Drug Class Overview OHSLA 2008_0

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Pharmacology Overview by
Drug Class
Dr Andrew P Mallon
Learning Objectives
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Recognize frequently prescribed drugs
Identify brand/generic names, drug
families, common indications, and
common side effects
Describe some legal issues with OTCs
and prescription drugs (federal and
state)
How a drug goes to market
FDA estimates
average time for drug
approval is 8.5 years
Patents last 20 years
Exclusivity, lasts 3-7
years, designed by
FDA to promote
balance between new
drug innovation and
generic competition.
http://www.fda.gov/cder/handbook/develop.htm
Certain drugs can be
fast-tracked if there is
a great need
Gastrointestinal: Acid Reducers
“Acid Reducers all OTC?”
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
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Switched to OTC when
“safe without MD advice”
Long term or short
term use
Know when to seek
medical attention
Gastrointestinal: Acid Reducers

Proton Pump Inhibitors

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H2 Receptor antagonists
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Omeprazole = Prilosec OTC
Lansoprazole = Prevacid
Pantoprazole = Protonix
Esomeprazole = Nexium
Rabeprazole = AcipHex
Ranitidine = Zantac OTC
Famotidine = Pepcid OTC
Side Effects

rare
Cardiovascular: Statins
“What statin are you taking?”
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Highest use drugs
Diet control should accompany drug therapy
Debatable difference between drugs BUT switch if not
effective
Expect long term use
Cardiovascular: “statins”
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Cholesterol Lowering
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Atorvastatin = Lipitor
Fluvastatin = Lescol
Lovastatin = Mevacor
Simvastatin = Zocor
Pravastatin = Pravachol
Rosuvastatin = Crestor
Side Effects:

few overall, muscle aches, weakness
Cardiovascular: Beta blockers
“Look, one more use for betablockers”
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Don’t stop taking abruptly
Watch for low blood pressure
symptoms (dizziness)
Can decrease sexual ability
Other uses: performance anxiety,
essential tremor, Raynaud’s
syndrome, migraine prophylaxis,
esophagus bleeding in ESLD
Cardiovascular: Beta Blockers, “olols”

Hypertension (high blood pressure),
Arrhythmias, Heart Failure, MI
(Myocardial Infarction), etc. 
 Metoprolol = Toprol XL, Lopressor
 Atenolol = Tenormin
 Propranolol = Inderal
 Carvedilol = Coreg
Cardiovascular: “Heart-ache” drugs

Digitalis: Heart Failure, A-fib

Digoxin = Lanoxin
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Side effects: Dose dependent, nausea
Nitrates: Angina
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Isosorbide Mononitrate = Imdur
Nitroglycerin sublingual tablets

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Side effects: headache but can adapt
Refill every 6 months - 1 year
Cardiovascular: Anticoagulants
“When to clot and when to not…”

Hold prior to surgery then bridge
therapy with low-molecular weight
heparin

Too much warfarin = Vitamin K

Monitoring is vital to safety

Avoid the term “blood thinner”
Cardiovascular: Anticoagulants
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Use: blood clot prevention or
decrease further development
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Warfarin = Coumadin
Clopidogrel = Plavix
Side effects:
 signs of bleeding/bruising
Diet should be consistent
regarding vitamin K content
Cardiovascular: Diuretics
“Latest study says add diuretics…”
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Dramatic increase in
use of inexpensive
drugs
Effective to decrease
blood volume and
hence the pressure
Cardiovascular: Diuretics

Decrease excess inside water
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Hydrochlorothiazide = HCTZ,
Hydrodiurel
Furosemide = Lasix
Triamterene/HCTZ= Maxzide,
Dyazide
Side effects:

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Nausea, photosensitivity, dizziness
Low blood pressure
Cardiovascular: ACE-I and ARBs
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Angiotensin constricts blood vessels

ACE-Inhibitors = “-prils”
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Captopril = Capoten
Lisinopril = Zestril/Prinivil
Quinapril = Accupril
Fosinopril = Monopril
Perindopril = Aceon
Side effects

Enalapril = Vasotec
Ramipril = Altace
Benazepril = Lotensin
Trandolapil = Mavik
Moexipril = Univasc
Cough, swollen tongue/lips, increased K+
Cardiovascular: ACE-I and ARBs
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Angiotensin Receptor Blockers (ARBs)
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Losartan = Cozaar
Valsartan = Diovan
Candesartan = Atacand
Irbesartan = Avapro
Olmesartan = Benicar
Telmisartan = Micardis
Eprosartan = Teveten
Side effects

Increased K+, little/no cough or angioedema
Cardiovascular: ACE-I and ARBs
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Uses

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Diabetes - prevent progression to chronic
kidney disease
Heart failure - decreased stiffening of heart
muscle
Hypertension
Cardiovascular: Hypertension
“I feel fine, why treat high blood
pressure?”



Check blood pressure
frequently
Device accuracy: Arm
cuff vs. finger device
When to contact the
physician
Cardiovascular: Hypertension


High Blood Pressure:
 Clonidine = Catapres
 Doxazosin = Cardura
 Amlodipine/Benazepril =
Lotrel
Side effects:

dizziness, headache
Respiratory: Allergies
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Antihistamines
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Cetirizine = Zyrtec OTC
Fexofenadine = Allegra
Loratadine = Claritin OTC
Side Effects
 Drowsiness or stimulant
Respiratory:
“Allergies/Cold Sxs: What works?”
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Combinations with
pseudoephedrine?
Combinations with
phenylephrine?
Combinations with
dextromethorphan effective?
Chicken soup, water and rest?
Hot Toddy? 
Pseudoephedrine scoop
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Effective decongestant
Schedule III in Oregon
All “EPP” products restricted by federal law Why?
Precursor to methamphetamine
Ephedrine
 No longer marketed
Phenylpropanolamine (PPA)
 No longer marketed
 FDA proposed final rule to place
PPA in Category III (not
approved for use) regarding OTC products
Pseudoephedrine
 Limited access by federal law
Respiratory: Allergies
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Nasal Corticosteroids
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Fluticasone = Flonase
Mometasone = Nasonex
Side Effects
 Headache, bloody nose
Concern regarding long term
use?
Respiratory: Asthma Inhalers

“Rescue”
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
Albuterol = Proair, Proventil
Side effects:
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“Controllers”
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Fluticasone/Salmeterol = Advair Diskus
Side effects:

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Increased heart rate, “jittery”
Headache
Thrush, voice changes
Aero Chamber device for accurate
administration
Respiratory: Asthma Oral
Medications
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Corticosteroids
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Prednisone
Methylprednisolone
Side effects:
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Insomnia, nervousness
Nausea: Take With Food
Long term use concern
Montelukast = Singulair

Side effects: rare
Antibiotics:
“The latest is the best! I want that one!”
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Side effects:
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Diarrhea
Nausea
Yeast infections
Tips:
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New drug isn’t always best
Resistance is inevitable--but we can delay it
Take until gone
With or w/o food variable
Antibiotics: Penicillins & their
relatives
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Penicillin VK

Amoxicillin = Trimox
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Amoxicillin/Clavulanate = Augmentin

Cephalexin = Keflex


Cautions: Cross-sensitivities and allergies
Can still be very effective even though “old
drugs”
Antibiotics:
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Azithromycin = Zithromax

Doxycycline

Cautions:
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Do not take with milk, antacids
Sun sensitivity
Trimethoprim/sulfamethoxazole = Cotrim,
Septra, Bactrim

Cautions: Sun sensitivity, Increase fluid intake,
allergies
Antibiotics: Quinolones
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Ciprofloxacin = Cipro
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Levofloxacin = Levaquin
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Cautions:

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Do not take with milk,
antacids
Sun sensitivity
Moxifloxacin = Avelox
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Cautions:


Do not take with milk,
antacids
Sun sensitivity
CNS: Antidepressants
“Let’s add them to the water”
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Frequently prescribed
Long term or short term use
Time to effect
Switch to another if not
effective
Often taper off drug
Okay for adolescents?

Suicidal ideology?
“Antidepressants a Suicide Risk for Young Adults
Study Says Cases Double for Those 18 to 25 Using
Medicine to Control Depression”

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Black box warning
2004
Washington Post
2006
FDA investigations
2007
Pediatric studies
lacking
CNS: Antidepressants
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SSRIs
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Fluoxetine = Prozac
Sertraline = Zoloft
Paroxetine = Paxil, Paxil CR
Citalopram = Celexa
Escitalopram = Lexapro
Side effects:

headache, nausea, insomnia or
somnolence
CNS: Antidepressants
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TCAs
 Amitriptyline = Elavil


Side effects: sedation, dry
mouth
“Other” types
 Bupropion = Wellbutrin,
Wellbutrin XL
 Venlafaxine = Effexor,
Effexor XR
 Trazodone = Deseryl

Side effects: dizziness,
drowsiness
CNS: Antianxiety and/or
Insomnia

“Popular” drugs
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Half-life varies
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Long - Diazepam
Short - Triazolam
Infrequent use extends
effectiveness
Caution in elderly
CNS: Antianxiety and/or
Insomnia
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Benzodiazepines
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Lorazepam = Ativan
Clonazepam = Klonipin
Diazepam = Valium
Temazepam = Restoril
Alprazolam = Xanax
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Side effects: drowsiness
Insomnia
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Zolpidem = Ambien
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Side effects: headache
CNS: Insomnia
Ambien and it’s interesting side effects

Sleepwalking
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Binge eating at night
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Nightmares

How to interpret and
advise patients: Take
pill as you get into
bed.
Questions?
Endocrine: Osteoporosis
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Alendronate = Fosamax
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Risedronate = Actonel
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Side Effects:
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Esophagitis, Nausea
Once weekly dosing possible
Raloxifene = Evista
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Side Effects:
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Hot flashes, Nausea
CNS
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Antipsychotics
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Risperidone = Risperdal
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Side effects: agitation,
insomnia
Don’t stop abruptly
Aripiprazole = Abilify
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Side effects: akathisia,
HA, weakness
Don’t confuse with PPI’s
which also end in “prazole”
CNS
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Anticonvulsant
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Gabapentin = Neurontin
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Pregabalin = Lyrica
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Side effects: dizziness, fatigue,
nausea
Used for nerve pain, etc
Approved for fibromyalgia!
Phenytoin = Dilantin
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Side effects: gingival hyperplasia
Important to monitor drug levels
Analgesic: Anti-inflammatory
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Ibuprofen = Motrin, Advil OTC
Naproxen = Naprosyn, Anaprox
OTC
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Side Effects:
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GI = take with food
Dizziness?
Caution with warfarin, history of
ulcer/GERD
Analgesic: Anti-inflammatory
“The next generation or off the
market?”
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Celecoxib = Celebrex
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Side Effects:
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GI (less)= take with food
Vioxx = Rofecoxib
(09/04 off market)
Bextra = Valdecoxib
(04/05 off market)
Analgesic: Muscle Relaxants
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Cyclobenzaprine = Flexeril
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Effectiveness vs. gorkiness
Carisoprodol = Soma
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Schedule IV in Oregon
Side Effects:
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Dizziness, Drowsiness
Dependence? Should it be a
Scheduled drug?
Do not take with alcohol
Controlled Substances Schedules
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I - High potential for abuse and/or no medical
use
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Heroin, LSD, mescaline
II - Highest potential for abuse with medical
use
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Opiate (eg, meperidine, codeine, morphine,
oxycodone, methadone, cocaine)
Non-opiate stimulants (eg, methylphenidate,
amphetamine, phenmetrazine, methamphetamine)
Non-opiate depressants (eg, barbiturates,
methaqualone)
CS Schedules - continued
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III - Narcotic combinations and others
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Up to 90 mg codeine per dose plus other active ingredients
Hydrocodone plus APAP
Doriden (glutethimide)
Anabolic steroids (eg, methyltestosterone)
Benzphetamine and phendimetrazine (Didex)
Barbiturate suppositories
Barbiturate combos (eg, Fiorinal, Fioricet with Codeine)
Marinol
Ephedrine, Pseudoephedrine, Phenylpropanolamine in
Oregon
CSA Schedules - continued
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IV - Primarily non-narcotics
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Benzodiazepines (eg, Valium, Halcion)
Meprobamate
Phenobarbital
Chloral hydrate
Phentermine, mazindol, diethylpropion
Propoxyphene dosage forms (powder = CII)
Dichloralphenazone (component of Midrin®) 9/01
Carisoprodol in OR
CSA Schedules - continued
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V - “Exempt narcotics”
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Low dose combinations of codeine with other
ingredients for diarrhea, pain, or cough -some may be sold OTC in other states
Diphenoxylate with atropine
Generally no more than 10 mg codeine per 5
mL (Tylenol w/ Codeine 12 mg/5mL)
No OTC Schedule V in Oregon currently
Analgesic: Narcotic
Combinations

Hydrocodone/APAP = Vicodin, Lortab

Codeine/APAP = Tylenol #3

Propoxyphene/APAP = Darvocet

Oxycodone/APAP = Percocet

Side Effects:

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Dizziness, Drowsiness
Constipation
Dependence? Abuse?
Do not take with alcohol
Analgesic: Opioids
“Abuse potential high yet effective”

Oxycodone = Oxycontin

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Side effects: see previous slide
High abuse potential due to
extended release formulation
Tramadol = Ultram

Side Effects:
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Dizziness, Drowsiness
Dependence? Abuse?
Do not take with alcohol
Analgesics:
“Abuse vs. Legitimate Use?”
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Sickle cell anemia
Fibromyalgia
Terminal cancer
Chronic back pain
Muscular dystrophy
Neuropathic pain
ADD, ADHD
How do you evaluate and help?
Medical Marijuana Act
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Oregon Medical Marijuana Act ORS 475.300 475.346This Act allows use of marijuana by Oregonians
with debilitating medical conditions for medical purposes
determined by their physician.
“Debilitating medical condition” includes glaucoma,
cancer, HIV or AIDS, or a condition which produces
cachexia, severe pain, severe nausea, seizures,
persistent muscle spasms or condition approved by the
department
A medical registry identification card is required for the
patient and caregiver
A registrant may possess 6 mature plants and 24 ounces
of usable marijuana at a time
Death With Dignity Act
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Death With Dignity Act
http://www.oregon.gov/DHS/ph/pas/index.shtmlOAR
333-009-0000 – 333-009-0030 ORS 127.800 –
127.897An adult, who is a resident of Oregon, has been
determined by the attending physician and consulting
physician to be suffering from a terminal disease. The
adult must make an oral and written request to end their
life.
15 days between oral request and written request
Authorized prescribers include MD or DO
Health care providers may choose not to participate
See link for necessary reporting
Endocrine: Estrogens
“Estrogen replacement
unnecessary?”
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How safe?
How necessary?
Risk vs. benefit
1970’s data and marketing campaign
Women’s Health Initiative study
Endocrine: Female Hormones

Menopausal women

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Oral contraceptives
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Conjugated Estrogens = Premarin
Conjugated Estrogens/ Medroxyprogesterone = Prempro
Estradiol
Medroxyprogesterone
Ortho-Tricyclen
Ortho-Novum
Ortho-Evra (transdermal)
Side effects:


Breast tenderness, spotting
Bloating, Nausea
Plan B OTC August 2006




Without a prescription if >18yo
Behind the counter at licensed
pharmacies or healthcare facilities
Pharmacist must be on duty but
not necessary to make the
transaction
No gender distinction, no log
required
Patient must receive information, pharmacist must be
available for questions
http://www.fda.gov/cder/foi/label/2006/021045s011lbl.pdf
Endocrine: Injectable Diabetic
agents

Insulin

Rapid acting


Short-acting

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
Regular
Intermediate acting


Novolog, Humalog
NPH
Combination products
Mixed insulin (70/30)
Synthetic vs. animal source
Endocrine: Diabetes

Side Effects:




Dose dependent
Okay at room temperature once
opened x 30days
Roll before withdrawing dose,
rotate sites, change syringes
Scheduled pump option
Endocrine: Oral Diabetic agents

Rosiglitazone = Avandia

Pioglitazone = Actos


Side Effects: dose dependent
Metformin = Glucophage

Side Effects: dose dependent

Glipizide ER

Glyburide
Endocrine: Diabetes
“Avandia May Cause Risk of Heart Attack and
Death”

How relevant?

Open display of results?

Remove from market?


Class effect? Do all
glitazones cause this
Would this happen
anyway?
Endocrine: Diabetes



Start with oral therapy, progress
to insulin if cannot control
Diet control in tandem with drug
therapy
Diligent foot care, eye care,
wound care

Consistency

http://www.diabetes.org/home.jsp
Endocrine: Erectile Dysfunction

Erectile Dysfunction

Sildenafil = Viagra



Side Effects: Nausea,
Headache, Visual
Tadalafil = Cialis
Another indication:
pulmonary hypertension

Compounded preparations
Endocrine: Erectile Dysfunction
“Fastest growing drug class”

Little blue pill

DTC advertising

Paradigm shift

Dietary supplement
availability

Drug content found
Supplements/Vitamins

Potassium supplements for
low potassium

Potassium chloride = K-Dur,
Klor Con, Micro-K”


Side effects: nausea, diarrhea
Folic Acid deficiency for
neonatal development

Folic Acid = Folate

Side effects: nausea
Prescription vs. Dietary Supplement
“Long Weekend Dietary
Supplement”

FDA Recall 2007

Contained undeclared tadalafil (Cialis)

“Zencore” recalled 9/2007


Keeping prescription drugs behind the
counter
What is really in a dietary supplement?
Dietary Supplement Health and
Education Act (DSHEA)

Federal Trade Commission regulates advertising

FDA through the DSHEA

DSHEA 1994: power by FDA to ensure safe, properly
labeled and claims made are substantiated
Pharmacists must use care in making claims not
otherwise allowed under this law

http://www.fda.gov/opacom/laws/dshea.html

Great Natural Products and Complementary Care
website:
http://nccam.nih.gov/
What is really in that pill?

Manufacturer Standards?

USP


Consumer Lab


http://www.usp.org/USPVerified/dietarySupplemen
ts/
http://www.consumerlab.com/aboutcl.asp#testpro
g
NSF International

http://www.nsf.org/
Cool Resources For You

Pharmacists Manual DEA


APhA Links

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http://www.cfsan.fda.gov/~dms/supplmnt.html
Pharmacy Compounding


http://www.clinicaltrials.gov/
Dietary Supplements


http://www.ashp.org/ahfs/index.cfm
Clinical Trials Repository


http://www.pharmacist.com/AM/Template.cfm?section=Links2
ASHP Drug Information


http://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/index
.htm
http://www.fda.gov/cder/pharmcomp/default.htm
Medication Information

http://medlineplus.gov/
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