Pseudoephedrine


Generic Medicine Info
Indications and Dosage
Oral
Nasal congestion
Adult: As conventional tab: 60 mg 4-6 hourly. Max: 240 mg daily. As extended-release tab: 120 mg 12 hourly or 240 mg 24 hourly.
Child: >12 years Same as adult dose.
Administration
May be taken with or without food.
Contraindications
Severe hypertension or coronary artery disease. Children <12 years. Concomitant or within 2 weeks of MAOI therapy.
Special Precautions
Patients with CV disease (e.g. hypertension, ischaemic heart disease), diabetes mellitus, increased intraocular pressure or angle-closure glaucoma, prostatic hyperplasia or urinary obstruction, seizure disorder, thyroid dysfunction. Mild to moderate renal and severe hepatic impairment. Children and elderly. Pregnancy and lactation.
Adverse Reactions
Significant: Severe skin reactions (e.g. acute generalised exanthematous pustulosis).
Cardiac disorders: Tachycardia, arrhythmia, palpitation.
Eye disorders: Angle-closure glaucoma.
Gastrointestinal disorders: Dry mouth, nausea, vomiting.
Nervous system disorders: Restlessness, tremors, headache, dizziness.
Psychiatric disorders: Insomnia, sleep disturbances, anxiety, nervousness. Rarely, hallucinations (children).
Renal and urinary disorders: Urinary retention.
Skin and subcutaneous tissue disorders: Skin rashes.
Vascular disorders: Hypertension.
Patient Counseling Information
This drug may cause dizziness, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor relief of congestion, cardiac and CNS changes prior and during therapy.
Overdosage
Symptoms: Irritability, restlessness, tremor, convulsions, palpitations, hypertension, and difficulty in micturition. Management: Maintain and support respiration, and control convulsions. Gastric lavage and catheterisation of the bladder may be performed if necessary. Acid diuresis or dialysis may accelerate pseudoephedrine elimination.
Drug Interactions
May increase blood pressure with TCAs, other sympathomimetic agents (e.g. decongestants, appetite suppressants, amphetamine-like psychostimulants). May partially antagonise antihypertensive effect of methyldopa, α- and β-blockers, bretylium, bethanidine, guanethidine, and debrisoquine. Elimination of pseudoephedrine may be enhanced by urinary acidifiers and decreased by urinary alkalinisers.
Potentially Fatal: May cause hypertensive crisis with MAOIs.
Food Interaction
May delay onset with food.
Lab Interference
May interfere with urine detection of amphetamine causing false-positive result.
Action
Description: Pseudoephedrine is a sympathomimetic agent and a stereoisomer of ephedrine. It directly stimulates α-adrenergic receptors thereby causing vasoconstriction of respiratory mucosa and β-adrenergic receptors causing relaxation of bronchial muscles, and increased heart rate and contractility.
Onset: 30 minutes.
Duration: 3-8 hours (immediate-release).
Pharmacokinetics:
Absorption: Readily and rapidly absorbed from the gastrointestinal tract. Time to peak plasma concentration: 1-3 hours (immediate release).
Distribution: Enters breast milk (small amounts). Volume of distribution: 2.64-3.51 L/kg.
Metabolism: Metabolised in the liver via N-demethylation to norpseudoephredrine (active metabolite).
Excretion: Via urine (43-96% as unchanged drug, 1-6% as norpseudoephedrine). Alkaline urine decreases renal elimination. Elimination half-life: 9-16 hours (pH 8); 3-6 hours (pH 5).
Chemical Structure

Chemical Structure Image
Pseudoephedrine

Source: National Center for Biotechnology Information. PubChem Database. Pseudoephedrine, CID=7028, https://pubchem.ncbi.nlm.nih.gov/compound/Pseudoephedrine (accessed on Jan. 21, 2020)

Storage
Store between 20-25°C. Protect from light.
ATC Classification
R01BA02 - pseudoephedrine ; Belongs to the class of systemic sympathomimetic preparations used as nasal decongestants.
References
Anon. Pseudoephedrine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 07/05/2020.

Buckingham R (ed). Pseudoephedrine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/05/2020.

Care Decongestant Oral Liquid (Thornton & Ross Ltd). MHRA. https://products.mhra.gov.uk/. Accessed 08/05/2020.

Joint Formulary Committee. Pseudoephedrine Hydrochloride. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 07/05/2020.

Nasal Decongestant Maximum Strength 30 mg Tablet, Film Coated (Better Living Brands , LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 07/05/2020.

Pseudoephedrine 60 mg Tablets (Ennogen Pharma Limited). MHRA. https://products.mhra.gov.uk/. Accessed 07/05/2020.

Pseudoephedrine HCl Tablet, Extended Release (Aurohealth LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 07/05/2020.

PSM Healthcare Limited, t/a API Consumer Brands. Sudomyl Tablet 60 mg data sheet November 2017. Medsafe. http://www.medsafe.govt.nz/. Accessed 07/05/2020.

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