RIZATRIPTAN-AU

What it is

RIZATRIPTAN-AU contains rizatriptan benzoate orally disintegrating tablets, with each tablet containing 14.53 mg of rizatriptan benzoate (corresponding to 10 mg of rizatriptan). The orally disintegrating tablets are rapidly dissolving and do not require administration with liquid.

Approved indications

— Acute treatment of migraine attacks with or without aura.

Dosing overview

The recommended dose is 10 mg, which provides optimal clinical benefit. Onset of relief can occur within 30 minutes after dosing. Doses should be separated by at least 2 hours; no more than 30 mg should be taken in any 24-hour period. Plasma concentrations of rizatriptan may be increased by concomitant administration of propranolol, and the 10 mg dose is not appropriate for these patients.

Key safety warnings

Rizatriptan should only be administered to patients in whom a clear diagnosis of migraine has been established, and should not be administered to patients with basilar or hemiplegic migraine. Rizatriptan should not be used to treat atypical headaches that might be associated with potentially serious medical conditions in which cerebrovascular vasoconstriction could be harmful. There have been rare reports of serious coronary events with this class of drugs including rizatriptan, and cardiovascular assessment should be considered in patients at risk for coronary artery disease prior to prescribing. Cases of life-threatening serotonin syndrome have been reported during combined use of selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) and triptans. If concomitant treatment is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. Overuse of acute migraine drugs may lead to medication overuse headache, which may present as migraine-like daily headaches or marked increase in frequency of migraine attacks, and detoxification may be necessary.

Contraindications

RIZATRIPTAN-AU is contraindicated in patients with hypersensitivity to rizatriptan or any of the ingredients, and in patients receiving concurrent administration of monoamine oxidase (MAO) inhibitors or use within 2 weeks of discontinuation of MAO inhibitor therapy. Based on mechanism of action, RIZATRIPTAN-AU is also contraindicated in patients with uncontrolled hypertension, established coronary artery disease (including ischemic heart disease and Prinzmetal's angina), history of stroke or transient ischaemic attack, and peripheral vascular disease.

PBS listing

The PBS listing information is not contained in the provided source documents.

Regulatory history

RIZATRIPTAN-AU was first listed on the Australian Register of Therapeutic Goods on 19 February 2015, with two registered variants: a 5 mg orodispersible tablet (ARTG 220023) and a 10 mg orodispersible tablet (ARTG 220028).