IMIGRAN

What it is

IMIGRAN is indicated for the acute relief of migraine attacks with or without aura. It is available as film-coated tablets in two strengths: 50 mg and 100 mg of sumatriptan succinate.

Approved indications

— Acute relief of migraine attacks with or without aura.

Dosing overview

The initial recommended adult dose is 50 mg, although some patients may require 100 mg, with the dose adjusted according to individual 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.

Key safety warnings

IMIGRAN is strongly not recommended for 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, smoking, obesity, diabetes, strong family history of coronary artery disease, females with surgical or physiological menopause, or males over 40 years of age. Serious cardiac events, including some that have been fatal, have occurred within a few hours following the use of IMIGRAN, though these events are extremely rare (less than 1 in 10,000) and the majority of 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. IMIGRAN 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) 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 IMIGRAN, with reactions ranging from cutaneous hypersensitivity to anaphylaxis, though evidence of cross sensitivity is limited and caution should be exercised.

Contraindications

IMIGRAN should not be used in patients with 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. IMIGRAN should not be used within 24 hours of treatment with an ergotamine-containing or ergot-type medication such as dihydroergotamine or methysergide. IMIGRAN should not be given to patients receiving monoamine oxidase inhibitors (MAOIs) or within two weeks of discontinuation of MAOI therapy. IMIGRAN should not be administered to patients with hemiplegic, basilar or ophthalmoplegic migraine.

PBS listing

The fast-disintegrating tablet formulation of 50 mg is listed on the PBS with a restriction, at an ex-manufacturer price of A$9.70.

Regulatory history

IMIGRAN sumatriptan 100 mg tablets were first listed on the ARTG on 20 March 1992. The current product information for IMIGRAN (Sumatriptan-WGR) was first approved on 11 May 2012 and last revised on 21 May 2024.