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Pseudoephedrine (Monograph)

Brand names: Childrens Silfedrine, Sudafed 24 Hour, Sudafed Nasal Decongestant
Drug class: alpha- and beta-Adrenergic Agonists
VA class: AU100
Chemical name: [S-(R*,R*)]-α-[1-(Methylamino)ethyl]-benzenemethanol hydrochloride
Molecular formula: C10H15NO•HClC10H15NO•H2SO4
CAS number: 345-78-8

Medically reviewed by Drugs.com on Oct 25, 2023. Written by ASHP.

Introduction

Sympathomimetic agent; decongestant.

Uses for Pseudoephedrine

Nasal Congestion, Sinus Congestion, and Other Respiratory Conditions

Pseudoephedrine is used for self-medication for temporary relief of nasal congestion associated with upper respiratory allergy (e.g., hay fever) or the common cold.108 109 110 112

Pseudoephedrine is used for self-medication for temporary relief of sinus congestion and pressure.109 110 112

Pseudoephedrine is used in fixed combination with other agents (e.g., acetaminophen, brompheniramine, chlorpheniramine, desloratadine, dextromethorphan, fexofenadine, guaifenesin, ibuprofen, loratadine, methscopolamine, triprolidine) for relief of nasal/sinus congestion and pressure and/or other symptoms (e.g., rhinorrhea, sneezing, lacrimation, itching eyes, oronasopharyngeal itching, cough, fever) associated with seasonal or perennial allergic rhinitis, nonallergic (vasomotor) rhinitis, other upper respiratory allergies, or the common cold.154 156 157 158 159 161 162 163 164 165

Single 60-mg oral doses of pseudoephedrine hydrochloride shown to be effective in relieving congestion in clinical studies.145 146 147 148 149

Pseudoephedrine may be used as an adjunct to analgesics, antihistamines, antitussives, expectorants, or antibiotics when indicated.a

Pseudoephedrine is labeled and has been used for self-medication for temporary relief of nasal congestion associated with sinusitis;109 110 135 however, efficacy data are lacking and/or controversial.135 136 137 In October 2005, FDA issued final rule to remove this indication from labeling of OTC nasal decongestants.135 Compliance date for preparations with annual sales <$25,000 was October 11, 2007; compliance date for all other preparations was April 11, 2007.135

Pseudoephedrine is ineffective as a bronchodilator.a

Combination of pseudoephedrine and caffeine not generally recognized as safe and effective for OTC use.105

In pediatric patients <2 years of age, OTC cough and cold preparations (i.e., containing nasal decongestants, antihistamines, cough suppressants, and expectorants) were not more effective than placebo in reducing acute cough and other symptoms of upper respiratory tract infection and reportedly are associated with adverse events and sometimes death (albeit rarely).150 (See Pediatric Use under Cautions.) Therefore, CDC states that, as an alternative to pseudoephedrine and other nasal decongestants, caregivers may consider using a rubber suction bulb to clear nasal congestion and using saline nasal drops or a cool-mist humidifier to soften secretions in infants.150

Otitic Barotrauma† [off-label] and Other Otic Conditions† [off-label]

Pseudoephedrine has been used for self-medication in adults to prevent symptoms of otitic barotrauma (aerotitis [barotitis] media)† [off-label] (e.g., otic discomfort, otic blockage, hearing loss, otalgia) associated with air travel or underwater diving.119 120 121 Efficacy not established in children.124

Pseudoephedrine may be useful in opening obstructed eustachian ostia in patients with otic inflammation or infection.a

Misuse and Abuse

Pseudoephedrine has been used in clandestine synthesis of methamphetamine and methcathinone.100 101 102 113

The Combat Methamphetamine Epidemic Act (CMEA) of 2005 was signed into law in March 2006 to tighten control over sale and distribution of pseudoephedrine and ephedrine.130 139 140 141 CMEA created a new class of products called “scheduled listed chemical products”, which are defined in the law as products containing pseudoephedrine, ephedrine, or phenylpropanolamine or any salt, optical isomer, or salt of an optical isomer salt of these drugs that are lawful nonprescription products in the US and set additional requirements for their sale.140 142 Effective September 30, 2006 under CMEA’s provisions, pharmacies and other retail distributors must store pseudoephedrine- and ephedrine-containing preparations behind the counter or in locked cabinets; purchasers must provide approved photographic identification and sign a written or electronic logbook for each purchase; pharmacies and other retail distributors must keep information about the purchasers (e.g., name, address, signature) and purchases (e.g., name of product, quantity sold, date and time of sale) for ≥2 years; and the amount that can be purchased is limited to ≤3.6 g per day or 9 g per month.130 131 139 140 141 For additional information about legal and regulatory requirements under CMEA, visit [Web].142 143 144

Use of pseudoephedrine in some states may be subject to additional controls.128 129 139 Where such state laws are more stringent than the provisions of CMEA, state requirements also must be followed.139 142 143 144

In response to federal and state restrictions, some manufacturers have voluntarily reformulated various existing pseudoephedrine-containing preparations, replacing the pseudoephedrine component with other decongestants such as phenylephrine.132 139

Pseudoephedrine Dosage and Administration

Administration

Oral Administration

Administer 240-mg extended-release tablets orally once daily.110 Swallow tablets whole with fluid; do not divide, crush, chew, or dissolve.110 Tablet does not completely dissolve and may be passed in the stool.110

Dosage

Single-entity preparation: Available as pseudoephedrine hydrochloride; dosage expressed in terms of the salt.108 109 110 112

Fixed-combination preparation: Available as pseudoephedrine hydrochloride or pseudoephedrine sulfate.133 a

Because combinations and dosage strengths vary for fixed-combination preparations, consult manufacturer’s product labeling for appropriate dosage of the specific preparation.

Pediatric Patients

Nasal Congestion, Sinus Congestion, and Other Respiratory Conditions
Oral

Self-medication in children <2 years of age: Consult a pediatrician.108 112 Currently there are no FDA-approved dosage recommendations for cough and cold preparations for patients <2 years of age.150 (See Pediatric Use under Cautions.)

Self-medication in children 2–5 years of age: Pseudoephedrine hydrochloride 15 mg every 4–6 hours.112 Alternatively, some pediatricians recommend 4 mg/kg or 125 mg/m2 daily, given in 4 divided doses.a (See Pediatric Use under Cautions.)

Self-medication in children 6–11 years of age: Pseudoephedrine hydrochloride 30 mg every 4–6 hours.112

Self-medication in children ≥12 years of age: Pseudoephedrine hydrochloride 60 mg (as conventional tablets) every 4–6 hours,108 112 120 mg (as extended-release tablets) every 12 hours,109 or 240 mg (as extended-release tablets) once daily.110

Discontinue therapy if symptoms persist for >7 days or are accompanied by fever.108 109 110 112

Adults

Nasal Congestion, Sinus Congestion, and Other Respiratory Conditions
Oral

Self-medication: Pseudoephedrine hydrochloride 60 mg (as conventional tablets) every 4–6 hours,108 112 120 mg (as extended-release tablets) every 12 hours,109 or 240 mg (as extended-release tablets) once daily.110

Discontinue therapy if symptoms persist for >7 days or are accompanied by fever.110 108 109 112

Otitic Barotrauma† [off-label]
Oral

Air travelers: Pseudoephedrine hydrochloride 120 mg (as extended-release tablets) 30 minutes before flight departure.119 120

Underwater divers: Pseudoephedrine hydrochloride 60 mg 30 minutes before diving.121

Prescribing Limits

Pediatric Patients

Nasal Congestion, Sinus Congestion, and Other Respiratory Conditions
Oral

Self-medication in children 2–5 years of age: Maximum 60 mg of pseudoephedrine hydrochloride in any 24-hour period.112

Self-medication in children 6–11 years of age: Maximum 120 mg of pseudoephedrine hydrochloride in any 24-hour period.112

Self-medication in children ≥12 years of age: Maximum 240 mg of pseudoephedrine hydrochloride in any 24-hour period (as conventional tablets,108 112 120-mg extended-release tablets,109 or 240-mg extended-release tablets).110

Adults

Nasal Congestion, Sinus Congestion, and Other Respiratory Conditions
Oral

Self-medication: Maximum 240 mg of pseudoephedrine hydrochloride in any 24-hour period (as conventional tablets,108 112 120-mg extended-release tablets,109 or 240-mg extended-release tablets).110

Detailed Pseudoephedrine dosage information

Cautions for Pseudoephedrine

Contraindications

Warnings/Precautions

Warnings

MAO Inhibitors

Allow at least 2 weeks to elapse between discontinuance of an MAO inhibitor and initiation of pseudoephedrine.108 109 110 112

Concomitant Diseases

Patients with CHD, hypertension, hyperthyroidism, diabetes mellitus, or difficulty urinating due to prostatic hypertrophy should consult a clinician before initiating therapy with pseudoephedrine.108 109 110 112

Sensitivity Reactions

Fixed dermatologic eruptions (erythematous nummular patches) reported rarely with fixed-combination preparation containing 60 mg of pseudoephedrine hydrochloride and 2.5 mg of triprolidine hydrochloride.a

General Precautions

CNS Effects

Discontinue therapy and consult a clinician if nervousness, dizziness, or insomnia develops during therapy.108 109 110 112

GI Effects

240-mg extended-release tablets rarely can cause GI obstruction, particularly in patients with severe narrowing of the esophagus, stomach, or intestine.110 Patients with GI obstruction or narrowing should consult a clinician before using extended-release tablets.110

Discontinue extended-release tablets and consult a clinician if persistent abdominal pain or vomiting develops.110

Duration of Therapy

Discontinue therapy if symptoms persist for >7 days or are accompanied by fever.108 109 110 112

Misuse and Abuse

Pseudoephedrine has been used in clandestine synthesis of methamphetamine and methcathinone.100 101 102 113

Potential for misuse and abuse.100 101 102 113 114 115 (See Misuse and Abuse under Uses.)

Use of Fixed Combinations

When used in fixed combination with other agents (e.g., acetaminophen, brompheniramine, chlorpheniramine, desloratadine, dextromethorphan, fexofenadine, guaifenesin, ibuprofen, loratadine, methscopolamine, triprolidine), consider the cautions, precautions, and contraindications associated with the concomitant agent(s).154 156 157 158 159 161 162 163 164 165

Specific Populations

Pregnancy

Pseudoephedrine: Category C.d

Lactation

Distributed into milk.104 106 107 Usually compatible with breast-feeding; however, use with caution.106

Pediatric Use

Safety and efficacy of extended-release preparations containing 120 or 240 mg of pseudoephedrine hydrochloride not established in children <12 years of age.109 110

Efficacy not established in children for treatment of otitic barotrauma (aerotitis [barotitis] media)† [off-label] (e.g., otic discomfort, otic blockage, hearing loss, otalgia) associated with air travel or underwater diving.119 120 121

Risk of overdosage and toxicity (including death) in children <2 years of age receiving OTC preparations containing antihistamines, cough suppressants, expectorants, and nasal decongestants alone or in combination for relief of symptoms of upper respiratory tract infection.150 151 CDC reported that cough and cold preparations containing pseudoephedrine and other drugs were found to be the underlying cause of death in 3 infants ≤6 months of age.150 151 Limited evidence of efficacy for these preparations in this age group; appropriate dosages not established.150 Therefore, FDA recommends not to use such preparations in children <2 years of age;c safety and efficacy in older children under evaluation.f h Because children 2–3 years of age also are at increased risk of overdosage and toxicity, some manufacturers of oral nonprescription cough and cold preparations agreed to voluntarily revise the product labeling to state that such preparations should not be used in children <4 years of age.e f g h FDA recommends that parents and caregivers adhere to dosage instructions and warnings on the product labeling that accompanies the preparation and consult a clinician about any concerns.e f g Clinicians should ask caregivers about use of OTC cough/cold preparations to avoid overdosage.b

Geriatric Use

Geriatric patients may be especially sensitive to the effects of sympathomimetic amines.a Overdosage in patients >60 years of age may cause hallucinations, CNS depression, seizures, and death.a Do not administer extended-release pseudoephedrine preparations in these patients until safety has been established with short-acting preparations.a

Common Adverse Effects

Nervous system effects (e.g., CNS stimulation, nervousness, excitability, restlessness, dizziness, weakness, insomnia, headache, drowsiness)108 109 110 112 and cardiovascular effects (e.g., increased irritability of heart muscle, altered rhythmic function of ventricles, tachycardia, palpitation).a

Drug Interactions

Sympathomimetic Drugs

Potential pharmacologic interaction (additive effects and increased toxicity).a Use with extreme caution, if at all.a

Specific Drugs

Drug

Interaction

Comment

β-Adrenergic blocking agents (e.g., propranolol)

Increased pressor effectsa

Methyldopa

Decreased antihypertensive effects of methyldopaa

MAO inhibitors

Increased pressor effects; infrequently may result in hypertensive crisisa

Avoid use with or for 2 weeks after discontinuance of MAO inhibitors108 109 110 112

Reserpine

Decreased antihypertensive effects of reserpinea
Pseudoephedrine drug interactions (more detail)

Pseudoephedrine Pharmacokinetics

Absorption

Bioavailability

Almost completely absorbed from the GI tract following oral administration.104 Peak plasma concentrations are attained in about 1.39–2.4 or 3.8–6.1 hours following oral administration as an oral solution or extended-release preparation, respectively.103 104

Onset

Onset of nasal decongestion occurs within 30 minutes following oral administration as tablets or oral solution.a

Duration

Nasal decongestion may persist for 8 hours following oral administration of 60 mg and up to 12 hours following 120 mg of the drug in extended-release capsules.a

Food

Food delays absorption when administered as a solution, but appears not to affect absorption when the drug is administered as extended-release preparations.104

Distribution

Extent

Presumed to cross the placenta and to enter CSF.a

About 0.5% of an oral dose is distributed into milk over 24 hours.104

Metabolism

Incompletely metabolized in the liver to an inactive metabolite.a

Elimination Route

Excreted in urine; 55–96% of a dose is eliminated as unchanged drug.a

Half-life

3–6 hours at urinary pH of 5; 9–16 hours at urinary pH of 8.16 103

Stability

Storage

Oral

Tablets

Conventional tablets: 15–25°C in a dry place.108

Extended-release tablets: 15–25°C in a dry place.109 Protect from light.109

Solution

15–25°C in a dry place.108 109 Avoid freezing.a

Actions

Advice to Patients

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Pseudoephedrine Hydrochloride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Bulk

Powder*

Oral

Solution

15 mg/5 mL

Children’s Silfedrine

Silarx

Children’s Sudafed Nasal Decongestant

McNeil

Tablets

30 mg*

Pseudoephedrine Hydrochloride Tablets

Sudafed Congestion

McNeil

Tablets, extended release

120 mg*

Pseudoephedrine Hydrochloride Extended Release Tablets

Tablets, extended-release, film-coated

120 mg

Pseudoephedrine Hydrochloride Extended Release Tablets
Pseudoephedrine Hydrochloride Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsules, liquid-filled

30 mg with Ibuprofen 200 mg

Advil Cold & Sinus Liqui-Gels

Pfizer

Solution

15 mg/5 mL with Chlorpheniramine Maleate 1 mg/5 mL and Dextromethorphan Hydrobromide 5 mg/5mL

Kid Kare Cough/Cold Liquid

Rugby

Tablets

30 mg with Acetaminophen 325 mg

Ornex Caplets

B.F. Ascher

30 mg with Chlorpheniramine Maleate 2 mg and Ibuprofen 200 mg

Advil Allergy Sinus

Pfizer

30 mg with Ibuprofen 200 mg

Advil Cold & Sinus

Pfizer

Tablets, extended-release

60 mg with Guaifenesin 600 mg

Mucinex D

Reckitt-Benekiser

120 mg with Fexofenadine Hydrochloride 60 mg

Allegra-D 12 Hour

Chattem

240 mg with Fexofenadine Hydrochloride 180 mg

Allegra-D 24 Hour

Chattem
Pseudoephedrine Sulfate Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, extended-release core (pseudoephedrine sulfate only)

120 mg with Desloratadine 2.5 mg

Clarinex-D 12 Hour

Schering-Plough

120 mg with Loratadine 5 mg

Alavert Allergy & Sinus D-12 Hour

Pfizer

Claritin-D 12 Hour

Schering-Plough

240 mg with Desloratadine 5 mg

Clarinex-D 24-Hour

Schering-Plough

240 mg with Loratadine 10 mg

Claritin-D 24 Hour

Schering-Plough

AHFS DI Essentials™. © Copyright 2024, Selected Revisions November 4, 2015. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

† Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration.

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