Otc Advisor_fever, Cough, Cold, And Allergy Final.pdf

Self-Care for Fever, Cough, Cold, and Allergy

Monograph 5

A continuing pharmacy education activity for pharmacists

Supported by an independent educational grant from

Provider: American Pharmacists Association Target Audience: Pharmacists Release Date: May 1, 2010 Expiration Date: May 1, 2013

ACPE Number: 202-000-10-126-H01-P CPE Credit Hours: 2.5 hours (0.25 CEUs) ACPE Activity Type: Knowledge-based Fee: There is no fee associated with this activity.

Activity Preview Fever, cough, cold, and allergy are among the most frequently occurring ailments affecting Americans, as well as the most commonly self-treated conditions. Pharmacists are the logical health care professionals to assist patients with self-care decisions related to these conditions, because pharmacists are available at the point of purchase and are the only health care professionals who receive in-depth formal education and skill development in nonprescription pharmacotherapy. This monograph addresses self-care for fever, cough, the common cold, and allergic rhinitis. Each condition is defined and its pathophysiology is reviewed. Exclusions for self-treatment are presented and explained. Self-care options—nonprescription medications and nonpharmacologic interventions—are discussed in the context of a self-treatment algorithm. Each section of the monograph concludes with a list of Points to Remember that provides a quick summary of the major concepts and recommendations.

Accreditation Information The American Pharmacists Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education (CPE). The ACPE Universal Activity Number assigned to this activity by the accredited provider is 202-000-10-126-H01-P. To obtain 2.5 hours of CPE credit (0.25 CEUs) for this activity, complete the CPE exam and submit it online at www.pharmacist.com/ education. A Statement of Credit will be awarded for a passing grade of 70% or better. You have two opportunities to successfully complete the CPE exam. Pharmacists who successfully complete this activity before May 1, 2013, can receive credit.

Learning Objectives At the completion of this activity, the pharmacist will be able to: 1. Discuss the etiology, pathophysiology, and detection of fever. 2. Describe the different types of cough and explain how the treatment approach differs for each. 3. Compare and contrast the pathophysiology and symptoms of the common cold with those of allergic rhinitis. 4. Differentiate between patients with the common cold, allergic rhinitis, cough, or fever who are candidates for selftreatment and patients whose care should be managed by a primary care provider. 5. Describe nonpharmacologic interventions for the common cold, allergic rhinitis, cough, and fever. 6. Discuss the nonprescription medications used to manage the common cold, allergic rhinitis, cough, and fever, including product selection considerations, correct dosing and administration, contraindications, and adverse effects. Advisory Board Kelly Scolaro, PharmD Clinical Assistant Professor Director of Pharmaceutical Care Labs Eshelman School of Pharmacy University of North Carolina Chapel Hill, North Carolina Karen Tietze, PharmD Professor of Clinical Pharmacy Philadelphia College of Pharmacy University of the Sciences in Philadelphia Philadelphia, Pennsylvania

Your Statement of Credit will be available online immediately upon successful completion of the CPE exam. Development This home-study CPE activity was developed by the American Pharmacists Association.

Support This activity is supported by an independent educational grant from Procter & Gamble.

Disclosures Kelly Scolaro, PharmD, has served as a reviewer for Elsevier. Karen Tietze, PharmD, declares no conflicts of interest or financial interests in any product or service mentioned in this activity, including grants, employment, gifts, stock holdings, and honoraria. APhA’s editorial staff declares no conflicts of interest or financial interests in any product or service mentioned in this activity, including grants, employment, gifts, stock holdings, and honoraria. This publication was prepared by Cynthia Knapp Dlugosz, BPharm, of CKD Associates, LLC, on behalf of the American Pharmacists Association.

Introduction

Fever, cough, cold, and allergy are among the most frequently occurring ailments affecting Americans. For example, as many as 30% of children presenting to their pediatrician’s office have fever as a complaint, and one out of five emergency room visits for children is related to fever. Cough has been identified as the most common symptom for which patients seek medical care. The common cold is one of the top five illnesses diagnosed in the United States, with as many as 1 billion cases occurring annually. An estimated 20% of adults and 40% of children in the United States have allergic rhinitis. Given their widespread prevalence, fever, cough, cold, and allergy are among the most common conditions that patients routinely self-treat. However, the considerable overlap among these conditions—coupled with the ever-increasing array of single-agent and combination products available for treating them —can lead to a great deal of patient confusion and inappropriate or even dangerous self-medication.

Fever

Fever is a controlled elevation in body temperature above the normal core temperature range. (Core temperature is the temperature of the blood that surrounds the hypothalamus.) Most fevers are self-limited and nonthreatening; the primary reason for treating fever is to alleviate patient discomfort. Whether and how fever should be treated is the subject of considerable debate. Body Thermoregulation Body temperature is regulated in the thermoregulatory center of the hypothalamus, which maintains body temperature around a set point—usually defined as 98.6°F (37.0°C)— through a complex negative feedback system. In this system, information is transmitted between the thermoregulatory center and thermosensitive neurons in the skin and central nervous system (CNS). When the information indicates that body temperature is above or below the set point, compensatory physiologic mechanisms and

behavioral adaptations help return the temperature to the normal range. Normal body temperature follows a circadian rhythm, reaching its lowest point in early morning (at approximately 6:00 am) and its highest point in late afternoon (between 4:00 pm and 6:00 pm). Depending on circadian fluctuations and activity level (body temperature may rise after vigorous activity or exercise), body temperature may vary by as much as 1.8°F (1.0°C) in adults and by as much as 2.58°F (1.44°C) in children. Fever, Hyperpyrexia, and Hyperthermia Studies in healthy individuals have defined a maximum normal oral temperature of 98.9°F (37.2°C) at 6:00 am and 99.9°F (37.7°C) at 4:00 pm. Accordingly, values that exceed these maximums may be considered to define fever. Signs and symptoms that typically accompany fever and cause a great deal of patient discomfort include headache, diaphoresis, gener­alized malaise, chills, tachycardia, arthralgia, myalgia, irri­tability, and anorexia. Fever occurs when substances known as pyrogens activate the body’s host defenses, resulting in an increase in the hypo­thalamic set point. This process is similar to resetting a home thermostat to a higher level to raise the ambient room temperature. Endogenous pyrogens— cytokines such as interleukins, interferons, and tumor necrosis factor that are released from, or in response to, damaged tissue—stimulate production of prostaglandins of the E2 series (PGE2). PGE2 in the brain acts on the hypothalamus to raise the set point. Neurons in the vasomotor center initiate peripheral vasoconstriction; as blood is shunted away from the periphery to the internal organs, the patient feels cold and makes behavioral adjustments (e.g., putting on additional clothing, covering up with a blanket) that help to raise body temperature. If these measures are not sufficient to raise core temperature to the new set point, shivering may be triggered to increase heat production. Once the new set point is reached, the hypothalamus maintains the set point at the new level until it is

OTC Advisor: Self-Care for Fever, Cough, Cold, and Allergy

reset downward by a reduction in the concentration of pyrogenic cytokines or the use of antipyretic agents, which inhibit the synthesis of PGE2 in the CNS. When the set point is lowered, heat dissipation occurs through vasodilation and sweating as well as behavioral adjustments (e.g., removing clothing or blankets). Because the set point is regulated by negative feedback, the upper range of temperature encountered during fever rarely exceeds 106°F (41.1ºC). The synthesis and release of the endogenous pyrogens that cause fever may be induced by a wide variety of exogenous pyrogens. Most exogenous pyrogens are microorganisms, microbial products, or microbial toxins; the classic example is the lipopolysaccharide endotoxin produced by gram-neg­ative bacteria. Fever also may be caused by malignancies, autoimmune disorders, and autoinflammatory diseases. Fever sometimes is idiopathic (i.e., fever of unknown origin). Hyperpyrexia Body temperature greater than 106.7ºF (41.5ºC) is termed hyperpyrexia. This extraordinarily high fever occurs most commonly in patients with CNS hemorrhages. Hyperpyrexia is associated with mental and physical consequences such as dehydration, delir­ium, seizures, coma, and irreversible neurologic or muscle damage. Hyperthermia Hyperthermia is an uncontrolled elevation in body temperature without elevation of the hypothalamic set point. Hyperthermia represents a malfunctioning of the normal thermoregulatory process at the hypothalamic level. It is important to distinguish between fever and hyperthermia because hyperthermia can be rapidly fatal. Antipyretic agents are not effective in lowering body temperature in patients with hyperthermia. Hyperthermia often is caused by inadequate heat dissipation in response to a warm environment. For example, work or exercise in higher than normal ambient temperatures or humidity can cause the body to produce heat faster than peripheral

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mechanisms can dissipate it, thereby leading to heat stroke. Young children and elderly adults are prone to nonexertional heat stroke, particularly if they are confined to poorly ventilated environments during heat waves. Drug-Induced Hyperthermia. Drug-induced hyperthermia occurs in up to 10% of all hospitalized patients and may account for more than 3% to 5% of all adverse drug reactions. It has been attributed to the following mechanisms: • Hypersensitivity. • Altered thermoregulation (e.g., interfering with peripheral heat dissipation, increasing basal metabolic rate). • Pharmacologic action (e.g., invoking a cellular immune response, mimicking the structure of endogenous pyrogens, inflicting direct tissue damage). • Factors related to drug administration (e.g., venous irritation from cephalothin) or the vehicle of the drug.

• An idiosyncratic reaction. Examples of medications that can induce hyperthermia are listed in Table 1. Hypersensitivity is the most common mechanism of drug-induced hyperthermia. An elevated body temperature usually develops after 7 to 10 days of treatment, although fever and other signs and symptoms (e.g., rash, urticaria, eosinophilia) may begin sooner if the patient was exposed to the causative agent previously. Hyperthermia induced by vaccines usually occurs within 48 hours of vaccination. Drug-induced hyperthermia can be differentiated from other causes by (1) establishing a temporal relationship between the fever and the administration of a drug, (2) observ­ ing a temperature elevation despite improvement of the underlying disorder, and (3) identifying possible “allergic” symptoms. Management involves discontinuing the suspected drug whenever pos­sible; if feasible,

Table 1. Selected Medications That Can Induce Hyperthermia Anti-infectives

• Aminoglycosides • Amphotericin B • Cephalosporins • Chloramphenicol • Clindamycin • Imipenem • Isoniazid • Macrolides • Mebendazole • Nitrofurantoin • Para-aminosalicylic acid • Penicillins • Rifampin • Streptomycin • Sulfonamides • Tetracyclines • Vancomycin

Antineoplastics

• l-Asparaginase • Bleomycin • Chlorambucil • Cytarabine • Daunorubicin • Hydroxyurea • 6-Mercaptopurine • Procarbazine • Streptozocin

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Cardiovascular agents • Epinephrine • Hydralazine • Methyldopa • Nifedipine • Procainamide • Quinidine • Streptokinase

Central nervous system agents

• Amphetamines • Barbiturates • Benztropine • Carbamazepine • Haloperidol • Lithium • Monoamine oxidase inhibitors • Nomifensine • Phenothiazines • Phenytoin • Selective serotonin reuptake inhibitors • Thioridazine • Tricyclic antidepressants • Trifluoperazine

Other agents

• Allopurinol • Atropine • Azathioprine • Cimetidine • Corticosteroids • Folate • Infliximab • Inhaled anesthetics • Interferon • Iodides • Metoclopramide • Propylthiouracil • Prostaglandin E2 • Salicylates • Tolmetin • Vaccines

all medications should be discontinued temporarily. If hyperthermia is indeed drug induced, the patient’s temperature generally will decrease within 24 to 72 hours after the offending drug is withdrawn. After patient safety and the identification of the offending drug have been considered, each medication may be restarted, one at a time, while monitoring for fever recurrence. Malignant Hyperthermia and Neuroleptic Malignant Syndrome. Malignant hyperthermia and neuroleptic malignant syndrome (NMS) are rare, but potentially life-threatening, idiosyncratic reactions. Malignant hyperthermia occurs in people with an inherited abnormality of skeletal-muscle sarcoplasmic reticulum. It develops in response to halothane and other inhaled anesthetics or to succinylcholine; it is characterized by body temperature greater than 104ºF (40ºC), muscle rigidity, and metabolic acido­sis. NMS is believed to be related to decreased dopamine activity in the CNS. Although it is associated most frequently with potent neuroleptic agents (e.g., fluphenazine, haloperidol), NMS can be precipitated by any antipsychotic agent—including clozapine, risperidone, prochlorperazine, and promethazine—as well as nonneuroleptic agents that block central dopamine pathways (e.g., amoxapine, lithium, metoclopramide). NMS also can occur following the abrupt discontinuation of antiparkinsonian agents. Patients with NMS typically pre­sent with high temperature, “lead pipe” muscle rigidity, abnormal body movements, sweating, tachycardia, high or low blood pressure, incontinence, and altered consciousness includ­ing delirium, stupor, or coma. Measuring Body Temperature The most important sign of a fever is elevated body temperature. Thus, the first step in assessing a patient with a complaint of fever is to obtain an objective, accurate temperature measurement. Core temperature is estimated at oral (sublingual), rectal, axillary (armpit), tympanic (ear canal), or temporal (temporal artery) sites using various types of thermometers. The axillary American Pharmacists Association

route is not recommended for routine use because axillary temperatures are notoriously unreliable. Temperature readings vary at the different sites of measurement. Examples of normal body temperature ranges for the most common routes of measurement are listed in Table 2. Because of these intersite variations,

be frightening to older children. Rectal tempera­ture measurement is slow to measure changes in body temperature because of the large muscle mass and poor blood flow to the area; therefore, the thermometer must be left in place longer compared with the oral route. The most common sources of error in rectal temperature

Table 2. Body Temperature Range Depending on Site of Measurement Site of Measurement

Normal

Fever

Oral

95.9ºF–99.9ºF (35.5ºC–37.7ºC)

≥100.0ºF (37.8ºC)

Rectal

97.9ºF–100.4ºF (36.6ºC–38.0ºC )

≥100.5ºF (38.1ºC)

Tympanic

96.3ºF–99.9ºF (35.7ºC–37.7ºC )

≥100.0ºF (37.8ºC)

body temperature should be measured using the same thermometer at the same site over the course of an illness. Oral and Rectal Measurements The oral route traditionally has been the most popular method of temperature measurement. The accuracy of oral measurements can be affected by the position of the thermometer: the device must be held under the tongue, and the mouth must remain closed around the device to prevent air from flowing over it. Oral temperature should not be taken when a patient is mouth breathing or hyperventilating; has recently had oral surgery; is not fully alert; or is uncooperative, lethargic, or confused. To ensure reliable measurement, patients should not engage in vigorous physical activity, nor should they heat or cool the oral cavity artificially by smoking or drinking hot or cold beverages, for a minimum of 20 minutes before temperature is measured. The rectal route remains the gold standard for body temperature measurement because it estimates core temperature most consistently. It is the preferred method of estimating fever in children younger than 6 months, but its intrusive nature can

mea­surement include stool impaction and poor technique in taking the temperature. Risks associated with taking a rectal temperature include retention of the thermometer, rectal or intestinal perforation, and perito­nitis. The patient should never be left unattended while the rectal thermometer remains in place, because a posi­ tional change may cause the thermometer to be expelled or to break. Rectal temperature measurement is relatively contraindicated in patients who are neutropenic, have had recent rectal surgery or injury, or have rectal pathology (e.g., obstructive hemorrhoids, diarrhea). Electronic probe thermometers may be used for both oral and rectal temperature measurements. The probe has an electronic transducer that provides a temperature reading in about 10 to 60 seconds. The electronic digital temperature display makes these thermometers easier to read than traditional glass ther­mometers; the use of disposable covers elim­inates the need for disinfection after their use. Most electronic thermometers are battery operated. (Any patients who still use mercury-in-glass ther­mometers

OTC Advisor: Self-Care for Fever, Cough, Cold, and Allergy

should be urged to dispose of them in accordance with local environmental standards and replace them with electronic thermometers.) Electronic probe thermometers are available in both pen and pacifier shapes. The pacifier shape is for oral use only and takes 2 to 6 minutes to provide a reading. Pacifier thermometers provide reliable temperature readings with a sensitivity of approximately 72% and specificity of 98% compared with rectal measurements; the readings are less accurate in children younger than 3 months of age. Proper methods of taking oral and rectal temperature measurements in children and adults are outlined in Appendices A and B. Tympanic Measurements Tympanic temperature measurements are made with infrared thermometers. When placed in the ear canal, the tip of the thermometer senses infrared heat from the blood ves­sels in the eardrum. The tympanic membrane is close to the hypothalamus, and the blood supply to these two ana­tomic areas is at the same temperature; thus, tympanic measurements provide an accu­rate reading of the body core temperature. However, the thermom­eter must be positioned in the ear canal properly to ensure that the measured infrared radiation is from the tympanic membrane and not from the ear canal or adjacent areas. Comparisons of tympanic and rectal measure­ments showed tympanic measurement to have a specificity of 94.8% to 100% but a sensitivity of only 58% to 68.3%. Vari­ations in temperature assessment have been attributed to cerumen impaction, inflammation in the ear canal (otitis media), patient age (i.e., size of the ear canal), and inappropriate technique. Tympanic thermometers mea­ sure body temperature in less than 5 seconds. They have digital read­ outs, and many can be set to provide either a rectal or an oral temperature equivalent. They also require batteries and are rela­tively expensive; nonetheless, many families with young children prefer them because of their convenience and noninvasive nature. The proper method of using tympanic

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thermometers is outlined in Appendix C. Tympanic thermometers are not recommended for use in infants younger than 6 months of age because the ear canal is not developed fully, leading to inappropriate technique and inaccurate readings. Temporal Measurements Temporal temperature measurements also are made with infrared thermometers. The temporal artery is one of the few arteries close enough to the skin surface to detect heat changes. Temporal thermometers are placed on the side of the forehead directly over the temporal artery and moved across the forehead (Appendix D); a temperature reading is provided in a few seconds. The rapid, noninvasive nature of temporal temperature measurement makes it a popular choice, and the temporal thermometer is sig­nificantly more sensitive than the tympanic thermometer for detecting fever. Temporal temperature mea­surement may differ from rectal temperature measure­ment by ± 2.3°F (1.3ºC). The presence of hair near the temporal area may interfere with the temperature reading, so hair must be pushed away before a reading is taken. Temporal thermometers must not be confused with color-change thermometers—adhesive strips containing heat-sensitive material that changes color in response to different temperature gradi­ents. Although these strips may be placed anywhere on the skin, they usually are placed on the forehead. Color-change thermometers are easy to use, but they are not sufficiently accurate or reliable. They may be useful in noting temperature trends but not absolute temperature. Exclusions for Self-Treatment Fever is a symptom of a larger underlying process, not a pathologic process in itself. Once the symptom of fever is established, inves­tigation into the underlying cause is important. Treatment should be directed primarily at the underlying cause of fever, not the temperature reading. The decision to treat the symptom of fever (i.e., to alleviate the discomfort of fever by reducing the body

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temperature to a normal level) is based on a patient-spe­cific riskbenefit ratio. Fever is not associated with many harmful effects unless body temperature exceeds 106ºF (41.1ºC). Arguments against treatment include the generally benign and self-limited course of fever, the possible elimination of a diagnostic or prognostic sign, and possible adverse effects of antipyretic medications. Patients should be evaluated by a primary care provider before attempting self-treatment of fever if they are: • 6 months of age or older with a rectal temperature of 104ºF (40ºC) or greater, or an equivalent temperature taken by another route. • Younger than 6 months of age with a rectal temperature of 101ºF (38.3ºC) or greater. Other exclusions for self-treatment of fever are listed in the algorithm depicted in Figure 1. Febrile seizures (i.e., seizures accompanied by fever in the absence of another cause, such as an acute metabolic disorder or CNS inflammation) occur in 2% to 5% of all children from the ages of 6 months to 5 years. Most initial febrile seizures occur in children younger than 3 years of age. Simple febrile seizures are most common; they are character­ized by nonfocal movements that last less than

15 minutes. Significant neurologic sequelae (e.g., impaired intellectual development, epilepsy) are unlikely after a sin­gle pediatric febrile seizure. Although both the magnitude and rate of temperature increase appear to be critical determinants in precipitating these seizures, the temperature at which a particular child will experience a seizure is unpredictable. The risk of recurrence is increased in children who have experienced a previous febrile seizure (especially if it occurred before 1 year of age or was a complex febrile seizure), who have a documented seizure disorder or other CNS disorder, or whose family history includes febrile seizures. Children with a history of febrile seizures or other seizures are not appropriate candidates for self-treatment of fever. Self-Treatment of Fever As shown in Figure 1, fever exceeding 101ºF (38.3ºC) orally may be treated with antipyretic agents and nonpharmacologic measures. Treatment also may be indicated at lower body temperatures if the patient experiences discomfort or is of advanced age. Because average body temperature decreases with age, a temperature less than 101ºF may indicate fever in older populations. Nonpharmacologic Therapy Nonpharmacologic therapy consists mainly of adequate fluid intake

Case 1. Fever The mother of JP—a 4-year-old girl—is called to pick up her child from preschool because JP has developed a fever. JP had seemed tired and irritable that morning, and refused to eat breakfast; however, when the mother checked JP’s temperature that morning as a precaution, it was in the normal range (98.4ºF using an electronic oral thermometer). JP’s temperature at 1:30 pm, as measured by the preschool teacher using an infrared tympanic thermometer, is 101.2ºF. According to the mother, JP has no history of high fevers or seizures. What is the best course of action in this case? a. b. c. d.

The mother should sponge JP with tepid water to help bring down the fever. The mother should administer a nonprescription antipyretic medication to JP as soon as possible, because JP’s temperature is dangerously high. JP should be seen by a primary care provider as soon as possible. The mother should dress JP in light clothing, encourage her to drink fluids, and monitor her temperature periodically using the same thermometer and site each time. Antipyretic medication could be administered if JP seems very uncomfortable.

Case study responses appear on page 26.

American Pharmacists Association

Sponging or baths have limited utility in the management of fever. Body sponging with tepid water may facilitate heat dissipation, because only a small temperature gradient between the body and the sponging medium is necessary to achieve an effective antipyretic response. However, sponging is not recommended routinely for patients with a temperature less than 104ºF (40ºC) because it usually is uncomfortable and often induces shivering, which could raise

to prevent dehydration. Fluid intake in febrile children should be increased by at least 30 to 60 mL (1 to 2 oz) of fluids per hour (e.g., sports drinks, fruit juice, water, ice pops) and by at least 60 to 120 mL (2 to 4 oz) per hour in adults, unless fluids are contraindicated (e.g., patients with renal failure, some patients with heart failure). Other interventions include wearing light clothing, removing blankets, and maintaining room temperature at 78ºF (25.6ºC).

the temperature fur­ther. The use of ice-water baths or sponging with hydroalcoholic solutions (e.g., isopropyl or ethyl alcohol) is not recommended. Alco­hol poisoning can result from cutaneous absorption or inhalation of topically applied alcohol solutions. Antipyretic Pharmacotherapy Nonprescription antipyretic agents—aspirin, acetaminophen, and the nonsteroidal anti-inflammatory drugs (NSAIDs) ibuprofen and

Figure 1. Algorithm for Self-Treatment of Fever Exclusions for for Self-Treatment Self-Treatment Exclusions Exclusions for Self-Treatment

Patient with suspected fever Patient with suspected fever

Ask patient/caregiver how body Ask patient/caregiver how body temperature was measured temperature was measured

Was body temperature measured Was body temperature measured accurately? accurately?

No No

Yes Yes

Offer to take patient’s Offer to take patient’s temperature. Explain proper temperature. Explain proper methods of temperature methods of temperature measurements. If fever present, measurements. go to next box If fever present, go to next box

Obtain symptom information, Obtain information, medicalsymptom history, allergy medical history, allergy information information

Exclusions for self-treatment Exclusions for self-treatment?

Yes Yes

Medical management Medical management

Yes

Nondrug measures ± antipyretic agent based on patient factors and preferences

No Oral temperature >101°F (38.3°C) or equivalent?

Exclusions for Self-Treatment Patients >6 months of age with rectal Patients >6 months of(40°C) age with temperature ≥104°F or rectal temperature equivalent ≥ 104°F (40°C) or equivalent Children <6 months of age with rectal Children <6 months of(38.3°C) age with rectal temperature ≥101°F temperature ≥ 101°F (38.3°C) that are Severe symptoms of infection Severe symptoms of infection that are not self-limiting not Riskself-limiting for hyperthermia Risk for hyperthermia Impaired oxygen utilization Impaired oxygen utilization (e.g., severe (e.g., severe COPD, respiratory distress, COPD, respiratory distress, heart failure) heart failure) Impaired immune function (e.g., cancer, HIV) CNS damage (e.g., head trauma, stroke) Children with history of febrile seizures or other seizures Fevers Fevers that that persist persist >3 >3 days days with with or or without without treatment treatment Children Children who who develop develop spots spots or or rash rash Children Children who who refuse refuse to to drink drink any any fluids fluids Children Children who who are are very very sleepy, sleepy, irritable, irritable, or or difficult difficult to to awaken awaken Children Children who who are are vomiting vomiting and and cannot cannot keep keep down down fluids fluids .

No Nondrug measures ± antipyretic agent if patient has discomfort or patient/caregiver requests agent

Fever resolved after 3 days of treatment?

No

MedicalMedical management management

Yes D/C therapy

CNS = central nervous system; COPD = chronic obstructive pulmonary disease; D/C = discontinue; HIV = human immunodeficiency virus. Source: Feret B. Fever. In: Berardi RR, Ferreri SP, Hume AL, et al., eds. Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care. 16th ed. Washington, DC: American Pharmacists Association; 2009:89

OTC Advisor: Self-Care for Fever, Cough, Cold, and Allergy

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Table 3. Recommended Adult Dosages of Nonprescription Antipyretic Agentsa Agent

Usual Adult Dosage (Maximum Daily Dosage)

Acetaminophen

325–1,000 mg every 4–6 h (4,000 mg)

Aspirin

650–1,000 mg every 4–6 h (4,000 mg)

Ibuprofen

200–400 mg every 4–6 h (1,200 mg)

Naproxen sodium

220 mg every 8–12 h (660 mg)

b

Dosages listed are for patients 12 years of age and older. Aspirin generally is not used as an antipyretic in children 15 years of age or younger because of the risk of Reye’s syndrome. a b

Table 4. Recommended Pediatric Dosages for Nonprescription Antipyretic Agents Agent

Weight (lb)

Single Dose (mg)

Acetaminophen

6–11 12–17 18–23 24–35 36–47 48–59 60–71 72–95 ≥96

40b 80b 120b 160 240 320 400 480 650

Ibuprofenc

6–11 12–17 18–23 24–35 36–47 48–59 60–71 72–95 ≥96

Not recommended 50 75 100 150 200 250 300 200–400 (maximum 1,200 mg/day)

a

a Dosing information based on a usual pediatric acetaminophen dosage of 10–15 mg/kg. Single doses may be repeated every 4–6 hours as needed, not to exceed five doses in 24 hours. b This dose is not included in the approved nonprescription labeling; it is provided to assist pharmacists in determining appropriate doses. c Dosing information based on a usual pediatric ibuprofen dosage of 7.5 mg/kg. Single doses may be repeated every 6–8 hours as needed, not to exceed four doses in 24 hours.

naproxen sodium—decrease the production of PGE2 by inhibiting the enzyme cyclooxygenase in the brain. Through this mechanism, antipyretics decrease the feedback between the thermoregulatory neurons and the hypothalamus, thereby lowering the hypothalamic set point during fever. Recommended adult and pediatric dosages of antipyretic agents

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are listed in Tables 3 and 4. Acetaminophen and ibuprofen are the primary antipyretic agents used for self-treatment of fever. Both agents typically produce a maximum temperature reduction at approximately 2 hours post dose. Naproxen sodium and aspirin also may be appropriate choices for adolescent and adult patients. (Naproxen sodium is approved

for self-treatment in patients 12 years of age and older.) Aspirin generally is not used as an antipyretic in children 15 years of age or younger because of the risk of Reye’s syndrome. Use of acetaminophen or ibuprofen in the pedi­atric population is complicated by the different strengths and formulations that are available. For example, unintended overdosing or under­dosing of acetaminophen can occur when parents switch between infant drops (80 mg/0.8 mL) and suspension (160 mg/5 mL), incorrectly assuming they are the same concentration. In addition, rapidly growing infants quickly outgrow previous dose requirements. Therefore, recalculation of the pediatric dose according to the patient’s current body weight is appro­priate at the time of each treatment course. Note that acetaminophen is not labeled for nonprescription use in children who are younger than 2 years of age or weigh less than 24 lb. Table 4 includes dosage information for weight ranges less than 24 lb, to assist pharmacists in determining appropriate dosages for patients who are being treated under the direction of a primary care provider. Ibuprofen is not recommended for use in children younger than 6 months of age (or weighing less than 12 lb). Although the practice of alternating doses of acetaminophen and ibuprofen has become widespread, it carries a substantial risk of overdose, medications errors, and increased adverse effects. A recent review of five randomized, controlled trials found no conclusive evidence of the superiority or safety of regimens that alternated antipyretics, compared with monotherapy. Alternating therapy is not recommended currently by the American Academy of Pediatrics. However, it is reasonable to initiate treatment with acetaminophen or ibuprofen, then switch to the alternate medication if the patient’s fever does not respond to the initial agent. Sponging sometimes is used as an adjunct to antipyretic therapy. However, unlike antipyretic agents, sponging does not reduce the hypothalamic set point. Sponging should follow antipyretic administration by 1 hour American Pharmacists Association

to permit the appropri­ate reduction of the hypothalamic set point and a more sustained temperaturelowering response. Safety Considerations for Acetaminophen. Acetaminophen is associated with few adverse effects at recommended nonprescription dosages. It is considered to be safe for use during both pregnancy and breastfeeding. Acetamin­ophen also is generally recognized as the nonprescription antipyretic/analgesic of choice in older adults. Acetaminophen is potentially hepatotoxic in doses exceeding 4 g per day in adults and 90 mg/kg per day in children, especially with chronic use. Unintended chronic overdose comprises about half of all cases of acetaminophen-induced acute liver failure. Hepatotoxicity is caused by an intermediate metabolite of the parent compound that is detoxified by glutathione. Patients should be cau­tioned against exceeding the recommended maximum daily dose; all prescription and nonprescription sources of acetaminophen—both single-agent and combination products—must be included in the total. More conser­vative dosing (e.g., 2 g per day or less in adults) or avoidance may be warranted in patients at increased risk for acetamin­ophen-induced hepatotoxicity, including patients with: • Concurrent use of other potentially hepatotoxic drugs. • Ingestion of three or more alcoholic drinks per day. • Poor nutritional intake. Patients with glucose-6-phosphate dehydrogenase deficiency—a genetic disorder that results in the breakdown of red blood cells when the person is exposed to certain drugs or the stress of infection—also should use acetaminophen with caution. Safety Considerations for Ibuprofen and Naproxen Sodium. The most frequent adverse effects of NSAIDs involve the gastrointestinal (GI) tract and include dyspepsia, heartburn, nausea, anorexia, and epigastric pain, even among children using pediatric formulations. Taking a dose with food, milk, or antacids can minimize the possibility of stomach upset.

Other possible adverse effects of NSAID therapy include dizziness, fatigue, headache, or nervousness. Rashes or itching may occur in some patients, and some cases of photosensitivity have been reported. However, these effects usually are rare at normal nonprescrip­tion doses. GI ulceration, perforation, and bleeding are uncommon but potentially serious complications of NSAID use. Risk factors include: • Age (60 years or older). • Previous ulcer disease or GI bleeding. • Concurrent use of anticoagulants (including aspirin). • Moderate use of alcohol. NSAIDs are associated with an increased risk for myocardial infarc-

tion, heart failure, hypertension, and stroke. The cardiovascular risk appears to be dependent on both dose and duration of therapy. Although naproxen is considered to be a safer choice than ibuprofen, the American Heart Association recommends that patients with or at high risk for cardiovascular disease (i.e., hyperlipidemia, hypertension, diabetes, or other macrovascular disease) avoid NSAIDs altogether. Patients with a history of impaired renal function, con­gestive heart failure, or diseases that compromise renal hemodynamics should not selfmedicate with NSAIDs. These agents may decrease renal blood flow and glomer­ular filtration rate as a result of inhibition of renal pros­ta glandin

Emerging Issues: Systemic Nonprescription Fever Reducers/ Pain Relievers

On April 28, 2009, the FDA issued a final rule requiring manufacturers of nonprescription antipyretic/analgesic products to revise their labeling to include new safety information. Of note, the word “acetaminophen” or “NSAID” (for products containing salicylates, ibuprofen, or naproxen sodium) must appear highlighted or in bold type in a prominent font size on both the product container and outer carton. This change applies to single-ingredient products as well as products that contain acetaminophen or NSAIDs in combination with other active ingredients. In addition, the product container and outer carton must include a warning about the risk of severe liver damage when using acetaminophen or the risk of severe stomach bleeding when using NSAIDs. Manufacturers are required to implement all of the changes listed in the final rule by April 28, 2010. On June 29 and 30, 2009, three FDA advisory committees considered a series of options for further reducing the incidence of liver injury associated with acetaminophen use that exceeds the maximum recommended daily dose (4 g per day). Their recommendations included: • Limiting the amount of acetaminophen in nonprescription products to 325 mg per tablet (650 mg recommended dose). • Lowering the maximum recommended daily dose of acetaminophen. • Standardizing the concentration of liquid acetaminophen products for pediatric use. The FDA had not taken any action on these recommendations at the time this monograph was finalized. The FDA has encouraged health care providers to help prevent the morbidity and mortality of acetaminophen-induced hepatotoxicity and NSAID-related GI and renal effects by educating their patients about the following: • Appropriate safety precautions for the use and storage of nonprescription antipyretics/ analgesics as drug products. • The wide variety of strengths, formulations, and combinations of acetaminophen- and NSAID-containing products available with and without a prescription. • Correct dosing frequency for each of the acetaminophen or the NSAID formulations. • Correct weight-based dose for each child. • Use of the correct measuring device for the liquid formulations. • Risks of taking nonprescription antipyretics/analgesics with prescription or other nonprescription medications. • Signs and symptoms of self-recognizable adverse effects. • Potential problems associated with simultaneous use of more than one antipyretic/ analgesic product.

OTC Advisor: Self-Care for Fever, Cough, Cold, and Allergy

7

synthesis. Consequently, increased blood urea nitrogen and serum creatinine concentrations can occur, often with concom­itant sodium and water retention. Advanced age, hypertension, diabetes, atherosclerotic cardiovascu­lar disease, and use of diuretics appear to increase risk of renal toxicity with ibuprofen use. Because NSAIDs are potent inhibitors of prostaglandin synthesis in peripheral tissues, they should be avoided during the last trimester of pregnancy. NSAIDs can cause delayed parturition, pro­longed labor, and increased postpartum bleeding; they also can have adverse fetal cardiovascular effects (e.g., premature closure of the ductus arteriosus). Ibuprofen and naproxen are considered to be compatible with breastfeeding. Safety Considerations for Aspirin. As an NSAID, aspirin shares many of the safety concerns of ibuprofen and naproxen sodium. However, aspirin is associated with more GI upset and bleeding than either ibuprofen or naproxen sodium. In addition, aspirin can produce mild salicylate intoxication (salicylism) in patients who ingest large doses, as well as urticarial symptoms (including angioedema) or bronchospastic symptoms (including difficulty in breathing or shock) in patients with aspirin intolerance. Aspirin can impair hemostasis. A single 650-mg dose of aspirin can double bleeding time; lower doses increase bleeding time to a lesser extent. Because of the effect on hemostasis, aspirin is con­traindicated in patients with a history of any bleed­ing disorder (e.g., hypoprothrombinemia, vitamin K deficiency, hemophilia) or a history of peptic ulcer disease. Aspirin should be avoided during the last trimester of pregnancy. Aspirin also should be avoided in women who are breastfeeding because it is excreted into breast milk in low concentrations. Drug Interactions. Clinically important drug interactions with nonprescription antipyretic agents are listed in Table 5. Most of these interactions involve aspirin or NSAIDs; acetaminophen generally is the safest nonprescription analgesic choice for patients

8

receiving concomitant drug therapy. Since 1999, the U.S. Food and Drug Administration (FDA) has required a warning regarding alcohol use on all nonprescription antipyretic/ analgesic products for adult use. Concomitant use of ethanol with salicylates or NSAIDs may increase the risk of GI bleeding; concomitant use of ethanol with acetaminophen may increase the risk of hepatotoxicity. Patients who consume three or more alcoholic drinks per day should use nonprescription antipyretic/analgesic agents only under the direction of a primary care provider. Follow-Up It is not unusual for parents and caregivers to exhibit “fever phobia,” with heightened anxiety and inappropriate treatment of fever. Fever phobia may prompt overly aggressive patient monitoring; in one study, 52% of caregivers said that they would check a febrile patient’s tem­perature at least hourly. A more appropriate monitoring schedule is to measure body temperature two to three times per day and assess fever-related symptoms (e.g., headache, chills, arthralgia, myalgia) daily. Nonprescription antipyretics should not be used for more than 3 days to treat fever. If the patient’s symptoms either do not improve or worsen over the course of 3 days with self-treatment—regardless of a drop in temperature—the patient should be evaluated by a primary care provider.

Cough

Cough is an important defensive respiratory reflex. It is produced when sensory receptors located throughout

the larynx and the proximal portion of the tracheobronchial tree are activated by mechanical or chemical (irritant) stimuli. Cough is primarily vagally mediated. Reflex (involuntary) cough is controlled by the “cough control center” in the medulla oblongata; voluntary cough is controlled in the cerebral cortex. Classification and Causes of Cough Cough is classified according to duration of symptoms: • Acute cough (duration less than 3 weeks). • Subacute cough (duration 3 to 8 weeks). • Chronic cough (duration more than 8 weeks). Viral upper respiratory tract infections (e.g., the com­mon cold) are the most common cause of acute cough. Subacute cough is commonly caused by infec­tion, bacterial sinusitis, and asthma. The most common causes of chronic cough in adult nonsmokers are upper airway cough syndrome (previously known as postnasal drip), asthma, and gastroesophageal reflux disease (GERD). In children, cough may be a symp­tom of viral or bacterial respiratory infection, heart disease, foreign body aspiration, aspiration caused by poor coor­dination of sucking and swallowing, or esophageal motility disorders. Coughs are further classified as productive or nonproductive. A productive cough (i.e., a wet or “chesty” cough) helps to expel lower respiratory tract secretions that, if retained, could impair ventilation and the lungs’ ability to resist infection. Productive coughs may be effective (secretions easily expelled) or ineffective (secre-

Points to Remember

• Fever is a controlled elevation in body temperature above the normal core temperature range. The febrile response is a normal physiologic reaction to disease, not a disease itself. • Most fevers are self-limiting and rarely pose severe conse­quences unless the oral temperature exceeds 106ºF (41.1ºC). The main reason for treating fever with antipyretic agents is to alleviate patient discomfort. • Rectal temperature measurement is the most accurate method; however, oral, tympanic, and temporal mea­surements also are accurate if taken appropriately. • Sponge baths using topical isopropyl or ethyl alcohol to reduce fever should be discouraged. • Patients should be evaluated by a primary care provider if a 3-day course of self-treatment is not successful.

American Pharmacists Association

tions present but dif­ficult to expel). The secretions may be clear (as in bron­chitis), purulent (a possible indicator of bacterial infection), discolored (e.g., yellow with inflammatory disorders), or malodorous (a possible indicator of anaerobic bacterial infection). A nonproductive cough (i.e., a dry or “hacking” cough) serves no useful physiologic purpose. Nonproductive coughs are associated

with viral respiratory tract infections, atypical bacterial infec­tions, GERD, cardiac disease, and some medications. Angiotensin-converting enzyme inhibitors cause dry cough in 20% or more of treated patients. Systemic and ophthalmic β-adrenergic blockers may cause cough in patients with obstructive airway diseases (e.g., asthma, chronic obstructive pulmonary disease [COPD]).

Exclusions for Self-Treatment Self-treatment options are appropriate only for patients with acute cough that has been present for 7 days or less. Patients who have experienced cough for more than 7 days should be evaluated by a primary care provider. Cough is a symptom of many acute and chronic diseases, and self-treatment may delay effective treat­ment of the underlying disease.

Table 5. Clinically Important Drug Interactions With Nonprescription Antipyretic Agents Management/ Preventive Measures

Antipyretic Agent

Drug

Potential Interaction

Acetaminophen

Alcohol

Increased risk of hepatotoxicity

Avoid concurrent use if possible; minimize alcohol intake when using acetaminophen

Acetaminophen

Warfarin

Increased risk of bleeding (elevations in INR)

Limit acetaminophen to occasional use; monitor INR for several weeks when acetaminophen 2–4 g/day is added or discontinued in patients taking warfarin

Aspirin

NSAIDs, including COX-2 inhibitors

Increased risk of gastroduodenal ulcers and bleeding

Avoid concurrent use if possible

Aspirin

Valproic acid

Displacement from protein-binding sites and inhibition of oxidation of valproic acid

Avoid concurrent use; use naproxen instead of aspirin (no interaction)

Ibuprofen

Aspirin

Decreased antiplatelet effect of aspirin

Aspirin should be taken at least 30 minutes before or 8 hours after ibuprofen; use acetaminophen (or other antipyretic) instead of ibuprofen

Ibuprofen

Phenytoin

Displacement from protein-binding sites

Monitor free phenytoin levels; adjust dose as indicated

NSAIDs (several)

Bisphosphonates

Increased risk of GI or esophageal ulceration

Use caution with concomitant use

NSAIDs (several)

Digoxin

Inhibited renal clearance of digoxin

Monitor digoxin levels; adjust dose as indicated

NSAIDs and aspirin

Alcohol

Increased risk of GI bleeding

Avoid concurrent use, if possible; minimize alcohol intake

NSAIDs and aspirin

Anticoagulants

Increased risk of bleeding, especially GI

Avoid concurrent use, if possible

NSAIDs (several) and aspirin

Antihypertensive agents, β-blockers, ACE inhibitors, vasodilators, diuretics

Antihypertensive effect inhibited; possible hyperkalemia with potassium-sparing diuretics and ACE inhibitors

Monitor blood pressure, cardiac function, and potassium levels

NSAIDs (several) and aspirin

Methotrexate

Decreased methotrexate clearance

Avoid aspirin and NSAIDs with high-dose methotrexate therapy; monitor levels with concurrent treatment

ACE = angiotensin-converting enzyme; COX = cyclooxygenase; GI = gastrointestinal; INR = international normalized ratio; NSAID = nonsteroidal anti-inflammatory drug.

OTC Advisor: Self-Care for Fever, Cough, Cold, and Allergy

9

Patients who have any of the chronic diseases listed in Table 6—or signs or symptoms of these chronic diseases—should not attempt to self-treat cough. This includes cough caused by an acute viral upper respiratory tract infection, because the acute infection can exacerbate the underlying disease. Patients with smoker’s cough should be counseled regard­ ing smoking cessation options. Other exclusions for self-treatment of cough are listed in Figure 2. Treatment of Cough The primary goal of self-treatment of cough is to reduce the number and severity of cough episodes. This goal may be achieved through a combination of nonpharmacologic measures and pharmacologic therapy. Pharmacologic therapy is targeted at either suppressing the cough with antitussive agents or changing the volume and character of the respiratory secretions with protussive agents (i.e., expectorants). Pharmacologic therapy for cough is symptomatic only; neither antitussives nor protussives resolve the underlying pathophysiology that is responsible for the coughing. The self-treatment of cough is outlined in Figure 2. Nonpharmacologic Therapy Nonpharmacologic options for the treatment of cough include: • Nonmedicated loz­enges or hard candies, which reduce throat irritation and may decrease coughing. • Honey, which was shown in one small study (105 children) to pro-

vide symptomatic relief of nocturnal cough associated with childhood upper respiratory infection. • Humidification, which increases the amount of moisture in inspired air and may soothe irritated airways. • Adequate hydration, which may promote the formation of secretions that are less viscous and thus easier to expel. Neither lozenges nor honey should be used to relieve cough in children younger than 1 year of age. Lozenges represent a potential choking hazard; honey may cause infant botulism. Humidifiers (ultrasonic, impeller, or evaporative types) and vaporizers (humidifiers with a medication well or cup for volatile inhalants) are used to increase the amount of moisture in inspired air. It is important to note that high humidity may increase the amount of mold and dust mites in the home, thereby worsening allergies. Humidifiers and vaporizers also disperse minerals and microorganisms into the air. Cool-mist humidifiers and vaporizers are preferred to warm-mist humidifiers and vaporizers because fewer bacteria grow at the cooler temperatures and there is less risk of scalding if the unit is tipped over. Humidifiers and vaporizers must be cleaned daily and disinfected weekly. To maintain adequate hydration, most people should consume approximately eight 8-oz glasses of water daily. The clinical benefits of increasing hydration beyond this level in patients with acute upper respiratory tract infections are debatable. Excessive fluid intake may cause fluid overload

and hyponatremia in patients with lower respira­tory tract infections; it is not known whether this effect occurs with upper respiratory tract infections. Cautious hydration is recommended for patients with lower respiratory tract infections, heart failure, renal failure, or other conditions potentially exac­ erbated by overhydration. Pharmacologic Therapy Antitussives (cough suppressants) control or eliminate cough and are the drugs of choice for nonproductive coughs. Dextromethorphan is the most common systemic nonprescription antitussive. Codeine—the gold standard antitussive—is available as a Schedule V product in 30 states (9 of which limit sales to products sold in a pharmacy by a pharmacist). The antihistamine diphenhydramine also is approved by the FDA as an antitussive. All of these agents act centrally in the medulla oblongata to increase the cough threshold. The volatile oils camphor and menthol are approved as topical antitussives. Dosage forms include topical oint­ments and creams (e.g., Vicks VapoRub), steam inhalants, and oral lozenges. Ointments, creams, and inhalation solutions containing camphor or menthol are toxic if ingested; as little as 4 teaspoons (approximately 20 mL) of products containing 5% camphor can be lethal to children. Protussives are the drugs of choice for coughs that have difficulty expelling thick, tenacious secretions from the lungs. Antitussives should not be used by patients with produc-

Table 6. Signs and Symptoms of Chronic Diseases Associated With Cough Disease

Signs and Symptoms

Asthma

Wheezing or chest tightness; coughing predominantly at night; cough in response to specific irritants such as dust, smoke, or pollen

Chronic obstructive pulmonary disease

Productive cough most days of the month at least 3 months of the year for at least 2 consecutive years

Congestive heart failure

Fatigue, dependent edema, breathlessness

Gastroesophageal reflux disease

Heartburn, worsening of symptoms when supine, improvement with acid-reducing drugs

Lower respiratory tract infection

Oral temperature >101.5ºF (38.6ºC); thick, purulent, discolored phlegm; drenching night sweats

Upper airway cough syndrome

Mucus drainage from nose, frequent throat clearing

10

American Pharmacists Association

Figure 2. Algorithm for Self-Treatment of Cough Exclusionsfor forSelf-Treatment Self-Treatment Exclusions for Self-Treatment Exclusions Exclusions for Self-Treatment

Patient with cough Patient with cough

Coughwith withthick thickyellow yellowsputum sputumoror Cough greenphlegm phlegm green Fever>101.5°F >101.5°F(38.6°C) (38.6°C) Fever Unintendedweight weightloss loss Unintended Drenchingnighttime nighttimesweats sweats Drenching Hemoptysis Hemoptysis Historyororsymptoms symptomsofofchronic chronic History underlyingdisease diseaseassociated associatedwith with underlying cough(e.g., (e.g.,asthma, asthma,COPD, COPD,chronic chronic cough bronchitis,CHF) CHF) bronchitis, Foreignobject objectaspiration aspiration Foreign Suspecteddrug-associated drug-associatedcough cough Suspected Coughfor for>7 >7days days Cough Coughthat thatworsens worsensduring duringselfselfCough treatment treatment Developmentofofnew newsymptoms symptoms Development duringself-treatment self-treatment during

Obtain medical history Obtain medical history and medication history, and medication history, use, including CAM: intended including CAM: intended use, previous use, length/frequency previous of use use, length/frequency of use

Exclusions for self-treatment Exclusions for self-treatment? (see box)?

Yes Yes

Medical management Medical management

Yes Yes

Centrally acting antitussive, Centrally acting lozenges, antitussive, nonmedicated or other nonmedicated lozenges, or other topical antitussive. Reevaluate topical antitussive. Reevaulate in 7 days in 7 days

No No Dry (nonproductive) cough? Dry (nonproductive) cough?

No No Nondrug measures (vaporizers, Expectorant + Nondrug measures hydration). Antitussive if cough (vaporizers, hydration). affects sleep or work. Antitussive if cough affects sleep Reevaluate in 7 days or work. Reevaluate in 7 days

Symptoms improved? Symptoms improved?

No No

Medical management Medical management

Yes Yes Continue treatment until cough Continue treatment until cough is gone. Reevaluate as needed is gone. Reevaluate as needed

CAM = complementary and alternative medicine; CHF = congestive heart failure; COPD = chronic obstructive pulmonary disease. Source: Tietze KJ. Cough. In: Berardi RR, Ferreri SP, Hume AL, et al., eds. Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care. 16th ed. Washington, DC: American Pharmacists Association; 2009:204.

tive coughs unless absolutely necessary (e.g., exhaustion from lack of sleep). Suppres­sion of productive coughs may lead to retention of lower respiratory tract secretions and potentially adverse conse­quences (e.g., secondary bacterial lower respiratory tract infection, airway obstruction). Nonprescription cough medications are marketed in a variety of dosage forms: syrups, liquids, tablets, capsules, lozenges, oral dis­ integrating strips, oral granules, oral sprays, ointments and creams, and vaporizer solutions. Some products contain various combinations of antitussives, protussives, antipyretic/analgesic agents, decongestants, and antihistamines. In general, singleagent products are preferred to products that contain both an antitussive and a protussive—a combination that is considered to be irrational. Few controlled clinical trials provide clear evidence of the efficacy

of nonprescription antitussives or expectorants in the treatment of acute cough in adults or children. In particular, there is little evidence that antitussives are effective for coughs associated with the common cold or other upper respiratory tract infections. The reason may be that cough associated with upper respiratory tract infections usually is a voluntary cough controlled in the cerebral cortex, while nonprescription antitussives act on the cough control center in the medulla oblongata. Pharmacists should be aware that patients are likely to continue using nonprescription antitussives and expectorants whether or not evidence of efficacy exists; these medications generally are well tolerated and usually pose few safety risks if administered in accordance with labeled instructions. Antitussive Agents. Codeine. Approved antitussive dosages of codeine are shown in Table 7. Codeine-

OTC Advisor: Self-Care for Fever, Cough, Cold, and Allergy

containing solutions and syrups that are available as Schedule V products must not contain more than 200 mg of codeine per 100 mL and must contain one or more noncodeine active ingredients (e.g., guaifenesin, antihistamines, decongestants). Usual antitussive dos­ages of codeine have little risk of addiction and low toxicity; the most common adverse effects are nausea, vomiting, sedation, dizziness, and con­stipation. The lethal dose of codeine in adults is 0.5 to 1 g, with death from marked respiratory depression and cardiopulmonary collapse. Because elderly patients may be more susceptible to the sedating effects of codeine, the dose should be started at the lower end of the dosage range and titrated as tolerated with careful monitoring. Concomitant use of codeine and CNS depressants (e.g., barbiturates, sedatives, alcohol) causes additive CNS depression. Patients with im-

11

paired respiratory reserve (e.g., those with asthma or COPD) or preexisting respiratory depression, and patients who take other respiratory depressants or sedatives (including alcohol), should use codeine with caution. Codeine is a Pregnancy Category C drug and should be used during pregnancy only if the potential benefits outweigh the risks. Nonteratogenic con­cerns include the risk of neonatal respiratory depression if codeine is taken close to the time of delivery, as well as neo­natal withdrawal if codeine is used regularly during the pregnancy. Although codeine is excreted in breast milk, the American Academy of Pediatrics lists codeine as a maternal medication usually compatible with breastfeed­ing. Dextromethorphan. Dextromethorphan is a nonopioid considered to be approximately equipo­tent with codeine. It has no analgesic, sedative, respiratory depressant, or addictive properties at usual antitussive doses (Table 7). Dosage forms include syrups, liquids, extended-release oral suspensions, liquid-filled gelcaps, oral disintegrating strips, oral sprays, and lozenges. Dextromethorphan has a wide margin of safety. Adverse effects with usual doses are uncom­mon but may include drowsiness, nausea, vomiting, stomach discomfort, or constipation. Over­doses may cause confusion, excitation, nervousness, irritability, restlessness, drowsiness, and severe nausea and vomiting; respiratory depression may occur with very high doses. Because elderly patients may be more susceptible to the sedating effects of dextromethorphan, the dose should be started at the lower end of the dosage range and titrated as tolerated with careful monitoring. Patients who take dextromethorphan concurrently with alcohol, antihista­mines, or psychotropic medications may experience additive CNS depression. Dextromethorphan blocks serotonin reuptake, and the combination of monoam­ine oxidase (MAO) inhibitors and dextromethorphan may cause serotonergic syndrome (e.g., increased blood pressure, hyperpyrexia, arrhythmias, myoclonus). Dex­ tromethorphan should not be admin-

12

istered for at least 14 days after MAO inhibitor therapy is discontinued. Although dextromethorphan is a Pregnancy Category C drug, it is viewed by some clinicians as proba­ bly safe for use during pregnancy. It is not known whether dextromethorphan is excreted in breast milk. The current statement from the American Academy of Pediatrics on the transfer of drugs and other chemicals into human milk makes no recommendation regarding dextromethorphan and breastfeeding. Dextromethorphan may be abused (particularly by teenagers) for

its euphoric effect, which is similar to that produced by phencyclidine. Possible consequences of abuse include psychosis and mania. Diphenhydramine. Diphenhy­ dramine is a nonselective (first-generation) antihistamine with significant sedating and anticholinergic properties. Its antitussive effect is more likely related to anticholinergic activity than to competitive histamine antagonism. Although diphenhydramine is not considered to be a first-line antitussive, the American Col­lege of Chest Physicians recommends the use of a first-generation antihistamine in com-

Emerging Issues: Status of Pediatric Cough and Cold Products In March 2007, a group of prominent pediatricians and public health officials filed a citizen petition with the FDA requesting an amendment to the Final Monograph for Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use. Specifically, the citizen petition requested that the labeling for nonprescription antihistamine, antitussive, expectorant, and nasal decongestant cough and cold products—as well as products containing combinations of those active ingredients—be amended to state that the products should not be used in children younger than 6 years of age. The petition argued that these medications (1) have not been shown to be effective for common cold symptoms in this age group and (2) carry a risk of significant, potentially fatal adverse effects, particularly in the case of unintentional overdosage. In response to the citizen petition, the FDA convened a joint meeting of the Nonprescription Drugs Advisory Committee and Pediatric Advisory Committee on October 18 and 19, 2007, to address the safety and efficacy of nonprescription cough and cold medications in children. The committee members voted 21 to 1 to ban the use of cough and cold products in children younger than 2 years of age, and voted 13 to 9 to ban them in children 2 to 5 years of age. At the time this monograph was published, a proposed rule on changes to the Final Monograph was expected in June 2010. In anticipation of the October 2007 meetings, a number of manufacturers initiated a voluntary market withdrawal of “infant” cough and cold products (i.e., products intended for children younger than 2 years of age). This withdrawal did not include single-ingredient antipyretic/analgesic products. The FDA followed by issuing a public health advisory in January 2008, recommending that nonprescription cough and cold medications not be used to treat infants and children younger than 2 years of age because of the possibility of serious and potentially life-threatening adverse effects. In October 2008, the Consumer Healthcare Products Association (CHPA) announced that its members were voluntarily transitioning the labeling on oral nonprescription pediatric cough and cold medications to state “do not use” in children younger than 4 years of age. In addition, products containing certain antihistamines would carry a new voluntary statement warning parents not to use antihistamine products to sedate children or make them sleepy. Although these changes are inconsistent with the existing Final Monograph for these products, the FDA voiced its support for the voluntary actions and stated that it would not object to the modifications because they reflect a more restrictive use of the drugs in children. These changes effectively divide children into the following age groups for purposes of treatment recommendations: • Children younger than 4 years of age, who should not be treated with nonprescription cough and cold medications (unless a primary care provider recommends such use). Pharmacists should recommend nondrug measures for children in this age group. • Children 4 years of age and older, who may be treated with nondrug measures or nonprescription medications administered in age-appropriate doses.

American Pharmacists Association

bination with a decongestant to treat acute cough, upper airway cough syndrome, and throat clearing associated with the common cold. Approved antitussive dosages of diphenhydramine citrate and diphenhydramine hydrochloride are shown in Table 7; they are lower than the dosages used for antihistamine effects. Dosage forms include syrups, liquids, and oral disintegrating strips. Diphenhydramine potentiates the depressant effects of narcotics, nonnarcotic analgesics, benzodiazepines, tranquilizers, and alcohol on the CNS and intensifies the anticholinergic effect of MAO inhibitors and other anticholinergics. Because of the increased risk of toxicity, diphenhydramine antitussives should not be used with any other product that contains diphenhydramine, including topical products. Symp­toms of diphenhydramine overdose include mild to severe CNS depression (e.g., mental confusion, sedation, respira­ tory depression), hypotension, and CNS stimulation (e.g., hallucinations, convulsions). Antihistamines are discussed in greater detail in the Common Cold and Allergic Rhinitis sections. Protussive Agents. Guaifenesin (glyceryl guaiacolate) is the only FDA-approved expectorant. It loosens and thins lower respiratory tract secretions, thereby mak­ing minimally productive coughs more productive.

However, few data support the efficacy of guaifenesin, especially at nonprescription dosages. Guaifenesin should not be used to treat effectively productive coughs. Guaifen­esin also should not be used for chronic cough associated with lower respiratory tract diseases such as asthma, COPD, emphysema, or smoker’s cough. Approved dosages of guaifenesin are shown in Table 7. Dosage forms include oral liquids, syrups, and immediate- and extended-release tablets. Guaifenesin generally is well toler­ ated. Adverse effects may include nausea, vomiting, dizziness, headache, rash, diarrhea, drowsiness, and stom­ach pain. Guaifenesin may have a mild uricosuric effect, and large dosages may cause urolithiasis. Most reports of guaifenesin overdosage involve combinations of drugs and therefore are difficult to assess; however, signs and symptoms of overdosage appear to be extensions of the adverse effects. There are no reported drug interactions involving guaifenesin. Follow-Up For most patients, 7 days of nonprescription drug therapy should relieve cough. If the cough persists but has improved at follow-up, the patient should continue the therapy until the cough is resolved. If the cough has wors­ened or the patient has devel-

oped other exclusions for self-treatment, the patient should be evaluated by a primary care provider.

Common Cold

The common cold is a self-limited viral infection of the upper respiratory tract. It can be caused by more than 200 different types of viruses, but the majority of colds in children and adults are caused by rhinoviruses. Other major pathogens are coronaviruses, influenza viruses, parainfluenza viruses, adenoviruses, echoviruses, respiratory syncytial virus, and coxsackieviruses. Although the common cold may occur at any time during the year, the incidence of rhinovirus infection peaks in the early fall (August to October) and late spring (April and May). Children contract the common cold more frequently than adults do; children average 6 to 10 colds per year (but may have 12 or more, especially if they attend day care), while adolescents and adults average 2 to 4 colds per year. Natural History The most efficient mode of transmission of common cold viruses is self-inoculation: a person touches a contaminated skin surface (e.g., shakes hands with an infected person) or environmental surface (e.g., doorknob, telephone), then inadvertently deposits the virus into his or

Table 7. Dosage Guidelines for Nonprescription Oral Antitussives and Expectorants Dosage (Maximum Daily Dosage) Adults and Children Age ≥12 y

Children Age 6–11 y

Children Age 4–5 ya

Codeine

10–20 mg every 4–6 h (120 mg)

5–10 mg every 4–6 h (60 mg)

…b

Dextromethorphan hydrobromide

10–20 mg every 4 h or 30 mg every 6–8 h (120 mg)

5–10 mg every 4 h or 15 mg every 6–8 h (60 mg)

2.5–5 mg every 4 h or 7.5 mg every 6–8 h (30 mg)

Diphenhydramine citrate

38 mg every 4 h (228 mg)

19 mg every 4 h (114 mg)

…b

Diphenhydramine HCl

25 mg every 4 h (150 mg)

12.5 mg every 4 h (75 mg)

…b

Guaifenesin

200–400 mg every 4 h (2.4 g)

100–200 mg every 4 h (1.2 g)

50–100 mg every 4 h (600 mg)

Drug

Current product labeling states “do not use” in children younger than 4 years of age, based on a voluntary action by manufacturers. Not recommended for use in children younger than 6 years of age except under the advice of a primary care provider.

a b

OTC Advisor: Self-Care for Fever, Cough, Cold, and Allergy

13

her nose or eye. A healthy person also may become infected through prolonged contact with aerosols produced by coughing, sneezing, or talking. Factors that increase a person’s susceptibility to colds include: • Smoking. • Allergic disorders affecting the nose or pharynx. • Increased population den­sity. • A sedentary lifestyle. • Chronic (duration 1 month or more) psychologic stress. Contrary to common belief, cold environments, sudden chilling, exposure to central heating, walking outside bare­foot, teething, or enlarged tonsils or adenoids do not increase susceptibility to viral upper respiratory infec­ tions. A predictable sequence of symptoms begins 1 to 3 days after infection. A sore or “scratchy” throat appears first and usually resolves quickly. Nasal obstruction (i.e., congestion) and rhinorrhea predominate by day 2 or 3. Nasal secretions initially are clear, thin, and watery. As the infection progresses, the secre­tions become thicker, and the color may change to yellow or green; when the infection begins to resolve, the secretions return to being clear, thin, and watery. Cough appears by day 4 or 5, although it develops in fewer than 20% of patients. Patients may have low-grade fever, but colds only rarely are associated with a temperature higher than 100ºF (37.8ºC). Symptoms typically disappear gradually after 7 to 10 days but may persist for 14 days or longer. Most people do not develop complications from colds. When complications do develop, they may be severe and, rarely, life threatening. Complications include sinusitis, middle-ear infections, bronchitis, bacterial pneumonia, and exacerba­tions of asthma or COPD. Exclusions for Self-Treatment The common cold usually is easy to recognize, based on its characteristic symptom pattern. However, patients may confuse a cold with other common respiratory disorders, some of which require antimicrobial therapy. Signs and symptoms of other common respiratory disorders are listed

14

in Table 8. Patients who are not good candidates for self-treatment of the common cold include: • Patients with concurrent underlying chronic cardiopulmonary diseases (asthma, COPD, congestive heart failure). • Patients with acquired immunodeficiency syndrome. • Frail patients of advanced age. Other exclusions for self-treatment are listed in Figure 3. Treatment and Prevention of the Common Cold There is no known cure for the common cold. Thus, the goal of selftreatment is to reduce bothersome symptoms. Self-treatment strategies for the common cold are outlined in Figure 3. Preventing transmission of common cold viruses is an important goal. The U.S. Centers for Disease Control and Prevention encourage people with a cold—as well as anyone who comes into direct contact with those people—to wash their hands frequently with soap and warm water for 15 to 20 seconds. As a point of reference, this is approximately the amount of time it takes to sing the “Happy Birthday” song twice. Individuals who do not have ready access to soap and water may use soap substitutes (e.g., hand sanitizers). Products containing ethyl alcohol (62% to 95% concentration), benzalkonium chloride, salicylic acid, pyroglutamic acid, or triclosan have been proven effective. Individuals who use gel sanitizers should rub their hands together until the gel is dry. Whenever possible, patients with the common cold should cough or sneeze into a tissue, dispose of the tissue, then wash their hands. If a tissue is not available, patients should cough or sneeze into the crook of the arm rather than using their hand to cover their nose or mouth. Rhinoviruses can survive up to 3 hours on skin and objects such as telephones and stair railings. Studies conducted during the 1980s found that use of antiviral disinfectants (e.g., Lysol) and antiviral tissues (e.g., Kleenex Anti-Viral) may help to prevent transmission of the common cold.

The ability of zinc to decrease the duration and severity of cold symptoms is controversial, and the results of clinical trials have been inconclusive. Trials that showed a benefit employed a rigorous administration schedule that started within 24 to 48 hours of symptom onset, involved multiple daily doses (as frequent as every 2 hours), and continued as long as symptoms persisted. However, a recent meta-analysis of 14 trials concluded that oral zinc lozenges were not effective. In June 2009, the FDA advised consumers not to use intranasal zinc products (gel or swabs) because of the risk of anosmia. The role of vitamin C in the prevention and treatment of the common cold has been debated for more than 60 years. A recent Cochrane review of 30 clinical trials that used a daily dose of at least 200 mg per day— either as continuous prophylaxis or after the onset of symptoms—found no definitive evidence of benefit; the authors concluded that routine mega-dose prophylaxis is not rationally justified for community use. The studies did show that taking vitamin C before the onset of cold symptoms reduced the duration of symptoms by 8% in adults and 13.6% in children. Doses of vitamin C of 4 g per day or greater are associated with diarrhea and other GI symptoms and should be avoided. Several alternative products claim to strengthen the immune system. Larch arabinogalactan—traditionally used as a food additive—is marketed as Natrol ImmunEnhancer; it is thought to have probiotic properties and to increase the activity of natural killer cells. Airborne effervescent tablets are a combination of 17 active ingredients including high doses of vitamins A and C, herbs (echinacea, ginger, and Chinese vitex), and amino acids (glutamine and lysine). Patients are urged to take the product before entering crowded environments such as airplanes, offices, and classrooms. Despite the popularity of these products, their safety and efficacy have not been proven. Nonpharmacologic Therapy General nonpharmacologic meaAmerican Pharmacists Association

Case 2. Common Cold GP, a 57-year-old woman, approaches the pharmacist with a package containing a combination product intended for the relief of common cold and flu symptoms. Each caplet contains acetaminophen 325 mg, dextromethorphan hydrobromide 10 mg, and phenylephrine hydrochloride 5 mg; the dosage is two caplets every 4 hours. GP asks the pharmacist whether this is a good choice for her symptoms and with her other medications. GP describes symptoms suggestive of the common cold, with nasal stuffiness, “runny nose,” sneezing, and a scratchy throat the past two or three mornings. GP identifies congestion and rhinorrhea as the most troublesome symptoms. Her current medications are: • Aspirin 81 mg daily. • Vicodin ES (hydrocodone 7.5 mg/acetaminophen 750 mg) one capsule four times daily as needed for pain. What should the pharmacist tell GP about the product she has selected? a. b. c. d.

The cold and flu product is an ideal choice for GP’s symptoms. The cold and flu product is a good choice but should be used for 1 or 2 days only. GP should not purchase this product. She would be better served by a different product. GP should not purchase this product. She should check with her primary care provider before attempting self-treatment.

Case study responses appear on page 26.

sures for the common cold include maintaining adequate fluid intake, getting adequate rest, eating a nutritious diet as tolerated, and increasing humidifica­tion with steamy showers, humidifiers, or vaporizers. Saline nasal sprays or drops may be used to soothe irritated mucosal membranes and loosen encrusted mucus; saline gargles may help to ease sore throat. Simple, inexpensive foods such as tea with lemon and honey, chicken soup, and hot broths are soothing and increase fluid intake. Limited evidence suggests that chicken soup could have anti-inflammatory activity. There is no evidence that milk increases cough or congestion, so milk products need not be withheld. Medical devices such as Breathe Right nasal strips are marketed for temporary relief from nasal congestion and stuffiness resulting from colds and allergies. These devices lift the nares open, enlarging the anterior nasal passages. A wide variety of aromatic products (e.g., SudaCare Shower Soothers vaporizing shower tablets, Triaminic Flowing Vapors portable vapor fan, Theraflu Vapor Patch,

Table 8. Differentiation of the Common Cold and Other Respiratory Disorders Disorder

Signs and Symptoms

Allergic rhinitis

Watery eyes; itchy nose, eyes, or throat; repetitive sneezing; nasal congestion; watery rhinorrhea; red, irritated eyes with conjunctival injection (i.e., prominent conjunctival blood vessels)

Asthma

Cough, dyspnea, wheezing

Bacterial throat infection

Sore throat (moderate to severe pain), fever, exudate, tender anterior cervical adenopathy

Common cold

Sore throat (mild to moderate pain), nasal congestion, rhinorrhea, and sneezing common; low-grade fever, chills, headache, malaise, myalgia, and cough possible

Croup

Fever, rhinitis, and pharyngitis initially, progressing to cough (may be “barking” cough), stridor, and dyspnea

Influenza

Myalgia, arthralgia, fever ≥100°F to 102°F (≥37.8°C to 38.9°C), sore throat, nonproductive cough, moderate to severe fatigue

Otitis media

Ear popping, ear fullness, otalgia, otorrhea, hearing loss, dizziness

Pneumonia or bronchitis

Chest tightness, wheezing, dyspnea, productive cough, changes in sputum color, persistent fever

Sinusitis

Tenderness over the sinuses, facial pain aggravated by Valsalva’s maneuver or postural changes, fever >101.5ºF (>38.6ºC), tooth pain, halitosis, upper respiratory tract symptoms for >7 days with poor response to decongestants

West Nile virus infection

Fever, headache, fatigue, rash, swollen lymph glands, and eye pain initially, possibly progressing to gastrointestinal distress, central nervous system changes, seizures, or paralysis

Whooping cough

Initial catarrhal phase (rhinorrhea, sneezing, mild cough, sneezing) of 1 to 2 weeks, followed by 1 to 6 weeks of paroxysmal coughing

OTC Advisor: Self-Care for Fever, Cough, Cold, and Allergy

15

Figure 3. Algorithm for Self-Treatment of the Common Cold Patient with complaints Patient with complaints suggestive of common cold suggestive of common cold

Exclusions forfor Self-Treatment Exclusions for Self-Treatment Exclusions Self-Treatment Exclusions for Self-Treatment

Obtain medical history and Obtain medical history and medication history, including medication history, including CAM. Evaluate medication CAM. Evaluate medication exclusions/precautions exclusions/precautions

Exclusions for self-treatment Exclusions (see box)? for self-treatment?

Yes Yes

management Medical Medical management

Yes Yes

See FIGURE 2 See Figure 2

Yes Yes

See FIGURE 4 See Figures 4 & 5

No No Recommend nondrug nondrugmeasures measures Recommend such as as adequate adequatehydration hydrationand and such rest. Identify Identify most mostproblematic problematic rest. symptoms symptoms

Cough primary complaint? Cough primary complaint?

Fever >101.5 °F (38.6 °C) Fever >101.5 °F (38.6 °C) Chest pain Chest pain Shortness of breath Shortness of breath Worsening of symptoms or Worsening of symptoms or development of additional symptoms development of additional symptoms during self-treatment during self-treatment Concurrent underlying chronic Concurrent underlying chronic cardiopulmonary diseases cardiopulmonary diseases (e.g., asthma, COPD, CHF) (e.g., COPD, CHF) AIDS orasthma, chronic immunosuppressant AIDS or chronic immunosuppressant therapy therapy Frail patients of advanced age Frail patients of advanced age Infants <9 months of age Infants <9 months of age Hypersensitivity to recommended OTHypersensitivity C medications to recommended OTC medications

No No Symptoms related relatedto toallergy allergy Symptoms alone? alone?

No No Gopage to next page Go to next

Vicks VapoRub) produce a soothing odor, which may ease nasal congestion. Aromatic products should be used with caution in children, because many of these products can be toxic if ingested. Nondrug therapy for infants includes upright posi­tioning to enhance nasal drainage, maintaining an ade­ quate fluid intake, increasing the humidity of inspired air, and irrigating the nose with saline drops. Because chil­dren typically cannot blow their own noses until about 4 years of age, carefully clearing the nasal passageways with a bulb syringe may be necessary if accumulation of mucus interferes with sleeping or eating. To use the syringe, the caregiver should squeeze the large end of the bulb and continue squeezing it while gently inserting the tip into the child’s nose. The caregiver then should release the pressure on the bulb slowly to draw out the nasal secretions. After

16

the pressure is released completely, the caregiver should remove the bulb from the child’s nose and expel the secretions from the syringe. Pharmacologic Therapy If a patient wishes to use nonprescription cold medications, symptomspecific therapy with single-entity products is recommended (Figure 3). Common cold symptoms appear, peak, and resolve at different times; products that combine two or more active ingredients are convenient, but the convenience must be weighed against the risks from taking unnecessary agents. Most of the active ingre­dients in FDA-approved cold medications are Pregnancy Category B or C. Because the common cold is a self-limiting condition with primarily bothersome symptoms, many clinicians recommend non­drug therapy. When drugs are considered, those with a long re-

cord of safety in animals and humans are preferred. To minimize possible adverse effects on the fetus or new­ born, women who are pregnant or breastfeeding should be advised to avoid: • Products labeled as extra or maximum strength. • Long-acting products. • Combination products. Respecting the recent changes affecting pediatric cough and cold products (see Emerging Issues: Status of Pediatric Cough and Cold Prod ucts on page 12), parents and other caregivers should be encouraged to rely primarily on nonpharmacologic measures for children younger than 6 years of age, particularly those younger than 4 years of age. Decongestants. Systemic and topical decongestants are the mainstay of therapy for the common cold. Decongestants are adrenergic agonists (sympathomimetics). By stimuAmerican Pharmacists Association

Figure 3. Algorithm for Self-Treatment of the Common Cold (Continued) Congestion and Congestion and rhinorrhea most rhinorrhea most problematic problematic

Saline nasal spray or Saline nasal spray or decongestant. decongestant. Consider using Consider using humidifier and raising humidifier and raising head of bed head of bed

Additional Additional complaint of complaint of sleeplessness? sleeplessness?

Yes Yes

Aches and pains most Aches and pains most problematic problematic

Fever most Fever most problematic problematic

Pharyngitis most Pharyngitis most problematic problematic

Systemic analgesics Systemic analgesics

Systemic Systemic antipyretics antipyretics

Saline gargles or Saline gargles or local anesthetic local anesthetic sprays or lozenges sprays or lozenges

Switch to nasal decongestant sprays and nighttime use of Switch to nasal decongestant sprays and nighttime use of AHs or alcohol-containing products AHs or alcohol-containing products

No No Symptoms resolved Symptoms resolved after 7-14 days of after 7-14 days of therapy? therapy?

No No

Adjust doses or switch to other agents. Refer for further Adjust doses or switch to other agents. Refer for further evaluation if alternative therapy fails evaluation if alternative therapy fails

Yes Yes Assess patient as Assess patient as needed needed AH = antihistamine; AIDS = acquired immunodeficiency syndrome; CAM = complementary and alternative medicine; CHF = congestive heart failure; COPD = chronic obstructive pulmonary disease; OTC = over-the-counter. Source: Scolaro KL. Disorders related to colds and allergy. In: Berardi RR, Ferreri SP, Hume AL, et al., eds. Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care. 16th ed. Washington, DC: American Pharmacists Association; 2009:180.

lating α-adrenergic receptors and thereby constricting blood vessels (throughout the body in the case of systemic agents), decongestants decrease sinusoid vessel engorgement and mucosal edema. Systemic Decongestants. Pseudoephedrine and phenylephrine are the only available nonprescription systemic decongestants. The recommended dosages of these agents are presented in Table 9. Phenylephrine is available as the hydrochloride salt and the bitartrate salt; the latter is used in effervescent dosage forms. Pseudoephedrine is a chemical precursor to methamphetamine and therefore subject to diversion. Although products containing pseudoephedrine continue to be available without a prescription, they must be stored behind the pharmacy counter

Points to Remember

• Cough is a symptom of diverse infectious and noninfectious disorders. A productive cough expels secretions from the lower respiratory tract. A nonproductive or dry cough is stimulated by a mechanical or chemical irritant and serves no useful physiologic purpose. • Only patients with acute cough are candidates for self-treatment. Patients whose cough has persisted for longer than 7 days should be evaluated by a primary care provider. • Nonprescription medications for the treatment of cough are antitussives (primarily dextromethorphan) or protussives (the expectorant guaifenesin). Antitussives are used to control nonproductive coughs. Guaifenesin is used to make a minimally productive cough more effective by facilitating the removal of thick, tenacious secretions from the lungs. • Antitussives should not be taken by patients with productive coughs unless absolutely necessary (e.g., exhaustion from lack of sleep). In general, the concomitant use of guaifenesin and an antitussive is considered to be irrational and should not be recommended. • Pharmacists should be aware of the abuse potential of dextromethorphan and its popularity as a recreational drug, especially among teenagers.

or in a similar secure location in accordance with the Combat Methamphetamine Epidemic Act of 2005. Patients must request these products

OTC Advisor: Self-Care for Fever, Cough, Cold, and Allergy

from the pharmacist or store personnel; purchases are limited to 3.6 g of pseudoephedrine (the equivalent of 120 30-mg tablets) per day and 9 g

17

Table 9. Dosage Guidelines for Nonprescription Systemic Nasal Decongestants Dosage (Maximum Daily Dosage) Drug

Adults and Children Age ≥12 y

Children Age 6–11 y

Children Age 4–6 ya

Phenylephrine bitartrateb

15.6 mg every 4 h (62.4 mg)

7.8 mg every 4 h (31.2 mg)

…c

Phenylephrine HCl

10 mg every 4 h (60 mg)

5 mg every 4 h (30 mg)

2.5 mg every 4 h (15 mg)

Pseudoephedrine

60 mg every 4–6 h (240 mg)

30 mg every 4–6 h (120 mg)

15 mg every 4–6 h (60 mg)

Current product labeling states “do not use” in children younger than 4 years of age, based on a voluntary action by manufacturers. Used in effervescent dosage forms. c Not recommended for use in children younger than 6 years of age except under the direction of a primary care provider. a b

Table 10. Drug Interactions Involving Decongestants Drug

Effect

MAO inhibitors (phenelzine, tranylcypromine, isocarboxazid, furazolidone, procarbazine)

Increased blood pressure

Methyldopa

Increased blood pressure

Tricyclic antidepressants (amitriptyline, nortriptyline, imipramine)

Increased blood pressure (direct-acting decongestantsa) Decreased decongestant activity (ephedrine)

Antacids/alkalinizers (potassium acetate, sodium acetate, sodium bicarbonate, sodium citrate, sodium lactate, potassium citrate, citric acid)

Decreased elimination (pseudoephedrine)

Oxymetazoline, phenylephrine, tetrahydrozoline. MAO = monoamine oxidase.

a

(the equivalent of 300 30-mg tablets) per month. Purchasers also must show photo identification and sign a logbook. (Some states have enacted stricter requirements than those mandated by the federal law.) In response to these restrictions, many products that contained pseudoephedrine were reformulated with phenylephrine, and new products containing phenylephrine were introduced. There is ongoing controversy about the effectiveness of phenylephrine as a systemic decongestant, particularly at the approved nonprescription dosage. The most common adverse effects of systemic decongestants are the result of CNS and cardiovascular stimulation. Possible CNS effects include restlessness, insomnia, anxiety, tremors, fear, and hallucinations. Possible cardiovascular effects include elevated blood pressure, tachycardia, palpitations, or arrhythmias. Overdoses cause excessive CNS stimulation,

18

para­doxical CNS depression, cardiovascular collapse, shock, and coma. Systemic decongestants may exacerbate diseases sensitive to adrenergic stimulation, such as hypertension, hyperthy­roidism, diabetes, coronary heart disease, ischemic heart disease, elevated intraocular pressure, and prostatic hypertrophy. Patients with any of these conditions (hypertension in particular) should use decongestants only with adequate medical supervision and monitoring. No clear evi­dence exists that any one agent is safer in patients with hypertension. Systemic decongestants interact with numerous drugs, as listed in Table 10. The use of decongestants is contraindicated in patients receiving concomitant therapy with MAO inhibitors. Although there is no clear association between birth defects and the use of decon­gestants during pregnancy, systemic decon­gestants theoretically decrease fetal blood

flow and should be avoided. Pseudoephedrine also has been linked to abdominal wall defects (gastroschisis) in newborns. Pseudoephedrine is compatible with breastfeeding and is the preferred decongestant for women who are breastfeeding. Pharmacists should advise patients who par­ticipate in organized sports that oral decongestants are considered “doping” products and should be used with caution. Topical Decongestants. Topical (i.e., intranasal) decongestants work locally. Systemic absorption is minimal, and systemic adverse effects generally are infrequent and mild. Most topical decongestants—ephedrine, epinephrine, levmetamfetamine, naphazoline, phenylephrine, propylhexedrine, and tetrahydrozoline— are categorized as short-acting. Xylometazoline is classified as intermediate-acting, and oxymetazoline is classified as long-acting. Topical decongestants are availAmerican Pharmacists Association

able as sprays and drops. Nasal sprays are simple to use, cover a large surface area, are relatively inexpensive, and have a fast onset of action. The disadvantages include imprecise dosage, a tendency for the tip to become clogged after repeated use, and a high risk of contamina­ tion from aspiration of nasal mucus into the bottle. Metered pump sprays deliver a more precise dose. Nasal drops are preferred for children, but this dosage form can be awkward to use, cover a limited surface area, and pass easily into the larynx. The dropper also is prone to contamination because of the tendency to touch it to the nose during administration. Although topical decongestants cause few systemic adverse effects, patients may experience adverse effects from the product propellant or vehi­cle (e.g., burning, stinging, sneezing, local dryness) or trauma from the tip of the administration device. Topical decongestants also can produce rhinitis medicamentosa (an apparent rebound congestion when the drug is discontinued) with continued use. The condition appears to

of the common cold are not primarily histamine mediated. Sedating (firstgeneration, nonselective) antihistamines may help to reduce rhinorrhea and sneezing when used in combination with decongestants, but not as monotherapy. Evidence-based guidelines from the American College of Chest Physicians recommend combination therapy with a first-generation antihistamine and decongestant to treat the virus-induced upper airway cough syndrome that is the most likely cause of cough associated with the common cold. Nonsedating (second-generation, peripherally selective) antihistamines have no effect on common cold symptoms. The recommended nonprescription dosages of sedating antihistamines are listed in Table 11. (These agents should not be administered to children younger than 6 years of age except with the advice and supervision of a primary care provider.) Consideration must be given to whether the potential benefits of sedating antihistamines outweigh their known risks. As the class name implies, the most notable adverse effects of these

be more common with short-acting agents; the preservative benzalkonium chloride may be a contributing factor. Use of topical decongestants should be limited to 3 to 5 days to reduce the risk of rhinitis medicamentosa, although some studies have shown durations of 10 days to 8 weeks to be safe. Treatment con­ sists of slowly withdrawing the topical decongestant (one nostril at a time); replacing the decongestant with topical normal saline, which soothes the irritated nasal mucosa; and, if needed, using topical corticosteroids and systemic decongestants. The mucous membrane usually returns to normal within 1 to 2 weeks. Oxymetazoline is the preferred topical decongestant during pregnancy. Intranasal phenylephrine usually is safe for use by breastfeeding women. Nasal preparations containing xylometazoline and naphazoline should be avoided by breastfeeding women. The efficacy of topical decongestants may be reduced in patients with nasal polyps, enlarged turbinates, or abnormalities such as septal deviation. Antihistamines. The symptoms

Table 11. Dosage Guidelines for Sedating Nonprescription Antihistamines Dosage (Maximum Daily Dosage) Drug

Adults and Children Age ≥12 y

Children Age 6–11 ya

Brompheniramine maleate

4 mg every 4–6 h (24 mg)

Chlorcyclizine HCl

25 mg every 6–8 h (75 mg)

…

Chlorpheniramine maleate

4 mg every 4–6 h (24 mg)

2 mg every 4–6 h (12 mg)

Clemastine fumarate

1.34 mg every 12 h (2.68 mg)

…

Dexbrompheniramine maleate

2 mg every 4–6 h (12 mg)

1 mg every 4–6 h (6 mg)

Dexchlorpheniramine maleate

2 mg every 4–6 h (12 mg)

1 mg every 4–6 h (6 mg)

Diphenhydramine citrate

38–76 mg every 4–6 h (456 mg)

19–38 mg every 4–6 h (228 mg)

Diphenhydramine HCl

25–50 mg every 4–6 h (300 mg)

12.5–25 mg every 4–6 h (150 mg)

Doxylamine succinate

7.5–12.5 mg every 4–6 h (75 mg)

3.75–6.25 mg every 4–6 h (37.5 mg)

Phenindamine tartrate

25 mg every 4–6 h (150 mg)

12.5 mg every 4–6 h (75 mg)

Pheniramine

12.5–25 mg every 4–6 h (150 mg)

6.25–12.5 mg every 4–6 h (75 mg)

Pyrilamine maleate

25–50 mg every 6–8 h (200 mg)

12.5–25 mg every 6–8 h (100 mg)

Thonzylamine HCl

50–100 mg every 4–6 h (600 mg)

25–50 mg every 4–6 h (300 mg)

Triprolidine HCl

2.5 mg every 4–6 h (10 mg)

1.25 mg every 4–6 h (5 mg)

2 mg every 4–6 h (12 mg) b

b

a

These medications are not recommended for use in children younger than 6 years of age except under the advice of a primary care provider.

b

These medications are not recommended for use in children younger than 12 years of age except under the advice of a primary care provider.

OTC Advisor: Self-Care for Fever, Cough, Cold, and Allergy

19

Points to Remember

• The common cold is a self-limited viral infection of the upper respiratory tract. Symptoms typically disappear gradually after 7 to 10 days but may persist for 14 days or longer. • The common cold usually begins with a sore throat, followed rapidly by rhinorrhea, nasal obstruction, and sneezing. Cough, when present, usually is nonproductive. In contrast to influenza, systemic symptoms (e.g., fever, myalgias) usually are absent or mild. • Because of unresolved concerns about the risks associated with the use of nonprescription cough and cold medications in children, parents and other caregivers should be encouraged to rely primarily on nonpharmacologic measures for children younger than 6 years of age, particularly those younger than 4 years of age. • The recommended approach to the use of nonprescription medications in older children and adults is symptom-specific therapy with single-entity products. Products that combine two or more active ingredients targeting multiple symptoms are convenient, but the convenience must be weighed against the risks from taking unnecessary agents. • Topical and systemic decongestants are the mainstays of symptomatic treatment for the common cold. They should be used with caution in patients with hypertension, diabetes, and other chronic diseases. Topical agents should not be used for more than 3 to 5 days to avoid rhinitis medicamentosa (rebound congestion). • Evidence does not support the use of antihistamine monotherapy, antitussives, or expectorants for treatment of symptoms related to colds. • Local anesthetics and systemic analgesics have good evidence for the treatment of pain due to sore throat or fever related to colds.

agents are sedation and impaired per­formance (e.g., impaired driving, poor work performance, incoordination, reduced motor skills, impaired information processing). Patients may be impaired even if they do not feel drowsy or if they have taken the dose the prior evening. Sedating antihistamines also may cause paradoxical CNS excitation, including anxiety, hallucinations, appetite stimulation, mus­cle dyskinesias, and activation of epileptogenic foci. Paradoxical excitation is more common in children and older adults. High doses of sedating antihistamines cause nervousness, tremor, insomnia, agitation, and irritability. Effects associated with cholinergic blockage include dryness of the eyes and mucous membranes (e.g., mouth, nose, vagina), blurred vision, urinary hesitancy and retention, constipa­tion, and tachycardia. Additional information about antihistamines is provided in the Allergic Rhinitis section. Local Anesthetics. Local anesthetics such as benzocaine and dyclonine hydrochloride may provide temporary relief of sore throat in patients with the common cold. Dosage forms include lozenges, throat sprays, and oral disintegrating strips. These products generally may be used every 2 to 4 hours. Patients with a history of allergic reactions to

20

anesthetics should avoid products containing benzocaine. Some products marketed for sore throat relief contain local antiseptics (cetylpyridinium chloride, hexylresorcinol), men­thol, or camphor. Local antiseptics are not effective for viral infections; the clinical efficacy of menthol or camphor is not well documented. Systemic Antipyretics/Analgesics. Systemic antipyretic/analgesic agents—aspirin, acetaminophen, ibuprofen, and naproxen—are effective for the fever or aches that sometimes are associated with colds. Concerns that the use of aspi­rin and acetaminophen may increase viral shedding and prolong illness have not been substantiated. As mentioned previously, aspirin-containing products should not be used in children 15 years of age or younger with viral illnesses because of the risk of Reye’s syndrome. Antitussives and Protussives. When present, cough associated with the common cold usually is nonproductive. However, neither dextromethorphan nor codeine has been shown to be effective for treatment of acute cough associated with viral upper respiratory tract infections in either adults or children. Similarly, the expectorant guaifenesin has not been proven effective in natural colds. Follow-Up Common cold symptoms typi-

cally disappear gradually after 7 to 10 days, although they may persist for 14 days or longer. Patients whose symptoms either do not improve or worsen after 14 days should be evaluated by a primary care provider. Patients who develop signs or symptoms of possible complications also should consult a primary care provider. However, pharmacists should keep in mind that nasal secretions change from clear to yellow or green during the normal course of the common cold; this discoloration usually does not indicate the presence of secondary bacterial sinus infection unless it fails to resolve after 10 to 14 days.

Allergic Rhinitis

Allergic rhinitis is a systemic disease with prominent nasal symptoms. The previous classifications of “seasonal allergic rhin­itis” and “perennial allergic rhinitis” have been replaced with a system that classifies patients’ symptoms in one of the following four categories, depending on the duration and severity of those symptoms (Table 12): • Mild intermittent allergic rhinitis. • Moderate/severe intermittent allergic rhinitis. • Mild persistent allergic rhinitis. • Moderate/severe persistent allergic rhinitis. It is possible for patients to experience intermittent allergic rhinitis only during defined times of the year, or to have mild persistent allergic rhinitis during most months of the year with more severe symptoms during certain seasons. Pathophysiology and Clinical Presentation Allergic rhinitis is triggered by indoor and outdoor environmental allergens. Pollen and mold spores are common outdoor aeroallergens (i.e., airborne allergens). Pollutants (e.g., ozone, diesel exhaust particles) are considered environmental triggers and are becoming more of a concern in highly populated areas. Common indoor aeroallergens include housedust mites, cockroaches, mold spores, cigarette smoke, and pet dander. Occupational aeroallergens include wool dust, latex, resins, biologic enzymes, organic dusts American Pharmacists Association

Table 12. Classification of Allergic Rhinitis

a

Mild Intermittent

Mild Persistent

• Symptoms occur ≤4 days per week OR ≤4 weeks • Symptoms do not impair sleep or daily activitiesa • No troublesome symptoms

• Symptoms occur >4 days per week AND >4 weeks • Symptoms do not impair sleep or daily activitiesa • No troublesome symptoms

Moderate/Severe Intermittent

Moderate/Severe Persistent

• Symptoms occur ≤4 days per week OR ≤4 weeks • Symptoms impair sleep or daily activitiesa or are troublesome

• Symptoms occur >4 days per week AND >4 weeks • Symptoms impair sleep or daily activitiesa or are troublesome

Daily activities include work, school, sports, and leisure.

Table 13. Symptoms of Allergic Rhinitis Common nasal symptoms • • • •

Frequent paroxysmal sneezing Itching of the nose and palate Anterior watery rhinorrhea Nasal congestion (variable)

Common ocular symptoms

• Red, irritated eyes with prominent conjunctival blood vessels (conjunctivitis) • Itching or burning that may be intense • Tearing • Stringy or watery discharge • Puffy eyelids, especially in the morning

Facial features

• Allergic gape (open-mouth breathing secondary to nasal obstruction) • “Allergic salute” (patient will rub the tip of the nose upward with the palm of the hand) • Allergic crease (horizontal crease just above the bulbar portion of the nose secondary to the allergic salute) • Allergic shiners (periorbital darkening secondary to venous congestion) • Dennie’s lines (wrinkles beneath the lower eyelids)

Systemic symptoms • • • •

(e.g., flour), and various chemicals (e.g., isocyanate, glutaraldehyde). In patients with allergic rhinitis, inhaled allergenic materials elicit a specific response mediated by immunoglobulin E (IgE). The patient becomes sensitized to the allergen on initial exposure. On subsequent exposures, binding of the allergen to IgE causes the rapid release of preformed mast cell mediators (e.g., histamine, proteases) and the synthesis of additional mediators (e.g., prostaglandins, kinins, leukotrienes, neuropeptides). This early phase is followed by a cellular recruitment phase in which circulating leukocytes, especially eosinophils, are attracted to the nasal mucosa and release

Cognitive impairment Fatigue Irritability Malaise

more inflammatory mediators. The late phase begins 2 to 4 hours after allergen exposure; symp­toms include mucus hypersecretion secondary to submu­cosal gland hypertrophy and congestion. Continued per­sistent inflammation “primes” the tissue, resulting in a lower threshold for allergicand nonallergic-mediated (e.g., cold air, strong odors) triggers. Common symptoms and physical findings of allergic rhinitis are listed in Table 13. Symptoms typically are bilateral; they often are worse upon awakening, improve during the day, then may worsen again at night. Allergic rhinitis must be differentiated from nonallergic rhinitis, which usually is characterized by unilateral symp-

OTC Advisor: Self-Care for Fever, Cough, Cold, and Allergy

toms (although they may be bilateral) that are constant day and night. The predominant symptoms of nonallergic rhinitis are (1) posterior rhinorrhea that is watery or thick and may be mucopurulent and (2) nasal obstruction that may be severe; sneezing and pruritus usually are absent. Allergic rhinitis can lead to both acute complications (e.g., sinusitis, otitis media with effusion) and chronic complications (e.g., nasal polyps, sleep apnea, dimin­ished sense of smell). Allergic rhinitis and asthma share a common pathology, and allergic rhinitis has been impli­cated in the development of asthma and exacerbations of preexisting asthma in children and adults. Depression, anxiety, delayed speech development, and facial or dental abnormalities also have been linked to allergic rhinitis. Exclusions for Self-Treatment Many patients with intermittent allergic rhinitis and mild persistent allergic rhinitis are able to manage their symptoms successfully with nonprescription medications. Patients with moderate/severe persistent allergic rhinitis generally require therapy with prescription medications (e.g., inhaled corticosteroids) and should not rely on self-treatment. Because pregnancy is a common cause of nonallergic rhinitis, pregnant women should use nonprescription medications only if they have been diagnosed with allergic rhinitis and are using the medications under the guidance of a primary care provider. Children younger than 12 years of age with symptoms of allergic rhinitis may have undiagnosed asthma; they should be referred to a primary care provider for a differential diagnosis. Other exclusions for self-treatment are listed in Figure 4. Treatment of Allergic Rhinitis Allergic rhinitis cannot be cured. The goals of therapy are to reduce symptoms and improve the patient’s functional status and sense of wellbeing. As shown in the algorithm in Figure 4, the treatment of allergic rhinitis begins with limiting exposure to allergens. However, because allergen avoidance usually is not suf-

21

Figure 4. Algorithm for Self-Treatment of Allergic Rhinitis Exclusions Exclusions for for Self-Treatment Self-Treatment Exclusions Exclusionsfor forSelf-Treatment Self-Treatment a

Patient with symptoms of Patient rhinitis with symptoms of allergic allergic rhinitis

Children <12 years Children years a women a Pregnant<12 or lactating a Pregnant or of lactating women Symptoms nonallergic rhinitis Symptoms rhinitis Symptomsof ofnonallergic otitis media, sinusitis, Symptoms sinusitis, bronchitis,of orotitis othermedia, infection bronchitis, infectionor Symptomsorofother undiagnosed Symptoms of undiagnosed or uncontrolled asthma (e.g., wheezing, uncontrolled asthma (e.g., wheezing, shortness of breath), COPD, or other shortness of breath), COPD, or other lower respiratory disorder lower respiratory disorder Moderate/severe PAR or symptoms Moderate/severe PAR or symptoms unresponsive to treatment unresponsive to treatment Severe or unacceptable side effects of Severe or unacceptable side effects of treatment treatment

Evaluate history, previous Evaluate history, previous therapies, and symptoms therapies, and symptoms Medical management Medical management

Yes Yes

Exclusions for self-treatment Exclusions for self-treatment

No No

Yes Yes

Recommend measures to control Recommend measuresSelect to control exposure to allergens. drug exposure to allergens. Select drug therapy based on symptoms therapy based on symptoms

Mild IAR Mild IAR

Moderate/severe PAR? Moderate/severe PAR?

No No Moderate/ Moderate/ severe IAR severe IAR

Mild PAR Mild PAR

Sneezing, Sneezing, rhinorrhea, rhinorrhea, or itching or itching

Conjunctivitis Conjunctivitis

Congestion Congestion

Sneezing, Sneezing, rhinorrhea, rhinorrhea, or itching or itching

Oral AH Oral AH

Intraocular AH Intraocular AH or saline or saline

Oral or topical Oral or topical decongestant decongestant

Oral AH and/or Oral AH and/or intranasal intranasal cromolyn cromolyn

Assess in Assess in 3-4 days 3-4 days

Side effects or Side effects or ADRs? ADRs?

Yes Yes

Symptom Symptom controlled? controlled?

Continue Continue therapy unless therapy unless symptoms symptoms worsen or worsen or ADRs occur ADRs occur

Yes Yes

Yes Yes

If PAR, recheck If PAR, recheck in 2-4 weeks in 2-4 weeks

Symptoms Symptoms controlled? controlled?

No No

No No

Assess adherence. If adherent, increase Assess adherence. If adherent, increase dose or switch to alternative drug. If dose or switch to alternative drug. If nonadherent, educate patient and continue nonadherent, educate patient and continue therapy. Assess in 1-2 weeks. If symptoms therapy. Assess in 1-2 weeks. If symptoms have worsened worsened or or are aresevere: severe:medical refer to PCP have for Rx therapy referral for Rx therapy

Switch to Switch to alternative alternative drug drug

a

No No

If IAR, continue If IAR, continue therapy as therapy as needed unless needed unless symptoms symptoms worsen or worsen or ADRs occur ADRs occur

Excluded from self-treatment unless already diagnosed with allergic rhinitis and nonprescription therapy approved by a PCP.

ADR = adverse drug reaction; AH = antihistamine; IAR = intermittent allergic rhinitis; PCP = primary care provider; PAR = persistent allergic rhinitis; Rx = prescription. Source: Scolaro KL. Disorders related to colds and allergy. In: Berardi RR, Ferreri SP, Hume AL, et al., eds. Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care. 16th ed. Washington, DC: American Pharmacists Association; 2009:193.

fi­ cient to provide complete relief of allergic rhinitis, tar­geted therapy with single-entity nonprescription medications is indicated for most patients. Nonprescription therapy with antihistamines, decongestants, or both usually is effective for most

22

symptoms. Allergen Avoidance and Nonpharmacologic Therapy Examples of recommended allergen avoidance measures are listed in Table 14. Pharmacists should edu-

cate patients that the best method of treating allergic rhinitis is to avoid allergens. However, pharmacists also should recognize the limitations of allergen avoidance; many patients have no control over their work environment or are unable to implement all of the American Pharmacists Association

preventive measures at home. Ventilation systems with highefficiency particulate air (HEPA) filters remove pollen, mold spores, and cat aller­gens from household air. They do not remove house-dust mite allergens, which settle to the floor too quickly to be filtered. HEPA filtration systems are expensive and not effective for all patients. Patients should be encouraged to rent a HEPA filtration device before investing in freestanding or per­manently installed systems. HEPA filters are also found in some vacuum cleaners. Weekly vacuuming of carpets, draperies, and upholstery may help reduce household aller­ gens, including dust mites. Using nasal wetting agents (e.g., saline, propylene, and poly­ethylene glycol sprays or gels)—or performing nasal irrigation with warm saline (isotonic or hypertonic) delivered via a syringe or neti pot—may relieve nasal mucosal irritation and dryness, thereby decreasing nasal stuffiness, rhinorrhea, and sneezing. Nasal wetting agents and nasal irrigation also aid in the removal of dried, encrusted, or thick mucus from the nose. Nasal wetting agents have no significant adverse effects; nasal irrigation may cause mild stinging or burning. Patients with allergic conjunctivitis may instill artificial tears as needed. Applying cold compresses to the eyes three to four times daily can help to reduce redness and itching. Pharmacologic Therapy Non­prescription medication options for allergic rhinitis include oral and ophthalmic antihista­mines, topical and oral decongestants, and the mast cell stabi­lizer cromolyn sodium. Because no single medication is ideal for all symptoms, combination drug regimens are commonly used. Systemic Antihistamines. Systemic antihistamines are used to relieve symptoms of sneezing, rhinorrhea, and itching. All antihistamines compete with his­tamine at central and peripheral histamine H1 receptor sites, preventing the histamine– receptor interaction and subse­quent mediator release. Nonsedating antihistamines also inhibit the release of mast cell mediators and may decrease cellular recruitment.

Table 14. Allergen Avoidance Measures House-dust mites

• Reduce household humidity to <40% • Encase mattresses, box springs, and pillows in mite-impermeable covers • Wash bedding that cannot be encased in allergen-proof covers in hot water (>130°F) at least weekly • Discard bedding that cannot be encased or laundered • Use wood, leather, or plastic furniture instead of upholstered furniture • Remove carpets (especially wall-to-wall carpeting) to the extent possible • Remove stuffed animals and bookshelves from the patient’s bedroom and other areas of the house if possible • Use acaricides as needed

Pollens

• Monitor pollen counts and limit outdoor activity when counts are high (counts are highest early in the morning and in the evening and lowest after rainstorms) • Keep windows and doors closed in home and motor vehicle (use air conditioning as needed) when pollen counts are high

Antihistamines are most effective when used regularly rather than episodically. Patients with intermittent allergic rhinitis should initiate therapy before being exposed to known allergens and continue therapy throughout the exposure (e.g., during pollen season). Patients with persistent allergic rhinitis should take antihistamines on a regular basis (daily if needed). Drug interactions involving antihistamines are listed in Table 15. All antihistamines decrease or prevent immediate dermal reactivity and should be discontinued at least 4 days before scheduled allergy skin testing. Nonsedating Antihistamines. Nonsedating antihistamines are recommended as first-line therapy for allergic rhinitis. Loratadine and cetirizine currently are the only nonsedating antihistamines available without a prescription (Table 16). They are marketed in a number of dosage forms, including tablets, syrups, and orally disintegrating tablets. Cetirizine also is available in spoon-shaped, prefilled plastic vials that provide a single pediatric dose (Children’s Zyrtec Perfect Measure).

OTC Advisor: Self-Care for Fever, Cough, Cold, and Allergy

Molds

• Avoid activities that disturb decaying outdoor plant material (e.g., raking leaves) • Lower household humidity • Remove house plants • Vent food preparation areas and bathrooms • Repair damp basements or crawl spaces • Apply fungicide frequently to obviously moldy areas

Cockroaches

• Keep areas clean • Store food tightly sealed • Treat infested areas with baits or pesticides

Pollutants

• Be aware of the air quality index (AQI, a measure of five major air pollutants per 24 hours); plan outdoor activities when the AQI is low

Comparisons of cetirizine and loratadine have shown cetirizine to be a more potent antihistamine. However, cetirizine causes sedation in approximately 10% of patients and should be used with caution in patients requiring mental alertness. Nonsedating antihistamines are associated with few adverse effects. Dosages of both cetirizine and loratadine should be adjusted in patients with renal or hepatic impairment. Both cetirizine and loratadine are considered to be safe for use during pregnancy, although they are not first-line options. Antihistamines may pass into breast milk and are not recommended for use by breastfeeding women, although the American Academy of Pediatrics lists loratadine as a maternal medication usually compatible with breastfeed­ing. Sedating Antihistamines. The role of sedating antihistamines in the treatment of allergic rhinitis is controversial. Sedating antihistamines are effective, and there is some evidence that they may be more effective than nonsedating antihistamines. They also are readily available and relatively inex­pensive. Nonetheless, these

23

natives if chlorpheniramine is not tolerated. Ophthalmic Antihistamines. Ophthalmic antihistamines are used for rapid relief of ocular symptoms of allergic rhinitis. They may be administered in conjunction with systemic antihistamines, especially in patients with prominent eye involvement. The ophthalmic antihistamines antazoline phosphate and pheniramine maleate are available for nonprescription use in combination products that also contain the ophthalmic decongestant naphazoline. These products may be used three to four times daily. Ketotifen fumarate is an ophthalmic antihistamine and mast cell stabilizer that recently was switched from prescription to nonprescription status. It has a fast onset of action and a long duration of action that permits twice-daily dosing. In

advantages generally are considered to be outweighed by the aforementioned risks of sedation, impaired performance, and anticholin­ergic effects. A variety of conditions preclude patients from using sedating antihistamines or necessitate using these agents with caution. Patients with lower respiratory tract diseases (e.g., emphysema, chronic bronchitis) generally should avoid using sedating anti­histamines if possible. The sedating antihistamines are contraindicated in patients with narrow-angle glaucoma, acute asthma exacerbation, stenosing peptic ulcer, symptomatic prostatic hypertrophy, and bladder neck and pyloroduodenal obstruction. Chlorphe­niramine is the systemic antihistamine of choice in pregnancy because of its long history of safety. Cetirizine and loratadine are alter-

Table 15. Drug Interactions Involving Antihistamines Drug

Effect

Cimetidine, erythromycin, ketoconazole

Increased loratadine plasma concentration

CNS depressants (alcohol, sedatives)

Increased sedation (sedating antihistamines)

MAO inhibitors (phenelzine, tranylcypromine, isocarboxazid, furazolidone, procarbazine)

Prolonged and intensified anticholinergic and CNS depressive effects (sedating antihistamines) Decreased blood pressure (dexchlorpheniramine)

Phenytoin

Decreased phenytoin elimination (chlorpheniramine)

Theophylline (doses >400 mg)

Increased cetirizine plasma concentration

CNS = central nervous system; MAO = monoamine oxidase.

contrast with other ophthalmic antihistamines, products containing ketotifen fumarate do not also contain a decongestant. Ketotifen fumarate is considered to be the safest and most effective option for ocular symptoms. It is approved for use for patients 3 years of age and older. Ophthalmic antihistamines may cause burning, stinging, or discomfort on instillation. They also have anticholinergic prop­erties and may cause pupil dilation. This effect is seen most commonly in people with light-colored irises or com­promised corneas (e.g., contact lens wearers). In sus­ceptible patients, pupil dilation can lead to angle-closure glaucoma and thus are contraindicated in patients with known risk factors. Intranasal Cromolyn Sodium. Cromolyn sodium is an anti-inflammatory agent that stabilizes mast cells, thereby preventing mediator release. The recommended dosage for patients 6 years of age and older is one spray in each nostril three to six times daily at regular intervals. Treat­ ment is more effective if it is started before seasonal symptoms begin. A therapeutic effect may not become apparent for 3 to 7 days, and 2 to 4 weeks of continued therapy may be needed before the maximal therapeutic benefit is achieved. Cromolyn sodium is noteworthy for its wide margin of safety. Less than 7% of an intranasal dose is absorbed systemically, and the small amount that is absorbed has no systemic activity. Swallowed drug is excreted unchanged in the feces. Accordingly, cromolyn sodium is the initial drug of choice for the treatment of allergic rhinitis in pregnant women. It also is a good choice for women

Table 16. Dosage Guidelines for Nonsedating Nonprescription Antihistamines Dosage (Maximum Daily Dosage)

a

Drug

Adults and Children Age ≥12 y

Children Age 6–11 y

Children Age 2–5 y

Cetirizine HCl

10 mg every 24 h

5–10 mg every 24 h (10 mg)

2.5–5 mg every 24 h (5 mg)

Loratadine

10 mg every 24 h

10 mg every 24 h

5 mg every 24 h

a

The 10-mg dose should be used by adults older than 65 years of age only with the advice and supervision of a primary care provider.

24

American Pharmacists Association

who are breastfeeding. No drug interactions with intranasal cromolyn sodium have been reported. Sneezing is the most common adverse effect reported for intranasal cromolyn. Other adverse effects include nasal stinging and burning. Decongestants. Congestion is a common symptom of allergic rhinitis. It usually can be controlled with systemic decongestants or short-term use (no more than 5 days) of topical nasal decongestants, as monotherapy or in addition to antihistamine therapy. Follow-Up Many patients achieve symptomatic relief with initial non­prescription drug therapy in 3 to 4 days, but complete relief of symptoms may take 2 to 4 weeks. Patients who respond poorly to treatment should be assessed to determine whether they are complying with allergen avoidance strategies and med­ication

Points to Remember

• Allergic rhinitis is a systemic disease with prominent nasal symptoms. It is classified as mild intermittent, moderate/severe intermittent, mild persistent, or moderate/severe persistent, based on the duration and severity of symptoms. • Allergic rhinitis is triggered by indoor and outdoor environmental allergens. Common symptoms include frequent paroxysmal sneezing; itching of the eyes, nose, and palate; anterior watery rhinorrhea; nasal congestion; and conjunctivitis (red, irritated eyes with prominent conjunctival blood vessels). • Allergen avoidance is considered to be the best method of treating allergic rhinitis. However, many patients have no control over their work envi­ronment or are unable to implement all of the recommended preventive measures at home. • The goals of nonprescription medication therapy for allergic rhinitis are to reduce symptoms and improve the patient’s functional status and sense of well-being. Options include oral and ophthalmic antihista­mines, topical and oral decongestants, and the mast cell stabi­lizer cromolyn sodium. • To be most effective, nonprescription medications for allergic rhinitis should be administered regularly rather than episodically.

regimens. Some patients may require an increase in medication dosage or a switch to a different agent or formulation. Patients who do not respond to nonprescription therapy despite these measures should be referred to a primary care provider. Patients who use ophthalmic

OTC Advisor: Self-Care for Fever, Cough, Cold, and Allergy

antihistamines should consult an eye care practitioner for symptoms that do not resolve within 72 hours.

25

Case Study Responses Case 1. Fever a. The mother should sponge JP with tepid water to help bring down the fever. Incorrect. Sponging is not recommended routinely for patients with a temperature less than 104ºF (40ºC). b. The mother should administer a nonprescription antipyretic medication to JP as soon as possible, because JP’s temperature is dangerously high. Incorrect. A tympanic temperature of 101.2ºF (38.4ºC) is not considered to be dangerous and may not require any treatment beyond general supportive measures. c. JP should be seen by a primary care provider as soon as possible. Incorrect. In the absence of other symptoms, children older than 6 months of age usually do not need to be seen by a medical provider unless they have a temperature equivalent to a rectal temperature of 104ºF (40ºC) or greater. d. The mother should dress JP in light clothing, encourage her to drink fluids, and monitor her temperature periodically using the same thermometer and site each time. Antipyretic medication could be administered if JP seems very uncomfortable. Correct. The mother should be counseled to contact JP’s primary care provider if JP’s symptoms are not improving or are worsening over the course of 3 days.

Case 2. Common Cold a. The cold and flu product is an ideal choice for GP’s symptoms. Incorrect. GP does not report fever or cough; therefore, use of all the ingredients found in this product is not warranted. In addition, concomitant use of this product and Vicodin ES (hydrocodone 7.5 mg/ acetaminophen 750 mg) might cause her to consume an excessive amount of acetaminophen. b. The cold and flu product is a good choice but should be used for 1 or 2 days only. Incorrect. The length of time GP might use the product is not a primary concern. c. GP should not purchase this product. She would be better served by a different product. Correct. GP does not need most of the medications found in this product. Because congestion and rhinorrhea are the most problematic symptoms, GP would be better served by a saline nasal spray or decongestant (or both) initially. d. GP should not purchase this product. She should check with her primary care provider before attempting self-treatment. Incorrect. While it is true that GP should not purchase this product (she does not need all the active ingredients), she does not have any obvious contraindications to self-treatment.

26

American Pharmacists Association

References

The following chapters in the Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care served as the primary sources of information for this monograph. Feret B. Fever. In: Berardi RR, Ferreri SP, Hume AL, et al., eds. Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care. 16th ed. Washington, DC: American Pharmacists Association; 2009:83–94. Scolaro KL. Disorders related to colds and allergy. In: Berardi RR, Ferreri SP, Hume AL, et al., eds. Handbook of Nonprescription Drugs: An Interactive Approach to SelfCare. 16th ed. Washington, DC: American Pharmacists Association; 2009:177–202.

Butler CC, Kinnersley P, Hood K, et al. Clinical course of acute infection of the upper respiratory tract in children: cohort study. BMJ. 2003;327:1088–9.

Hendeles L, Hatton RC. Oral phenylephrine: an ineffective replacement for pseudoephedrine? J Allergy Clin Immunol. 2006; 118:279–80.

Caruso TJ, Prober CG, Gwaltney JM Jr. Treatment of naturally acquired common colds with zinc: a structured review. Clin Infect Dis. 2007;45:569–74.

Hersh EV, Moore PA, Ross GI. Over-thecounter analgesics and antipyretics: a critical assessment. Clin Ther. 2000;22:500–48.

Centers for Disease Control and Prevention. Stopping germs at home, work, and school. Available at: http://www.cdc. gov/germstopper/home_work_school.htm. Accessed January 15, 2010.

Irwin RS, Madison JM. The diagnosis and treatment of cough. N Engl J Med. 2000;343:1715–21. Kelly LF. Pediatric cough and cold preparations. Pediatr Rev. 2004;25:115–23.

Crocetti M, Moghbeli N, Serwint J. Fever phobia revisited: have parental misconceptions about fever changed in 20 years? Pedi­atrics. 2001;107:1241–6.

Kliegman RM, Behrman RE, Jenson HB, et al., eds. Nelson Textbook of Pediatrics. 18th ed. Philadelphia, PA: Saunders Elsevier; 2007.

Tietze KJ. Cough. In: Berardi RR, Ferreri SP, Hume AL, et al., eds. Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care. 16th ed. Washington, DC: American Pharmacists Association; 2009:203–12.

Dinarello CA, Gelfand JA. Fever and hyperthermia. In: Fauci AS, Braunwald E, Kasper DL, et al., eds. Harrison’s Online. Available at: http://www.accessmedicine. com.proxy.lib.umich.edu/content.aspx?aid= 2871330. Accessed January 15, 2010.

Mackowiak PA. Concepts of fever. Arch Intern Med. 1998;158:1870–81.

Additional primary sources of information for this monograph are listed below.

DiPiro JT, Talbert RL, Yee GC, et al., eds. Pharmacotherapy: A Pathophysiologic Approach. 7th ed. New York, NY: McGrawHill Medical; 2008.

Nabulsi M. Is combining or alternating antipyretic therapy more beneficial than monotherapy for febrile children? BMJ. 2010;340:92–9.

Douglas RM, Hemilä H, Chalker E, et al. Vitamin C for preventing and treating the common cold. Cochrane Database Syst Rev. 2007;3:CD000980.

National Institute of Allergy and Infectious Diseases, National Institutes of Health. Common cold. Available at: http:// www3.niaid.nih.gov/topics/commonCold. Accessed January 15, 2010.

American Academy of Pediatrics Committee on Drugs. The transfer of drugs and other chemicals into human milk. Pediat­rics. 2001;108:776–89. American College of Obstetricians and Gynecologists; American College of Allergy, Asthma, and Immunology. The use of newer asthma and allergy medications during pregnancy. Ann Allergy Asthma Immunol. 2000;84:475–80. Benzer TI. Neuroleptic malignant syndrome. eMedicine from WebMD Web site. Available at: http://emedicine.medscape. com/article/816018-overview. Updated August 18, 2009. Accessed February 17, 2010. Bolser DC. Cough suppressant and pharmacologic protussive therapy: ACCP evidence-based clinical practice guidelines. Chest. 2006;129(suppl):238S–49S. Bousquet J, Khaltaev N, Cruz AA, et al. Allergic rhinitis and its impact on asthma (ARIA) 2008 update. Allergy. 2008;63 (suppl 86):8–160. Bukutu C, Le C, Vohra S. Complementary, holistic, and integrative medicine: the common cold. Pediatr Rev. 2008;29:e66–71.

Eccles R. Efficacy and safety of over-thecounter analgesics in the treatment of common cold and flu. J Clin Pharm Ther. 2006;31:309–19. Farrell SE. Toxicity, acetaminophen. eMedicine from WebMD Web site. Available at: http://emedicine.medscape. com/article/820200-overview. Updated September 23, 2009. Accessed February 17, 2010. Gilbert C, Mazzotta P, Loebstein R, et al. Fetal safety of drugs used in the treatment of allergic rhinitis. Drug Saf. 2005;28:707– 19. Guppy MPB, Mickan SM, Del Mar CB. “Drink plenty of fluids”: a systematic review of evidence for this recommendation in acute respiratory infections. BMJ. 2004;328:499– 500. Hatton RC, Winterstein AG, McKelvey RP, et al. Efficacy and safety of oral phenylephrine: systematic review and meta-analysis. Ann Pharmacother. 2007;41:381–90.

OTC Advisor: Self-Care for Fever, Cough, Cold, and Allergy

Mayoral CE, Marino RV, Rosenfeld W, et al. Alternating antipyretics: is this an alternative? Pediatrics. 2000;105:1009–12.

National Institute of Neurological Disorders and Stroke, National Institutes of Health. NINDS neuroleptic malignant syndrome information page. Available at: http:// www.ninds.nih.gov/disorders/neuroleptic_ syndrome/neuroleptic_syndrome.htm. Accessed February 17, 2010. Nice FJ, Snyder JL, Kotansky BC. Breastfeeding and over-the-counter medications. J Hum Lact. 2000;16:319–31. Paul IM, Beiler J, McMonagle A, et al. Effect of honey, dextromethorphan, and no treatment on nocturnal cough and sleep quality for coughing children and their parents. Arch Pediatr Adolesc Med. 2007;161:1140–6. Pratter MR. Cough and the common cold: ACCP evidence-based clinical practice guidelines. Chest. 2006;129(suppl):72S– 74S.

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Ramey JT, Bailen E, Lockey RF. Rhinitis medicamentosa. J Investig Allergol Clin Immunol. 2006;16:148–5. Skoner DP. Complications of allergic rhinitis. J Allergy Clin Immu­nol. 2000;105:S605–9. Sutter AI, Lemiengre M, Campbell H, et al. Antihistamines for the common cold. Cochrane Database Syst Rev. 2003; 3:CD001267. Wright AD, Liebelt EL. Alternating antipyretics for fever reduction in children: an unfounded practice passed down to parents from pediatricians. Clin Pediatr. 2007;46:146–50.

Appendix A. Guidelines for Oral Temperature Measurements Using Electronic Thermometers

Appendix B. Guidelines for Rectal Temperature Measurements Using Electronic Thermometers 1. 2. 3.

4.

Digital Probe 1. 2. 3. 4. 5. 6.

7.

Wait 20 to 30 minutes after drinking or eating. Place a clean disposable probe cover over the tip of the thermometer. Turn on the thermometer and wait until it is ready for use. Place the tip of the thermometer under tongue. Close mouth and breathe through nose. Hold the thermometer in place until it beeps and temperature is displayed (usually after 5–30 seconds); note temperature. Remove and dispose of probe cover.

Digital Pacifier Thermometer 1. 2. 3. 4. 5.

6. 7.

28

Wait 30 minutes after drinking or eating. Inspect the pacifier for any tears or cracks. Do not use if worn. Press the button to turn on the thermometer. Place the pacifier in child’s mouth. Have the child hold pacifier in mouth without moving (if possible) for amount of time specified by manufacturer (2 to 6 minutes). Note temperature when thermometer beeps. Clean the pacifier by wiping the surface with a damp cloth or sponge using mild liquid soap, then wiping with clear water. Wipe dry or air dry. Do not immerse the pacifier in water.

5. 6. 7.

8.

Cover the tip of the thermometer with a probe cover. Turn on the thermometer and wait until it is ready for use. Apply a water-soluble lubricant to the tip of the thermometer to allow for easy passage through the anal sphincter and reduce the risk of trauma. Insert the thermometer tip into the rectum. — For infants or young children, place child face down over your lap and separate the buttocks with the thumb and forefinger of one hand; insert the thermometer gently in the direction of the child’s navel with the other hand. For infants, insert the thermometer to the length of the tip. For young children, insert it about 1 inch into the rectum. — For adults, have the patient lie on one side with the legs flexed to about a 45º angle from the abdomen. Insert the tip 0.5 to 2 inches (1.3 cm to 5.1 cm) into the rectum by holding the thermometer 0.5 to 2 inches (1.3 cm to 5.1 cm) away from the tip and inserting it until the finger touches the anus. Have the patient take a deep breath during this process to facilitate proper positioning of the thermometer. Hold the thermometer in place until it beeps and a temperature is displayed; note temperature. Remove the thermometer. Clean by wiping away from the stem toward the tip. Dispose of probe cover. Clean and disinfect the tip of the thermometer with an antiseptic such as alcohol or povidone-iodine solution and rinse with cool water. Wipe away any remaining lubricant from the anus.

Appendix C. Guidelines for Tympanic Temperature Measurements 1. 2. 3.

4. 5. 6.

Place a clean disposable lens cover over the ear probe. Turn on the thermometer and wait until it is ready for use. Place the ear probe into the ear canal. — For children younger than 1 year of age, pull the ear backward to straighten the ear canal. Place the ear probe into the canal and aim the tip of the probe toward the patient’s eye. — For patients 1 year of age and older, pull the ear backward and up to straighten the ear canal. Place the ear probe into the canal and aim the tip of the probe toward the patient’s eye. Press the button for temperature measurement (usually only 1 to 5 seconds). Read the displayed temperature. Discard the lens cover.

Appendix D. Guidelines for Temporal Temperature Measurements 1.

2. 3. 4.

5. 6.

Disinfect the thermometer by drawing it through a swab moistened with an antiseptic such as alcohol or povidone-iodine solution. Place the probe on one side of the forehead (near the temporal area). Turn on the thermometer and wait until it is ready for use. Sweep the thermometer across the hairline to the other side of the forehead. Make sure the probe remains in contact with the skin at all times. Lift the thermometer from the forehead and read the displayed temperature. Turn off the thermometer.

American Pharmacists Association

CPE Exam Instructions: The assessment questions printed below allow you to preview the online CPE exam. Please review all of your answers to be sure you have marked the proper letter on the online CPE exam. There is only one correct answer to each question.

1. The upper range of temperature encountered during fever rarely exceeds: a. 102°F (38.9°C). b. 104°F (40°C). c. 106°F (41.1°C). d. 110°F (43.3°C). 2. Which of the following sites is not recommended for routine use of body temperature measurement? a. Axillary. b. Oral. c. Rectal. d. Tympanic. 3. In which of the following patients would it be acceptable to initiate nonprescription antipyretic therapy without first consulting a primary care provider? a. A 5-month-old infant with a rectal temperature of 102°F (38.9°C). b. A 7-year-old boy with a history of febrile seizures. c. A 25-year-old woman with suspected influenza and a temperature of 102.6°F (39.2°C). d. A 67-year-old man with severe COPD.

4. Which of the following statements about the practice of alternating doses of acetaminophen and ibuprofen to lower fever in children is true? a. This practice is beneficial because it takes advantage of the different mechanisms of action of acetaminophen and ibuprofen. b. This practice is recommended only when children have an oral temperature >101ºF (38.3ºC) or equivalent. c. Both a and b are correct. d. This practice is not recommend ed because of the risk of overdose, medication errors, and increased adverse effects. 5. The maximum recommended duration of self-treatment for fever is: a. 2 days. b. 3 days. c. 5 days. d. 7 days. 6. Cough is considered to be acute if its duration does not exceed: a. 4 days. b. 7 days. c. 3 weeks. d. 8 weeks. 7. Which of the following types of medications is the agent of choice for treating nonproductive cough? a. Antihistamine. b. Antitussive. c. Expectorant. d. Nonproductive cough should not be treated.

OTC Advisor: Self-Care for Fever, Cough, Cold, and Allergy

8. Which of the following statements best describes the concomitant use of guaifenesin and dextromethorphan? a. This combination is first-line therapy for cough associated with the common cold. b. This combination is not as effective as concomitant use of guaifenesin and codeine. c. This combination generally is considered to be irrational. d. None of the above. 9. Patients should consult a primary care provider if their cough fails to improve after what period of selftreatment? a. 3 to 5 days. b. 7 days. c. 2 weeks. d. 3 weeks. 10. Which of the following medications found commonly in cough and cold preparations has the potential for abuse, especially by teenagers? a. Chlorpheniramine. b. Cromolyn sodium. c. Dextromethorphan. d. Phenylephrine. 11. The usual order in which common cold symptoms appear is: a. Cough first; fever second; nasal symptoms last. b. Fever first; sore throat second; nasal symptoms last. c. Nasal symptoms first; sore throat second; cough last. d. Sore throat first; nasal symptoms second; cough last.

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12. Which of the following decongestants is subject to the storage and sales restrictions of the Combat Methamphetamine Epidemic Act of 2005? a. Oxymetazoline. b. Phenylephrine. c. Pseudoephedrine. d. Tetrahydrozoline. 13. Treatment with topical decongestants should not exceed: a. 24 hours. b. 48 hours. c. 3 to 5 days. d. 5 to 7 days. 14. The nasal secretions of a patient with the common cold turn yellow after 6 days. Which of the following actions should the pharmacist take? a. Advise the patient to seek immediate medical attention. b. Recommend that the patient be evaluated by a primary care provider for likely bacterial sinus infection. c. Assure the patient that this color change is an expected development during the normal course of the common cold. d. None of the above.

16. Which of the following allergen avoidance measures is most likely to be effective against house-dust mites? a. Encasing mattresses, box springs, and pillows in impermeable covers. b. Installing a ventilation system with HEPA filters. c. Removing house plants. d. All of the above. 17. Which of the following symptoms of allergic rhinitis is not relieved by antihistamines? a. Nasal congestion. b. Rhinorrhea. d. Sneezing. d. All of these symptoms are relieved by antihistamines.

19. The initial drug of choice for use in pregnant women with allergic rhinitis is: a. Chlorpheniramine. b. Cromolyn sodium. c. Loratadine. d. Pheniramine. 20. A fixed-dose combination oral product containing loratadine and pseudoephedrine is likely to be of greatest benefit to patients with: a. Allergic rhinitis. b. Common cold. c. Productive cough. d. All of the above.

18. A patient with allergic rhinitis experiences symptoms 3 days per week and the symptoms interfere with her sleeping. This patient would be classified as having: a. Mild intermittent allergic rhinitis. b. Moderate/severe intermittent allergic rhinitis. c. Mild persistent allergic rhinitis. d. Moderate/severe persistent allergic rhinitis.

15. Which of the following symptoms is associated primarily with allergic rhinitis, and therefore can be used to differentiate allergic rhinitis from the common cold? a. Itchy eyes. b. Nasal congestion. c. Rhinorrhea. d. Sneezing.

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American Pharmacists Association

CPE Instructions Completing a posttest at www.pharmacist.com/education is as easy as 1-2-3… 1. 2. 3.

Go to Online CPE Quick List and click on the title of this activity. Log in. APhA members enter your user name and password. Not an APhA member? Just click “Create one now” to open an account. No fee is required to register. Successfully complete the CPE exam and evaluation form to gain immediate access to your Statement of Credit.

Live step-by-step assistance is available Monday through Friday, 8:30 am to 5:00 pm ET from APhA Member Services at 800-237-APhA (2742) or e-mail [email protected].

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