasone propionate: Hoarseness and candidiasis (thrush) of the mouth and throat can occur in some patients. Cutaneous hypersensitivity reactions have been reported.
Rare cases of facial and oropharyngeal edema have been reported.
Commercial Pack: Bexitrol ® F 25 / 250: Each canister contains 60 and 120 metered doses, each actuation delivers Salmeterol Xinafoate BP equivalent to 25 mg Salmeterol and Fluticasone Propionate BP 250 mg.
Bexitrol ® F 25 / 125: Each canister contains 120 metered doses, each actuation delivers
Salmeterol Xinafoate BP equivalent to 25 mg Salmeterol and Fluticasone Propionate BP
125 mg.
Bexitrol ® F 25 / 50: Each canister contains 120 metered doses, each actuation delivers
Salmeterol Xinafoate BP equivalent to 25 mg Salmeterol and Fluticasone Propionate BP
50 mg.
®
Dry Powder Inhaler
Bexitrol F Bexicap capsule is a combination of Salmeterol Xinafoate BP and Fluticasone
Propionate BP.
Indications: Bexitrol -F Bexicap is indicated in the regular treatment of asthma where use of a combination (long-acting ß2-agonist and inhaled corticosteroid) has been found to be appropriate, and in patients with severe Chronic Obstructive Pulmonary Disease
(COPD).
Dosage and Administration:
Asthma
Adults and Adolescents (12 years and older)
Bexitrol-F 50 / 100 Bexicap capsule: One Bexicap capsule twice daily
Bexitrol-F 50 / 250 Bexicap capsule: One Bexicap capsule twice daily
Bexitrol-F 50 / 500 Bexicap capsule: One Bexicap capsule twice daily
Children (4 years and older)
Bexitrol-F 50 / 100 Bexicap capsule: One Bexicap capsule twice daily
COPD
Bexitrol-F 50 / 250 Bexicap capsule: One Bexicap capsule twice daily
Bexitrol-F 50 / 500 Bexicap capsule: One Bexicap capsule twice daily
Contraindications: Contraindicated in patients with a history of hypersensitivity to any of the ingredients.
Warnings and Precautions: Consideration should be given to additional corticosteroid therapies, and to including administration of antibiotics if an infection is present. Care should be taken in patients with active or quiescent pulmonary tuberculosis and thyrotoxicosis.
346

bexinfo: T
HERAPEUTIC
G
UIDE
Pediatric Use: Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. The long-term effects of this reduction including the impact of final adult height are unknown.
Use in Pregnancy and Lactation: Administration of drugs during pregnancy and lactation should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus or child.
Drug Interaction: Both non-selective and selective b-blockers should be avoided in patients with asthma, unless there are compelling reasons for their use. Due to the very low plasma concentrations achieved after inhaled dosing clinically significant drug interactions are unlikely. Care should be taken when co-administering known strong
CYP3A4 inhibitors (e.g. ketoconazole, ritonavir), as there is potential for increased systemic exposure to Fluticasone Propionate.
Side Effects: Salmeterol: Tremor, subjective palpitations and headache, have been reported, but tend to be transient and reduce with regular therapy. Cardiac arrhythmia
(including atrial fibrillation, supraventricular tachycardia and extra systoles) may occur, usually in susceptible patients. There have been reports of arthralgia and hypersensitivity reactions, including rash, edema and angioedema. There have been reports of oropharyngeal irritation.
Fluticasone propionate: Hoarseness and candidiasis (thrush) of the mouth and throat can occur in some patients. Cutaneous hypersensitivity reactions have been reported.
Rare cases of facial and oropharyngeal edema have been reported.
Commercial Pack: Bexitrol ® F 50 / 100 Bexicap Capsule: Box containing 30 capsules in Alu-Alu blister strips. Each Bexicap capsule contains Salmeterol Xinafoate BP equivalent to Salmeterol 50 mcg and Fluticasone Propionate BP 100 mcg.
Bexitrol ® F 50 / 250 Bexicap Capsule: Box containing 30 capsules in Alu-Alu blister strips.
Each Bexicap capsule contains Salmeterol Xinafoate BP equivalent to Salmeterol 50 mcg and Fluticasone Propionate BP 250 mcg.
Bexitrol ® F 50 / 500 Bexicap Capsule: Box containing 30 capsules in Alu-Alu blister strips.
Each Bexicap capsule contains Salmeterol Xinafoate BP equivalent to Salmeterol 50 mcg & Fluticasone Propionate BP 500 mcg.
347

bexinfo: T
HERAPEUTIC
G
UIDE
®
HFA Inhalation Aerosol
This is a preparation of Ipratropium Bromide BP. The bronchodilation following inhalation of Ipratropium Bromide is primarily a local, site-specific effect and not a systemic one.
Indications: Ipratropium Bromide inhaler administered either alone or with other bronchodilators, especially β− adrenergics, is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.
Dosage and Administration: Adults, 20–40 micrograms, in early treatment up to 80 micrograms at a time, 3–4 times daily.
Child up to 6 years 20 micrograms 3 times daily, 6–12 years 20–40 micrograms 3 times daily.
Contraindications: Ipratropium Bromide inhalation aerosol is contraindicated in patients with a history of hypersensitivity to soya lecithin or related food products such as soya bean and peanut.
Ipratropium Bromide is contraindicated in known or suspected cases of hypersensitivity to Ipratropium Bromide, or to atropine and its derivatives.
Warning and Precautions: General: Ipratropium Bromide should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy or bladder-neck obstruction.
Pregnancy and Lactation: Pregnancy Category B: Ipratropium Bromide should be used during pregnancy only if clearly needed.It is not known whether Ipratropium Bromide is excreted in human milk. So, caution should be exercised when Ipratropium Bromide is administered to a nursing woman.
Pediatric Use: Safety and effectiveness in Pediactric population have not been established.
Side Effects: Headache, pain, influenza-like symptoms, back pain, chest pain, hypertension / hypertension aggravated, dizziness, insomnia, tremor, nervousness; dry mouth, nausea, constipation, arthritis, coughing, dyspnea, bronchitis, bronchospasm, sputum increased, respiratory disorder, pharyngitis, rhinitis, sinusitis. Aggravation of
COPD symptoms are more common when the total daily dose of Ipratropium Bromide equals or exceeds 2,000 mcg.
Commercial Pack: Ipramid ® Inhaler: Each canister contains 200 metered doses, each actuation delivers 20 mg Ipratropium Bromide BP.
348

bexinfo: T
HERAPEUTIC
G
UIDE
®
HFA Inhalation Aerosol
Iprasol inhalation aerosol is combination of Salbutamol (as Salbutamol Sulphate BP) and
Ipratropium Bromide BP.
Indications: This is indicated for use in patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator who continue to have evidence of bronchospasm and who require a second bronchodilator. It is also useful as regular bronchodilator in patients with asthma featuring COPD symptoms, in patients with asthma who have history of smoking >10 pack-years, and as reliever bronchodilator in asthmatic children below 2 years of age.
Dosage and Administration: The dosage of Iprasol should be adjusted according to disease type and severity of the individual patients and according to the dose of the individual ingredient.
Adults (including the elderly and adolescents over 12 years of age): 2 puffs four times a day. Patients may take additional puffs as required; however, the total number of puffs should not exceed 12 puffs in 24 hours.
Side Effects: Salbutamol: Mild tremor and headache have been rarely reported.
Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse have been reported very rarely. Ipratropium: Body as a whole-general disorders: Headache, Pain, Influenza, Chest Pain; Gastro-intestinal System Disorders:
Nausea; Respiratory System Disorders: Bronchitis, Dyspnea, Coughing, Pneumonia, and
Bronchospasm in lower part and Pharyngitis, Sinusitis and Rhinitis in the upper part.
Contraindications: This is contraindicated in patients hypersensitive to any other components of the drug product or to atropine or its derivatives. It is also contraindicated in patients with a history of hypersensitivity to soya lecithin or related food products such as soybean and peanut.
Warning and Precautions: General: Effects Seen with anticholinergic Drugs: Iprasol inhalation aerosol contains Ipratropium bromide and, therefore, it should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy or bladder-neck obstruction.
Effects Seen with Sympathomimetic Drugs: Preparations containing sympathomimetic amines such as Salbutamol sulphate should be used with caution in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus and in patients who are unusually responsive to sympathomimetic amines. β -adrenergic agents may also produce significant hypokalemia in some patients (possibly through intracellular shunting) which has the potential to produce adverse cardiovascular effects. The decrease in serum potassium is usually transient, not requiring supplementation.
Use in Hepatic or Renal Disease: Iprasol inhalation aerosol has not been studied in patients with hepatic or renal insufficiency. It should be used with caution in those patient populations.
349

bexinfo: T
HERAPEUTIC
G
UIDE
Paradoxical Bronchospasm: Iprasol inhalation aerosol can produce paradoxical bronchospasm that can be life threatening.
Cardiovascular Effect: This can produce a clinically significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure and / or symptoms. So this should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmia and hypertension. Immediate Hypersensitivity Reactions:
Immediate hypersensitivity reactions may occur after administration of Ipratropium bromide or Salbutamol sulphate, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis and oropharyngeal edema.
Uses in Pregnancy and Lactation: Ipratropium Bromide: Pregnancy Category B. Animal studies have demonstrated no evidence of teratogenic effects as a result of Ipratropium bromide. Salbutamol: Pregnancy Category C. Salbutamol has been shown to be teratogenic in mice. So, this should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether the components of Iprasol inhalation aerosol are excreted in human milk. So, caution should be exercised when this is administered to a nursing mother.
Drug Interactions: Iprasol inhalation aerosol has been used concomitantly with other drugs, including sympathomimetic bronchodilators, methylxanthines and steroids, commonly used in the treatment of COPD, without adverse drug reactions. Caution is therefore advised in the co-administration of Iprasol inhalation aerosol with other anticholinergic, β -adrenergics and diuretics: MAO and tricyclic antidepressant etc.
Commercial Pack: Iprasol ® Inhaler: Each canister contains 200 metered doses for inhalation aerosol with each actuation (Puff) containing 100 mcg of Salbutamol (as
Salbutamol Sulphate BP) and 20 mcg of Ipratropium Bromide BP.
®
Tablet
The active ingredient of Monocast tablet is Montelukast Sodium INN which is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene
CysLT
1 receptor.
Indications: This is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older, for the relief of symptoms of seasonal allergic rhinitis in adults and pediatric patients 2 years of age and older.
Dosage and Administration: General Information: Monocast should be taken once daily.
For asthma, the dose should be taken in the evening. For seasonal allergic rhinitis, the time of administration may be individualized to suit patients’ needs. Patients with both asthma and seasonal allergic rhinitis should take only one tablet daily in the evening.
Adults and Adolescents 15 years of age and older with asthma or seasonal allergic rhinitis: The dosage is one 10 mg tablet daily.
350

bexinfo: T
HERAPEUTIC
G
UIDE
Pediatric patients 6 to 14 years of age with asthma or seasonal allergic rhinitis: The dosage is one 5 mg chewable tablet daily. No dosage adjustment within this age group is necessary.
Pediatric patients 2 to 5 years of age with asthma or seasonal allergic rhinitis: The dosage is one 4 mg chewable tablet daily.
Pediatric patients 12 to 23 months of age with asthma: The dosage is one 4 mg chewable tablet daily to be taken in the evening. Safety and effectiveness in pediatric patients younger than 12 months of age have not been established.
Contraindication: Hypersensitivity to any component of this product.
Side Effects: Adolescents and Adults 15 years of age and older: Asthenia / fatigue, Fever,
Pain, Dyspepsia, Gastroenteritis,Dizziness, Headache; Respiratory System: Congestion,
Cough, Influenza; Skin: Rash; Laboratory adverse experiences: ALT increase, AST increase, Pyuria.
Pediatric patients 6 to 14 years of age: Diarrhea, laryngitis, pharyngitis, nausea, otitis, sinusitis, and viral infection.
Warning and Precautions: This is is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmaticus. Patients should be advised to have appropriate rescue medication available. Montelukast should not be abruptly substituted for inhaled or oral corticosteroids and should not be used as monotherapy for the treatment of exercise-induced bronchospasm. Patients who have exacerbation of asthma after exercise should continue to use their usual regimen of inhaled ß-agonist as prophylaxis and have available for rescue a short-acting inhaled ßagonist. Patients with known Aspirin sensitivity should continue avoidance of aspirin or non-steroidal anti-inflammatory agents while taking Montelukast. Although Montelukast is effective in improving airway function in asthmatics with documented aspirin sensitivity, it has not been shown to truncate bronchoconstrictor response to aspirin and other nonsteroidal anti-inflammatory drugs in aspirin-sensitive asthmatic patients.
Pediatric Use: Safety and efficacy of Montelukast has been established in adequate and well-controlled studies in pediatric patients with asthma and allergic rhinitis between age
1 to 14 years.
Geriatric Use: No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. But greater sensitivity of some older individuals cannot be ruled out.
Use in Pregnancy and Lactation: There are, however, no adequate and well-controlled studies in pregnant women. Montelukast should be used during pregnancy only if clearly needed. It is not known if Montelukast is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Montelukast is given to a nursing mother.
351

bexinfo: T
HERAPEUTIC
G
UIDE
Drug Interactions: Montelukast has been administered with other therapies routinely used in the prophylaxis and chronic treatment of asthma with no apparent increase in adverse reactions. In drug-interaction studies, the recommended clinical dose of
Montelukast did not have clinically important effects on the pharmacokinetics of
Theophylline, Prednisolone, oral contraceptives (norethindrone 1 mg / ethinyl estradiol
35 mg), Terfenadine, Digoxin, and Warfarin, thyroid hormones, sedative hypnotic, nonsteroidal anti-inflammatory agents, benzodiazepines, and decongestants. Clinical monitoring is necessary when potent cytochrome P450 enzyme inducers, such as
Phenobarbital or Rifampicin, are co-administered with Montelukast.
Commercial Pack: Monocast ® 10 Tablet , Monocast ® 5 Tablet and Monocast ® 4 Tablet:
Each box containing 20 film coated tablets in 2x10’s Alu-Alu form packs. Each tablet contains Montelukast Sodium INN equivalent to 10 mg Montelukast, 5 mg Montelukast and 4 mg Montelukast respectively.
®
HFA Inhalation Aerosol
Symbion HFA Inhaler is a combination of Formoterol Fumarate Dihydrate BP and
Budesonide BP.
Indication: This is indicated in maintenance Treatment of Asthma, and maintenance
Treatment of Chronic Obstructive Pulmonary Disease (COPD)
Dosage and Administration:
Asthma
Dosage is individual and should be adjusted according to disease severity. Symbion is taken as regular maintenance and as needed in response to symptoms. Patients should be advised to have their separate rapid acting bronchodilator available for rescue use at all times.
Adults (18 Years and Older)
Symbion 4.5 / 80 or Symbion 4.5 / 160 HFA Inhaler: 1-2 inhalations, twice daily
Adolescents (12-17 Years)
Symbion 4.5 / 160 HFA Inhaler: 1-2 inhalations, twice daily
Children (6-11 Years)
Symbion 4.5 / 160 HFA Inhaler: 1 inhalation, twice daily
The maximum recommended dosage is Symbion 4.5 / 160 mg two inhalations twice daily.
For all patients it is desirable to titrate to the lowest effective strength after adequate asthma stability is achieved. Not more than 6 inhalations should be taken on any single occasion.
352

bexinfo: T
HERAPEUTIC
G
UIDE
The recommended maintenance dosage for adult is 2 inhalations per day as maintenance therapy (either one inhalation twice daily, or two inhalations in either the morning or the evening), although some patients may require two inhalations twice daily. Patients should take 1 additional inhalation as needed in response to symptoms. If symptoms persist after a few minutes, an additional inhalation should be taken.
COPD (Chronic Obstructive Pulmonary Disease)
Symbion 4.5 / 160 HFA Inhaler: 2 inhalations, twice daily
Contraindications: This is contraindicated in patients with a history of hypersensitivity to any of the components of the drug. Symbion HFA Inhaler is not indicated for the relief of acute bronchospasm.
Side Effects: Formoterol Fumarate Dihydrate: Most common adverse events with
Formoterol are tremor, palpitations, headache etc. some uncommon and rare adverse events that occurred in the groups receiving Formoterol are cardiac arrhythmias, muscle cramps, and hypersensitivity reactions such as rash, edema and angiooedema etc.
Budesonide: The incidence of common adverse events with Budesonide are oropharyngeal candidiasis, hoarseness or throat irritation, dysphonia, back pain, nausea,sinusitis, adrenal suppression, etc.
Warnings and Precautions: It is recommended that the dose is tapered when the treatment is discontinued and should not be stopped abruptly. If patients find the treatment ineffective, or exceed the highest recommended dose of Symbion HFA Inhaler, medical attention must be sought. Sudden and progressive deterioration in control of asthma is potentially life threatening and the patient should undergo urgent medical assessment. Patients should be advised to have their rescue inhaler available at all times
Patients should be reminded to take their Symbion HFA Inhaler maintenance dose as prescribed, even when asymptomatic.
Pediatric use: It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroids is regularly monitored. If growth is slowed, therapy should be re-evaluated with the aim of reducing the dose of inhaled corticosteroid.
Use in Pregnancy and Lactation: Administration of Symbion HFA Inhaler in pregnant women should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus. It is not known whether Formoterol passes into human breast milk.
Drug Interactions: The metabolic conversion of Budesonide is impeded by substances metabolized by CYP P450 3A4 (e.g. itraconazole, ritonavir). The concomitant administration of these potent inhibitors of CYP P450 3A4 may increase plasma levels of Budesonide. The concomitant use of these drugs should be avoided unless the benefit outweighs the increased risk of systemic side-effects. In patients using potent CYP3A4 inhibitors, Symbion HFA Inhaler maintenance and reliever therapy is not recommended.
353

bexinfo: T
HERAPEUTIC
G
UIDE
Commercial Pack: Symbion ® 4.5 / 80 HFA Inhaler (With and without Dose Counter
Actuator): Each canister contains 120 metered doses, each actuation delivers Formoterol
Fumarate Dihydrate BP 4.5 µg and Budesonide BP 80 µg.
Symbion ® 4.5 / 160 HFA Inhaler (With and without Dose Counter Actuator): Each canister contains 120 metered doses, each actuation delivers Formoterol Fumarate Dihydrate BP
4.5 µg and Budesonide BP 160 µg.
®
Dry Powder Inhaler
Symbion Bexicap capsule is a combination of Formoterol Fumarate Dihydrate and
Budesonide.
Indications: Symbion Bexicap is indicated in the regular treatment of asthma, where the use of a combination (long-acting, β
2-agonist and inhaled corticosteroid) has been found to be appropriate. It is also indicated in the symptomatic treatment of severe Chronic
Obstructive Pulmonary Disease (COPD), with a history of repeated exacerbations despite regular therapy with long-acting bronchodilators.
Dosage and Administration: Asthma: Dosage is individual and should be adjusted according to disease severity. When control has been achieved, the dose should be titrated to the lowest effective dose. Patients should be advised to have their separate rapid acting bronchodilator available for rescue use at all times.
In adult (18 years and older) and Adolescents (12-17 years), Symbion 6 / 100 and 6/200 bexicap capsule is to be taken in 1-2 bexicap twice daily. In children (6-11 years), 6/100 bexicap is to be taken in 2 bexicap twice daily.
Patients take a daily maintenance dose of Symbion Bexicap and in combination take
Symbion Bexicap as needed in response to symptoms. Patients should be advised to always have Symbion Bexicap available for use.
The recommended maintenance dosage for adult is 2 inhalations per day as maintenance therapy (either one inhalation twice daily, or two inhalations in either the morning or the evening), although some patients may require two inhalations twice daily.
Not more than 6 inhalations should be taken on any single occasion. A total daily dose of more than 8 inhalations is not normally needed; however, a total daily dose of up of 12 inhalations could be used for a limited period. Patients using more than 8 inhalations daily should be strongly recommended to seek medical advice.
Chronic Obstructive Pulmonary Disease (COPD): Symbion 6 / 200 Bexicap: 2 Bexicap capsule, twice daily.
Side Effects: Formoterol: Most common adverse events with Formoterol are tremor, palpitations, headache etc. Some uncommon and rare adverse events that occurred in
354

bexinfo: T
HERAPEUTIC
G
UIDE the groups receiving Formoterol are cardiac arrhythmias, muscle cramps, and hypersensitivity reactions such as rash, edema and angioedema etc.
Budesonide: The incidence of common adverse events with Budesonide are oropharyngeal candidiasis, hoarseness or throat irritation, dysphonia, back pain, nausea,sinusitis, adrenal suppression, etc
Contraindications: Symbion Bexicap is contraindicated in patients with a history of hypersensitivity to any of the components of the drug product.
Warnings and Precautions: It is recommended that the dose is tapered when the treatment is discontinued and should not be stopped abruptly. If patients find the treatment ineffective, or exceed the highest recommended dose of Symbion Bexicap, medical attention must be sought. Sudden and progressive deterioration in control of asthma is potentially life threatening and the patient should undergo urgent medical assessment.
Pediatric use: It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroids is regularly monitored. If growth is slowed, therapy should be re-evaluated with the aim of reducing the dose of inhaled corticosteroid.
Pregnancy and Lactation: Administration of Symbion Bexicap in pregnant women should only be considered if the expected benefit to the mother is greater than any possible risk to the fetus. Budesonide is excreted in breast milk. However, at therapeutic doses no effects on the suckling child are anticipated. It is not known whether Formoterol passes into human breast milk.
Drug Interactions: Same like Symbion HFA Inhalation Aerosol.
Commercial Pack: Symbion ® 6 / 100 Bexicap Capsule and Symbion ® 6 / 200 Bexicap
Capsule: Each box containing 30 capsules in alu-alu blister strips. Each Bexicap capsule contains Formoterol Fumarate Dihydrate BP 6 µg and Budesonide BP 100 µg. AND
Formoterol Fumarate Dihydrate BP 6 µg & Budesonide BP 200 µg.respectively.
®
Dry Powder Inhaler
Tioriva Bexicap capsule contains Tiotropium Bromide INN as the active ingredient which is a long acting, antimuscarinic agent, which is often referred to as an anticholinergic.
Indication: Tioriva Bexicap is indicated for the long term, once daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease
(COPD), including chronic bronchitis and emphysema.
Dosage and Administration: Adult over 18 years: The recommended dose of Tioriva
Bexicap capsule is 18 mcg (1 capsule) once daily, with the Bexihaler device.
355

bexinfo: T
HERAPEUTIC
G
UIDE
The contents of the Tioriva Bexicap capsules are only for oral inhalation and should only be used with the Bexihaler device.
No dosage adjustment is required for geriatric, hepatically impaired, or renally impaired patients. However, patients with moderate to severe renal impairment given Tioriva
Bexicap capsule should be monitored closely for anticholinergic effects.
Contraindication: This is contraindicated in patients with a history of hypersensitivity to atropine or its derivatives, including ipratropium, or to any component of this product.
Warning and Precaution: As an anticholinergic drug, Tioriva Bexicap may potentially worsen symptoms and signs associated with narrow-angle glaucoma, prostatic hyperplasia or bladder-neck obstruction and should be used with caution in patients with any of these conditions.
Use in Pregnancy and Lactation: Pregnancy Category C. This should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The safety and effectiveness of Tioriva Bexicap has not been studied during labor and delivery.
Side Effects: The most commonly reported adverse drug reaction was dry mouth. Other side effects are constipation, increased heart rate, blurred vision, glaucoma, urinary difficulty, and urinary retention.
Drug Interactions: An interaction study with Tioriva Bexicap (14.4 mcg intravenous infusion over 15 minutes) and cimetidine 400 mg three times daily or ranitidine 300 mg once daily was conducted. Concomitant administration of cimetidine with Tioriva Bexicap resulted in a 20% increase in the AUC0-4h, a 28% decrease in the renal clearance of
Tioriva Bexicap and no significant change in the Cmax and amount excreted in urine over
96 hours. Co-administration of Tioriva Bexicap with ranitidine did not affect the pharmacokinetics of Tioriva Bexicap.
Commercial Pack: Tioriva ® Bexicap Capsule: Each box containing 30 capsules in Alu-
Alu blister strips. Each Tioriva Bexicap Capsule contains Tiotropium Bromide INN equivalent to Tiotropium 18 mcg.
ROPHYLAXIS
®
HFA Inhalation Aerosol
This is a preparation of Budesonide BP which is a corticosteroid designated that exhibits potent glucocorticoid activity and weak mineralocorticoid activity.
Indication: This is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients six years of age or older. It is also indicated for patients requiring oral corticosteroid therapy for asthma. Many of those patients may be able to reduce or eliminate their requirement for oral corticosteroids over time.
356

bexinfo: T
HERAPEUTIC
G
UIDE
Dosage and Administration: Aeronid Inhaler should be administered by the orally inhaled route in asthmatic patients aged 6 years and older.
The recommended starting dose and the highest recommended dose of Aeronid Inhaler are based on prior asthma therapy.
Recommended adult starting dose for bronchodilator and inhaled corticosteroid is 200-
400 mcg twice daily and maximum dose is 400 mcg and 800 mcg respectively. For children, recommended dose for bronchodilator and inhaled corticosteroid is 200 mcg twice daily and maximum dose is 400 mcg.
Side Effects: General: Headache, flu syndrome, pain, back pain, fever, neck pain, asthenia; Respiratory System: Respiratory infection, pharyngitis, sinusitis, rhinitis, voice alteration, cough aggravation; Digestive System: Oral candidiasis, dyspepsia, gastroenteritis, nausea, abdominal pain, dry mouth, vomiting; Cardiovascular: syncope;
Metabolic and Nutritional: Weight gain; Musculoskeletal: Fracture, myalgia; Nervous:
Hypertonia, migraine; Bleeding and Clotting: Ecchymosis; Psychiatric: Insomnia;
Resistance Mechanisms: Infection; Special Senses: Taste perversion; Musculoskeletal:
Arthralgia. Pediatric Studies: There were no clinically relevant differences in the pattern or severity of adverse events in children compared with those reported in adults.
Warning and Precautions: Budesonide Inhaler will often permit control of asthma symptoms with less suppression of HPA function than therapeutically equivalent oral doses of prednisone. Since budesonide is absorbed into the circulation and can be systemically active at higher doses, the full beneficial effects of Budesonide Inhaler in minimizing HPA dysfunction may be expected only when recommended dosages are not exceeded and individual patients are titrated to the lowest effective dose. Patients treated with these drugs should be observed carefully for any evidence of systemic corticosteroid effects. Care should be taken for patients with active or quiescent tuberculosis, untreated microbial infections, and post-operative patients. Cataract and glaucoma have been rarely reported.
Pregnancy Category C and Lactation: This should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when it is administered to nursing women.
Pediatric use: Safety and effectiveness in pediatric patients below 6 years of age have not been established. A reduction of growth velocity in children or teenagers may occur.
Physicians should closely follow the growth of all pediatric patients.
Contraindications: Budesonide inhalation aerosol is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. This is also contraindicated to hypersensitivity to budesonide contraindicates the use of Budesonide Inhaler.
Commercial Pack: Aeronid ® Inhaler: Each canister contains 200 metered doses for inhalation aerosol with each actuation (Puff) containing 200 mcg of Budesonide BP.
357

bexinfo: T
HERAPEUTIC
G
UIDE
®
HFA Inhalation Aerosol
Cesonide is a pressurised, metered-dose aerosol intended for oral inhalation only. The active component is Ciclesonide INN, an anti-inflammatory corticosteroid.
Indication: Ciclesonide is indicated for treatment to control persistent asthma in adults
(18 years and older).
Dosage and Administration: Ciclesonide is for inhalation use only. The recommended starting dose of Ciclesonide is 160 micrograms once daily which is usually also the maximum dose.
Side Effects: Common (1-10%): Paradoxical bronchospasm; uncommon (0.1-1%): Bad taste, application site reactions, application site dryness, hoarseness, cough after inhalation, rash and eczema.
Warning and Precautions: Care should be taken for patients with active or quiescent pulmonary tuberculosis, untreated microbial infections, and post-operative patients.
Cataract and glaucoma have been rarely reported.
Use in Pregnancy and Lactation: As with other inhaled glucocorticoids, Ciclesonide should only be used during pregnancy or lactation if the potential benefit to the mother justifies the potential risk to the mother, fetus or child.
Drug Interaction: Co-administration with a potent inhibitor of the cytochrome P450 3A4 system (e.g. ketoconazole, itraconazole and ritonavir or nelfinavir) should be considered with caution. The risk of clinical adverse effect (e.g. cushingoid syndrome) cannot be excluded.
Contraindications: Hypersensitivity to Ciclesonide or any of the excipients.
Commercial Pack: Cesonide ® 80 Inhaler and Cesonide ® 160 Inhaler: Each canister contains 120 metered doses for inhalation aerosol. Single actuation delivers Ciclesonide
INN 80 micrograms and Ciclesonide INN 160 micrograms respectively.
®
HFA Inhalation Aerosol
This is a preparation of Beclometasone Dipropionate BP.
Indications: Decomit HFA is indicated in the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older. This is also indicated for asthma patients who require systemic corticosteroid administration, where adding Beclometasone dipropionate may reduce or eliminate the need for the systemic corticosteroids.
Beclometasone dipropionate is not indicated for the relief of acute bronchospasm.
358

bexinfo: T
HERAPEUTIC
G
UIDE
Dosage and Administration: Recommended starting dose in adult for bronchodilator and inhaled corticosteroid is ( twice daily ) 50-100 mcg and 50-200 mcg respectively.
Highest recommended dose is 400 mcg for both. In case of children aged between 5-11 years, dose of bronchodilator and that of inhaled steroid is 50 mcg with maximum dose of 100 mcg for both drugs.
Warning and Precautions: Patients should be made aware of the prophylactic nature of therapy with Decomit inhaler and that it should be taken regularly, even when they are asymptomatic. The maximum daily administration of Decomit inhaler should not exceed
1mg (1000 mcg). Significant reduction in plasma cortisol levels has been reported in patients who receive twice this amount. Care should be taken for patients with active or quiescent pulmonary tuberculosis, untreated microbial infections, and post-operative patients. Cataract and glaucoma have been rarely reported.
Side Effects: Headache, pharyngitis, URTI, rhinitis, sinusitis, pain, back pain, nausea, dysphonia etc. In some patients, inhaled Beclometasone dipropionate may cause hoarseness or throat irritation.
Contraindications: Hypersensitivity to Beclometasone inhaler is a contraindication; and special care is necessary in patients with active or quiescent pulmonary tuberculosis.
Commercial Pack: Decomit ® 100 HFA Inhaler and Decomit ® 50 HFA Inhaler: Each canister contains 200 metered doses, each containing 100 mcg of beclometasone dipropionate BP and 50 mcg of beclometasone dipropionate BP respectively.
®
Tablet / Syrup
Tofen is a preparation of Ketotifen, which has antiallergic properties and has been used similarly, to sodium chromoglycate in the prophylactic treatment of asthma. It also has the properties of an antihistamine.
Indications: Prophylactic treatment of bronchial asthma, symptomatic treatment of allergic conditions including rhinitis and conjunctivitis.
Dosage and Administration: Adults:1 mg twice daily with food. If necessary the dose may be increased to 2 mg twice daily in severe cases.
Children above 2 years: 1 mg twice daily with two years food. Patient’s known to be easily sedated should begin treatment with 0.5 to 1 mg at night for the first few days or as directed by the physician.
Use in elderly: Same as adult dose or as advised by the physician.
Side Effects: Drowsiness and in isolated cases, dry mouth and slight dizziness may occur at the beginning of treatment, but usually disappear spontaneously after a few days.
359

bexinfo: T
HERAPEUTIC
G
UIDE
Contraindications: A reversible fall in the platelet count has been observed in a few patients receiving Ketotifen concomitantly with oral antidiabetic agent and it has been suggested that this combination should therefore be avoided. Although there is no evidence of any teratogenic effect, recommendations for Ketotifen in pregnancy or when breast-feeding can not be given.
Warning and Precautions: It is important to continue the previous treatment for a minimum of two weeks after starting Tofen to avoid the possibility of exacerbation of asthma. If inter current infection occurs, Tofen treatment must be supplemented by specific antimicrobial therapy. During the first day of treatment with this, reactions may be impaired and patients should be warned not to take charge of vehicle or machinery until the effect of treatment on the individual is known. Patient should be advised to avoid alcoholic drinks. This may potentiate the effects of sedatives, hypnotics, antihistamines and alcohol.
Commercial Pack: Tofen ® Tablet: Box containing 10 blister strips of 10 tablets & 20 blister strips of 10 tablets, each tablet contains Ketotifen Fumarate BP equivalent to 1 mg Ketotifen.
Tofen ® Syrup: 100 ml syrup in amber glass bottle, each 5 ml contains Ketotifen Fumarate
BP equivalent to 1 mg Ketotifen.
®
Tablet
Zukast contains Zafirlukast which is a synthetic, selective peptide leukotriene receptor antagonist (LTRA) that acts as a prophylactic agent against inflammation in asthma.
Indications: Zukast is indicated for the treatment of asthma.
Dosage and Administration: Zukast should be taken continuously. Pediatric patients 7 through 11 years of age: The recommended dose of ‘Zukast’ in children 7 through 11 years of age is 10 mg twice daily. Adult and children aged 12 years and over: The dosage is one 20 mg tablet twice daily. This dosage should not be exceeded. Higher doses may be associated with elevations of one or more liver enzymes consistent with hepatotoxicity.
As food may reduce the bioavailability of Zafirlukast, 'Zukast' should not be taken with meals. The clearance of Zafirlukast is significantly reduced in elderly patients (over 65 years old), and caution is recommended until further information is available. Children under 7 years of age: There is no clinical experience of the use of 'Zukast' in children under 7 years of age. Until safety information is available, use of 'Zukast' in this age group is contraindicated. Renal Impairment: No dosage adjustment is necessary in patients with mild renal impairment.
Side Effects: Headache, gastrointestinal disturbance, bruising, bleeding disorders, including menorrhagia (rare), thrombocytopenia and agranulocytosis (very rare), hypersensitivity reactions, rashes.
360

bexinfo: T
HERAPEUTIC
G
UIDE
Contraindications: Zukast should not be given to patients who have previously experienced hypersensitivity to the product or any of its ingredients, a history of moderate or severe renal impairment, hepatic impairment or cirrhosis, in children under 7 years of age until safety information is available.
Use in pregnancy and lactation: The safety of 'Zukast' in human pregnancy has not been established. In animal studies, Zafirlukast did not have any apparent effect on fertility and did not appear to have any teratogenic or selective toxic effect on the foetus. The potential risks should be weighed against the benefits of continuing therapy during pregnancy and
'Zukast' should be used during pregnancy only if clearly needed. Zafirlukast is excreted in human breast milk. 'Zukast' should not be administered to mothers who are breastfeeding.
Commercial Pack: Zukast ® Tablet: Box containing 10 tablets in 1X10’s alu-alu form pack, each tablet contains Zafirlukast INN 20 mg.
361

bexinfo: T
HERAPEUTIC
G
UIDE
B
RONCHODILATORS
®
Tablet
Azmasol tablet contains Salbutamol Sulphate BP which is a synthetic sympathomimetic agent with predominant β -adrenergic activity and selective action on receptors of bronchial muscle. It is used for the treatment of reversible obstruction of the airway.
Indications: This is indicated for the relief of bronchospasm in bronchial asthma, bronchitis, emphysema and also in bronchospasm where heart disease or hypertension is co-existing.
Dosage and Administration: Adult: 2-4 mg, 3-4 times daily. In some patients higher doses upto 8 mg may be given.
Children: 2-6 years: 1 mg, 3-4 times daily, 6-12 years: 2 mg, 3-4 times daily, Over 12 years: 2-4 mg, 3-4 times daily.
Contraindications: It should not be prescribed together with β -blocking drugs. Azmasol should not be used for prevention of premature labour associated with toxaemia of pregnancy or antepartum hemorrhage or for threatened abortion during the first and second trimesters of pregnancy.
Warning and Precautions: Salbutamol should be given with caution to hypersusceptible patients or those with hyperthyroidism, in patients with diabetes mellitus, serious cardiovascular disorders or hypertension. In asthmatic patients, whose condition deteriorates despite of Salbutamol therapy, alternative or additional therapy, including corticosteroids should be instituted promptly. Adverse metabolic effects of high doses of
Salbutamol may be exacerbated by concomitant, administration of high doses of corticosteroids. Hypokalemia associated with high doses of Salbutamol may result in increased susceptibility to digitalis-induced cardiac arrhythmias. Concomitant administration of aminophylline may enhance the effects of Salbutamol. Long term treatment may increase the risk of dental caries and hence adequate dental hygiene should be maintained.
Side Effects: Salbutamol may cause fine tremor for skeletal muscle (particularly the hands), palpitations and muscle cramps. Slight tachycardia, tense feeling, headache and peripheral vasodilation have been reported after large doses.
Treatment of Overdosage: The preferred antidote for overdosage with Salbutamol is a cardioselective
β
-blocking agent, but
β
-blocking drugs should be used with caution in patients with a history of bronchospasm.
Commercial Pack: Azmasol ® 2 Tablet: Box contains 50 blister strips of 10 tablets, each tablet contains Salbutamol Sulphate BP equivalent to Salbutamol 2 mg.
Azmasol ® 4 Tablet: Box contains 50 blister strips of 10 tablets, each tablet contains
Salbutamol Sulphate BP equivalent to Salbutamol 4 mg.
362

bexinfo: T
HERAPEUTIC
G
UIDE
®
HFA Inhalation Aerosol
Azmasol inhaler is an environment friendly, CFC-free inhaler. It contains Salbutamol (as
Salbutamol Sulphate BP) as the active ingredient which is a ß2-adrenoceptor agonist used in the treatment of asthma and other forms of diffuse reversible airways obstruction.
Indication: This is indicated for the treatment and prophylaxis of bronchial asthma and for the treatment of reversible airways obstruction associated with bronchitis and emphysema.
Dosage and Administration: Adults: For the relief of acute bronchospasm and for managing intermittent episodes of asthma: One or two inhalation as a single dose. For chronic maintenance or prophylactic therapy: Two inhalations three or four times daily.
For prevention of exercise induced bronchospasm: Two inhalations before exertion.
Children: For the relief of acute bronchospasm, management of episodic asthma and for prevention of exercise induced bronchospasm: One inhalation. For routine maintenance and prophylaxis: One inhalation three or four times daily, increasing if necessary to two inhalations three or four times daily.
Elderly: The dosage is the same as that for adults.
Side Effects: Mild tremor and headache have been rarely reported. These usually disappear with continuous treatment. There have been very rare reports of transient muscle cramp. Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse have been reported very rarely. As with other inhalation therapy, the potential for paradoxical bronchospasm should be kept in mind. If it occurs, the preparation should be discontinued immediately and alternative therapy should be instituted.
Contraindications: Salbutamol inhaler preparations are not appropriate for managing premature labor. This should not be used for threatened abortion during the first or second trimesters of pregnancy. This is contraindicated in patients with a history of hypersensitivity to any of its components.
Warning and Precautions: In the event of previously effective dose of Salbutamol inhaler failing to give relief for at least three hours, the patient should be advised to seek medical advice in order that any necessary additional steps may be taken. Salbutamol should be administered cautiously to patients suffering from thyrotoxicosis.
Commercial Pack: Azmasol ® HFA 200 and Azmasol ® HFA 300: Azmasol is available in two different packs containing 200 & 300 metered doses, each puff containing 100 mcg of Salbutamol (as Salbutamol Sulphate BP).
363

bexinfo: T
HERAPEUTIC
G
UIDE
®
Respirator Solution
This contains 20 ml Respirator Solution. Each ml of solution contains Salbutamol (as
Salbutamol Sulphate BP) 5 mg. This is one of a group of medicines called bronchodilators or 'relievers' and it is a ß2-adrenoceptor agonist, used in the treatment of asthma and other forms of diffuse reversible airways obstruction.
Indications: This is indicated for the treatment of severe acute asthma (status asthmaticus) and also other forms of bronchospasm.
Dosage and Administration: Adult: Respirator Solution 0.5 - 1.0 ml should be diluted to final volume of 2.0 - 4.0 ml with normal saline for injection. The resulting solution is inhaled from a suitably driven nebuliser until aerosol generation ceases. Using a correctly matched nebuliser and driving source this should take about 10 minutes. Some adult patients may require higher doses of salbutamol up to 10 mg in which case nebulisation may continue until aerosol generation ceases.
Children under 12 years age: 0.5 ml of the solution diluted to 2.0 - 4.0 ml with normal saline. Some children may however require higher doses of upto 1.0 ml of the solution.
Intermittent treatment may be repeated four times a day.
By Continuous Administration: The Respirator Solution is diluted with normal saline for injection, 1-2 ml solution made upto 100 ml with diluent. The diluted solution is administered as an aerosol by a suitably driven nebuliser. The usual rate of administration is 1-2 mg / hour. Delivery of the aerosol may be by face mask or via an endotracheal tube. Intermittent positive pressure may be used but is rarely necessary. When there is risk of anoxia through hypoventilation, oxygen should be added to the inspired air.
Side Effects: A small increase in heart rate may occur in patients who inhale large doses.
This is not usually accompanied by any changes in ECG. Other side effects which occur with high doses are peripheral vasodilatation and fine tremor of skeletal muscle.
Contraindications: History of hypersensitivity to any of its components. It should not be used for threatened abortion during the first or second trimester of pregnancy.
Warning and Precautions: Salbutamol Respirator Solution must only be used by inhalation from a nebuliser and must not be injected or swallowed. It should be used with care in patients known to have received large doses of other sympathomimetic drugs. It should be used with care in patients suffering from thyrotoxicosis. This should be used with a respirator or nebuliser, only under the direction of a physician. Patients receiving treatment at home with Salbutamol Respirator Solution should be warned that if either usual relief or usual duration of action is diminished . For further increment of dose and frequency should be done only by a physician.
Use in Pregnancy: Unnecessary administration of drugs during the first trimester of pregnancy is undesirable.
Dilution: Azmasol ® Respiration Solution may be diluted with Sodium Chloride Injection
BP (normal saline). Solutions in nebulisers should be replaced daily.
364

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablet / Syrup
Bronkolax is a preparation of Salbutamol Sulphate which is a synthetic sympathomimetic agent with predominant β -adrenergic activity and selective action on receptors of bronchial muscle.
Indications: Bronkolax is indicated for the relief of bronchospasm in bronchial asthma, bronchitis, emphysema and also in bronchospasm where heart disease or hypertension is co-existing.
Dosage and Administration: Adults: 2-4 mg, 3-4 times daily. In some patients higher doses upto 8 mg may be given.
Children: 2-6 years: 1 mg, 3-4 times daily, 6-12 years: 2 mg, 3-4 times daily, Over 12 years: 2-4 mg, 3-4 times daily
Contraindications: It should not be prescribed together with β -blocking drugs.
Bronkolax should not be used for prevention of premature labor associated with toxemia of pregnancy or antepartum hemorrhage or for threatened abortion during the first and second trimesters of pregnancy.
Warning and Precautions: Bronkolax should be given with caution to hypersusceptible patients or those with hyperthyroidism, diabetes mellitus, serious cardiovascular disorders or hypertension. In asthmatic patients, whose condition deteriorates despite of
Salbutamol therapy, alternative or additional therapy should be instituted promptly.
Adverse metabolic effects of high doses of Salbutamol may be exacerbated by concomitant administration of high doses of corticosteroids. Hypokalemia associated with high doses of Salbutamol may result in increased susceptibility to digitalis-induced cardiac arrhythmias. Concomitant administration of aminophylline may enhance the effects of
Salbutamol. Long term treatment may increase the risk of dental caries and hence adequate dental hygiene should be maintained.
Side Effects: Bronkolax may cause fine tremor for skeletal muscle (particularly the hands), palpitations, and muscle cramps. Slight tachycardia, tense feeling, headache, and peripheral vasodilation have been reported after large doses.
Treatment of Overdosage: The preferred antidote for overdosage with Salbutamol is a cardioselective β -blocking agent, but β -blocking drugs should be used with caution in patients with a history of bronchospasm.
Commercial Pack: Bronkolax ® 2 Tablet: Box containing 10 aluminium strips of 10 tablets, each tablet contains Salbutamol Sulphate BP equivalent to Salbutamol 2 mg.
Bronkolax ® 4 Tablet: Box containing 10 blister strips of 10 tablets, each tablet contains
Salbutamol Sulphate BP equivalent to Salbutamol 4 mg.
Bronkolax ® Syrup: Bronkolax Syrup is available in 50 ml and 100 ml amber glass bottle, each 5 ml contains Salbutamol Sulphate BP equivalent to Salbutamol 2 mg.
365

bexinfo: T
HERAPEUTIC
G
UIDE
®
Respirator Solution
This is a preparation of Terbutaline Sulfate which is a selective β2-adrenergic agonist used as a bronchodilator and tocolytic.
Indication: Used to open up the airways in people with asthma, bronchitis and other breathing problems, used to relieve trouble breathing upon exertion, for the prevention and reversal of bronchospasm in patients 12 years of age and older with reversible, obstructive airway disease, symptomatic management of reversible bronchospasm associated with bronchitis and emphysema.
Dosage and Administration: The recommended adult dose for treating asthma, emphysema or bronchitis is 2.5-5 mg 3 times daily approximately 6 hours apart while awake. The maximum dosage is 15 mg / day.
Warning and Precautions: Before you use this drug, tell your doctor if you have: any allergies, heart disease, high blood pressure, an overactive thyroid gland, seizures, diabetes. Tell your doctor if you ever had a bad reaction to albuterol, bitolterol, ephedrine, epinephrine, isoetharine, isoproterenol, metaproterenol, pseudoephedrine, or pirbuterol or other similar agents. Tell your doctor if you are pregnant before using this medication.
Terbutaline is excreted into breast milk. Consult with your doctor before breast-feeding.
Terbutaline is not recommended for children under the age of 6. Caution is advised in the elderly.
Use in Pregnancy and Lactation: Bricasol should only be administered with caution during the first trimester of pregnancy. Terbutaline is secreted via breast milk, but effect on the infant is unlikely at therapeutic doses.
Contraindications: Do not use Terbutaline if the patients are allergic to any ingredient in Terbutaline or to a sympathomimetic amine (eg, epinephrine, albuterol). The patient need to treat prolonged (more than 48 to 72 hours) premature labor.
Side Effects: Dry mouth, irritated throat, nausea, dizziness, headache, heartburn, loss of appetite, altered taste sensation, restlessness, anxiety, nervousness, trembling, and sweating may occur but should subside as your body adjusts to the medication.
Commercial Pack: Bricasol ® Respirator Solution: Box containing 1 x 5 ampoules of 2 ml. Each 2 ml ampoule contains Terbutaline Sulfate USP 5 mg.
366

bexinfo: T
HERAPEUTIC
G
UIDE
®
Respirator Solution
This is a preparation of Arformoterol INN. This is a selective long acting β2-adrenoceptor agonist that helps the muscle around airways in lungs stayed relaxed to prevent symptoms such as wheezing, cough, chest tightness and shortness of breath.
Indications: This is indicated for the long term, twice daily (morning and evening) maintenance treatment of bronchoconstriction in patients with COPD, including chronic bronchitis and emphysema. It controls the symptoms of COPD in adults.
Dosage and Administration: The recommended dose of Forterol respirator solution for
COPD patients is 15 mg administered twice a day (morning and evening) by nebulization.
A total daily dose greater than 30 mcg (15 mg twice daily) is not recommended. The solution should be administered by the inhaled route via a standard jet nebulizer connected to an air compressor.
Forterol requires no dilution before administration by nebulization.
Side Effects: Sudden shortness of breath immediately after use of Forterol. Cardiac arrhythmia, hypertension, serious allergic reaction including rash, swelling of the face, mouth and tongue can also occur. Chest or back pain, diarrhea, sinus congestion, headache, tremor, rash, fever, vomiting, chest congestion or bronchitis.
Contraindications: History of hypersensitivity to any of its components. All long acting
β
2-agonists are contraindicated in patients with asthma without use of long term asthma control medication.
Warning and Precautions: This should not be used to treat acute symptoms of COPD.
It should not be used with other medicines that contain long acting
β
2-agonist medicine.
Forterol should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, Cardiac arrhythmias and hypertension, convulsive disorders or thyrotoxicosis.
Use in Pregnancy and Lactation: Avoid taking this drug without medical advice during pregnancy or breast feeding.
Pediatric Use: COPD does not occur in children. The safety and effictiveness of Forterol in pediatric patients have not been established.
Overdose: Overdosage should be strictly avoided, because cardiac arrest and even death may be associated with an overdose of Forterol.
Commercial Pack: Forterol ® Respirator Solution: Box containing 1 x 5 Ampoules of 2 ml. Each 2 ml Ampoule contains Arformoterol Tartrate INN equivalent to Arformoterol
15mg.
367

bexinfo: T
HERAPEUTIC
G
UIDE
®
Respirator Solution
This is a preparation of Ipratropium Bromide 250 mcg / ml which is an anticholinergic bronchodilator. It inhibits vagally mediated reflexes by antagonizing, the action of acetylcholine, the transmitter agent released from the vagal nerve.
Indications: Ipratropium bromide Respirator Solution is indicated for the treatment of acute exacerbations of COPD. It is also indicated as a bronchodilator for maintenance treatment for bronchospasm associated with chronic obstructive pulmonary disease.
Ipratropium bromide Respirator Solution when used in conjunction with Salbutamol is indicated for acute asthmatic attacks.
Dosage and Administration: The dosage should be adapted to the individual requirements of the patient. Patients should also be kept under medical supervision during treatment. The recommended dose is to be diluted with physiological saline to a final volume of 3-4 ml and nebulised and inhaled until the solution is consumed. The solution should be rediluted each time before use, any residual solution should be discarded. Adults (including the elderly and adolescents over 14 years of age): 0.4 ml -
2 ml (100 mcg - 500 mcg) three or four times daily. Children (6-14 years): 0.4 ml - 2 ml
(100 mcg - 500 mcg) three or four times daily. Children (Under 6 years of age): Because there is limited information in this age group, the following dose is recommended, which should be given under medical supervision; 0.4 - 1 ml (100 mcg - 250 mcg) three or four times daily. The dose may be repeated after intervals for at least 2 hours, if required.
Daily doses exceeding 2 mg should be given under medical supervision.
Side Effects: In isolated cases there may be local reactions such as dryness of the mouth, throat irritation, or allergic reactions. As with other bronchodilators, in some cases cough, in very rare instances paradoxical bronchoconstriction have been observed. If, by inappropriate handling, the aerosol enters the eyes in patients with narrow angle glaucoma, a rise of intraocular pressure may occur. In these cases eye drops to induce moisis should be administered.
Contraindications: Hypersensitivity to atropine or its derivatives.
Warning and Precautions: Ipratropium bromide is not indicated for the initial treatment of acute episodes of bronchospasm where rapid response is required. The patient should be warned to seek medical advice, when a reduced response becomes apparent during therapy. Caution is generally advocated in the use of anticholinergic agents in patients with narrow-angle glaucoma and urinary outflow obstruction due to prostatic hypertrophy.
It is advisable not to greatly exceed the recommended daily dose during both acute and maintenance treatment. If therapy does not produce significant improvement or if the patient's condition gets worse, medical advice must be sought in order to determine a new plan of treatment. In the case of acute or rapidly worsening dyspnea (difficulty in breathing) a doctor should be consulted immediately.
368

bexinfo: T
HERAPEUTIC
G
UIDE
Use in Pregnancy: Preclinicial studies have shown no hazard but safety during human pregnancy has not yet been established. The usual precautions regarding the use of drugs at this time, especially during the first trimester should be observed. Nursing
Mothers: Safety has not yet been established.
Commercial Pack: Ipramid ® Respirator Solution: Glass bottle of 20 ml Respirator
Solution. Each ml of solution contains Ipratropium Bromide BP 250 mcg.
®
Respirator Solution
This Inhalation Solution is a combination of the anticholinergic bronchodilator, ipratropium bromide, and the ß2-adrenergic bronchodilator, salbutamol sulfate.
Indications: For the management of bronchospasm in patients suffering from Chronic
Obstructive Pulmonary Disease (COPD) who require regular treatment with both ipratropium and salbutamol.
Dosage and Administration: Adults and Children over 12 years: COPD: Required amount may be administered from a suitable nebulizer or an intermittent positive pressure ventilator. The recommended dosage is 0.5 mg of Ipratropium Bromide and 2.5 mg of
Salbutamol 3 or 4 times daily.
Dilution Instructions: If necessary, before use, doses may be diluted to a total nebulization volume of 3 to 5 mL with preservative-free 0.9% sterile sodium chloride solution and used immediately. Nebulize over 10 to 15 minutes at gas flow of 6 to 10 L / min. Repeat every
6 hours as necessary.
Side Effects: Hypertension, nervousness, tachycardia, tremor and palpitations, and urinary retention especially in susceptible patients. Fatigue, abdominal pain, dyspepsia, sinusitis, and dysuria, headache, dizziness, nervousness, fine tremor of skeletal muscles and palpitations, ocular accommodation disturbances, gastrointestinal motility disturbances.
Contraindications: In patients with cardiac tachyarrhythmias, hypertrophic obstructive cardiomyopathy and patients with a history of hypersensitivity to any of its components or to atropine or its derivatives.
Warning and Precautions: The solution is intended only for inhalation with suitable nebulizing devices and should not be taken orally or administered parenterally. Patients must be instructed in the correct use of respirator solution and warned not to allow the solution or mist to enter the eyes. Acute angle glaucoma has been reported rarely when nebulized solutions of ipratropium have been used in conjunction with β
2-agonist bronchodilators. Solution should only be used after careful risk / benefit assessment in conditions like hypertrophic obstructive cardiomyopathy, tachyarrhythmia, inadequately
369

bexinfo: T
HERAPEUTIC
G
UIDE controlled diabetes mellitus, recent myocardial infarction and / or severe organic heart or vascular disorders, hyperthyroidism, pheochromocytoma, risk of narrow-angle glaucoma, prostatic hypertrophy, urinary retention, or bladder-neck obstruction.
High Risk Group: Pregnancy: The safety of this Inhalation Solution in pregnancy has not been established. The benefits of using the drug when pregnancy is present or suspected must be weighed against possible hazards caused to the fetus.
Lactation: The benefits of this Inhalation Solution use during lactation should therefore be weighed against possible effects on the infant.
Children: The efficacy and safety in children under 12 years have not been established.
Commercial Pack: Iprasol ® Respirator Solution: Glass bottle of 20 ml Respirator
Solution. Each ml of solution contains Ipratropium Bromide BP 0.5 mg and Salbutamol
(as Salbutamol Sulphate BP) 2.5 mg.
®
Tablet
This is a preparation of Aminophylline BP which is a stable mixture or combination of theophylline and ethylenediamine.
Indications: It is indicated for the treatment and prophylaxis of bronchospasm associated with asthma, emphysema and chronic bronchitis. Also indicated in adults for the treatment of cardiac asthma and left ventricular or congestive cardiac failure.
Dosage and Administration: Larnox LA tablets possess a slow release mechanism, which gives an effective therapeutic blood levels, lasting up to 12 hours. The recommended initial dose is 1 tablet (350 mg aminophylline) every 12 hours. The dosage may be gradually increased to a maximum of 2 tablets (700 mg aminophylline) twice a day depending on the patient’s response.
Note: Tablets should be swallowed whole and not chewed because of the structure of the tablet.
Contraindications: Aminophylline should not be administered to patients with hypersensitivity to xanthines or ehylenediamine. It should not be administered to patients with active peptic ulcer, since it may increase the volume and acidity of gastric secretions.
Side Effects: The most common adverse effects are gastric irritation, nausea, vomiting, diarrhea, hematemesis, epigastric pain and tremor. These are usually early signs of toxicity; however, with high doses, ventricular arrhythmias or seizures may be the first signs to appear and reactivation of peptic ulcer, headache, irritability, restlessness, insomnia, twitching, convulsion and reflex hyperexcitability, palpitation, tachycardia,
370

bexinfo: T
HERAPEUTIC
G
UIDE hypotension, circulatory failure, ventricular arrhythmias, and flushing, albuminuria, diuresis and hematuria. Also inappropriate ADH syndrome may occur.
Warning and Precautions: Aminophylline should be given with caution to patients with peptic ulceration, hyperthyroidism, hypertension, cardiac arrhythmias or other cardiovascular disease, or epilepsy, as these conditions may be exacerbated. They should also be given with caution to patients with heart failure, hepatic dysfunction, chronic alcoholism, acute febrile illness, and to neonates and the elderly, since in all of these circumstances theophylline clearance may be decreased, resulting in increases in serum-theophylline concentrations and serum half-life.
Use in Pregnancy and Lactation: Use of aminophylline in pregnant women should be balanced against the risk of uncontrolled disease.
Commercial Pack: Larnox ® LA Tablet: Box containing 50 tablets in 5x10’s blister strips; each tablet contains Aminophylline BP 350 mg
®
Respirator Solution
This is a preparation of Acetylcysteine. Mucomist Respirator Solution is a derivative of the amino acid, cysteine.
Indications: This is indicated as adjuvant therapy for patients with abnormal, viscid, or inspissated mucus secretions in such conditions as: Chronic bronchopulmonary disease
(chronic emphysema, emphysema with bronchitis, chronic asthmatic bronchitis, tuberculosis, bronchietasis, and primary amyloidosis of the lungs), Acute bronchopulmonary disease (pneumonia, bronchitis, tracheobronchitis), Pulmonary complications of cystic fibrosis, Tracheostomy care, Pulmonary complications associated with surgery, during anesthesia, Post-traumatic chest conditions, Atelectasis due to mucus obstruction, Diagnostic bronchial studies (bronchograms, bronchospirometry and bronchial wedge catheterization), As an Antidote for Acetaminophen Overdose.
Dosage and Administration: The 20% solution may be diluted to a lesser concentration with either Sodium Chloride for Injection, Sodium Chloride for Inhalation, Sterile Water for Injection, or Sterile Water for Inhalation. Acetylcysteine may be administered using conventional nebulizers made of plastic or glass. Acetylcysteine should not be placed directly into the chamber of a heated (hot pot) nebulizer.
When nebulized into a face mask, mouthpiece, or tracheostomy, 1-10 mL of the 20% solution may be given every 2-6 hours. The recommended dose for most patients is 3-5 mL of the 20% solution, 3-4 times a day.
Nebulization Tent or Croupette: Under special circumstances, it may be necessary to nebulize into a tent or croupette, and this method of use must be individualized and requires very large volumes of the solution, occasionally as much as 300 mL during a single treatment period. The recommended dose is the volume of acetylcysteine (using
20%) that will maintain a very heavy mist in the tent or croupette for the desired period.
371

bexinfo: T
HERAPEUTIC
G
UIDE
When used by direct instillation, 1-2 mL of a 20% solution may be given as often as every hour. When used for the routine nursing care of patients with tracheostomy, 1-2 mL of a
20% solution may be given every 1-4 hours by instillation into the tracheostomy.
Acetylcysteine may be introduced directly into a particular segment of the bronchopulmonary tree by inserting (under local anaesthesia and direct vision) a small plastic catheter into the trachea. Then, 2-5 mL of the 20% solution may be instilled by means of a syringe connected to the catheter. Acetylcysteine may also be given through a percutaneous intratracheal catheter.
Here, 1-2 mL of the 20% solution, every 1-4 hours, may be given via a syringe attached to the catheter.
For diagnostic bronchial studies, two to three administrations of 1-2 mL of the 20% solution should be given by nebulization or by instillation intratracheally, prior to the procedure.
As an Antidote for Acetaminophen Overdose: Regardless of the overdose of acetaminophen ingested, administer acetylcysteine immediately if 24 hours or less have elapsed from the reported time of ingestion. Do not wait for the results of the assays for acetaminophen before initiating treatment with acetylcysteine.
The stomach should be emptied promptly by lavage or by inducing emesis with syrup of ipecac. In the case of mixed drug overdose, activated charcoal may be indicated.
However, if activated charcoal has been administered, lavage before administering acetylcysteine treatment.
Administer the loading dose of acetylcysteine at 140 mg per kg of body weight. Then, 4 hours after the loading dose, administer the first maintenance dose (70 mg of acetylcysteine per kg of body weight). The maintenance dose should then be repeated at 4-hour intervals for totally 17 doses, unless the acetaminophen assay reveals a nontoxic level as discussed below.
If the patient vomits the loading dose or any maintenance dose within 1 hour of administration, repeat that dose.
In the occasional instances where the patient is persistently unable to retain the orally administered acetylcysteine, the antidote may be administered to duodenal intubation.
Preparation of Acetylcysteine for Oral Administration
Oral administration requires dilution of the 20% solution with diet cola or other diet soft drinks, to a final concentration of 5%. If administered via a gastric tube or a Miller-Abbott tube, water may be used as the diluent. The dilutions should be freshly prepared and utilized within 1 hour. The remaining undiluted solutions in the opened vials can be stored in the refrigerator up to 96 hours.
372

bexinfo: T
HERAPEUTIC
G
UIDE
Dosage Guide and Preparation: Doses in Relation to Body Weight
Body Weight
(kg)
Grams
Acetyl-cysteine
Loading Dose of Acetylcysteine mL of 20%
Acetylcysteine mL of Diluent
5% Solution
Total mL of
100-109 15
90-99 14
75 225 300
80-89 13
70-79 11 55 165
60-69 10
50-59 8 40 120
30-39 6
20-29 4 20 60
100-109 7.5 37 113 150
90-99 7 35 105
80-89 6.5
70-79 5.5
33
28
97 130
82 110
60-69 5 25 75
50-59 4 20 60
40-49 3.5 18 52 70
30-39 3 15 45
20-29 2 10 30
** If a patient weighs less than 20 kg (usually, patients younger than 6 years of age), calculate the dose of acetyleysteine. Each mL of 20% solution contains 200 mg of acetylcysteine. The loading dose is 140 mg / kg of body weight. The maintenance dose is 70 mg / kg. To each mL of 20% acetylcysteine, 3mL of diluent should be added. Do not decrease the proportion of diluent.
Contraindications: Hypersensitivity to acetylcysteine, its derivatives, or any of the components in the preparation.
Warnings and Precautions: After proper administration of acetylcysteine, an increased volume of liquefied bronchial secretions may occur. When cough is inadequate, the airway must be maintained open by mechanical suction if necessary. When there is a mechanical block due to foreign body or local accumulation, the airway should be cleared by endotracheal aspiration, with or without bronchoscopy. Asthmatics under treatment with acetylcysteine should be watched carefully. Most patients with bronchospasm are quickly relieved by the use of a bronchodilator given by nebulization. If bronchospasm progresses, the medication should be discontinued immediately.
Pregnancy: Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies may not always be predictive of human responses, Mucomist Respirator Solution should be administered to pregnant women only if clearly needed.
373

bexinfo: T
HERAPEUTIC
G
UIDE
Lactation: It is not known if this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Mucomist Respirator Solution are administered to nursing mothers.
Side Effects: Adverse effects have included stomatitis, nausea, vomiting, fever, rhinorrhea, drowsiness, clamminess, chest tightness, and bronchoconstriction. Clinically overt acetylcysteine-induced bronchospasm occurs infrequently and unpredictably, even in patients with asthmatic bronchitis or bronchitiscomplicating bronchial asthma. Acquired sensitization to acetylcysteine has been reported rarely. Reports of irritation to the tracheal and bronchial tracts have been received and, although, haemoptysis has occurred in patients receiving acetylcysteine, such findings are not uncommon in patients with bronchopulmonary disease and a causal relationship has not been established. Oral administration of acetylcysteine, especially in the large doses needed to treat acetaminophen overdose, may result in nausea, vomiting and other gastrointestinal symptoms. Rash, with or without mild fever, has been observed rarely.
Commercial Pack: Mucomist ® Respirator Solution: Box containing 1 x 5 ampoules of 3 ml in blister pack. Each 3 ml ampoule contains Acetylcysteine USP 600 mg.
®
Tablet / Syrup
Respira is a preparation of Levosalbutamol Sulphate INN which is a single isomer β 2 agonist. This is an effective bronchodilator.
Indications: This is indicated for the treatment or prevention of bronchospasm in adults, adolescents and children 4 years of age and older with reversible obstructive airway disease.
Dosage and Administration: Adults and adolescents above 12 years: 1-2 mg three times daily. Children (6 -11 years): 1 mg three times daily. Syrup: Adults: 5-10 ml three times daily. Children (6-11 years): 5 ml three times daily.
Contraindications: Hypersensitivity to any of the components of the formulations.
Side Effects: Potentially serious hypokalemia may result from b2-agonist therapy. This effect may be potentiated by hypoxia. Particular caution is advised in severe asthma, with monitoring of serum potassium levels. Other side effects such as palpitation, fine tremors of the skeletal muscle (particularly the hand) and muscle cramps may occur. In few cases nervousness, headache, dizziness, fatigue and sleeplessness have also been reported.
Warning and Precautions: Asthma may deteriorate acutely over a period of hours, or chronically over several days or longer. If the patient needs more doses of oral
Levosalbutamol than usual, this may be a marker of destabilization of asthma and
374

bexinfo: T
HERAPEUTIC
G
UIDE requires re-evaluation of the patient and the treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment eg. corticosteroids.
Levosalbutamol, like all other β -adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure and / or symptoms. Although such effects are uncommon after administration of
Levosalbutamol at recommended doses, if they occur, the drug may need to be discontinued. Oral Levosalbutamol should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias or hypertension.
Use in Pregnancy and Lactation: Administration of the drug during pregnancy should be considered only if the expected benefit to the mother is greater than any possible risk to the fetus. It is not known whether Levosalbutamol is excreted in human milk. Caution should be exercised when Levosalbutamol is administered to a nursing woman.
Commercial Pack: Respira ® 1 Tablet: Box containing 100 tablets in 10 X 10’s blister strips. Each tablet contains Levosalbutamol Sulphate INN equivalent to Levosalbutamol
1 mg.
Respira ® 2 Tablet: Box containing 100 tablets in 10 X 10’s blister strips. Each tablet contains Levosalbutamol Sulphate INN equivalent to Levosalbutamol 2 mg.
Respira ® Syrup: Bottle contains 100 ml of syrup. Each 5 ml contains Levosalbutamol
Sulphate INN equivalent to Levosalbutamol 1 mg.
375

bexinfo: T
HERAPEUTIC
G
UIDE
N
ASAL
P
REPARATIONS
®
Nasal Spray
Decomit nasal spray is a metered dose manual pump spray unit containing a microcrystalline suspension of Beclomethasone Dipropionate in a mixture of suspending agents.
Indication: Decomit nasal spray is indicated for the prophylaxis and treatment of perennial and seasonal allergic rhinitis including hay fever and vasomotor rhinitis.
Beclomethasone Dipropionate nasal spray is also indicated for the prevention of recurrence of nasal polyps following surgical removal.
Dosage and Administration: Decomit nasal spray is for administration by the intranasal route only.
Adults and children: The recommended dosage is one or two applications into each nostril twice, thrice or four times as required by the physician daily. Total daily administration should not normally exceed eight applications. It should be explained that maximum effect may not be obtained within the first few applications.
For children under six years, there are insufficient clinical data to recommend use.
Contraindications: Decomit nasal spray is contraindicated in patients with a history of hypersensitivity to any of its components.
Warning and Precautions: Infections of the nasal passages and paranasal sinuses should be appropriately treated but do not constitute a specific contraindication to treatment with Decomit nasal spray. Care must be taken while transferring patients from systemic steroid treatment to Decomit nasal spray if there is any reason to suppose that their adrenal function is impaired.
Systemic effects may rarely occur. These include hypothalamic-pituitary-adrenal(HPA) suppression and growth retardation in children. Although Decomit nasal spray will control seasonal allergic rhinitis in most cases, an abnormally heavy challenge of summer allergens may, in certain instances necessitate appropriate additional therapy particularly to control eye symptoms.
Side Effects: As with other nasal sprays, dryness and irritation of the nose and throat, unpleasant taste and smell and epistaxis have been reported rarely.
Rare cases of raised intra-ocular pressure or glaucoma in association with intranasal formulations of Beclomethasone Dipropionate have been reported.
Commercial Pack: Decomit ® Nasal Spray: Each bottle contains 200 metered doses, each containing 50 mg of beclomethasone dipropionate BP.
376

bexinfo: T
HERAPEUTIC
G
UIDE
®
Nasal Spray
This is a preparation of Mometasone, a corticosteroid demonstrating anti-inflammatory properties.
Indications: This is indicated for the treatment and prophylaxis of the nasal symptoms of seasonal allergic rhinitis and for the prophylaxis of the nasal symptoms of perennial allergic rhinitis, in adults and pediatric patients 2 years of age and older. It is also indicated for the treatment of nasal polyps in patients 18 years of age and older.
Dosage and Administration: Allergic Rhinitis: Adults and Children 12 Years of age and older: The recommended dose for prophylaxis and treatment of the nasal symptoms of seasonal allergic rhinitis and treatment of the nasal symptoms of perennial allergic rhinitis is 2 sprays in each nostril once daily. In patients with a known seasonal allergen that precipitates nasal symptoms of seasonal allergic rhinitis, prophylaxis with Nasomet Nasal
Spray is recommended 2 to 4 weeks prior to the anticipated start of the pollen season.
Children 2 to 11 years of age: The recommended dose for treatment of the nasal symptoms of seasonal allergic and perennial allergic rhinitis is 1 spray in each nostril once daily.
Nasal Polyps: Adults 18 years of age and older: The recommended dose for nasal polyps is 2 sprays in each nostril twice daily. A dose of 2 sprays in each nostril once daily is also effective in some patients.
Side Effects: Generally side effects are mild and included headache, viral infection, sore throat, nosebleeds and coughing.
Warning and Precautions: Use with caution in active or inactive tuberculosis infection, herpes simplex virus infection of the eye, untreated infections affecting the body as a whole etc.
Use in Pregnancy and Lactation: Mometasone Furoate, like other corticosteroids should be used during pregnancy only if the potential benefits justify the potential risk to the fetus. It is not known if Mometasone Furoate is excreted in human milk. Since other corticosteroids are excreted in human milk, caution should be used when Mometasone
Furoate is administered to nursing women.
Contraindications: Hypersensitivity to any of the ingredients of this preparation contraindicates its use.
Commercial Pack: Nasomet ® Nasal Spray: Each bottle contains 120-metered doses, each actuation delivers 50 mcg of Mometasone Furoate BP.
377

bexinfo: T
HERAPEUTIC
G
UIDE
®
Nasal Spray
Oxymetazoline Hydrochloride, the active ingredient of Nazolin nasal spray, is a sympathomimetic amine of the imidazoline class. The chemical name of the active ingredient is 2-(4-tert-butyl-2, 6-dimethyl-3-hydroxybenzyl)-2-imidazoline hydrochloride.
Indication: As a nasal decongestant in allergic rhinitis, with or without the addition of topical antihistamines or sodium cromoglycate, as a nasal decongestant in sinusitis where there is evidence of obstruction of ostea to the sinuses, as nasal decongestant in otitis media where there is evidence of obstruction of eustachian tube, especially in subacute serious otitis media (‘glue ear’) and otitic barotrauma, as a decongestant in an infective rhinitis(e.g. an acute viral upper respiratory tract infection). Where there is a secondary bacterial infection, there is no evidence of benefit.
Dosage and Administration: For nasal use, 2-3 sprays should be instilled into each nostril twice daily. The nasal spray can be used with the patient in the upright position.
Sprays are generally unsuitable for very young children because of the small size of their nostril. However it may be used in children over the age of 5.
Contraindications: 1. As a sympathomimetic, oxymetazoline should not be used in patients being simultaneously treated with monoamine oxidase inhibitor therapy. 2.
Narrow-angle glaucoma. 3. The safety of use in pregnancy has not fully been established and administration of oxymetazoline during that time should be avoided unless absolutely essential.
Warning and Precautions: The drug should be used with caution in patients suffering from Coronary artery disease, Hypertension, Hyperthyroidism, Diabetes mellitus. A treatment course should not normally exceed three to five days, and on no account should it be continued for longer than two weeks because of the risk of developing ‘rhinitis medicamentosa’.
Side Effects: Stinging, discomfort or a dryness locally in the nose or eye is encountered infrequently. Other common side effects are: Headache, ciliostasis, hypertension, dizziness, nervousness, irritability, and insomnia.
As oxymetazoline is an α 2 adrenergic agonist, it might be expected to produce effects similar to those of clonidine and sedation as a result of inhibition of sympathetic outflow from brain.
Commercial Pack: Nazolin ® Nasal Spray: Each bottle contains 200 metered doses of
0.05% aqueous nasal preparation of Oxymetazoline Hydrochloride USP in a total volume of 10 ml. Each actuation delivers 0.05 ml containing 25 mg of Oxymetazoline
Hydrochloride.
378

bexinfo: T
HERAPEUTIC
G
UIDE
®
Nasal Spray
Perinase nasal spray is an aqueous suspension of microfine Fluticasone Propionate for topical administration to the nasal mucosa by means of a metering, atomizing spray pump.
Indications: This is indicated for the management of the nasal symptoms of seasonal and perennial allergic and nonallergic rhinitis in adults and pediatric patients 4 years of age and older. Safety and effectiveness of Fluticasone Propionate in children below 4 years of age have not been adequately established.
Dosage and Administration: For Adult and child over 12 years: 2 sprays (100 mcg) into each nostril once daily, preferably in the morning, increased to maximum twice daily if required, when control achieved reduce to 1 spray (50 mcg) into each nostril once daily.
Child 4-11 years: 1 spray (50 mcg) into each nostril once daily, increased to maximum twice daily if required.
Use in Pregnancy and Lactation: This drug should be used in pregnant woman only if the potential benefit justifies the potential risk to the foetus.
Because Fluticasone Propionate is excreted in human milk, caution should be taken when it is administered in a nursing mother.
Side Effects: When administered by nasal spray in doses used clinically, Fluticasone
Propionate is reported to have little or no systemic effect.
Contraindications: Perinase is contraindicated in patients with a hypersensitivity to its ingredient.
Drug Interactions: No drug interaction studies have been conducted with Perinase Nasal spray; however care should be exercised when this drug is coadministered with longterm Ketoconazole and other known cytochrome P-450 inhibitors.
Commercial Pack: Perinase ® Nasal Spray: Each bottle contains 120 metered doses, each actuation delivers 50 mcg of Fluticasone Propionate BP.
379

T
P

bexinfo: T
HERAPEUTIC
G
UIDE
A
NTI
-A
CNE
®
Cream
This cream is a topical anti-acne preparation containing Tretinoin USP 0.025%.
Indications: For topical application in the treatment of acne vulgaris in which comedones, papules and pustules predominate.
Dosage and Administration: Cosmotrin cream should be applied sparingly to the whole affected area once or twice daily. The skin should be thoroughly cleaned and dried before application. Patient should be advised that 6 to 8 weeks of treatment may be required before a therapeutic effect is observed. Moisturizer’s and cosmetics may be used during treatment with Cosmotrin cream but should not be applied to the skin at the same time.
Astringent toiletries should be avoided.
Side Effects: Initial external application of Tretinoin generally may cause burning or slight irritation. Erythema and peeling at the site of application may occur. If irritation becomes severe and persists, application should be discontinued and consultation with physicians is required, if necessary.
Drug Interactions: Other topical acne treatments should be used with caution during treatment with Tretinoin. Particular caution should be exercised when using preparation containing a peeling agent for example benzoyl peroxide. It is also possible to apply
Tretinoin and benzoyl peroxide alternately. The suggested regimens are either Tretinoin in the morning and benzoyl peroxide in the evening or the preparations should be used on alternate days.
Warning & Precautions: Contact of Tretinoin with lips, mouth, eyes, eyelids, nostrils or other mucous membrane should be avoided. If contact in these areas occur, careful washing with water is recommended. Apply the cream to sensitive areas of skin, such as the neck, with caution. Do not use it on broken, eczematous or sun burned skin.
Use in Pregnancy & Lactation: Not recommended in pregnancy and lactation.
Contraindications: Tretinoin is contraindicated to those who are highly sensitive to any of the ingredients. This cream should not be used in patients with a personal or family history of cutaneous epithelioma (skin cancer).
Commercial Pack: Cosmotrin ® Cream: Tube containing 10 gm cream, each gm contains
Tretinoin USP 0.25mg.
383

bexinfo: T
HERAPEUTIC
G
UIDE
A
NTIBIOTIC
®
Cream
This is a soft white cream containing Silver Sulfadiazine 1% USP.
Indications: Prophylaxis and treatment of infection in burn wounds:
• As an adjunct to short-term treatment of infection in: Leg ulcers, Pressure sores.
• As an adjunct to prophylaxis of infection in: Skin graft donor sites, Extensive abrasions.
• Conservative management of Finger-tip injuries.
Dosage & Administration:
Burns: The burn wound should be kept in clean condition & apply Burnsil over the affected area to a depth of 3-5 mm. In burns, Burnsil should be re-applied at least every 24 hours, or more frequently if the volume of exudate is large.
Hand burns: Apply Burnsil to the burn area & enclose with a clean plastic bag or glove up to wrist. The patient should be encouraged to move the hand and fingers. The dressing should be changed when an excessive amount of exudate has accumulated in the bag.
Leg ulcers/pressure sores: The cavity of ulcer should be filled with Burnsil to a depth of at least 3-5mm. Application of Burnsil should be followed by an absorbed pad or gauze dressing, with further application of pressure bandaging as appropriate for the ulcer. The dressings should normally be changed daily but for wounds which are less exudative, less frequent changes (every 48 hours) may be acceptable.
Fingertip injuries: Hemostasis of the injury should be achieved prior to the application of a 3-5 mm layer of Burnsil. A conventional finger dressing may be used. Alternatively waterproof adhesive tape can be used on finger covered by a plastic or surgical glove.
Dressings should be changed every 2-3 days.
Side Effects: In prolonged treatment of burn wounds involving extensive areas of the body the serum Sulfonamide concentrations may approach the levels equal to those in systemic treatment.
Warning & Precautions: Caution is required in the presence of hypersensitivity to
Sulfonamide, in patients with inborn glucose-6-phosphate dehydrogenase deficiency, and in the presence of hepatic & renal dysfunction. When treatment with Burnsil cream involving prolonged administration or large burn surfaces, the white blood cell count should be monitored, as leukopenia may occur.
384

bexinfo: T
HERAPEUTIC
G
UIDE
Use in Pregnancy: It should not be used in pregnancy, except in cases when the potentially life-saving benefits of the medication outweigh possible hazard to the fetus.
Contraindications: This is contraindicated in premature infants and neonates because of possibility of kernicterus.
Commercial Pack: Burnsil ® Cream: Tube containing 25gm of cream. Each gm of cream contains Silver Sulfadiazine USP 10mg.
®
Cream
This cream is a preparation of 0.2% Nitrofurazone, a broad spectrum topical antibacterial agent.
Indications: Furasep is indicated in the infectious conditions of the skin such as burns, wounds, ulcers, skin infections and skin grafting.
Dosage & Administration: It should be applied directly to the lesion or on gauze first;
2-3 times daily or as advised by the physician.
Side Effects: Sensitization and generalized allergic skin reactions may be produced after few days of initial application. Cross sensitization to other Nitrofurazone derivatives may occur. Intolerance to Nitrofurazone necessitating withdrawal has been encountered.
Contraindications: It is contraindicated to patients with known sensitivity to
Nitrofurazone. It should be used with caution in patients with known or suspected renal impairment.
Commercial Pack: Furasep ® Cream: Tube containing 20 gm cream, each gm contains
Nitrofurazone USP 2 mg.
®
Cream
This is a preparation of Gentamicin Sulphate which is a water soluble antibiotic of the aminoglycoside group, active against a wide variety of pathogenic Gram-positive and
Gram-negative microorganisms.
Indications: It is indicated for the topical treatment of the primary and secondary bacterial infections of the skin caused by the organisms sensitive to Gentamicin.
Dosage and Administration: A small amount of Gentosep should be applied gently to the affected areas three to four times daily. The area treated may be covered with a gauze dressing if desired. Before applying the medication the affected area should be cleaned properly.
385

bexinfo: T
HERAPEUTIC
G
UIDE
Side Effects: This cream is well tolerated, no evidence of irritation and sensitization after using the cream.
Warning & Precautions: Use of topical antibiotics occasionally cause overgrowth of non susceptible organisms including fungi. If this occurs or if irritation, treatment with
Gentosep should be discontinued and appropriate therapy should be instituted.
Contraindication: It is contraindicated in patients with known hypersensitivity to any of its components.
Commercial Pack: Gentosep ® Cream: Each pack has a tube containing 15 gm cream.
Each gm contains Gentamicin Sulphate BP equivalent to 3 mg Gentamicin base.
386

bexinfo: T
HERAPEUTIC
G
UIDE
A
NTIBIOTIC
, A
NTI
-F
UNGAL
& A
NTI
-I
NFLAMMATORY
®
Cream
This is a preparation of Clobetasol Propionate-a highly active corticosteroid with topical anti-inflammatory activity, Nystatin, an anti-fungal agent and Neomycin, a broad-spectrum antibiotic.
Indications: Exovate N cream is indicated in more resistant dermatoses such as recalcitrant eczemas and psoriasis (excluding widespread plaque psoriasis) where secondary bacterial or candidal infection is present, suspected or likely to occur, as when using occlusive dressings.
Dosage and Administration: Adults and children over 2 years: Apply sparingly to the affected area once or twice daily until improvement occurs. As with other highly active topical steroid preparations therapy, it should be discontinued when control is achieved.
In the more responsive conditions this may be within a few days.
In very resistant lesions, especially where there is hyperkeratosis, the anti-inflammatory effect of cream can be enhanced, if necessary, by occluding the treatment area with polythene. Overnight occlusion only is usually adequate to bring about a satisfactory response, thereafter improvement can be usually maintained by application without occlusion.
Treatment should not be continued for more than 7 days without medical supervision. If a longer course is necessary, it is recommended that treatment should not be continued for more than 4 weeks without the patient's condition being reviewed. Repeated short courses of cream may be used to control exacerbations. If continuous steroid treatment is necessary, a less potent preparation should be used.
Dosage in Renal Impairment: Dosage should be reduced in patients with reduced renal function.
Side Effects: As with other topical corticosteroids, prolonged use or treatment of extensive areas can result in sufficient systemic absorption to produce the features of hypercortisolism. This effect is more likely to occur in infants and children and if occlusive dressings are used. Prolonged and intensive treatment with highly active corticosteroid preparations may cause local atrophic changes in the skin such as thinning, striae, and dilatation of the superficial blood vessels, particularly when occlusive dressings are used, or when skin folds are involved. There are reports of pigmentation changes and hypertrichosis with topical steroids.
Warning & Precautions: Long-term continuous topical therapy should be avoided where possible, particularly in infants and children, as adrenal suppression can occur readily even without occlusion.
387

bexinfo: T
HERAPEUTIC
G
UIDE
If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye, as glaucoma might result. If cream does enter the eye, the affected eye should be thoroughly washed with copious amount of water. Exovate N cream is suitable for use in the elderly. Caution should be exercised in cases where a decrease in renal function exists and significant systemic absorption of Neomycin Sulfate may occur. Exovate N cream is suitable for use in children (2 years and over) at the same dose as adults.
Use in Pregnancy and Lactation: Not recommended in pregnancy and lactation.
Contraindications: This cream is contraindicated in rosacea, acne vulgaris and perioral dermatitis, primary cutaneous viral infections (eg. herpes simplex, chickenpox) and hypersensitivity to the preparation. A possibility of increased absorption exists in very young children, thus it is not recommended for use in neonates and infants (younger than
2 years).
Commercial Pack: Exovate ® N Cream: Tube containing 25 gm cream, each gm contains
Clobetasol Propionate BP 0.05 % w/w, Neomycin Sulfate USP 0.5 % and Nystatin BP
1,00,000 units.
388

bexinfo: T
HERAPEUTIC
G
UIDE
A
NTIBIOTIC
& A
NTI
-I
NFLAMMATORY
®
Ointment
This is a topical steroid-antibiotic ointment which contains Sodium Fusidate BP 2% and
Hydrocortisone Acetate BP 1%.
Indications: Eczema and dermatitis with secondary bacterial infections, including atopic eczema, primary irritant dermatitis and allergic and seborrheic dermatitis where the organisms are known to be or believed to be sensitive to Fusidic Acid.
Dosage and Administration: Adults and children: Uncovered lesions: Apply gently 3 to
4 times daily.
Covered lesions: Less frequent applications may be adequate.
Side Effects: Hypersensitivity reactions in the form of skin rashes and mild stinging irritation on application have been reported rarely.
Warning & Precautions: As with all topical antibiotics, bacterial resistance and contact sensitization may occur. These risks may increase with extended or recurrent application.
Caution should be exercised when used near the eye. Steroid-antibiotic combinations should not be used for more than seven days without clinical improvement since in this situation occult extension of the infection may occur due to the masking of the steroid.
Similarly, steroids may also mask hypersensitivity reactions. Long-term continuous use should be avoided in infants.
Use in Pregnancy and Lactation: There is inadequate evidence of safety in pregnancy and nursing mothers. Use requires benefit to be weighed against possible hazards to the fetus.
Contraindications: Contraindicated in patients with hypersensitivity to Fusidic Acid or its salts. Also in cases of primary bacterial, viral and fungal infections.
Commercial Pack: Fusidic ® Plus Ointment: It is supplied in aluminium tube of 10 gm and 20 gm capacity. Each gm of Fusidic Plus ointment contains Sodium Fusidate BP 20 mg and Hydrocortisone Acetate BP 10 mg.
389

bexinfo: T
HERAPEUTIC
G
UIDE
A
NTI
-F
UNGALS
®
Cream
This cream is a preparation of Clotrimazole which has a reliable action on dermatophytes, yeasts and other fungi. Neosten cream is odorless, can be washed off and does not stain.
Indications: All dermatomycoses due to dermatophytes (e.g. Trichophyton species), yeasts (Candida species), moulds and other fungi and skin diseases showing superinfections with these fungi.
The above mentioned dermatomycoses include interdigital mycoses (e.g. athlete’s foot), paronychia (associated with nail mycoses), mycoses in skin folds, Candida vulvitis,
Candida balanitis, Pityriasis versicolour, erythrasma.
Dosage & Administration: Skin should be washed with soap and water and dry thoroughly. Apply a thin layer of the cream 2-3 times daily and gently massage over affected area as directed by the doctor. For athlete’s foot, pay special attention to the spaces between the toes. Best results in athlete’s foot and ringworm are usually obtained with 4 weeks use of this product and in jock itch with 2 weeks use. The cream should be applied two or three times daily for one month or for at least two weeks after the disappearance of all signs of infection.
For best results, follow directions and continue treatment for length of time indicated. The duration of treatment varies; it depends among other factors on the extent and localization of the disease.
Dermatomycoses: 3-4 weeks.
Candida vulvitis and Candida balanitis: 1-2 weeks.
Erythrasma and Pityriasis versicolor (approx.): 3 weeks. In fungal infection of the feet, to prevent relapses, treatment should be continued for about 2 weeks beyond the disappearance of all signs of disease.
Commercial Pack: Neosten ® Cream: Tube containing 20 gm cream, each gm contains
Clotrimazole BP 10 mg.
390

bexinfo: T
HERAPEUTIC
G
UIDE
®
Vaginal Tablets
This is a preparation of Clotrimazole BP. It has broad-spectrum antimycotic with fungicidal and trichomonacidal action. Neosten VT acts reliably on dermatophytes, yeasts and other fungi; it is also effective against Trichomonas vaginalis and Gram-positive microorganisms
(streptococci/staphylococci) and Gram-negative microorganisms (Bacteroides/
Haemophilus vaginalis ).
Indications: Infectious vaginal discharge, vaginitis due to fungi (mainly Candida and/or
Trichomonas) and superinfections with Neosten VT-sensitive bacteria
Dosage & Administration: In general, a 3-day treatment is sufficient for candida vaginitis. On 3 consecutive nights, 1 Neosten vaginal tablet is inserted as deeply as possible into the vagina (see the directions for use of applicator). This is best achieved when lying on one’s back with the knees slightly bent. If necessary, 1 Neosten vaginal tablet daily can be used unhesitatingly for 6-12 days. Treatment should be timed so as to avoid the menstrual period and be finished before the onset of menstruation. To avoid reinfection, the partner should undergo local treatment with Neosten cream at the same time.
Contraindications: It is contraindicated in patients with known hypersensitivity to any of the components of this product.
Commercial Pack: Neosten® VT Tablet: Pack containing 3 vaginal tablets of
Clotrimazole BP 0.2 gm, each sealed in aluminium strip with applicator.
®
Cream
This is a preparation of Butenafine Hydrochloride, a broad-spectrum antifungal agent.
Butenafine Hydrochloride is hypothesized to act by inhibiting the epoxidation of squalene, thus blocking the biosynthesis of ergosterol, an essential component of fungal cell membranes.
Indications: Tenafin cream is indicated for the topical treatment of the following superficial dermatophytosis: interdigital tinea pedis (athlete's foot), tinea corporis
(ringworm) and tinea cruris (jock itch) due to E. floccosum, T. mentagrophytes, T. rubrum, and T. tonsurans.
Dosage and Administration: In the treatment of interdigital tinea pedis, Tenafin should be applied twice daily for 7 days or once daily for 4 weeks. Patients with tinea corporis or tinea cruris should apply Tenafin once daily for two weeks. Sufficient Tenafin cream should be applied to cover affected areas and immediately surrounding skin of patients with interdigital tinea pedis, tinea corporis and tinea cruris.
391

bexinfo: T
HERAPEUTIC
G
UIDE
Side Effects: Hypersensitivity reactions may occur. Rarely local mild burning or irritation may be experienced.
Warning and Precautions: Tenafin is not for ophthalmic, oral, or intravaginal use, the cream is for external use only. If irritation or sensitivity develops with the use of this cream, treatment should be discontinued and appropriate therapy instituted.
Contraindications: It is contraindicated in individuals who have known or suspected sensitivity to Butenafine Hydrochloride or any of its components.
Commercial Pack: Tenafin ® Cream: Tube containing 15 gm cream, each gm contains
Butenafine Hydrochloride INN 10 mg.
392

bexinfo: T
HERAPEUTIC
G
UIDE
A
NTI
-F
UNGAL
& A
NTI
-I
NFLAMMATORY
®
Cream
This cream is a soft white cream containing 1% Econazole Nitrate BP and 0.1%
Triamcinolone Acetonide BP.
Indications: Econazole Nitrate is a broad spectrum antifungal agent. It is effective against various dermatophytes, yeasts and moulds. Moreover, it has activity against Gram positive bacteria. Triamcinolone Acetonide is a potent corticosteroid with antiinflammatory, antipruritic and anti allergic activity.
The more important indications of Ecotrim are dermatomycosis caused by dermatophytol yeast and fungus with clear inflammatory and allergic symptoms such as various eczematous mycosis, diaper dermatitis, eczema marginatum, intertrigo, folliculitis, tricophytica and sycosis barbae. Ecotrim is also indicated for the treatment of mycosis present in various folds of the body.
Dosage and Administration: The cream should be applied by gently rubbing into the skin with the finger once or twice daily for 14 days or as directed by a registered physician.
Side Effects: This cream is well tolerated, even to sensitive skin. Burning sensation, pruritis and redness of skin have rarely been reported.
Warning & Precautions: Long term continuous steroid therapy should be avoided since adrenal suppression can occur, particularly when infants or children are treated or when occlusive dressings are applied. Discontinuation of the medication is advised if hypersensitivity occurs. Topical steroids should not be used in large amounts or for prolonged periods.
Use in Pregnancy: The use of corticosteroids during pregnancy has not been established.
Contraindications: Like all preparations containing corticosteroids, this cream should not be used on tubercular skin infections or in viral diseases (e.g., herpes, vaccinia, and varicella) and hypersensitivity to any of the component of this product.
Commercial Pack: Ecotrim ® Cream: Tube containing 10 gm cream, each gm contains
Econazole Nitrate BP 1% and Triamcinolone Acetonide BP 0.1%.
393

bexinfo: T
HERAPEUTIC
G
UIDE
®
Cream
This is a preparation of Clotrimazole BP and Hydrocortisone BP. Clotrimazole is a broadspectrum antifungal agent active on dermatophytes, yeasts and other fungi.
Hydrocortisone is a glucocorticoid with both glucocorticoid and to a lesser extent mineralocorticoid activity.
Indications: Neosten HC is indicated in the treatment of fungal infections where coexisting symptoms of inflammation e.g., itching, require rapid relief.
• All dermatomycoses due to dermatophytes (e.g. Trichophyton species), moulds and other fungi.
• All dermatomycoses due to yeasts (Candida species).
•
Skin diseases showing secondary infection with these fungi.
• The treatment of nappy rash where infection due to Candida albicans is present.
Dosage and Administration: It should be applied thinly and evenly to the affected area twice daily.
Side Effects: Rarely local mild burning or irritation may be experienced. Hypersensitivity reactions may occur.
Warnings and Precautions: In infants, the napkins may act as an occlusive dressing and increase absorption. Treatment should be for a maximum period of seven days.
Contraindications: Contraindicated in patients with known hypersensitivity to any of the components of this preparation.
Commercial Pack: Neosten ® HC 10 gm Cream: Tube containing 10 gm Cream, each gm contains Clotrimazole BP 10 mg and Hydrocortisone BP 10 mg.
Neosten ® HC 20 gm Cream: Tube containing 20 gm Cream, each gm contains
Clotrimazole BP 10 mg and Hydrocortisone BP 10 mg.
394

bexinfo: T
HERAPEUTIC
G
UIDE
A
NTI
-I
NFLAMMATORY
®
Ointment
This is a preparation of Tacrolimus, a topical immunomodulator molecule that modify the immune response locally when applied to the skin.
Indications: Atopic dermatitis, Allergic contact dermatitis, severe Eczema, Psoriasis,
Alopecia areata, Pyoderma gangrenosum, Cutaneous lupus erythematosus and
Dermatomyositis.
Dosage & Administration: Tacrolimus Ointment, applied twice daily, is safe and effective in both child and adult cases of Atopic dermatitis over a period of 1 year.
Side Effects: Transient burning or heat sensation at the site of application is frequently observed. Other side-effects include skin erythema, flu-like symptoms, headache and skin infection
Warning & Precautions: It should be used with caution in people who have liver failure and should not be used by children under 2 year.
Use in Pregnancy & Lactation: Not recommended in pregnancy and lactation.
Contraindications: Tacrolimus should not be applied to eczema that is infected, or to skin affected by viral infections such as herpes simplex (cold sores) or herpes zoster
(chicken pox).
Commercial Pack: Atolimus® Ointment: Tube contains 5 gm ointment. Each gm ointment contains Tacrolimus Monohydrate INN equivalent to 0.3 mg Tacrolimus.
®
Cream / Ointment
This is a preparation of Clobetasol Propionate, a very active topical corticosteroid.
Indications: Clobetasol Propionate is used in short courses for the treatment of more resistant dermatoses such as psoriasis (excluding widespread plaque psoriasis), recalcitrant eczemas and other conditions which do not respond satisfactorily to less active steroids.
Dosage and Administration: A small quantity should be applied to the affected area once or twice daily until improvement occurs. Therapy should be discontinued when control is achieved. It is recommended that treatment should not be continued for more
395

bexinfo: T
HERAPEUTIC
G
UIDE than two or four weeks without the patients’ condition being reviewed. If continuous steroid treatment is required a less potent preparation is used.
Side Effects: Skin atrophy especially with occlusion or in skin folds, hypercorticism.
Provided the weekly dosage is less than 50g in adults, any pituitary-adrenal suppression is likely to be transient. Occasionally hypersensitivity reactions may occur.
Warning & Precautions: Long term continuous therapy with Clobetasol should be avoided, particularly in infants and children, in whom adrenal suppression occurs readily.
If Clobetasol is required for use in children, or on the face, it is recommended that the treatment should be reviewed weekly. The face, more than other areas of the body, may exhibit atrophic changes after prolonged treatment with potent topical corticosteroids.
Avoid contact with eye as it may cause glaucoma. Topical steroid may be hazardous in psoriasis; careful patient supervision is important. Consider if infection spreads. Do not use near a naked flame.
Use in Pregnancy and Lactation: Not recommended in pregnancy.
Contraindications: Rosacea, acne and peri-oral dermatitis, skin lesion caused by infection with viruses (e.g., Herpes simplex, chicken pox), fungi (e.g., Candidiasis, tinea) or bacteria (e.g., Impetigo), peri-anal and napkin eruption. Hypersensitivity to the preparation. Dermatoses in children under one year of age.
Commercial Pack: Exovate ® Cream: Tube containing 10 gm cream, each gm contains
Clobetasol Propionate USP 0.5 mg.
Exovate ® Ointment: Tube containing 10 gm ointment, each gm contains Clobetasol
Propionate USP 0.5 mg.
396

bexinfo: T
HERAPEUTIC
G
UIDE
A
NTI
-P
SORIATIC
®
Cream
This is a preparation of Tazarotene. It is a retinoid prodrug which is converted to its active form, the cognate carboxylic acid of Tazarotene, by rapid de-esterification in man.
Indications: Tazarotene is used to treat plaque psoriasis of the skin. It also works to treat acne on the face.
Dosage and Administrations: For psoriasis: Tazarotene cream should be applied once per day, in the evening, to psoriatic lesions, using enough to cover only the lesion with a thin film. If a bath or shower is taken prior to application, the skin should be dried before applying the cream. If emollients are used, they should be applied at least one hour before application of Tazarotene cream. For acne: Cleanse the face gently. After the skin is dry, apply a thin layer of Tazarotene cream once per day, in the evening, to the skin areas where acne lesions appear. Use enough to cover the entire affected area.
Elderly (Over 65 yrs.): There is no specific information comparing the use of Tazarotene in the elderly with use in other age groups.
Side Effects: The most frequent adverse events are desquamation, dry skin irritation and pruritus. For acne treatment 10-30% patient reports desquamation, dry skin, face pain, irritation and stinging sensation.
Drug Interactions: Concomitant dermatologic medications and cosmetics that have a strong drying effect should be avoided.
Warning & Precautions: Tazarotene cream is for external use only. Avoid contact with eyes, eyelids and mouth. Retinoids should not be used on eczematous skin, as they may cause severe irritation. Patients must be warned to use sunscreens and protective clothing when using Tazarotene cream. Some individuals may experience excessive pruritus, burning, skin redness or peeling. It should not be used near a naked flame.
There is no specific information comparing use of Tazarotene in children up to 12 years of age.
Use in Pregnancy & Lactation: Not recommended in pregnancy and lactation.
Contraindications: This cream is contraindicated in women who are or may become pregnant.
Commercial Pack: Soritene ® Cream: Each pack has a tube containing 25 gm cream.
Each gm contains Tazarotene INN 1 mg.
397

bexinfo: T
HERAPEUTIC
G
UIDE
A
NTI
-S
CABIES
®
Cream
This cream is a preparation of 5% (w/w) Permethrin INN. Permethrin is a photo stable synthetic pyrethroid that possesses a broad spectrum of insecticidal activity and is generally rated as the safest insecticide because of its low primary toxicity.
Indications: It is indicated for the treatment of scabies.
Dosage and Administration:
• Adults and children (over 12 years) A full tube
• Children aged 6-12 years up to ½ of a tube
• Children aged 1-5 years up to ¼ of a tube
• Children aged 2 months to 1 year up to 1 /
8 of a tube
Patients of >2 months of age can use Noscab cream. Cream should be applied to clean, dry and cool skin. If the body is hot due to warm bath or any other reason, skin should be allowed to cool. It should be applied to the whole body excluding head. The whole body should be washed thoroughly 8-12 hours after treatment. Adults and children above
12 years will use a full tube as a single dose. If necessary maximum two tubes can be used as a single dose.
Side Effects: In scabies patients, skin discomfort, usually described as burning, stinging or tingling occurs in a few individuals soon after the cream is applied. Other transient effects are erythema, numbness, rash and pruritus.
Drug Interactions: The treatment of eczematous like reactions with corticosteroids should be withheld prior to treatment with Permethrin, as there is a risk of exacerbating the scabies infestation by reducing the immune response to the mite.
Warning & Precautions: This is not an eye irritant, but the cream itself may cause marked irritation. The cream should not be applied to the vicinity of mouth and areas close to the eyes. Nursing staff who routinely apply Noscab, may wear gloves to avoid any possible irritation to the hands.
Use in Pregnancy & Lactation: Any risk to the fetus following treatment with Permethrin is minimal. Consideration should be given to discontinuing nursing temporarily or to withholding the drug while the mother is nursing.
Contraindications: Permethrin is contraindicated in patients with known hypersensitivity to the product, its components, other pyrethroids or pyrethrins.
Commercial Pack: Noscab ® Cream: Each pack has a tube containing 25 gm of Noscab cream. Each gm contains Permethrin INN 50 mg.
398

bexinfo: T
HERAPEUTIC
G
UIDE
E
MOLLIENT
®
Cream
This cream contains 10% Urea BP. Topical urea is bacteriostatic, bactericidal, fungistatic, proteolytic, hygroscopic and has mild local anesthetic properties.
Indications: Eukrim cream is indicated for Ichthyosis and dry skin conditions, management of Eczemas and in the management of Psoriasis.
Dosage and Administration: Eukrim cream is applied topically. Wash affected areas well, rinse off all traces of soap, dry and apply sparingly twice daily. Occlusive dressings may be used, but are usually unnecessary because of the self-occlusive nature of the cream. It can be used in all groups.
Side Effects: No serious toxicity has been reported with topical Urea. Historically it is considered a safe drug, but on some occasions, topical urea has been shown to cause irritation, if applied to inflammed, broken or exudative skin eruptions.
Drug Interaction: No hazardous drug interaction has been reported.
Warning and Precautions: Not to be used in eyes.
Use in Pregnancy and Lactation: Eukrim can be used during pregnancy and lactation.
Contraindications: In some instances, Urea 10% cream may cause local irritation and edema, when applied to sensitive skin. If the condition is aggravated or there is no improvement the doctor should be consulted.
Commercial Pack: Eukrim ® Cream: Each pack has a tube containing 15 gm of the Urea
BP. Each gm contains 100 mg Urea BP.
399

bexinfo: T
HERAPEUTIC
G
UIDE
H
EMORRHOID AND
F
ISSURE
®
Ointment
Anustat is a pale yellow coloured homogeneous ointment containing Cinchocaine
Hydrochloride BP, Hydrocortisone BP, Neomycin Sulphate USP, Esculin Sesquihydrate.
It provides an excellent combination of anti-inflammatory, anti-allergic and antipruritic action.
Indications: Internal & external hemorrhoid, anal fissure, anal pruritus, perianal eczema, proctitis, pre-operative and post operative treatment of hemorrhoidectomy, post partum hemorrhoidal condition and as prophylaxis in between attacks.
Dosage and Administration: A small quantity of the ointment should be applied with finger in the painful pruritic area in the morning and evening and after each stool. For deep application nozzle should be attached to the tube and inserted to full extent and the tube should be squeezed gently from the lower end while withdrawing.
Side Effects: Side effects which have been reported for individual constituents may occur and appropriate precaution should be taken when using Anustat.
Warning & Precautions: Long term use should be avoided& it should not be given to extensively damaged skin.
Use in Pregnancy: Topical steroid should not be used extensively in pregnancy.
Contraindication: Sensitivity to any one of the constituents of Anustat.
Commercial Pack: Anustat ® Ointment: 15 gm ointment is sealed with a nozzle for application. Each 1 gm contains Cinchocaine Hydrochloride BP 0.5% mg, Hydrocortisone
BP 0.5% mg, Neomycin Sulfate USP 1% equivalent to Neomycin 10 mg and Esculin
Sesquihydrate Ger.P1%.
400

bexinfo: T
HERAPEUTIC
G
UIDE
M
USCULOSKELETAL
®
®
Cream
Icycool is a topical preparation of methyl salicylate and menthol. The cream is the dual action topical pain reliever.
Indications: The cream is used to relieve pain of muscle aches and sprains, rheumatism, arthritis and similar conditions.
Dosage & Administration: This medication is for use on the skin only. Do not use on scraped, irritated or broken skin. To use, apply a thin layer to the affected area and rub it gently. Do not cover with a tight bandage or do not use with a heating pad as this may cause skin damage. The cream is applied liberally to the painful area, with gentle massage until absorbed. This treatment can be repeated as necessary.
Side Effects: Redness or irritation may occur, especially in persons with sensitive skin.
If this continues or skin become itchy, swollen or patient develop a rash, doctor should be notified. If applied to large areas or broken skin, the medication may be absorbed.
Ringing in the ears, nausea or vomiting may also occur.
Warning & Precautions: In allergies (especially to aspirin or aspirin-like drugs), this cream should be used cautiously. Keep away from children to avoid accidental poisoning.
The cream should be kept away from eyes, mucous membrane and broken or irritated skin. If skin irritation develops, discontinue its use. Therapy might be hazardous for patients with impaired kidney or liver disease or for smaller children. Menthol may give rise to hypersensitivity reactions including contact dermatitis.
Use in Pregnancy & Lactation: This medication should be used only if clearly needed during pregnancy and lactation.
Contraindications: Allergy to salicylate or sensitivity to any of the components of the drug. Application to broken skin or raw surface is contraindicated.
Commercial Pack: IcyKool ® Cream: Tube containing 25 gm cream, each gm cream contains Methyl salicylate BP 150 mg and Menthol BP 100 mg.
IcyKool ® Max Cream: Tube containing 25 gm cream, each gm cream contains Methyl salicylate BP 300 mg and Menthol BP 80 mg.
401

bexinfo: T
HERAPEUTIC
G
UIDE
N
ON
-S
TEROIDAL
A
NTI
-I
NFLAMMATORY
D
RUG
®
Gel
This is a preparation of Diclofenac Diethylamine BP equivalent to Diclofenac Sodium 10 mg.
Indication: Indicated for the quick relief from pain, swelling and inflammation due to musculo-skeletal disorders such as sprains, strains, tendinitis, bursitis, hands, neck & shoulder pain, sciatica, muscle stiffness, joint pain, back ache and lumbago.
Dosages and Administration: A thin layer should be applied to the affected site three to four times daily with rubbing.
Side Effect: Usually well tolerated. Extremely low frequency of hypersensitivity reactions.
Warning and Precaution: For external use only. Avoid contact with the eyes. Stop use and ask a doctor if condition worsens or does not improve within 7 days. Keep out of the reach of children. If swallowed, get medical help or contact a poison control center right away.
Contraindication: Known hypersensitivity to any component of the preparation.
Commercial Pack: Voligel ® Gel: Each pack has a tube containing 30 gm gel. Each gm contains Diclofenac Diethylamine BP equivalent to Diclofenac Sodium 10 mg.
402

bexinfo: T
HERAPEUTIC
G
UIDE
S
KIN
C
ARE
®
Ointment
This is an ointment containing Zinc Oxide 40% w/w.
Indications: To treat or prevent skin irritations (e.g., burns, bed sore, cuts, poison ivy,diaper rash). Protects chafed skin due to diaper rash and helps seal out wetness.
Dosage & Administration: Apply thin layer topically every 8 hour interval. Wet and soiled diapers should be changed. The diaper area should be cleaned promptly and allow the area to be dried out. Ointment should be applied liberally and as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged. In other damaged skin conditions ointment should be applied as required.
Side Effects: Usually well tolerated, extremely low frequency of hypersensitivity reaction.
Warning & Precautions: The ointment should be used only externally. Avoid contact with the eyes. If condition worsens or does not improve within 7 days then it should be discontinued.
Use in Pregnancy and Lactation: This medication should be used only if clearly needed during pregnancy or while breast-feeding.
Contraindications: Known hypersensitivity to any component of the preparation.
Commercial Pack: Q-Rash ® Ointment: Tube containing 25 gm of ointment. Each gm ointment contains Zinc Oxide BP 400 mg.
®
Tablet
This is a preparation of Finasteride. It is a competitive inhibitor of steroid Type II 5 α reductase, an intracellular enzyme that converts the androgen testosterone into 5αdihydrotestosterone (DHT).
Indications: Recur is indicated for the treatment of male pattern hair loss (androgenic alopecia) in MEN ONLY.
Dosage & Administration: The recommended dosage is 1 mg once a day, may be administered with or without meals. In general, daily use for three months or more is necessary before benefit is observed. Continued use is recommended to sustain benefit.
Withdrawal of treatment leads to reversal of effect within 12 months.
403

bexinfo: T
HERAPEUTIC
G
UIDE
Side Effects: Finasteride is well tolerated. In clinical studies, the following adverse reactions were reported as possibly drug related in >1% of patients treated for 12 months with Finasteride 1mg daily: decreased libido (1.8%), erectile dysfunction (1.3%), ejaculation disorder (1.2%) and decreased volume of ejaculate (0.8%).
Drug Interactions: No drug interactions of clinical importance have been identified.
Warning & Precautions: Caution should be used in the administration of Recur in patients with liver function abnormalities, as Finasteride is metabolized extensively in the liver. Women who are or may potentially be pregnant should not handle or broken tablets of Recur.
Contraindications: Hypersensitivity to any component of this medication. Finasteride use is contraindicated in women and pediatric patients.
Commercial Pack: Recur ® Tablet: Box containing 3 blister strips of 10 tablets, each tablet contains Finasteride USP 1 mg.
404

U
D

bexinfo: T
HERAPEUTIC
G
UIDE
®
Tablet
Adafil tablet is an oral preparation for erectile dysfunction, is a selective inhibitor of cyclic guanosine monophosphate (cGMP), a specific phosphodiesterase type 5 (PDE5). Adafil has the empirical formula C22H19N3O4 representing a molecular weight of 389.41.
Indications: Adafil is indicated for the treatment of erectile dysfunction. It gives faster results, has a higher success rate, lasts up to 32 hours longer, and causes fewer unpleasant side effects. This is also known to Increase sex drive, boost sexual performance, cause fuller & harder erections, increase stamina & endurance and help with quicker recharges.
Dosage & Administration: The recommended starting dose of Adafil in most patients is
10 mg, taken prior to anticipated sexual activity (20 minutes before). The dose may be increased to 20 mg or decreased to 5 mg, based on individual efficacy and tolerability.
The maximum recommended dosing frequency is once per day in most patients. Adafil may be taken without regard to food. In case of mild renal insufficiency (creatinine clearance 31 to 50 mL/min), no dose adjustment is required. For patients with moderate renal insufficiency, a starting dose of 5 mg not more than once daily is recommended, and the maximum dose should be limited to 10 mg not more than once in every 48 hours.
For patients with severe renal insufficiency (creatinine clearance <30 ml/min) on hemodialysis, the maximum recommended dose is 5 mg.
Side Effects: The most common side effects are headache, dyspepsia, back pain, myalgia, nasal congestion, facial flushing, pain in limb etc.
Drug Interactions: Tadalafil is a substrate of CYP3A4 and predominantly metabolized by it. Studies have shown that drugs that inhibit CYP3A4 can increase Tadalafil exposure,
Ketoconazole, HIV Protease inhibitor. Based upon these results, in patients taking concomitant potent CYP3A4 inhibitors, the dose of Tadalafil should not exceed 10 mg, and Tadalafil should not be taken more frequently than once in every 72 hours. Other
CYP3A4 inhibitors, such as Erythromycin, Itraconazole, and Grape fruit juice, would likely increase Tadalafil exposure. Drugs like Rifampin that induce CYP3A4 can decrease
Tadalafil exposure.
Tadalafil is not expected to cause clinically significant inhibition or induction of the clearance of drugs metabolized by cytochrome P450 (CYP) isoforms and it does not inhibit or induce P450 isoforms CYP1A2, CYP3A4, CYP2C9, CYP2C19, CYP2D6, and
CYP2E1. Tadalafil had no clinically significant effect on the pharmacokinetics of
Theophylline, on exposure (AUC) to Midazolam or Lovastatin, no clinically significant effect on exposure (AUC) to S-warfarin or R-warfarin, nor did Tadalafil affect changes in prothrombin time induced by warfarin.
Warning & Precautions: Before using this drug, patient should disclose to the physician the medical history, including any allergies (especially drug allergies), any penis conditions such as fibrosis/scarring, history of painful/prolonged erection (priapism), sickle
407

bexinfo: T
HERAPEUTIC
G
UIDE cell anemia, blood system cancers (such as leukemia or myeloma), or Peyronie's disease, eye problems (retina diseases), kidney or liver disease, bleeding disorders , active stomach ulcers, heart diseases, stroke or severe high or low blood pressure and history of alcohol intake, as it may aggravate side effects of this drug. To avoid dizziness and lightheadedness when rising from a seated or lying position, patient should get up slowly. The elderly may be more sensitive to the side effects of this drug; therefore caution is advised in this group. There have been rare reports of prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) for this class of compounds. Priapism, if not treated promptly, can result in irreversible damage to the erectile tissue. Patients who have an erection lasting greater than 4 hours, whether painful or not, should seek emergency medical attention.
High Risk Group: Adafil is not indicated for use in newborns, children, or women.
Overdosage & Contraindication: Tadalafil is contraindicated for patients with a known hypersensitivity to Tadalafil or any component of the tablet. Administration of Tadalafil to patients who are using any form of organic nitrate, either regularly and/or intermittently, is contraindicated. In clinical pharmacology studies, Tadalafil was shown to potentiate the hypotensive effect of nitrates. This is thought to result from the combined effects of nitrates and Tadalafil on the nitric oxide/cGMP pathway. Administration of Tadalafil to patients taking any α -adrenergic antagonist other than 0.4 mg once-daily Tamsulosin is contraindicated. In a drug-drug interaction study, when Tadalafil 20 mg was administered to healthy subjects taking Doxazosin (8 mg daily), there was a significant augmentation of the blood-pressure-lowering effect of Doxazosin.
Commercial Pack: Adafil ® 10 Tablet & Adafil ® 20 Tablet: Box containing 4 tablets in
1x4’s blister strip. Each film coated tablet contains Tadalafil INN 10 mg and Tadalafil INN
20 mg respectively.
®
Tablet
This is a preparation of Sildenafil Citrate, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE5).
Indications: Erectile dysfunction and pulmonary hypertension.
Dosage & Administration: Erectile dysfunction: For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. However,
Enegra may be taken anywhere from 4 hours to 0.5 hour before sexual activity. Based on effectiveness and toleration, the dose may be increased to a maximum recommended dose of 100 mg or decreased to 25 mg. The maximum recommended dosing frequency is once per day.
Pulmonary hypertension: 20 mg 3 times daily.
Children: Not recommended.
408

bexinfo: T
HERAPEUTIC
G
UIDE
Side Effects: The most common side effects are headache, flushing of the face, and upset stomach; less commonly temporary changes in color vision, more sensitivity of eye to light, or blurred vision may occur.
Drug Interaction: Sildenafil metabolism is principally mediated by the cytochrome P450
(CYP) isoforms 3A4 (major route) and 2C9 (minor route). Therefore, inhibitors of these iso-enzymes may reduce clearance of Enagra and inducers of these iso-enzymes may increase its clearance. The concomitant administration of the protease inhibitor substantially increases serum concentrations of Sildenafil, therefore co-administration of protease inhibitor with Sildenafil Citrate is not recommended. Sildenafil Citrate has vasodilator properties, resulting in mild and transient decreases in blood pressure.
Administration of Sildenafil Citrate to patients with pulmonary veno-occlusive disease
(PVOD) is not recommended. The signs of pulmonary edema occur when sildenafil is administered, the possibility of associated PVOD should be considered. Caution is advised when phosphodiesterase type 5 (PDE5) inhibitors are co-administered with αblockers. PDE5 inhibitors, including sildenafil, and α-adrenergic blocking agents are both vasodilators with blood pressure lowering effects.
Warning& Precaution: Sildenafil Citrate should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie’s disease) or in patients who have conditions, which may predispose them to priapism
(such as sickle cell anemia, multiple myeloma or leukemia).
Use in Pregnancy & Lactation: It is not recommended for pregnant or lactating women.
Contraindication: Consistent with its known effects on the nitric oxide/cGMP pathway,
Sildenafil Citrate was shown to potentiate the hypotensive effects of nitrates, and its administration to patients who are using organic nitrates, either regularly and/or intermittently, in any form is therefore contraindicated. Sildenafil Citrate is contraindicated in patients with a known hypersensitivity to any component of the tablet.
Commercial Pack: Enegra ® 50 Tablets and Enegra ® 100 Tablet: Box containing 4 tablets in 1x4’s blister strip. Each film-coated tablet contains Sildenafil Citrate INN equivalent to Sildenafil 50 mg and Sildenafil Citrate INN equivalent to Sildenafil 100 mg respectively.
®
Tablet
This is a preparation of Oxybutynin Chloride, an antispasmodic, anticholinergic agent and relaxes bladder smooth muscle.
Indications: It is a once-daily controlled release tablet indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency for urination, frequent urination and nocturnal enuresis.
409

bexinfo: T
HERAPEUTIC
G
UIDE
Dosage and Administration: The recommended starting dose of Uricon is 5 mg once daily, with or without food. Dosage may be adjusted in 5 mg increments to achieve a balance of efficacy and tolerability (up to a maximum of 30 mg/day). In general, dosage adjustment may proceed at approximately weekly intervals.
Side Effects: The incidence of dry mouth may occur which is dose-related. Abdominal pain, dry nasal and sinus mucous membranes, back pain, hypertension, palpitation, vasodilatation, flatulence, gastro-esophageal reflux, insomnia, nervousness, confusion, cough, sinusitis, bronchitis, dry skin, rash, impaired urination (hesitancy), urinary retention, etc. may be reported.
Drug Interactions: Anticholinergic agents, cytochrome P450 enzyme inhibitors, such as antimycotic agents (e.g., Ketoconazole, Itraconazole, and Miconazole) or macrolide antibiotics (e.g., erythromycin and clarithromycin), have not been performed. No specific drug-drug interaction studies have been performed with Oxybutynin.
Warning & Precautions: Oxybutynin Chloride should be used with caution in patients with hepatic or renal impairment, clinically significant bladder outflow obstruction because of the risk of urinary retention, gastrointestinal obstructive disorders because of the risk of gastric retention, conditions such as ulcerative colitis, intestinal atony, and myasthenia gravis, gastro-esophageal reflux and/or who are concurrently taking drugs (such as bisphosphonates) that can cause or exacerbate esophagitis.
Use in Pregnancy & Lactation: Oxybutynin Chloride should not be given to pregnant women unless, the probable clinical benefits outweigh the possible hazards, caution should be exercised when it is administered to a nursing woman.
Contraindications: Oxybutynin Chloride is contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow angle glaucoma and in patients who are at risk for these conditions. It is also contraindicated in patients who have demonstrated hypersensitivity to the drug substance or other components of the product.
Commercial Pack: Uricon ® Tablet: Box containing 30 tablets in 3 x 10’s blister strips.
Each controlled release tablet contains Oxybutynin Chloride USP 5 mg.
410

bexinfo: T
HERAPEUTIC
G
UIDE
A
NTI
-BPH A
GENT
®
Tablet
This is a preparation of Finasteride, a competitive inhibitor of the 5 α-reductase enzyme which metabolizes testosterone to dihydrotestosterone. Finasteride has no affinity for the androgen receptor.
Indications: Prosfin is indicated for the treatment and control of benign prostatic hyperplasia (BPH) to cause regression of the enlarged prostate, to improve urinary flow, and to improve the symptoms associated with BPH.
Dosage & Administration: The recommended dosage is one 5 mg tablet daily.
Although early improvement may be seen, treatment for at least six months may be necessary to assess whether a beneficial response has been achieved. Thereafter, treatment should be continued.
Side Effects: Prosfin is usually well tolerated. The common adverse effects are asthenia, hypotension, peripheral edema, dizziness, decreased libido, rhinitis, abnormal ejaculation, impotence and abnormal sexual function.
Drug Interactions: No clinically meaningful interactions were found with Antipyrine,
Digoxin, Propranolol, Theophylline and Warfarin.
Warning & Precautions: In patients with large residual urine volume and/or severely diminished urinary flow should be carefully monitored for obstructive uropathy, Finasteride causes a decrease in concentration of prostate specific antigen (PSA). Therefore, in patients with BPH treated with Finasteride does not rule out concomitant prostate cancer.
Women should not handle crushed or broken Prosfin tablets who are pregnant or may have potentially become pregnant because of the possibility of absorption of Finasteride and the subsequent potential risk to a male fetus.
Overdosage & Contraindications: Hypersensitivity to any component of this medication. It is also contraindicated in women and children.
Commercial Pack: Prosfin ® Tablet: Box containing 3 blister strips of 10 tablets, each film coated tablet contains Finasteride USP 5 mg.
411

bexinfo: T
HERAPEUTIC
G
UIDE
®
Capsule
This is a preparation of Tamsulosin hydrochloride INN which is a Sulfonamethylamine derivative α1a-adrenergic blocking agent. Tamsulosin has higher affinity and selectivity for the α1a-adrenergic receptors.
Indications: Uroflo is used in Lower Urinary Tract Symptoms (LUTS) and in Benign prostatic hyperplasia (BPH). It relaxes smooth muscle in BPH producing an increase in urinary flow rate and an improvement in obstructive symptoms.
Dosage and Administration: Uroflo Capsule 0.4 mg once daily is recommended for the treatment of the signs and symptoms of BPH. It should be administered approximately one and half-hour following the same meal each day. For those patients who fail to respond to the 0.4 mg dose after 2 to 4 weeks of dosing, the dose of Uroflo can be increased to 0.8 mg once daily.
Side Effects: Side effects of Tamsulosin include drowsiness, asthenia, depression, headache, dry mouth, nausea, vomiting, diarrhea, constipation, edema, blurred vision, rhinitis, erectile disorders, tachycardia and palpitation. Hypersensitivity reactions including rash, pruritus, angio-edema have been reported in some cases.
Drug Interactions: Tamsulosin should not be used in combination with other αadrenergic blocking agents. Caution should be exercised with concomitant administration of Warfarin and Tamsulosin.
Warning & Precautions: Caution may be required in the elderly and in patients with hepatic impairment and severe renal impairment.
Use in Pregnancy and Lactation: This is not indicated for use in women.
Contraindications: Tamsulosin is contraindicated in patients known to be hypersensitive to Tamsulosin or any component of the product. It should be avoid in patients with a history of orthostatic hypotension and micturition syncope.
Commercial Pack: Uroflo ® Capsule: Each Box containing 20 capsules in 2 x 10’s blister strips. Each modified release capsule contains Tamsulosin Hydrochloride INN 0.4 mg.
412

bexinfo: T
HERAPEUTIC
G
UIDE
D
IAGNOSTIC
D
YE
®
Injection
This is a preparation of Iopamidol, an organic Iodine compound and used as a non-ionic water soluble radiographic contrast medium. Iopamidol blocks X-rays as they pass through the body, thereby allowing body structures not containing Iodine to be visualized.
The degree of opacity produced by Iopamidol is directly proportional to the total amount of the iodinated contrast agent in the path of the X-rays. The visualization of body structures is dependent upon the distribution and elimination of Iopamidol.
Indications: Neurology: Lumber myelography, thoraco-cervical myelography.
Angiography: Cerebral angiography, selective coronary angiography, left ventriculography, aortography, angiocardiography, selective visceral arteriography, peripheral arteriography, digital subtraction angiography, venography, urography.
Other diagnostic procedure: Contrast enhancement in CT scanning, arthrography, fistulography.
Dosage & Administration: Adult dosage: Neurology: Lumber myelography: Lopidam
370, 6-13 ml, Thoraco-cervical myelography: Lopidam 370, 6-13 ml. Urography: Lopidam
370, 40-80 ml IV up to 1.5 ml/kg in severe renal disease. Children: 1-2.5 ml/kg. Other
Diagnostic Procedure: Contrast enhancement in CT scanning: Lopidam 370, 0.5-2.0
ml/kg
Angiography: Cerebral angiography: Lopidam 370, 6-13 ml, Selective coronary arteriography: Lopidam370, 4-8 ml/artery, Peripheral arteriography: Lopidam 370, 20-50 ml, Venography: Lopidam 370, 24-60 ml, Angiocardiography: Lopidam 370, 30-80 ml,
Left ventriculography: Lopidam 370, 30-80 ml, Percutaneous transfemoral/ renal arteriography: Lopidam 370, 30 ml, Selective renal arteriography: Lopidam370, 5-10 ml,
Hepatic angiography: Lopidam 370, 70 ml, Coeliac angiography: Lopidam 370, 40-70 ml,
Superior mesenteric angiography: Lopidam 370, 25-50 ml, Inferior mesenteric angiography: Lopidam 370, 5-30 ml, Digital subtraction angiography: 30-50 ml (10-20 ml/sec) of Lopidam 370, IV 25 ml (left ventricle), 2-5 ml (coronary arteries) ,15 ml/sec. of
Lopidam 370 i.a for cardiac imaging
Side Effects: Nausea, vomiting, widespread erythema, generalized heat sensation, headache, coryza, fever, sweating, asthenia, dizziness, pallor, dyspnea, and moderate hypotension. Skin reactions occur in the form of various types of rash or diffuse blister formation. More severe reactions involving the cardiovascular system such as peripheral vasodilation with pronounced hypotension, tachycardia, dyspnea, agitation, cyanosis and loss of consciousness, may require emergency treatment. During intra-cardiac and /or coronary arteriography, ventricular arrhythmia may infrequently occur. Hyperthyroidism may recur in patients previously treated for graves disease.
413

bexinfo: T
HERAPEUTIC
G
UIDE
Drug Interactions: Lopidam 370 may interfere with thyroid function. Biguanide compete for excretion in the kidneys with contrast media and this could lead to reduction in kidney function. Patient taking Metformin or other Biguanides should therefore not take any doses of Metformin for 48 hours before or 48 hours after the X-ray examination.
Warning & Precautions: Lopidam 370 should not be drawn into the syringe until immediately before use. When examining small children or babies, do not limit fluid intake before administering a hypertonic contrast solution. Any existing water and electrolyte imbalance should be corrected. X-ray examination of woman should also, if possible be conducted during the pre-ovulation phage of menstrual cycle. In patients scheduled for thyroid examination with a radioactive Iodine tracer, one must take into consideration that
Iodine uptake in the thyroid gland will be reduced for several days (up to two weeks) after dosing with an iodinized contrast medium that is eliminated through kidney. In the event of CSF blockade, as much as possible the administrated contrast solution should be removed of. Patients receiving treatment with anticonvulsant drugs must continue such treatment before and after the procedure. Should a convulsive seizure develop during the examination, administer diazepam or sodium Phenobarbital intravenously.
Neuroleptics, analgesics, antiemetics, antihistamines and sedatives of the phenothiazine group must be absolutely avoided because they lower the seizure threshold. Whenever possible, treatment with such drug should be discontinued at least 48 hours before administration of the contrast medium and not to be resumed less than 12 hours after completion of the procedure. A fairly frequent cardiovascular reaction to dosing with
Lopidam is bradycardia associated with systemic hypotension. Severe neurological sequelae may arise as direct complications of pre-existing pathology in the individual patient. Such reactions are diverse and may include tonic/clonic convulsions, aphasia, fainting, hemiparesis and coma. The risk may be increased by conditions such as advanced arteriosclerosis, hypertension, heart failure, major systemic disease and recent cerebral embolism or thrombosis. Right heart insufficiency and pulmonary hypertension may precipitate bradycardia and systemic hypotension when the organic iodine solution is injected. Care should be exercised in patients with moderate to severe impairment of renal function.
Use in Pregnancy & Lactation: Iopamidol injection should be administered in pregnancy only if the procedure is considered essential by the physician.
Contraindications: Hypersensivity to any of the component of this product,
Waldenstrom' macroglobulinemia, multiple myeloma and severe liver and kidney disease.
Commercial Pack: Lopidam ® 370: Each vial (50 ml) contains: 37.75 g of Iopamidol USP equivalent to 18.5 g of Iodine.
Lopidam ® 370: Each vial (100 ml) contains: 75.50 g of Iopamidol USP equivalent to
37.00g of Iodine.
414

A
I

A
Acifix Tablet
Adafil Tablet
Aerovil Syrup
Aeronid Inhaler
Alastine Eye Drops
Alphin DS Tablet
Amdova Tablet
Amdocal Tablet
Amdocal Plus Tablet
Antacid Max Tablet
Anustat Ointment
Apresin Tablet
Aristocal Tablet
Aristocal D Tablet
Aristocal M Tablet
Aristoferon Syrup
Aristoplex Syrup
Aristovit B Tablet
Aristovit B Injection
Aristovit M Tablet
Aristovit X Tablet
Arixon Injection
Arlin Tablet / Suspension / Infusion
Ascobex Tablet
Atova Tablet
Atolimus Ointment
Atralin Tablet
Atrizin Tablet / Syrup / Pediatric drops
Avitron V Tablet
Avifanz Tablet
Avifix Tablet
Avilam Tablet
Avidro Tablet
Axodin Tablet / Suspension
Azithrocin Capsule / Tablet / Suspension / Injection
Azmasol Tablet
Azmasol Inhaler
Azmasol Respiration Solution
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
B
Bexidal Tablet
Bextram Tablet
Bextram Gold Tablet
Bextram Silver Tablet
Bextram KIDZ Syrup
-
-
-
-
bexinfo: T
HERAPEUTIC
G
UIDE
101
104
106
255
38
62
362
363
364
145
395
245
37
282
280
281
60
61
282
276
277
278
278
279
183
400
245
275
275
196
407
37
356
313
96
120
119
119
40
283
284
285
286
417

bexinfo: T
HERAPEUTIC
G
UIDE
Bextram Teen Hm Tablet
Bextram Teen Hr Tablet
Bexitrol Inhaler
Bexitrol F Inhaler
Bexitrol F Bexicap Capsule
Bizoran Tablet
Bronkolax Tablet / Syrup
Bricasol Respirator Solution
Burnsil Cream
C
Calorate Tablet
Calorate Kit Tablet
Carnitab Tablet
Carocet Tablet
Cardopril Tablet
Cerivin Tablet
Cesonide Inhaler
Chlormet Eye Drops
Citicol IM / IV Injection
Cinarex Eye Drops
Cinarex D Eye Drops
Cleven
Clobex Capsule / Syrup
Co Diaglit Tablet
Cox B Capsule
Contra Eye Drops
Cosmotrin Cream
Curin Tablet
D
Deflux Tablet / Suspension / Pediatric Drop
Dexifen Tablet / Suspension
Dextromethorphan Syrup
Decomit Inhaler
Decomit Nasal Spray
Diavix Tablet
Diactin Tablet
Diaglit Tablet
Diapro Tablet
Diapro 30 MR Tablet
Diaryl Tablet
Digecid Plus Tablet / Suspension
Dilapress Tablet
Dinovo Tablet
418
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
137
64
165
221
317
358
314
266
315
315
383
40
289
290
293
294
123
151
287
288
344
345
346
122
365
366
384
168
169
170
170
183
123
223
210
222
157
358
376
107
166

E
Ecotrim Cream
Emonium Tablet
Emonium Injection
Enaril 5 Tablet
Enegra Tablet
Epilep Tablet / CR Tablet
Etrocin Tablet / Suspension
Eukrim Cream
Evo Tablet / Oral Solution
Evo IV Infusion
Evo Eye Drops
Evo TS Eye Drops
Exovate Cream / Ointment
Exovate N Cream / Ointment
Ezeta Tablet
F
Feburic Tablet
Fertil Tablet
Fenamic Capsule / Tablet / Suspension
Filmet Tablet / Suspension
Filmet IV Infusion
Flatameal DS Suspension
Flubex Capsule/ Syrup/DS Syrup
Flurium Tablet
Formula E Tablet
Forterol Respirator Solution
Frenxit Tablet
Fungistin Suspension
Furasep Cream
Fusidic Plus Ointment
G
Gastalfet Tablet
Gentosep Cream
Glipita Tablet
Glipita M Tablet
Glucovis Eye Drops
H
Hemofix Tablet
Hemofix FZ Tablet
Hyprosol Eye Drops
Hypersol 5 Eye Drops bexinfo: T
HERAPEUTIC
G
UIDE
295
367
246
92
385
389
215
179
225
55
56
184
68
256
197
385
172
174
320
399
66
68
318
319
395
387
146
393
191
191
124
408
253
65
297
297
321
322
419
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-

bexinfo: T
HERAPEUTIC
G
UIDE
I
IcyKool / IcyKool Max Cream
Indelix SR Tablet
Informet Tablet / Informet LA Tablet
Inflavis Eye / Ear Drops
Intracef Capsules / Suspension / Pediatric Drops/ Injection
Intramol Eye Drops
Ipramid Inhaler
Iprasol Inhaler
Ipramid Respirator Solution
Iprasol Respirator Solution
Isofloxin Tablet
Ivera 6 Tablet
J
Jointec Max Tablet
K
Keolax Tablet
L
Labeta Tablet
Lactameal Tablet / Suspension
Larnox LA Tablet
Lonet Tablet
Loverin Tablet / Syrup
Lofat Capsule
Lospan Tablet
Lopidam Injection
Lucidol Capsule / Suppository
M
Maxidime Injection
Megadox Capsule
Megatrim DS Tablet / Megatrim Suspension
Melphin Suspension
Melev 20 Tablet
Metazine MR Tablet
Metoprol XL Tablet
Misopa Tablet
Mobicam Tablet
Momento Tablet / Syrup
Monate Tablet
Modipran Capsule
420
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
216
267
401
126
175
322
69
324
348
349
368
369
72
97
98
247
114
129
198
73
75
76
226
41
113
248
127
185
370
128
192
148
217
413
27

Momvit Plus Tablet
Monocast Tablet
Mucosol Syrup / Pediatric Drops
Mucomist Respirator Solution
Mydrate Eye Drops
N
Napa Tablet/ Syrup / Suspension / Suppository / Pediatric Drops
Napa IV Infusion
NapaDol Tablet
Napa Extend Tablet
Napa Extra Tablet
Napa Soft Tablet
Nasomet Nasal Spray
Nazolin Nasal Spray
Neofloxin Tablet / Suspension
Neofloxin IV Infusion
Neoceptin R Tablet / Syrup
Neoceptin R Injection
Neodrop Pediatric Drops
Neo Kit Tablet / Capsule
Neofloxin Eye / Ear Drops
Neofloxin D Eye/Ear Drops
Neosten Cream
Neosten VT Tablet
Neosten HC Cream
Nerkein Injection
Nervalin Capsule
Neurocare Tablet
Neurocare Tablet
Nightus Tablet
Nitaxide Tablet / Suspension
Nitrosol Spray
NoKOF Capsule / Syrup / DS Syrup
Noscab Cream
Nutrimin Solution
Nutrimin D Solution
Nuprafen Tablet
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
bexinfo: T
HERAPEUTIC
G
UIDE
298
350
158
371
325
299
268
57
114
159
391
394
262
264
271
398
300
302
227
186
201
326
327
390
378
77
80
199
200
28
30
31
31
32
33
377
O
Ocutrex Eye / Ear Drops
Odrel Tablet
Odrel Plus Tablet
Olmesan Tablet
Olmesan Plus Tablet
Olopan Nasal Spray
-
-
-
-
-
-
328
139
140
130
132
42
421

bexinfo: T
HERAPEUTIC
G
UIDE
Olopan Eye Drops
Olopan DS Eye Drops
Omastin Capsule / Suspension / Infusion
Omastin Duo Capsule / Cream
Onsat Tablet / Syrup
Onsat Injection
Opanac Eye Drops
Opton Tablet / IV Injection
Oseflu Capsule
Ovalac Tablet
P
P
Pacet Tablet
Pantobex Tablet / IV Injection
Pedeamin Syrup
Perinese Nasal Spray
Pericam Tablet
Prasuva Tablet
Pretin Tablet
Pretin D Tablet
Premil Tablet
Pregvit Capsule
Primace Capsule / Tablet
Promezin Syrup
Prosan Tablet
Prosan HZ Tablet
Prosfin Tablet
Proceptin Capsule / IV Injection
Protolan Capsule
Prudex Syrup
Q
Q-Rash Ointment
R
Recur Tablet
Relentus Tablet
Repitol Tablet
Resitone Tablet
Resitone Plus Tablet
Respira Tablet / Syrup
Reumafen Tablet / Suspension
Ribox Tablet
Rostil Tablet
Rosutin Tablet
Rubalon Eye Drops
422
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
33
47
135
135
411
204
206
160
141
44
45
177
304
115
203
43
379
260
329
330
92
94
187
188
331
202
99
100
403
403
218
258
142
143
374
228
229
193
149
332

S
Saloride Eye Drops
Serelose Solution
Seropam Tablet
Soritene Cream
Sparlin Tablet
Spanil Tablet
Spulyt Tablet / Syrup
Symbion Inhaler
Symbion Bexicap Capsule
T
Tamona Tablet
Taverin Tablet
Tearex Eye Drops
Tearon Eye Drops
Tenafin Cream
Terbex Cream / Tablet
Tetracef Injection
Thalin Tablet
Tioriva Bexicap Capsule
Tobasol Respirator Solution
Tofen Tablet / Syrup
Tofen Eye Drops
Tolmic Tablet
Tolmus Tablet
Tranexil IV Injection
Tripec Syrup
Triocim Capsule / Suspension
Triovix Tablet
Turbocef Tablet / Injection
Tycil Capsule / Suspension / Pediatric Drops
Tyclav Tablet
Tynisol Drop
U
Ultrafen Tablet / Suppository
Ultrafen IM Injection
Ultrafen Plus Tablet
Ultrafen Extra IM Injection
Uricon Tablet
Uroflo Capsule
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
bexinfo: T
HERAPEUTIC
G
UIDE
91 / 343
359
335
231
219
117
162
84
108
85
51
194
334
334
391
95
82
143
355
86
88
305
232
233
234
235
409
412
333
212
249
397
81
194
161
352
354
423

bexinfo: T
HERAPEUTIC
G
UIDE
V
Vasolax Tablet
Veniron Injection
Vercef Suspension / Pediatric Drops
Viscocid Tablet / Suspension
Vitonic Syrup
Vivis Capsule
Vivis Capsule
Voligel Gel
Vomec Tablet
Vomec-Plus Tablet
X
Xalanol Eye Drop
Xalaprost Eye Drops
Xegal Eye Drops
Xetril Tablet
Xidolac Tablet
Xidolac IM / IV Injection
Xidolac Eye Drops
Xynofen 100 SR Capsule
Xynor Tablet
Y
Yamadin Tablet
Z
Zedex DS Syrup
Zocil Tablet
Zolax Tablet
Zolfin Tablet
Zukast Tablet
Zymet Tablet
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
152
306
89
207
307
308
336
237 / 402
251
252
337
338
338
268
237
238
340
240
58
208
309
153
270
241
360
209
424