Drugs and Behavior
Dr. Renjilian
Week 10 - Over the Counter Drugs
Definition
Self-prescribed and self-administered drugs available without a
physician's prescription
Types of OTC Drugs
- Stimulants
- Weight Control drugs
- Sleep Aids
- Analgesics
- Cold/flu/allergy meds
- Antacids
- Topical compounds
- Toothpaste with fluoride
FDA Guidelines
- GRAS - generally recognized as safe
- GRAE - generally recognized as effective
- GRAHL - generally recognized as honestly labeled
FDA Categories
- Category I - ingredient is GRAS and GRAE
- Category II - ingredient is not GRAS and/or GRAE. Manufacturer
has 6 months to prove safety and effectiveness or cannot ship the
drug in interstate commerce
- Category III - ingredient has insufficient data on safety and
effectiveness. Manufacturer has 1 year to prove GRAS or ingredient
is placed in Category II.
Stimulants
- OTC stimulants can only contain caffeine (100 - 200 mgs)
- Mail order stimulants may contain ephedrine or
phenylpropanolamine (PPA)
Weight Control Products
- All weight control products contain 75 mg of PPA as their
active ingredient per dose
- Many brands are made by the same company
Sleep Aids
- Used to include scopolamine and antihistamine
- Now include contain the antihistamine diphenhydramine in 25 mg
dosages
Analgesics
- The term means "without pain"
- Generally meant to relieve mild to moderate "Somatic Pain"
(pain related to muscles, bones, sprains, headaches, etc.)
Analgesics - Aspirin
- Acetylsalicyclic acid has antipyretic, analgesic and
anti-inflammatory properties
- Works by blocking the production of prostoglandins
- Side effects: GI bleeding; increased blot clotting time,
increased production of viruses for those who have a cold or other
infection; Reye's Syndrome
- Overdose is best diagnosed by ringing in the ears
Analgesics - Acetaminophen
- A non anti-inflammatory analgesic.
- Also reduces fever.
- Believed to be safer than aspirin as long as dosage limits are
not exceeded
Analgesics - Ibroprofen
- An NSAID
- Strong anti-inflammatory drug, used to treat pain and
arthritis.
- Not listed as an effective anipyretic
- Can cause stomach bleeding, nausea and GI pain, possible liver
damage with long term use
Cold and Flu Remedies
- Antihistamines - Most common is chlorpheniramine maleate.
- Decongestants - common ones are ephedrine and
pseudoephedrine.
- Cough Suppressants - such as dextromethorphan
Antacids
- Calcium Carbonate (associated with acid rebound)
- Aluminum hydroxide (can cause constipation)
- Magnesium hydroxide (is both a laxative and antacid)
- Contraceptives
- Oral contraceptives, condoms, spermicides, and implanted drugs
are regulated by the FDA
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