A continuing pharmacy education activity for pharmacists

Transcription

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
1
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
2
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
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
3
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
4
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.
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
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
5
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
6
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
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.
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.
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.
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.
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]).
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.
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 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
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?
(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-
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.
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)
…b
Diphenhydramine HCl
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
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.
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.
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.
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
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
(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.
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
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
Drug
Adults and Children
Age ≥12 y
Phenylephrine bitartrateb
15.6 mg every 4 h (62.4 mg)
7.8 mg every 4 h (31.2 mg)
…c
Phenylephrine HCl
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
Drug
Adults and Children Age ≥12 y
Brompheniramine maleate
Chlorcyclizine HCl
…
Chlorpheniramine maleate
Clemastine fumarate
1.34 mg every 12 h (2.68 mg)
…
Dexbrompheniramine maleate
Dexchlorpheniramine maleate
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)
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.
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
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-
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.
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.
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
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
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
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.
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).
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
a
Drug
Adults and Children
Age ≥12 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
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
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
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.
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.
27
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.
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.
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).
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.
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.
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.
29
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.
30
CPE Instructions
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1.
2.
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Log in. APhA members enter your user name and password. Not an APhA member? Just click “Create one now”
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A continuing pharmacy education activity for pharmacists

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