Chapter 9
Over-the-Counter Medications
and Skin Care Products
Copyright © 2004 by Elsevier Inc. All rights reserved.
Introduction
• OTC medications–no prescriptions
necessary
• Drugs–common staples in home
medicine cabinet
• Acetaminophen (Tylenol), cough syrup,
Ibuprofen (Motrin)
• OTC drugs–50% medication purchased
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Introduction
• It is important that consumers learn
about appropriate dosages and proper
use of these medications
• Pharmacists need to know what OTC
medications are being taken
• Patients need to know what to avoid
• Buying drugs OTC–substantial savings
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Introduction
• Consumers use OTC products:
– To save money
– To be involved in their
own treatment
– Because they are more
readily available
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Over-the-Counter Drug
Considerations
• Wide variety of drugs
• Identify the cause of the problem
• Misuse of drugs–contribute to
hospital stays
• Expiration dates need to be checked
• Tamper-proof packaging needs to
be checked
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Over-the-Counter Drug
Considerations
• Dosages for children under 2 years
not recommended
• Many OTC medications have identical
ingredients
• Manufacturers swap “like ingredients”
without notifying the customer.
The label will show the change
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Over-the-Counter Drug
Considerations
• No adverse reaction reports required
• Patients with special diets, allergies,
diabetes, and other medications need
to exercise caution
• Extra care for babies and young
children when purchasing
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Three Categories of OTC Drugs
• FDA classification:
– Safe and effective for claimed
therapeutic indication
– Not recognized as safe and effective
– Additional data must determine
whether safe and effective
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FDA Regulations
• Five major safety areas:
– Purity
– Potency
– Bioavailability
– Efficacy
– Safety and toxicity
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Purity
• Purity of a product represents the lack
of contamination from environmental
factors of the chemical (drug)
contained in the product
• Additives include fillers, dyes,
solvents, buffers, and waxes
• Various ingredients increase the
size of the medication, decrease
absorption, improve taste
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Potency
• Refers to the strength of the drug
• Measurement done in grams,
milligrams, or micrograms
• Drug tested on research animals
• Strength measured in units
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Bioavailability
• Level at which a drug is both absorbed
and transported to the site of action
• Measured by the concentration of the
drug in the blood or tissue at the peak
time of administration
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Efficacy
• The ability of the drug to produce the
desired chemical change in the body
• Clinical trials judge effectiveness
• Variances affect end results
• Variance–unknown health conditions,
age, weight, lifestyle, gender, and
genetic influences
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Safety and Toxicity
• Represent opposite effects of a drug
being studied
• Lab animals used as test subjects in
beginning stages of trials
• Later years, published results include
effects of drugs on pregnancy
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Safety and Toxicity
• Any drug can be toxic if not taken
correctly
• Difference between toxic and desirable
effects documented
• Difference “margin of safety”
• Drug falls into “margin of safety” is
“therapeutic dose”
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How a Prescription Becomes
an OTC Drug
• Amount of research extensive
• FDA approves all new drugs entering
the marketplace
• FDA uses three phases of testing
• Monograph gives information about
a drug
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3 FDA Phases
OTC Drug Approval
• Phase 1: Advisers evaluate agent for
safety and efficacy
• Phase 2: Final review done on
ingredients
• Phase 3: After evidence presented
and all aspects of the agent
are exhausted, the final
monograph is published
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How a Prescription
Becomes an OTC Drug
• Agent meets criteria–approved as
an OTC drug
• Some legend drugs become
OTC– strength is lowered
• Legend Ibuprofen
(400 mg, 600 mg, 800 mg)
• OTC Ibuprofen (200 mg)
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How a Prescription
Becomes an OTC Drug
• FDA in charge of recalls
• Manufacturers must show consistency
between batches of drugs on a
day-to-day basis
• OTC drugs can be taken off the
market if not consistent
Copyright © 2004 by Elsevier Inc. All rights reserved.
Conditions Treated with
OTC Drugs
• Table 9.2 in the textbook lists the
most common OTC medications
with symptoms treated and route
of administration
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OTC Agents–Patient Information
• Analgesics and Antipyretics–help
reduce or relieve pain and fever
• Aspirin–antiinflammatory agent;
decreases platelets; prophylaxis to
decrease risk of blood clotting in
heart disease and stroke
• Associated with Reye’s syndrome
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Antiinflammatories
• Nonsteroidal antiinflammatory drugs
(NSAIDs)–treat inflammation
• Reduce pain
• Used as antipyretic and analgesic
• May cause drowsiness, upset stomach;
take with food or milk
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Analgesics
and Antipyretic Products
Condition
Product
Dosage Forms
Fever/pain
Acetaminophen
(Tylenol)
Tab, cap,
liq supp
Fever/pain
Aspirin (Bayer,
Alka-Seltzer)
Tab, cap,
powder
Fever/pain
Ibuprofen (Motrin)
Tab, cap, liq
Pain/arthritis
Capsaicin (Zostrix)
Top
Tab, Tablet; cap, capsule; liq, liquid; top, topical; supp, suppository.
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Allergy and Cold Agents
• Relief of common cold–decongestants
and antihistamines
• Decongestants dry out membranes,
open airways, cause vasoconstriction,
reduce congestion
• Antihistamines–used with allergic
symptoms; action blocks histamine
(H-1) that causes allergic reaction
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Decongestant Products
Condition
Product
Dosage Forms
Common
cold/allergies
Oxymetazoline
(Afrin)
Spray
Phenylephrine
(Neo-Synephrine)
Spray
Normal saline
(Ocean)
Spray
Pseudoephedrine*
(Sudafed)
Clemastine (Tavist)
Tab, cap, liq
Common cold
Tab, liq
Tab, Tablet; cap, capsule; liq, liquid.
*Pseudoephedrine (Sudafed) is a decongestant and is less likely to cause
drowsiness. It is used exclusively as a decongestant, not for allergies.
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Antihistamine Products
Condition
Product
Dosage Forms
Congested
Chlorpheniramine
(Chlor-Trimeton)
Tab, cap nose,
Diphenhydramine
(Benadryl)
Tab, cap, liq
Loratadine
(Claritin)
Tab, cap
sinus
Tab, Tablet; cap, capsule; liq, liquid.
*These agents also come in many combinations with agents that treat cough,
fever, and pain.
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Antihistamines
• First-generation–common side effect
is sleepiness
• Second-generation–require a
prescription
• May cause drowsiness
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Decongestants
• Indicated for stuffiness and congestion
of nasal passages and sinuses
• Acts to open passages and allow release
of mucus
• Used for chest congestion–permits
coughing up of phlegm
• Available in both OTC and prescription
preparations
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Headache Products
• Analgesics
• Some contain additives–caffeine
• Migraines–prescription drug required
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Headache Products
Condition
Product
Severe
headache/migraine
ASA/caffeine/
acetaminophen
combination (Excedrin)
Dosage Forms
Tab
Caplet
ASA/calcium
carbonate combination
(Bayer Women's Aspirin
Plus Calcium)
Acetaminophen/
caffeine combination
(Excedrin Tension
Headache [aspirin free])
ASA, Acetylsalicylic acid (aspirin); tab, tablet.
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Caplet
Interactions Between
Aspirin and Other Agents
• Table 9.8 in the textbook lists
common interactions
• Pharmacist alerted by technicians
about interactions
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Sleep Aid
• Diphenhydramine or magnesium
salicylate used to treat insomnia
• Anti-Insomnia products are listed in
Table 9.9 in the textbook
• Diphenhydramine–most commonly
prescribed agent ordered in hospitals
for sleep
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Sleep Aid
• May cause drowsiness
• Avoid alcoholic beverages
• Do not use if suffering with asthma,
glaucoma, emphysema, or an enlarged
prostate
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Cough
• Largest OTC section–cold and flu
• Congested coughs–expectorants
• Dry nonphlegm-producing coughs–
suppressant
• Do not use if suffering with asthma,
glaucoma, emphysema, heart
problems, or an enlarged prostate
Copyright © 2004 by Elsevier Inc. All rights reserved.
Cold and Cough Products
Condition
Product
Dosage Forms
Congested cough
Guaifenesin/
pseudoephedrine
(Robitussin PE)
Tab, liq, syr
Guaifenesin
(Robitussin)
Tab, cap, syr
Guaifenesin/
dextromethorphan
(Robitussin DM)
Liq, syr
Dry cough
Tab, Tablet; liq, liquid; syr, syrup; cap, capsule.
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Sore Throat Products
• Cold or flu–causes of sore, scratchy,
and dry throats
• Sore throat–can be symptom of Strep
throat (treat with antibiotics)
• Syrups and sprays–relieve throat pain
• Phenol, Menthol, alcohol, and
benzocaine
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Sore Throat Products
Condition
Product
Dosage Forms
Sore throat
Benzocaine
(Chloraseptic)
Lozenges
Dyclonine HCl
(Cepacol)
Lozenges
Dyclonine/alcohol
(Sucrets)
Lozenges
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Stomach Remedies
• Common upset stomach remedies
• Histamine-2 (H2) antagonists–decrease
acid secretions (heartburn)
• Proton pump inhibitors–relieve acid
secretions
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Stomach Products/Antacids
Condition
Heartburn
Antacids
Product
Cimetidine
(Tagamet-HB)
Ranitidine
(Zantac-75)
Famotidine
(Pepcid-AC)
Nizatidine
(Axid-AR)
Calcium hydroxate
(Tums)
Aluminum
hydroxide/magnesium
hydroxide/simethicone
(Mylanta)
Tab, Tablet; liq, liquid.
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Dosage Forms
Tab, liq
Tab
Tab
Tab
Chewable tab
Tab, liq, gelcap
Stomach Remedies
• Antacid agents–used to balance
pH level of the stomach
(decrease heartburn)
• Taken for short-term relief
of heartburn
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Intestinal Remedies
• Intestinal discomfort–constipation,
diarrhea, gas (flatulence)
• Intestinal products contain oil or
saline solution
• Diarrhea–anticholinergic agent, fiber
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Intestinal Products
Condition
Product
Dosage Forms
Constipation
Combination
stimulant (Ex-Lax)
Tab, chew tab
Docsuate sodium
(Colace)
gelcap
Loperamide
(Imodium A-D)
Tab, cap, liq
Stool softeners
Diarrhea
Flatulence
Simethicone
(Mylicon)
Irregular bowels
Psyllium
(Metamucil)
Tab, Tablet; cap, caplet; liq, liquid.
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Tab, chew tab,
liq
Powder
Intestinal Remedies
• Loperamide, Metamucil
• Most commonly used gas treatment–
simethacone (Gas-X)
• Laxatives–do not use if abdominal
pain, nausea, and vomiting are present
• Loperaminde–may cause drowsiness
or dizziness
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Skin Anatomy
• Skin–integumentary system, largest
organ in the body
• Includes–skin, hair, subcutaneous
tissues
• One of the most abused organs
in the body
• Protects the body, regulates
temperature, is a sensor or stimuli
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Skin Anatomy
• Keratin–top layer of skin; for protection
• Epidermis and dermis–layers beneath
keratin
• Below dermis–subcutaneous layer
of fat
• Epidermis–no blood flow of its own
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Skin Anatomy
• Dermis–much thicker; holds nerves,
blood vessels, and other connective
tissue
• Skin–can absorb moisture and
medications
• Diabetics–inject insulin subcutaneously
• Intradermal route–between the
dermis layer
• Intramuscular–into the muscle layer
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Anatomy of the Skin
Epidermis
Dermis
Adipose
Tissue
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Hypodermis
Conditions Affecting the Skin
• Common dosage forms and types
of conditions they treat are listed
in Table 9.14 in the textbook
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Skin Disorders and Medications
• Proper diagnosis–physical
assessment, family history, drug
history, lab tests, possible biopsy
• Two very common skin conditions–
sunburn and acne
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Sunscreen Skin
Protectant Factor
• SPF agents–topical form; prevent
sunburn
• UVA rays and UVB rays–two main
wavelengths of rays that cause
concern
• UV rays–cause premature aging,
changes in the DNA, erythema,
and blistering
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Sunscreen Skin
Protectant Factor
• Overexposure to the sun can cause
mutations in DNA
• Cancer can occur and discoloration
of prematurely aged skin
• Melanin–chemical for skin color
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Sunscreen Skin
Protectant Factor
• Two types of protectants:
– Sunscreens–protect from UVA
and UVB rays
– Sun blocks–reflect UV rays
• SPF factor important
• Choose coverage based on skin types
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Skin Protectant Factor Guide
for Application of Sunscreen
Skin Type
I
Skin Characteristics
After 10 Min Sun Exposure
Burns easily/rarely tans
Suggested
Minimum Coverage
20 to 30 SPF
II
Burns easily/tans minimally
12 to 20 SPF
III
Burns moderately/tans gradually
8 to 12 SPF
IV
Burns minimally/tans well
4 to 8 SPF
V
Rarely burns/always tans
2 to 4 SPF
VI
Never burns/deeply pigmented
None
SPF, Skin protectant factor.
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Acne Development
and Treatment
• Acne affects teenagers and adults
• Caused by hormonal changes and
genetics
• Hormones enlarge the glands of
the skin
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Acne Development
and Treatment
• Two productive glands:
– Sweat: regulate temperature
– Sebaceous: produce skin oil
or sebum
• Increased sebum traps bacteria
• Keep skin clean and free from bacteria
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Acne Development
and Treatment
• Acne classified into two groups:
– Noninflammatory–treatment is
mild medication (keratolytics)
– Inflammatory–Benzoyl peroxide
most common OTC product
recommended
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Acne Development
and Treatment
• Antibiotics used–tetracycline,
erythromycin, clindamycin
• Topical Agents–retinoic acid,
isotretinoin (Accutane), and tretinoin
(Retin A)
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Miscellaneous Skin Conditions
• Two categories:
– Noninfectious inflammatory
conditions
– Infectious inflammatory conditions
• See physician for persistent symptoms
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Hives/Inflammation
• Common noninfectious conditions
include: urticaria (hives), eczema
(red skin rash), psoriasis (plaques,
scaly skin), seborrheic dermatitis
(rash), and atopic dermatitis (rash)
• Topical agents: used for hives and
skin rashes causing inflammation
from severe itching
• Psoriasis: consult a doctor
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Infectious Inflammatory
Skin Conditions
• Warts–viral, contagious
(See Table 9.18 in the textbook)
• Genital warts–see doctor
• Athlete’s foot–caused by fungus; treat
with powdered antibiotics
(See Table 9.19)
• Canker sores–inside cheek of mouth;
small topical ulcers (See Table 9.20)
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Topical Antibiotics
• Used to treat abrasions, small cuts,
and scrapes
• Clean wound properly
• See the list of agents for treating
such wounds on the next slide
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Antibiotic Products
Product
Trade Names
Dosage Forms
Bacitracin
Bacitracin
Oint
Neomycin
Neomycin
Oint
Myciguent
Cream
Neosporin
Oint, cream
Polymyxin B,
neomycin,
bacitracin
Oint, Ointment.
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Psoriasis
• Genetic skin condition; cannot be
cured; lasts a lifetime
• Not contagious but looks bad
when inflamed
• Most affected areas: joints, limbs,
neck, scalp
• Potent drugs used: corticosteroids
(require physician’s prescription)
• Sunlight treatments
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