DEMAZIN

What it is

Demazin Original 6 Hour Relief contains chlorphenamine maleate 4 mg and pseudoephedrine sulfate 60 mg per tablet. The tablet is round and convex, blue in colour, plain on one side with a score-line on the other. Demazin is an antihistamine plus decongestant combination, containing chlorphenamine for prophylaxis and treatment of allergy symptoms and pseudoephedrine for relief of nasal and sinus congestion.

Approved indications

— Relief of upper respiratory mucosal congestion and hypersecretion accompanying conditions such as the common cold, nasal allergy, hayfever, and sinusitis.

Dosing overview

Adults and children 12 years and over should take one tablet every 6 hours when necessary.

Key safety warnings

Chlorphenamine may cause drowsiness and may increase the effects of alcohol, with drowsiness potentially continuing the following day. Those affected should not drive or operate machinery. Pseudoephedrine may cause sleeplessness if taken up to several hours before going to bed. Cases of ischaemic colitis have been reported with pseudoephedrine, and the product should be discontinued with medical advice sought if sudden abdominal pain, rectal bleeding or other symptoms of ischaemic colitis develop. Cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported with pseudoephedrine, with increased risk in patients with severe or uncontrolled hypertension or severe acute or chronic kidney disease. Pseudoephedrine should be discontinued and immediate medical assistance sought if sudden severe headache or thunderclap headache, nausea, vomiting, confusion, seizures and/or visual disturbances occur. Cases of ischaemic optic neuropathy have been reported with pseudoephedrine, and the product should be discontinued if sudden loss of vision or decreased visual acuity such as scotoma occurs.

Contraindications

Hypersensitivity to chlorphenamine, pseudoephedrine or to other drugs of similar chemical structure or any of the other ingredients in this medicine is a contraindication. Severe or uncontrolled hypertension and severe coronary artery disease are contraindications. Severe acute or chronic kidney disease or renal failure, and taking monoamine oxidase inhibitors (MAOIs) or having taken MAOIs within the previous 14 days, are contraindications. Chlorphenamine is contraindicated in patients taking an antihypertensive agent. Narrow angle glaucoma, stenosing peptic ulcer, symptomatic prostatic hypertrophy, bladder neck obstruction and pyloroduodenal obstruction are contraindications. Demazin Original 6 Hour Relief should not be used in children under 12 years of age.

Regulatory history

Demazin Original 6 Hour Relief (ARTG 18815) was first listed on the Australian Register of Therapeutic Goods on 8 October 1991.