SUMATRAN

What it is

Sumatran contains sumatriptan succinate as its active ingredient. Sumatran tablets are available in two strengths, 50 mg and 100 mg. The 50 mg formulation contains sumatriptan succinate equivalent to 50 mg sumatriptan, while the 100 mg formulation contains sumatriptan succinate equivalent to 100 mg sumatriptan. Sumatriptan is a specific vascular 5-hydroxytryptamine-1 (5HT1) receptor agonist with no effect at other 5HT receptor subtypes. The vascular 5HT1 receptor is found predominantly in cranial blood vessels and mediates vasoconstriction. Experimental evidence suggests that sumatriptan inhibits trigeminal nerve activity, and both these actions may contribute to the antimigraine action of sumatriptan in humans.

Approved indications

— Acute relief of migraine attacks with or without aura — Acute intermittent relief of cluster headache

Dosing overview

The initial recommended adult dose of Sumatran is 50 mg, though some patients may require 100 mg. The dose should be adjusted according to the individual's response. If symptoms recur, further doses may be given in the next 24 hours provided not more than 300 mg are taken in any 24 hour period. The tablet should be swallowed whole with water. Sumatran should not be used prophylactically.

Key safety warnings

Sumatriptan should not be given to patients in whom risk factors indicate a possibility of unrecognised coronary artery disease unless a cardiovascular evaluation provides satisfactory clinical evidence that the patient is reasonably free of coronary artery and ischaemic myocardial disease or other significant underlying cardiovascular disease. Risk factors include hypertension, hypercholesterolaemia, smoker status, obesity, diabetes, strong family history of coronary artery disease, female with surgical or physiological menopause, or male over 40 years of age. Serious cardiac events, including some that have been fatal, have occurred within a few hours following the use of Sumatriptan tablets. These events are extremely rare (less than 1 in 10,000) and the majority of these case reports were confounded by patients having pre-existing heart disease or risk factors for ischaemic heart disease. Cerebral haemorrhage, subarachnoid haemorrhage, stroke, and other cerebrovascular events have been reported in patients treated with oral Sumatriptan, and some have resulted in fatalities. Sumatran should not be administered if the headache being experienced is atypical of the patient. Overuse of acute migraine treatments has been associated with the exacerbation of headache (medication overuse headache, MOH) in susceptible patients, and withdrawal of the treatment may be necessary. Patients with known hypersensitivity to sulphonamides may exhibit an allergic reaction following administration of Sumatran. Reactions may range from cutaneous hypersensitivity to anaphylaxis; however, evidence of cross sensitivity is limited and caution should be exercised before using Sumatriptan in these patients.

Contraindications

Sumatran should not be used in patients who have hypersensitivity to any component of the preparation, a history of myocardial infarction, peripheral vascular disease or symptoms or signs consistent with ischaemic heart disease, Prinzmetal's angina or coronary vasospasm, uncontrolled hypertension, cerebrovascular accident or transient ischaemic attack, or severe hepatic impairment. Sumatran should not be used within 24 hours of treatment with an ergotamine-containing or ergot-type medication such as dihydroergotamine or methysergide. Sumatran should not be given to patients receiving monoamine oxidase inhibitors (MAOIs) or within two weeks of discontinuation of MAOI therapy. Sumatran should not be administered to patients with hemiplegic, basilar or ophthalmoplegic migraine.

PBS listing

Information regarding PBS listing status is not available in the provided documents.

Regulatory history

Sumatran received its first approval on 11 May 2012. The 50 mg and 100 mg formulations were first listed on the Australian Register of Therapeutic Goods on 2012-05-11, with a third variant (SUMATRAN ACUTE MIGRAINE RELIEF 50 mg) first listed on 2021-11-22.