Rizatriptan

What it is and how it works

Mechanism of Action Rizatriptan binds with high affinity to human cloned 5-HT 1B/1D receptors. Rizatriptan benzoate presumably exerts its therapeutic effects in the treatment of migraine headache by binding to 5-HT 1B/1D receptors located on intracranial blood vessels and sensory nerves of the trigeminal system.

Indications

Rizatriptan benzoate tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use Rizatriptan benzoate tablets should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with rizatriptan benzoate tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks. Rizatriptan benzoate tablets are not indicated for use in the management of hemiplegic or basilar migraine . Rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of rizatriptan benzoate tablets have not been established for cluster headache.

Dosage and administration (summary)

Adults: 5 mg or 10 mg single dose; separate repeat doses by at least two hours; maximum dose in a 24-hour period: 30 mg Pediatric patients 6 to 17 years: 5 mg single dose in patients less than 40 kg (88 lb); 10 mg single dose in patients 40 kg (88 lb) or more Adjust dose if co-administered with propranolol Dosing Information in Adults The recommended starting dose of rizatriptan benzoate tablets is either 5 mg or 10 mg for the acute treatment of migraines in adults. The 10 mg dose may provide a greater effect than the 5 mg dose, but may have a greater risk of adverse reactions .

Contraindications

Rizatriptan benzoate tablets are contraindicated in patients with: Ischemic coronary artery disease (angina pectoris, history of myocardial infarction, or documented silent ischemia), or other significant underlying cardiovascular disease . Coronary artery vasospasm including Prinzmetal's angina . History of stroke or transient ischemic attack (TIA) [s ee Warnings and Precautions ] . Peripheral vascular disease (PVD) . Ischemic bowel disease . Uncontrolled hypertension .

Warnings and precautions

Myocardial ischemia, myocardial infarction, and Prinzmetal's angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors Arrhythmias: Discontinue dosing if occurs Chest/throat/neck/jaw pain, tightness, pressure, or heaviness; Generally not associated with myocardial ischemia.

Pregnancy

Pregnancy Risk Summary Available human data on the use of rizatriptan benzoate in pregnant women are not sufficient to draw conclusions about drug-associated risk for major birth defects and miscarriage.

Storage and supply

Rizatriptan Benzoate Tablets USP, 5 mg are a pale pink-colored, circular, flat, beveled-edge uncoated tablets debossed with ‘X’ on one side and ‘13’ on other side. NDC: 71335-1149-1: 30 Tablets in a BOTTLE NDC: 71335-1149-2: 18 Tablets in a BOTTLE Storage Store rizatriptan benzoate tablets USP at 20° to 25°C (68° to 77°F) .

Source: Rizatriptan Benzoate (Rizatriptan Benzoate) — US FDA prescribing information, 2024-04-03, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.