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Pseudoephedrine (Systemic)


VA CLASSIFICATION
Primary: RE200

Commonly used brand name(s): Balminil Decongestant Syrup; Benylin Decongestant; Cenafed; Chlor-Trimeton Non-Drowsy Decongestant 4 Hour; Decofed; Dimetapp Decongestant; Dimetapp Decongestant Pediatric Drops; Drixoral N.D.; Drixoral Nasal Decongestant; Efidac/24; Eltor 120; Genaphed; Maxenal; Myfedrine; PediaCare Infants' Oral Decongestant Drops; Pseudo; Pseudo 60's; Robidrine; Sudafed; Sudafed 12 Hour; Sudafed Children's Nasal Decongestant Liquid Medication; Sudafed Decongestant; Sudafed Decongestant 12 Hour; Sudafed Decongestant Extra Strength; Triaminic AM Decongestant Formula; Triaminic Infant Oral Decongestant Drops.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Decongestant, nasal (systemic)—

Indications

Accepted

Congestion, nasal (treatment)
Congestion, sinus (treatment) or
Congestion, eustachian tube (treatment)—Pseudoephedrine is indicated for temporary relief of congestion associated with acute coryza, acute eustachian salpingitis, serous otitis media with eustachian tube congestion, vasomotor rhinitis , and aerotitis (barotitis) media. Pseudoephedrine also may be indicated as an adjunct to analgesics, antihistamines, antibiotics, antitussives, or expectorants for optimum results in allergic rhinitis , croup, acute and subacute sinusitis, acute otitis media, and acute tracheobronchitis. {01} {02} {03} {09} {10} {11} {17} {18} {19} {20} {21} {22} {23} {24} {27} {32}


Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    Pseudoephedrine hydrochloride: 201.70
    Pseudoephedrine sulfate: 428.54

Mechanism of action/Effect:

Pseudoephedrine acts on alpha-adrenergic receptors in the mucosa of the respiratory tract, producing vasoconstriction. The medication shrinks swollen nasal mucous membranes; reduces tissue hyperemia, edema, and nasal congestion; and increases nasal airway patency. Also, drainage of sinus secretions may be increased and obstructed eustachian ostia may be opened.

Biotransformation:

Pseudoephedrine is incompletely metabolized in the liver.

Onset of action:

15 to 30 minutes.

Time to peak effect:

Within 30 to 60 minutes.

Duration of action:

Tablets, oral solution, and syrup—3 to 4 hours.

Extended-release capsules and tablets—8 to 12 hours.

Elimination:
    Renal. About 55 to 75% of a dose is excreted unchanged. The rate of excretion is accelerated in acidic urine.


Precautions to Consider

Cross-sensitivity and/or related problems

Patients sensitive to other sympathomimetics (for example, albuterol, amphetamines, ephedrine, epinephrine, isoproterenol, metaproterenol, norepinephrine, phenylephrine, phenylpropanolamine, terbutaline) may be sensitive to this medication also.

Pregnancy/Reproduction

Pregnancy—
Studies in humans have not been done.

Studies in animals have not shown that pseudoephedrine causes teratogenic effects in the fetus. However, pseudoephedrine reduced average weight, length, and rate of skeletal ossification in the animal fetus.

FDA Pregnancy Category B. {01}

Breast-feeding

Pseudoephedrine is distributed into breast milk; use by nursing mothers is not recommended, because of the higher than usual risk to infants, especially newborn and premature infants, of side effects from sympathomimetic amines. {32}

Pediatrics

Pseudoephedrine should be used with caution in infants, especially newborn and premature infants, because of the higher than usual risk of side/adverse effects.


Geriatrics


No information is available on the relationship of age to the effects of pseudoephedrine in geriatric patients. However, elderly patients are more likely to have age-related prostatic hypertrophy, which may require adjustment of dosage in patients receiving pseudoephedrine.

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.

Anesthetics, hydrocarbon inhalation, such as:
Chloroform
Cyclopropane
Enflurane
Halothane
Isoflurane
Methoxyflurane
Trichloroethylene    (administration of pseudoephedrine prior to or shortly after anesthesia with chloroform, cyclopropane, halothane, or trichloroethylene may increase the risk of severe ventricular arrhythmias, especially in patients with pre-existing heart disease, because these anesthetics greatly sensitize the myocardium to the effects of sympathomimetics)

    (enflurane, isoflurane, or methoxyflurane may also cause some sensitization of the myocardium to the effects of sympathomimetics; caution is recommended in patients taking pseudoephedrine)


Antihypertensives or
Diuretics used as antihypertensives    (antihypertensive effects may be reduced when these medications are used concurrently with pseudoephedrine; the patient should be monitored carefully to confirm that the desired effect is being obtained {01} {20} {32})


» Beta-adrenergic blocking agents    (concurrent use with pseudoephedrine may inhibit the therapeutic effect of these medications; beta-blockade may result in unopposed alpha-adrenergic activity of pseudoephedrine, with a risk of hypertension and excessive bradycardia and possible heart block {20} {32})


Central nervous system (CNS) stimulation–producing medications, other (see Appendix II )    (concurrent use with pseudoephedrine may result in additive CNS stimulation to excessive levels, which may cause unwanted effects such as nervousness, irritability, insomnia, or possibly convulsions or cardiac arrhythmias; close observation is recommended)


Citrates    (concurrent use may inhibit urinary excretion and prolong the duration of action of pseudoephedrine)


» Cocaine, mucosal-local    (in addition to increasing CNS stimulation, concurrent use with pseudoephedrine may increase the cardiovascular effects of either or both medications and the risk of adverse effects {04} {05} {06} {07} {08})


Digitalis glycosides    (concurrent use with pseudoephedrine may increase the risk of cardiac arrhythmias; caution and electrocardiographic monitoring are very important if concurrent use is necessary)


Levodopa    (concurrent use with pseudoephedrine may increase the possibility of cardiac arrhythmias; dosage reduction of the sympathomimetic is recommended)


» Monoamine oxidase (MAO) inhibitors, including furazolidone, procarbazine, and selegiline    (concurrent use may prolong and intensify the cardiac stimulant and vasopressor effects of pseudoephedrine because of release of catecholamines, which accumulate in intraneuronal storage sites during MAO inhibitor therapy, resulting in headache, cardiac arrhythmias, vomiting, or sudden and severe hypertensive and/or hyperpyretic crises; pseudoephedrine should not be administered during or within 14 days following administration of MAO inhibitors {01} {03} {20} {21} {32})


Nitrates    (concurrent use with pseudoephedrine may reduce the antianginal effects of these medications {01})


Rauwolfia alkaloids    (concurrent use may inhibit the action of pseudoephedrine by depleting catecholamine stores {01} {20})


Sympathomimetics, other    (in addition to possibly increasing CNS stimulation, concurrent use may increase the cardiovascular effects of either the other sympathomimetics or pseudoephedrine and the potential for side effects {01})


Thyroid hormones    (concurrent use may increase the effects of either these medications or pseudoephedrine; thyroid hormones enhance risk of coronary insufficiency when sympathomimetic agents are administered to patients with coronary artery disease; dosage adjustment is recommended, although problem is reduced in euthyroid patients)


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problems exist
Cardiovascular disease, including ischemic heart disease, or{01}{02}{03}{09}{10}{11}{20}{21}{24}{32}{35}
» Coronary artery disease, severe or{01}{02}{03}{09}{10}{11}{20}{21}{24}{32}{35}
Hypertension, mild to moderate or{01}{02}{03}{09}{10}{11}{20}{21}{24}{32}{35}
» Hypertension, severe{01}{02}{03}{09}{10}{11}{20}{21}{24}{32}{35}    (condition may be exacerbated due to drug-induced cardiovascular effects)


Diabetes mellitus{01}{02}{03}{09}{10}{11}{20}{21}{24}{32}{35}    (may lead to increased blood glucose concentrations)


Glaucoma, predisposition to{01}{02}{03}{09}{10}{11}{20}{21}{24}{32}    (condition may be aggravated)


Hyperthyroidism{01}{02}{03}{09}{10}{11}{20}{21}{24}{32}{35}    (symptoms may be exacerbated)


Prostatic hypertrophy{01}{02}{03}{09}{10}{11}{20}{21}{24}{32}    (urinary retention may be precipitated)


Sensitivity to pseudoephedrine or other sympathomimetics{01}{02}{03}{09}{10}{11}{20}{21}{24}{32}


Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence rare
—more frequent with high doses    
Convulsions {01}{03}{20}{32}
    
hallucinations {01}{03}{20}{32}
    
irregular or slow heartbeat {01}{03}{20}{32}
    
shortness of breath or troubled breathing {01}{03}{20}{32}



Those indicating need for medical attention only if they continue or are bothersome
Incidence more frequent
    
Nervousness {01}{20}{32}
    
restlessness {01}{20}{32}
    
trouble in sleeping {01}{20}{32}

Incidence less frequent
    
Difficult or painful urination {01}{20}{32}
    
dizziness or lightheadedness {01}{20}{32}
    
fast or pounding heartbeat {01}{20}{32}
    
headache {01}{20}{32}
    
increased sweating {01}{20}{32}
    
nausea or vomiting {01}{20}{32}
    
trembling {01}{20}{32}
    
unusual paleness {01}{20}{32}
    
weakness {01}{20}{32}





Overdose
For more information on the management of overdose or unintentional ingestion, contact a Poison Control Center (see Poison Control Center Listing ).

Clinical effects of overdose
The following effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parenthesis where appropriate)–not necessarily inclusive:
Acute and chronic effects
    
Convulsions {20}{32}
    
fast breathing {20}{32}
    
hallucinations {20}{32}
    
increase in blood pressure {20}{32}
    
irregular heartbeat, continuing {20}{32}
    
shortness of breath or troubled breathing, severe or continuing {20}{32}
    
slow or fast heartbeat, severe or continuing {20}{32}
    
unusual nervousness, restlessness, or excitement {20}{32}


Treatment of overdose


To decrease absorption:
Because pseudoephedrine is rapidly absorbed from the gut, emetics and gastric lavage should be instituted within 4 hours of overdosage in order to be effective. Charcoal is useful only if administered within 1 hour. However, if an extended-release preparation was taken, there will be more time for benefit from these measures.



To enhance elimination:
Forced diuresis will increase elimination of pseudoephedrine provided renal function is adequate; however, diuresis is not recommended for severe overdosage.



Specific treatment:
For delirium or convulsions, intravenous diazepam may be administered.

The cardiac state should be monitored and serum electrolytes measured. If there are signs of cardiac toxicity, intravenous propranolol may be indicated.

Hypokalemia may be treated, if necessary, with a slow infusion of a dilute potassium chloride solution; serum potassium concentration should be monitored during and for several hours after administration of potassium chloride.



Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Pseudoephedrine (Systemic).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Sensitivity to pseudoephedrine or other sympathomimetics

Pregnancy—In animal studies, pseudoephedrine caused reduced average weight, length, and rate of skeletal ossification in animal fetus





Breast-feeding—Pseudoephedrine distributed into breast milk; use by nursing mothers not recommended because of higher than usual risk of side effects for infants, especially newborn and premature infants





Use in children—Caution should be used in infants, especially newborn and premature infants, because of higher than usual risk of side/adverse effects

Other medications, especially beta-adrenergic blocking agents, mucosal-local cocaine, or monoamine oxidase (MAO) inhibitors
Other medical problems, especially severe coronary artery disease or severe hypertension

Proper use of this medication

Proper administration of extended-release dosage forms
Swallowing capsules or tablets whole; if capsule too large to swallow, mixing contents with jam or jelly and swallowing without chewing

Not crushing or chewing capsules; not crushing, breaking, or chewing tablets
» Taking the medication a few hours before bedtime to minimize the possibility of insomnia

» Importance of not taking more medication than the amount recommended

» Proper dosing
Missed dose: Taking right away if remembered within an hour or so; not taking if remembered later; not doubling doses

» Proper storage

Precautions while using this medication
» Checking with physician if symptoms do not improve within 7 days or if fever is present {27} {29} {30} {31}


Side/adverse effects
Signs of potential side effects, especially convulsions, hallucinations, irregular or slow heartbeat, and shortness of breath or troubled breathing


General Dosing Information
To minimize the possibility of insomnia, the last dose of pseudoephedrine for each day should be administered a few hours before bedtime.

For patients who have difficulty in swallowing the extended-release capsule, the contents of the capsule may be mixed with jam or jelly and taken without chewing.


Oral Dosage Forms

PSEUDOEPHEDRINE HYDROCHLORIDE CAPSULES

Usual adult and adolescent dose
Decongestant, nasal
Oral, 60 mg every four to six hours. {15} {18} {25} {56}


Usual adult prescribing limits
240 mg in twenty-four hours. {15} {18} {25} {56}

Usual pediatric dose
Decongestant, nasal
Children up to 12 years of age: Use is not recommended. {15} {18} {25}

Children 12 years of age and over: See Usual adult and adolescent dose . {15} {18} {25}


Strength(s) usually available
U.S.—


30 mg (OTC) [Dimetapp Decongestant{48}{49}]

Canada—
{18}

60 mg (OTC) [Benylin Decongestant]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer.


PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES

Usual adult and adolescent dose
Decongestant, nasal
Oral, 120 mg every twelve hours, or 240 mg every twenty-four hours. {01} {10} {20} {32}


Usual adult prescribing limits
240 mg in twenty-four hours. {01} {10} {20}

Usual pediatric dose
Decongestant, nasal
Children up to 12 years of age: Use is not recommended. {01} {10} {20} {32}

Children 12 years of age and over: See Usual adult and adolescent dose. {01} {10} {20} {32}


Strength(s) usually available
U.S.—
Not commercially available.

Canada—


120 mg (OTC)[Generic]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a tight container, unless otherwise specified by manufacturer. Protect from light.

Auxiliary labeling:
   • Swallow capsules whole.


PSEUDOEPHEDRINE HYDROCHLORIDE ORAL SOLUTION

Usual adult and adolescent dose
Decongestant, nasal
See Pseudoephedrine Hydrochloride Capsules. {02} {03} {09} {13} {23}


Usual adult prescribing limits
See Pseudoephedrine Hydrochloride Capsules. {02} {03} {09} {13} {23}

Usual pediatric dose
Decongestant, nasal
Oral, 4 mg per kg of body weight or 125 mg per square meter of body surface area per day, administered in four divided doses; {02} {03} {09} {14} or for

Children up to 2 years of age: Dosage must be individualized. {33} {34} {35}

The manufacturer recommends the following dosing guidelines: {55}


Children 4 to 12 months of age (5.4 to 7.7 kg):
Oral, 7.5 mg every four to six hours not to exceed four doses (30 mg) in twenty-four hours. {55}



Children 12 to 23 months of age (8.2 to 10.4 kg):
Oral, 11.25 mg every four to six hours not to exceed four doses (45 mg) in twenty-four hours. {55}



Children 2 to 6 years of age:
Oral, 15 mg every four to six hours, not to exceed 60 mg in twenty-four hours. {13} {18} {23} {33} {34} {35}



Children 6 to 12 years of age:
Oral, 30 mg every four to six hours, not to exceed 120 mg in twenty-four hours. {13} {18} {23} {34} {35}



Children 12 years of age and over:
See Pseudoephedrine Hydrochloride Capsules. {18} {23}



Strength(s) usually available
U.S.—


7.5 mg per 0.8 mL (OTC) [Dimetapp Decongestant Pediatric Drops{48}{49}{50}] [PediaCare Infants' Oral Decongestant Drops{49}{52}{53}] [Triaminic Infant Oral Decongestant Drops{49}{54}{55}]


15 mg per 5 mL (OTC) [Sudafed Children's Nasal Decongestant Liquid Medication{49}{56}]


30 mg per 5 mL (OTC) [Decofed{59}] [Myfedrine{57}]

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer. Protect from freezing. Protect from light. {35}


PSEUDOEPHEDRINE HYDROCHLORIDE SYRUP USP

Usual adult and adolescent dose
Decongestant, nasal
See Pseudoephedrine Hydrochloride Capsules. {13} {23}


Usual adult prescribing limits
See Pseudoephedrine Hydrochloride Capsules. {13} {23}

Usual pediatric dose
Decongestant, nasal
Children up to 12 years of age: See Pseudoephedrine Hydrochloride Oral Solution. {13} {14} {18} {23}

Children 12 years of age and over: See Pseudoephedrine Hydrochloride Capsules.


Strength(s) usually available
U.S.—


15 mg per 5 mL (OTC) [Triaminic AM Decongestant Formula{49}{54}]


30 mg per 5 mL (OTC) [Cenafed{58}][Generic]

Canada—


30 mg per 5 mL (OTC) [Balminil Decongestant Syrup (alcohol)] [Robidrine (alcohol 1.4%)] [Sudafed]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight, light-resistant container. Protect from freezing.


PSEUDOEPHEDRINE HYDROCHLORIDE TABLETS USP

Usual adult and adolescent dose
Decongestant, nasal
See Pseudoephedrine Hydrochloride Capsules. {09} {13} {23} {30}


Usual adult prescribing limits
See Pseudoephedrine Hydrochloride Capsules. {09} {13} {23} {30}

Usual pediatric dose
Decongestant, nasal
Children up to 12 years of age: See Pseudoephedrine Hydrochloride Oral Solution. {09} {13} {14} {18} {23} {30}

Children 12 years of age and over: See Pseudoephedrine Hydrochloride Capsules.


Strength(s) usually available
U.S.—


30 mg (OTC) [Genaphed{61}] [Pseudo{62}] [Sudafed{49}{66}{67}][Generic]


60 mg (OTC) [Cenafed{58}{65}] [Pseudo 60's{70}] [Sudafed{49}{66}][Generic]

Canada—


30 mg (OTC) [Sudafed Decongestant{75}]


60 mg (OTC) [Robidrine (scored)] [Sudafed Decongestant Extra Strength{75} (scored)]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container.


PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS

Usual adult and adolescent dose
Decongestant, nasal
See Pseudoephedrine Hydrochloride Extended-Release Capsules. {27} {31}


Usual adult prescribing limits
See Pseudoephedrine Hydrochloride Extended-Release Capsules. {27} {31}

Usual pediatric dose
Decongestant, nasal
Children up to 12 years of age: Use is not recommended.

Children 12 years of age and over: See Pseudoephedrine Hydrochloride Extended-Release Capsules. {27} {31}


Strength(s) usually available
U.S.—


120 mg (OTC) [Sudafed 12 Hour{49}{65}{66}{71}]


240 mg (OTC) [Efidac/24{49}{72}]

Canada—


120 mg (OTC) [Eltor 120{76}] [Maxenal] [Sudafed Decongestant 12 Hour{75}]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a tight container, unless otherwise specified by manufacturer. Protect from light.

Auxiliary labeling:
   • Swallow tablets whole.


PSEUDOEPHEDRINE SULFATE TABLETS

Usual adult and adolescent dose
Decongestant, nasal
See Pseudoephedrine Hydrochloride Capsules. {26} {36}


Usual adult prescribing limits
See Pseudoephedrine Hydrochloride Capsules. {26} {36}

Usual pediatric dose
Decongestant, nasal
Children up to 12 years of age: See Pseudoephedrine Hydrochloride Oral Solution. {26} {36}

Children 12 years of age and over: See Pseudoephedrine Hydrochloride Capsules.


Strength(s) usually available
U.S.—


60 mg (OTC) [Chlor-Trimeton Non-Drowsy Decongestant 4 Hour{49}{69} (scored)]

Canada—
Not commercially available.

Packaging and storage:
Store between 2 and 30 °C (36 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer. Protect from light.


PSEUDOEPHEDRINE SULFATE EXTENDED-RELEASE TABLETS

Usual adult and adolescent dose
Decongestant, nasal
See Pseudoephedrine Hydrochloride Extended-Release Capsules. {11} {22} {24} {37}


Usual adult prescribing limits
See Pseudoephedrine Hydrochloride Extended-Release Capsules. {01} {10} {20} {24} {37}

Usual pediatric dose
Decongestant, nasal
Children up to 12 years of age: Use is not recommended. {11} {22} {24} {37}

Children 12 years of age and over: See Pseudoephedrine Hydrochloride Extended-Release Capsules. {11} {22} {24} {37}


Strength(s) usually available
U.S.—


120 mg (OTC) [Drixoral Nasal Decongestant{73}]

Canada—


120 mg (OTC) [Drixoral N.D.{74}]

Packaging and storage:
Store between 2 and 30 °C (36 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer. Protect from light.

Auxiliary labeling:
   • Swallow tablets whole.



Revised: 12/14/1998



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  1. Dimetapp Decongestant and Dimetapp Decongestant Pediatric (Whitehall-Robins). In: Drug Topics Red Book 1998. Montvale, NJ: Medical Economics Company; 1998. p. 696.
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  1. Triaminic AM Decongestant Formula and Triaminic Infant Decongestant (Novartis). In: Drug Topics Red Book 1998. Montvale, NJ: Medical Economics Company; 1998. p. 878.
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  1. Eltor 120 (Hoechst Marion Roussel). In: Gillis MC, editor. CPS Compendium of pharmaceuticals and specialties. 33rd ed. Ottawa: Canadian Pharmacists Association; 1998. p. 558.
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