APO-RIZATRIPTAN

What it is

APO-RIZATRIPTAN is an orally disintegrating tablet containing 14.53 mg of rizatriptan benzoate (corresponding to 10 mg of rizatriptan). The tablet is white, round, flat, and bevel-edged. Rizatriptan is a potent, orally active serotonergic agonist that acts selectively at 5-HT1B/1D receptors.

Approved indications

— Acute treatment of migraine attacks with or without aura.

Dosing overview

The recommended dose is 10 mg. 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. The physician should consider alternative therapies for these patients, such as other 5-HT1B/1D agonists that do not have this drug interaction. APO-RIZATRIPTAN orally disintegrating tablets are rapidly dissolving tablets and administration with liquid is not necessary.

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 such as stroke or ruptured aneurysm. 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 with rizatriptan and an SSRI or SNRI 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 exacerbation of headache (medication overuse headache), which may present as migraine-like daily headaches or as a marked increase in frequency of migraine attacks.

Contraindications

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

Regulatory history

APO-RIZATRIPTAN was first registered on the ARTG on 19 February 2015 as a 10 mg orally disintegrating tablet (ARTG 220030).