Skip to Content
Be ready for a severe allergy emergency. Read more >>

Pseudoephedrine

Pronunciation

Pronunciation

(soo doe e FED rin)

Index Terms

  • d-Isoephedrine Hydrochloride
  • Pseudoephedrine HCl
  • Pseudoephedrine Hydrochloride
  • Pseudoephedrine Sulfate
  • Sudafed

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Gel, Oral, as hydrochloride:

ElixSure Congestion: 15 mg/5 mL (120 mL [DSC]) [alcohol free; contains brilliant blue fcf (fd&c blue #1), carbomer 934p, propylene glycol, propylparaben; grape bubblegum flavor]

Liquid, Oral, as hydrochloride:

Childrens Silfedrine: 15 mg/5 mL (118 mL, 237 mL) [grape flavor]

Nasal Decongestant: 30 mg/5 mL (118 mL) [contains fd&c red #40, methylparaben, saccharin sodium, sodium benzoate; raspberry flavor]

Sudafed Childrens: 15 mg/5 mL (118 mL) [alcohol free, sugar free; contains brilliant blue fcf (fd&c blue #1), edetate disodium, fd&c red #40, menthol, polyethylene glycol, saccharin sodium, sodium benzoate; grape flavor]

Syrup, Oral, as hydrochloride:

Nasal Decongestant: 30 mg/5 mL (473 mL) [contains fd&c red #40, methylparaben, saccharin sodium, sodium benzoate; raspberry flavor]

Tablet, Oral, as hydrochloride:

Genaphed: 30 mg

Nasal Decongestant: 30 mg [contains fd&c red #40 aluminum lake, fd&c yellow #6 aluminum lake]

Nasal Decongestant: 30 mg [contains fd&c red #40 aluminum lake, polysorbate 80]

Psudatabs: 30 mg [contains fd&c red #40, fd&c yellow #10 (quinoline yellow), fd&c yellow #6 (sunset yellow)]

Shopko Nasal Decongestant Max: 30 mg [contains fd&c red #40 aluminum lake]

Simply Stuffy: 30 mg

Sudafed: 30 mg

Sudafed: 30 mg [contains fd&c red #40 aluminum lake, fd&c yellow #10 aluminum lake, fd&c yellow #6 aluminum lake]

Sudanyl: 30 mg [DSC]

SudoGest: 30 mg [contains fd&c red #40 aluminum lake, fd&c yellow #10 aluminum lake, fd&c yellow #6 aluminum lake]

SudoGest: 30 mg [contains fd&c red #40 aluminum lake, fd&c yellow #6 aluminum lake]

SudoGest: 60 mg [scored]

Suphedrine: 30 mg

Generic: 30 mg, 60 mg

Tablet Abuse-Deterrent, Oral, as hydrochloride:

Nexafed: 30 mg

Zephrex-D: 30 mg

Tablet Extended Release 12 Hour, Oral, as hydrochloride:

Decongestant 12Hour Max St: 120 mg [contains polysorbate 80]

Shopko Nasal Decongestant: 120 mg

Sudafed 12 Hour: 120 mg

Sudafed 12 Hour: 120 mg [contains fd&c blue #1 aluminum lake]

SudoGest 12 Hour: 120 mg

Generic: 120 mg

Tablet Extended Release 24 Hour, Oral, as hydrochloride:

Sudafed 24 Hour: 240 mg

Brand Names: U.S.

  • Childrens Silfedrine [OTC]
  • Decongestant 12Hour Max St [OTC]
  • ElixSure Congestion [OTC] [DSC]
  • Genaphed [OTC]
  • Nasal Decongestant [OTC]
  • Nexafed [OTC]
  • Psudatabs [OTC]
  • Shopko Nasal Decongestant Max [OTC]
  • Shopko Nasal Decongestant [OTC]
  • Simply Stuffy [OTC]
  • Sudafed 12 Hour [OTC]
  • Sudafed 24 Hour [OTC]
  • Sudafed Childrens [OTC]
  • Sudafed [OTC]
  • Sudanyl [OTC] [DSC]
  • SudoGest 12 Hour [OTC]
  • SudoGest [OTC]
  • Suphedrine [OTC]
  • Zephrex-D [OTC]

Pharmacologic Category

  • Alpha/Beta Agonist
  • Decongestant

Pharmacology

Directly stimulates alpha-adrenergic receptors of respiratory mucosa causing vasoconstriction; directly stimulates beta-adrenergic receptors causing bronchial relaxation, increased heart rate and contractility

Absorption

Rapid (Simons, 1996)

Distribution

Children: ~2.5 L/kg (Simons, 1996); Adults: 2.64-3.51 L/kg (Kanfer, 1993)

Metabolism

Undergoes n-demethylation to norpseudoephedrine (active) (Chua, 1989; Kanfer, 1993); Hepatic (<1%) (Kanfer, 1993)

Excretion

Urine (43% to 96% as unchanged drug, 1% to 6% as active norpseudoephedrine); dependent on urine pH and flow rate; alkaline urine decreases renal elimination of pseudoephedrine (Kanfer, 1993)

Onset of Action

Decongestant: Oral: 30 minutes (Chua, 1989); Peak effect: Decongestant: Oral: ~1-2 hours (Chua, 1989)

Time to Peak

Children (immediate release) ~2 hours (Simons, 1996)

Adults (immediate release): 1-3 hours (dose dependent) (Kanfer, 1993)

Duration of Action

Immediate release tablet: 3-8 hours (Chua, 1989)

Half-Life Elimination

Varies by urine pH and flow rate; alkaline urine decreases renal elimination of pseudoephedrine (Kanfer, 1993)

Children: ~3 hours (urine pH ~6.5) (Simons, 1996)

Adults: 9-16 hours (pH 8); 3-6 hours (pH 5) (Chua, 1989)

Use: Labeled Indications

Temporary symptomatic relief of nasal congestion due to common cold, upper respiratory allergies, and sinusitis; also promotes nasal or sinus drainage

Contraindications

Hypersensitivity to pseudoephedrine or any component of the formulation; with or within 14 days of MAO inhibitor therapy

Dosing: Adult

Nasal congestion: General dosing guidelines: Oral: Immediate release: 60 mg every 4-6 hours; Extended release: 120 mg every 12 hours or 240 mg every 24 hours; maximum: 240 mg/24 hours

Dosing: Geriatric

Nasal congestion: Use caution in this population; initiate using immediate release formulation: 30-60 mg every 6 hours as needed

Dosing: Pediatric

Nasal congestion: General dosing guidelines: Oral:

Children:

4-5 years: 15 mg every 4-6 hours; maximum: 60 mg/24 hours

6-12 years: 30 mg every 4-6 hours; maximum: 120 mg/24 hours

>12 years: Refer to adult dosing.

Dosing: Renal Impairment

No dosage adjustment provided in manufacturer's labeling.

Dosing: Hepatic Impairment

No dosage adjustment provided in manufacturer's labeling.

Administration

Do not crush extended release drug product, swallow whole. May administer with or without food. Sudafed® 24 Hour tablet may not completely dissolve and appear in stool

Dietary Considerations

Some products may contain sodium. May be taken with or without food.

Drug Interactions

Alkalinizing Agents: May increase the serum concentration of Alpha-/Beta-Agonists (Indirect-Acting). Monitor therapy

Alpha1-Blockers: May diminish the vasoconstricting effect of Alpha-/Beta-Agonists. Similarly, Alpha-/Beta-Agonists may antagonize Alpha1-Blocker vasodilation. Monitor therapy

AtoMOXetine: May enhance the hypertensive effect of Sympathomimetics. AtoMOXetine may enhance the tachycardic effect of Sympathomimetics. Monitor therapy

Benzylpenicilloyl Polylysine: Alpha-/Beta-Agonists may diminish the diagnostic effect of Benzylpenicilloyl Polylysine. Management: Consider use of a histamine skin test as a positive control to assess a patient's ability to mount a wheal and flare response. Consider therapy modification

Cannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Exceptions: Cannabidiol. Monitor therapy

Carbonic Anhydrase Inhibitors: May increase the serum concentration of Alpha-/Beta-Agonists (Indirect-Acting). Monitor therapy

Doxofylline: Sympathomimetics may enhance the adverse/toxic effect of Doxofylline. Monitor therapy

Ergot Derivatives: May enhance the hypertensive effect of Alpha-/Beta-Agonists. Ergot Derivatives may enhance the vasoconstricting effect of Alpha-/Beta-Agonists. Exceptions: Ergoloid Mesylates; Nicergoline. Avoid combination

FentaNYL: Alpha-/Beta-Agonists (Indirect-Acting) may decrease the serum concentration of FentaNYL. Specifically, fentanyl nasal spray serum concentrations may decrease and onset of effect may be delayed. Monitor therapy

Iobenguane I 123: Sympathomimetics may diminish the therapeutic effect of Iobenguane I 123. Avoid combination

Linezolid: May enhance the hypertensive effect of Sympathomimetics. Management: Reduce initial doses of sympathomimetic agents, and closely monitor for enhanced pressor response, in patients receiving linezolid. Specific dose adjustment recommendations are not presently available. Consider therapy modification

MAO Inhibitors: May enhance the hypertensive effect of Alpha-/Beta-Agonists (Indirect-Acting). While linezolid is expected to interact via this mechanism, management recommendations differ from other monoamine oxidase inhibitors. Refer to linezolid specific monographs for details. Exceptions: Linezolid; Tedizolid. Avoid combination

Serotonin/Norepinephrine Reuptake Inhibitors: May enhance the tachycardic effect of Alpha-/Beta-Agonists. Serotonin/Norepinephrine Reuptake Inhibitors may enhance the vasopressor effect of Alpha-/Beta-Agonists. Consider therapy modification

Spironolactone: May diminish the vasoconstricting effect of Alpha-/Beta-Agonists. Monitor therapy

Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Monitor therapy

Tedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Monitor therapy

Urinary Acidifying Agents: May decrease the serum concentration of Alpha-/Beta-Agonists (Indirect-Acting). Monitor therapy

Test Interactions

Interferes with urine detection of amphetamine (false-positive)

Adverse Reactions

Frequency not defined.

Cardiovascular: Arrhythmia, cardiovascular collapse with hypotension, hypertension, palpitation, tachycardia

Central nervous system: Chills, confusion, coordination impaired, dizziness, drowsiness, excitability, fatigue, hallucination, headache, insomnia, nervousness, neuritis, restlessness, seizure, transient stimulation, vertigo

Dermatologic: Photosensitivity, rash, urticaria

Gastrointestinal: Anorexia, constipation, diarrhea, dry throat, ischemic colitis, nausea, vomiting, xerostomia

Genitourinary: Difficult urination, dysuria, polyuria, urinary retention

Hematologic: Agranulocytosis, hemolytic anemia, thrombocytopenia

Neuromuscular & skeletal: Tremor, weakness

Ocular: Blurred vision, diplopia

Otic: Tinnitus

Respiratory: Chest/throat tightness, dry nose, dyspnea, nasal congestion, thickening of bronchial secretions, wheezing

Miscellaneous: Anaphylaxis, diaphoresis

Warnings/Precautions

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with cardiovascular disease (including hypertension and ischemic heart disease).

• Diabetes: Use with caution in patients with diabetes mellitus.

• Increased intraocular pressure/glaucoma: Use with caution in patients with increased intraocular pressure or angle-closure glaucoma.

• Prostatic hyperplasia/urinary obstruction: Use with caution in patients with prostatic hyperplasia and/or GU obstruction.

• Renal impairment: Use caution in patient with renal impairment; consider dosage adjustments.

• Seizure disorder: Use with caution in patients with seizure disorder; may produce CNS stimulation.

• Thyroid dysfunction: Use with caution in patients with thyroid dysfunction.

Special populations:

• Elderly: Use with caution in the elderly; may be more sensitive to adverse effects.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC, 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors, 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer’s labeling.

• Sodium: Some products may contain sodium.

Other warnings/precautions:

• Self-medication (OTC use): When used for self-medication (OTC), notify healthcare provider if symptoms do not improve within 7 days or are accompanied by fever. Discontinue and contact healthcare provider if nervousness, dizziness, or sleeplessness occur. Not for OTC use in children <4 years of age.

Pregnancy Considerations

Use of pseudoephedrine during the first trimester may be associated with a possible risk of gastroschisis, small intestinal atresia, and hemifacial microsomia due to pseudoephedrine's vasoconstrictive effects; additional studies are needed to define the magnitude of risk. Single doses of pseudoephedrine were not found to adversely affect the fetus during the third trimester of pregnancy (limited data); however, fetal tachycardia was noted in a case report following maternal use of an extended release product for multiple days. Decongestants are not the preferred agents for the treatment of rhinitis during pregnancy. Oral pseudoephedrine should be avoided during the first trimester.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience insomnia or tablet shell in stool. Have patient report immediately to prescriber angina, tachycardia, severe anxiety, severe headache, severe dizziness, passing out, severe abdominal pain, severe vomiting, or severe nausea (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Hide