Adult: For symptomatic relief of cases associated with common cold or upper respiratory allergies: As conventional tab, softgel cap, or oral solution: 60 mg 4-6 hourly. As extended-release cap: 120 mg 12 hourly. As extended-release tab: 120 mg 12 hourly or 240 mg 24 hourly. Max: 240 mg/24 hours. Dosage recommendations may vary among countries and between individual products (refer to local or specific product guidelines). Child: For symptomatic relief of cases associated with common cold or upper respiratory allergies: 4-5 years As oral solution: 15 mg 4-6 hourly (Max: 60 mg/24 hours); 6-11 years As softgel cap or oral solution: 30 mg 4-6 hourly (Max: 120 mg/24 hours); ≥12 years Same as adult dose. Starting age for child dosing and dosage recommendations may vary among countries and between individual products (refer to local or specific product guidelines).
Renal Impairment
Severe: Contraindicated. Recommendations may vary among countries and between individual products (refer to local or specific product guidelines).
Administration
Pseudoephedrine May be taken with or without food.
Contraindications
Severe or uncontrolled hypertension, severe coronary artery disease. Severe renal impairment (including severe acute or chronic kidney failure). Concomitant use or within 2 weeks of discontinuing MAOI therapy.
Special Precautions
Patient with diabetes, CV disease (e.g. ischaemic heart disease, coronary artery disease), hypertension, hyperthyroidism, prostatic hypertrophy or bladder dysfunction, raised intraocular pressure, predisposition to angle-closure glaucoma; obstruction/narrowing of the gastrointestinal tract (extended-release formulation). Intended for short-term use only and should not be used for prolonged periods. Severe hepatic and mild to moderate renal impairment. Treatment with pseudoephedrine in children (especially under 6 years old) should be considered carefully due to potential risks and limited evidence on efficacy. Elderly. Pregnancy and lactation.
Adverse Reactions
Significant: Hallucinations, restlessness, sleep disturbances, severe skin reactions (e.g. acute generalised exanthematous pustulosis), ischaemic colitis, ischaemic optic neuropathy. Rarely, posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS); gastrointestinal obstruction (particularly when 24-hour extended-release tab is used in patients with severe narrowing of the oesophagus, stomach or intestine). Cardiac disorders: Tachycardia, palpitations, arrhythmia. Eye disorders: Angle-closure glaucoma. Gastrointestinal disorders: Nausea, vomiting, dry mouth. Immune system disorders: Hypersensitivity reactions. Nervous system disorders: Headache, dizziness, tremor. Psychiatric disorders: Insomnia, anxiety, irritability, excitability. Rarely, psychotic disorder. Renal and urinary disorders: Urinary retention. Skin and subcutaneous tissue disorders: Rash, erythematous nodular patches. Vascular disorders: Hypertension, impaired circulation to the extremities.
Monitoring Parameters
Monitor cardiac and CNS changes. Assess for the signs and symptoms of severe skin reactions; PRES and RCVS (e.g. sudden, severe or thunderclap headache, sudden nausea and vomiting, visual disturbances, confusion, seizures).
Overdosage
Symptoms: Nervousness, irritability, tremor, anxiety, insomnia, nausea, vomiting, restlessness, dry mouth, cardiac arrhythmias, tachycardia, palpitations, convulsions, hypertension, urinary retention. Management: Supportive treatment. Consider administering activated charcoal. Alternatively, perform gastric lavage if it is within 1 hour of ingestion. Treat hypertension and convulsions as necessary. Monitor pulse, blood pressure and cardiac rhythm.
Drug Interactions
Concomitant use with other sympathomimetic agents (e.g. apraclonidine), appetite suppressants, amphetamine-like psychostimulants, TCAs, and furazolidone may increase the risk of hypertension. May attenuate the therapeutic effects of antihypertensive agents (e.g. methyldopa, guanethidine, reserpine, α-adrenergic blockers, β-blockers). May increase the risk of arrhythmias with cardiac glycosides, quinidine, volatile anaesthetics (e.g. cyclopropane, halothane), or anticholinergic drugs (e.g. TCAs). Increased risk of ergotism with ergot alkaloids, including ergotamine or methysergide. Elimination of pseudoephedrine may be enhanced or reduced by urinary acidifiers or urinary alkalinisers, respectively. Potentially Fatal: Concomitant administration with MAOIs may result in hypertensive crisis.
Food Interaction
Onset of effect may be delayed with food.
Lab Interference
May interfere with the urine detection of amphetamine causing false-positive results.
Action
Description: Mechanism of Action: Pseudoephedrine, a direct- and indirect-acting sympathomimetic agent, is a stereoisomer of ephedrine with lower pressor activity and fewer CNS effects. It acts directly on α-adrenergic receptors of the respiratory mucosa causing vasoconstriction. Pseudoephedrine also directly stimulates β-adrenergic receptors resulting in bronchial relaxation, increased heart rate and contractility. Onset: Decongestant: 30 minutes. Duration: 3-8 hours (conventional tab). Pharmacokinetics: Absorption: Readily and completely absorbed from the gastrointestinal tract. Food may delay the onset of effect. Time to peak plasma concentration: 1-3 hours (conventional tab). Distribution: Enters breast milk (small amounts). Metabolism: Metabolised in the liver via N-demethylation into norpseudoephedrine (active metabolite). Excretion: Via urine (43-96% as unchanged drug; 1-6% as active metabolite). Elimination half-life: 3-6 hours (urine pH 5); 9-16 hours (urine pH 8).
Chemical Structure
Pseudoephedrine Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 7028, Pseudoephedrine. https://pubchem.ncbi.nlm.nih.gov/compound/Pseudoephedrine. Accessed July 26, 2024.
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