2010
AY09/10
SEMESTER 2
[ PR3107 – PHARMACY
PRACTICE II]
GENERAL SALES LIST AND PHARMACIST
MEDICATION MONOGRAPH
Table of Contents
1. HYDROCORTISONE 0.5% CREAM ............................................................................................... 4
2. CROTAMITON CREAM ................................................................................................................ 8
3. CALAMINE LOTION ................................................................................................................... 10
4. EUCALYPTUS OIL TOPICAL PREPARATIONS .............................................................................. 13
5. METHYL SALICYLATE TOPICAL PREPARATIONS ........................................................................ 16
6. MALATHION LIQUID ................................................................................................................. 19
7. LIGNOCAINE TOPICAL PREPARATIONS .................................................................................... 22
8. MINOXIDIL SCALP LOTION ....................................................................................................... 25
9. CICLOPIROX LIQUID.................................................................................................................. 28
10. COAL TAR SOLUTION................................................................................................................ 31
11. ZINC PYRITHIONE LIQUID ......................................................................................................... 33
12. SELENIUM SULFIDE SOLUTION ................................................................................................ 35
13. KETOCONAZOLE CREAM/LIQUID ............................................................................................. 37
14. CLOTRIMAZOLE VAGINAL TAB/CREAM .................................................................................... 43
15. MICONAZOLE CREAM/POWDER .............................................................................................. 46
16. TERBINAFINE CREAM ............................................................................................................... 48
17. SALICYLIC ACID SOLUTION ....................................................................................................... 50
18. ISOCONAZOLE TABLET/CREAM ................................................................................................ 53
19. AMOROLFINE NAIL LACQUER .................................................................................................. 55
20. HUMULIN 30/70 INJECTION ..................................................................................................... 59
21. PANADEINE .............................................................................................................................. 63
22. ALEVE TABLETS......................................................................................................................... 66
23. ASPIRIN .................................................................................................................................... 69
24. KETOPROFEN PLASTER ............................................................................................................. 73
25. DICLOFENAC GEL ...................................................................................................................... 75
26. CHLORPHENIRAMINE SYRUP/TABLET ...................................................................................... 77
27. PROMETHAZINE SYRUP............................................................................................................ 80
28. POLARAMINE SYRUP/TABLET .................................................................................................. 83
29. LORATADINE ............................................................................................................................ 86
30. PSEUDOEPHEDRINE TABLET .................................................................................................... 89
31. SALBUTAMOL SYRUP / TABLET ................................................................................................ 92
32. DIPHENHYDRAMINE................................................................................................................. 96
33. N-ACETYLCYSTEINE EFFERVESCENT TABLETS/ GRANULES/ LOZENGES ................................... 99
2
34. AMBROXOL SYRUP/ TABLET .................................................................................................. 102
35. GUAIFENESIN SYRUP .............................................................................................................. 104
36. DEXTROMETHORPHAN SYRUP ............................................................................................... 108
37. OXYMETAZOLINE NASAL SPRAY/DROP .................................................................................. 111
38. SERRATIOPEPTIDASE TABLETS ............................................................................................... 113
39. TRACHISAN LOZENGES ........................................................................................................... 115
40. BENZYDAMINE LOZENGES ..................................................................................................... 117
41. NAPHCON-A EYE DROP .......................................................................................................... 120
42. VIDISIC EYE GEL ...................................................................................................................... 123
43. PRINCI-B FORT TABLETS ......................................................................................................... 125
44. SANGOBION CAPSULES .......................................................................................................... 127
45. GINGKO BILOBA ..................................................................................................................... 129
46. GLUCOSAMINE ....................................................................................................................... 132
47. FOLIC ACID TABLETS............................................................................................................... 134
48. ASCORBIC ACID TABLET ......................................................................................................... 136
49. CALTRATE PLUS TABLET ......................................................................................................... 139
50. DAFLON TABLET ..................................................................................................................... 142
51. FAMOTIDINE TABLET ............................................................................................................. 144
52. SIMETHICONE ........................................................................................................................ 147
53. GAVISCON LIQUID/TABLET .................................................................................................... 149
54. ENZYPLEX TABLET .................................................................................................................. 152
55. ATROPINE/DIPHENOXYLATE TABLETS ................................................................................... 154
56. LOPERAMIDE TABLET ............................................................................................................. 156
57. ACTIVATED CHARCOAL .......................................................................................................... 159
58. SMECTA POWDER .................................................................................................................. 163
59. BISACODYL TABLET/SUPPOSITORY ........................................................................................ 165
60. SENNA .................................................................................................................................... 168
61. LACTULOSE ............................................................................................................................. 171
62. ISPAGHULA HUSK ................................................................................................................... 174
63. LACTEOL FORTE POWDER ...................................................................................................... 176
3
Student name
Ang Xiaohui
Aw Chai Ching Rebecca
Matric number
U085481A
U084935N
Date
31 Jan 2010
31 Jan 2010
HYDROCORTISONE 0.5% CREAM
Brand / Generic Name: DermAid (Ego)
Generic name: Hydrocortisone 0.5% Cream
Proprietary name: Efcortelan® Cream (GlaxoSmithKline)
Active ingredient: Hydrocortisone 0.5% w/w
Sources of information:
 British National Formulary (BNF) 58, September 2009
 MIMS Singapore
Legal classification in Singapore: P
Source of information: MIMS Singapore
Approved indication(s):
For temporary relief of minor skin irritation, inflammation and itching, such as allergic
rashes; irritant contact dermatitis, which may be caused by detergents, soaps, bleaches,
washing powders and various chemicals; insect bites and mild eczema. It may also be used
in the treatment of nappy rash under medical supervision.
Sources of information:
 APhA Handbook of Non-Prescription Drugs
 BNF 58
 MIMS
 Product insert
Therapeutic classification: Topical corticosteroid.
Mechanism of action(s):
Hydrocortisone decreases inflammation by suppression of migration of polymorphonuclear
leukocytes, reversal of increased capillary permeability and vasoconstriction.
Sources of information: Lexi-comp Drug Information Handbook, Product insert
4
Available dosage form(s): Cream, ointment, lotion.
Sources of information:
 APhA Handbook of Non-Prescription Drugs
 BNF 58
 Lexi-comp Drug Information Handbook
 Martindale – The Complete Drug Reference (34th Ed)
 MIMS
Dosing and administration:
Strength: The cream is available over-the-counter in concentrations 0.25%, 0.5% and 1%.
Prescriptions will be required for higher concentrations.
Topical administration: direct application on the affected area as a thin film one to two
times daily until inflammation is suppressed, for a maximum period of 1 week. Frequency
of application depends on the severity of the skin condition.
Sources of information:
 BNF 58
 Lexi-comp Drug Information Handbook
 MIMS
 Product insert
5
Side effects / Cautions:
 Common side effects: Slight stinging sensation or irritation of skin.
(As the cream is a mild potent topical corticosteroid preparation, severe side effects
associated with more potent prescription-only topical steroids are less likely to
occur if it is used with care.)

Adverse drug reactions:
- Spread and worsening of untreated infections
- Thinning of the skin, damage is reversible upon stopping application
- Irreversible striae atrophicae (stretch marks) and telangiectasia (small dilated
blood vessel near the skin surface)
- Contact dermatitis (rash)
- Perioral dermatitis (red papules)
- Acne, or worsening of acne or acne rosacea (flushing of the face)
- Hypertrichosis (abnormal hair growth- increase in length and density)

Cautions:
- Avoid contact with eyes.
- Do not use under occlusive bandages
- Do not use on broken skin or large areas of the body.
- Do not apply more than twice daily.
- Avoid prolonged use (daily application for maximum of 1 week).
- Use with caution during pregnancy and lactation or in infants.
Sources of information:
 BNF 58
 Martindale – The Complete Drug Reference (34th Ed)
 MIMS
 Product insert
Contraindication(s):
The cream should not be used for untreated viral skin infections, such as herpes simplex
(cold sores) and chicken pox; fungal infections, such as candidiasis, ringworm and athletes
foot; bacterial infections, such as impetigo; perioral dermatitis; acne rosacea; scabies and
ulcerative conditions.
Patients hypersensitive to any of the components and excipients such as cetostearyl alcohol
and chlorocresol.
Sources of information:
6
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APhA Handbook of Non-Prescription Drugs
BNF 58
Lexi-comp Drug Information Handbook
MIMS
Product insert
Patient education / Counselling points:
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Store in a cool dry place below 30⁰C.
The cream is for external use only.
Wash the affected area before application.
Apply sparingly and rub in well.
Stop applying once the skin condition is relieved.
If any discomfort arises, stop medication and seek medical attention immediately.
Keep away from children.
(Including the points on cautions.)
Sources of information:
 APhA Handbook of Non-Prescription Drugs
 MIMS
 Product insert
7
Student Name
Bay Li Xuan Michelle
Cassandra Leong Shan Neng
Matric Number
U084905B
U085615X
Date
25th Jan 2010
25th Jan 2010
CROTAMITON CREAM
Brand / Generic Name: Eurax/Crotamiton
Generic name: Crotamiton
Proprietary name: Eurax
Active ingredient: Crotamiton
Source of information: British Approved Names 2002
Legal Classification in Singapore: GSL
Source of information: Health Sciences Authority, Singapore
Approved Indication(s):
 Treatment of pruritis
 Treatment of scabies
Source of information: Lexi-Comp Drug Information Handbook, Martindale
Therapeutic Classification: Topical antihistamines, antipruritics, antifungals, antiparasites
Mechanism of Action(s):
Antipruritic: Acts as a counter-irritant to produce a cooling effect
Scabicide: Has scabicidal and antipruritic activity against Sarcoptes scabei. Mechanism of
action remains unknown
Source of information: MIMS, Lexi-Comp Drug Information Handbook
Available Dosage Form(s):
 Crotamiton 10% Cream
 Crotamiton 10% Lotion
Source of information: Martindale , MIMS Singapore, BNF 54 2007
Dosing and Administration:
 For pruritis: Massage cream into affected areas until medication absorbed. Repeat
8
as necessary.
-Adult: Apply 2-3 times daily.
-Child below 3 years: Apply once daily.
 For scabies: After bathing and towel drying, apply cream as a thin layer from neck to
toes and massage into skin. Pay attention to skin folds and the interdigital spaces. If
cream should be washed off, reapply immediately. Repeat this treatment after 24
hours. Continue this daily for up to about 5 days.
Source of information: Lexi-Comp Drug Information Handbook, BNF 54 2007
Side Effects / Cautions:
 Contact dermatitis
 Warm sensation
 Rash
 Skin Irritation
 Ingestion may cause nausea, vomiting, abdominal pain with irritation to oral,
oesophagal and gastric mucosa
 Avoid contact with eyes, face or mucous membrane
 Use on doctor’s advice for children under 3 years
Source of information: Martindale, MIMS, BNF 54 2007
Contraindication(s):
 Hypersensitivity
 Should not be used in cases of acute exudative dermatitis
 Should not be applied on excoriated skin
 Pregnancy
Source of information: Lexi-Comp Drug Information Handbook, MIMS Singapore
Patient Education / Counselling Points:
 For topical use only
 Avoid applications to eyes, face and mucous membrane
 If suffering from scabies, all contaminated linen and bedsheets should be washed to
prevent reinfestation
 Avoid scratching to prevent onset of secondary infection
 Keep fingernails short and clean
Source of information: Lexi-Comp Drug Information Handbook (took the last 2 pts from
notes)
9
Student Name
Chan Choi Wai Bernice
Chan Qing Fei Charmaine
Matric Number
U084959A
U084904N
Date
30/1/2010
30/1/2010
CALAMINE LOTION
Brand name: Calamol®
Generic name: Calamine
Active ingredients:
 Calamine
 Zinc oxide
Sources of information:
 electronic Medicines Compendium
 MIMS
Legal Classification in Singapore: General Sales List
Source of information: MIMS
Approved Indication(s):
 To treat pruritus (itching) – a symptom of numerous skin disorders, but may also be
indicative of systemic illnesses like obstructive jaundice, chronic renal disease,
endocrine disease, certain malignancies, or hypersensitivity to a drug.
 To soothe and relieve minor skin irritations, including pain, insect bites, rashes and
discomfort, particularly brought on by poison ivy, poison oak and poison sumac.
 A skin protectant for first degree and minor second-degree thermal burns and
sunburns.
Sources of information:
 electronic Medicines Compendium
 Martindale
 Micromedex
 Pray W. Non-prescription Drug Therapeutics, Lippincott Williams and Wilkins
 Product label
 U.S. Food and Drug Administration (FDA)
Therapeutic Classification:
 Astringent
10
 Skin protectant
 Topical antipruritic/antihistamine
Mechanism of Action(s):

Calamine acts as an astringent by coagulating protein to constrict skin tissues and
blood capillaries as well as decrease cell volume, thus minimising oozing, discharge
or bleeding when applied to the skin.
 A powdery zinc oxide layer is left on the skin upon application; hence it acts as a skin
protectant in addition to calamine.
 As an antihistamine, calamine helps to relieve itching and swelling caused by the
release of histamines during the body’s exposure to allergens.
 It also has absorbant properties, helping to absorb fluids from weeping lesions of
poison ivy/oak/sumac dermatitis.
Sources of information:
 Martindale
 Micromedex
 MIMS
 Pray W. Non-prescription Drug Therapeutics, Lippincott Williams and Wilkins
Available Dosage Form(s):
 Cream
 Lotion
 Ointment
Sources of information:
 electronic Medicines Compendium
 MIMS
 British Pharmacopoeia
Dosing and Administration:



Cleanse and dry the affected region before application of the lotion.
Shake the bottle well before use.
Apply to the affected area of the skin when necessary, or as directed by the doctor.
The lotion may be applied on a piece of soft cloth or cotton wool for easy
application.
Sources of information:
 electronic Medicines Compendium
 Micromedex
11

Product label
Side Effects / Cautions:
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Contact dermatitis.
Do not use if allergic to any one of the ingredients.
Do not use on open wounds.
The lotion is for external use only, not to be taken orally.
If side effects worsen or if the lotion is ingested accidentally, consult a pharmacist or
doctor immediately.
 Avoid contact with the eyes and the mucous membranes of the nose and anogenital
area. If the preparation gets into any of these regions, rinse it out with plenty of
warm water.
Sources of information:
 electronic Medicines Compendium
 MIMS
 WHO Model Prescribing Information. Drugs Used in Skin Diseases
Contraindication(s):

There are no clinically significant interactions of medications or medical conditions
with calamine at present.
Source of information:
 electronic Medicines Compendium
Patient Education / Counselling Points:
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

Do not use the preparation if you are allergic to any one of the ingredients.
Use by the expiry date on the label.
Before first use, check to ensure that the cap seal is unbroken. If it is, do not apply
the lotion.
 Shake the bottle well before use.
 Store in a cool, dry place, away from direct heat and sunlight.
 Keep the medicine out of reach of children.
 Application of the lotion is expected to cause crusting of the skin. Please do not peel
the crust off but let it heal on its own.
 If symptoms do not subside, please consult your physician.
Source of information:
 electronic Medicines Compendium
12
Student Name
Chau Yi Ting
Chee Beng Tatt
Matric Number
U084946X
U084978J
Date
15th Jan 2010
15th Jan 2010
EUCALYPTUS OIL TOPICAL PREPARATIONS
Brand Name/ Active Ingredient: Eucalyptus Oil
Source of information: Martindale
Legal Classification in Singapore (i.e. P or GSL): General Sales List (GSL)
Source of information: Health Sciences Authority, MedlinePlus
Approved Indication(s):
Used for inhalation as a decongestant often in combination with other volatile
substances.
- Used topically as a rubefacient for treatment of rheumatic complaints
Source of information: Martindale, WHO Monographs on Selected Medicinal Plants (Volume
2)
-
Therapeutic Classification: Counter-irritant, decongestant
Mechanism of Action(s):
-
Eucalyptus oil has mild irritant and rubefacient actions causing a sensation of
warmth and redness of the skin due to dilation of blood vessels of the skin. It
relieves pain indirectly by stimulating rather than suppressing sensations of warmth,
and sometimes itching. It also has nasal decongestant activity which is able to relief
cold and flu symptoms if inhaled. It loosens congestion in the chest and releases
mucous build up.
Source of information: APhA Handbook of Non-prescription Drugs, WHO Monographs on
Selected Medicinal Plants (Volume 2)
13
Available Dosage Form(s):
- Essential oil
- Liniment
- Lotion
- Ointment
- Tincture
Source of information: AltMedDex®
Dosing and Administration:
For Adults and Children > 2 years:
-
Topical:
 For use as a topical rubefacient, apply 0.5% to 3% concentration to the affected
area not more than three or four times a day.
 For common cold and coughs, oil can be applied and massaged briskly onto the
chest and back.
 For use to alleviate body chills, the oil can be rubbed onto the chest and back
gently to increase body warm.
 For joint and muscular aches, sprains, and bruises, the oil should be gently
massaged onto the affected parts until a warm glow is felt. It is then repeated at
intervals until the pain or swelling disappears.
-
Inhalation:
 For inhalation, add 12 drops of eucalyptus oil to a bowl of 150ml of boiling
water, cover the head with a towel and inhale the penetrating vapours to help
relief cold and flu symptoms. To clear nasal passages, sprinkle a few drops on
tissue or handkerchief and inhale gently.
Source of information: Martindale, APhA Handbook of Non-prescription Drugs, Product
Insert of Eagle Brand Eucalyptus Oil, WHO Monographs on Selected Medicinal Plants Volume 2
Side Effects / Cautions:
-
Side Effects:
 Contact dermatitis (inflammation of the skin caused by direct contact with an
irritating or allergy-causing substance)
 Sensitivity reactions
14
-
Drug Interaction:
 When applied to the skin with 5-fluorouracil lotion (5-FU, Efudex®, Carac®),
eucalyptus may increase the absorption of 5-FU.
-
Cautions:
 Eucalyptus oil is currently classified as Category III ingredients (insufficient data
are available to establish safety and effectiveness) by FDA. Although topical use
or inhalation of eucalyptus oil at low concentrations revealed no evidence of
toxicity, beware of accidental ingestion as significant and potentially lethal
toxicity has been consistently reported with oral use and may occur with
inhalation use as well.
 Eucalyptus oil is not recommended for use by infants and young children,
especially near the face and nose as it may produce laryngeal spasm and
subsequent respiratory arrest
Source of information: AltMedDex®, APhA Handbook of Non-prescription Drugs,
MedlinePlus
Contraindication(s):
 Hypersensitivity to eucalyptus oil
Source of information: AltMedDex®
Patient Education / Counselling Points:
-
For external use only
Pregnant and breastfeeding women should avoid using eucalyptus oil topical
preparations
Keep out of the reach of children
Store in well-filled airtight containers at a temperature not exceeding 25°C
Protect from light
Source of information: Martindale, MedlinePlus, WHO Monographs on Selected Medicinal Plants Volume 2
15
Student Name
Chen Bing Rong
Chen Weilin Eileen
Matric Number
U084866R
U084920L
Date
20th January 2010
20th January 2010
METHYL SALICYLATE TOPICAL PREPARATIONS
Brand / Generic Name: Ben-Gay, Counterpain
Generic name: Methyl Salicylate Topical Preparation
Proprietary name: Ben-gay, Counterpain
Active ingredient: Methyl Salicylate
Source of information: http://www.medicinenet.com/methyl_salicylate_and_mentholtopical/article.htm, MIMS 2008
Legal Classification in Singapore: General Sales List
Source of information: MIMS 2008
Approved Indication(s):
 Temporary relief of minor aches and pains in muscles and joints associated with
strains, bruises and sprains
 For minor burns, scalds, blisters, sore or rough skin, sunburn and the relief of
stiffness.
Source of information: MIMS, http://emc.medicines.org.uk/
Therapeutic Classification: Analgesics Anti-inflammatory Drugs and Antipyretics
Mechanism of Action(s):
Cyclooxygenase (COX) produces prostaglandin which causes inflammation and pain. Methyl
Salicylate inhibits prostaglandin synthesis in the tissue by reversibly acetylating and
inactivating cyclooxygenase, thus reducing inflammation by suppressing antigen-antibody
reactions.
Source of information:
http://www.mims.com/Page.aspx?menuid=mng&name=Methyl+Salicylate+Cream%2C+Co
mpound+GPO+cream&CTRY=TH, AHFS Drug Information
Available Dosage Form(s): Balm 30g, 60g, 120g
Source of information: MIMS
16
Dosing and Administration:
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Apply on the skin only. Do not ingest medication.
Do not use on scraped, irritated or broken skin.
To use, apply a thin layer to the affected area and rub in gently.
Apply medication promptly and liberally: reapply as and when required.
Do not cover with a tight bandage or use with a heating pad as this may cause skin
damage.
Avoid use near the eyes and mucous membranes.
Wash hands thoroughly after applying.
Source of information: http://www.medicinenet.com/methyl_salicylate_and_mentholtopical/article.htm, http://emc.medicines.org.uk/
Side Effects / Cautions:
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Salicylate intoxication can occur following ingestion or topical application to large
areas or broken skin. Ingestion of methyl salicylate poses threat of severe, rapid
onset salicylate poisoning. If some of the medicine is swallowed, visit the doctor
immediately.
Notify your doctor if you experience: ringing in the ears, nausea or vomiting after
use of the medication.
Potential warfarin anticoagulation may occur following topical application of
medication. Excessive application may increase risk of bleeding in patients on
warfarin.
Patients allergic to aspirin may be allergic to methyl salicylate and should avoid it
Local irritation may be possible (Redness or irritation may occur especially in
persons with sensitive skin.) Notify your doctor if irritation continues or if skin
becomes itchy, swollen or if a rash develops.
Not for children under 2 years old.
Source of information: Martindale 33rd Ed/ MIMS 2008 /
Pray W. Non-prescription Drug Therapeutics, Lippincott Williams and Wilkins
http://www.medicinenet.com/methyl_salicylate_and_menthol-topical/article.htm
Contraindication(s):
 Patients who are hypersensitive to any of the active ingredients
Source of information: MIMS, http://emc.medicines.org.uk/
17
Patient Education / Counselling Points:
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For external use only
Apply two to three times daily to intact skin
The ointment should be massaged well into the skin. It should not be applied to
broken or inflamed skin or near to the eyes or mucous membranes.
Patients with increased risk of developing salicylate adverse effect should use this
with caution. Methyl salicylate absorption is enhanced by exercise, heat, occlusion,
or disruption of the integrity of the skin, applying large amount, repeated
application and increased area of application.
Tell your doctor if you have: other illnesses, allergies (especially to aspirin or aspirinlike drugs).
Pregnant or breast feeding women should consult the doctor before applying
medication.
Tell your doctor if you are on any other medication (e.g. blood thinners). Do not
start or stop any medicine without doctor or pharmacist approval.
If the condition for which this was prescribed does not improve after 7 to 10 days,
notify your health care professional.
If you miss a dose, resume your usual dosing schedule. Do not "double-up" the
dose.
Store at room temperature between 15 to 30oC. Keep this and all medication out of
the reach of children.
Source of information: MIMS 2008, Martindale,
http://www.medicinenet.com/methyl_salicylate_and_menthol-topical/article.htm
18
Student Name
Chen Weiyu
Chen YiRong
Matric Number
U084933R
U084936B
Date
30 Jan 2010
30 Jan 2010
MALATHION LIQUID
Brand / Generic Name: Derbac M, Quelleda M, Prioderm
Generic name: Malathion
Proprietary name: A-Lices suspension, Lice Care lotion, Debarc-M liquid
Active ingredient: Malathion
Source of information: Micromedex
Legal Classification in Singapore: GSL (General Sales List)
Source of information: MIMS
Approved Indication(s):
 Pediculus humanus capitis (head lice)
 Eradication of crab (pubic) lice
 Eradication of scabies mite and their eggs
Source of information: MIMS
Therapeutic Classification: Topical antifungals and antiparasites
Mechanism of Action(s): Malathion acts via cholinesterase inhibition.
Source of information: MIMS and Micromedex
Available Dosage Form(s):
 Lotion (0.5% * 50mL)
 Suspension (1% * 30mL)
 Liquid (0.5% * 50mL)
Source of information: MIMS
19
Dosing and Administration:
Pediculus humanus capitis – Apply to the affected area, leave it on for 12 hours and rinse
off. If a reinfestation occurs, apply not earlier than 7 days after the first treatment.
Crab lice – Apply the 0.5% preparation to the whole body except the head and leave
overnight before rinsing off.
Scabies – (Adult) Apply the treatment to the whole body except the head and leave on for
24 hours before rinsing off. (Children < 2 years) Apply the treatment to the whole body
including the scalp, face and ears. Leave the lotion on for 24 hours before rinsing off.
Source of information: MIMS
Side Effects / Cautions:
Side effects:
Dermatologic: Contact hypersensitivity reaction, skin irritation of the skin and scalp,
stinging of skin
Ophthalmic: Conjunctivitis upon accidental contact with the eyes
Cautions:
 For children: Use only under direct supervision of an adult
 Upon eye exposure, flush immediately with water and consult a physician if eye
irritation persists
 Lotion is flammable. Do not expose lotion and wet hair to open flames or electric
heat sources, including hair dryers and electric curlers. Do not smoke while applying
lotion or while hair is wet.
 If skin irritation occurs, discontinue until it resolves. Reapply the lotion and if
irritation reoccurs, consult a physician.
Source of information: Micromedex
Contraindication(s):
 Infants (< 6 months)
 Hypersensitivity to malathion or any ingredient in the vehicle
Source of information: MIMS and micromedex
20
Patient Education / Counselling Points:

Lotion is flammable. Patient should not expose lotion and wet hair to open flames
or electric hear sources. Patient should not smoke when applying lotion or while
hair is wet.
 Drug may cause skin irritation or stinging.
 Avoid drug contact with eyes.
 Use drug only on scalp hair.
 Medical supervision is required for children below 6 months.
 For topical use only.
Source of information: Mircomedex and MIMS
21
Student Name
Chen Yoong Wend
Cheryl Neoh Chia Chin
Matric Number
U084957E
U084929N
Date
27 January 2010
27 January 2010
LIGNOCAINE TOPICAL PREPARATIONS
Brand / Generic Name:, Lignocaine 2% with Chlorhexidine 0.05%, Lignocaine Gel,
Generic name: Lignocaine, Lidocaine
Proprietary name: Gesicain, SOOV Bite® Gel, SOOV Cream, Dentinox Teething Gel, EMLA
Cream, Xylocaine 5% Ointment, Xylocaine Jelly, Xylocaine Viscous Solution, Medijel, CoPhenylcaine Forte Spray
Active ingredient: Lignocaine HCl 0.33%-5%
Source of information: http://mims.com.sg, www.hsa.gov.sg, MIMS 2006
Legal Classification in Singapore: Pharmacy Only (P) and General Sales List (G)
Source of information: www.hsa.gov.sg, MIMS 2006
Approved Indication(s):
 Immediate cooling and temporary relief from pain due to insect bites and stings.
 Antiseptic and anaesthetic for cuts and grazes, minor burns, scalds and sunburn;
itching due to haemorrhoids.
 Relief pain and inflammation of gums due to teething in infants.
 Surface anaesthesia of leg ulcers prior to cleaning and superficial surgical
procedures. Surface anaesthesia of the genital mucosa.
 Pain relief in minor burns and skin abrasion, sore nipples, pruritus, insect bites,
herpes zoster and labialis, haemorrhoids and anal fissures.
 Surface anaesthesia & lubrication for male & female urethra during cystoscopy,
catheterisation, endourethral procedures, endoscopy, proctoscopy, rectoscopy and
intubation.
 Symptomatic treatment of cystitis and urethritis.
 Introduction of instruments and catheters into the respiratory and digestive tracts.
 Relief of irritated or inflamed mucous membranes of the mouth and pharynx,
painful diseases of the upper GIT.
 Mouth ulcers and relief of soreness of gums and denture rubbing.
Source of information: http://mims.com.sg, MIMS 2006
22
Therapeutic Classification: Local Anaesthetic
Mechanism of Action(s): Lignocaine blocks voltage-gated sodium channels on the neuronal
membrane and thus reduces the permeability of the membrane to sodium ions which
creates a loss of sensation at the site of administration.
Source of information: http://mims.com.sg, Micromedex
Available Dosage Form(s): Gel, Cream, Ointment, Solution, Spray
Source of information: http://mims.com.sg
Dosing and Administration:
 SOOV Bite Gel: Dab onto affected skin up to 4 times daily.

SOOV Cream: For minor burns, apply cold water first. Clean the affected area and
apply SOOV Cream 2-4 times daily.

Dentinox Teething Gel: Rub onto gums.

Medijel: Apply gel. Repeat after 20 minutes if needed.

EMLA Cream: Apply a thick layer, cover with an occlusive dressing for the
appropriate application time and wipe off cream before commencing with
procedure.

Xylocaine Jelly & Xylocaine 5% Ointment: Apply on intended area of anaesthesia or
on equipment as lubricant.

Xylocaine Viscous Solution: For tube and catheter insertion into the stomach, 1015ml swallowed. For irritated or inflamed mucous membranes in mouth, 5 – 10ml
rinsed around mouth and spat out. For irritated or inflamed mucous membranes in
pharynx, 5 - 10ml gargled and swallowed. For painful upper GIT, 5-15ml rapidly
swallowed.

Lignocaine 2% with Chlorhexidine 0.05%: Apply to affected area.

Co-Phenylcaine Forte Spray: Spray into nasal area.
Source of information: http://mims.com.sg, MIMS 2006
23
Side Effects / Cautions:
 Transient local reactions and skin irritations eg edema, paleness, redness, itching.
 Sore throat following post endotracheal tube lubrication, allergic reactions.
 Excitatory or depressant central nervous system reactions.
 Drowsiness, nausea, vomiting.
 Hypotension.
Source of information: http://mims.com.sg, Micromedex
Contraindication(s):
 Patients with dermatitis, eczema, and anal or genital itching

Sensitivity to any of the constituents of SOOV preparations (i.e. SOOV Bite Gel:
lignocaine, cetrimide, menthol, phenoxyisopropanol; SOOV Cream: lignocaine,
phenoxyisopropanol, cetrimide, chlorhexidine gluconate)

Premature infants (born before wk 37 of pregnancy).

Hypersensitivity to local anaesthesia of the amide type.

Hypersensitivity to methyl and/or propyl parahydroxybenzoate (methyl/propyl
paraben), or to their metabolite para amino benzoic acid (PABA).

Patients with advanced liver disease, severe renal dysfunction, on Class 3
antiarrhythmic drugs.

Patients on epileptic drugs.
Source of information: http://mims.com.sg, Micromedex
Patient Education / Counselling Points:
 For external use only unless otherwise indicated.
 Avoid contact with eyes.
 Do not use on children below 2 years old unless recommended by a doctor.
 Do not use for dermatitis, eczema, anal or genital itching.
 If itching persists, or if skin irritation occurs, discontinue use immediately.
Source of information: http://mims.com.sg, Micromedex
24
Student Name
Chew Yue Xin Cindy
Chew Zi Yan Ignatius
Matric Number
U084871E
U083640N
Date
10th January 2010
MINOXIDIL SCALP LOTION
Brand / Generic Name: Growell, Minoxitrim, Regaine, Regro
Generic name: Minoxidil
Proprietary name:
Synonyms: Minoksidiili, Minoksidilis, Minoxidilum
Active ingredient: Minoxidil
Source of information:
 Martindale thirty-three edition
 MIMS Singapore 2007 issue
Legal Classification in Singapore: P-Pharmacy only
Source of information
 http://www.hsa.gov.sg/
 MIMS Singapore 2007 issue
Approved Indication(s):

Used for treatment of alopecia androgenetica and alopecia areata in men and
women.
 It stimulates hair growth and prevents loss of hair resulting in pattern baldness.
 It is also used for the treatment of severe, symptomatic hypertension unresponsive
to standard therapy.
 It also serves as an adjunct to hair transplantation.
Source of information:
 http://www.hsa.gov.sg/
 AHFS Drug information 2000
 Martindale- The Complete Drug Reference Thirty-three edition
 Mims Singapore 2007 issue
 Martindale- The Complete Drug Reference
Therapeutic Classification:
 Dermatological
25
Mechanism of Action(s):
 Minoxidil stimulates vertex hair growth in androgentic (male-pattern) alopecia but
its mechanism is not fully known yet.
 It prolongs growth phase and gradually enlarges miniaturized follicles (vellus hairs)
into mature terminal hairs.
 At the level of hair follicle, it induces the proliferation of the hair epithelial cells near
the base of the hair follicle directly and strengthens the hair shaft by incorporating
more cysteine and glycine.
Source of information
 MIMS Singapore 2007 issue
 http://www.merck.com/mmpe/sec10/ch124/ch124b.html#sec10-ch124-ch124b977
 AHFA Drug Information 2000
Available Dosage Form(s):
 Growell: 2% × 60 mL, 3% ×60 mL, 5 % × 60 mL topical solution
 Minoxitrim: 5% × 80 mL topical solution
 Regaine: 2% × 60 ml and 5% × 60 mL topical solution
 Regro: 3% × 60 mL, 5% ×60 mL topical solution
Source of information:
 MIMS Singapore 2007 issue
 Martindale- The Complete Drug Reference
Dosing and Administration:
 Apply 1mL (5-8 sprays) twice daily to the affected area
 A maximum of 2 mL daily.
 Spread the solution with the fingertips to cover it over the bald area
Source of information
 MIMS Singapore 2007 issue
26
Side Effects / Cautions:



It should not be used by pregnant or lactating women.
Extra precautions have to be taken for patients with hypertension, cardiovascular
diseases
(such as myocardial infarction), HIV, porphyria and renal impairment.
Headache, nausea, dry skin, erythema, burning sensation and rashes.
Source of information
 MIMS Singapore 2007 issue
 AHFS Drug Information 2000
 http://www.hsa.gov.sg
 Martindale- The Complete Drug Reference
Contraindication(s):





Pheochromocytoma, acute myocardial infarction, dissecting aortic aneurysm
Pregnant and lactating women
History of hypersensitivity to any pharmaceutical ingredients used in the
formulation (e.g. alcohol and propylene glycol)
Under 18 years old or above 65 years old
Do not administer on red, inflamed, irritated, painful or infected scalp
Source of information
 MIMS Singapore 2007 issue
 AHFS Drug Information 2000
 http://www.hsa.gov.sg
Patient Education / Counselling Points:

Avoid contact with eyes, mouth, mucous membranes, broken, infected and
inflamed skin.
 Extra precaution should be taken for patients with hypertension, cardiovascular
diseases, HIV, porphyria and renal impairment.
 Pregnant and lactating women should not use it.
 Precautions should be taken for patients of age 50 years and above.
Source of information


MIMS Singapore 2007 issue
Martindale- The Complete Drug Reference
27
Student Name
Chua Chin Wee Dennis
Chua Rui Min
Matric Number
U080399X
U084948W
Date
21st Jan 2010
21st Jan 2010
CICLOPIROX LIQUID
Generic name: Ciclopirox
Proprietary name: Stieprox
Active ingredient: Ciclopirox Olamine
Synonyms: Ciclopiroxum, Ciklopiroksas, Hoe-296b, Siklopiroksi,
6-Cyclohexyl-1-hydroxy-4-methyl-2-pyridone
Source of information: MIMS, Martindale
Legal Classification in Singapore: Pharmacy-only Medicine, 1st schedule
Source of information: MIMS
Approved Indication(s):
 Treatment of scalp disorder such as mild to severe dandruff
 Seborrhoeic dermatitis
 Pruritus associated with these condition
Source of information: MIMS
Therapeutic Classification: Topical Anti-Fungal Agent
Mechanism of Action(s): Ciclopirox Liquid is active against the fungus, Pityrosporum ovale.
It acts by the chelation of polyvalent cations (Fe3+ or Al3+), resulting in the inhibition of the
metal-dependent enzymes that are responsible for the degradation of peroxides within the
fungal cell. It may exert its inhibiting or fungicidal effects through intracellular depletion of
essential substrates, such as potassium ions and block the uptake of these intracellular
materials from the medium. Ciclopirox also interferes with the synthesis of RNA and DNA.
Source of information: Micromedex, Rx list
Available Dosage Form(s): Cream, gel, solution, shampoo, suspension.
Source of information: Micromedex
28
Dosing and Administration:



Apply 5 mL topically to the wet scalp (up to 10 mL for long hair).
Massage scalp to produce foam, leave on for 3 minutes, and then rinse.
Use the preparation twice per week for 4 weeks with at least 3 days between
applications.
Source of information: Micromedex
Side Effects / Cautions:




Ciclopirox Liquid may cause discolouration or yellowing of white or artificially
coloured or blonded hair.
Ciclopirox Liquid may cause skin irritation.
Ciclopirox Liquid is not recommended for use in children under 10 years of age.
Ciclopirox Liquid is not for ophthalmic, oral, or intravaginal use.
Source of information: Micromedex, www.mydr.com.au/cmis/PDFs/CMI4423.pdf
Contraindication(s):


Stieprox Liquid is not recommended for pregnant or breast-feeding women.
Stieprox Liquid is not recommended for patients who are hypersensitive to
ciclopirox olamine products.
Source of information: Micromedex, www.mydr.com.au/cmis/PDFs/CMI4423.pdf
Patient Education / Counselling Points:





Apply a palmful of Ciclopirox Liquid topically to the wet scalp (up to 2 palmfuls for
long hair). Massage scalp to produce foam, leave on for 3 minutes, then rinse. Use
the preparation twice per week for 4 weeks with at least 3 days between
applications.
Do not use more medicine or use it more often than your doctor tells you to.
Do not get any in your eyes, mouth, or vagina. If it does get on these areas, rinse it
off right away.
Do not cover the treated area with a bandage unless your doctor has told you to.
Keep using this medicine for the full treatment time, even if you feel better after the
first few doses. Your infection may not clear up if you stop using the medicine too
soon.
29




Ciclopirox liquid may cause discolouration or yellowing of white or artificially
coloured or blonded hair.
Ciclopirox Liquid may cause skin irritation.
Store the medicine in a closed container at room temperature, away from heat,
moisture, and direct light. Do not freeze.
Keep all medicine away from children and never share your medicine with anyone.
Source of information: MIMS, Micromedex
30
Student Name
Chua Yan Yee
Clara Wong Su Ying
Matric Number
U084973B
U084907Y
Date
18th January 2010
18th January 2010
COAL TAR SOLUTION
Brand / Generic Name: Polytar liquid
Proprietary name: Polytar liquid
Active ingredient: Coal tar solution BP 0.1%w/w
Synonym: Pix Carbonis
Source of information: Virtual Pharmacy of Changi General Hospital (mypharmacy.com.sg),
MIMS Singapore, British National Formulary Number 18 (September 1989)
Legal Classification in Singapore: General Sales List (GSL)
Source of information: www.hsa.gov.sg
Approved Indication(s):
 Psoriasis, Eczema, Seborrhoeic Dermatitis, and other skin disorders.
Source of information: Martindale 33rd edition
Therapeutic Classification: Dermatological drugs (Topical Antihistamines, Antipruritics)
Mechanism of Action(s): Coal tar is cytostatic and has antipruritic, antiseptic, antifungal
and vasoconstrictive properties. It slows down excessive epidermal cell turnover and
reduces the size of epidermal cells. Coal tar also has anti-inflammatory effects, and relieves
itching.
Source of information: MIMS Singapore
Available Dosage Form(s):
 Liquid (Polytar Liquid 150ml & 350ml),cream (Coal Tar in Aqueous Cream 10% 30g),
solution (Coal Tar Solution U.S.P), ointment (Coal Tar Ointment), paste (Coal Tar
Paste B.P), paint (Coal Tar Paint B.N.F, B.P.C), lotion (Coal Tar & Alkali Lotion B.P.C
1949), gel (EgoPsoryl T.A Gel 30g), application, emulsion (Coal Tar Emulsion), bar
soap (Polytar soap 100g), emollient (PolyTar Emollient)
31
Source of information: Martindale 33rd edition, British National Formulary Number 18
(September 1989), Virtual Pharmacy of Changi General Hospital (mypharmacy.com.sg)
Dosing and Administration:
 Wet hair. Apply enough Polytar Liquid to produce an abundant lather while
massaging into the scalp and adjacent areas. Rinse and repeat. Use as required or as
recommended by your doctor.
Source of information: Virtual Pharmacy of Changi General Hospital (mypharmacy.com.sg)
Side Effects:
 Folliculitis (inflammation of the hair follicles)
 Contact dermatitis
 Unpleasant odour due to coal tar
 Photosensitivity (increase the tendency of getting a sunburn or tan)
Cautions:
 For external use only.
 It should not be applied to inflamed or broken skin areas.
 May stain fabric, skin and hair.
 Keep out of reach of children.
 Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.
Source of information: MIMS Singapore
Contraindication(s):
 Application to inflamed or broken skin.
Source of information: MIMS Singapore
Patient Education / Counselling Points:
 Do not apply to genital or rectal areas.
 Avoid exposing skin to sunlight after applying this product for at least 24-72 hrs. It
may increase your tendency to sunburn for up to 24 hours after application.
 If symptoms worsen or do not improve after use of this product as directed,
discontinue use and consult a doctor.
Source of information: MIMS Singapore, British National Formulary Number 18 (September
1989)
32
Student Name
Deborah Chia Miao Hui
Eileen Choong
Matric Number
U084908L
U084953J
Date
30 Jan 2010
30 Jan 2010
ZINC PYRITHIONE LIQUID
Brand / Generic Name:
Generic name: Zinc Pyrithione Liquid
Proprietary name: Head & Shoulders (Procter & Gamble), Herbal Essences No Flakin Way
Antidandruff (Procter & Gamble), Pantene Anti- Dandruff (Procter & Gamble), Fongitar
(Stiefel), pHisoHex Reformulated (Sanofi Synthelabo)
Active ingredient: Zinc Pyrithione
Synonym(s): Zinc pryridinethione, Bis-2-pyridylthiolzinc 1,1’-dioxide, Zinc omadine.
Source of information:
 Micromedex
 Martindale- The Complete Drug Reference (34th Ed.) (Pharmaceutical Press; 2005)
p1156.2.
 Drugs synonyms & properties (2nd Ed.) edited by GWA Milne.
Legal Classification in Singapore: GSL (General Sales List)
Source of information: MIMS Online http://www.mims.com [Date accessed: 21 Jan 2010]
Approved Indication(s): Dandruff, Seborrheic dermatitis
Source of information: APhA Handbook of Non-prescription Drugs (11th Ed.) p555-556
Therapeutic Classification: Antifungal and antibacterial
Mechanism of Action(s): Cytostatic agent
Non-specific toxicity for epidermal cells decreases the rate of epidermal cell turnover and
normalises epidermal differentiation, in order to bring about dramatic decrease in visible
scales. Pyrithione moiety is strongly bound to hair and the external skin layers. Drug does
not penetrate the dermal region. Its absorption increases with contact time, temperature,
concentration and frequency of application.
Source of information: APhA Handbook of non-prescription drugs (11th Ed.) p551-556
Available Dosage Form(s): Shampoo
Source of information: Drug information for Healthcare Professional (USPDI) (19th Ed.)
Vol.1, p3337.
33
Dosing and Administration:


Shampoos currently available in 1 and 2% concentrations.
0.3-2% (to be washed off after brief exposure), 0.1-0.25% (for leave-on) in
treatment for dandruff
 0.95-2% (to be washed off after brief exposure), 0.1-0.25% (for leave-on) in
treatment for seborrheic dermatitis.
 Zinc pyrithione is only for external use on the skin or scalp. Do not ingest.
 Zinc pyrithione shampoo should be used twice a week or as directed by the
healthcare professional.
 Some consider zinc pyrithione slower acting than selenium sulphide
Source of information: APhA Handbook of non-prescription drugs (11th Ed.)
Side Effects / Cautions: Contact dermatitis (rare)
Source of information: APhA Handbook of Non-prescription Drugs p556. (11th Ed.)
Contraindication(s): None given
-
Patient Education / Counselling Points:






For external use only.
Avoid contact with broken or abraded skin.
Keep away from children.
Store at room temperature. Keep tightly closed and discard after expiry.
Avoid getting zinc pyrithione into eyes.
Patient is advised to use non-medicated shampoo to remove scales, dirt and oil
before using medicated shampoo so that maximal contact is achieved.
 With medicated shampoo, contact time improves effectiveness. The patient should
be counselled to allow medicated shampoo to remain on the hair for approximately
2-5min before rinsing thoroughly.
 If condition worsens or does not improve after regular use of this product as
directed, consult a physician.
Source of information: APhA Handbook of non-prescription drugs (11th Ed.) p556
34
Student Name
Gavin Cheah Jia Sheng
Fariha Amin
Matric Number
U084980M
U084900U
Date
25/01/2010
SELENIUM SULFIDE SOLUTION
Brand / Generic Name: Seldron, Selsun, Exsel / Selenium sulfide solution
Active ingredient: Selenium Sulfide
Source of information: MIMS Singapore 110th Ed. 2007
Legal Classification in Singapore: General Sales List (GSL)
Source of information: MIMS Singapore 110th Ed. 2007
Approved Indication(s):
 Dandruff (pityriasis capitis)
 Seborrhoeic dermatitis of the scalp
 Pityriasis versicolor (flaky, discoloured patches on the skin)
 Adjunct to systemic treatment of tinea capitis (fungal infection of scalp)
Source of information: Martindale 33rd Edition
Therapeutic Classification: Dermatological antifungal drug
Mechanism of Action(s): It has direct anti-mitotic effect on epidermal cells and works by
decreasing the rate of replication of epidermal cells, reducing the turnover rate, therefore
reduce the visible flaking of dead skin cells which are fed upon by fungus.
Source of information: Handbook on Non-Prescription Drugs 11th Edition.
Available Dosage Form(s): Cleaning lotion
Source of information: Martindale 33rd Edition
Dosing and Administration:

Dosing: Available in the 1% lotion or 2.5% lotion. If using the 1% lotion to treat
dandruff and seborrheic dermatitis, use on scalp two times a week. If using the 2.5%
35

lotion, use on the scalp two times a week for two weeks, decrease to only once a
week or less often thereafter. For the treatment of tinea versicolor, use the 2.5%
lotion on body once a day for seven days.
Administration: For the treatment of dandruff or seborrheic dermatitis, wet hair and
scalp first with lukewarm water, then apply 1 to 2 teaspoonfuls to the scalp. Wait
for 2 to 3 minutes before rinsing. Apply the medicine again and rinse well. After
that, wash hands properly. For the treatment of tinea versicolor, apply medicine to
affected areas, except face and genitals. Work up a lather and wait for 10 minutes
before rinsing well.
Source of information Micromedex 1998
Side Effects / Cautions:




Skin irritation
Unusual dryness or oiliness of hair or scalp
Increase in normal hair loss
Avoid contact with blisters, raw or oozing areas of skin and also the eyes
Source of information Micromedex 1998
Contraindication(s):
 Not advisable for use on the body during pregnancy.
Source of information Micromedex 1998
Patient Education / Counselling Points:





Avoid contact with broken skin to avoid irritation.
Keep out of reach of children.
Store away from heat and light.
To wash hair thoroughly for 5 minutes after using medication to reduce chance of
hair discolouration for dyed hair.
Use the medicine as soon as possible if you miss a dose, however, if it is almost time
for the next dose, skip the missed dose and go back to regular dosing schedule.
Source of information Micromedex 1998
36
Student Name
Goe Xian Hao
Geraldine Wong
Matric Number
U084966N
U084932E
Date
30 January 2010
30 January 2010
KETOCONAZOLE CREAM/LIQUID
Brand / Generic Name: Extina, Fungarest, Fungoral, Ketoderm, Ketoisdin, Ketozole, Nizoral,
Nizoral Cream, Nizoral Shampoo, Nizoral a-D, Nizoral a-D Shampoo, Orifungal, Orifungal M,
Panfungol, Sebazole, Nizoral Cream, Nizoral Shampoo, Beatoconazole Cream, Dezor
Cream, Dezor Shampoo, DHA-Ketozole Shampoo, Formycon Topical Cream, Ketozole
Cream, Ninazol Shampoo, Nitozol Cream, Nitozol Shampoo, Phytoral Ointment, Pristine
Shampoo, Pristinex Cream, Sebizole Shampoo, Sunazol Cream
Generic name: Ketoconazole Cream/Liquid
Proprietary name: Nizoral
Active ingredient: Ketoconazole
Source of information
 http://www.drugbank.ca/drugs/DB01026
 http://www.medicinenet.com/ketoconazole/article.htm
Legal Classification in Singapore: Pharmacy Only Medication
Source of information: HSA
Approved Indication(s):
 Generally used for skin, hair, and mucosal mycoses that cannot be treated with
other antifungals (including dermatophytoses, pityrosporumfolliculitis, cutaneous
candidiasis, chronic mucocutaneous candidiasis, oropharyngeal and oesophageal
candidiasis, chronic recurrent vaginal candidiasis.
 It is also used for systemic mycoses that cannot be treated with other antifungals
(including histoplasmosis, blastomycosis, coccidioidomycosis,
paracoccidioidomycosis.
 Treatment of dermatophyte infections of the skin: tinea corporis (ringworm of the
body), tinea manus (fungal infection of the hand) and tinea pedis (athlete’s foot)
due to Trichophyton rubrum, Trichophyton mentagrophytes, Microsporum canis and
Epidermophyton floccosum.
 Treatment of serborrhoeic dermatitis, a skin condition related with the presence of
Pityrosporum ovale and pityriasis capititis (dandruff on the scalp) due to fungal
infection in adults.
 Also used in the treatment of cutaneous candidosis and tinea/pityriasis versicolor
37
(white spots).
Source of information:
 British National Formulary (BNF)
 MIMS
 Product information of Nizoral Cream
Therapeutic Classification: Topical Antifungals
Mechanism of Action(s):
 Has a potent antifungal activity against dermatophytes eg, Trichophyton species,
Epidermophyton floccosum and Microsporum species.
 Also useful against yeasts including Malassezia species.
 Ketoconazole is structurally similar to imidazole which interferes with the fungal
synthesis of ergosterol, a constituent of cell membranes, as well as certain enzymes.
 It interacts with 14-α demethylase, a cytochrome P-450 enzyme necessary for the
conversion of lanosterol to ergosterol. This results in inhibition of ergosterol
synthesis and increased fungal cellular permeability – ultimately preventing the
growth of the fungi.
 Ketoconazole is specific for fungi and not other microorganisms.
 Other mechanisms may involve the inhibition of endogenous respiration, interaction
with membrane phospholipids, inhibition of yeast transformation to mycelial forms,
inhibition of purine uptake, and impairment of triglyceride and/or phospholipid
biosynthesis. Ketoconazole can also inhibit the synthesis of thromboxane and
sterols such as aldosterone, cortisol, and testosterone.
Source of information
 http://www.drugbank.ca/drugs/DB01026
 MIMS
 http://www.medicinenet.com/ketoconazole/article.htm
 Martindale: The Complete Drug Reference
Available Dosage Form(s):
 cream: 2% (15g, 30g, 60g)
 shampoo: 2% (120ml)
 Gel: 2%
 Foam: 2%
Source of information:
 http://www.medicinenet.com/ketoconazole/article.htm
38
Dosing and Administration:
 shampoo
 Wet hair and scalp completely using water. Apply enough shampoo to
produce sufficient lather to clean hair and scalp. Massage gently over entire
scalp for approximately one minute. Rinse hair with warm water. Repeat this
process only leave the shampoo on the scalp for 3 minutes. Dry hair
thoroughly after the second rinse. Be sure to thoroughly rinse after use. The
shampoo should be used twice weekly for 4 weeks with at least 3 days
between each shampooing. It can then be used intermittently depending on
the response of the condition. Avoid contact with the eyes.
 topical
 rub gently into the affected areas once daily to twice daily
 Clean and dry the affected area before applying the medication. To apply,
gently massage a small amount of the medication to the affected area and
surrounding skin. Continue to use the medication as prescribed for the full
time prescribed. Stopping therapy too early may not clear the infection
causing it to return. Cover with a bandage only if instructed to do so by your
doctor. It may take one week before any improvement is seen. If no
improvement is seen after 2 - 4 weeks, consult your doctor. Another
medication may be necessary.
 Cutaneous candidiasis, tinea corporis, tinea cruris, tinea pedis, and tinea
(pityriasis) versicolor: It is recommended that ketoconazole cream, 2% be
applied once daily to cover the affected and immediate surrounding area.
Clinical improvement may be seen fairly soon after treatment is begun;
however, candidal infections and tinea cruris and corporis should be treated
for two weeks in order to reduce the possibility of recurrence.
 Patients with tinea versicolor usually require two weeks of treatment and
patients with tinea pedis require six weeks of treatment.
 If a patient shows no clinical improvement after the treatment period, the
diagnosis should be redetermined.
 Seborrheic dermatitis: Ketoconazole cream, 2% should be applied to the
affected area twice daily for four weeks or until clinical clearing.
Source of information
http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=2692#nlm34070-3,
http://www.medicinenet.com/ketoconazole-shampoo/article.htm,
http://www.rxlist.com/ketoconazole-cream-drug.htm
39
Side Effects / Cautions:
 There are no known drug interactions with topical ketoconazole.
 Topical
 This medication may cause burning, stinging or redness when first applied to
the skin. This should disappear in a few days as your body adjusts to the
medication. If these effects persist or worsen, inform your doctor. If you
notice other effects not listed above, contact your doctor or pharmacist.
 Be sure your doctor knows your medical history, especially of: allergies.
 This medication should be used cautiously during pregnancy only if clearly
needed. This medication may appear in breast milk. Consult with your doctor
before breast-feeding. Tell your doctor if you are pregnant before using this
cream.
 Tell your doctor of all prescription and non-prescription drugs you may use,
especially of: other skin products. Do not start or stop any medicine without
doctor or pharmacist approval.
 Shampoo
 This medication may cause abnormal hair texture, scalp pustules (pimples),
dry skin and itching. There may also be oiliness and dryness of the hair and
scalp. Rarely, there may be some hair loss. Inform your doctor if these should
persist or worsen. Also inform your doctor if there is any chemical sensitivity
to the shampoo. If you notice other effects not listed above, contact your
doctor or pharmacist.
 Tell your doctor of any over-the-counter or prescription medication you may
take, especially: hair or scalp products. Do not start or stop any medicine
without doctor or pharmacist approval.
 The following have been reported with the use of ketoconazole 2%
shampoo: hair discoloration and abnormal hair texture, removal of the
curl from permanently waved hair, itching, skin burning sensation and
contact dermatitis, hypersensitivity, alopecia, rash, urticaria, skin
irritation, dry skin, and application site reactions.
 Ketoconazole has been shown to be teratogenic. Its use is not recommended during
pregnancy.
 May cause itchy skin.
Source of information
 http://www.medicinenet.com/ketoconazole/article.htm
 MIMS
 http://www.medicinenet.com/ketoconazole-cream/article.htm
 http://www.drugs.com/pro/ketoconazole-shampoo.html
40
Contraindication(s):
 There are no known drug interactions with topical ketoconazole.
 Hypersensitivity to ketoconazole or any component such as sulphites.
 Pregnancy and Lactating mothers
Source of information:
MIMS
British National Formulary (BNF)
http://www.medicinenet.com/ketoconazole-cream/article.htm
Patient Education / Counselling Points:
 Topical
 Use this medication on the skin only.
 Clean and thoroughly dry the area to be treated.
 Do not apply this more often than prescribed. Your condition will not clear
faster, but side effects may be increased.
 Apply enough medication to cover the affected skin and some of the
surrounding skin. After applying this medication, wash your hands. Do not
wrap, cover or bandage the area unless directed to do so by your doctor.
 Do not apply this medication in the eyes, nose, mouth, or vagina. If this
medication gets in the eyes, rinse thoroughly with water.
 Continue to use this medication until the full prescribed amount is finished,
even if symptoms disappear after starting ketoconazole.
 Inform your doctor if your condition persists after the prescribed amount of
treatment or worsens at any time.
 If you miss a dose, use it as soon as you remember. If it is near the time of
the next dose, skip the missed dose and resume your usual dosing schedule.
Do not double the dose to catch up.
 Store at room temperature between 59-86 degrees F (15-30 degrees C) away
from heat and light. Do not store in the bathroom. Keep all medicines away
from children and pets.
 Check expiration date before use.
 This medication is prescribed for your current condition only. Do not use it
for another infection or share it with someone else. Another infection later
on may require a different medicine.
 Stop usage if itching and red skin occurs after application and consult the
doctor/pharmacist for further advice. If you develop rashes, breathlessness,
swollen mouth or eyes, stop the medicine and inform your doctor quickly.
These could be signs of an allergic reaction.
 Ketoconazole Cream, 2% contains sodium sulfite anhydrous, a sulfite that
41

may cause allergic-type reactions including anaphylactic symptoms and lifethreatening or less severe asthmatic episodes in certain susceptible people.
Shampoo
 This shampoo may remove the curl from a permanent wave in the hair
 Use the missed dose and resume your regular schedule. Do not "double-up"
the dose.
 Store at room temperature away from heat and sunlight.
 When using the shampoo, avoid contact with the eyes. If this happens, rinse
the eyes thoroughly with water
 Store at room temperature between 59-86 degrees F (15-30 degrees C) away
from heat and light.
Source of information
 http://www.medicinenet.com/ketoconazole/article.htm
 http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=2692#nlm34070-3
 http://www.medicinenet.com/ketoconazole-cream/page2.htm
http://www.rxlist.com/ketoconazole-cream-drug.htm
 MIMS
42
Student Name
Goh Daolin
Goh Choo Hua
Matric Number
U080104A
U084890L
Date
19/01/10
19/01/10
CLOTRIMAZOLE VAGINAL TAB/CREAM
Brand / Generic Name: Canesten VT® [vag tab] / Canesten 1% Cream
Generic name: Clotrimazole
Proprietary name: Canesten VT® [vag tab] / Canesten 1% Cream
Active ingredient: Clotrimazole
Source of information: MIMS Singapore
Legal Classification in Singapore:
G (effective date 18 Sep 2000) for Canesten 1% Cream
P (effective date 10 Nov 1995) for Canesten VT ® [vag tab]
Source of information : http://www.hsa.gov.sg/
Approved Indication(s):


Vaginal fungal infections:
o Vaginitis due to fungi, (Candida and Trichomonas). Superinfections with
Canesten –senstive bacteria.
o However, vaginal fungal infection (vulvovaginal candidiasis [VVC]) is the only
one that the patients can self-medicate.
o Both Canesten 1% Cream and Canesten VT ® can be used for vaginal
application
Topical Usage
o Canesten 1% Cream is used topically for superficial fungal infections
(athlete’s foot or jock itch) and secondary infection
o Dermatophytoses, superficial mycoses, and cutaneous candidiasis
Source of information:
 MIMS Singapore
Pray w. Non-presciption Drug Therapeutics, Lippincott Williams and Wilkins
 Lexi-comp Drug Information Handbook
43
Therapeutic Classification:
G01AF02 Belongs to the class of imidazole derivative antiinfectives. Used in the treatment
of gynecological infections
D01AC01 Belongs to the class of imidazole and triazole derivatives for topical use. Used in
the treatment of fungal infection.
Mechanism of Action(s):

Anti-fungal that interferes with synthesis of ergosterol, an important component of
fungal cell membrane and causes loss of critical intracellular cell structures.
Source of information: MIMS Singapore
Pray w. Non-presciption Drug Therapeutics, Lippincott Williams and Wilkins
Available Dosage Form(s):
Canesten 1% cream (10g and 20g) and vaginal tablet (100mg and 500mg)
Source of information: MIMS Singapore
Dosing and Administration:


Cream :
o Intravaginal: Insert 1 applicatorful of 1% vaginal cream daily (preferably at
bedtime) for 7 consecutive days OR insert 2 applicatorful of 1% vaginal
cream daily (preferably at bedtime) for 3 consecutive days
o Topical: Apply thin layer of 1% cream to affected area twice daily(morning
and evening) for 2 to 4 weeks
Tablet (for intravaginal insertion):
o Insert 100 mg intravaginally daily for 7 days OR insert 200 mg intravaginally
daily for 3 days OR insert 500mg intravaginally at bedtime once only
o If condition is recurrent, consult a physician as it might be indicative of
resistance or other conditions.
Source of information: Micromedex and Lexi-Comp Drug Information Handbook
Pray w. Non-presciption Drug Therapeutics, Lippincott Williams and Wilkins
44
Side Effects:
 Local irritation and burning sensation will be experienced with topical application
 Increased vaginal discharge (vaginal preparations)
Cautions:




For aged 12 and above
Preparation with hydrogenated vegetable or mineral oil damages latex condoms.
Not used for systemic fungal infection
Canesten VT ® preferably used during last 4-6weeks of pregnancy for sanitation of
birth canal
Source of information: Martindale and Lexi-Comp Drug information Handbook
Pray w. Non-presciption Drug Therapeutics, Lippincott Williams and Wilkins
MIMS Singapore
Contraindication(s): Hypersensitivity to Clotrimazole
Source of information: Micromedex
Patient Education / Counselling Points:

o
o
o
o
o
o
o

o
o
o
o
o
General advice:
May cause irritation to the skin. Wash hands before and after medication.
Avoid contact with eyes.
Wear only clean cotton underwear (panties)
Wear minipad or sanitary napkin to protect clothing. Avoid using tampons.
Continue usage during menstrual period.
Finish the course of medication. Consult your doctor immediately if symptoms
remain after completing the full course.
Store in cool dry place away from sunlight.
Special Instruction of use of vaginal applicator (Intra-vaginally):
Screw applicator onto the tube of cream.
Pull plunger out all the way and squeeze the tube until the applicator is full.
OR place vaginal tab in the applicator with the pointed side up. Wet the tablet with
warm water or a water soluble lubricating gel (K-Y® Jelly). Avoid using petroleum
jelly (Vaseline®).
Gently push the applicator high into vagina and push plunger all the way in.
Wash both applicator and plunger with warm, soapy water. (Not boiling)
Source of information: Lexi-Comp Drug information Handbook and MicroMedex
Pray w. Non-presciption Drug Therapeutics, Lippincott Williams and Wilkins
45
Student Name
Goh Si Han
Goh Wei Jiang
Matric Number
U084914L
U084862W
Date
20/01/2010
20/01/2010
MICONAZOLE CREAM/POWDER
Brand / Generic Name: Miconazole
Proprietary name: Daktarin; Decozol; Liconar; Mycoban; Resolve; Zarin
Active ingredient: Miconazole nitrate
Synonyms: Miconazole Nitrate, Mikonatsoli, Mikonazolas
Source of information: Martindale 35 Edition
Legal Classification in Singapore:
 Miconazole dermatological preparations not exceeding 2%: General Sales List
 Miconazole vaginal preparations: Pharmacy only
Source of information: Health Sciences Authority (www.hsa.gov.sg)
Approved Indication(s):


Treatment of skin fungal infections (Tinea infections and Superficial candidiasis)
Treatment of vulvovaginal candidiasis
Source of information: APhA Handbook of Non-Prescription Drugs 3rd Edition, Micromedex
Therapeutic Classification: Topical antifungal
Mechanism of Action(s):
 Inhibits biosynthesis of sterols, triglycerides and phospolipids, damaging fungal cell
wall membrane, thereby increasing permeability of the cell wall membrane, causing
the leakage of nutrients.
Source of information: APhA Handbook of Non-Prescription Drugs 3rd Edition, Micromedex
Available Dosage Form(s): Cream or powder. Also available as lotion, oral gel, intravenous
injection, and pessary.
Source of information: Martindale 35 Edition
46
Dosing and Administration:


Treatment of skin fungal infection: Apply miconazole twice daily as a 2% cream,
lotion, or powder to affected area. Do not stop using the medication until at least a
week after all symptoms have disappeared. Do not treat the infected part alone but
apply the product to the area around it.
Treatment of vulvovaginal candidiasis: 5g of 2% intravaginal cream is inserted into
vagina once daily for 10 to 14 days or twice daily for 7 days.
Source of information: Martindale 35 Edition, BNF 50 (September 2005)
Side Effects:
 Skin rash, itching, local irritation
Cautions:
 Miconazole products should not be used during pregnancy.
 Miconazole is unsafe for use in patients with porphyria.
 Do not apply the cream or powder to the eyes.
Source of information: APhA Handbook of Non-Prescription Drugs 3rd Edition, Martindale
Contraindication(s):
 Hypersensitivity to miconazole.
Source of information: APhA Handbook of Non-Prescription Drugs 3rd Edition, Micromedex
Patient Education / Counselling Points:




Protect preparation from heat. Darkening of preparation indicates deterioration.
Do not use a larger dose or apply more often than required.
Discontinue use if irritation occurs
For intravaginal preparations:
 Insert high into vagina and complete full course of therapy
 Refrain from intercourse to prevent recurrent infection during treatment.
 May damage latex contraceptives, hence alternative or additional
contraceptives may be required.
Source of information: Martindale 35 Edition, APhA Handbook of Non-Prescription Drugs
3rd Edition, MIMS 2006, Micromedex, Daktarin product insert
47
Student Name
Goh Zong’ En Jonathan
Heng Fu Xun Marcus
Matric Number
U080096U
U084961H
Date
12/01/10
12/01/10
TERBINAFINE CREAM
Brand / Generic Name: Lamisil
Proprietary name: LAMISIL
Active ingredient: Terbinafine Hydrochloride
Source of information: Martindale 33rd Ed
Legal Classification in Singapore: GSL
Source of information : MIMS 110th Ed 2007, Mims.com.sg
Approved Indication(s):
To treat different types of fungi infection of the skin:
 Dermatophytoses
 Pityriasis Versicolor
 Cutaneous Candidiasis
Source of information: Martindale 33rd Ed
Therapeutic Classification: Allylamine antifungal with broad spectrum activity.
Mechanism of Action(s): Acts through inhibition of fungal sterol synthesis.
Source of information: Martindale 33rd Ed
Available Dosage Form(s):
1% Terbinafine HCl Cream 7.5 g tubes (Lamisil)
1% Terbinafine HCl Cream 15 g tubes (Lamisil)
Source of information: Lamisil Product Leaflet
48
Dosing and Administration:
For Adults & Children over 12 years old:
Dermatophytoses
Tinea Corporis/Tinea Cruris: Apply 1-2 times daily for 1-2 weeks.
Tinea Pedis (Athlete’s Foot): Apply 1 time daily for 1 week.
Cutaneous Candidiasis
Apply 1-2 times daily for 2 weeks.
Pityriasis Versicolor
Apply 1-2 times daily for 2 weeks.
Source of information: Mims.com.sg, Martindale 33rd Ed, Lamisil Product Leaflet
Side Effects / Cautions:
 Irritations, redness or mild burning sensation.
Source of information: Mims.com.sg, Martindale 33rd Ed
Contraindication(s):
 Hypersensitivity, active or chronic liver disease, lactation.
 Not to be taken by:
1) Children under 12 years old
2) Patients who exhibit skin rash upon use
3) Lactating or pregnant mothers, under FDA pregnancy category B
Source of information: Mims.com.sg, Martindale 33rd Ed, Lamisil Product Leaflet
Patient Education / Counselling Points:


Discontinue use if rash occurs
If there is no improvement after 1 week of use, consult your doctor.
Source of information: Martindale 33rd Ed
49
Student Name
Heng Shi Thong
Hiew Tze Ning
Matric Number
U084962U
U084902R
Date
22 January 2010
22 January 2010
SALICYLIC ACID SOLUTION
Brand / Generic Name: Salicylic acid solution
Generic name: Salicylic acid
Proprietary name:
 Pyralvex® [1% salicylic acid]
 Sato Uonome Solution® [5% salicylic acid, 8.85% lactic acid]
 Verrumal® Solution [10% salicylic acid, 5% fluorouracil, 8% dimethylsulfoxide]
 Scholl Corn and Callus Removal Liquid [12.5% salicylic acid, 3.11% camphor]
 Duofilm® [16.7% salicylic acid, 16.7% lactic acid]
 Derma Tech Wart Treatment® [17% salicylic acid, 17% lactic acid]
Active ingredient: Salicylic acid (2-hydroxybenzoic acid)
Source of information: www.hsa.gov.sg, MIMS, www.emc.medicines.org.uk
Legal Classification in Singapore: GSL
Source of information: www.hsa.gov.sg
Approved Indication(s):
 Hyperkeratotic and scaling skin conditions
 Acne
 Warts and calluses
 Fungal infection
Source of information: MIMS
50
Therapeutic Classification: Acne Treatment Preparations / Keratolytic
Mechanism of Action(s):
Salicylic acid has a potent keratolytic (treatment to remove warts and other lesions in which
the epidermis produces excess skin) action and a slight antiseptic action when applied
topically. It softens and destroys the stratum corneum by increasing endogenous hydration
which causes the cornified epithelium layer to swell, soften, and then desquamate (peel
off). At high concentrations, salicylic acid has a caustic (burning) effect. It also possess weak
antifungal and antibacterial activity.
Source of information: MIMS
Available Dosage Form(s): Solution
(FYI: also available as cream, ointment and lotion but not part of assignment requirement
thus not elaborated)
Source of information: Martindale 35th edition
Dosing and Administration:
Acne vulgaris: Apply topically in concentrations of 0.5% to 10%.
Psoriasis: Apply topically in concentrations of 3% to 6. It should not exceed 6% for pediatric
dosing.
Hyperkeratotic skin conditions: Apply topically in concentrations of 2% to 6%.
Warts: Apply topically once or twice daily in concentrations of 5% to 40%, up to 12 weeks.
Concentrations of up to 60% may be used for plantar warts, corns and calluses.
Source of information: Martindale 35th Edition, Micromedex
51
Side Effects / Cautions:
Might cause mild irritation to the skin. Common symptoms include erythema, pruritus
(itchiness) and dermatitis. Burning sensation and stinging feelings may be experienced by
some people.
Excessive use may lead to acute systemic salicylate poisoning.
It is recommended that salicylic acid not be used before phototherapy or in phototesting
procedures.
Caution should be exercised during the use of caustic preparations in patients with
significant peripheral neuropathy (damage to nerve of peripheral nervous system).
Source of information: Martindale 35th Edition), Micromedex
Contraindication(s):
 age less than 2 yrs

diabetes

hypersensitivity to salicylic acid
 impaired circulation
Besides, do not use on moles, birthmarks, unusual warts with hair growth, on facial warts, or
in the anal or perineal region.
Source of information: Micromedex, www.emc.medicines.org.uk
Patient Education / Counselling Points:




Do not use salicylic acid for prolonged periods, in high concentrations, on large
areas of the body, or on inflamed or broken skin.
Avoid contact with mouth, eyes and other mucous membranes.
Do not apply the preparation onto broken or damaged skin areas.
Symptomatic improvement of skin may not be seen for up to 6 weeks; improvement
of warts may take up to 12 weeks.
Source of information: Martindale (35th Edition), Micromedex, www.emc.medicines.org.uk
52
Student Name
Ho Choon Siang
Ho Chun Yim
Matric Number
U084853L
U084863H
Date
30th Jan 2010
30th Jan 2010
ISOCONAZOLE TABLET/CREAM
Brand / Generic Name: Travogen® Cream, Gyno-Travogen® Ovule
Generic name: Isoconazole
Proprietary name: Travogen® Cream, Gyno-Travogen® Ovule
Active ingredient: Isoconazole nitrate
Source of information: Mims-online, Martindale
Legal Classification in Singapore: P
Source of information: Mims-online
Approved Indication(s):
 Gyno-Travogen® Ovule: Vaginal mycoses
 Travogen® Cream: Superficial fungal infection of skin; erythrasma
Source of information: Mims-online, Martindale
Therapeutic Classification: Antifungal agent
Mechanism of Action(s): Isoconazole is an imidazole-derivative anti-fungal with a wide
spectrum of activity. It is also active against dermatrophytes, Candida spp., Malessezia
furfur, yeasts, yeast-like fungi, moulds and Gram-positive bacteria.
Source of information: PubChem, Mims-online, Martindale, British Pharmacopoiea
Available Dosage Form(s): Pessary, Cream
Source of information: Mims-online
53
Dosing and Administration:


Travogen® Cream: Available as either 1% or 2 % cream. Apply once daily.
Gyno-Travogen® Ovule: Single dose of 600mg or 300mg daily for 3 days. Ovule
should be inserted deep into the vagina. Treatment should not be continued during
menstruation.
Source of information: Mims-online, Martindale
Side Effects / Cautions:


Travogen® Cream: Avoid rubbing on eyes, may cause skin irritation
Gyno-Travogen® Ovule: May cause smarting and itching in the vagina during the
first 12-24h. May damage latex contraceptives and additional contraceptive
measures are therefore needed during local administration of isoconazole.
Source of information: Mims-online, Martindale
Contraindication(s):
 N/A
Source of information
Patient Education / Counselling Points:

Travogen® Cream: - Store in cool, dry place. Protect from light.
- Treatment should be continued 2 weeks after healing to
prevent recurrence

Gyno-Travogen® Ovule: - Store in cool, dry place. Protect from light.
-Vaginal douching should be avoided for 1 week after
insertion of the ovule
-Personal linen should be changed and boiled daily to
avoid renewed infection
-Treatment should not be continued during
menstruation
Source of information: Mims-online, Martindale, British Pharmacopoeia
54
Student Name
Keith Foo Khai Tsen
Jasmine Yow
Matric Number
U084970R
U084922J
Date
24/01/2010
24/01/2010
AMOROLFINE NAIL LACQUER
Brand / Generic Name: Amorolfine Nail Lacquer
Generic name: Amorolfine Nail Lacquer
Proprietary name: Loceryl
Active ingredient: Amorolfiini; Amorolfin; Amorolfina; Amorolfine; Amorolfinum; (±)-cis2,6-Dimethyl-4-[2-methyl-3-(p-tert-pentylphenyl)propyl]morpholine
Source of information
1. Martindale: The Complete Drug Reference. Sean C. Sweetman. Pharmaceutical Press,
2009. 36th Edition.Volume 1. London; Chicago.
2. Extracted from http://www.rpsgb.org.uk/pdfs/otcamorguid.pdf on 16th January 2010;
Royal Pharmaceutical Society of Great Britain.
Legal Classification in Singapore:
Pharmacy Only Medicine – to be sold from any pharmacy under the supervision of a
pharmacist.
Patients should be referred to a GP if there are more than two nails affected and/or if
occurrence of underlying conditions that predisposes fungal infections, for example
peripheral circulatory disorders, diabetes mellitus and immunosuppresion.
Source of information
1. Martindale: The Complete Drug Reference. Sean C. Sweetman. Pharmaceutical Press,
2009. 36th Edition.Volume 1. London; Chicago.
2. Extracted from http://www.rpsgb.org.uk/pdfs/otcamorguid.pdf on 16th January 2010;
Royal Pharmaceutical Society of Great Britain.
Approved Indication(s):

Treatment of onychomycosis, an infection of the nail apparatus by fungi, for
example, dermatophytes, yeasts and moulds.
Source of information: MIMS Annual. Singapore. DIMS. 1998/1999. 9th Edition. MediMedia
International Group.
55
Therapeutic Classification:
Amorolfine is a morpholine derivative which acts as an antimycotic agent.
Mechanism of Action(s):
It has a fungistatic and fungicidal effect by inhibiting sterol biosynthesis which disrupts the
fungal cell membrane, leading to cell death.
Active in vitro against various pathogenic and opportunistic fungi including dermatophytes,
Blastomyces dermatititdis, Candida spp., Histoplasma capsulatum, and Sporothrix schenkii.
Source of information
1. Martindale: The Complete Drug Reference. Sean C. Sweetman. Pharmaceutical Press,
2009. 36th Edition.Volume 1. London; Chicago.
2. Extracted from http://www.rpsgb.org.uk/pdfs/otcamorguid.pdf on 16th January 2010;
Royal Pharmaceutical Society of Great Britain
Available Dosage Form(s): Nail lacquer for topical use.
Source of information
1. Martindale: The Complete Drug Reference. Sean C. Sweetman. Pharmaceutical Press,
2009. 36th Edition.Volume 1. London; Chicago.
Dosing and Administration:

Amorolfine nail lacquer contains an equivalent of 5% amorolfine and is applied to
affected fingernails or toenails once or twice weekly.
Administration should be practiced as follows:




Before painting amorolfine nail lacquer, the infected areas of the nail have to be
filed down as thoroughly as possible and the surface cleansed with a cleaning pad.
A spatula with a measured dosage is supplied. Using this spatula, dip it into the
lacquer and avoid wiping it on the neck of the bottle before applying it on the
affected area of the nail.
Allow the nail to dry as the solvent evaporates to leave a highly concentrated
deposit of amorolfine in an occlusive film on the nail. It acts as a depot from which
amorolfine penetrates and diffuses through the nail plate into the nail bed.
Treatment should be continued until the infected nails are completely cured and
regrown. This will normally take 6 months for fingernails and 9 to 12 months for
toenails.
56
Source of information
1. Martindale: The Complete Drug Reference. Sean C. Sweetman. Pharmaceutical Press,
2009. 36th Edition.Volume 1. London; Chicago.
2. MIMS Annual. Singapore. DIMS. 1998/1999. 9th Edition. MediMedia International Group.
3. Extracted from
http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/western_medici
nes/reclassified_medicines.html on 16th January 2010; Health Sciences Authority.
4. Extracted from http://www.rpsgb.org.uk/pdfs/otcamorguid.pdf on 16th January 2010;
Royal Pharmaceutical Society of Great Britain.
Side Effects / Cautions:







Do not swallow the preparation.
Do not reuse nail files used for infected nails on healthy nails.
Do not contact skin, eyes, ears and mucous membranes with the preparation.
Do not use cosmetic lacquer or artificial nails during treatment.
Do not practice treatment on children as its effectiveness in children has not been
established.
Do not practice treatment during pregnancy and lactation as its effectiveness has
not been established.
Occasionally, patients experience a mild and transient burning feeling in the area
surrounding the treated nail(s). Irritation and redness of skin may also be present in
the form of erythema or pruritus.
Source of information
1. MIMS Annual. Singapore. DIMS. 1998/1999. 9th Edition. MediMedia International Group.
2. Extracted from
http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/western_medici
nes/reclassified_medicines.html on 16th January 2010; Health Sciences Authority.
3. Extracted from http://www.rpsgb.org.uk/pdfs/otcamorguid.pdf on 16th January 2010;
Royal Pharmaceutical Society of Great Britain.
4. Martindale: The Complete Drug Reference. Sean C. Sweetman. Pharmaceutical Press,
2009. 36th Edition.Volume 1. London; Chicago.
57
Contraindication(s):

Patients who have shown hypersensitivity to amorolfine nail lacquer in the past
must not administer this treatment.
Source of information
1. Extracted from http://www.rpsgb.org.uk/pdfs/otcamorguid.pdf on 16th January 2010;
Royal Pharmaceutical Society of Great Britain
Patient Education / Counselling Points:




Wear gloves to protect the coat of nail lacquer on fingernails when working with
solvents (eg. Paint thinners, turpentine, paraffin etc).
Remembering to use the treatment may be difficult. As such, apply amorolfine on
the same day(s) each week and note down the date of use in a diary card or on the
box to encourage good running check.
Keep skin cool and dry as debris from infected nails can be a source of reinfection
for skin.
For storage purposes, screw the bottle top of the medicine tightly after use and
avoid from placing it in places such as bathroom, sink or car window sills.
Source of information
1. Extracted from
http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/western_medici
nes/reclassified_medicines.html on 16th January 2010; Health Sciences Authority.
2. Extracted from http://www.rpsgb.org.uk/pdfs/otcamorguid.pdf on 16th January 2010;
Royal Pharmaceutical Society of Great Britain.
58
Student Name
Koh Jye Shyang
Koh Seow Ken
Matric Number
U080473J
U084944Y
Date
31/1/2010
31/1/2010
HUMULIN 30/70 INJECTION
Brand / Generic Name: Humulin
Generic name: Insulin isophane and Insulin regular
Proprietary name: Humulin 30/70
Active ingredient: Mixture of insulin injection (human) 30% and isophane insulin injection
(human) 70%
Source of information: Martindale
Legal Classification in Singapore: Pharmacy Only
Source of information: HSA Website
Therapeutic Classification: Hormones
Source of information: Micromedex DRUGDEX® Evaluations
Approved Indication(s):

Diabetes Mellitus Type I

Diabetes Mellitus Type II
Source of information: Micromedex DRUGDEX® Evaluations
Mechanism of Action(s):
Insulin is secreted by the beta cells of the pancreas (islets of Langerhans). Insulin given
endogenously or exogenously stimulates glucose uptake and storage as glycogen in cardiac
muscle, skeletal muscle and adipose tissue. In addition, lipogenesis is stimulated with
inhibition of lipolysis from adipose cells; protein synthesis is stimulated. Electrolytes are
affected, with both potassium and magnesium shifted intracellularly, decreasing serum
levels of each.
Source of information: Micromedex DRUGDEX® Evaluations
Available Dosage Form(s):
Parenteral preparation:
- Humulin 30/70 injection 100 iu/ml (cartridge)
- Humulin 30/70 injection 100 iu/ml (vial)
Source of information: HSA website
59
Dosing and Administration:
1) Adult
a) Concentrated human regular insulin, 500 units/milliliter (Humulin(R) R U-500) may
result in irreversible insulin shock if inadvertently used instead of human regular
insulin, 100 units/milliliter (Humulin(R) R U-100). Humulin(R) R U-500 should only be
administered subcutaneously (Prod Info HUMULIN(R) U-500 Solution for subcutaneous
injection, 2007).
2) Diabetes mellitus - Insulin resistance
a) give SUBQ, dosing is individualized per patient needs
3) Diabetes mellitus - Pregnancy
a) give SUBQ, dosing is individualized per patient needs
4) Diabetes mellitus type 1
a) give SUBQ, dosing is individualized per patient needs
5) Diabetes mellitus type 2
a) give SUBQ, dosing is individualized per patient needs
6) Diabetes mellitus with hyperosmolar coma, Nonketotic
a) initial, 0.1 unit/kg IV, followed by continuous infusion of 0.1 unit/kg/hour until blood
glucose falls to 250 mg/dL
7) Diabetic ketoacidosis
a) initial, 0.15 unit/kg IV, followed by continuous infusion of 0.1 unit/kg/hour; if no
biochemical response in 2 to 4 hours, double infusion rate; when glucose level falls to
250 mg/dL or less, halve infusion rate or add dextrose 5% infusion to maintain blood
glucose between 200 and 250 mg/dL; continue until acidosis is corrected
8) Gestational diabetes mellitus
a) give SUBQ, dosing is individualized per patient needs
9) Pediatric
a) Concentrated human regular insulin, 500 units/milliliter (Humulin(R) R U-500) may
result in irreversible insulin shock if inadvertently used instead of human regular
insulin, 100 units/milliliter (Humulin(R) R U-100). Humulin(R) R U-500 should only be
administered subcutaneously
Source of information: Micromedex DRUGDEX® Evaluations, Prod Info HUMULIN(R) U500 Solution for subcutaneous injection, 2007
60
Side Effects / Cautions:

Hypoglycaemia. Hypoglycaemia is the major adverse effect of insulin treatment.
Severe hypoglycaemia may lead to loss of consciousness and in extreme cases,
death.

Lipodystrophy- the degeneration of adipose tissue due to repeated injection at the
same site.

Localised skin allergy- swelling, redness or itching at site of injection. Symptoms
usually wear off within a few days to a few weeks.

Systemic allergy to insulin is less common but potentially more serious. Generalized
allergy to insulin may cause rash over the whole body, shortness of breath,
wheezing, reduction in blood pressure, rapid pulse or sweating. Severe cases of
generalized allergic reaction may be life-threatening.

Weight gain
Source of information : Micromedex DRUGDEX® Evaluations, www.mims.com.sg
Contraindication(s):
1) Hypoglycemia
2) Hypersensitivity to human regular insulin or one of its excipients
3) Drug interaction with beta-adrenergic blocking agents, corticosteriods or pentamidine
Source of information: Micromedex DRUGDEX® Evaluations
Patient Education / Counselling Points:
Possible side effects:
Patients should be counselled on how to recognise and react to the early warning
symptoms of hypoglycaemia.
Injection:
-
-
-
-
Use the syringe marked for the strength of insulin to be injected as failure to do so
can lead to mistake in dosage.
Ensure patient is aware of proper injecting technique and care must be taken to
ensure that the injection does not enter the blood vessel. Prepare patients for
possible bruising due to improper injection techniques.
Remind patient to be consistent with the area of the body that is injected. (Eg,
buttocks, abdomen, thighs or upper arms. However, patient should rotate the
injections between various sites within the same area.
Do not use Humulin if insulin substance remains at the bottom of the bottle after
mixing. Do not use if there are clumps in the insulin after mixing and if solid particles
stick to the bottom or wall of the bottle, giving it a frosted appearance.
61
Lifestyle:
Patient ability to concentrate and react may be impaired as a result of
hypoglycaemia and should be advised to avoid driving and operating heavy
machinery when hypoglycemic.
- Patient should be counselled on using glucometers to monitor their blood glucose
level regularly. In particular, expectant mothers should monitor their blood glucose
to meet the changing needs for insulin during and after pregnancy to prevent
maternal and fetal problems.
Source of information: www.mims.com.sg
-
62
Student Name
Kuek Qi Min
Kum Sin Yen Evon
Matric Number
U084972N
U084894H
Date
PANADEINE
Brand / Generic Name: Panadeine
Generic name: Co-codamol
Proprietary name: Active ingredient: Paracetamol and Codeine Phosphate
Source of information: Online MIMS Singapore (Extracted on 18 Jan 2010)
Legal Classification in Singapore: P (Pharmacy only)
Source of information: Online MIMS Singapore (Extracted on 18 Jan 2010)
Approved Indication(s):



Short-term relief of painful disorders: Headache, dysmenorrhea, musculoskeletal
pain, myalgias and neuralgias.
Conditions accompanied by discomfort and fever (e.g. common cold and viral
infection)
As analgesic after dental work and tooth extractions
Source of information:
 Online MIMS Singapore (Extracted on 18 Jan 2010)
 Panadeine product information leaflet (Sanofi Aventis)
Therapeutic Classification: Analgesics (non-opioid) and Antipyretics
Mechanism of Action(s):
Paracetamol produces analgesia by elevation of pain threshold, mediated peripherally and
centrally. Its antipyretic properties are produced by a central action on the hypothalamic
regulatory centre.
Codeine phosphate is an opiate. It acts on sites within the central nervous system (CNS) to
produce analgesia by binding to specific receptors in the CNS. Thus altering the perception
and response to pain stimuli while producing generalized CNS depression.
63
Source of information:
- Online MIMS Singapore (Extracted on 18 Jan 2010) http://www.mims.com.sg
- Panadeine product information leaflet (Sanofi Aventis)
Available Dosage Form(s): Tablets
Source of information: Online MIMS Singapore (Extracted on 18 Jan 2010)
Dosing and Administration:
Strength: Paracetamol BP 500 mg and codeine phosphate BP 8 mg.
 For adults: 1 to 2 tablets, 3 or 4 times daily, maximum of 8 tablets daily
 For children of ages 7 to 12 years: ½ to 1 tablets, 3 or 4 times daily, up to 4 tablets
daily
Not recommended for children under 7 years old
May be taken with or without food orally
Source of information
 Online MIMS Singapore (Extracted on 18 Jan 2010) http://www.mims.com.sg
 Panadeine product information leaflet (Sanofi Aventis)
Side Effects / Cautions:






Codeine may be addictive
Panadeine may produce sedation in some patients. This may impair the mental
and/or physical abilities required for potentially hazardous tasks such as driving a
car or operating machinery
Patients who are pregnant or breastfeeding need to seek advice of healthcare
professionals before taking Panadeine
If sensitivity reactions occur, the use of product should be discontinued
Care need to be exercised with patients with acute abdominal conditions and in
other special risk patients e.g. those with head injury
Prompt medical attention is critical for cases of accidental overdosage
Source of information: Panadeine product information leaflet (Sanofi Aventis)
64
Contraindication(s):
 Hypersensitivity to paracetamol or codeine
 Patients with compromised hepatic function
Source of information:
 Panadeine product information leaflet (Sanofi Aventis)
 Online MIMS Singapore (Extracted on 18 Jan 2010) http://www.mims.com.sg
Patient Education / Counselling Points:


Keep out of reach of children
Do not take Panadeine for more than 10 days unless advised by a healthcare
professional
 If pain persists or get worse, if new symptoms occur, or if redness of swelling is
present, consult a doctor as these could be signs of a serious condition
 Do not drink alcohol whilst taking Panadeine
 Do not drive or operate machinery when taking Panadeine as it may cause
drowsiness
 Do not take any other medicines containing paracetamol at the same time with
Panadeine
 Store in a cool, dry place in a well-closed container
Source of information: Panadeine product information leaflet (Sanofi Aventis)
65
Student Name
Lee Hoi Lun
Lee Lai Wei
Matric Number
U084927R
U084882M
Date
19 January 2010
19 January 2010
ALEVE TABLETS
Brand / Generic Name: Aleve®
Generic name: Naproxen sodium
Proprietary name: Aleve®
Active ingredient: Naproxen sodium
Source of information: AFHS Drug Information 2000, MIMS Singapore
Legal Classification in Singapore: Pharmacy-only Medication
Source of information: MIMS Singapore
Approved Indications:

Analgesic – Naproxen sodium relieves pain resulting from post-operation, after
childbirth, menstrual cycle, orthopaedic, headache, and cancer-related visceral pain.
It also helps to relieve pain and stiffness in patients with osteoarthritis. Aleve®,
which is the OTC form of Naproxen sodium, helps to relieve minor pains and aches
associated with the common cold, headache, toothache, muscular aches and
backache.
 Anti-inflammatory – Naproxen sodium is used to reduce swelling and improve
dexterity and grip of patients suffering from rheumatoid arthritis.
 Anti-pyretic – Naproxen sodium helps to alleviate fever resulting from common
cold.
Source of information: MIMS Singapore and AFHS Drug Information 2000
Therapeutic Classification: Non-steroidal Anti-inflammatory Drugs (NSAIDs)
Mechanism of Action(s): Prostaglandins are a group of mediators synthesized in the body
from arachidonic acid by enzymes known as cyclooxygenases. The second isoform of
cyclooxygenase known as COX-2 is activated during inflammation. The prostaglandins
produced by COX-2 results in typical inflammatory events such as swelling and pain.
Naproxen sodium inhibits the synthesis of prostaglandins by inhibiting the enzyme, thus
exerting its anti-inflammatory and analgesic properties.
66
Source of information: AFHS Drug Information 2000, Martindale 33rd Edition
Available Dosage Form(s): 220mg tablets in packs of 10
Source of information: MIMS Singapore
Dosing and Administration:

For adults: Take 1 tablet every 8-12 hours when necessary. If in severe pain, take 2
tablets at a go and 1 more tablet after 12 hours.
Maximum dosage is 3 tablets a day.
 For elderly patients (≥65 years old): Take 1 tablet every 8-12 hours when necessary.
If in severe pain, take 2 tablets at a go.
Maximum dosage is 2 tablets a day.
 To be taken with food (after meals).
Source of information: MIMS Singapore
Side Effects / Cautions:





There is an increase in gastric acidity and discomfort which may result in ulceration
and bleeding.
Wounds may take longer to stop bleeding.
Lungs and salivary glands may swell up due to accumulation of eosinophils if patient
is hypersensitive to NSAIDs. Generalised rash may be seen around the salivary
glands.
Pregnancy Category B during the first two trimesters and D in 3rd trimester till
childbirth.
Not recommended for children.
Source of information: AFHS Drug Information 2000, Martindale 33rd Edition
Contraindication(s):
Aleve® is unsuitable for patients




consuming other NSAIDs such as aspirin or ibuprofen.
consuming antiepiletics such as diazepam or carbamazepine.
suffering from ulceration in the stomach or the duodenum.
suffering from impairment in renal and hepatic functions.
67
 suffering from heart failure.
 suffering from allergic symptoms such as rhinitis and urticaria.
Source of information: MIMS Singapore, Martindale 33rd Edition
Patient Education / Counselling Points:







For adults: Take 1 tablet every 8-12 hours when necessary. If in severe pain, take 2
tablets at a go and 1 more tablet after 12 hours.
Maximum dosage is 3 tablets a day.
For elderly patients (≥65 years old): Take 1 tablet every 8-12 hours when necessary.
If in severe pain, take 2 tablets at a go.
Maximum dosage is 2 tablets a day.
To be taken with food (after meals).
Not to be taken with other NSAIDs and/or paracetamol unless specified by a
physician.
Stop medication and seek medical attention
o if pain persists for more than 10 days and/or fever persists for more than 3
days.
o if the pain and/or fever gets worse during the treatment.
o if there is reddening and swelling in the painful area.
Avoid activities such as driving and operating machineries when on Aleve® due to
impairment of mental alertness and physical coordination.
Avoid heavy drinking of more than 3 cups a day when consuming Aleve®.
Source of information: MIMS Singapore, AFHS Drug Information 2000
68
Student Name
Lee Nian Rong
Lee Sze Yun Kaye
Matric Number
U084921X
U084898A
Date
31/1/10
31/1/10
ASPIRIN
Brand / Generic Name:
Generic name: Aspirin
Proprietary name: Aspirin Bayer tab, Aspirin Cardio enteric-coated tab, Aspirin Protect
enteric-coated tab, Astrix Enteric-coated controlled-release cap, Bokey Entericmicroencapsulated cap, Disprin tab, Dusil tab, Alka Seltzer effervescent tab, Anacin tab,
Bufferin Enteric Low Dose cap
Active ingredient: Acetylsalicylic Acid
Source of information: www.mims.com.sg, MIMS Singapore 1st 2004 Issue
Legal Classification in Singapore: General Sales List
Source of information: www.hsa.gov.sg
Approved Indication(s):





Prophylaxis of myocardial infarction
Stent implantation
Juvenile rheumatoid arthritis
Mild to moderate pain and fever
Pain and inflammation associated with musculoskeletal and joint disorders
Source of information: www.mims.com.sg
Therapeutic Classification: Aspirin is an analgesic, anti-inflammatory and antipyretic. It is
also classified under Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics) /
Nonsteroidal Anti-inflammatory Drugs (NSAIDs).
Mechanism of Action(s):
It inhibits cyclooxygenase, which is responsible for the synthesis of prostaglandin and
thromboxane. It also inhibits platelet aggregation.
Duration: 4-6 hr.
Absorption: Rapidly absorbed from the GI tract (oral); less reliable (rectal); absorbed
69
through the skin (topical). Peak plasma concentrations after 1-2 hr.
Distribution: Widely distributed; crosses the placenta; enters breast milk. Protein-binding:
80-90%.
Metabolism: Hepatic; converted to metabolites.
Excretion: Via urine by glomerular filtration, active renal tubular secretion and passive
tubular reabsorption (as unchanged drug); via haemodialysis; 15-20 minutes (elimination
half-life, parent drug).
Source of information: www.mims.com.sg
Available Dosage Form(s):
Effervescent Tablets, capsules, enteric-coated tablet, enteric-coated capsules & capsules
Source of information: www.mims.com.sg
Dosing and Administration:
 Oral
Prophylaxis of myocardial infarction
Adult: 75-325 mg once daily. Lower doses should be used in patients receiving ACE
inhibitors.
 Oral
Stent implantation
Adult: 325 mg 2 hr before procedure followed by 160-325 mg/day thereafter.
 Oral
Juvenile rheumatoid arthritis
Child: 80-100 mg/kg daily in 5 or 6 divided doses. Up to 130 mg/kg daily in acute
exacerbations if necessary.
 Oral
Mild to moderate pain and fever
Adult: 325-650 mg repeated every 4-6 hr according to response. Max: 4 g/day. May
also be given rectally.
 Oral
Pain and inflammation associated with musculoskeletal and joint disorders
Adult: Initial: 2.4-3.6 g/day in divided doses. Usual maintenance: 3.6-5.4 g/day.
Monitor serum concentrations.
 Should be taken with food.
Source of information: www.mims.com.sg
70
Side Effects:
















Dysepsia (bloated feeling, abdominal pain, nausea, belching)
Sweating
Deafness
Black or bloody faeces
Blood loss
Ringing in ears (tinnitus)
Headache
Nausea
Vomiting
Dizziness
Mental confusion
Hallucinations
Drowsiness
Iron-deficiency anaemia in long term therapy
Thrombocytopenia
May cause hypothrombinemia (inefficient in clotting of blood), hyperventilation,
fever, restlessness, ketosis, respiratory alkalosis, metabolic acidosis, coma,
cardiovascular collapse, respiratory failure & hypoglycaemia when overdosed
Cautions:

History of peptic ulcer or those prone to dyspepsia and those with gastric mucosal
lesion
 Asthma or allergic disorders
 Dehydrated patients
 Uncontrolled hypertension
 Impaired renal or hepatic function
 Elderly
 Do not take concurrently with NSAIDs
Source of information: www.mims.com.sg, Martindale The Complete Drug Reference
71
Contraindication(s):





Hypersensitivity (attacks of asthma, angioedema, urticaria or rhinitis)
Active peptic ulceration
Pregnancy (3rd trimester)
Children <12 yr
Patients with haemophilia or haemorrhagic disorders, gout, severe renal or hepatic
impairment, lactation.
Source of information: www.mims.com.sg, Martindale The Complete Drug Reference
Patient Education / Counselling Points:








Aspirin for cardiovascular disease should be used under a doctor’s supervision
Stop the medication and see a doctor if the patient has any symptoms of bleeding in
the intestines or stomach
Avoid drinking alcohol while taking aspirin
Avoid the medication if the patient is allergic to it or to NSAIDs
Avoid the medication if the patient has stomach or intestinal bleeding recently
Avoid the medication if the patient has bleeding disorders
Consult a doctor if the patient is pregnant, wants to be pregnant or breastfeeding
while taking aspirin
Take the medicine after a meal with a glass of water or milk
Source of information:
http://www.drugs.com/aspirin.html
http://www.homepharmacy.com.au/products/products_view.cfm?ProductID=90
72
Student Name
Lee Wei Xian
Lee Wee Boon
Matric Number
U084850B
U084865E
Date
29/1/2010
29/1/2010
KETOPROFEN PLASTER
Brand / Generic Name: Ketoprofen Plaster
Generic name: Ketoprofen
Proprietary name: KefenTech plaster® Kenhancer plaster®
Active ingredient: Ketoprofen 30mg
Source of information: www.mims.com
Legal Classification in Singapore: P
Source of information: www.hsa.gov.sg
Approved Indication(s):
Anti-inflammation & soothing of pain caused by :
 Arthritis deformans
 Periarticular inflammation of shoulder
 Tendinitis
 Peritendinitis
 Epicondylitis of humerus
 Myalgia
 Trauma
Source of information: www.mims.com
Therapeutic Classification: Non-steroidal anti-inflammatory preparations for topical use
Mechanism of Action(s): Ketoprofen exhibits anti-inflammatory, analgesic and antipyretic
activities. It potently inhibits the enzyme cyclooxygenase resulting in prostaglandin
synthesis inhibition. It also prevents formation of thromboxane A2 by platelet aggregation.
Source of information: www.mims.com
73
Available Dosage Form(s): Topical Plaster
Source of information: www.mims.com
Dosing and Administration:
 Remove film coated thin paper from lint fabric then apply lint fabric to affected part.
 Apply 1 plaster bd.
Source of information: www.mims.com/www.wooshinmed.com
Side Effects / Cautions:





Redness
Rash
Pruritus
Skin dryness & irritation
Hypersensitivity
Treatment should be discontinued in the event of such symptoms.
Source of information: www.mims.com
Contraindication(s):
 Patients with aspirin asthma (induced by NSAIDs) or its previous history.
 Patients with severe renal impairment.
Source of information: www.mims.com/Martindale-The Complete Drug Reference
Patient Education / Counselling Points:





Avoid contact with eyes and mucosa.
Avoid use in women who are or may be pregnant.
Do not use for occlusive dressing.
Use with caution in conditions such as renal and hepatic impairment.
When used on affected parts without epidermis, feeling of skin contraction or a
smarting pain may occur. Use with caution.
Source of information: www.mims.com, www.wooshinmed.com, MartindaleThe Complete Drug Reference
74
Student Name
Leontius Adhika Pradhana
Lew Si Min
Matric Number
U087752J
U084945L
Date
27/01/10
DICLOFENAC GEL
Brand / Generic Name: Voltaren
Generic name: Diclofenac Diethylamine
Proprietary name:Voltaren® Emulgel® 1%
Active ingredient: Diclofenac Diethylamine
Source of information
 British Pharmacopoeia 2007
 Martindale Online
 Health Sciences Authority Online Search
 Wikipedia List of Pharmaceutical Companies
(http://en.wikipedia.org/wiki/List_of_pharmaceutical_companies)
 MIMS online
Legal Classification in Singapore: GSL
Source of information: Health Sciences Authority Online Search
Approved Indication(s):

Pain, inflammation and swelling caused by sports injuries or accidents (e.g. sprains,
strains, and bruises) on tendons (tendinitis), ligaments, muscles, and joints
 Localised forms of soft-tissue rheumatism (e.g. tenosynovitis, bursitis, shoulderhand syndrome, periarthropathy, osteoarthrosis of peripheral joints and of the
vertebral column)
 Backaches
 Localised mild arthritis
Source of information: MIMS Online, Voltaren® Emulgel® 1% product leaflet
Therapeutic Classification: Non-Steroidal Anti-Inflammatory Drug (NSAID)
Mechanism of Action(s): Diclofenac works within the body by blocking the production of
prostaglandins, which are involved in the development of pain and inflammation.
Source of information: Voltaren® Emulgel® 1% product leaflet
75
Available Dosage Form(s):
 Diclofenac diethylamine gel 1.16% (w/w) (equivalent to diclofenac sodium 1%
(w/w))
 Diclofenac sodium 1% (w/w)
Source of information: Voltaren® Emulgel® 1% product leaflet, MIMS online
Dosing and Administration:




For adults and adolescents older than 12 years of age: apply 2--4 g, 3 to 4 times a
day to the affected area and rub in gently.
Do not use for more than 2 weeks, unless recommended by doctor.
Consult your doctor if pain and swelling persists or gets worse for more than 7
days.
Food does not affect the actions of this drug.
Source of information:
 MIMS Online
 Martindale The Complete Drug Reference, 36th Edition
 Voltaren® Emulgel® 1% product leaflet
Contraindication(s):
 Patients with asthma attacks
 Urticaria or acute rhinitis when taking acetylsalicylic acid (Aspirin™) or NSAIDs e.g.
ibuprofen
 Hypersensitivity to diclofenac or other NSAIDS; propylene glycol; or isopropyl alcohol
 Do not use with occlusive dressing
Source of information: MIMS, MIMS Online
Patient Education / Counselling Points:
 FDA Pregnancy Category B. Category D in 3rd trimester or near delivery
 Storage information:
 do not store above 30 C
 keep out of reach of children
 do not store past expiry date
Source of information: MIMSonline
76
sedStudent Name
LI JIAHUI
LIAN WANXI TRACY
Matric Number
U084926E
U084956U
Date
CHLORPHENIRAMINE SYRUP/TABLET
Brand / Generic Name: Allerief®, Allermin®, Allersin®, Alleryl®, Antamin®, Axcel
Chlorpheniramine®, Calimal®, Chloramine®, Chlormine®, Chlor-Trimeton®, Chlorpyrimin®,
Horamine®, Pirimat®, Piriton®
Generic name: Chlorpheniramine
Proprietary name: Piriton®, Chlor-Trimeton®
Active ingredient: Chlorpheniramine Maleate
Source of information – MIMS online; BNF
Legal Classification in Singapore: P
Source of information – MIMS 2007
Approved Indication(s):


Anaphylactic conditions
Allergic conditions of the skin & mucous membrane.
(Eg. Acute urticaria, atopic dermatitis, allergic rhinitis and hay fever. )
 Antihistamine-indicated conditions
Source of information – MIMS 2007; MIMS 2006; MIMS online
Therapeutic Classification: Antihistamines & Antiallergics
Mechanism of Action(s): Chlorphenamine is a H1-receptor antagonist which competes with
histamine for H1-receptor sites on tissues. It also has antimuscarinic effect.
Source of information – MIMS online; Product insert by DHA
Available Dosage Form(s): Oral tablets, Oral solution, Parental subcutaneous/intramuscular
injection, Parenteral intravenous injection.
Source of information – MIMS 2007; BNF
77
Dosing and Administration:

Tablet : For adults & children above 12years old: 4mg tds/qds(Max : 24mg daily)
: For children between 6 - 12years : 2 - 4mg tds/qds (Max : 12mg daily)
: For children between 1 - 5years : 1 - 2 mg tds (Max : 6mg daily)
 Syrup : For adults : 4 mg bd/tds
: For children : 2 mg bd/tds
 Subcutaneous/intramuscular inj : For adults : 10-20mg (Max : 4mg in 24hours)
 Intravenous inj over 1 minute : For adults : 10-20mg
: For children between 6-12years : 5-10mg
: For children between 1-5years: 2.5-5mg
: For children under 1 year: 250micrograms/kg
Source of information – BNF; MIMS 2007
Side Effects / Cautions:





Sedation and inability to concentrate
Headaches
Dizziness
Muscular weakness and incoordination
Gastro-intestinal disturbances such as nausea, vomiting, diarrhoea or constipation,
abdominal pain, difficulty in micturition(urination), and dryness of mouth
 Blurred vision
 Allergic reactions including exfoliative dermatitis, photosensitivity, skin reactions,
and urticaria.
Source of information – Product insert by DHA ; MIMS online
Contraindication(s):







Hypersensitivity, neonates
Central Nervous System(CNS) depressants
Anticholinergics
Alcohol
Ototoxic drugs
Phenytoin sodium
Incompatible with calcium chloride, kanamycin sulfate, noradrenaline acid tartrate,
pentobarbital sodium and meglumine adipiodone
Source of information BNF, MIMS 2007
78
Patient Education / Counselling Points:









To be taken after meals
Avoid alcohol as the sedative effects of alcohol may be increased
This preparation may cause drowsiness & dulling of mental alertness. If affected, do
not drive, operate machinery, or perform other tasks requiring mental alertness.
This preparation may have an additive effect when used concurrently with CNS
depressants including barbiturates, hypnotics, anxiolytics, narcotic analgesics,
sedatives and tranquilizers causing potentiation of drowsiness. Therefore patients
should avoid concurrently taking any CNS depressants or seek advice before doing
so.
This preparation may also enhance effects of anticholinergic drugs administered
concomitantly.
This preparation inhibits phenytoin metabolism and can lead to phenytoin toxicity.
Therefore patients should avoid taking phenytoin sodium which is a common
antiepileptic or any phenytoin containing drugs.
Do not exceed the recommended daily intake.
Do not take during pregnancy or whilst breast feeding unless advised by your
doctor.
Seek medical advice if symptoms persist.
Source of information – MIMS online; Product insert by DHA
79
Student Name
Liew Xin Yi Cindy
Lim Hui Yang
Matric Number
U084940A
U084856W
Date
30-01-2010
30-01-2010
PROMETHAZINE SYRUP
Brand / Generic Name: Promethazine syrup
Generic name: Promethazine Hydrochloride
Proprietary name: Phenergan®
Active ingredient: Promethazine Hydrochloride
Source of information: Health Sciences Authority, USP Micromedex (18th Edition)
Legal Classification in Singapore: Pharmacy Only
Source of information: Health Sciences Authority (HSA)
Approved Indication(s):

Pre-operative and post-operative in surgery and obstetrics for its sedative effects
and relief of apprehension.
 Anti-emetic action in prevention and treatment of nausea and vomiting in
conditions such as motion sickness, drug-induced vomiting, and post-operative
vomiting.
 Sedating antihistamine with anti-muscarinic actions.
 Common ingredient of compound preparations for the symptomatic treatment of
coughs and common cold
 Symptomatic relief of allergic conditions including urticaria, anginedema, rhinitis,
conjunctivitis and pruritic skin conditions.
Source of information: Martindale 32th Edition- The complete drug reference, Micromedex
Therapeutic Classification: Anti-histamine, anti-allergic, anti-vertigo.
Mechanism of Action(s): Promethazine hydrochloride competitively blocks histamine H1receptors without blocking the secretion of histamine.
Source of information: Micromedex, MIMS, British National Formulary (BNF)
80
Available Dosage Form(s): Oral solution, syrup, tablet, suppository, intramuscular injection.
Source of information: Martindale 32th Edition- The complete drug reference, BNF,
Micromedex
Dosing and Administration:
 Allergic conditions:
 Adults: 25mg at night, increase to 25mg twice a day if necessary; or give 10-20mg
two or three times daily.
 Children: 2-5 yrs 5-15mg; 5-10 yrs 10-25 mg
Doses for children are taken daily in one or two divided doses.
 Night sedation/ Short-term Management of Insomnia:
 Adults: 20-50mg at bedtime.
 Children: 2-5 yrs 15-20 mg; 5-10 yrs 20-25 mg. Doses are taken at bedtime.
 Prevention of motion sickness:
 Adults: 20 or 25mg
 Children: 2-5 yrs 5 mg; 5-10 yrs 10 mg.
Both adult and children doses are taken the night before travelling, and can be
repeated on the following morning if necessary.
Source of information: Martindale 32th Edition- The complete drug reference, MIMS, BNF,
Micromedex
Side Effects / Cautions:

Drowsiness and blurring of vision may occur, thus patient should avoid operating
machinery or driving the following day
 Do not take Promethazine for more than 7 days without a doctor's advice
 Fever, headache, sweating, confusion, disorientation, muscle stiffness
 Restlessness and nervousness
 Nausea, vomiting, loss of appetite, stomach upset
 Dryness of mouth
 Retention of urine and constipation
 Drug may not be suitable for use in patients with Parkinson's disease, myasthenia
gravis and diabetes
Source of information: Martindale 32th Edition- The complete drug reference, MIMS,
Micromedex
81
Contraindication(s):
 Neonates and young children below the age of 2
 Pregnant or lactating women
 Young children and teenagers with vomiting from unknown cause and dehydration
 Hypersensitivity or history of an idiosyncratic reaction to promethazine or other
phenothiazines
 Patients who have previously received large doses of antidepressants
 Heart, liver or kidney disease
 Lower respiratory tract symptoms, including asthma
 Epilepsy
 Glaucoma
 Diabetes
 Stomach or intestinal ulcers or obstruction
 Prostate hypertrophy
 Porphyria
 Hypokalaemia
 Sleep apnea
 Alcohol
Source of information: MIMS, Martindale 32th Edition- The complete drug reference,
Micromedex
Patient Education / Counselling Points:
 For dosing please refer to dosing administration.
 Medication has sedative effects and can cause drowsiness. Patient should avoid
driving or operating heavy machinery.
 Exercise caution when administering to pediatric patients 2 years of age and older
and use at the lowest effective dose. Avoid concomitant use of other drugs with
respiratory depressant effects.
 The following groups should not take the medication:
 Children with asthma, liver disease, seizure disorders or glaucoma;
 Patients with respiratory, heart, liver or kidney problems;
 Patients allergic to promethazine or other phenothiazine medicines;
 Pregnant and lactating patients and children of less than 2 years of age.
 Take the medication after meals.
 Do not drink alcohol when you are using this medication
 Store in airtight containers and keep at a cool dry place away from light
Source of information: Martindale 32th Edition- The complete drug reference, Micromedex
82
Student Name
Lim Jin Rui, Nicholas
Lim Ken Juin
Matric Number
U084852Y
U084976L
Date
22 Jan 2010
22 Jan 2010
POLARAMINE SYRUP/TABLET
Brand / Proprietary Name: Allerphen, Chlorpyrimine, Piriton, Polaramine (by Schering
Plough), Rhiniramine
Generic name: Chlorpheniramine Maleate (Chlorphenamine Maleate)
Dexchlorpheniramine Maleate is a dextrorotatory isomer of the drug, with approximately
twice the activity of chlorpheneramine by weight.
Active ingredient: Chlorpheniramine Maleate (Chlorphenamine Maleate)
Source of information : Martindale, The Complete Drug Reference, 33rd Edition Pg.412
Legal Classification in Singapore: P (Pharmacy Only Medicine)
Source of information: MIMS
Approved Indication(s):

Symptomatic relief of cough, common cold, allergic conditions including seasonal
allergic rhinitis (hay fever), conjunctivitis, urticaria and angioedema, pruritic skin
disorders.

As an adjunct treatment of anaphylactic shock, to decrease duration and severity of
symptoms and prevent relapse (after initial treatment by adreneline)
Source of information: Martindale, The Complete Drug Reference, 33rd Edition, Pg.412
Therapeutic Classification:

Antihistamine, antiallergic, antipruritic, antimuscarinic, antiepileptics
Mechanism of Action(s):

Chlorpheramine is a H1 histamine receptor antagonist, competes with histamine for
effector cell receptor sites.

Causes reduction in bronchial and nasal secretions.
83
Source of information

Martindale, The Complete Drug Reference, 33rd Edition, Pg.406-408, 412

MIMS
Available Dosage Form(s):

Polaramine Tablet : 2mg Dexchlorpheniramine maleate per tablet.

Polaramine Repetablet : 6mg Dexchlorpheniramine maleate per tablet.

Polaramine Syrup : per 5 mL contains 2mg Dexchlorpheniramin maleate,100mg
guaifenesin and 20mg pseudoephedrine sulfate.
Source of information

MIMS

Martindale, The Complete Drug Reference, 33rd Edition, Pg.406-408, 412
Dosing and Administration:
From Martindale,

Dexchlorpheniramine Malate, the dextrorotatory isomer, has twice the activity of
chlorpheniramine by weight.

Dexchlorpheniramine malate is given by mouth in doses of 2mg every 4 to 6 hours
up to a maximum of 12mg daily.

Children aged 2 to 5 years old may be given 0.5mg every 4 to 6 hours (maximum
3mg daily) , and those aged 6 to 12 years, 1mg every 4 to 6 hours (maximum 6mg
daily)

Modified-realease oral preparations are available in some countries.
From MIMS,

Chlorphenamine malate is given by mouth doses of 4mg every 4 to 6 hours up to a
maximum of 24mg daily.

Doses for children are:
- 1 to 2 years old, 1mg twice daily
- 2 to 5 years old, 1mg every 4 to 6 hours (maximum 6mg daily)
- 6 to 12 years old, 2mg every 4 to 6 hours (maximum 12mg daily)

Chlorpheniramine malate may be given by intramuscular, by subcutaneous, or by
slow intravenous injection over a period of 1 minute. The usual dose is 10 to 20mg
and the total dose given by these routes in 24 hours should not normally exceed
40mg.

For children, doses of 87.5g per kg bodywight subcutaneously four times daily
have been suggested.
84
Source of information

Martindale, The Complete Drug Reference, 33th Edition, Pg.412

MIMS
Side Effects / Cautions:
 Similar to sedating antihistamines in general, rashes and hypersensitivity may
occur.
 Exfoliative dermatitis may develop. Injections may be irritant and cause transient
hypotension or stimulation of the CNS.
 There are several isolated cases of blood dyscrasia after administration reported.
 Sense of smell and taste can be affected.
 Facial dyscrasia may occur after administration by mouth.
 Drowsiness, urticaria, drug rash, anaphylactic shock, photosensitivity, excessive
perspiration; chills; dry mouth, nose and throat. Severe hypotension.
cardiovascular, hematologic, neurologic, gastrointestinal , and respiratory
reactions.
Source of information
 MIMS
 Martindale, The Complete Drug Reference, 33th Edition, pg 412
Contraindication(s):

The use of Polaramine Tab/ Syr is contraindicated in pataients with severe
hypertension; coronary artery disease; hyperthyroidism; as well as in premature
infants & newborn.

Concomitant use with Monoamine Oxidase Inhibitors (MAOI) should be
prevented.
Source of information: MIMS
Patient Education / Counselling Points:

Storage: Keep away from light and store at room temperature

Please consult your doctor first before taking the medication if you are pregnant

As the medication can cause drowsiness and lead to change in work
performance, avoid operating machinery after consumption.
Source of information

MIMS

Martindale, The Complete Drug Reference, 33th Edition, Pg.412
85
Student Name
Lim Pei Qi
Lim Ping Siew
Matric Number
U084984J
U084881B
Date
25 January 2010
25 January 2010
LORATADINE
Brand / Generic Name
Generic name: Loratadine
Proprietary name (Brand): Clarityne (Schering-Plough), Loratadine Teva (Teva)
Active ingredient: Loratadine
Source of information: MIMS (www.mims.com.sg)
Legal Classification in Singapore: Pharmacy Only Medicine (P)
Source of information: MIMS (www.mims.com.sg)
Approved Indication(s):


Relief of symptoms associated with hay fever and allergic rhinitis. Such symptoms
include sneezing, runny nose, nasal discharge and itching, as well as ocular itching &
burning.
Also for relief of symptoms & signs of chronic urticaria & other allergic dermatologic
disorders. Such symptoms include rash, itching or urticaria.
Source of information: MIMS (www.mims.com.sg)
Therapeutic Classification: Long-acting, non-sedating antihistamine (second-generation
antihistamine)
Mechanism of Action(s): Loratadine is a potent long-acting tricyclic antihistamine with
selective peripheral H1-receptor antagonistic activity.
Source of information: MIMS (www.mims.com.sg) and Micromedex (Martindale database)
Available Dosage Form(s): • 10mg oral tablets
• 5mg/5ml oral syrup
Source of information: MIMS (www.mims.com.sg)
86
Dosing and Administration:
 Administration: May be taken with or without food.
 Dosing:
 Adult and children aged 12 years old and above – take one 10mg tablet or
10ml syrup (5mg/5ml) once daily.
 6 to 12 years old (>30 kg body weight) – take one 10mg tablet or 10ml syrup
(5mg/5ml) once daily.
 6 to 12 years old (≤30 kg body weight) – take half 10mg tablet or 5ml syrup
(5mg/5ml) once daily.
Source of information: MIMS (www.mims.com.sg)
Side Effects:
 Fatigue
 Headache
 Somnolence
 Fainting
 Hair loss
 Dry mouth
 GI disorders (e.g. nausea or gastritis)
 Rash
 Severe allergic reaction
 Disturbance in heart rhythm
 Decrease liver function
Cautions:
 Severe liver impairment could occur.
 Children aged below 2 years old should be avoided.
 Pregnant or breast-feeding mothers should avoid the use of this drug.
Source of information: MIMS (www.mims.com.sg) and Micromedex (Martindale and
Drugdex database)
Contraindication(s):
 Cimetidine
 Erythromycin
 Clarithromycin
 Ketoconazole
87




Quinidine
Fluconazole
Fluoxetine
Patients who have shown hypersensitivity to Loratadine.
Source of information: MIMS (www.mims.com.sg) and Micromedex (Martindale database)
Patient Education / Counselling Points:
 Do not drive or operate heavy machineries.
 Do not take this drug if you are pregnant or breastfeeding.
 Seek medical advice if your body experience any of the side effects upon
consumption of this drug. Immediate attention should be given to the following:
 allergic reactions (eg itching and swelling of hands or face, tightness in chest
and trouble brething)
 extreme weakness
 fast or irregular heartbeat
 uncontrolled movements of the head, neck, eyes or tongue
 Seek medical advice before consumption of other drugs, especially the
antibacterials, antifugals and gastrointestinal drugs.
 Tell your doctor/pharmacist if you are allergic to Loratadine or if you have other
allergies.
 Tell them your medical history, especially of kidney disease and liver disease.
 Avoid alcohol consumption.
 Keep all medicine out of the reach of children.
 Store in room temperature away from heat and direct sunlight. Do not freeze.
Source of information: Micromedex (Martindale and Drugdex database)
88
Student Name
Lim Shu Li
Lim Shu Qing Lynette
Matric Number
U084939L
U084880N
Date
21 January 2010
21 January 2010
PSEUDOEPHEDRINE TABLET
Brand / Generic Name: Pseudoephedrine Tablet /Pseudoephedrine Hydrochloride Tablet
Generic name: Pseudoephedrine/ Pseudoephedrine Hydrochloride
Proprietary name: Actifed tab( GlaxoSmithKline),
Panadol For Cough and Cold (GSK, Singapore),Sudafed tab (GlaxoSmithKline) ,Pseudorine
(Sunward, Singapore), Clarinase 24 hr Extended-release tab (Schering-Plough)
Active ingredient: Pseudoephedrine
Source of information: Martindale (online website), BNF 47 March 2004
Legal Classification in Singapore: Over-the-counter (OTC)
Source of information: HSA (online website)
Approved Indication(s):
 Congestion of nasal sinus (common cold)
 Allergic rhinitis
Source of information: Micromedex 2.0 (online website)
Therapeutic Classification:
 Alpha-adrenergic agonist
 Systemic decongestant
 Sympathomimetic
Mechanism of Action(s): Pseudoephedrine stimulates the alpha-adrenergic receptors of
vascular smooth muscle, leading to the constriction of the dilated arterioles found in the
nasal mucosa. The constriction of the blood vessels results in a decrease in fluid flow to the
nose, throat and sinus regions. Hence, inflammation of the nasal membranes as well as
mucus production is reduced.
Source of information: Micromedex 2.0 (online website), BNF 47 March 2004
89
Available Dosage Form(s):
 15 mg tablet
 60 mg tablet
Source of information: Micromedex 2.0 (online website)
Dosing and Administration:
Oral administration
Adult dosage:
 60 mg tablet every 4 – 6 hours, not exceeding 240 mg (4 doses) in 24 hours.
 For the sustained release tablets, recommended dose is 120 mg in 12 hours.
Paediatric dosage:
 Recommended dose is 4 mg per kg (child’s weight) per day, taken in 4 divided doses.
 For children aged 2 to 5, 15 mg every 6 hours without exceeding 60 mg in 24 hours.
 For children aged 6 to 12, 30 mg every 6 hours, not exceeding 120 mg in 24 hours.
Source of information: Micromedex 2.0 (online website), Martindale (online website)
Side Effects / Cautions:
Adverse Effects
 Hypertensions, tachyarrhythmia (cardiovascular)
 Insomnia (neurologic)
 Anxiety, nervousness, restlessness (psychiatric)
 Rash (dermatological)
 Urinary retention (renal)
 Hallucinations (psychiatric) [NB: in rare cases]
 Nausea and vomiting
Precautions/Warnings
 Pregnant women and breastfeeding mothers should avoid taking this medication.
 Patients prone to panic or anxiety attacks should use the medication with caution.
 Use of medication should be taken with caution in children and generally avoided
with young children (below 6 years)
 The medication should be used with caution in patients with prostate hypertrophy,
hepatic and renal impairment.
 The elderly (60 years and above) are more likely to have adverse reactions to the
medication, overdosage may result in hallucinations, convulsions, central nervous
system depression and death.
90
Source of information: Micromedex 2.0 (online website), BNF 47 March 2004, Product
Information (Pseudorine Tablet)
Contraindication(s):



Not to be used by patients with severe hypertension and coronary artery disease,
closed angle glaucoma, diabetes mellitus, hyperthyroidism.
Not to be taken with MAOIs (monoamine oxidase inhibitors) and SSRIs (selective
serotonin uptake inhibitors)
Not to be used by patients who have shown hypersensitivity to pseudoephedrine or
other sympathomimetics.
Source of information: Product information (Pseudorine Tablet), BNF 47 March 2004
Patient Education / Counselling Points:

Swallow the tablet whole, do not chew unless medication is in chewable tablet
form.
 If you miss a dose, use it as soon as you can. If it is almost time for your next dose,
wait until then to use the medicine and skip the missed dose. Do not use extra
medicine to make up for a missed dose.
 Store in an airtight container, in a cool dry place. Protect from direct light.
 Keep out of reach of children
 You should not use this medicine for more than 7 days unless ordered by a doctor.
 If you do not get better within 1 week, or experience any adverse side effects, do
consult your doctor immediately.
Source of information: Martindale (online website), Micromedex 2.0 (online website)
91
Student Name
Lim Sin Yii Schezn
Lim Sue Lynn
Matric Number
U084928A
U084889U
Date
28 01 10
28 01 10
SALBUTAMOL SYRUP / TABLET
Brand / Generic Name:
Generic name: Salbutamol (Salbutamol)
Synomyms: Ipratropium, Albuterol
Proprietary name: Ventolin tablet, Ventolin syrup, Volmax controlled-release tablet
Active ingredient: Salbutamol syrup/tablet contains salbutamol sulphate as the active
ingredient, and has the IUPAC name al-[(tert-Butylamnio)methyl]-4-hydroxy-m-xylene-a,a1diol sulphate.
Source(s) of information:
http://www.rxlist.com
http://www.medicinenet.com
http://www.mims.com.sg
Legal Classification in Singapore: Pharmacy Only
Source of information: http://www.hsa.gov.sg
Approved Indication(s):
Salbutamol syr/tab belongs to the class of antiasthmatic and COPD preparations, and is
used for the relief of bronchospasm in chronic bronchitis, emphysema and bronchial
asthma.
Salbutamol tab is also used for maintenance therapy in premature labour.
Source of information: http://www.mims.com.sg
Therapeutic Classification: Beta-adrenergic Agonist
Mechanism of Action(s):

The racemic form of albuterol, albuterol sulphate, is a relatively selective beta2adrenergic bronchodilator.
92

Albuterol’s primary action is to stimulate adenyl cyclase which catalyzes the
formation of cyclic AMP from ATP in beta-adrenergic cells. Increased cyclic AMP
levels lead to relaxation of bronchial smooth muscles and inhibition of release of
mediators of immediate hypersensitivity from cells, especially from mast cells.

Albuterol is rapidly and well absorbed following oral administration. After oral
administration of 10 mL of Salbutamol Syrup (4 mg albuterol) in normal volunteers,
maximum plasma albuterol concentrations of about 18 ng/mL are achieved within 2
hours, and the drug is eliminated with a half-life of about 5 to 6 hours.
Source(s) of information:
http://www.hc-sc.gc.ca
http://www.rxlist.com
Available Dosage Form(s):
Salbutamol syrup (Ventolin) contains 2mg of albuterol as 2.4mg of albuterol sulphate in
each 5ml of the syrup. It is a clear yellow liquid and artificially flavoured with strawberry
flavouring.
Ventolin tablet contains 2mg of albuterol as 2.4mg albuterol sulphate in each tablet.
Source(s) of information:
http://www.rxlist.com
http://www.mims.com.sg
Dosing and Administration:
Adults and pediatric patients over 12 years of age: The usual starting dosage for adults
and children over 12 years of age is 2 mg (1 teaspoonful) or 4 mg (2 teaspoonfuls) three or
four times a day.
Pediatric patients 6 to 12 years of age: The usual starting dosage for children 6 to 12 years
of age is 2 mg (1 teaspoonful) three or four times a day.
Pediatric patients 2 to 6 years of age: Dosing in children 2 to 6 years of age should be
initiated at 0.1 mg/kg of body weight three times a day. The starting dosage should not
exceed 2 mg (1 teaspoonful) three times a day.
Dosage Adjustment
Adults and pediatric patients over 12 years of age: For adults and children over 12 years of
age, a dosage above 4 mg four times a day should be used only when the patient fails to
93
respond to this dosage. If a favorable response does not occur with the 4 mg initial dosage,
it may be cautiously increased stepwise as tolerated, but not to exceed 8 mg four times a
day (total daily dose should not exceed 32 mg).
Pediatric patients 6 to 12 years of age who fail to respond to the initial starting dosage of
2 mg four times a day: For children 6 to 12 years of age who fail to respond to the initial
starting dosage of 2 mg four times a day, the dosage may be cautiously increased stepwise
as tolerated but not to exceed 6 mg four times a day (total daily dose should not exceed 24
mg).
Pediatric patients 2 to 6 years of age who do not respond satisfactorily to the initial
dosage: For children 2 to 6 years of age who do not respond satisfactorily to the initial
starting dosage, the dosage may be increased stepwise to 0.2 mg/kg of body weight three
times a day as tolerated, but not to exceed a maximum of 4 mg (2 teaspoonfuls) given three
times a day (total daily dose should not exceed 12 mg).
Elderly patients and those sensitive to beta-adrenergic stimulators: The initial dosage
should be restricted to 2 mg three or four times a day. If adequate bronchodilation is not
obtained, dosage may be increased gradually as tolerated to as much as 8 mg three or four
times per day (total daily dose should not exceed 32 mg).
Source of information: http://www.rxlist.com
Side Effects / Cautions:





Tremors, headaches and hyperactivity are relatively common side effects
experienced.
Hypersensitivity reactions such as angioedema, urticaria, bronchospasm,
hypotension and collapse may occur, but are very rare.
Muscle cramps or the feeling of muscle tension are possible side effects
experienced when taking the tablet or syrup dosage forms.
Other common side effects include chest pain, rapid heart rate and palpitations.
Generally, the reactions are transient and it is not necessary to discontinue
treatment. However, the dosage can be temporarily reduced and once the reaction
has subsided, it can be increased by small increments to the optimal dosage.
Source(s) of information:
http://www.rxlist.com
http://www.mims.com.sg
94
Contraindication(s):




Salbutamol Syrup should be used with caution in patients with cardiovascular
disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension;
in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus; and in
patients who are unusually responsive to sympathomimetic amines. Clinically
significant changes in systolic and diastolic blood pressure have been seen and could
be expected to occur in some patients after use of any beta-adrenergic
bronchodilator.
Use of Salbutamol Syrup for relief of bronchospasm during labor should be
restricted due to the potential interference between beta-agonist with uterine
contractility.
Safety and effectiveness in children below the age of 2 years have not been
established.
Salbutamol Syrup is contraindicated in patients with a history of hypersensitivity to
albuterol or any of its components.
Source of information: http://www.rxlist.com
Patient Education / Counselling Points:
The effect of Salbutamol syrup/tablet may last up to 6 hours, or even longer. It should not
be taken more frequently than recommended, and neither should one increase the dosage
without consulting a physician. If treatment becomes less effective for symptomatic relief,
symptoms worsen and/or it needs to be taken with more frequency than usual, medical
attention should be immediately sought. Other inhaled drugs and medications should only
be taken with Salbutamol as directed by the physician. Pregnant or lactating individuals
should consult a physician before usage of this drug. Salbutamol has drug interactions with
diuretics, Beta-Blockers, digoxin and oxidase Inhibitors and tricyclic Antidepressants.
Source of information: http://www.rxlist.com
95
Student Name
Lim Xi Wei
Lim Yan Ling
Matric Number
U084954W
U084910N
Date
15 January 2010
15 January 2010
DIPHENHYDRAMINE
Brand / Generic Name:
Generic name: Diphenhydramine
Proprietary name: Benadryl ®Cough Syrup [Johnson & Johnson Pte. Ltd.]
Active ingredient: Diphenhydramine HCl 12.5 mg/5mL
Ammonium chloride 125 mg/5mL
Source of information: www.hsa.gov.sg, MIMS Singapore 109th Edition 2007
Legal Classification in Singapore:
- Pharmacy Only (Sold from any pharmacy by or under the supervision of a pharmacist)
Source of information: www.hsa.gov.sg
Approved Indication(s):
-
Control of cough and alleviation of nasal stuffiness, sneezing, lachrymation and
bronchial congestion.
Source of information: www.mims.com.sg
Therapeutic Classification:
Mechanism of Action(s):
-
Antitussive and antihistamine.
Antitussive action: Diphenhydramine acts on the medullary cough center.
Antihistamine action: Diphenhydramine, an ethanolamine antihistamine, competes
with histamine at the H1-histamine receptors of the GI tract, blood vessels and
respiratory tract.
Source of information: Handbook of Non-prescription Drugs 11th Edition, Micromedex,
Martindale 33rd Edition, www.mims.com.sg
96
Available Dosage Form(s): Syrup
Source of information: www.hsa.gov.sg
Dosing and Administration:
-
For adults, Diphenhydramine HCl is given orally in doses of 25-50mg, three or four
times daily.
For children over 1 year, the dosage is 6.25-25mg, three or four times daily or a total
daily dose of 5mg per kg of body weight given in divided doses.
The maximum dose in adults and children is about 300 mg daily.
May be taken with or without food.
Source of information: Martindale 33rd edition, MIMS Singapore 109th Edition 2007,
www.hsa.gov.sg
Side Effects / Cautions:
-
Drowsiness.
Additive sedative effect if used with CNS depressants such as alcohol, barbiturates,
hypnotics, opoid analgesics, anxiolytic sedatives, tranquilizers and antipsychotics.
May cause antimuscarinic effects such as dry mouth, thick respiratory tract secretions
and increased gastric reflux.
Additive antimuscarinic effects if used with other antimuscarinic drugs such as
monoamine oxidase inhibitors (MAOIs), atropine.
Source of information: MIMS Singapore 109th Edition 2007, Martindale 33rd Edition,
www.hsa.gov.sg
Contraindication(s):
- Patients hypersensitive to diphenhydramine or to other antihistamines
- Newborns or premature infants
- Nursing mothers
Source of information: Micromedex, www.hsa.gov.sg
97
Patient Education / Counselling Points:
-
May cause drowsiness. Do not drive or operate machinery if affected. Avoid alcohol.
Young children may experience excitation effects instead.
Do not use together with other sedating drugs (hypnotics, barbiturates) and
antimuscarinics (MAOIs).
If cough persists for more than one week, tends to recur, or is accompanied by high
fever, rash or persistent headache, consult a physician.
To be used with caution in pregnant women and nursing mothers.
Do not give to children under 1 year of age except under the advice and supervision of
a physician.
Store at room temperature.
Source of information: Martindale 33rd Edition, Micromedex, www.hsa.gov.sg
98
Student Name
Lim Yu Cai
Lim Yuan Ghee Alana
Matric Number
U084909X
U084923W
Date
23/01/2010
23/01/2010
N-ACETYLCYSTEINE EFFERVESCENT TABLETS/ GRANULES/
LOZENGES
Brand / Generic Name:
1. Fluimucil A 600 effervescent tablets
2. Fluimucil oral granules
3. Solmucol Lozenges
4. Solmucol 200 granules
5. L-Cimexyl oral granules
Generic name: N-Acetylcysteine
Proprietary name: Fluimucil A, Fluimucil, Solmucol, L-Cimexyl
Active ingredient: N-Acteylcysteine
Source of information: www.mims.com.sg
Legal Classification in Singapore: Pharmacy Only
Source of information: www.hsa.gov.sg
Approved Indication(s):
 Paracetemol poisoning
 Acute and chronic respiratory pathologies with viscous secretions including
bronchitis, laryngitis, tracheitis, flu, bronchial asthma, sinusitis and chronic
bronchopulmonary disease (COPD)
 Acute cough associated with excessive or viscous mucus
Source of information: www.mims.com.sg
Therapeutic Classification:
 Antidote
 Cough and cold preparations
 Antiasmathtic and COPD preparations
 Detoxifying agents and drugs used in substance dependence
99
Mechanism of Action(s):
Acetylcysteine, which is a mucolytic agent, may decrease the viscosity of secretions by
splitting of disulphide bonds in mucoproteins by its free sulfhydryl group. During
paracetemol overdoes, It promotes the detoxification of an intermediate paracetamol
metabolite that is formed in excessive amounts by reducing the metabolite to its parent
compound or providing sulfhydryl for conjugation of the metabolite.
Source of information: www.mims.com.sg, www.drugs.com
Available Dosage Form(s):




Effervescent tablet 600mg per tab
Granules 100mg per sachet or 200mg per sachet
Lozenges 100mg per lozenges
Capsule 200mg per capsule
Source of information: www.mims.com.sg
Dosing and Administration:
The dosings listed below are for oral administration as lozenges/ effervescent tablets/
granules after food.
FOR RESPIRATORY PATHOLOGIES AND COUGH
Adult: 200mg tid
Child: 100mg tid
FOR MUCOVISCIDOSIS
Child >6yr: 200mg tid
Child 2-6yr: 100mg tid
Child <2yr: 50mg tid
FOR PARACETAMOL POISONING
After gastric lavage or induction of emesis with ipecac syrup, administer loading dose of
140mg/kg, followed by maintenance doses of 70mg/kg every 4 hours for a total of 17
doses. Repeat dose if the patient vomits within 1 hour of administration. Continue therapy
until paracetamol levels are not detectable and there is no evidence of hepatotoxicity.
Source of information: www.mims.com.sg
100
Side Effects / Cautions:
 Side effects: Fever, stomatitis, nausea, vomiting, headache, rhinorrhoea,
bronchospasm, GI irritation, hives, drowiness and swelling of face, lips, tongue or
throat
 Precautions: Asthmatic patients, pregnancy, lactation, peptic ulceration, patients with
history of bronchospasm
Source of information: www.mims.com.sg, www.hsa.gov.sg, www.drugs.com
Contraindication(s):
 Antibiotics including penicillins and tetracyclines and metals (particularly iron, nickel
and copper)
Source of information: www.mims.com.sg
Patient Education / Counselling Points:




Do not take this drug together with other oral antibiotics.
Take this drug after food with plenty of water.
Mild nausea or vomitting may be experienced.
This drug may cause GI irritation, asthma attacks or allergic reactions like rashes,
breathlessness or ringing in the ear. Stop if you experience any of these side effects
and consult your physician immediately.
Source of information: www.mims.com.sg
101
Student Name
Ling Sok Ying
Loh Shu Yi
Matric Number
U084918H
U084892J
Date
29/1/2010
29/1/2010
AMBROXOL SYRUP/ TABLET
Brand / Generic Name: Ambroxol HCl
Proprietary name: Mucosolvan
Synonyms: Ambroxol
Active ingredient: Ambroxol HCl
Manufactured: Boehringer Ingelheim
Source of information: MIMS & Micromedex
Legal Classification in Singapore: P
Source of information: www.hsa.gov.sg
Approved Indication(s):
Secretolytic therapy in acute and chronic bronchopulmonary diseases associated with
abnormal mucus secretion and impaired mucus transport.
Source of information: MIMS
Therapeutic Classification:
Belongs to the class of mucolytics. Use to treat wet cough.
Mechanism of Action(s):
Ambroxol is an active N- desmethyl metabolite of the mucolytic bromhexin. It has been
shown to increase respiratory tract secretion. It also enhances pulmonary surfactant
production and stimulates ciliary activity. These actions result in improved mucus flow and
transport (mucociliary clearance). Enhancement of fluid secretion and mucociliary
clearance facilitates expectoration and eases cough.
Source of information: MIMS & Micromedex
Available Dosage Form(s):
Mucosolvan Tablet 30 mg
Mucosolvan Liquid 30 mg/5 ml
Source of information: www.hsa.com
102
Dosing:
Tablet: Take 1 tablet 3 times a day for adults. For better effect, can take 2 tablets 2 times a
day.
Liquid: Take 2 teaspoons (10ml) 2 times a day for adults and children above 12 years old.
Take 1 teaspoon (5ml) 2-3 times a day for children between 6-12 years old.
Administration:
Should be taken after food.
Source of information: www.hsa.com
Side Effects / Cautions:
Generally well tolerated. Side effects include nausea, diarrhoea, indigestion, vomiting and
heartburn.
Source of information: www.hsa.com
Contraindication(s):
1) Mucosolvan should not be used in patients known to be hypersensitive to
Ambroxol.
2) Patient with rare hereditary fructose intolerance should not take Mucosolvan
Liquid.
3) Patient with rare hereditary galactose intolerance, the Lapp lactase deficiency or
glucose-galactose malabsoption should not take Mucosolvan Tablet.
4) Administration of Ambroxol with antibiotics (Amoxicillin, Cefuroxime, Erythromycin,
Doxycycline) leads to higher antibiotic concentration in the lung tissue.
Source of information: MIMS & www.hsa.com
Patient Education / Counselling Points:
1) Keep in a dry place, below 30oC.
2) Sought medical advice if the symptoms last longer than 14 days and/or if the
symptoms increase in spite of treatment.
3) During pregnancy, the use of Mucosolvan in first trimester is not recommended.
4) During lactation, Mucosolvan should be used only if absolutely necessary.
5) Do not use medicine after expiry date.
6) Keep out of reach of children.
Source of information: MIMS & www.hsa.com
103
Student Name
Loo ShiLei
Magdeline Lee Xin Hui
Matric Number
U084942B
U084925U
Date
29/1/10
29/1/10
GUAIFENESIN SYRUP
Brand / Generic Name:
Generic name: Guaifenesin
Proprietary name: Breacol [syr], Cofen [100 syr], Cofen [50 syr], Decosyn [syr], Guardian
Cough [syr], Robitussin EX [syr], Wood's Peppermint Cough Syrup Adult, Wood's
Peppermint Cough Syrup Children
Active ingredient: Guaifenesin
Source of information:
1. MIMS Singapore [Internet]. [Cited 2010 Jan 21]. Available from:
www.mims.com.sg
2. Sweetnam S.C. Martindale: The Complete Drug Reference. 33rd ed. Pharmaceutical
Press; 2002. [Cited 2010 Jan 25].
Legal Classification in Singapore:
Guaifenesin is a General Sales List (GSL) medication and can be purchased without a
doctor’s prescription
Source of information:
1. Health Sciences Authority [Internet]. [Updated 2010 Jan 20; Cited 2010 Jan 29].
Available from:
http://www.hsa.gov.sg/publish/hsaportal/en/home.html
Approved Indication(s):
 Cough
 Female Infertility
 Hyperuricemia
 Abnormal amount of sputum
Source of information:
1. MICROMEDEX 2.0 [Internet]. Thomson Reuters. 1974 – 2010 [Cited 2010 Jan 25].
104
Therapeutic Classification:
Mechanism of Action(s):
Guaifenesin is reported to increase the volume and reduce the viscosity of tenacious
sputum and is used as an expectorant for productive cough
Source of information:
1. MICROMEDEX 2.0 [Internet]. Thomson Reuters. 1974 – 2010 [Cited 2010 Jan 25].
Available Dosage Form(s):
 Liquid syrup
 Immediate-release tablets
 Sustained-release tablets
Source of information:
1. MICROMEDEX 2.0 [Internet]. Thomson Reuters. 1974 – 2010 [Cited 2010 Jan 25].
Dosing and Administration:




For adults and children 12 years and older:
Recommended 2 to 4 teaspoonfuls (200 to 400 milligrams) every 4 hours, not to
exceed 24 teaspoonfuls (2400 milligrams) in 24 hours
For children 6 years to under 12 years:
Recommended 1 to 2 teaspoonfuls (100 to 200 milligrams (mg) every 4 hours, not to
exceed 12 teaspoonfuls (1200 mg) in 24 hours
For children 2 years to under 6 years:
Recommended 0.5 to 1 teaspoonful (50 to 100 mg) every 4 hours, not to exceed 6
teaspoonfuls (600 mg) in 24 hours
For children under 2 years of age:
Recommended 0.25 to 0.5 teaspoonful (25 to 50 milligrams (mg) every 4 hours, not
to exceed 3 teaspoonfuls (300 mg) in 24 hours
Source of information:
1. MICROMEDEX 2.0 [Internet]. Thomson Reuters. 1974 – 2010 [Cited 2010 Jan 25].
Side Effects:
 Gastrointestinal discomfort
 Nausea
 Vomiting
 Rash
105
 Dizziness
 Headache
Side effects are observed particularly in large doses.
Cautions:
 Take caution when used for cough accompanied by too much mucus
 Take caution when used with phenylpropanolamine in patients with hypertension,
cardiac disorders, diabetes or peripheral vascular disease, prostatic hypertrophy and
glaucoma
 Take caution when used for persistent or chronic cough
Source of information:
1. MICROMEDEX 2.0 [Internet]. Thomson Reuters. 1974 – 2010 [Cited 2010 Jan 25].
2. Sweetnam S.C. Martindale: The Complete Drug Reference. 33rd ed. Pharmaceutical
Press; 2002. [Cited 2010 Jan 25].
Contraindication(s):



Unsafe in patients with porphyria
Unsafe in patients with hypersensitivity to guaifenesin products
Should not be used together with Dextromethorphan in patients taking Monoamine
Oxidase Inhibitors (MAOI)
Source of information:
1. MICROMEDEX 2.0 [Internet]. Thomson Reuters. 1974 – 2010 [Cited 2010 Jan 25].
2. Sweetnam S.C. Martindale: The Complete Drug Reference. 33rd ed. Pharmaceutical
Press; 2002. [Cited 2010 Jan 25].
Patient Education / Counselling Points:






Drink lots of water when using the medication for maximum effectiveness
Do not use if you have allergic reactions to guaifenesin in the past
Follow the instructions on the medicine label. Do not take more or use the
medication more often than stated
Measure the amount of syrup with a marked measuring spoon, oral syringe, or
medicine cup
Store in a closed container at room temperature, away from heat, moisture, and
direct light
Do not freeze the medication
106







Keep away from children
Consult your doctor or pharmacist for instructions if you miss a dose
Consult your doctor or pharmacist before using together with any other medications
If you are pregnant or breast feeding, consult your doctor or pharmacist before
using the medication
If your cough is caused by asthma, emphysema, bronchitis or smoking, consult your
doctor before using the medication
Product may contain alcohol
Inform your doctor immediately if you experience any side effects – cough, fever,
rash, drowsiness, ongoing headache, nausea, vomiting, diarrhoea, stomach pain
Source of information:
1. MICROMEDEX 2.0 [Internet]. Thomson Reuters. 1974 – 2010 [Cited 2010 Jan 25].
107
Student Name
MICHELLE LAW MEIXIN
MAH CHOON SIONG
Matric Number
U084867A
U084949H
Date
30th Jan 2010
30th Jan 2010
DEXTROMETHORPHAN SYRUP
Brand / Generic Name: Axcel Dextromethorphan, Metophan, Robitussin Honey Cough
Generic name: Dextromethorphan HBr
Proprietary name: Axcel Dextromethorphan, Metophan, Robitussin Honey Cough
Active ingredient: Dextromethorphan HBr
Source of information: www.mims.com.sg
Legal Classification in Singapore: Pharmacy only (P)
Source of information: www.mims.com.sg, MIMS Singapore 112th Ed 2008
Approved Indication(s):
 Metophan: Suppression of cough associated w/ common cold, influenza, tracheitis,
acute bronchitis, pneumonia, pulmonary embolism, whooping cough & measles.
 Axcel Dextromethorphan and Robitussin Honey Cough: Cough suppressant.
Source of information: www.mims.com.sg
Therapeutic Classification: Respiratory - Cough and cold preparations
Mechanism of Action(s):
Dextromethorphan, a derivative of levorphanol, is an antitussive agent. It controls cough
spasm by depressing the medullary cough centre
Source of information: www.mims.com.sg, MIMS annual Singapore 2002/2003
Available Dosage Form(s): Tablet, elixir, lozenges, lintus and syrup
Source of information: www.mims.com.sg, MIMS Singapore 112th Ed 2008
Dosing and Administration:
 Oral, may be taken with or without food.
 Metophan
o Adult & child: >12 yr 5-10 mL, 6-12 yr 5 mL, 2-5 yr 2.5 mL. To be taken 6-8
108
hrly.
 Axcel Dextromethorphan and Robitussin Honey Cough
o Adult: 10-20 mg every 4 hr, or 30 mg every 6-8 hr.
 Extended-release oral suspension:
 60 mg bid.
 Max: 120 mg/day.
o Child:
 6-12 yr: 5-10 mg every 4 hr or 15 mg every 6-8 hr;
 2-6 yr: 2.5-5 mg every 4 hr or 7.5 mg every 6-8 hr;
 Up to 2 yr: Individualised dosage.
 Extended release oral suspension:
 6-12 yr: 30 mg bid;
 2-6 yr: 15 mg bid.
 Max: 6-12 yr: 60 mg/day; 2-6 yr: 30 mg/day.
Source of information: www.mims.com.sg
Side Effects / Cautions:
 Adverse effects:
o Drowsiness
o Dizziness
o Excitation
o Mental Confusion
o Gastrointestinal disturbances
 Special Precautions
o Metophan
Not recommended for:
 Liver disease
 Infants <2 yr
 Caution in childn ≥2 yr
o Axcel Dextromethorphan and Robitussin Honey Cough
Not recommended for:
 3rd trimester of pregnancy
 Atopic childn
 Child <1 yr
 Sedated or debilitated patients
 Patients confined to supine position
 History of asthma
 Moderate to severe renal impairment
 Liver disease
Source of information: www.mims.com.sg, MIMS annual Singapore 2002/2003
109
Contraindication(s):


History of intolerance to dextromethorphan
Metophan
o Asthmatic patients.
 Axcel Dextromethorphan and Robitussin Honey Cough
o Patients who have, or are at risk of developing respiratory failure.
o Persistent or chronic cough
o Patients receiving MAOI or for 2 wk after discontinuing them
Source of information
www.mims.com.sg
MIMS annual Singapore 2002/2003
Patient Education / Counselling Points:


Avoid driving or operation of machinery.
If you experience severe diarrhoea lasting for 3 or more days, please see your
physician.
 If your cough persists for 8 or more weeks, please discontinue your medication and
see your physician.
Source of information: MIMS annual Singapore 2002/2003, www.mayoclinic.com
110
Student Name
Nashirah Kamal Mustapa
Natalia Sutiman
Matric Number
U084963E
U084963E
Date
January 12, 2010
January 12, 2010
OXYMETAZOLINE NASAL SPRAY/DROP
Brand / Generic Name: Oxymetazollie Nasal Spray/Drop
Generic name: Oxymetazoline
Proprietary name: Afrin, Iliadin, Nazolin, Oxy-nase, Utabon
Active ingredient: Oxymetazoline hydrochloride
Source of information: HSA, MIMS, Micromedex
Legal Classification in Singapore: General Sale List
Source of information: HSA
Approved Indication(s):


For fast relief of stuffy noses due to head colds and hayfever
For the symptomatic relief of congestion of the upper respiratory tract due to the
common cold, hay fever and sinusitis
Source of information: MIMS
Therapeutic Classification:
Nasal decongestants
Mechanism of Action(s):
Oxymetazoline is a direct-acting sympathomimetic with marked alpha-adrenergic activity. It
is a vasoconstrictor and reduces swelling and congestion when applied to mucous
membranes.
It acts within a few minutes and the effect lasts for up to 12 hours.
Source of information: Micromedex, Martindale
Available Dosage Form(s): Nasal spray, nasal drop
Source of information: MIMS/EMC
111
Dosing and Administration:
 For adults and children above 6 years of age: 2-3 sprays or drops of 0.05%
oxymetazoline hydrochloride in each nostril twice daily for up to three days
 Administration: operation on nose
Source of information: Micromedex
Side Effects / Cautions:
 Neurologic: Headache, insomnia
 Psychiatric: Feeling nervous
 Respiratory: Nasal congestion, rebound, nasal mucosa dry, nasal stinging/burning,
sneezing
Source of information: Micromedex
Contraindication(s):
Do not use if you
 Are allergic to the active substance oxymetazoline hydrochloride or any other
adrenergic agents
 Are taking (or have taken during the last two weeks) monoamine oxidase inhibitors
(which are used in the treatment of Parkinson’s disease and depression)
 Suffer from acute heart disease or cardiac asthma
 Suffer from increased eyeball-pressure (narrow-angle glaucoma)
 Have had an operation to remove your pituitary gland
 Have inflamed skin or mucous membranes of your nostrils or have scabs in your
nose
 Have thyroid disease
 Have prostatic enlargement
Source of information: EMC
Patient Education / Counselling Points:
 Not to be administered to children under 6 years without medical advice.
 The spray should not be used in excess of the stated dosage nor for longer than
three days without medical advice.
 Talk to your doctor if you are pregnant or breastfeeding.
 If your symptoms do not go away, talk to your doctor.
 Avoid using monoamine oxidase inhibitor or tricyclic depressant therapy while
taking the drug
Source of information: Micromedex
112
Student Name
Ng Hui Ting
Ng Hui Wen
Matric Number
U084883Y
U084968M
Date
SERRATIOPEPTIDASE TABLETS
Generic name/Synonyms: Serratiopeptidase, serrapeptase,
Serrapeptasa;Serrapeptasum;Serrapeptidase;Serratia Extracellular Proteinase
Proprietary name: Danzen®, Korzen® , Serrazyme®, Sinsia® , Tolpa®
Active ingredient: Serratiopeptidase
Source of information: MIMS Singapore www.mims.com.sg
Legal Classification in Singapore: all GSL except Tolpa® (POM)
Source of information: MIMS Singapore www.mims.com.sg
Approved Indication(s):
 Inflammation after operation and traumatic injury
 Elimination of inflammatory edema and swelling in sinusitis, engorgement of breast
(during lactation), cystitis, epididymitis, pericoronitis of wisdom tooth and abscess
 Difficulty in expectoration (spitting out) of sputum (mucus or phlegm) in bronchitis,
pulmonary tuberculosis, bronchial asthma and after anaesthesia
Source of information: MIMS Singapore www.mims.com.sg
Therapeutic Classification: Anti-inflammatory Enzymes
Mechanism of Action(s):
Serrapeptase is a proteolytic enzyme derived from Serratia E-15 protease.
Anti-Inflammatory and Anti-Swelling Actions:
Serratiopeptidase improves the circulation at the inflammatory focus by breaking down
abnormal exudates and protein, and by promoting the absorption of the decomposed
products through the blood and lymphatic vessels.
Enhancing Effect on the Discharge of Sputum, Pus and Hematoma: Serratiopeptidase
accelerates the elimination of sputum, pus and hematoma by breaking down and liquefying
mucous secretions and fibrin clots.
Serratiopeptidase appears to decrease the dry weight and viscosity of nasal discharge in
patients with chronic sinusitis.
Source of information: MIMS Thailand
http://www.mims.com/Page.aspx?menuid=mng&name=Danzen+entericcoated+tab&brief=false&CTRY=TH#Actions
113
Available Dosage Form(s): Tablets
Source of information: MIMS Singapore www.mims.com.sg
Dosing and Administration:
 Available in 5mg/tab or 10 mg/tab
 1-2 tab 3 times a day
 Should be taken with food
Source of information: MIMS Singapore www.mims.com.sg
Side Effects / Cautions:
 Occasionally cause gastrointestinal disturbances such as anorexia, diarrhoea, gastric
discomfort and nausea.
 May cause rashes and pruritus (itch).
 For patients with blood coagulation abnormalities, severe hepatic and renal
disturbances or treatment with anti-coagulants, it should be given under careful
observation.
Source of information: MIMS Singapore www.mims.com.sg
MIMS Thailand http://www.mims.com/Page.aspx?menuid=mng&name=Danzen+entericcoated+tab&brief=false&CTRY=TH#Actions
Contraindication(s):
 Patients with history of hypersensitivity to ingredients of this drug.
Source of information: MIMS Thailand
http://www.mims.com/Page.aspx?menuid=mng&name=Danzen+entericcoated+tab&brief=false&CTRY=TH#Actions
Patient Education / Counselling Points:
 Take after meals.
 Store in a cool, dry place.
 If you experience any gastric discomfort, diarrhoea or nausea, please consult your
healthcare provider immediately.
 Administration should be discontinued when hypersensitivity symptoms such as
rashes or itchiness appear and consult your healthcare provider immediately.
 If you are taking anti-coagulants concurrently, precautions and special observation
have to be taken.
Source of information: MIMS Singapore www.mims.com.sg
114
Student Name
Ng Yin Shan
Ng Kian Ming Jansen
Matric Number
U084930H
U080132U
Date
27/01/10
27/01/10
TRACHISAN LOZENGES
Brand Name: Trachisan® Lozenges
Generic Name: Tyrothricin, Chlorhexidine gluconate, Lidocaine hydrochloride monohydrate
Proprietary name: Trachisan® lozenges
Active ingredient: Tyrothricin 0.5mg, Chlorhexidine gluconate 1.0mg, Lidocaine
hydrochloride monohydrate 1.0mg
Source of information: Product insert
Legal Classification in Singapore: Pharmacy only medication
Source of information: Heath Sciences Authority of Singapore (HSA) official website,
Singapore MIMS 2005 edition
Approved Indication(s):
Inflammations and infections of the oral and pharyngeal cavities (inflammations of the oral
mucosa and the gums, tonsillitis). Infections of the upper respiratory tract, sore throat,
difficulty in swallowing. Prior to surgical intervention in the oral and pharyngeal cavities
(tonsillectomy, tooth extractions).
Source of information: online MIMS (Singapore), product insert
Therapeutic Classification: Anti-bacterial, local anaesthetic
Mechanism of Action(s):
Tyrothricin and Chlorhexidine gluconate are anti-bacterial agents that exert germicidal
properties, thus effectively acting against pathogens. Lidocaine hydrochloride is a local
anaesthetic that rapidly relieves pain by preventing both the generation and conduction of
nerve impulses.
Source of information: product insert, online Micromedex
Available Dosage Form(s): Lozenges
Source of information: product insert, online Micromedex
115
Dosing and Administration:
One lozenge to be dissolved slowly in the mouth every 2 hours (unless prescribed
otherwise)
 Adult: Up to 8 lozenges per day
 Children: Up to 6 lozenges per day
The lozenges may be taken before or after food.
Source of information: product insert
Side Effects / Cautions:
 The lozenges may cause gustatory disturbances lasting up to one hour which disappears
completely afterwards
 Yellow to brownish discolouration of tongue and teeth may rarely occur, which can be
cleared by thorough oral hygiene and when medicine is discontinued
 The lozenges should not be taken for a period of time exceeding 6 weeks without a
physician’s advice
Source of information: product insert
Contraindication(s):
 Known hypersensitivity to any of the preparation’s active ingredients
Source of information: product insert, online Micromedex
Patient Education / Counselling Points:
 Symptoms should generally subside after a few days, but take the lozenges for 2-3 days
longer to ensure successful therapy
 Consult a physician if no improvement is achieved after 10 days
 Trachisan lozenges should be stored in a dry place below 25°C
 Product should not be taken after the expiry date
 Keep the medicine out of reach of children
 Use of the product is safe in pregnancy and lactation if taken as described
Source of information: product insert
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Student Name
Ng Ying Ting
Ng Yiwei
Matric Number
U084952X
U084912M
Date
28/01/2010
28/01/2010
BENZYDAMINE LOZENGES
Brand / Generic Name: DIFFLAMTM Anti-inflammatory Lozenges
Generic name: Benzydamine Hydrochloride
Proprietary name: DIFFLAMTM Lozenges
Active ingredient: Benzydamine Hydrochloride
Source of information : DIFFLAMTM lozenges product insert; Martindale-The Complete Drug
Reference
Legal Classification in Singapore: Pharmacy Only Medicine, Ist Schedule (P)
Source of information: MIMS Singapore 110th Edition 2007
Approved Indication(s):
It is used for the temporary relief of painful and inflammatory (including redness and
swelling) conditions of the oral cavity including tonsillitis, sore throat, radiation mucositis,
aphthous ulcers, post-orosurgical and periodontal procedures, pharyngitis, swelling and
inflammatory conditions.
It can be taken by diabetic patients as it is sugar free.
Source of information: DIFFLAMTM Anti-inflammatory lozenges product insert
Therapeutic Classification: Other agents for local oral treatment (A01AD02)
Mechanism of Action(s):
 Pharmacology: Benzydamine is effective against pain and oedema caused by
inflammatory conditions and also inhibits granuloma formation. The analgesic
activity of benzydamine is more pronounced against inflammatory than in noninflammatory pain and possesses anti-pyretic activity.
 Pharmacodynamics: Benzydamine inhibits the biosynthesis of prostaglandins under
certain conditions. The stabilising effect on cellular membranes may also be
involved in the mechanism of action.
 Pharmacokinetics:
 Absorption- Benzydamine is well absorbed following oral administration into
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the inflamed oral mucosa where it exerts anti-inflammatory and local
anaesthetics actions.
 Excretion- Benzydamine and its metabolites excreted largely in the urine.
Source of information : MIMS Singapore (Online)
Available Dosage Form(s): Solid dosage form-Lozenges
Source of information: DIFFLAMTM Anti-inflammatory lozenges product insert
Dosing and Administration:


Strength: 3mg/lozenge
How medicine should be administered:
Difflam Anti-inflammatory Lozenges should not be chewed. They should be slowly
dissolved in the mouth. One lozenge should be sucked slowly every one to two
hours as required up to a maximum of 12 lozenges per day. Uninterrupted
treatment should not exceed seven days.
Source of information: DIFFLAMTM Anti-inflammatory lozenges product insert
Side Effects:
Most commonly reported local reaction is oral numbness, occasional burning or stinging
sensation, dryness or thirst, tingling, warm feeling in mouth and altered sense of taste.
Systemic adverse reactions are very uncommon, consisting mainly of nausea, vomiting,
retching, gastro-intestinal disorders, dizziness, headache and drowsiness. Hypersensitivity
reactions are rare but may be associated with pruritis, rash urticaria, photodermatitis and
occasionally laryngospasm or bronchospasm.
Cautions:
Patients with impaired liver/renal function: Since absorbed benzydamine and its
metabolites are highly metabolised in the liver and excreted in the urine, the possibility of
systemic effects should be considered in patients with severe hepatic impairment and renal
impairment.
If a sore throat is either caused or complicated by bacterial infection, appropriate
antibacterial therapy should be considered in addition to the use of Difflam lozenges.
The safety of benzydamine HCl has not been established in pregnant patients.
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Due to lack of sufficient clinical experience, Difflam lozenges are not recommended for
children below 6 years old.
Source of information: DIFFLAMTM Anti-inflammatory lozenges product insert, MIMS
Singapore (Online)
Contraindication(s):
Patients with known hypersensitivity to benzydamine or any of the components of the
vehicle.
Source of information: DIFFLAMTM Anti-inflammatory lozenges product insert
Patient Education / Counselling Points:
If a sore throat is either caused or complicated by a bacterial infection, appropriate
antibacterial therapy should be considered in addition of the use of Difflam Antiinflammatory Lozenges.
Excess consumption containing isomalt (inactive ingredient) may have a laxative effect.
Difflam Anti-inflammatory Lozenges are not recommended in children under 6 years of age.
Source of information: DIFFLAMTM Anti-inflammatory lozenges product insert
119
Student Name
Ong Yong Sheng
Phar Mian Yi
Matric Number
U084858U
U084960W
Date
16/01/09
16/01/09
NAPHCON-A EYE DROP
Brand / Generic Name: Naphcon-A
Generic name: Naphazoline Ophthalmic
Proprietary name: Naphcon-A Sterile Opthalamic Solution
Active ingredient: Naphazoline HCL (0.025%), Pheniramine Maleate (0.3%)
Source of information: Health Sciences Authority
Legal Classification in Singapore: Pharmacy Only; can be obtained without a doctor’s
prescription from a pharmacy under the supervision of a pharmacist registered with the
Singapore Pharmacy Board.
Source of information: Health Sciences Authority
Approved Indication(s):
 Relief of ocular irritation &/or congestion or for the treatment of allergic or
inflammatory ocular conditions.
Source of information: MIMS
Therapeutic Classification:
 Non-specific anti-conjunctivitis preparation
Mechanism of Action(s):
 Stimulates alpha-adrenergic receptors, reducing ocular congestion and redness
(sympathomimetic).
Source of information: MIMS
Available Dosage Form(s): Solution
Source of information: Health Sciences Authority
Dosing and Administration:
 1-2 drops 3-4 hourly or less frequently as required.
Source of information: MIMS
120
Side Effects / Cautions:
Serious reactions:
 Pupillary dilation
 Increased intraocular pressure
 Punctuate epithelial keratitis
 Hyperglycemia
 Hypertension
 Arrhythmias
Common reactions:
 Mydriasis
 Increase in ocular redness
 Transient ocular stinging, irritation
 Blurred vision
 Increase in lacrimation
 Dizziness, Nausea
 Headache
Cautions:
 Caution if cardiovascular DZ
 Caution if hypertension
 Caution if hyperthyroidism
 Caution if diabetes mellitus
Source of information: MIMS
Contraindication(s):
 Narrow-angle glaucoma
 Hypersensitivity to drug/class/component
 MAO inhibitor use within 14 days
Source of information: MIMS
Patient Education / Counselling Points:
 To avoid contamination, do not touch tip of container to any surface.
 Replace cap after using.
 If solution changes color or becomes cloudy, do not use.
 Stop use and ask a doctor if you feel eye pain, changes in vision occur, redness or
irritation
of the eye(s) gets worse or lasts more than 72 hours.
 When using this product, pupils may become enlarged temporarily.
121



Do not use this product if you have heart disease, high blood pressure, narrow angle
glaucoma or trouble urinating unless directed by a physician.
Store at 20°- 25°C. Protect from light.
Use before the expiration date marked on the carton or bottle.
Source of information: DailyMed
122
Student Name
Praveena D/O Kandasamy
Pu Yu Xi
Matric Number
U084938Y
U084958R
Date
31st Jan 2010
31st Jan 2010
VIDISIC EYE GEL
Brand / Generic Name: Vidisic eye gel
Generic name: Carbomer (2 mg), cetrimide (0.1 mg Per g)
Proprietary name:
Active ingredient: Carbomer
Source of information:
http://www.12buys.com/productgroup.asp?Ptype=Generic&Pchar=S,
Legal Classification in Singapore: GSL
Source of information: MIMS online (http://www.mims.com.sg)
Approved Indication(s):
 Substitute for lacrimal fluid in deficiency of tear production, dry eye.
Source of information: http://www.pharmaoffshore.com/index.php?cPath=482
Therapeutic Classification: ophthalmological agent, ocular lubricant
Mechanism of Action(s): The active ingredient, carbomer is a polymer that can spread
quickly and adhere tightly to the mucous membrane of the cornea and conjunctiva. With its
many polar groups, it can lock moisture in the eye and form a lubricating protective film.
Source of information:
- Micromedex Healthcare Series
- MIMS (www.mims.com)
- Electronic Medicines Compendium (http://emc.medicines.org.uk/)
Available Dosage Form(s): Gel
Source of information: http://www.pharmaoffshore.com/index.php?cPath=482
Dosing and Administration:
 Adults and elderly: Apply one drop into the conjunctival sac 3-5 daily, when
123
necessary.
 Children: refer to physician
Source of information:
- MIMS (www.mims.com.sg)
- Electronic Medicines Compendium (http://emc.medicines.org.uk/)
Side Effects / Cautions:
 Prolonged usage may result in corneal irritation due to cetrimide content
 Do not use while wearing contact lenses. May cause blurring.
 Caution when driving vehicles or operating machines.
Source of information:
- Electronic Medicines Compendium (http://emc.medicines.org.uk/)
http://www.mims.com.tw/
Contraindication(s):
 Patients with allergy or hypersensitivity to carbomer (polyacrylic acid) or cetrimide
Source of information: Electronic Medicines Compendium (http://emc.medicines.org.uk/)
Patient Education / Counselling Points:
 Wash hands before applying and refrain from allowing contact between the tip of
the dropper and eye when applying.
 May experience some discomfort in the eye, sticky eyelids, blurred vision that clears
with blinking after application. Advise patient these are normal and need not worry.
 Transient blurring of vision may occur with overdose or frequent usage. If affected,
do not drive or operate machinery
 Contact lens should not be worn when applying visidic eye gel, and can only be
reinserted after 30mins
 In instances when additional ophthalmic medications are to be applied, there
should be a minimum of 5min in between and vidisic eye gel should always be the
last ophthalmic medication to be applied.
 If eye condition does not improve or go away after a week, seek medical attention
from your doctor
 Product should be stored in original packaging, in a cool dry place below 25⁰C, out
of reach from children
 Discard product 28 days after opening
Source of information: Electronic Medicines Compendium (http://emc.medicines.org.uk/)
124
Student Name
Rajalakshmi d/o Rajaram
Qiu Xinhui
Matric Number
U084915X
U084884L
Date
16th janurary 2009
16th janurary 2009
PRINCI-B FORT TABLETS
Brand / Generic Name: Princi-B Fort®
Generic name: Vitamin B Complex
Proprietary name: Princi-B Fort
Active ingredient: Vitamin B1 (thiamine mononitrate) 250 mg, Vitamin B12 (cyanocobalamin)
1,000 mcg, Vitamin B6 (pyridoxine HCl) 250 mg
Source of information: http://www.mimsonline.com
Legal Classification in Singapore:
Pharmacy Only Medicine
Source of information: http://www.mimsonline.com
Approved Indication(s):
Neurological and other disorder associated with disturbance of nerve cell metabolism in
which high dose B-complex vitamins play a role.
E.g. Polyneuritis (widespread inflammation of nerves)
Neuralgias(pain in one or more nerves) e.g. lumbalgia, trigeminal neuralgia
Shoulder-arm syndrome
herpes zoster
Cervical syndrome
Ischialgia
Metabolic & neuropathic changes due to pregnancy & oral contraceptives
Convalescence
Source of information: http://www.mimsonline.com
Therapeutic Classification:
Mechanism of Action(s):
Thiamine is involved in carbohydrate metabolism and in nerve transmission and is absorbed
from the gastrointestinal tract and widely distributed to most body tissues. It is excreted in
urine as thiamine or pyrimidine. Pyridoxine is involved in amino acid and protein
metabolism. It is converted to pyridoxic acid and excreted in the urine. Cyanocobalamin is
125
involved in the formation and metabolism of purines and pyrimidines, and in the synthesis
of nucleoproteins. It is excreted in the bile and urine.
Source of information: http://www.mimsonline.com
Available Dosage Form(s): Tablets, film coated
Source of information: http://www.mimsonline.com
Dosing and Administration:
Dose
Therapeutic Dose: 1-3 tabs daily for 7-10 days
Maintenance Dose: 1 tab daily
Administration
Princi-B Fort should be swallowed whole, during or immediately after meals.
Source of information: http://www.mimsonline.com
Side Effects / Cautions:
Allergic hypersensitivity reactions have occurred rarely following the administration of the
vitamin B12 compounds.
Source of information: http://www.mimsonline.com
Contraindication(s):
Past history of allergy to cobalamins or intolerance to vitamin B1
Source of information: http://www.mimsonline.com
Patient Education / Counselling Points:
Do not take the tablets on an empty stomach
Source of information: http://www.mimsonline.com
126
Student Name
Saw Xiao Shi
Reena Silas Patel
Matric Number
U084924H
U087751X
Date
22/1/10
22/1/10
SANGOBION CAPSULES
Brand / Generic Name: Sangobion® Capsules
Generic name:
Proprietary name: Sangobion
Active ingredient: Copper sulfate 200 mcg, Ferrous gluconate 250 mg, folic acid 1 mg,
manganese sulfate 200 mcg, sorbitol 25 mg, vit B12 7.5 mcg, vit C 50 mg
Source of information = MIMS Singapore
Legal Classification in Singapore: General Sales List (GSL)
Source of information = MIMS Singapore
Approved Indication(s):


For defiency anaemia
Prophylaxis and therapy of anaemia due to deficiency or increased requirement of
blood eg.
--In haemorrhage of traumatic or endogenous origin
--Pregnancy
--Growth
--Convalescence
--Senility
--Poor nutrition
--Blood donation
Source of information = MIMS Singapore
Therapeutic Classification: Antianemics/Pre & Post Natal Vitamins
Mechanism of Action(s): Ferrous gluconate is used as a source of iron for iron-deficiency
anaemia.
Source of information = MIMS Singapore, Martindale
127
Available Dosage Form(s): Capsule
Source of information = MIMS Singapore
Dosing and Administration:
 1-2 capsules per day, through oral route of administration
Source of information = MIMS Singapore
Side Effects / Cautions:
 May cause GI disorders
Source of information = MIMS Singapore
Contraindication(s):
 Iron accumulation
 Disorders in iron utilization
Source of information = MIMS Singapore
Patient Education / Counselling Points:
 Should be taken with food (Take during or after meals)
 May result in constipation
Source of information = MIMS Singapore
128
Student Name
See Cheng Shang
Shanavas Rusana Banu
Matric Number
U080389B
U084934A
Date
January 2010
January 2010
GINGKO BILOBA
Generic Name: Ginkgo biloba (scientific name)
Brand name / proprietary name: Giloba cap®, Gincare film-coated tab®, Ginkgo Hovid tab®,
Ginkapran tab®, Ginkosen tab®
Active ingredient: Flavonoids, biflavonoides, trilactonic diterpenes (ginkgolide A, B, C),
trilactonic sesquiterpene bilabolids.
Source of information
1. MIMS Singapore. http://www.mims.com.sg/index.aspx [Accessed 17 January 2010].
2. Thomson Healthcare. PDR for Herbal Medicines. 4th ed. Montvale, NJ: Thomson
Healthcare Inc 2007.
Legal Classification in Singapore: General Sales List
Source of information
1. MIMS Singapore 107th Edition 2006. CMPMedica United Business Media.
Approved Indication(s):
 Cerebral insufficiency
 Tinnitus
 Vertigo
 Intermittent claudication
 Dementia
Source of information
1. Thomson Healthcare. Micromedex® Healthcare Series [intranet database].
[Accessed 23 January 2010].
2. MIMS Singapore 107th Edition 2006. CMPMedica United Business Media.
Therapeutic Classification:
Nootropic (cognitive enhancing agent), antioxidant.
Mechanism of Action(s):
The active constituents bilobalide and ginkgolides increases cerebral blood flow, thereby
improving the tolerance of brain tissue to hypoxia. Blood flow to the brain is increased by
ginkgo through arterial vasodilation via stimulation of prostaglandin biosynthesis or indirect
129
stimulation of norepinephrine release. Ginkgo has also been reported to possess antiinflammatory, spasmolytic and free-radical scavenging activity.
Source of information
1. Thomson Healthcare. Micromedex® Healthcare Series [intranet database].
[Accessed 23 January 2010].
2. Memorial Sloan Kettering Cancer Center – About Herbs, Botanicals & Other
Products. http://www.mskcc.org/mskcc/html/69235.cfm [Accessed 17 January
2010].
3. University of Maryland Medical Center. Complementary and Alternative Medicine
Guide. http://www.umm.edu/altmed/articles/ginkgo-biloba-000247.htm [Accessed
17 January 2010].
Available Dosage Form(s):
Ginkgo is available in capsules, tablets, liquid extracts and dried leaf for teas.
Source of information
1. University of Maryland Medical Center. Complementary and Alternative Medicine
Guide. http://www.umm.edu/altmed/articles/ginkgo-biloba-000247.htm [Accessed
17 January 2010].
2. Thomson Healthcare. PDR for Herbal Medicines. 4th ed. Montvale, NJ: Thomson
Healthcare Inc 2007.
Dosing and Administration:
 Adults (over 18 years old)
The dose that has been used and studied is 80 to 240 milligrams of a 50:1 standardized leaf
extract (standardized to 24% to 25% ginkgo flavones glycosides and 6% terpine lactones)
taken daily by mouth in 2 to 3 divided doses.
 Children (under 18 years old)
There is insufficient scientific evidence to recommend use of ginkgo in children.
Source of information
1. MedlinePlus – Drugs & Supplements.
http://www.nlm.nih.gov/medlineplus/druginfo/natural/patient-ginkgo.html
[Accessed 17 January 2010]
130
Side Effects / Cautions:
 Common side effects include headache, diarrhoea, gastrointestinal upset,
flatulence, dizziness, contact dermatitis, and palpitations.
 For patients with bleeding disorders and patients using drugs or supplements which
may increase the risk of bleeding, caution is advised.
 Ginkgo seeds should not be eaten as they are associated with a risk of tonic-clonic
seizures and loss of consciousness.
 Use of ginkgo is not recommended during pregnancy and breastfeeding.
Source of information
1. Memorial Sloan Kettering Cancer Center – About Herbs, Botanicals & Other
Products. http://www.mskcc.org/mskcc/html/69235.cfm [Accessed 17 January
2010].
2. MedlinePlus – Drugs & Supplements.
http://www.nlm.nih.gov/medlineplus/druginfo/natural/patient-ginkgo.html
[Accessed 17 January 2010]
Contraindication(s):
 Hypersensitivity to ginkgo or any of its constituents.
 Concomitant use of aspirin or other antiplatelet medication.
Source of information
1. Thomson Healthcare. PDR for Herbal Medicines. 4th ed. Montvale, NJ: Thomson
Healthcare Inc 2007.
2. Thomson Healthcare. Micromedex® Healthcare Series [intranet database].
[Accessed 23 January 2010].
Patient Education / Counselling Points:
 Patients should be encouraged to inform their doctor and pharmacists of any
complementary and alternative practices they use.
 Patients who are allergic to ginkgo or any of its constituents should not use ginkgo.
 Patients on antiplatelet medication or aspirin should not use ginkgo.
 Patients with bleeding disorders or using any drugs or supplements which may
increase the risk of bleeding should avoid ginkgo.
 Patients should be informed of the possible side effects from the use of ginkgo.
Source of information
1. National Center for Complementary and Alternative Medicine – CAM basics.
http://nccam.nih.gov/health/decisions/talkingaboutcam.htm [Accessed 23 January
2010].
131
Student Name
Shereen Chan Shimin
Shih Shan Wei Shannon
Matric Number
U084982L
U084859E
Date
12/01/2010
12/01/2010
GLUCOSAMINE
Brand / Generic Name:
Generic name: Glucosamine sulphate
Proprietary name: Artril 250, Artronil Forte, Glutilage, Viartril-S, Vital, Donna Capsule
(Glucosamine sulphate)
Glutilage Plus , Artril C (Glucosamine sulphate 250 mg, chondroitin sulphate 200 mg)
Active ingredient: 2-Amino-2-deoxy-beta-D-glucopyranose
Source of information: MIMS Singapore, Micromedex
Legal Classification in Singapore: General Sales List
Source of information: MIMS Singapore, www.hsa.gov.sg
Approved Indication(s): . Symptomatic relief of mild to moderate osteoarthritis of the
knee, maintenance of healthy joints and cartilage
Source of information: MIMS Singapore , British National Formulary
Therapeutic Classification: Antirheumatic, Anti-inflammatory analgesics
Mechanism of Action(s):
a) Help to develop and stimulate important components, cartilage and bone tissues
b) Lubricant activity through improvement of synovial fluid viscosity and production
for better joint movement and mobility
c) Reduce joint pain. Improve joint functions and inhibit degenerative processes.
Source of information: MIMS Singapore, Micomedex
Available Dosage Form(s): Capsule, Sachets
Source of information: MIMS Singapore
132
Dosing and Administration:
ADULTS (over 18 years) 1.25 g once daily
2 capsules twice daily for at least 6 weeks.
Taken with food, preferably at meals.
Source of information: MIMS Singapore, Product Insert
Side Effects/Cautions: Epigastric tenderness, heartburn, diarrhea and nausea.
Source of information: MIMS Singapore, British National Formulary
Contraindication(s): Contraindicated in patients hypersensitive to glucosamine, or with
shellfish allergy.
Source of information: MIMS Singapore, British National Formulary
Patient Education/Counselling Points:
a) Product should be taken for at least 6 weeks for any positive benefits to be
observed. Review treatment if no benefit observed after 2-3 months.
b) If you are a pregnant or breastfeeding mother, please seek a physician’s advice
before using product.
Source of information: British National Formulary
133
Student Name
Siti Nurhana Bte Abdul Karim
Soh Huimin
Matric Number
U084941N
U087747W
Date
29th Jan 10
29th jan 10
FOLIC ACID TABLETS
Brand / Generic Name: Folic Acid Tablet
Generic name: Folic Acid
Proprietary name: Folacin-800® Schering Plough, Folic Acid® Watson Pharmceuticals, Folic
Acid Beacons®, Folic Acid DHA®
Active ingredient: Folic Acid 0.8 mg, Folic Acid 1 mg. Folic Acid 5 mg
Synonyms: B complex vitamin, folacin, folate, pteroylglutamic acid, pteroylmonoglutamic
acid, pteroylpolyglutamate, vitamin B9, vitamin M
Source of information: Medline Plus, www.drugs.com, medicines.org.uk
Legal Classification in Singapore: General Sales List (GSL)
Source of information: MIMS Singapore
Approved Indication(s):
 Treatment of megaloblastic anaemia due to folic acid deficiency
 Prophylaxis of megaloblastic anaemia in pregnancy
 Prophylaxis of neural tube defect in pregnancy
 As a supplement for women of child-bearing potential
Source of information: medicines.org.uk, MIMS Singapore
Therapeutic Classification: Antianemics/ Pre & Post Natal Vitamins
Mechanism of Action(s):
Folic acid is necessary for the formation of a number of coenzymes in many metabolic
systems and important in the maintenance of erythropoiesis.
It also stimulates white blood cells and platelet production in folic acid-deficiency anaemia.
Source of information: MIMS Singapore, Micromedex
Available Dosage Form(s): Tablets (oral-most common, sublingual), capsules, injections,
solution.
Source of information: www.drugs.com
Dosing and Administration: Depends on indication the drug is used for. All tablets taken
134
orally, with or without food.
 Treatment of megaloblastic anaemia: 5mg daily for 4 months, up to 15mg daily in
malabsorption states.
 Prevention of anaemia in pregnancy: 0.2-0.5mg daily
 Prevention of neural tube defect in pregnancy: 4-5mg daily starting pregnancy and
continued through the first trimester.
 Supplement for women of child-bearing potential: 0.4mg daily.
Source of information MIMS Singapore
Side Effects / Cautions / Relative Contraindications:
 Folic Acid is generally well-tolerated in recommended doses. Gastric disturbances
and hypersensitivity reactions are reported rarely.
 Treatment resistance may occur in patients with depressed haematopoiesis,
alcoholism, deficiencies of other vitamins.
 High doses mask anaemia in patients with vitamin B12 deficiency and lead to serious
neurological damage.
 Folic acid should never be given alone of with inadequate amounts of vitamin B 12.
 Possible interactions with some anti-epileptic drugs, oral contraceptives and folic
acid antagonists.
Source of information: Folic Acid Product Insert, Martindale
Absolute Contraindication(s):
 Undiagnosed megaloblastic anaemia; pernicious, aplastic or normocytic anaemias.
Source of information: Medline Plus
Patient Education / Counselling Points:
 Follow the dosing instructions closely. If you miss a dose, take it as soon as possible.
If it is almost time for your next dose, skip the missed dose and go back to your
regular dosing schedule. Do not double-dose.
 Check any other vitamin products you may be taking for folic acid content. Tell your
doctor or pharmacist if you are taking any other medicines or supplements.
 Inform your doctor if you are planning to get pregnant before continuing on the
usual dosage.
 Do not take alcohol when under this medication.
 Remember to watch out for any allergic reactions such as rashes, sore eyes or lips.
 Store medication in a cool, dry place and away from light.
 Keep medication out of the reach of children.
Source of information: Medline Plus
135
Student Name
Stephanie Lee Shi Hui
Tan Huei Zhen Sarah
Matric Number
U084869B
U084911B
Date
31 Jan 2010
31 Jan 2010
ASCORBIC ACID TABLET
Brand / Generic Name: Ascorbic Acid Tablet
Generic name: Ascorbic Acid Tablet
Proprietary name: Redoxon (by Bayer), Sunkist Vitamin C (by Novartis), Cebion (by Merck),
Cecon (by Abbott), Celin (by GSK)
Active ingredient: Ascorbic Acid
Source of information: Wikipedia, MIMS Singapore
Legal Classification in Singapore: General Sales Only – GSL
Source of information: Health Sciences Authority of Singapore
Approved Indication(s):
 For the prevention and treatment of scurvy (vitamin C deficiency)
 Adjunct in treatment of wounds and infections
Source of information: MIMS Singapore,
http://xpil.medicines.org.uk/viewpil.aspx?docid=18032
Therapeutic Classification: Vitamins / Dietary supplements
Mechanism of Action(s):
Ascorbic acid is a functional and principal in vivo form of vitamin C, an essential watersoluble vitamin which is fundamental in the synthesis of collagen and intercellular
materials. Ascorbic acid is readily absorbed from the gastrointestinal tract and is widely
distributed in the body tissues. Plasma concentration of ascorbic acid rises as the dose
ingested is increased until a plateau is reached with doses of about 90 to 150mg daily.
Ascorbic acid is reversibly oxidised to dehydroascorbic acid ; some is metabolised to
ascorbate-2-sulfate, which is inactive, oxalic acid which are excreted in the urine. Ascorbic
acid in excess of the body’s needs is also rapidly eliminated unchanged in the urine.
Source of information: Martindale (33rd edition)
136
Available Dosage Form(s):
 Tablets (chewable tablet and effervescent tablet)
 Lozenges
 Extended-release tablet form
 Extended-release capsule form
Source of information: Martindale (33rd edition),
http://www.inchem.org/documents/pims/pharm/ascorbic.htm, MIMS Singapore
Dosing and Administration:
Oral administration
 Per effervescent tablet: Vit C 1000 mg
 Per chewable tablet: Vit C 500 mg
 Per sustained release capsule: Vit C 500 mg
 Per kids chewable tablet: Vit C 100 mg
 Effervescent tab Adult 1 tab daily. Children 6-12 yr 1/2 tab daily. Tablet to be
dissolved in 1 glass of water before administering orally.
 Chewable tab Adult 2 tab daily. Children 6-12 yr 1 tab daily. Tablet to be sucked or
chewed slowly in the mouth.
 Sustained release cap or tab Adult 1-2 cap or tab daily. Capsule or tablet to be
swallowed whole.
 Kids chewable tab 1-5 tab daily.
May be taken with or without food. (Best taken at least 1 hr before or 2 hr after meals. May
be taken with meals to reduce GI discomfort.)
Source(s) of information: Martindale (33rd edition), MIMS Singapore
Side Effects / Cautions:
 Can cause allergic-type reactions including anaphylactic symptoms and
bronchospasm in susceptible people, especially those with a history of asthma or
allergy.
 Diarrhea, GI disturbances. Serious side effects may include painful urination,
pink/bloody urine. Very serious allergic reactions such as rash, itching/swelling,
severe dizziness, difficulty in breathing are rare.
 May cause acidification of the urine; precipitation of urate, cystine or oxalate stones,
or drugs in the urinary tract.
 Large doses of ascorbic acid may give false negative tests in enzyme dip tests for
137

glycosuria and false positive tests when Benedict's Solution is used as a test for
glycosuria (excretion of glucose in urine).
Drug interactions: Deferroxamine, hormonal contraceptives, flufenazine, warfarin,
elemental iron, salicylates, warfarin, fluphenazine, disulfiram, mexiletine, vitamin
B12.
Source of information: http://xpil.medicines.org.uk/viewpil.aspx?docid=18032, MIMS
Singapore
Contraindication(s):
 Ascorbic acid is contraindicated in patients with hyperoxaluria (excessive urinary
excretion of oxalate) and G6PD deficiency.
 Haemochromatosis (iron overload).
 Diabetics.
 Patients prone to recurrent renal calculi (kidney stones).
 Neonates; pregnancy (Ingestion of large doses has resulted in scurvy in neonates);
lactation.
 In the presence of these circumstances, ascorbic acid tablets should be
administered with caution.
Source of information: Martindale (33rd edition), MIMS Singapore
Patient Education / Counselling Points:
 This product is not a substitute for a proper diet. It is best to get your vitamins from
healthy foods. Ascorbic acid is commonly found in citrus fruit (such as oranges),
tomatoes, brussels sprouts, cauliflower, and broccoli, among others.
 If you miss a dose, take it as soon as you remember. If it is near the time of the next
dose, skip the missed dose and resume your usual dosing schedule. Do not double
the dose to catch up.
 Store the product in a cool, dry place, in an airtight container. Store product away
from light.
Source of information: MIMS Singapore
138
Student Name
Tan Kiat Yun
Tan Kai Lin
Matric Number
U084917W
U084943M
Date
CALTRATE PLUS TABLET
Brand / Generic Name: Caltrate Plus Tablet
Proprietary name: Ca-C (Novartis OTC, Singapore), Calcium-D (Beacons, Singapore),
Calcium-Sandoz (Novartis OTC, Singapore) , Cal-Sup (iNova, Singapore), Caltrate + Soy
(Wyeth Consumer, Singapore)
Active ingredients: Ca carbonate [1,500 mg], Vitamin D [200 iu], Magnesium [50 mg], Zinc
[7.5 mg], Copper [1 mg], Manganese [1.8 mg]
Source of information: MIMS Singapore
Legal Classification in Singapore: GSL
Source of information: MIMS Singapore
Approved Indication(s):
Calcium supplement for calcium deficiency and conditions that require increased calcium
intake (e.g osteoporosis, osteomalacia). Can also be used to promote good menopausal
health.
Source of information: MIMS Singapore
Therapeutic Classification: Calcium Supplement
Mechanism of Action(s):
 Calcium supplement with vitamin D and minerals.
 Calcium Plus provides a concentrated form of calcium, formulated for optimal
absorption.
 Vitamin D helps in the absorption of calcium.
 Magnesium is necessary for strong teeth and bones.
 Zinc, copper and manganese are essential for skeletal development and repair.
Source of information: Product Insert (Caltrate plus)
139
Available Dosage Form(s): Tablets, chewable tablet
Source of information: MIMS Singapore
Dosing and Administration:
 1-2 tab daily.
 Should be taken with food
Source of information: Product insert (Caltrate plus)
Side Effects:



Overdosing of Caltrate plus tablets will cause hypercalcemia, which is characterized
by nausea, vomiting, decreased appetite, abdominal pain and dry mouth.
Severe hypercalcemia may cause confusion, delirium, stupor and coma
Calcium enhances the effect of cardiac glycosides on the heart and may precipitate
arrhythmias
Cautions:



Impaired renal function, history of renal calculi
Decreased absorption of tetracycline and quinolone antibiotics
Corticosteroids inhibits absorption of Calcium
Source of information:
o http://www.medicinenet.com/calcium_carbonate/article.htm
o Martindale - The Complete Drug Reference
o MIMS Singapore
Contraindication(s): Hypercalcaemia & hypercalciuria; severe renal failure
Source of information: MIMS Singapore
Patient Education / Counselling Points:





To increase calcium level through dietary sources: milk and other dairy products.
Take food that is rich in vitamin D (margarine and egg) as vitamin D can increase
absorption of calcium.
Do weight bearing exercise to improve bone health
May cause GI symptoms such as: bloating, flatulence, constipation and nausea.
Not common but serious adverse effects include: anorexia, hypercalcemia, kidney
stones.
140

Consult doctor before use, if patient is pregnant, nursing or taking medication, as
with any supplement.
Source of information:
o Handbook of Non-prescription drugs 10th edition Page 301
o Micromedex – Drug Information in Lay Language (Volume II)
o http://www.caltrate.com/products/caltrate600dplus_lbl.asp
141
Student Name
Tan Qiu Xuan Eve
Tan Wee Pin
Matric Number
U087745X
U084855J
Date
29/01/2010
29/01/2010
DAFLON TABLET
Brand name: Daflon 500mg tablet
Generic name/ Synonyms: Diosmin, Hesperidin
Proprietary name: Daflon, Duo-CVP, Bo-Gum
Active ingredient: Diosmin, Hesperidin
Source of information: Martindale
Legal Classification in Singapore: General Sale List (GSL)
Source of information: www.hsa.gov.sg
Approved Indication(s):
 For the treatment of organic and functional chronic venous insufficiency of the
lower limbs with these symptoms:
- Swollen legs
- Pain
- Nocturnal cramps
 For the treatment of chronic haemorrhoids and acute hemorrhoidal attacks.
Source of information: www.hsa.gov.sg
Therapeutic Classification:
 Belongs to the class of bioflavanoids used as capillary stabilising agents.
Mechanism of Action(s):
 Daflon 500mg is a vascular protector which increases resistance in small blood
vessels and venous tone.
 1t reduces venous distensibility and venous stasis.
 In the microcirculation, it normalizes capillary permeability and reinforces capillary
resistance.
Source of information: www.hsa.gov.sg, Martindale
Available Dosage Form(s): Tablet
Source of information: www.hsa.gov.sg
142
Dosing and Administration:
 Usual dose in chronic conditions:
-2 tablets daily in two divided doses morning and evening at mealtimes.
 In acute hemorrhoidal attacks:
-6 tablets daily (in 3 divided doses) for 3 to 4 days, then 4 tablets daily for 3 days (in
2 divided doses), 2 tablets thereafter
 Should be taken with food
Source of information: www.hsa.gov.sg , MIMS Singapore
Side Effects / Cautions:
 Minor gastric disorders and neurovegetative disorders (feeling of discomfort)
Source of information: www.hsa.gov.sg
Contraindication(s):
 Nil
Source of information: www.hsa.gov.sg, MIMS Singapore
Patient Education / Counselling Points:


Store medication in a cool, dry place
If you are pregnant or breast feeding, you should ask your doctor or pharmacist for
advice before using the medication.
Source of information: www.hsa.gov.sg, MIMS Singapore
143
Student Name
Tan Wei Yan Cheryl
Tan Weilin Rachel
Matric Number
U084878L
U084916J
Date
31/1/10
31/1/10
FAMOTIDINE TABLET
Brand / Generic Name: Famotidine Tablet
Generic name: Famotidine
Proprietary name: Pepcidine tab® (Merck Sharp & Dohme) , Pepcid® (Johnson & Johnson)
Active ingredient: Famotidine
Source of information: MedicineNet (http://www.medicinenet.com/famotidine/article.htm)
Legal Classification in Singapore: P (pharmacy-only)
Source of information: Health Sciences Authority of Singapore (www.hsa.gov.sg)
Approved Indication(s):
 Benign duodenal and gastric ulcers
 hyper-secretory conditions eg Zollinger-Ellison syndrome
 prevention of relapse of duodenal or benign gastric ulcer
 Symptomatic relief of GERD (Gastro-Oesophageal Reflux)
 Healing & prophylactic treatment of oesophageal erosion or ulceration associated
with GERD
Source of information: MIMS (www.mims.com.sg)
Martindale 33rd edition. The complete drug reference
Therapeutic Classification: Antacids, Antireflux Agents & Antiulcerants

Belongs to the class of H2-receptor antagonists.
Mechanism of Action(s):
- Famotidine, a H2-antagonist, inhibits gastric acid secretion by competitively blocking
H2-receptors on parietal cells, thus healing gastric and duodenal ulcers.
- It suppresses nocturnal and basal gastric acid secretion and meal-stimulated acid
secretion.
- It also inhibits acid secretion stimulated by acetylcholine and gastrin receptors on
144
-
the parietal cell, calcium, and other stimuli.
By inhibiting gastric acid secretion, H2-antagonists increase gastric pH and
subsequently inhibit pepsin activity.
Source of Information: British National Formulary (March 1998)
Handbook of Non-Prescription Drugs
Available Dosage Form(s): 20 mg & 40 mg film-coated tablets
Source of Information: Health Sciences Authority of Singapore (www.hsa.gov.sg)
Dosing and Administration:
 Duodenal or benign gastric ulcer Initial daily oral dose: 40 mg at night for up to 4-8
wk. Maintenance: 20 mg at night to prevent recurrence of duodenal ulcer.
 Zollinger-Ellison syndrome Initially 20 mg 6 hrly. Max: 800 mg daily.
 GERD Symptomatic relief: 20 mg bd.
 Treatment of oesophageal erosion or ulceration associated w/ GERD 40 mg bd.
Maintenance: 20 mg bd.
 May be taken with or without food. Not significantly affected by presence of food
Source of information: MIMS (www.mims.com.sg)
Caution:
- Gastric neoplasm
- Renal and liver dysfunction
- Pregnancy and breastfeeding
Side Effects:
- Diarrhea and other gastrointestinal disturbances
- Dizziness
- Tiredness
- Headache
- Rashes
- Reversible confusional states
- Altered liver function
Source of Information: MIMS (www.mims.com.sg)
British National Formulary (March 1998)
Martindale 33rd Edition
145
Contraindication(s):
- Famotidine acts as a H2-receptor antagonist, which alters the gastric pH and hence
may affect the absorption of some other drugs.
-
Not to be administered to patients with history of hypersensitivity to other H2receptor antagonists.
-
Avoid taking Probenecid, which inhibits renal secretion of famotidine and reduces
renal clearance of famotidine.
-
Avoid taking antacids, or take them at least 1 hour before or 2 hours after taking
Famotidine to avoid reduction in famotidine absorption.
Source of information: MIMS (www.mims.com.sg)
Martindale 33rd Edition
Patient Education / Counselling Points:
- Alert doctor if pregnant or breastfeeding or have liver or kidney disease. Do not
breastfeed while consuming Famotidine.
-
You should not use this medication if you are allergic to famotidine or ranitidine
(Zantac), cimetidine (Tagamet), or nizatidine (Axid).
Before consumption of Famotidine, inform your doctor if you have kidney or liver
disease, stomach cancer or other problems, or asthma, COPD, or other breathing
problems.
-
May cause dizziness.
If dizzy, do not drive or take part in any activities which require alertness.
-
Avoid alcohol.
-
May cause reversible confusional states in the elderly and the severely ill, such as
those with renal failure.
Source of information: MIMS (www.mims.com.sg)
Martindale 33rd Edition
Drugs.com ( http://www.drugs.com/famotidine.html)
146
Student Name
Tan Xing Yu
Tan Yen Yen
Matric Number
U084897R
U084955H
Date
31 Jan 2010
31 Jan 2010
SIMETHICONE
Brand / Generic Name:
Generic name: Simethicone
Proprietary name: Infacol emulsion®, RidWind baby drops®, Simcone chewable tab®
Active ingredient: Simethicone
Source of information: MIMS, British Pharmacopeia
Legal Classification in Singapore: General Sales List (GSL)
Source of information: www.hsa.gov.sg
Approved Indication(s):
 Relief of flatulence and infant colic
Source of information: MIMS
Therapeutic Classification: GIT Regulators, Antiflatulents & Anti-inflammatories
Mechanism of Action(s):
Simethicone lowers surface tension and facilitates gas dispersion by causing coalescence
of gas bubbles in the gastro-intestinal tract, thus helping in their dispersion.
Source of information: MIMS
Available Dosage Form(s):
Tablets, chewable tablets, capsules, softgel and liquid.
Source of information: Electronic U.S. National Library of Medicines
Dosing and Administration:
 Adult: Take 100-250 mg three to four times daily as when needed. Child: Take
20-40 mg with feeds (for example, milk).
147


Chewable tablets should be chewed thoroughly before being swallowed; do not
swallow them whole.
For best results, it can be taken after meals and at bedtime.
Source of information: MIMS
Side Effects / Cautions:
 Simethicone is physiologically inert and is unabsorbed in the gastrointestinal
tract after oral administration. Therefore, there are usually no side effects.
 Effects of Simethicone are reduced by antacids.
Source of information: MIMS
Contraindication(s):
 Due to the inert nature of the drug, there is usually no contraindication present.
Source of information: MIMS
Patient Education / Counselling Points:
 Keep the medication in an airtight container, and keep it out of reach of children.
 Store it at room temperature (at 15-30oC).
 Throw away the medication when expired.
 If you missed a dose, you can take it as soon you remember it. However, if it is
almost time for the next dose, skip the missed dose and continue your regular
dosing schedule. Do not take a double dose to make up for a missed one.
Source of information: Electronic U.S. National Library of Medicines, MIMS
148
Student Name
TANG ZHI XIONG IMMANUEL
THAM YU SHENG
Matric Number
U080052M
U087746J
Date
GAVISCON LIQUID/TABLET
Brand / Generic Name:
 Gaviscon liqd®
Per 10 mL liqd: Na alginate 500 mg, Na bicarbonate 267 mg, Ca carbonate 160 mg

Gaviscon tab®
Per tab: Alginic acid 500 mg, Na bicarbonate 170 mg, dried Al(OH)3 gel 100 mg, Mg
trisilicate 25 mg
Source of information: www.mims.com
Legal Classification in Singapore: General Sales List
Source of information: www.hsa.gov.sg
Approved Indication(s):
Treatment of symptoms of gastro-oesophageal reflux such as acid regurgitation, heartburn
and indigestion related to reflux
Source of information: www.mims.com
Therapeutic Classification:


MIMS Class - Antacids, Antireflux Agents & Antiulcerants
ATC - A02BX (Other drugs for peptic ulcer and gastro-oesophageal reflux disease)
Mechanism of Action(s):
 Na alginate / Alginic acid and bicarbonate creates a physical foam barrier or "raft" that
floats on the stomach contents after it has made contact with the stomach acid . This
raft protects the food pipe from the attack of acid.
 Na bicarbonate, Ca carbonate, Na bicarbonate, Aluminum hydroxide, Mg trisilicate
neutralises gastric acid to provide fast relief from indigestion and heartburn.
Source of information
149
http://en.wikipedia.org/wiki/Anatomical_Therapeutic_Chemical_Classification_System
www.rxmed.com
www.mhra.gov.uk
www.mims.com
Available Dosage Form(s): Suspension, Tablets
Source of information: www.mims.com
Dosing and Administration:

Tablet: Adults and Children >12 years: 1 or 2 tabs. Children <12 years: 1 tab. To be taken
after meals and before retiring or as prescribed by the doctor. Tablets should be
chewed thoroughly and swallowed when they become sticky. This may be followed by a
drink of water if desired.

Liquid: Shake well before use. Adults and Children >12 years: 10-20 mL (2-4.5
spoonfuls). Children 6-12 years: 5-10 mL (1-2.5 spoonfuls). <6 years: Seek for doctor's
advice. To be taken after meals and at bedtime.
Source of information: www.mims.com
Side Effects / Cautions:






Diarrhoea, constipation, loss of appetite, a bloated feeling & stomach cramps may occur
Patients with sodium (salt) restriction diet
Patients with Heart failure & renal dysfunction
Medication should be taken 2 hours after taking any oral drug especially antibiotics and
meals
Medication should not be used with other antacids that contain simethicone in the
formulation as the simethicone will cause bubbles of the foam to coalesce rendering
the drug ineffective
Can be taken if pregnant or breastfeeding
Source of information: www.mims.com, Pray W. Non-prescription Drug Therapeutics,
Lippincott Williams and Wilkins
150
Contraindication(s):
 Patients allergic to any of the components
Source of information: www.mims.com
Patient Education / Counselling Points:






Do not take medication for longer than 2 weeks or in larger than recommended
doses unless directed by doctor.
Tablet should be chewed thoroughly and swallowed with a glass of water to allow
foam to form fully
Tablet should be taken in an upright position where alginates can exert its effect
more readily.
Shake the oral liquid well so that it is thoroughly mixed
Store the medications in a cool and dry place ( below 30°C)
Consult a physician if symptoms persist after 2 weeks of medication usage.
Source of information: Pray W. Non-prescription Drug Therapeutics, Lippincott Williams
and Wilkins, www.mims.com
151
Student Name
Thurga Devi Balasubramanian
Tran Anh Nhi
Matric Number
U084977X
U087753W
Date
23/01/2010
23/01/2010
ENZYPLEX TABLET
Brand / Generic Name:
Generic name: Proprietary name: Enzyplex ®
Active ingredient: Amylase, protease, lipase, vitamin B substances (B1,B2,B6, B12)
desoxycholic acid, dimethylpolysiloxane, calcium pantothenate, niacinamide
Source of information: http://www.mims.com.sg
Legal Classification in Singapore: General Sales List(GSL)
Source of information: http://www.mims.com.sg
Approved Indication(s): Digestive disorders manifested by excessive gas, bloating, food
intolerance, belching, flatulence, abdominal discomfort and nervous indigestion
Source of information: http://www.mims.com.sg and product insert.
Therapeutic Classification: Digestives
Mechanism of Action(s): Enzyplex® increases the level of digestive enzymes in the stomach
and gut to digest food more efficiently. Amylase breaks down carbohydrates, lipase breaks
down fats and protease breaks down proteins. Dimethylpolysiloxane drives gas away from
the stomach. Desoxycholic acid breaks down the fat before being digested by lipase.
Vitamin B complex is to help in enhancing digestive process and metabolism.
Source of information: http://www.mims.com.sg and product insert.
Available Dosage Form: Enteric-film coated tablet
Source of information: product insert
152
Dosing and Administration: Adults to take 1 to 2 tablets orally. Tablets should be taken 3
times daily with or after meals
Source of information: MIMS Singapore (2005 edition) and product insert.
Side Effects / Cautions:
Side effects: Gastric pain (due to Vitamin B complex)
Cautions: Caution should be observed with patients who have a history of hypersensitivity
reactions and those with obstruction of the bile ducts.
Source of information: pharmacist (Guardian, Singapore) and product insert
Contraindication(s): Patients who cannot tolerate animals’ protein, patient with acute or
chronic pancreatitis. Drug can't be used together with tetracycline because tetracycline
and dimethylpolysiloxane will interact
Source of information: http://www.mims.com.vn and pharmacist (Guardian, Singapore)
Patient Education / Counselling Points:





Do not exceed the stated dose
For the first 24 hours, drink plenty of caffeine-free clear liquids. During the next 24
hours, bland food such as porridge, bread, cooked cereal and crackers may be taken
Keep out of reach of children
Store in cool and dry place, in air tight container, away from heat and direct sunlight
If the symptoms persist, consult your doctor
Source of information: http://www.nuh.com.sg and product insert
153
Student Name
Valerie Ng Yun Ting
Viki Tay Wei Qi
Matric Number
U084887W
U084903A
Date
ATROPINE/DIPHENOXYLATE TABLETS
Brand / Generic Name:
Generic name: Diphenoxylate Hydrochloride/Atropine Sulphate
Proprietary name: Beamotil®, Dhamotil®
Active ingredients: Diphenoxylate HCl, Atropine Sulphate
Source of information MIMS.com
Legal Classification in Singapore: Pharmacy Only Medicine (POM)
Source of information MIMS.com
Approved Indication(s):
 Acute and Chronic Diarrhoea
Source of information MIMS.com
Therapeutic Classification: Anti-diarrheals
Mechanism of Action(s): Acts on the smooth muscle of the gastrointestinal tract to reduce
intestinal motility and excessive GI propulsion.
Source of information MIMS.com
Available Dosage Form(s): Tablet and Oral Solution
Source of information Micromedex, MIMS.com
Dosing and Administration:
 Oral administration
 May be taken with or without food
 Initial dose for adults is 10 mg , followed by 5 mg every 6 hours
 Dose for children over 12 years is 5 mg 3 times daily, 9 to 12 years is 2.5 mg 4 times
daily and 4 to 8 years is 2.5 mg 3 times daily
 Maximum dose is 20 mg/day
154
Source of information MIMS.com
Side Effects / Cautions:
 Abdominal discomfort, nausea and vomiting, numbness of extremities, allergic
reactions. May experience euphoria.
Source of information MIMS.com, Micromedex
Contraindication(s):
 Infants and children under the age of 4 years
 Obstructive jaundice
 Diarrhoea associated with pseudomembranous colitis or enterotoxin-producing
bacteria
Source of information Martindale, MIMS.com
Patient Education / Counselling Points:








You should not use this medicine more often or in larger doses than your doctor
ordered.
Do not use in subsequent diarrheal episodes without healthcare professional
approval.
Inform your doctor before taking if you are pregnant, breastfeeding, or have liver or
kidney disease, colitis, or other medical problems.
This medicine may cause drowsiness. Be careful if you drive a car or use machinery.
Inform your doctor if you experience any of the following: abdominal discomfort,
nausea, vomiting, dizziness, headache, trouble urinating, dehydration.
Store at room temperature, away from heat, moisture, and direct light. Do not
freeze the oral liquid.
Patient should avoid using MAO inhibitors or additional CNS depressants.
Discontinue use if no clinical improvement is noted after 10 days of continuous
usage at 20 mg/day.
Source of information Micromedex
155
Student Name
Wang Xiaojie
Wee Zhen Yang
Matric Number
U084906M
U080343X
Date
30 Jan 2010
30 Jan 2010
LOPERAMIDE TABLET
Brand / Generic Name: Imodium / Loperamide
Generic Name: Loperamide
Proprietary name: Imodium
Active ingredient: Loperamide Hydrochloride
Source of information www.mims.com.sg, Micromedex Healthcare Series,
http://www.hsa.gov.sg/publish/hsaportal/en/home.html
Legal Classification in Singapore: Pharmacy only Medicine
Source of information www.mims.com.sg
Approved Indication(s): Diarrhoeal
Loperamide is used in the control and symptomatic relief of acute and chronic diarrhoea
associated with inflammatory bowel disease.
Source of information www.mims.com.sg, American Hospital Formulary Service,
Micromedex Healthcare Series
Therapeutic Classification: Belongs to the class of antipropulsives. Used in the treatment of
diarrhoea.
Mechanism of Action(s): Loperamide binds to the intestinal wall muscles receptors and
inhibit the release of prostaglandins and acetylcholine, resulting in a reduction in peristalsis
and increase in transit time. This reduces the faecal volume and increases its viscosity,
resulting in less fluid and electrolyte loss.
Source of information www.mims.com.sg
Available Dosage Form(s):
Loperamide is available in the form of 2mg tablets, 2mg capsules and 1mg/5ml syrup.
Source of information www.mims.com.sg
156
Dosing and Administration:
May be taken with or without food.
For Acute diarrhoea
Adult: Initially, 4 mg followed by 2 mg after each loose stool. Usual dose: 6-8 mg daily. As
oxide: Initially, 2-4 mg followed by 1 mg after each loose stool. Max dose as hydrochloride:
16 mg daily; as oxide: 8 mg daily.
Child: 4-8 yr: 1 mg 3 or 4 times daily for up to 3 days; 9-12 yr: 2 mg 4 times daily for up to 5
days.
For Chronic diarrhoea – Irritable Bowel Syndrome
Adult: Initially, 4-8 mg daily in divided doses, adjusted if necessary. Max: 16 mg daily;
discontinue if no improvement at this dose after 10 days.
Child: Treatment in children is generally not recommended.
Source of information www.mims.com.sg, Micromedex Healthcare Series
Side Effects / Cautions:
- constipation
- hyperglycemia
- abdominal pain
- drowsiness
- fatigue
- nausea
- stomach cramps
- loss of appetite
- dry mouth
- bloating
- changes in vision, such as trouble focusing
Loperamide should be used with caution in patients with hepatic impairment because of
reduced first pass metabolism and so the drug may reach systemic circulation. Loperamide
should not be used in children below age of 6 years due to risk of paralytic ileus and
depression of CNS.
Source of information http://emc.medicines.org.uk, Micromedex Healthcare Series
157
Contraindication(s):
Loperamide should not be used in patients with:
• abdominal pain in the absence of diarrhoea
• acute dysentery
• hypersensitivity to loperamide or to any of the excipients
• Infants below 24 months of age
Loperamide should also not be used when inhibition of peristalsis is to be avoided due to
the possible risk of significant sequelae including ileus, megacolon and toxic megacolon, in
particular:
• when ileus or constipation are present or when abdominal distension develops,
particularly in severely dehydrated children
• in patients with acute ulcerative colitis
• in patients with bacterial enterocolitis caused by invasive organisms including
Salmonella, Shigella, and Campylobacter
• in patients with pseudomembranous colitis associated with the use of broadspectrum antibiotics
Source of information http://emc.medicines.org.uk, Micromedex Healthcare Series
Patient Education / Counselling Points:
 Adequate hydration should be maintained during treatment
 Loperamide may cause drowsiness in some people, therefore exercise caution
when you are driving or dealing with heavy machineries
 Loperamide may cause nausea, vomiting, dizziness or fatigue.
 Stop consumption when you abdominal pain, distention, and discomfort;
constipation, dizziness or rash
 AIDS patients are to stop therapy and inform doctor immediately at the first sign
of abdominal distention
 Do not consume loperamide if you are pregnant or breast-feeding
 Discontinue use if no clinical improvement is observed within 48 hours in
patients and inform your doctor
 Store medication in air-tight containers at room temperature, away from heat
and moisture
 Keep all medicine out of the reach of children
Source of information http://emc.medicines.org.uk, Micromedex Healthcare Series
158
Student Name
Wong Fui Chung
Wong Dimin Mandy
Matric Number
U084895U
U084888H
Date
27 Jan ‘10
27 Jan ‘10
ACTIVATED CHARCOAL
Brand / Generic Name: Actidose-Aqua Advance (Cambridge), Carbomix (Meadow),
Charcodote (PLIVA), Charcoal Camden tablets
Generic name: Activated charcoal
Proprietary name: Charcoal Camden
Active ingredient: Activated charcoal
Source of information: British National Formulary (BNF), MIMS
Legal Classification in Singapore: General Sales List
Source of information: Health Sciences Authority (HSA)
Approved Indication(s):
 Acute oral poisoning
 Gastrointestinal disorders such as diarrhoea and indigestion
Source of information: MIMS
Therapeutic Classification: Adsorbent, gastrointestinal agent, nutriceutical, antidote,
detoxifying agents, drugs used in substance dependence.
Mechanism of Action(s):
With its large surface area and porous surface, charcoal is able to adsorb toxic substances
or irritants in the gastrointestinal tract, inhibiting its absorption into systemic circulation.
One of the constituents of activated charcoal is sorbitol, which induces a hyperosmotic
environment in the lumen of the GI tract, causing catharsis. Charcoal also disrupts the
enterohepatic circulation of bile acids, which ultimately result in the lowering of the
cholesterol level.
Activated charcoal adsorbs many drugs and chemicals, thus reduces the amount of the
agent available for absorption. In vitro, agents that are best adsorbed are nondissociated
salts and low water solubility compounds. In vivo adsorption can not always be predicted
from in vitro studies, thus humans studies are needed to confirm the efficacy of activated
charcoal for a particular substance.
159
Source of information: Micromedex, MIMS
Available Dosage Form(s): Oral suspension, tablet, powder
Source of information: BNF, MIMS
Dosing:
 Acute oral poisoning
Adult
Single dose treatment: 25 – 100 g in a single dose.
Multiple dose treatment: 50 – 100 g as an initial dose followed by not less than
12.5g every hour. Alternatively, 25 g per 2 hours, or 50 g every 4 hours.
Children
Single dose treatment: < 1 year: 1 g/kg/dose. 1 – 12 years: 25 – 50g/dose.
Multiple dose treatment: Repeat half the initial dose as stated above, every 2 to 6
hours as needed.

Gastrointestinal disorder
Adult
0.975 – 3.9 g three times a day.
Administration:
If in powder form, allow to disintegrate in water with stirring, or take whole with liquid.
Source of information: MIMS
160
Cautions:
 Impaired intestinal motility, increases risk of gastrointestinal obstruction
 Avoid prolonged use in infants and children below 3 years old
 Pregnant women and breastfeeding mothers
 Dehydration
 Milk products such milk, ice cream, cocoa, and sherbet reduces absorptive capacity
of charcoal
 Use of other cathartics
Side effects:






Vomiting
Constipation
Black stools
Diarrhoea (due to sorbital present in the medication)
Swelling of abdomen
Bowel obstruction
Drug interactions:
 May reduce the absorption of other drugs from the GIT, simultaneous oral therapy
should be avoided.
 In treatment of acute oral poisoning, concurrent medication should be given
parenterally.
 Should not be used when a specific oral antidote eg methionine is given.
Source of information: Micromedex, MIMS
Contraindication(s):








Absence of bowel sounds
Gastrointestinal perforation
Intestinal obstruction
Recent surgery
Risk of gastrointestinal haemorrhage
Not to be treated for poisoning by petroleum distillate, corrosive substances,
alcohols, clofenotane, malathion and metal salts including lithium and iron salts.
Fructose intolerance
Children below 1 year
Source of information: Micromedex, MIMS
161
Patient Education / Counselling Points:







Do not take if you have ingested petroleum products or corrosive agents.
Do not administer to a groggy or unconscious person.
Food, nutritional supplements or herbs must not be taken within 2 hours of
ingestion of charcoal.
Let health professionals know if you are pregnant, breastfeeding, have digestive
problems, constipation or lactose intolerance.
Do not take if you have allergic reactions to the ingredients.
If a dose is missed, do not take more charcoal during the next dose to compensate.
For oral suspensions, shake for at least 30 seconds before ingesting.
Source of information: Hospital District of Helsinki and Uusimaa
162
Student Name
Wong Li Yi Lynette
Wong Li Yu Agnes
Matric Number
U084913Y
U084951L
Date
SMECTA POWDER
Brand / Generic Name: Smecta® Sachet
Generic name: Smecta
Proprietary name: Smecta
Active ingredient: Dioctahedral Smectite
Source of information: MIMS Singapore, Micromedex
Legal Classification in Singapore: G
Source of information: MIMS Singapore
Approved Indication(s): Treat symptoms of acute and chronic diarrhoea.
Gastro-oesophageal reflux and irritable bowel syndrome.
Source of information: MIMS Singapore, Martindale
Therapeutic Classification:
Antidiarrheal, Intestinal Anti-inflammatory/ Anti-infective agent
Mechanism of Action(s):
Pharmacodynamics:
Smecta possesses a powerful coating property on the gastrointestinal mucosa.
By interacting with glycoproteins of mucus, Smecta increases the resistance of the mucosal
gel in response to aggressive agents.
It is radiolucent, does not colour the stools and at usual doses, does not modify the
physiological intestinal transit time.
Pharmacokinetics:
Smecta is not adsorbed. It will be eliminated through the faeces.
Source of information: MIMS Singapore, Product Insert(Beaufour IPSEN Pharma)
Available Dosage Form(s): Sachets each containing 3.000g powder for oral suspension. Box
of 10 or 30 sachets.
163
Source of information: MIMS Singapore, Product Insert(Beaufour IPSEN Pharma)
Dosing and Administration:


For adults - 3sachets/day
For children –
>2yrs: 2-3sachets/day
1-2yrs: 1-2sachets/day
<1 yr: 1 sachet/day
To be administered in 2-3 divided doses. In acute diarrhoea, the dosage can be
doubled at the beginning of treatment.
Smecta should be taken with meals or just before meals in cases of colitis or spastic
colon.
Source of information: MIMS Singapore
Side Effects / Cautions:
In very rare cases, aggravation of constipation was reported.
Source of information: MIMS SINGAPORE
Contraindication(s):
None.
Source of information: Product Insert(Beaufour IPSEN Pharma)
Patient Education / Counselling Points:
Smecta is not a rehydration therapy. The treatment does not dispense with
rehydration, should this prove to be necessary.
As the adsorbent properties of Smecta may interfere with the rates and/or levels of
absorption of other substances, it is recommended not to administer any other drug
at the same time as Smecta.
Source of information: MIMS MALAYSIA, Product Insert(Beaufour IPSEN Pharma)
164
Student Name
Wong Xin Yi
Wong Yoong Kuan
Matric Number
U084876M
U084868N
Date
BISACODYL TABLET/SUPPOSITORY
Generic Name: Bisacodyl
Brand/Proprietary Name: Dulcolax
Active ingredient: Bisacodyl
Source of information: MIMS, Electronic Medicines Compendium (EMC), Lexi-Comp Drug
Information Handbook
Legal Classification in Singapore: GSL
Source of information: MIMS
Approved Indication(s):


Treatment of constipation
Preparation for diagnostic procedures, pre- and post-op treatment, where
defecation is required i.e. bowel evacuation
Source of information: MIMS, Dulcolax product information leaflet
Therapeutic Classification: Laxatives, Purgatives
Mechanism of Action(s): Local acting, anti-resorptive laxative. After hydrolysis in the large
intestine, stimulates peristalsis of the colon by directly irritating the colonic intramural
plexus and promotes accumulation of water and electrolytes in the colonic lumen. The
rectum is also stimulated to cause increased motility and a feeling of rectal fullness.
Source of information: MIMS, Dulcolax product information leaflet, EMC
Available Dosage Form(s): Enteric-coated tablet, suppositories
Source of information: MIMS, Dulcolax product information leaflet, Lexi-Comp Drug
Information Handbook
165
Dosing and Administration:

Constipation: For adults and children over 10 years: 1-2 tablets (5-10 mg). 1
suppository may also be used instead. For children 4-10 years: 1 tablet (5 mg);
children under 4 years: Paediatric suppositories recommended. Only use 1
suppository a day. Avoid using for more than 7 days.
Tablets should be taken at night to produce evacuation the following morning (Act
in 10-12 hours). They should be swallowed whole with adequate fluid. The tablets
should not be taken together with milk or antacids. Tablets should be swallowed
whole, not chewed or crushed, and should not be ingested within 1 hour of antacid
or food consumption. Suppositories should be taken if fast effect is required (Act in
15-60 minutes).

For Preparation for Diagnostic Procedures and Preoperative Treatment: Tablets
should be combined with the suppositories in order to achieve complete
evacuation of the intestine. The dosage recommended for adults is 2-4 tablets the
night before and 1 suppository to be inserted the following morning.
Children of age 4 years and older, 1 tablet in the evening and 1 paediatric
suppository on the following morning is recommended
Source of information: MIMS, Dulcolax product information leaflet, Micromedex
Side Effects / Cautions:

Abdominal discomfort including cramps and abdominal pain; suppository may cause
irritation and proctitis
 Diarrhoea with excessive loss of water and electrolytes
 Dizziness
 Nausea and vomiting
 Inflammatory bowel disease
Source of information: MIMS, Dulcolax product information leaflet , EMC, Lexi-comp
Handbook, Martindale
166
Contraindication(s):





Ileus, intestinal obstruction, acute surgical abdominal conditions
Severe dehydration
Known hypersensitivity to Bisacodyl
Appendicitis
Acute inflammatory bowel diseases
Source of information: MIMS, Dulcolax product information leaflet, Micromedex
Patient Education / Counselling Points:






Use suppository in the morning before work or school as it is fast acting (15-60
minutes)
Take tablet at night before bedtime or at least 1 hour after meal
Do not chew tablet or cut tablet up before swallowing
Drug should only be taken during pregnancy on medical advice
Drug should not be taken on a continuous daily basis for long periods of time
Drink adequate amounts of water to replenish fluid and electrolyte loss
Source of information: Dulcolax product information leaflet, MIMS
167
Student Name
Yeo Chao Ming Samuel
Wong Zhi Xin
Matric Number
U084857H
U084879X
Date
30/1/2010
30/1/2010
SENNA
Brand / Generic Name: Senna
Generic name: Senna
Proprietary name: Tux(Pfizer), Bilax(Bayer), Pursennid(Novartis), Perdiem(Novartis), ExLax(Novartis), Prodiem Plus(Novartis), Pursennid(Novartis), Tamarine(GSK), Naturetti
(Sanofi-Aventis), Agiolax (Abbott), Califig (Merck), Laxtam(Merck), Laxikal Forte(Teva),
Prompt(Procter & Gamble), Prunacolon(Nycomed), Prunasine(Nycomed),
Agiolax(Nycomed), Cirulaxia(Nycomed), Darlin(Nycomed), Herbesan (Nycomed), Bekunis
(Abdi), Senokot (Reckitt Benckiser)
Active ingredient: Senna glycosides, also known as sennosides
Micromedex
Legal Classification in Singapore: General Sales List
http://www.mims.com.sg
Approved Indication(s):
 Constipation
 Bowel evacuation before investigational procedures or surgery
Micromedex, http://www.mims.com.sg
Therapeutic Classification:
Mechanism of Action(s):
Colonic bacteria break down sennoside glycosides to release active anthraquinones. Active
anthraquinones act directly on the intestinal mucosa to enhance the rate of colonic motility
and prevent water and electrolyte secretion. They may also have an effect on the
intramural nerves and plexes of the colon. The effect is usually seen six to twelve hours
following oral administration.
http://www.mims.com.sg, Micromedex
168
Available Dosage Form(s):
 Tablet
 Syrup
 Granules
 Suppository
Micromedex
Dosing and Administration:
For bowel evacuation
For adults, one dose of 75 ml of a standardized Senna preparation
For children, one dose of 1 ml/kg body weight of a standardized Senna preparation
For Constipation
 Tablet
For adults and children above 12 years old, take 15 to 30 mg, once to twice daily.
For children 6 to 12 years old, take 7.5 to 15 mg once every night or morning.
For children 2 to 6 years old, take 3.75 to 7.5 mg once daily in the morning
Take the tablets with water.
May be taken with or without food.
 Granules
For adults, take one to two 5-ml spoonful (326 mg) with water at night, and if needed,
twice a day. For a child between 5 to 12 years old, take one 5-ml spoonful daily.
 Suppository
For adults, administer 1 suppository (652 mg) at bedtime, repeat after 2 hours if necessary.
For children, administer a half-suppository (326 mg) at bedtime.
 Syrup
For adults, take 10 to 15 ml (436 to 654 mg), up to a maximum of 30 ml daily, at bedtime.
For children between 5 to 15 years old, take 5 to 10 ml (218 to 436 mg) to a maximum of 20
ml daily, at bedtime.
For children 1 to 5 years old, take 2.5 to 5 ml (109 to 218 mg) up to a maximum of 10 ml
daily, at bedtime.
For children 1 month to 1 year old, take 1.25 to 2.5 ml (55 to 109 mg) up to a maximum of 5
ml daily, at bedtime.
http://www.mims.com.sg, British National Formulary, March 1998
169
Side Effects / Cautions:





Temporary mild griping may occur after adjustment of the dosage
Mild abdominal discomfort such as colic and intestinal cramps
Coloration of the urine to become yellowish-brown at acid pH, red at alkaline pH
Tenesmus
Prolonged use can result in inflammatory bowel disease, diarrhoea, muscular
weakness, weight loss, atonic non-functioning colon and hypokalaemia
http://www.mims.com.sg
British National Formulary, March 1998
Martindale
Pray W. Non-prescription Drug Therapeutics, Lippincott Williams and Wilkins
Contraindication(s):
 Intestinal obstruction
 Inflammatory bowel disease
 Undiagnosed abdominal symptoms.
 Nausea or vomiting
 Appendicitis
 Fluid or electrolyte imbalance
http://www.mims.com.sg, Martindale
Patient Education / Counselling Points:




Avoid prolonged and long term use
Preferable to administer at bedtime on an empty stomach
Store dry below 30°C in the original package to protect from moisture
If laxatives are needed every day or abdominal pain persists after usage, consult a
doctor.
http://www.mims.com.sg, National British Formulary, March 1998
170
Student Name
Yeo Hui Ing Fiona
Yeo WeiLong
Matric Number
U084870U
U080387A
Date
21/1/2010
21/1/2010
LACTULOSE
Brand / Generic Name: Dhactulose syr Duphalac syr Lactulose Stada syr Lactus
syr PMS-Lactulose syr
Generic name: Lactulose
Proprietary name: Bifinorma (Merckle, Ger.) Bifiteral (Solvay, Belg.) Dulcolactol (Boehringer
Ingelheim, Indon) Loraga (Pfizer, Fin.) Melaxose (UCB, Fr.) Monilac (Chugai, Jpn) Regulose
(Novartis Consumer, UK)
Active ingredient: Lactulose
Source of information MIMS, Martindale
Legal Classification in Singapore: G
Source of information: MIMS
Approved Indication(s):
 Treatment of Constipation
 Hepatic Encephalopathy ( Portal Systemic Encephalopathy)
Source of information: Lexi-comp Drug Information Handbook, BNF
Therapeutic Classification: Purgatives, Class of osmotically acting laxatives
Mechanism of Action(s):
Lactulose is a synthetic disaccharide osmotic laxative. In the treatment of constipation,
it is broken down by colonic bacteria mainly into lactic acid. This exerts a local osmotic
effect in the colon leading to increased faecal bulk and stimulation of peristalsis. In the
treatment of hepatic encephalopathy, it reduces absorption of ammonium ions and
toxic nitrogenous compounds, resulting in reduced blood ammonia concentrations and
an improvement in mental function.
Source of information: Martindale, MIMS & Lexi-comp Drug Information Handbook
171
Available Dosage Form(s): Oral Powder, Oral Liquid, Solution, Concentrate
Source of information: Martindale & MIMS
Dosing and Administration:



Constipation:
Adult: Initially, 10-20 g (15-30 ml) daily as a single dose or in 2 divided doses;
gradually adjust according to patient's response. Max dose: 45 ml (or up to 40 g of
the reconstituted oral powder formulation)/day.
Child: As 3.35 mg/5 ml solution: 1 mth to 1 yr: 2.5 ml; 1-5 yr: 5 ml; 5-10 yr: 10 ml;
10-18 yr: 15 ml. All doses to be given twice daily.
Hepatic encephalopathy (Oral)
Adult: 60-100 g (90-150 ml) daily in 3 divided doses; adjust to produce 2 or 3 soft
stools each day.
Hepatic encephalopathy (Rectal)
Adult: Mix 200 g (300 ml) with 700 ml water or 0.9% sodium chloride as a retention
enema. Retain enema for 30-60 minutes; repeat every 4-6 hr until oral medication
can be administered.
Source of information: MIMS & Martindale
Side Effects / Cautions:


Diarrhoea (dose-related), nausea, vomiting, hypokalaemia, bloating and abdominal
cramps.
Potentially Fatal: Dehydration and hypernatraemia on aggressive treatment.
May prevent release of Mhoeesalazine in the colon. Decreased effect with oral
neomycin, antacids.
Source of information: MIMS
Contraindication(s):


Galactosaemia, intestinal obstruction. Patients on low galactose diet.
Care to be taken in patients with lactose intolerance and diabetic patients
Source of information: MIMS & Martindale
172
Patient Education / Counselling Points:




Lactulose can be take ‘as is’ or diluted with water fruit juice or milk, or taken with
food.
Do not take with antacids or neomycin as it may decrease effect
It may take 2 to 3 days before the effect of Lactulose sets in to relieve constipation.
If you miss a dose of Lactulose, take it as soon as you remember. If it is almost time
for your next dose, continue taking the medication at the original time and interval.
Source of information: MIMS & Lexi-comp Drug Information Handbook
173
Student Name
Yeow Jian Sheng
Er Xuan Hua Patrick
Matric Number
U084854X
U090005N
Date
15/01/2010
ISPAGHULA HUSK
Brand / Generic Name: Fybogel
Proprietary name: Fybogel
Active ingredient: Ispaghula husk
Source of information: MIMS
Legal Classification in Singapore: GSL
Source of information: MIMS
Approved Indication(s):
Relieve constipation (including constipation during pregnancy/breastfeeding); Maintains
normal bowel function among patients with irritable bowel syndrome, colostomy or
ileostomy, haemorrhoids (piles), anal fissure, persistent diarrhoea associated with
diverticular disease, ulcerative colitis.
Source of information: MIMS, product information leaflet
Therapeutic Classification:
Bulk Laxative
Mechanism of Action(s):
Ispaghula husk in Fybogel is a natural plant material which is high in fibre. It works by
absorbing water and increasing the bulk of the food passing through the digestive system,
helping the body to work normally.
Source of information: MIMS
Available Dosage Form(s):
Granules 3.5 g (pale orange-coloured, orange-flavoured) x 10 or 30 sachets.
Source of information: MIMS
174
Dosing and Administration:




Adults including Elderly, Children > 12 yr: 1 sachet b.d. (morning, evening)
Children 6-12yr: ½ to 1 level 5ml spoonful b.d. (morning, evening)
Children < 6 yr: Not to be given unless prescribed by a doctor. ½ to 1 level 5ml
spoonful b.d. (morning, evening)
Stir powder into glass of cold water (150 ml) and drink straight away.
Source of information: MIMS, product information leaflet
Side Effects / Cautions:

Due to increased fibre intake, flatulence or bloating may occur during the first few
days of taking the medication.
Source of information: MIMS
Contraindication(s):

Difficulty in swallowing, blockage of the bowel (intestinal obstruction or faecal
impaction), muscle weakness of the bowel wall (colonic atony).
Source of information: MIMS and BNF
Patient Education / Counselling Points:


Take after meals.
Do not take Fybogel without water. If you accidentally take too much Fybogel, drink
plenty of water.
 If no bowel movement occurs within 3 days, children of this age (6-12yr) should
consult a doctor.
Source of information: product information leaflet
BNF: British National Formulary September 2008
Product information leaflet: Taken from Fybogel Orange
175
Student Name
Yip Suting
Zhang YanXin Tracy
Matric Number
U084931U
U084873A
Date
23 Jan 2010
LACTEOL FORTE POWDER
Brand / Generic Name: Lacteol Fort®
Generic name: Lactobacillus Acidophilus - oral
Proprietary name: Lacteol® (sachets) [manufactured by Axcan
Pharma]
Active ingredient: Lactobacillus acidophilus (lyophilized killed
microbial bodies)
Source(s) of information:
- Axcan Pharma website
- Lacteol Fort® product insert
- Micromedex (online database)
- MIMS Singapore website
- Martindale (33rd ed)
Legal Classification in Singapore: General Sales List
Source of information: MIMS Singapore website
Approved Indication(s):
 Symptomatic treatment of diarrhea
Source(s) of information:
- APhA Handbook on Non-Prescription Drugs (11th ed)
- Lacteol Fort® product insert
Therapeutic Classification:
 Anti-diarrheal
Mechanism of Action(s):
The lactobacilli in Lactéol Fort exhibit bacteriostatic action by adhering to intestinal
cells, thus inhibiting adherence of invasive or toxinogentic enteropathogenic organisms
(such as Escherichia Coli and Camphylobacter jejuni) to epithelial cells. At the same
176
time, the growth of defensive acidogenic intestinal flora is also stimulated. Non-specific
immunostimulation of the mucosa results in increased synthesis of lgA.
Source of information:
- Lacteol Fort® product insert
- MIMS Singapore website
- Peking Medical Union College website
Available Dosage Form(s): Lacteol Fort capsule, Lacteol Fort sachet
Source of information:
- Lacteol Fort® product insert
- MIMS Singapore website
Dosing and Administration:
 Lacteol Fort should be taken 2 times a day at the first sign of diarrhea. The contents
of either dosage form (capsule or sachet) can be mixed into water.
 Capusle:
o For infants (<2 years old), 2 capsules should be given for the first dose on the
first day. Subsequently, the patient can take either 1 or 2 capsules per dose.
Rehydration therapy should be used in conjunction*
o For children, 2 capsules should be given per dose.
o For adults, 4 capsules should be given for the first dose on the first day.
Subsequently, the patient should take 2 capsules per dose.
 Sachet:
o For infants (<2 years old), 1 sachet should be given per dose. Rehydration
therapy should be used in conjunction*
o For children, 1 or 2 sachets should be given for the first dose on the first day.
Subsequently, the patient should take 1 sachet per dose.
o For adults, 2 sachets should be given for the first dose on the first day.
Subsequently, the patient should take 1 sachet per dose.
o The 2nd dose can be taken 6-8 hours after the first dose.
*Use
at own discretion (see under contraindications)
Source of information:
- Lacteol Fort® product insert
177
Side Effects / Cautions:





Increase in flatulence
Burping
Diarrhea
Hiccups
Vomiting
Source of information:
- Medicinenet.com
- Micromedex (online database)
Contraindication(s):
 Hypersensitivity to any Lactobacillus product component
 Hypersensitivity to lactose or milk
 Over-the-counter commercial preparations are not to be used in children less than 3
years unless under the direction of a physician*
Source of information:
- Lacteol Fort® product insert
- Micromedex (online database)
Patient Education / Counselling Points:

Patient should consult their doctor if diarrhea persists for more than 2 days,
especially if patient has fever as well.
 Store in a cool, dry place.
Source of information:
- Medicinenet.com
178