ZOLTRIP

What it is

Zoltrip is presented as round, yellow (2.5 mg) film-coated tablets containing 2.5 mg zolmitriptan.

Approved indications

— Acute treatment of migraine with or without aura

Dosing overview

The recommended initial dose of Zoltrip 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, but it should not be taken within 2 hours of the initial dose. In the event of recurrent attacks, the total intake of Zoltrip in a 24-hour period should not exceed 10 mg. The onset of action in responders is apparent within 1 hour of dosing, and Zoltrip is equally effective whenever the tablets are taken during a migraine attack, although it is advisable that tablets are taken as early as possible after the onset of migraine headache.

Key safety warnings

Cerebrovascular events have been reported in patients treated with 5HT 1 agonists, and Zoltrip should only be used when a clear diagnosis of migraine has been established. Care should be taken to exclude other potentially serious neurological conditions. This class of compounds has been associated with coronary vasospasm, angina pectoris and myocardial infarction; in very rare cases this has occurred with Zoltrip, and in patients with risk factors for ischaemic heart disease, cardiovascular evaluation prior to commencement of treatment 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), and is a potentially life-threatening condition. Careful observation of the patient is advised when Zoltrip 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 or coronary vasospasm; peripheral vascular disease; or 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 Zoltrip. Other 5HT 1D receptor agonists should not be used concomitantly with Zoltrip. Creatinine clearance of less than 15 mL/min. On theoretical grounds, Zoltrip should not be administered to patients with a history of cerebrovascular accident (CVA) or transient ischaemic attack (TIA).

Regulatory history

Zoltrip was first approved on 20 April 1998. Zoltrip 2.5 mg tablet (ARTG 200877) was first listed on 19 June 2013.