Nonprescription Products

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CHAPTER 26 Nonprescription Products

I. Introduction

A. Nonprescription or over-the-counter (OTC) products are medicines that can be bought without a prescription. They are relatively safe and effective when directions on the label are followed and when used as the prescriber or health care professional directs.
B. These products are regulated by the Food and Drug Administration (FDA).
C. Reasons consumers self-diagnose and use OTC products

1. Products readily available in pharmacies and grocery stores
2. High insurance costs (for medication or doctor’s visits) or no insurance
3. Availability of information on the web (i.e., WebMD.com)
4. Time constraints (e.g., doctor’s visits, travel time, missed time from work)

D. There are more than 80 therapeutic categories of OTC drugs, ranging from acne drug products to weight-control drug products.
E. Common OTC products

1. Cough and cold
2. Otics
3. Ophthalmics
4. Pain, fever
5. Sleep aids, stimulants
6. Constipation, diarrhea, nausea, vomiting
7. Smoking cessation
8. First aid
9. Topical (e.g., for jock itch, lice)

F. Special considerations when using OTC products

1. Drug interactions (drug-disease, drug-drug, drug-food, drug-herbal)
2. Pediatrics
3. Pregnant, nursing
4. Geriatrics
5. Disease state

II. Cough and Cold

A. The common cold may involve the nose, throat, sinuses, eustachian tubes (connects the ears to the throat), trachea (windpipe), larynx (voice box), and bronchial tubes (airways).
B. The cause of developing a cold is due to a viral infection, including rhinoviruses (most common), coronaviruses, adenoviruses, echoviruses, respiratory syncytial viruses (RSV), and coxsackieviruses.
C. In response to infection, the immune system triggers a series of events, including release of inflammatory cytokines (a group of proteins that help regulate inflammation, blood cell production, and immunity), such as interleukin-6 (IL-6), interleukin-8 (IL-8), and granulocyte-macrophage colony-stimulating factor (GM-CSF), fluid leakage (runny nose), mucous membrane swelling (stuffy nose), increased mucous production, and stimulation of sneeze and cough reflexes.

1. Symptoms usually appear about 1 to 3 days after exposure to a cold virus. Nasal symptoms can begin as early as 2 hours after exposure; cough and sore throat symptoms usually begin 10–12 hours after exposure to the virus.
2. Signs and symptoms may include runny or stuffy nose, itchy or sore throat, dry cough, facial pressure due to sinuses (hollow bones in the front of the face), slight body aches or a mild headache, sneezing, itchy, watery eyes, low-grade fever (less than 102 °F), and mild fatigue (tiredness).
3. Nasal discharge may become thicker as the cold runs its course.
4. Colds last on average for 1 week. Mild colds may last only 2 or 3 days; severe colds may last a maximum of 2 weeks. Cough due to a cold can last hours or days.

D. Risk factors

1. Social activity

a) Being around children (teachers, day care workers)
b) Traveling in airplanes or buses
c) Being around people who are sneezing and coughing
d) Touching public railings and doors
e) Workplace
f) Healthcare workers

2. Age

a) Infants’ immune systems not fully developed
b) Colds generally occur less frequently with age

3. Seasonal changes

a) In cold months, air is dry and heating dries air even more.
b) In hot months, air conditioning dries air.
c) Dry air dehydrates the mucous membranes in the nose and throat, which are the first line of defense against the viruses. This allows the viruses to attack the tissue in the nose and throat.

4. Environmental toxins

a) Injure airways and damage the cilia

(1) Cigarette smoke
(2) Industrial smoke
(3) Other air pollutants

5. Lowered immunity
6. HIV
7. Cancer
8. Medications (e.g., corticosteroids, chemotherapy)
9. Stress
10. Too much exercise
11. Malnutrition
12. Lack of sleep

E. Treatment

1. There is no cure for the common cold.
2. OTC cold preparations may be used for symptoms.

a) Annually Americans spend about $2.9 billion on OTC drugs in addition to $400 million on prescription medicines for symptomatic relief from colds.

F. Pharmacological therapy

1. Pain relievers and fever reducers

a) Indication: fever, sore throat, body aches, and headache
b) Examples: acetaminophen (Tylenol), ibuprofen (Advil, Motrin)
c) Considerations

(1) Acetaminophen (Tylenol)

(a) Does not affect platelet function or increase blood clotting time
(b) Does not cause gastrointestinal (GI) irritation
(c) Analgesic-antipyretic of choice for children with viral infections or chicken pox (no risk for Reye syndrome)
(d) May be used in patients with gout taking probenecid
(e) Caution with use in patients with hepatic disease
(f) Acetaminophen can cause liver damage, especially if taken chronically, or in doses that exceed 4 grams daily

(2) NSAID (e.g., aspirin, ibuprofen)

(a) Upper GI disturbances are common
(b) Risk for increased bleeding
(c) Drug interactions: antacids, heparin, or oral anticoagulants
(d) Caution with use in patients with stomach ulcers, poor kidney function
(e) Duration of antipyretic effect may be slightly longer (3–4 versus 5 hours)
(f) It is recommended never to give aspirin to children ages 3 to 12 years old. Aspirin may play a role in causing Reye syndrome, a rare but potentially fatal illness in children with concomitant viral illness.

2. Decongestants help open swollen mucous membranes of the nasal passages so the individual can breathe easier.

a) Indication: nasal or sinus congestion
b) Decongestants include tablets, sprays, inhalers, and nose drops.
c) Examples

(1) Oral decongestant pseudoephedrine (e.g., Sudafed)

(a) Considerations: alpha-adrenergic activity; avoid use in patients with cardiac disease, hypertension, etc.
(b) Not recommended in the pediatric population because of the potential for cardiac stimulation, hypertension, or neurologic complications

(2) Nasal spray oxymetazoline 0.05% (Afrin), phenylephrine 0.5% (Neo-Synephrine)

(a) Considerations: use should not exceed more than 72 hours because of a tolerance effect and possible rebound congestion; purulent secretions present in the nose should be removed before administration.

(3) Nasal inhaler propylhexedrine (Benzedrex)
(4) Nasal inhaler levmetamfetamine (Vicks Vapor Inhaler)

d) Side effects

(1) Stinging, burning, sneezing, increased nasal discharge, drying of the nostrils, and altered taste may occur.
(2) Other side effects include rapid or pounding heartbeat, dizziness, trouble sleeping, shaking of the hands, and tremors.

e) Caution

(1) Nasal decongestants are safe for most patients, except people with heart disease, high blood pressure, thyroid disease, glaucoma (increased pressure in the eyes), diabetes, seizure disorders, or enlarged prostate, or by individuals using a monoamine oxidase inhibitor (MAOI).

f) Contraindications

(1) Nasal decongestants are not safe in individuals using a MAOI. Healthcare professionals recommend not using decongestants while pregnant or breastfeeding.

g) Counseling points

(1) Over time, decongestant nose drops, inhalers, and sprays can actually cause rebound congestion, which means the nasal passages are not able to function normally without using these medications.
(2) Prolonged use can also cause chronic inflammation of the mucous membranes.
(3) Decongestant nasal drops and sprays are not to be used for more than 3 days, which helps to stop the potential of nasal rebound.
(4) If symptoms worsen, a doctor may need to evaluate the situation.

3. Antihistamines

a) Indications: symptoms like runny or stuffy nose, itchy or sore throat, sneezing, and itchy, watery eyes
b) Examples

(1) First-generation, nonselective antihistamines that cause sedation

(i) Diphenhydramine (Benadryl)
(ii) Clemastine (Tavist-1)
(iii) Chlorpheniramine (Chlor-Trimeton)
(iv) Brompheniramine (Dimetane)

(2) Second-generation, selective, nonsedating antihistamines

(i) Loratadine (Claritin)
(ii) Cetirizine (Zyrtec)

c) Side effects

(1) Anticholinergic (mostly with first generation)

(i) Dry mouth
(ii) Dry eyes
(iii) Urinary retention
(iv) Constipation
(v) Elevated heart rate
(vi) Sedation

d) Caution

(1) Antihistamines can cause confusion and increased risk of falls if administered to elderly patients, particularly first-generation agents

4. Cough syrups

a) Indication: for symptomatic relief of cough associated with a cold.
b) Examples (Figure 26-1)

(1) Various combinations of antihistamines, decongestants, and cough suppressants
(2) If the cough is productive (brings up mucus), the ingredient guaifenesin can help break up the chest congestion (water intake is also important).
(3) If the cough is dry and hacking, a cough suppressant (dextromethorphan) can stop the cough.
c) Considerations

(1) Dextromethorphan

(a) Can use in pregnancy
(b) Less constipation than with use of opiate

(2) Codeine

(a) Can use in pregnancy

d) Caution

(1) Many doctors strongly discourage the use of these combination cough syrups for any child younger than 2 years old, in whom accidental overdoses could be fatal.

e) Counseling points

(1) Coughs associated with a cold usually last less than 2–3 weeks. If a cough lasts longer than 3 weeks, the patient should see a doctor.
(2) Cough due to colds in adults may be safely treated for as long as 7 days.
(3) The American Academy of Pediatrics highly recommends the use of calibrated measuring devices for the administration of all liquid medications to children and infants.

5. Lozenges

a) Indication: sore throat caused by a cold
b) Examples

(1) Lozenges for sore throat contain active ingredients such as the anesthetics benzocaine, menthol, dyclonine, phenol/sodium phenolate, and hexylresorcinol.

(a) Phenol/sodium phenolate and hexylresorcinol also have antibacterial properties.

c) Side effects are rare
d) Counseling points

(1) Experts recommend not self-treating sore throat for more than 2 days.
(2) If a sore throat lasts more than 7 days, healthcare professionals recommend seeing a doctor.

G. Nonpharmacological therapy can help reduce cold symptoms and is recommended by healthcare professionals for all infants younger than 9 months.

1. Rest and increased intake of fluids
2. Saline nasal drops
3. Nasal bulb aspirator
4. Elevating the head
5. Humidification
6. Petroleum jelly

III. Otics

A. Otic preparations (ear drops) are commonly used in adults and children and may be used to relieve pain, itching, and inflammation in the ear caused by ear infections, for example. Otic preparations can also be used to remove cerumen (ear wax) and to clear water from the clogged ear (ear drying aid).
B. They are made as solutions and suspensions.
C. Anti-infective

1. Indication: external ear infections, all are prescription-only medications
2. Examples

a) Neomycin and polymyxin B (AK-Spore HC, Cortisporin, and Otocort)

D. Anesthetics

1. Indication: ear pain, prescription only
2. Examples

a) Benzocaine (Americaine Otic and Otocain)
b) Combination of antipyrine (an anti-inflammatory) and benzocaine (Auralgan, Auroto, Otocalm)

E. Ear wax removal

1. Indication: to soften, loosen, and remove excessive ear wax
2. Examples

a) Carbamide peroxide (Murine, Debrox)
b) Carbamide peroxide with anhydrous glycerin (Physicians’ Choice Ear Drops Ear Wax Removal Kit)
c) Hypertonic seawater (EARinse)

F. Ear drying aid

1. Indication: water-clogged ear after swimming, showering, washing the hair
2. Examples

a) Isopropyl Alcohol (95%) in Anhydrous Glycerin (5%) (Auro-Dri and Swim-Ear)

G. Side effects

1. Dry skin
2. Itching
3. Skin rash
4. Redness
5. Swelling or other sign of irritation in or around the ear not present before use of this medicine

H. Counseling points

1. It is best to warm the ear drops to body temperature (37 °C or 98.6 °F) by holding the bottle in the hand for a few minutes and gently rolling the bottle before using the medicine. This helps to lessen the pain in the ear.
2. The individual must lie down or tilt the head so that the infected ear faces up.
3. The earlobe is gently pulled up and back for adults (down and back for children) to straighten the ear canal.
4. The medicine is then dropped into the ear canal as directed, keeping the ear facing up for approximately 5 minutes to allow the medicine to coat the ear canal.

a) For young children and other patients who cannot stay still for 5 minutes, keeping the ear facing up for at least 1 or 2 minutes may be best.
b) Watching television can also help keep children from moving around.

5. Cotton may be placed in the ear canal to keep the medicine from running out.
6. Keep the medicine as germ-free as possible, do not touch the dropper to any surface (including the ear), and keep the container tightly closed.
7. To help clear up the infection completely, the patient should keep using this medicine for the full time of treatment, even if the symptoms have disappeared, and do not miss doses.
8. Ask a doctor before use if a patient has:

a) Ear drainage or discharge
b) Ear pain
c) Irritation or rash in the ear
d) Dizziness
e) An injury or perforation (hole) of the eardrum
f) Recently had ear surgery

9. Stop use and ask a doctor if:

a) A patient needs to use more than 4 days
b) Excessive earwax remains after use of this product

IV. Ophthalmics

A. Ophthalmic products include eye drops and lubricants. They are commonly used to relieve redness, dryness, itching, and inflammation in the eye caused by seasonal allergies or from working in front of a computer, to name a few examples. Some ophthalmic products can also be used to rinse the eye of debris.
B. Ocular decongestants

1. Indication: redness of the eye
2. Examples

a) Naphazoline (Clear Eyes, AK-Con, or Opcon)
b) Tetrahydrozoline (Visine AC)
c) Naphazoline/Pheniramine combination (Opcon-A)

3. Side effects

a) Uncommon

4. Counseling points

a) These medications provide quick relief, but the effects usually only last a few hours. However, long-term use may worsen symptoms.
b) Overuse may cause the eyes to become red.

C. Antihistamines

1. Indication: swelling, redness, and itching of the eye
2. Examples

a) Ketotifen ophthalmic solution (Zaditor)
b) Antazoline phosphate (Vasocon-A)
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