ARTG Entry

IPTAM

ARTG entry for IPTAM (sumatriptan), ARTG 124086 — Product Information, dosage form, registration history. Compiled by arcimedes.

What it is

IPTAM contains sumatriptan succinate as its active ingredient. IPTAM tablets are available in two strengths, 50 mg and 100 mg. The 50 mg strength is a pink coloured, capsule shaped biconvex film coated tablet, plain on both sides. The 100 mg strength is a white to off-white coloured, capsule shaped biconvex film coated tablet, plain on both sides.

Approved indications

— Acute relief of migraine attacks with or without aura.

Dosing overview

The initial recommended adult dose of IPTAM is 50 mg, though some patients may require 100 mg, with the dose 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.

Key safety warnings

IPTAM 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, with risk factors including hypertension, hypercholesterolaemia, smoking, obesity, diabetes, strong family history of coronary artery disease, female with surgical or physiological menopause, or male over 40 years of age. IPTAM may cause short lived elevation of blood pressure and peripheral vascular resistance and should therefore be administered with caution to patients with controlled hypertension. Cerebral haemorrhage, subarachnoid haemorrhage, stroke, and other cerebrovascular events have been reported in patients treated with IPTAM, and some have resulted in fatalities. IPTAM should not be administered if the headache being experienced is atypical of the patient, and care should be taken to exclude other potentially serious neurological conditions before treating headaches in patients not previously diagnosed as migraineurs and in migraineurs who present with atypical symptoms. Patients with known hypersensitivity to sulphonamides may exhibit allergic reactions following administration of IPTAM, with reactions ranging from cutaneous hypersensitivity to anaphylaxis, and caution should be exercised before using IPTAM in these patients.

Contraindications

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

PBS listing

Information regarding PBS listing for IPTAM is not available in the provided source documents.

Regulatory history

IPTAM sumatriptan 50 mg and 100 mg tablet blister packs were first listed on the ARTG on 15 August 2006. A further ARTG entry for IPTAM MIGRAINE RELIEF sumatriptan 50 mg tablet blister pack was first listed on 13 October 2022.

TGA Public Summary — ARTG 124086