ZOMIG

What it is

Zomig is presented as round, yellow (2.5 mg) or pink (5 mg), biconvex film-coated tablets containing 2.5 mg or 5 mg zolmitriptan. Zomig Rapimelt is presented as orally dispersible white round uncoated orange flavoured tablets containing 2.5 mg zolmitriptan. The Zomig Rapimelt orally dispersible tablet rapidly dissolves when placed on the tongue and is swallowed with the patient's saliva, and a drink of water is not required when taking the Zomig Rapimelt orally dispersible tablet.

Approved indications

— Acute treatment of migraine with or without aura.

Dosing overview

The recommended initial dose of Zomig to treat a migraine attack is 2.5 mg. If symptoms of migraine persist or recur within 24 hours of an initial response, a second dose may be taken, and if a second dose is required, it should not be taken within 2 hours of the initial dose. If a patient does not achieve satisfactory relief with 2.5 mg doses, subsequent attacks can be treated with 5 mg doses of Zomig. In the event of recurrent attacks, it is recommended that the total intake of Zomig, in a 24-hour period, should not exceed 10 mg. The onset of action in responders is apparent within 1 hour of dosing.

Key safety warnings

Cerebrovascular events have been reported in patients treated with 5HT 1 agonists, some resulting in fatalities, and in a number of cases, it appears that the cerebrovascular events were primary, the agonist having been administered in the incorrect belief that the symptoms were a consequence of the migraine. Zomig should only be used when a clear diagnosis of migraine has been established. This class of compounds (5HT 1B/1D agonists) has been associated with coronary vasospasm, angina pectoris and myocardial infarction, and in very rare cases this has occurred with Zomig. In patients with risk factors for ischaemic heart disease, cardiovascular evaluation prior to commencement of treatment with this class of compounds, including Zomig, is recommended. Serotonin Syndrome has been reported with combined use of triptans and other serotonergic medicines, such as Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin Noradrenaline Reuptake Inhibitors (SNRIs). Serotonin Syndrome is a potentially life-threatening condition. Signs and symptoms may include mental status changes (eg agitation, hallucinations, coma), autonomic instability (eg tachycardia, labile blood-pressure, hyperthermia), neuromuscular aberrations (eg hyperreflexia, in-coordination, weakness), and/or gastrointestinal symptoms (eg nausea, vomiting, diarrhoea). Careful observation of the patient is advised when Zomig is administered with an SSRI or SNRI, particularly during treatment initiation and dosage increases. Overuse of acute migraine medications may lead to exacerbations of headache (medication overuse headache), which may present as migraine-like daily headaches or as a marked increase in frequency of migraine attacks.

Contraindications

— Hypersensitivity to any component of the product. — A history of myocardial infarction. — Ischaemic heart disease; Prinzmetal angina/coronary vasospasm; peripheral vascular disease; symptoms or signs consistent with ischaemic heart disease. — Moderate or severe hypertension and mild uncontrolled hypertension. — Ergotamine or ergotamine derivatives should not be used concomitantly with Zomig. — Other 5HT 1D receptor agonists should not be used concomitantly with Zomig. — Creatinine clearance of less than 15 mL/min. — On theoretical grounds, Zomig should not be administered to patients with a history of cerebrovascular accident (CVA) or transient ischaemic attack (TIA).

PBS listing

Zomig 2.5 mg tablet is listed on the PBS as a restricted item with an ex-manufacturer price of A$5.52.

Regulatory history

Zomig 2.5 mg tablet (ARTG 61325) was first listed on 20 April 1998. Zomig Rapimelt 2.5 mg tablet (ARTG 70175) was first listed on 4 April 2001.