NARAMIG

What it is

NARAMIG is indicated for the acute treatment of migraine attacks with or without aura. It contains naratriptan 2.5 mg as the active ingredient. Naratriptan is a selective agonist for 5 hydroxytryptamine1 (5-HT1) receptors found predominantly in intracranial blood vessels, with high affinity for human cloned 5-HT1B and 5-HT1D receptors. Experimental evidence suggests that naratriptan inhibits trigeminal nerve activity, and both vascular constriction and nerve inhibition may contribute to its anti-migraine action.

Approved indications

— Acute treatment of migraine attacks with or without aura

Dosing overview

The recommended adult dose is a single 2.5 mg tablet. If symptoms recur, a second dose may be taken provided that there is a minimum interval of four hours between the two doses. The total daily dose should not exceed two 2.5 mg tablets in any 24 hour period. NARAMIG should be taken as early as possible after the onset of a migraine headache but it is effective if taken at a later stage. NARAMIG should not be used prophylactically. For adult patients with renal impairment, the maximum total daily dose is a single 2.5 mg tablet. For adult patients with hepatic impairment, the maximum total daily dose is a single 2.5 mg tablet.

Key safety warnings

Naratriptan should only be used where there is a clear diagnosis of migraine and is not indicated for use in the management of hemiplegic, basilar or ophthalmoplegic migraine. Naratriptan should not be given to patients in whom unrecognised cardiac disease is likely without a prior evaluation for underlying cardiovascular disease, including postmenopausal women, males over 40 and patients with risk factors for coronary artery disease. Serotonin syndrome including altered mental status, autonomic instability and neuromuscular abnormalities has been reported following concomitant treatment with triptans and selective serotonin reuptake inhibitors (SSRIs) or serotonin noradrenaline reuptake inhibitors (SNRIs); appropriate observation of the patient is advised if concomitant treatment is clinically warranted. Naratriptan contains a sulphonamide component, therefore there is a theoretical risk of a hypersensitivity reaction in patients with known hypersensitivity to sulphonamides. 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.

Contraindications

Hypersensitivity to any component of the preparation. A history of myocardial infarction, ischaemic heart disease, Prinzmetal's angina or coronary vasospasm, or signs or symptoms consistent with ischaemic heart disease. A history of cerebrovascular accident (CVA) or transient ischaemic attack (TIA), or peripheral vascular disease. Uncontrolled hypertension. Concomitant use of other 5HT1 receptor agonists. Severely impaired renal function (creatinine clearance less than 15 mL/min) or severely impaired hepatic function (Child-Pugh grade C).

PBS listing

NARAMIG 2.5 mg tablets are listed on the PBS as 2 items with authority required restriction, at an ex-manufacturer price of A$5.69.

Regulatory history

NARAMIG was first approved on 3 June 1998. ARTG registration 62900 for NARAMIG naratriptan 2.5 mg tablet blister pack was first listed on 17 June 1998.