27. Nonprescription Medications - Amanda Howard-Thompson, PharmD, BCPS

27-1. Cough, Cold, and Allergy


The Consumer Health Care Products Association announced in October 2008 that manufacturers were voluntarily updating all cough and cold products to state "do not use" in children under age 4. These actions have not changed the official U.S. Food and Drug Administration (FDA) monograph for these drug products. The American Academy of Pediatrics would like the age limit increased to age 6 because of lack of clear evidence of efficacy. The FDA is currently investigating the use of these products in children age 4-6 to determine if further restriction is needed.


Selected cough products are shown in

Table 27-1.


• Upper respiratory infection (viral or bacterial)

• Sinusitis

• Rhinitis

• Asthma and chronic obstructive pulmonary disease

• Gastroesophageal reflux disease

• Congestive heart failure

• Drug-induced cough

Cough characteristics

• Productive

• Nonproductive


A cough is an important defense mechanism to rid the airways of mucus and foreign bodies. A cough may be acute (< 3 weeks duration) or chronic (> 3 weeks duration).

Nonprescription treatment

Antitussives and cough suppressants

Antitussives and cough suppressants may be narcotic or nonnarcotic.


Codeine, a narcotic, is the gold standard of antitussives:

• Availability: Without prescription in some states

• Mechanism of action: Centrally mediated suppression of cough

• Adult dose: 10-20 mg q4-6h (120 mg/d maximum)

• Role in therapy: Primarily for night cough

• Side effects: Sedation, nausea, and constipation


Dextromethorphan is only category I over-the-counter (OTC) nonnarcotic antitussive:

• Mechanism of action: Centrally mediated suppression of cough

• Adult dosage: 10-30 mg q4-8h (120 mg/d maximum)

• Role in therapy: Nonproductive cough

• Side effects: Drowsiness and gastrointestinal (GI) effects

• Drug interactions: Monoamine oxidase (MAO) inhibitors


Diphenhydramine is a category II antitussive:

• Mechanism of action: Centrally mediated suppression of cough center and anticholinergic

• Adult dosage: 25 mg q4h (75 mg/d maximum)

[Table 27-1. Selected Examples of Nonprescription Cough Products]


Guaifenesin (Robitussin, Mucinex, Humibid) is the only category I OTC expectorant:

• Mechanism of action: Thinning of mucus to enhance clearance

• Adult dosage:

• Immediate-release 200-400 mg q4h (maximum 2,400 mg/d)

• Extended-release: 600-1,200 mg q12h (maximum 2,400 mg/d)

• Role in therapy: Productive cough

• Side effects: GI discomfort

• Patient education: Increase fluid intake.

Topical antitussives

Of the volatile oils, only camphor and menthol are FDA approved:

• Mechanism of action: Local anesthetic effect in nasal mucosa

• Product availability: Lozenge, ointment, and steam inhalation

• Patient education: Ointment and solution are toxic if ingested.

Sore throat remedies

Sore throat remedies include the following:

• Saline gargle

• Sprays and lozenges:

• Benzocaine: Chloraseptic lozenges and Cepacol lozenges

• Dyclonine: Cepacol Spray

• Phenol: Chloraseptic Gargle

• Menthol: Halls

Common Cold


• Usually viral, most commonly rhinoviruses

• Transmitted through hand-to-hand contact followed by touching eyes or nasal mucosa


A cold results in the release of numerous inflammatory mediators, primarily cytokines.

Clinical presentation

• Sore throat, nasal symptoms, watery eyes, sneezing, cough, malaise, and low-grade fever occur.

• High fever and myalgias are more characteristic of influenza.

• There is a gradual onset with slow progression.

• Duration is 1-2 weeks.


Nonpharmacologic therapy

• Humidifiers

• Increase fluid intake

• Rest

Nonprescription medication treatment (symptomatic)

• Decongestants for nasal congestion

• Antihistamines for excess nasal discharge

• Analgesics for related pain or headaches

• Local anesthetic lozenges or sprays for sore throat (pharyngitis)

Allergic Rhinitis


Allergic rhinitis results from exposure to perennial or seasonal allergens, which lead to the development of nasal symptoms.


The pathophysiology of allergic rhinitis is complex, involving numerous mediators (primarily histamine) and cell types (mast cells).

Clinical presentation

• Nasal: Congestion, rhinorrhea, nasal pruritus, sneezing, and postnasal drip

• Ocular: Itching, lacrimation, redness, and irritation

• General: Headache, malaise, mood swings, and irritability


Nonpharmacologic therapy

Patients should avoid the offending allergens:

• Limit outside exposure during periods of high pollen.

• Avoid indoor and outdoor mold.

• Avoid dust, especially in the bedroom.

• Avoid pet dander, especially cats.

Pharmacotherapeutic options

• Mild allergies: Patients should use antihistamines as needed.

• Moderate allergies: Patients should use an antihistamine plus decongestant for nasal symptoms and an ophthalmic antihistamine for ocular symptoms.

• Chronic allergies: Use cromolyn sodium (Nasalcrom) nasal spray and scheduled nonsedating antihistamine.


Table 27-2. Selected Nonprescription Antihistamine Products]

Nonprescription Therapy for Treatment of the Common Cold and Allergies

Selected products for treating the common cold and allergies are shown in Tables 27-2,

27-3, and



Selected antihistamines are described in Table 27-2.


• Antihistamines are H1-receptor antagonists.

• First-generation antihistamines are nonselective and sedating.

• Second-generation antihistamines are peripherally selective, have low incidence of sedation, and have no anticholinergic effects.

Side effects

• Sedation

• Anticholinergic effects (primarily with first-generation antihistamines)

• Dry mouth

• Dry eyes

• Urinary retention

[Table 27-3. Selected Nonprescription Oral Decongestant Products]

[Table 27-4. Selected Nonprescription Cold, Allergy, and Sinus Combination Products]

• Constipation

• Paradoxical stimulation in some children and elderly patients

Precautions and contraindications

• Do not drive or operate heavy machinery.

• Avoid use with alcohol.

• Prostatic hyperplasia can occur.

• Narrow-angle glaucoma is possible.

Oral decongestants

Selected oral decongestant products are described in Table 27-3.


• α-adrenergic agonists and vasoconstrictors

• Constriction of blood vessels to decrease blood supply to nasal mucosa and decrease mucosal edema

• No effect on histamine or allergy-mediated reaction


The 2005 Combat Methamphetamine Epidemic Act has the following requirements:

• Pseudoephedrine must be kept either behind the counter or in a locked cabinet.

• Quantity is limited to 3.6 g/d and 9 g/month per patient.

• Pharmacists must maintain a logbook with the following information: product name, quantity sold, patient's name and address, and time and date of sale.

• Patients must show valid identification and sign a logbook.

Side effects

These products are relatively safe with no dependence. They can be used long term. The most common side effects are as follows:

• Nervousness

• Irritability

• Restlessness

• Insomnia

Less common side effects include the following:

• Increased heart rate

• Increased blood pressure

• Irregular heartbeat

• Palpitations

Precautions and contraindications

• Hypertension: These agents are generally accepted with mild or well-controlled hypertension; they should not be used with uncontrolled hypertension.

• Heart disease (arrhythmias and ischemic heart disease): They increase the heart rate.

• Diabetes: They have a minimal effect on blood sugar level.

• Hyperthyroidism: This condition is more sensitive to sympathomimetics.

• Enlarged prostrate: Benign prostatic hyperplasia (BPH) is exacerbated by constricting smooth muscle of the bladder neck.

• Narrow-angle glaucoma: Dilation increases intraocular pressure.

• Blood pressure: MAO inhibitors interact with decongestants to increase blood pressure.

Topical decongestants


• α-adrenergic agonists act locally as vasoconstrictors.

• These agents constrict blood vessels, decrease blood supply to nose, and decrease mucosal edema.

• They have no effect on histamine or allergy-mediated reaction.

Side effects

Minimal systemic absorption results in few side effects. Local effects may include burning, nasal irritation, and sneezing.

Precautions and contraindications

Rhinitis medicamentosa (rebound congestion) may occur if duration of use is > 3-5 days.

Dosage forms


Sprays are the simplest dosage delivery. A large surface area is covered. Imprecise dosing and contamination of the bottle are possible. Products include the following:

• Short-acting: Phenylephrine (Neo-Synephrine and Vicks Sinex)

• Longest-acting: Oxymetazoline (Afrin and Mucinex)


Drops are preferred for use in small children. They cover a small surface area. They pass to the larynx, where they may be swallowed and result in systemic effects.

Nasal inhaler

A nasal inhaler requires an unobstructed airway to deliver drug to the nasal mucosa. Nasal inhalers contain sympathomimetic amines, as well as camphor and menthol. Medications lose efficacy after 2-3 months. Products include the following:

• Propylhexedrine (Benzedrex inhaler)

• Levodesoxyephedrine (Vicks inhaler)

Nasal saline solution

This solution is very safe and is good for use in infants and children. It can be used with oral decongestants. Products include the following:

• Saline drops (Ayr)

• Saline sprays (Ayr, Ocean Nasal Spray, and HuMist)

Cromolyn (Nasalcrom)

Cromolyn is used to prevent and treat allergic symptoms:

• Pharmacology: Mast cell stabilizer; prevention of the mast cells from releasing inflammatory mediators

• Dosage: One spray per nostril q4-6h up to four to six times daily

• Onset of action: Approximately 1 week; 2-3 weeks for maximal effect

• Efficacy: Not efficacious if taken prn; must be taken on a scheduled basis

• Side effects: Nasal irritation, nasal burning, stinging, sneezing, cough, unpleasant taste


Analgesics treat the pain, fever, and headaches associated with cold, flu, or allergies. Medications include the following:

• Aspirin (mostly replaced now by acetaminophen and nonsteroidal anti-inflammatory drugs [NSAIDs])

• Acetaminophen (N-acetyl-para-aminophenol, or APAP)


• Ibuprofen

• Ketoprofen

• Naproxen

27-2. Constipation

Clinical Presentation

• Patient has difficult or infrequent passage of stools.

• Patient may complain of abdominal or rectal fullness.


Table 27-5 shows the common causes of constipation.


Nonpharmacologic therapy

• Increase fluid intake.

• Increase dietary fiber.

• Exercise.

• Establish good bowel habits.

Nonprescription medication therapy

Bulk-forming laxatives

Selected bulk-forming laxative products are described in

Table 27-6.

Mechanism of action

Natural or semisynthetic hydrophilic polysaccharide derivatives are present in bulk-forming laxatives. They absorb water to soften stool, increase bulk, and facilitate peristalsis and elimination. Effects may not be seen for 2-3 days.

Role in therapy

Bulk-forming laxatives are the safest, most natural therapy for constipation. They are the most often recommended medication for chronic use.

[Table 27-5. Common Causes of Constipation]

[Table 27-6. Additional Nonprescription Treatments of Constipation Not Listed in Text]

Drug interactions

• These laxatives may bind with digoxin, warfarin, and other drugs.

• Calcium complexes may bind with tetracycline, inhibiting its absorption.

• Recommend separating doses from other medications.

Side effects

• Potential exists for allergic reaction or anaphylaxis.

• Inhalation of powder is reported to cause bronchospasm.

• Caution diabetics about sugar content of some products.

Emollient laxatives (stool softeners)

Emollient laxatives act as surfactants, absorbing water into the stool. Effects may take 2-3 days. Emollient laxatives may cause systemic absorption of mineral oil; therefore, concurrent use is contraindicated.

Emollient laxatives are often used in combination products. They are useful for patients who should avoid straining during the following:

• Rectal surgery

• Postpartum time period

• Recent myocardial infarction

Selected emollient laxative products are described in Table 27-6.

Stimulant laxatives

Stimulant laxatives stimulate bowel motility through localized mucosal irritation. They increase secretion of fluids into bowel. They can cause cramping. Impaired colon function occurs with chronic use.

Dangers of chronic stimulant laxative use include the following:

• Laxative habit

• Cathartic colon

• Melanosis coli

• Loss of fluids on electrolytes

• Cramping pains


Senna (Senokot and Ex-Lax) is an anthraquinone:

• Pharmacology: Anthraquinones are absorbed into bloodstream with action on the large intestines. Onset of effects is 6-12 hours. This medication should be taken at bedtime.

• Side effects: Such effects include discoloration of urine, stimulant habituation, and melanosis coli (i.e., dark pigmentation of colonic mucosa).

• Precautions and contraindications: Do not take while breast-feeding.


Bisacodyl (Dulcolax tablets or suppositories) is a diphenylmethane. Minimal systemic absorption occurs with this drug. Bisacodyl is the only stimulant compatible with breastfeeding. This medication is enteric coated: do not crush or take with antacids. The onset of effects varies with route of administration:

• Oral: 6-8 hours

• Rectal: 15-60 minutes

Stimulant oils

Castor oil is a stimulant oil that acts on small intestine. It is a strong cathartic and may induce fluid or electrolyte disturbances. Onset is rapid: 2-6 hours. Castor oil is contraindicated in pregnancy because it may induce labor.

Hyperosmotic laxatives


Glycerin has an osmotic effect and is a local irritant that stimulates bowel movement. Onset of action is usually within 30 minutes. Glycerin suppositories are safe for infants.

Products include Fleets Babylax Liquid and Fleet Glycerin Suppository.

Polyethylene glycol 3350

Polyethylene glycol 3350 was approved for OTC status in October 2006. Its mechanism of action is similar to that of glycerin. This agent is meant for short-term therapy for constipation. Onset of action is usually within 1-3 days. The adult dosage is 17 grams of powder in 4-8 ounces of water. Side effects are as follows:

• Bloating

• Abdominal discomfort

• Cramping

• Flatulence

Products include MiraLAX.

Saline laxatives

With saline laxatives, nonabsorbable cations create osmotic gradient to pull water into intestine. Onset varies depending on the route of administration:

• Rectal: 5-30 minutes

• Oral: 30 minutes to 4 hours

Twenty percent of magnesium may be absorbed systemically.

Saline laxatives are contraindicated in patients with impaired renal function (magnesium- or phosphate-containing), congestive heart failure, or hypertension (sodium-containing).

Selected saline laxative products are described in Table 27-6.

Lubricant laxatives

Selected lubricant laxative products are as follows:

• Mineral oil: Liquid petrolatum

• Olive oil: "Sweet oil"

Lubricant laxatives soften the feces by emulsifying the contents of the intestinal tract. Onset of action is 6-8 hours.

These agents may decrease absorption of fat-soluble vitamins and some drugs. They are contraindicated in children and elderly patients because of the risk of aspiration and lipid pneumonitis. Do not administer with stool softeners.


Enemas include Fleet Enema (monobasic and dibasic sodium phosphates). They have the following characteristics:

• Oil retention

• Soap suds

• Warm tap water

Special patient populations

Care must be taken with patients who are pregnant:

• Hormonal changes cause smooth muscle relaxation early in pregnancy.

• An enlarged uterus compresses the colon.

• Recommend only bulk-forming laxatives or stool softeners.

27-3. Diarrhea

Clinical Presentation

Diarrhea is the abnormal increase in frequency of stools and stool looseness. It may be acute (< 14 days) or chronic (> 4 weeks).


Common causes of diarrhea are shown in

Table 27-7.


• Dehydration (especially in infants and elderly patients)

• Electrolyte abnormalities

Nonpharmacologic Treatment

• Administer oral rehydration therapy, such as Pedialyte.

• Avoid fatty and spicy foods and those with high sugar content.

[Table 27-7. Common Causes of Diarrhea]

Nonprescription Medication Therapy

Loperamide (Imodium AD)

Loperamide is a synthetic opioid agonist that slows GI motility. The dosage is 4 mg initially and then 2 mg after each loose stool. For OTC use, maximum dose is 8 mg/d, but it can be increased to 16 mg/d with medical supervision.

The medication is well tolerated, but side effects are as follows:

• Constipation

• Dizziness

• Dry mouth

Precautions and contraindications are as follows:

• Loperamide is not recommended for children under age 6 without medical supervision.

• It should not be used if the patient has bloody or black stool; consult physician before use if the patient has a fever, mucus in stool, or a history of liver disease.

• Antiperistaltic action could worsen effects of invasive or inflammatory bacterial infection.

Bismuth subsalicylate

Bismuth subsalicylate (Pepto-Bismol) reacts with stomach acid to form salicylic acid and bismuth oxychloride. It reduces frequency of diarrhea and improves stool consistency. It has a direct antimicrobial effect; therefore, it is effective in traveler's diarrhea.

Side effects include the following:

• Salicylate toxicity (tinnitus)

• Bismuth toxicity (neurotoxicity)

• Gray-black discoloration of tongue or stool

The medication is contraindicated in the following:

• Aspirin allergy

• Children and teens with viral illness (Reye's syndrome)

• Patients having a history of GI bleeding, or using warfarin

New labeling recommends a physician should be consulted prior to use in patients younger than age 12.

27-4. Nausea and Vomiting


• Nausea: The sensation that one is about to vomit.

• Vomiting: The forceful expulsion of gastric contents through the mouth.


Vomiting is coordinated by the vomiting center in the medulla. Stimuli from the peripheral nervous system and within the central nervous system (CNS) act on the vomiting center. Responding to these impulses, the vomiting center stimulates the abdominal muscles, stomach, and esophagus to induce vomiting.


Common causes of nausea and vomiting are shown in

Table 27-8.


• Dehydration

• Electrolyte imbalance

• Aspiration

• Malnutrition

• Acid-base disturbances

Nonprescription Medication Therapy

In addition to the medications described in this section,

Table 27-9 describes drugs of choice for the nausea or vomiting associated with motion sickness.


Antihistamines cross the blood-brain barrier to depress vestibular excitability.

Phosphorated carbohydrate solution (Emetrol)

This agent is a hyperosmolar solution. It is a mixture of levulose (fructose), dextrose (glucose), and phosphoric acid. It is buffered to a pH of 1.5. It reduces gastric muscle contraction through an unknown direct effect. It must not be diluted (which raises the pH).

Bismuth salts (Pepto-Bismol)

Bismuth salts are available as nonprescription suspension, caplet, and chewable tablet. See Section 27-3 for additional information.

Histamine 2-receptor antagonists

Histamine 2-receptor antagonists (H2RAs) may provide symptomatic relief by inhibiting gastric acid secretion. Potential drug interactions occur with cimetidine.

Side effects are as follows:

• Headache

• Constipation

• Diarrhea

See Section 21-1 on peptic ulcer disease in Chapter 21 for additional information on H2RAs.


Antacids may treat nausea, dyspepsia, and stomach upset associated with excessive intake of food or drink. They are combinations of magnesium hydroxide, sodium salts, aluminum hydroxide, calcium carbonate,

[Table 27-8. Common Causes of Nausea and Vomiting]

[Table 27-9. Nonprescription Drugs of Choice for Prevention of Motion Sickness]

and magnesium carbonate. The usual adult dosage is 15 mL 30 minutes after meals and at bedtime.

Side effects include the following:

• Constipation

• Diarrhea

• Sodium overload

Antacids may decrease absorption of some medications. Therefore, administer other medications 1-2 hours before or after antacids.

Nausea may be associated with pregnancy, especially during the first trimester. Nonpharmacologic therapy is recommended in such cases:

• Eat small, frequent meals.

• Avoid rich, fatty foods.

• Snack on salty crackers or pretzels.

Refer the patient to the primary care provider if pharmacologic therapy is being considered.

27-5. Pain and Fever

Pathophysiology of Pain

Nociceptors are peripheral pain receptors. They send pain stimuli to the spinal cord through afferent, nociceptive nerves. Impulses then pass to the brain through dorsal root ganglia.

Pathophysiology of Fever

The core temperature is the temperature of the blood surrounding the hypothalamus. The thermoregulatory center in the anterior hypothalamus controls body temperature through physiologic and behavioral mechanisms. Pyrogens—fever-producing substances—increase the thermoregulatory set point, raising the body temperature.

Nonprescription Medication Therapy

Selected analgesic and antipyretic products are shown in

Table 27-10.


Acetaminophen exerts analgesic and antipyretic activity through central inhibition of prostaglandin synthesis. It does not have peripheral anti-inflammatory activity.

Acetaminophen is generally well tolerated; however, hepatotoxicity is a possible side effect.

[Table 27-10. Selected Analgesic and Antipyretic Products]

Drug interactions can occur as follows:

• Alcohol: Risk of hepatotoxicity is increased.

• Warfarin: Higher doses may enhance hypoprothrombinemic effect of warfarin.

Patients should be aware of the following precautions and contraindications:

• Increased risk of hepatotoxicity

• Dose > 4 g/d

• Preexisting liver disease

• Alcohol use

• Fasting

Use is accepted during pregnancy and breast-feeding.


Salicylates inhibit peripheral prostaglandin synthesis. They reduce pain, inflammation, and fever. Acetylated salicylates (e.g., aspirin) inhibit platelet aggregation. Nonacetylated salicylates (e.g., prescription salsalate, choline magnesium salicylate) do not have significant antiplatelet activity.

Several side effects are associated with salicylates:

• Gastritis

• Gastric ulcers and bleeding

• Allergy and hypersensitivity:

• Rare (< 1%) in the general population

• Higher risk in individuals with asthma and nasal polyps

• Reye's syndrome, a potentially fatal illness associated with salicylate use in children and teens with concurrent viral illness (influenza, varicella-zoster)

Drug interactions may occur:

• Alcohol: Gastrointestinal toxicity is enhanced.

• Methotrexate: Salicylates displace methotrexate from protein-binding sites.

• Warfarin: Salicylates enhance hypoprothrombinemic effects of warfarin.

Patients should be aware of the following precautions and contraindications:

• Bleeding disorders

• Hemophilia

• Peptic ulcer disease

• Children or teenagers with viral illness (Reye's syndrome)

• Gout

Salicylates should be avoided in the third trimester of pregnancy.

Nonsteroidal anti-inflammatory drugs

NSAIDs provide peripheral inhibition of prostaglandin synthesis. They offer analgesic, antipyretic, and anti-inflammatory activity.

The ketoprofen (Orudis KT) OTC formulation was discontinued by the manufacturer because of lack of consumer demand.

Side effects include the following:

• Gastrointestinal effects, including bleeding

• Rash

• Photosensitivity

• High incidence of cross-reactivity in individuals with aspirin allergy

Drug interactions may occur as follows:

• Warfarin: Increased bleeding risk

• Alcohol: Increased risk of gastrointestinal bleeding

• Methotrexate: Decreased methotrexate clearance

• Antihypertensives:

• Angiotensin-converting enzyme (ACE) inhibitors: Decreased hypotensive effects, hyperkalemia

• β-blockers: Decreased hypotensive effects

• Potassium-sparing diuretics: Hyperkalemia

• Digoxin: Decreased renal clearance, risk of digoxin toxicity

Precautions and contraindications are as follows:

• Alcohol (increased risk of GI bleeding)

• Renal impairment

• Congestive heart failure

Special patient populations should be aware of the following:

• Ibuprofen and naproxen are compatible with breastfeeding.

• Avoid NSAIDs in third trimester of pregnancy.

27-6. Ophthalmic Disorders

Dry Eye

• Definition: Tear film instability caused by a deficiency of any component of the tear film

• Clinical presentation: Ocular discomfort, blurred vision, desire to rub the eyes, and burning or redness


• Aqueous tear deficiency

• Exposure to dry air

• Keratoconjunctivitis sicca

• Sjogren's syndrome

• Blepharitis

• Vitamin A deficiency

• Allergic conjunctivitis

• Contact lenses

• Drug-induced (anticholinergic agents and antihistamines) condition

Nonpharmacologic treatment

• Avoid known irritants.

• Use a cool-mist humidifier or warm-steam vaporizer.

Nonprescription medication therapy

Table 27-11 describes the pharmacologic treatment of dry eyes.

Loose Foreign Material in the Eye


Symptoms include irritation, inflammation, involuntary tearing, uncontrollable blinking, and discomfort.


Foreign materials may include dirt, an eyelash, or particles suspended by the tears.

Nonprescription treatment

Eyewashes are isotonic, buffered solutions of sterile water. They should not be used if the patient has open wounds near the eye. Contact lens wearers should remove their lenses prior to using eyewashes. Use of eye cups should generally be avoided.

Redness Caused by Minor Irritation


Eye redness can be caused by airborne pollutants (gases or smoke), chlorinated water, infectious diseases, or glaucoma.

Nonprescription treatment

Ophthalmic vasoconstrictors, as described in

Table 27-12, are used to treat eye redness.

The medications constrict blood vessels of the conjunctiva. Instill 1-2 drops in the affected eye up to four times daily. Minimize systemic absorption by closing the eye after instillation and occluding the tear duct with a finger (punctual occlusion).

These agents are contraindicated in patients with narrow-angle glaucoma because they cause mydriasis. Contact lens wearers also should avoid ophthalmic vasoconstrictors.

A rebound hyperemia can occur, especially with overuse. Tachycardia and aggravate arrhythmias can occur if absorbed systemically.

[Table 27-11. Pharmacologic Treatment of Dry Eyes]

[Table 27-12. Ophthalmic Vasoconstrictors]

Ocular decongestants should be avoided in patients with heart disease, high blood pressure, an enlarged prostate, or narrow-angle glaucoma.

Allergic Conjunctivitis


Symptoms include chronic and recurring itching. Eyes are slightly red and tear and burn, but they have little discharge.


Animal hair, pollen, ragweed, or plants are possible allergens.

Nonprescription treatment

Antihistamine and mast cell stabilizer

Ketotifen fumarate 0.025% (Zaditor and Alaway), an antihistamine and mast cell stabilizer, may be used to treat allergic conjunctivitis. Instill 1 drop q8-12h in the affected eye. Use in patients ≥ 3 years of age. Relief is provided within minutes, and effects may last up to 12 hours.

Combination products

The following combination products containing an ophthalmic vasoconstrictor and an ocular antihistamine may be used:

• Naphazoline + pheniramine (Naphcon A, Visine A, and Opcon-A)

• Naphazoline + antazoline (Vasocon-A)

Instill 1-2 drops in the affected eye up to four times daily.

Combination products containing ocular decongestants should be avoided in patients with heart disease, high blood pressure, enlarged prostate, or narrow-angle glaucoma.

Conditions Requiring Referral to a Physician or Eye Care Specialist

Corneal edema


Symptoms include foggy vision, haloes around lights, photophobia, irritation, sensation of a foreign body, and extreme pain.


Prolonged contact lens wearing, infection, glaucoma, and iritis are possible causes.

Nonprescription treatment

Sodium chloride (2-5%) can be used to treat corneal edema. Instill 1-2 drops in the affected eye every 6 hours. If eye drops do not provide relief, add ointment to therapy.

Foreign body in the eye

Foreign bodies include metal shavings, wood splinters, and dust. Improper removal may lead to permanent damage.

Ocular trauma

Automobile accidents and sports injuries can result in ocular trauma.

Chemical exposure

If chemical exposure occurs, follow these steps:

• Remove contact lenses.

• Flush eye immediately with lukewarm water for at least 15 minutes.

• Do not place drops in the eyes.

27-7. Otic Disorders

Impacted Cerumen

Cerumen-softening agents

Cerumen-softening agents are used as follows:

• Instill in ear.

• Follow with warm water irrigation using otic syringe.

Various types of agents are available:

• Carbamide peroxide 6.5% in anhydrous glycerin: Products include Debrox and Murine Earwax Removal System. This agent softens ear wax and facilitates its removal.

• Hydrogen peroxide and water: A 1:1 solution of warm water and 3% hydrogen peroxide is used. This mixture is not an effective drying agent.

• Glycerin: This emollient and humectant may facilitate the removal of ear wax.

• Olive oil: Sometimes called sweet oil, olive oil can also be used.

Water-Clogged Ears

A solution of 95% isopropyl alcohol in 5% anhydrous glycerin (Swim Ear or Auro Dri Drops) may be used to treat water-clogged ears. This solution is the only FDA-approved ear-drying aid.

A compounded solution 50:50 acetic acid (5%) + isopropyl alcohol (95%) may also be used. This combination is recommended by the American Academy of Otolaryngology.


Boils occur when hair follicles in the ear canal become infected. They are usually self-limiting. They are treated by applying a warm compress.

27-8. Home Monitoring and Test Devices

Fertility Prediction Tests

Basal thermometry

Temperatures can be taken orally, rectally, and vaginally. Temperatures are taken every morning before arising.

Resting temperatures are usually below normal for first part of the reproductive cycle. Temperatures are closer to normal after ovulation.

Temperature results are plotted graphically against time to assess spikes (ovulation). Tests are very user dependent.

Bioself, Fertility Indicator

This device is used to take digital temperature readings. The user must input the first day of menses into the device. The device calculates user's average cycle length and predicts the user's most fertile period.

Each morning, the indicator displays a prediction (90% effective). The device indicates if the user is in a nonfertile phase, if conception is possible, or if the user is in the most fertile phase. The user can obtain a printout through modem download.

Ovulation prediction kits

This test contains antibodies that bind to the lutenizing hormone (LH) in urine. An LH surge is detected by a difference in color or color intensity from one day to the next.

Early morning urine collection is recommended. The user must know the length of the past three cycles before using. Testing usually begins 2-4 days prior to ovulation (based on the average of the past three cycles).

Pregnancy detection

Early testing is very important. Tests detect levels of human chorionic gonadotropin (hCG) in urine (within 1-2 weeks after conception). Antibodies designed to react with hCG form the shape of a straight line, check, or plus sign. If the user is pregnant, color is produced.

Pregnancy tests are 98-100% accurate; however, human error decreases that rate to 50-75% (see

Table 27-13).

Important tips for patients using pregnancy tests follow:

• Use of first morning urine to test is encouraged because hCG is more concentrated.

• If use of first morning urine is not possible, the patient should restrict fluids 4-6 hours before urine collection.

• Use only supplied collection devices.

• Try to test the sample immediately after collection. If this is not possible, allow refrigerated samples to come to room temperature.

[Table 27-13. Causes of Error in Home Pregnancy Testing]

• If the test is negative, wait 1 week and retest if the cycle has not yet started.

• If the test is positive, contact an obstetrician-gynecologist immediately and start prenatal vitamins.

Urinary Tract Infection Tests

Two categories are available:

• Tests for nitrites in urine (UTI Bladder Infection Test)

• Tests for nitrites and leukocyte esterase (AZO strips)

Both are specific only for gram-negative organisms.

Inaccurate results are possible in the following circumstances:

• False-negative result: Vegetarian diet, vitamin C, or tetracycline

• False-positive result: Phenazopyridine


Mercury column devices

These devices use a blood pressure reference standard. Routine home use is discouraged because the devices are cumbersome.

Aneroid devices

Aneroid devices are light, portable, and affordable. Many come with an attached stethoscope. They require good eyesight and hearing for effective use (large-print devices are available).

Digital devices

Digital devices are less accurate than aneroid devices.


CholesTrak Home Cholesterol Test

This test checks for total cholesterol only. Results are available without the need for a lab.

Biosafe Total Cholesterol Panel

Fingerstick blood is placed on a small collection card. The sample is mailed to Biosafe Lab. Results for a whole lipid profile are given. A licensed doctor reviews the results before they are sent to the patient.


Cardiocheck has the potential to test for TC (total cholesterol), HDL (high-density lipoprotein), and TG (triglycerides). LDL (low-density lipoprotein) must be calculated.

The unit stores results. It is reusable.

Fecal Occult Blood Tests

Three categories are available:

• Toilet tests (EZ-Detect Stool Blood Test), which use biodegradable paper that is placed in the toilet bowl after a bowel movement

• Stool wipes (LifeGuard)

• Manual stool application tests (Colon-Test-Sensitive)

A colorimetric assay is used for hemoglobin. A blue-green color indicates a positive test.

Tests are more likely to detect lower GI problems. False-positive test can occur with the ingestion of red meat or vitamin C.

Acquired Immune Deficiency Syndrome (AIDS)

Home Access and Home Access Express HIV-1 tests check for antibodies to HIV (human immunodeficiency virus). Patients should be aware that it can take 3 weeks to 6 months before antibodies are detectable following infection.

A fingerstick blood sample is placed on the specimen card. The card is mailed to the lab within 10 days. Home Access provides results in 7 days. Home Access Express provides results in 3 days.

27-9. Smoking Cessation


Unless the patient has contraindications, pharmacotherapy should be offered to all patients attempting to quit smoking (

Table 27-14).

First-line agents double long-term smoking abstinence rates:

• Nicotine replacement therapy (NRT):

• Nicotine gum (Nicorette and generic): OTC

• Nicotine patch (Nicotrol, Nicoderm CQ, and generic): OTC

• Nicotine lozenge (Commit): OTC

• Nicotine inhaler (Nicotrol inhaler): prescription only

• Nicotine nasal spray (Nicotrol NS): prescription only

[Table 27-14. The "5 A's" Clinicians Should Use to Assist Patients in Smoking Cessation]

• Bupropion SR (Zyban): prescription only

• Varenicline (Chantix): prescription only

Second-line agents are available if patients fail or cannot tolerate first-line agents:

• Clonidine

• Nortriptyline

Combination NRT

Combining the nicotine patch with a self-administered form of NRT (either the nicotine gum or nicotine nasal spray) is useful for some patients. Combined treatment should be recommended if the patient is unable to quit using a single type of first-line pharmacotherapy.

Side Effects

NRT can have various side effects:

• Gum

• Patients may experience an unpleasant taste, mouth irritation, jaw muscle soreness, hypersalivation, hiccups, and dyspepsia.

• Gum can stick to dental work.

• Warn patients against chewing the gum too fast.

• Patients with temporomandibular joint pain may want to avoid gum.

• Lozenge

• Mouth irritation, nausea, hiccups, cough, heartburn, headache, flatulence, and insomnia can occur.

• Do not use more than one lozenge at a time.

• Patch

• Local skin reactions (erythema, burning, pruritis) can occur. Treat by rotating sites or applying hydrocortisone or triamcinolone cream.

• Vivid or abnormal dreams, insomnia, and headache can arise. These effects are more common in the 24-hour patch. Patients can minimize the effects by using the 16-hour patch or by removing the patch at night before bed.

Contraindications and Precautions

Cardiovascular disease is a contraindication in the following cases:

• < 2 weeks following myocardial infarction

• Serious arrhythmias

• Serious or worsening angina

Esophagitis and peptic ulcer disease is contraindicated with the gum form.

NRT patients should seek medical advice if they are pregnant or breast-feeding.

Patients should not smoke while using NRT.

Allergies, asthma, and sinus conditions are contraindicated with the nasal spray.

27-10. Natural and Herbal Products

Complementary and Alternative Medicine Definitions

• Conventional treatment: Medical practices widely accepted and practiced by the mainstream medical community

• Complementary therapy: Therapy used in addition to conventional treatments.

• Alternative therapy: Therapy used instead of conventional treatments.

• Dietary supplement: According to the Dietary Supplement and Health Education Act of 1994, "a product intended to supplement the diet that . . . contains one or more of the following dietary ingredients: a vitamin, mineral, herb, or other botanical, amino acid; a dietary substance for use by man to supplement the diet by increasing the total daily intake; or a concentrate, metabolite, constituent, extract, or combination of these ingredients"

Regulation of Dietary Supplements

Dietary supplements are not regulated as closely as drugs.

Table 27-15 provides a comparison.

The following agencies are responsible for regulation:

• U.S. Food and Drug Administration: Regulates labeling, safety, and manufacturing

• U.S. Federal Trade Commission: Regulates advertising

[Table 27-15. Drugs versus Dietary Supplements]

Herbal Products

Alpha lipoic acid

Common uses

Alpha lipoic acid is used for diabetic peripheral neuropathy.

Proposed mechanisms

This product is thought to be a cofactor for several enzymes required for glucose metabolism. It is believed to allow for increased glucose uptake and is considered a chelating and antioxidant agent.


The dosage is 600 mg tid orally, taken on an empty stomach and separated at least 2-3 hours from the ingestion of antacids.

Side effects

Side effects include headache, nausea, allergic rash, and hypoglycemia.


Patients with thyroid disease should not take this product.

Asian ginseng (Panax ginseng)

Common uses

Asian ginseng is taken to decrease fatigue and enhance concentration.

Proposed mechanisms

This product is thought to suppress and stimulate the CNS. Corticosteroid activity and hypoglycemic activity are considered to occur.


The dosage is 1-2 g of crude root or 100-400 mg of ginseng extract tid.

Side effects

Side effects are hypertension; euphoria, restlessness, nervousness, and insomnia; rash; edema; and diarrhea.


Contraindications are as follows:

• Renal failure

• Acute infection

• Pregnancy and lactation

• Active bleeding (peptic ulcer)

Ginseng should be stopped 7-10 days prior to surgery to avoid potential bleeding complications.


Caution is warranted in the following circumstances:

• Cardiovascular disease

• Hypertension with or without medical treatment

• Diabetes (specifically with patients receiving medications that may cause hypoglycemia or having diagnosis of hypoglycemia unaware)

• History of hypotension


• Risk with anticoagulants and antiplatelet agents (aspirin, ticlopidine, clopidogrel, dipyridamole, warfarin) and other herbs (ginkgo, garlic)

• Stimulants (including caffeine)

• Antipsychotics

Coenzyme Q10 (Ubiquinone)

Common uses

Coenzyme Q10 (CoQ10) is commonly used for cardiovascular conditions.

Proposed mechanisms

CoQ10 is a cofactor for many functions associated with energy production. It is a powerful antioxidant that helps in the regeneration of other antioxidants. It also stabilizes membranes and may have vasodilatory and inotropic effects.


For heart failure, cardiomyopathy, and hypertension, the dosage is 100 mg qd bid.

Side effects

Side effects include nausea, GI distress, headache, irritability, and dizziness.


• CoQ10 has a similar structure to synthetic vitamin K, which may cause a decrease in international normalized ratio (INR) levels if used concomitantly with warfarin.

• HMG CoA (3-hydroxy-3-methylglutaryl-coenzyme A) reductase inhibitors reduce serum levels of CoQ10.

Echinacea purpurea

Common uses

Echinacea purpurea is used for colds and other respiratory tract infections. It is used topically for poorly healing wounds and chronic ulcerations.

Proposed mechanisms

This product is thought to stimulate the immune system. It is believed to increase white blood cells and provide antiviral, antifungal, and anti-inflammatory action.


Dosing should begin at the onset of viral symptoms. On day 1, take 50-100 mg tid. Then take 250 mg qid. Continue treatment until 24-48 hours after symptoms abate.

Side effects

Allergic reactions can occur. Limit use to 6-8 weeks at a time.


This product should not be taken by patients with severe systemic illness (HIV/AIDS, multiple sclerosis, tuberculosis) or autoimmune disorders (rheumatoid arthritis).


Potentially severe allergic response, including anaphylaxis, may occur in individuals with asthma or allergies to members of the daisy family (ragweed, daisies, chrysanthemums, marigolds). Immunosuppressive agents may interact with this product.

Fish oil

Common uses

Fish oil is often taken to improve cardiovascular health and by patients with hypertriglyceridemia, rheumatoid arthritis, or psoriasis.

Proposed mechanisms

Fish oil provides a source of omega-3 fatty acids (docosahexaenoic acid and eicosapentaenoic acid). It is considered to increase anti-inflammatory cytokines and decrease pro-inflammatory cytokines. It is thought to decrease the intestinal absorption of cholesterol and inhibit the synthesis and degradation of very-low-density lipoprotein particles.


• General use: 1-2 g daily

• Hypertriglyceridemia: 2-4 g daily

• Rheumatoid arthritis: 4 g daily

• Psoriasis: 3-4 g daily

Side effects

Side effects include GI distress and fish burp, which may be avoided by using enteric-coated products, taking with meals, or keeping the capsules in the freezer.


At doses > 4 g daily, increased bleeding risk is present; therefore, patients on anticoagulation or antiplatelet therapy should be limited to 3 g daily.

Garlic (Allium sativum)

Common uses

Garlic is taken to lower cholesterol, prevent atherosclerosis, treat bacterial and fungal infections, and prevent various cancers.

Proposed mechanisms

Garlic is considered to exhibit antimicrobial action through sulfur-containing compounds, inhibit platelet aggregation, act as a free radical scavenger, stimulate fibrinolysis, and lower cholesterol and lipid levels by inhibition of HMG-CoA reductase.


Dosage is as follows:

• 4 g fresh minced garlic bulb

• 600-900 mg/d (100 mg garlic powder tablets)

• 3-5 mg allicin daily

Side effects

Side effects include malodorous breath and smell of garlic that may permeate the skin; GI discomfort, heartburn, and gas; and dermatitis and allergic reactions.


Active bleeding (peptic ulcer) can occur. Garlic should be stopped 7-10 days prior to surgery to avoid potential bleeding complications.


• Anticoagulants and antiplatelet agents: Aspirin, ticlopidine, clopidogrel, dipyridamole, warfarin, ginkgo, ginseng

• Saquinavir AUC (area under curve): 50% decrease in healthy volunteers


Common use

Ginger is used as an antiemetic.

Proposed mechanism

It is thought to stimulate gastric secretions and peristalsis.


• Pregnancy-induced nausea or vomiting: Dried ginger 250 mg qid

• Motion sickness: Two 500-mg capsules of dried powdered ginger root taken 30 minutes prior to travel, followed by one to two more 500-mg capsules as needed every 4 hours

Side effects

Heartburn and dermatitis may occur.


Ginger may increase the risk of hypoglycemia. It alters platelet function at doses > 1 g/d. Use with caution in patients receiving antiplatelet and anticoagulation therapy.

Ginkgo biloba

Common uses

Ginkgo biloba is used to enhance memory and concentration. It is used to treat or prevent Alzheimer's disease and vascular dementias. It is also used to treat intermittent claudication, vertigo, and tinnitus.

Proposed mechanisms

Ginkgo biloba is thought to increase blood flow, act as an antioxidant, and inhibit platelet aggregation.


Recommend a standardized product, 120-240 mg/d divided bid or tid.

Side effects

• Mild: GI distress, headache, and dizziness can occur.

• Serious: Spontaneous bleeding has been reported (e.g., subdural hematomas and subarachnoid hemorrhage).


This product may interact with both medications (aspirin, ticlopidine, clopidogrel, dipyridamole, warfarin) and herbs (garlic, ginseng). Interactions are due to antiplatelet or anticoagulant activity.


Ginkgo should be stopped 7-10 days prior to surgery to avoid potential bleeding complications.

Glucosamine and chondroitin sulfate

Common uses

Glucosamine and chondroitin sulfate products are used for osteoarthritis.

Proposed mechanisms

This product serves as a precursor to glycosaminoglycans, which make up cartilage and synovial fluid. It may help regenerate cartilage and replete synovial fluid.


Dosage is as follows:

• Glucosamine: 500 mg tid (with meals) glucosamine sulfate

• Chondroitin: 400 mg tid

These agents are often in a combination product; however, glucosamine has more evidence supporting its use. Full effects may not be seen for 6-8 weeks.

Side effects

Mild GI effects such as nausea and heartburn may occur. Little is known about the long-term use of this product.


Patients with severe shellfish allergy should not take this product.

Green tea

Common uses

Green tea is taken as a performance enhancer and to protect from the development of cardiovascular disease and cancer.

Proposed mechanisms

Green tea contains caffeine, which has a stimulant effect, and antioxidants (EGCG [Epigallocatechin gallate]), which protect against oxidative damage.


The common consumption in Asian countries is 3 cups daily. Dosage varies from 1-10 cups daily.

Side effects

GI irritation and both CNS and cardiac stimulation can occur because of caffeine content. Green tea can contain a range of 8-30 mg of caffeine per tea bag.

Drug interactions

Large doses may decrease INR levels, although brewing destroys most of the vitamin K content.


Common uses

Kava-kava is used for anxiety or stress.

Proposed mechanisms

Kava-kava possibly binds at GABA (γ-aminobutyric acid) receptors. It possibly acts as a dopamine antagonist.


The dosage is 100 mg two to three times daily.

Side effects

Side effects are similar to those that occur with alcohol (i.e., it adversely affects motor reflexes and judgment for driving or operating heavy machinery), but kava-kava does not act as a CNS depressant.

Mydriasis and extrapyramidal symptoms may occur.

Yellow, flaking, and scaly skin and eye redness are possible effects.

Liver failure, leading to transplantation or death, is a serious concern (

Table 27-16).


Patients who have preexisting liver disease or who regularly ingest alcohol should not take this product.


Patients should be counseled as follows:

• Do not take for > 4 weeks.

• Discontinue immediately if jaundice occurs.


• L-dopa: Decreased effectiveness

• Barbiturates, benzodiazepines, and alcohol: Additive sedative effects


Common uses

Melatonin is commonly used for sleep disorders and to reset the sleep-wake cycle (jet lag).

Proposed mechanisms

Melatonin mimics endogenous release of melatonin from the pineal gland. Concentrations increase significantly 1-2 hours before sleep.


Dosages are as follows:

• Insomnia: 0.3-5 mg 30 minutes prior to bedtime

• Jet lag: 2-5 mg in the evening between 5:00 pm and 10:00 pm on the day of arrival and at bedtime for 2-5 days after arrival

Long-term administration is not recommended.

[Table 27-16. Natural Products Associated with Serious Toxicity]

Side effects

Melatonin may worsen depression. Other side effects include headache and confusion. Melatonin is possibly an immune stimulant.


When melatonin is taken with benzodiazepines, anxiolytic effects are enhanced.


Common uses

Probiotics are taken for antibiotic-induced diarrhea, GI disorders, atopic dermatitis, and allergies.

Proposed mechanisms

Probiotics contain Lactobacillus sp, Bifidobacteria sp, or Sacchromyces boulardii. They are thought to decrease intestinal permeability, normalize gut flora, and decrease inflammatory responses. They possess immunomodulating activity.


Lactobacillus sp and Bifidobacteria sp are dosed at 1 billion to 10 billion colony-forming units per day. Sacchromyces boulardii is dosed at 250-500 mg bid-qid.

Side effects

Bloating, flatulence, and diarrhea may occur.


Because of reports of systemic infection, immunocompromised patients should avoid use.


Probiotics may decrease antibiotic absorption; therefore, antimicrobial agents should be administered several hours apart from taking probiotics.

Saw palmetto (Serenoa repens)

Common uses

Saw palmetto is used for benign prostatic hyperplasia.

Proposed mechanism

It inhibits 5α-reductase and dihydrotestosterone binding to androgen receptors.


For a product with 80-90% fatty acids, the dose is 160 mg bid or 320 mg qd. Take with morning and evening meals to decrease GI upset. Treatment usually lasts for 3 months.

Side effects

Rarely, GI upset, headache, or hypertension may occur. Urinary tract symptoms (urine retention, dysuria) are possible. Impotence may occur.


Recommend a thorough prostate exam and discussion with physician before starting treatment to rule out prostate cancer.

St. John's wort (Hypericum perforatum)

Common uses

St. John's wort is used to treat depression and anxiety.

Proposed mechanisms

This product is thought to inhibit dopamine, serotonin, and norepinephrine reuptake and to decrease IL-6 (interleukin-6) concentrations.


This product is standardized to 0.3% hypericin or 5% hyperforin. The recommended dose is 300-600 mg tid.

Side effects

Mild GI distress, paresthesias, dizziness, fatigue, insomnia, itching, dry mouth, and loss of libido can occur. Photosensitivity can occur: recommend sun avoidance or sunscreen.


Interactions are well documented and clinically significant.

Antidepressants (SSRIs [selective serotonin reuptake inhibitors] and TCAs [tricyclic antidepressants]) interact with this product because of a similar mechanism of action resulting in serotonin syndrome.

St. John's wort is an inducer of CYP (cytochrome) 450-3A4, 1A2, and 2C9, causing decreased levels of medications and possibly resulting in reduced therapeutic effects. Medications affected include the following:

• Cyclosporine

• Indinavir

• Digoxin

• Oral contraceptives (Estradiol component)

27-11. Sleep Aids and Stimulants


Nonpharmacologic treatment of insomnia

Nonpharmacologic treatments include the following:

• Establish regular waking and sleeping schedule.

• Exercise regularly.

• Do not nap during the daytime.

• Avoid caffeine, especially after noon.

• Avoid large meals close to bedtime.

• Participate in a relaxing activity at bedtime (e.g., reading or hot bath).

Nonprescription medication treatment

Selected nonprescription products are described in

Table 27-17.


Administer diphenhydramine 25-50 mg 30-60 minutes before bedtime (elderly patients, 25 mg).

Antihistamines block histamine1 and muscarinic receptors. They should be used for short-term management of occasional insomnia in conjunction with good sleep hygiene. Do not exceed 14 days of therapy (to avoid tolerance).

Side effects

Sedation, especially the next morning, may occur. Anticholinergic effects may occur as follows:

• Dry mouth or eyes

• Constipation

• Urinary retention

• Confusion (elderly patients)

Contraindications and precautions

Patients with benign prostatic hyperplasia, dementia, or narrow-angle glaucoma should not use this medication.

[Table 27-17. Selected Nonprescription Products for Insomnia]


Nonpharmacologic treatment of drowsiness

Good sleep hygiene is preferable to drug therapy (see previous discussion of insomnia).

Nonprescription medication treatment

Caffeine is the only FDA-approved nonprescription stimulant. It acts as a CNS stimulant.

Physical dependence can develop. Taking 50-200 mg results in increased alertness and decreased fatigue. Taking > 200 mg can result in nervousness, insomnia, and irritability.

Precautions exist with patients with peptic ulcer disease, cardiac dysrhythmias, and anxiety disorders.

Patients who are pregnant should restrict their caffeine intake to < 300 mg daily. Patients who are breast-feeding should be aware that 1% of caffeine crosses into breast milk; peak effect is 1 hour after consumption.

27-12. Overweight and Obesity

Clinical Indicators

The National Heart Lung and Blood Institute of the National Institutes of Health (NHLBI) and World Health Organization definition is based on body mass index (BMI):

• Overweight = BMI 25-29.9

• Obese I = BMI 30-34.9

• Obese II = BMI 35-39.9

• Obese III = BMI ≥ 40

NHLBI also assesses a patient's morbidity and mortality risk with regard to waist circumference:

• Males with a waist circumference > 40 inches

• Females with a waist circumference > 35 inches

These persons are at increased risk of developing type 2 diabetes and cardiovascular disease.

Nonpharmacologic Therapy

Nonpharmacologic therapy involves lifestyle modification.

Caloric restriction

Usually restriction of calories sufficient to create a deficit of 800-100 kcal/d is recommended. A low calorie diet results in a typical weight loss of 1-2 lbs/week. Portion control is essential.

Altered proportions of food groups is an important lifestyle modification:

• Fat: < 30% of total calories from fat and < 8-10% of total calories from saturated fat

• Carbohydrates: 45-65% of total calories

• Protein: 10-35% of total calories

Use of food additives

Artificial sweeteners and fat substitutes can be helpful.

Physical Activity

Increasing physical activity is recommended:

• For reduction of chronic disease: Engage in 30 minutes of moderate intensity exercise most days of the week.

• For prevention of body weight gain over time: Engage in 60 minutes of moderate to vigorous intensity exercise most days of the week.

• For sustaining weight loss: Engage in 60 minutes of moderate intensity exercise most days of the week.

Behavioral therapy

Behavioral therapy involves environmental modification, modified thinking patterns, maintenance of a healthy attitude, and social support.

Nonprescription medication therapy

Orlistat (Alli)

The FDA approved orlistat for nonprescription status in 2007. Orlistat decreases the absorption of dietary fats and inhibits gastric and pancreatic lipases.


Orlistat is indicated for use in patients ≥ 18 years of age who are overweight (BMI ≥ 25) in conjunction with lifestyle modification.


Patients should take one 60 mg capsule before meals. They do not have to take the medication if the meal does not contain fat.

Side effects

Side effects include the following:

• Flatulence with oily spotting

• Loose and frequent stools

• Fatty stools

• Fecal urgency

• Incontinence

Decreasing the amount of ingested fat can minimize these effects. Effects generally resolve within a few weeks of initiating therapy.


Patients on cyclosporine and patients with malabsorption disorders should not use this medication. Patients with a history of thyroid disease, cholelithiasis, nephrolithiasis, or pancreatitis should consult a primary care physician prior to use.


Decreased absorption of fat-soluble vitamins (especial D & E) occurs. Take a multivitamin at bedtime or separate it from orlistat dose by at least 2 hours.

Concern exists over Vitamin K absorption and possible effects on warfarin; therefore, recommend increased monitoring.

27-13. Key Points

Cough, Cold, and Allergy

• Cough and cold products are not to be used in children < 4 years of age.

• Nonprescription drug therapy for the common cold includes symptomatic management using decongestants (nasal congestion), antihistamines (excess nasal discharge), analgesics (headache), and local anesthetic lozenges or sprays (pharyngitis).

• Nonprescription treatment of allergies includes systemic antihistamines (sedating or nonsedating), ocular antihistamines, decongestants (if nasal congestion), and cromolyn (scheduled, not as needed).

• Cough can be relieved by a product containing a cough suppressant (dextromethorphan). An expectorant (guaifenesin) should be recommended to enhance clearance of mucus.


• Diet and lifestyle changes should always be recommended to prevent or treat constipation (exercise and an increase in fiber and fluid intake).

• Bulk-forming laxatives and stool softeners are the safest products to prevent and treat constipation and can be used chronically.

• Stimulant laxatives should be used only occasionally to prevent laxative dependence or other complications.


• Loperamide or bismuth subsalicylate may be recommended to treat diarrhea.

• Maintaining adequate hydration is very important, especially in young children and elderly patients.

Nausea and Vomiting

• Nonprescription treatment options for nausea and vomiting include antihistamines (meclizine, dimenhydrinate) and phosphorated carbohydrate solution (Emetrol).

• H2RAs (cimetidine, ranitidine); antacids; or bismuth salts (Pepto-Bismol) may relieve gastric discomfort or indigestion.

Pain and Fever

• Pain and fever may be treated with aspirin and other salicylates, NSAIDs, or acetaminophen.

• Aspirin and NSAIDs inhibit platelet aggregation. Nonacetylated salicylates and acetaminophen do not have antiplatelet activity.

• Salicylates and NSAIDs can cause gastropathy, including gastritis, gastric ulcers, and gastric bleeding. They may decrease the effectiveness of some antihypertensives and may have deleterious effects on kidney function.

• Acetaminophen does not have anti-inflammatory activity and can be hepatotoxic in excessive doses (> 4 g/d) or when used concurrently with alcohol.

Ophthalmic Disorders

• Dry eyes can be treated with artificial tears or ocular emollients.

• Ophthalmic vasoconstrictors (ocular decongestants) cause vasoconstriction in the conjunctiva to treat redness. Naphazoline is the ocular decongestant of choice. Ocular decongestants are contraindicated in patients with narrow-angle glaucoma because of the potential to cause rebound.

• Ketotifen fumarate is the safest and most effective product for the treatment of allergic conjunctivitis. Twice daily dosing and safety of this product for children ≥ 3 years of age make it the primary therapy for patients with this condition.

Otic Disorders

• Impacted cerumen can be treated with cerumen-softening agents (carbamide peroxide in anhydrous glycerin + alcohol; hydrogen peroxide + water).

• Water-clogged ears may be managed with the commercial preparation of isopropyl alcohol + anhydrous glycerin or with compounded acetic acid + isopropyl alcohol.

Home Monitoring and Testing Devices

• Other testing devices that were not discussed in detail in this chapter include diabetic meters, male fertility tests, illicit drug use tests, and the hepatitis C test.

• When counseling patients on the use of these devices, it is important to ensure that they understand the directions for use (appropriate timing and causes of false-positive and false negative results), check for expiration dates, and make certain the product is developed to give them the results they are seeking.

Smoking Cessation

• First-line agents for pharmacotherapy in smoking cessation are as follows:

• Nicotine gum (Nicorette, generic) OTC

• Nicotine patch (Nicotrol, Nicoderm CQ) OTC

• Nicotine inhaler (Nicotrol inhaler)

• Nicotine nasal spray (Nicotrol NS)

• Bupropion SR (Zyban)

• Varenicline (Chantix)

• Contraindications and precautions for nicotine replacement therapy are as follows:

• Cardiovascular disease

• < 2 weeks post-myocardial infarction

• Serious arrhythmias

• Serious or worsening angina

• Esophagitis and peptic ulcer disease (gum)

• Patients should seek medical advice if pregnant or breast-feeding.

• Patients should not smoke while using nicotine replacement therapy.

Natural and Herbal Products

• Herbal products that should be stopped 7-10 days prior to surgery include ginkgo, garlic, and ginseng.

• St. John's Wort takes several weeks to see effect and has the potential for serious drug interactions.

Sleep Aids

• Diphenhydramine should be used for short-term management of occasional insomnia in conjunction with good sleep hygiene.


• Caffeine, a CNS stimulant, is the only nonprescription stimulant approved by the FDA.

• The recommended dosage of 50-200 mg may increase alertness and decrease fatigue.

• Doses exceeding 200 mg may cause nervousness, insomnia, and irritability.

Overweight and Obesity

• Overweight and obese persons in the United States have reached epidemic proportions. This condition is significant because it is associated with increased morbidity from cardiovascular disease, diabetes, gall bladder disease, osteoarthritis, respiratory problems, and several different types of cancer.

• Orlistat (Alli) is an FDA-approved nonprescription medication used for the treatment of overweight patients ≥ 18 years of age. This medication has many side effects that patients may find unpleasant, and as a result, patients should be counseled on these side effects and ways to avoid them. The use of this medication may decrease the absorption of fat-soluble vitamins from the GI tract.

27-14. Questions


Which of the following is the primary advantage of recommending dextromethorphan instead of codeine?

A. It is twice as effective as codeine in suppression of cough.

B. It has less dependence potential.

C. It has peripheral rather than central action.

D. It is less expensive.

E. It is much longer acting than codeine.



All of the following statements regarding guaifenesin are correct except

A. it is the only OTC expectorant approved by the U.S. Food and Drug Administration (FDA).

B. it requires large amounts of water to be effective.

C. it is available OTC as Robitussin.

D. it may cause a decrease in platelet aggregation and an increase in bleeding time.

E. it is available in some prescription cough and cold formulations.



All of the following statements regarding diphenhydramine are true except

A. it is less likely to cause drowsiness than other OTC antihistamines.

B. it is the active ingredient in some OTC products for insomnia.

C. it is available OTC under the trade name of Benadryl.

D. a small percentage of children may exhibit a paradoxical CNS stimulant effect.

E. elderly patients may experience delirium or confusion with diphenhydramine.



All of the following statements about the routine use of oral decongestants in treating the common cold are true except

A. They cannot be used in patients on MAO inhibitor antidepressants.

B. They are relatively safe, with no dependence.

C. They are absolutely contraindicated in patients with controlled diabetes and mild hypertension.

D. The most common side effects are nervousness and insomnia.



All of the following are correct generic and trade name combinations except

A. Chlor-Trimeton = chlorpheniramine

B. Tavist = diphenhydramine

C. Claritin = loratadine

D. Nasalcrom = cromolyn

E. Zyrtec = cetirizine



Which of the following is not a side effect of loperamide?

A. Sedation

B. Dizziness

C. Dry mouth

D. Drowsiness

E. Insomnia



Which of the following is not an adverse effect of Pepto-Bismol?

A. Anticholinergic effects, dry mouth, and dry eyes

B. Tinnitus

C. Cross-sensitivity to aspirin allergy

D. Grayish-black tongue

E. Dark stools



Which of the following drugs exhibits analgesic and antipyretic properties, but not peripheral anti-inflammatory properties?

A. Ibuprofen

B. Sodium salicylate

C. Acetaminophen

D. Magnesium salicylate

E. Naproxen



Which drug does not interact with NSAIDs?

A. Methotrexate

B. Warfarin

C. Antihypertensive agents

D. Diphenhydramine

E. None of the above



Mary is a 32-year-old female with asthma and serious aspirin sensitivity. She comes to the pharmacist seeking assistance in selecting a nonprescription product for aches and pains. Which of the following should the pharmacist recommend for Mary?

A. Ibuprofen

B. Naproxen

C. Acetaminophen

D. A and B only

E. All of the above



Nonprescription antiemetics are primarily useful for preventing which type of nausea?

A. Nausea caused by alterations in the vestibular apparatus

B. Nausea caused by drugs acting centrally on the chemoreceptor trigger zone

C. Nausea caused by visceral pain

D. Nausea caused by cortical stimulation from smells or sight

E. Nausea caused by afferent impulses from the gastrointestinal tract



A mother requests advice for her 6-month-old child, who has been constipated for the past 2 days after beginning cereal feedings. Which of the following agents would be the best laxative agent to recommend?

A. Dulcolax

B. Fletcher's Castoria

C. Mineral oil

D. Glycerin suppositories

E. Milk of magnesia



All of the following statements about stool softeners are true except

A. they are not safe to use in pregnancy.

B. the onset of action is usually within 1-2 days.

C. they are useful in patients with constipation who have hemorrhoids.

D. extra water helps their effectiveness.

E. they are often combined with mild stimulant laxatives.



All of the following statements about bisacodyl are true except

A. it should not be taken concurrently with antacids.

B. it can be crushed or chewed if needed.

C. it should not be recommended in pregnancy.

D. it is available in oral tablet and suppository dosage forms.

E. it is the active ingredient in Dulcolax.



Which of the following antihistamines are available in OTC products for insomnia?

A. Diphenhydramine

B. Cetirizine

C. Loratadine

D. B and C

E. All of the above



Baby Matthew is 1 year old and weighs 24 lb. He has a fever of 102°F, is irritable, seems uncomfortable, and is not sleeping well. His mother is confused by the assortment of fever relief products. You recommend acetaminophen. Which product and dosage do you recommend?

A. Tylenol Infant Drops 80 mg/0.8 mL; give 1.6 mL q4-6h

B. Tylenol Children's Liquid 160 mg/5 mL; give 2 tsp. q6-8h

C. Advil Infant Drops 50 mg/1.25 mL; give 1.25 mL q4-6h

D. Motrin Children's Suspension 100 mg/5 mL; give 2.5 mL q6-8h

E. Tylenol Infant Drops 80 mg/0.8 mL; give 3.2 mL q4-6h



The next morning, baby Matthew's mother returns to your pharmacy. Her pediatrician recommended alternating the maximum dose of ibuprofen with the acetaminophen, and she is asking for help selecting an ibuprofen product and dosage. Which do you recommend?

A. Advil Infant Drops 50 mg/1.25 mL; give 0.625 mL q8h

B. Motrin Children's Suspension 100 mg/5 mL; give 2 tsp q4h

C. Motrin Infant Drops 50 mg/1.25 mL; give 2.5 mL q6h

D. Advil Children's Chewable Tablet 50 mg; give one tablet q8h

E. Advil Children's Chewable Tablet 50 mg; give one-half tablet q4h



Which of the following tests does not require a blood sample?

A. Cholesterol test

B. Ovulation prediction tests

C. HIV tests

D. Hepatitis C test

E. Accu-Chek Advantage



B. R. is a 62-year-old obese male who has been diagnosed by his physician with benign prostatic hyperplasia. Which of the following herbal remedies might be used to treat his symptoms?

A. Ginseng

B. Echinacea


D. Garlic

E. Saw palmetto



Which of the following products should be discontinued prior to surgery?

A. Ginkgo biloba

B. Gentian root

C. Glutamine

D. Glucosamine

E. Folic acid



Cough and cold products are not to be used in children less than _____ years of age.

A. 2

B. 4

C. 6

D. 8

E. 12



When a patient is considering the use of nonprescription orlistat, which of the following vitamins may the patient need as additional supplementation because of decreased absorption?

A. B12

B. B6

C. D

D. C


27-15. Answers


B. Although there have been reports of limited recreational abuse of dextromethorphan, its potential for dependence and addiction is significantly less than that of codeine.



D. Guaifenesin does not have any effects on platelet aggregation or bleeding time. It is the only FDA-approved OTC expectorant, works better with increased fluid intake, and is included in Robitussin products.



A. Diphenhydramine, an ethanolamine, is the most sedating OTC antihistamine.



C. Systemic decongestants are not recommended in individuals with uncontrolled diabetes or hypertension because of their sympathomimetic effects. They are contraindicated with MAO inhibitors and can commonly cause nervousness or insomnia.



B. Tavist contains clemastine.



E. Sedation, dizziness, dry mouth, and drowsiness are common side effects of loperamide. Insomnia is not.



A. Common adverse effects of Pepto-Bismol include tinnitus and grayish-black tongue or stools. Pepto-Bismal does contain a salicylate and, therefore, should not be used in individuals with aspirin allergy.



C. Acetaminophen is a centrally acting antipyretic and analgesic, but it does not exhibit peripheral anti-inflammatory activity. Salicylates and other NSAIDs do.



D. NSAIDs can significantly decrease methotrexate clearance, enhance the effect of warfarin, and blunt the hypotensive effect of hypertensive medications. There is no known interaction with diphenhydramine.



C. All NSAIDs and aspirin-containing products should be avoided in individuals with aspirin sensitivity. Acetaminophen can be recommended in this setting.



A. Nonprescription antiemetics are antihistamines that exert their effect by inhibiting histamine in neural centers controlling vomiting, salivation, and vestibular excitability, making them especially well suited for motion sickness.



D. Glycerin suppositories are safe for infants. The other agents should not be used in this patient population.



A. Stool softeners are safe to use in pregnancy and usually exert their effect within 1-2 days. Stool softeners are recommended for individuals in whom hard stools or straining could cause pain or complications (e.g., hemorrhoids, postoperative or postpartum time periods, or post-myocardial infarction). Increased fluid intake enhances their effectiveness. They are frequently used in combination products containing stimulant laxatives.



B. Because bisacodyl is an enteric-coated product, it should not be taken with antacids or be crushed, chewed, or broken. It should not be used in pregnancy. It is available in both oral tablets and rectal suppositories.



A. Diphenhydramine is an ethanolamine used in sleeping aids. Cetirizine and loratadine are nonsedating antihistamines.



A. The pediatric dosage of acetaminophen is 10-15 mg/kg q4-6h:


24 lb × kg/2.2 lb = 10.9 kg × 10-15 mg/kg = 109.0-163.5 mg


Tylenol Infant Drops 80 mg/0.8 mL; 1.6 mL = 160 mg acetaminophen



C. The pediatric dosage of ibuprofen is 5-10 mg/kg q6-8h:


24 lb × kg/2.2 lb = 10.9 kg × 5-10 mg/kg = 54.5-109.0 mg


Motrin Infant Drops 50 mg/1.25 mL; 2.5 mL = 100 mg ibuprofen



B. Cholesterol, HIV, hepatitis C, and blood glucose tests all require a blood sample. Most ovulation prediction tests use urine.



E. Saw palmetto may have some efficacy in treating benign prostatic hyperplasia, although the patient should be evaluated by a physician to rule out prostate cancer.



A. Ginkgo biloba has antiplatelet activity and should, therefore, be withheld prior to surgical procedures.



B. The Consumer Health Care Products Association announced in October 2008 that manufacturers were voluntarily updating all cough and cold products to state "do not use" in children under 4 years of age.



C. Vitamin D is a fat-soluble vitamin that may have decreased absorption with concomitant orlistat use despite multivitamin supplementation. A multivitamin is best taken at bedtime or separate from an orlistat dose by at least 2 hours.


27-16. References

Berardi RR, ed. Handbook of Nonprescription Drugs: An Interactive Approach to Self Care. 16th ed. Washington, D.C.: American Pharmacists Association; 2009.

Fiore MC, Bailey WC, Cohen SJ, et al. Treating Tobacco Use and Dependence: Clinical Practice Guideline. Rockville, Md.: U.S. Department of Health and Human Services; 2008.

Pray WS. Nonprescription Product Therapeutics. 2nd ed. Baltimore: Lippincott Williams & Wilkins; 2006.

Robbers JE, Tyler VE. Tyler's Herbs of Choice: The Therapeutic Use of Phytomedicinals. New York: Hayworth Herbal Press; 1999.

Scott GN, Elmer GW. Update on natural product-drug interactions. Am J Health-Syst Pharm. 2002; 59:339-47.