pseudoephedrine hydrochloride
Cenafed, Decofed, Dimetapp, Efidac/24, Genaphed, PediaCare Infants’ Decongestant Drops, Sudafed, Triaminic

pseudoephedrine sulfate
Drixoral 12 Hour Non-Drowsy Formula

Available forms
Available without a prescription
pseudoephedrine hydrochloride
Capsules: 60 mg
Capsules (liquid gel): 30 mg
Oral solution: 7.5 mg/0.8 ml, 15 mg/5 ml, 30 mg/5 ml
Tablets: 30 mg, 60 mg
Tablets (chewable): 15 mg
Tablets (controlled-release): 240 mg
Tablets (extended-release): 120 mg, 240 mg
pseudoephedrine sulfate
Tablets (extended-release): 240 mg

Indications and dosages
 Nasal and eustachian tube decongestant. Adults and children age 12 and older: 60 mg P.O. q 4 to 6 hours; or 120 mg P.O. extended-release tablet q 12 hours; or 240 mg P.O. controlled-release tablet daily. Maximum dose is 240 mg daily.
Children ages 6 to 12: 30 mg P.O. q 4 to 6 hours. Maximum dose is 120 mg daily.
Children ages 2 to 5: 15 mg P.O. q 4 to 6 hours. Maximum dose is 60 mg daily, or 4 mg/kg or 125 mg/m² P.O. divided q.i.d.

Pharmacodynamics
Decongestant action: Directly stimulates alpha-adrenergic receptors of respiratory mucosa to produce vasoconstriction; shrinkage of swollen nasal mucous membranes; reduction of tissue hyperemia, edema, and nasal congestion; an increase in airway (nasal) patency and drainage of sinus excretions; and opening of obstructed eustachian ostia. Relaxation of bronchial smooth muscle may result from direct stimulation of beta-adrenergic receptors. Mild CNS stimulation may also occur.

Pharmacokinetics
Absorption: Nasal decongestion within 30 minutes; lasts 4 to 6 hours after oral dose of 60-mg tablet or oral solution. Effects last 8 hours after 60-mg dose; up to 12 hours after 120-mg dose of extended-release form.
Distribution: Widely distributed throughout body.
Metabolism: Incompletely metabolized in liver by N -demethylation to inactive compounds.
Excretion: 55% to 75% of dose excreted unchanged in urine; remainder excreted as unchanged drug and metabolites.

Contraindications and precautions
Contraindicated in patients with severe hypertension or severe coronary artery disease; in those receiving MAO inhibitors; and in breast-feeding women. Extended-release preparations are contraindicated in children younger than age 12.
  Use cautiously in elderly patients and in patients with hypertension, cardiac disease, diabetes, glaucoma, hyperthyroidism, or prostatic hyperplasia.

Interactions
Drug-drug. Beta blockers: Increases pressor effects of pseudoephedrine. Monitor patient.
MAO inhibitors: Potentiates pressor effects of pseudoephedrine. Use together cautiously.
Methyldopa, reserpine: Reduces antihypertensive effects. Monitor blood pressure.
Other sympathomimetics: Causes additive effects. Monitor patient for toxicity.
Tricyclic antidepressants: Antagonizes effects of pseudoephedrine. Monitor patient.

Adverse reactions
CNS: anxiety, transient stimulation, tremor, dizziness, headache, insomnia, nervousness.
CV: arrhythmias, palpitations, tachycardia.
GI: anorexia, nausea, vomiting, dry mouth.
GU: difficulty urinating.
Respiratory: respiratory difficulties.
Skin: pallor.

Effects on lab test results
None reported.

Overdose and treatment
Toxicity may cause exaggeration of common adverse reactions, particularly seizures, arrhythmias, and nausea and vomiting.
 Treatment of toxicity may include an emetic and gastric lavage within 4 hours of ingestion. Charcoal is effective only if administered within 1 hour, unless extended-release form was used. Forced diuresis will increase elimination. Don’t force diuresis in severe overdose. I.V. propranolol may control cardiac toxicity; I.V. diazepam may be helpful to manage delirium or seizures; dilute potassium chloride solutions (I.V.) may be given for hypokalemia.

Special considerations
• Administer last daily dose several hours before bedtime to minimize insomnia.
• If symptoms persist longer than 5 days or fever is present, reevaluate therapy.
Breast-feeding patients
• Drug appears in breast milk. Avoid use in breast-feeding women; infant may be susceptible to drug effects.
Pediatric patients
• Don’t use extended-release form in children younger than age 12.
Geriatric patients
• Elderly patients may be sensitive to effects of drug; lower dose may be needed. Overdose may cause hallucinations, CNS depression, seizures, and death in patients older than age 60. Use extended-release preparations with caution in elderly patients.

Patient education
• If patient finds swallowing capsules difficult, suggest opening capsules and mixing contents with applesauce, jelly, honey, or syrup. Mixture must be swallowed without chewing.
• Tell patient that dry mouth may occur and suggest using ice chips, sugarless gum, or hard candy for relief.
• Instruct patient to take missed dose if remembered within 1 hour. If beyond 1 hour, patient should skip missed dose and resume regular schedule; he shouldn’t double the dose.
• Tell patient to store drug away from heat and light (not in bathroom medicine cabinet) and safely out of reach of children.
• Caution patient that many OTC preparations may contain sympathomimetics, which can cause additive, hazardous reactions.
• Advise patient to take last dose at least 2 to 3 hours before bedtime to avoid insomnia.

Reactions may be common, uncommon, life-threatening, or COMMON AND LIFE THREATENING.
◆ Canada only
◇ Unlabeled clinical use