Rizatriptan

MAXALT ® and MAXALT-MLT ® 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 MAXALT 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 MAXALT, the diagnosis of migraine should be reconsidered before MAXALT is administered to treat any subsequent attacks. MAXALT is not indicated for use in the management of hemiplegic or basilar migraine. MAXALT is not indicated for the prevention of migraine attacks. Safety and effectiveness of MAXALT have not been established for cluster headache. MAXALT is a serotonin (5-HT) 1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age.

Rizatriptan binds with high affinity to human cloned 5-HT 1B/1D receptors. MAXALT 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.

Although rizatriptan benzoate 5 mg tablets and orally disintegrating tablets are available in the marketplace, MAXALT Tablets and MAXALT-MLT Orally Disintegrating Tablets are no longer marketed in the 5 mg strength. Adults: 5 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

MAXALT is 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). Peripheral vascular disease (PVD). Ischemic bowel disease. Uncontrolled hypertension. Recent use (i.e., within 24 hours) of another 5-HT 1 agonist, ergotamine-containing medication, or ergot-type medication (such as dihydroergotamine or methysergide). Hemiplegic or basilar migraine.

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, Evaluate patients at high risk. Cerebral hemorrhage, subarachnoid hemorrhage, and stroke: Discontinue dosing if occurs. Gastrointestinal ischemic events, peripheral vasospastic reactions: Discontinue dosing if occurs. Medication overuse headache: Detoxification may be necessary. Serotonin syndrome: Discontinue dosing if occurs

The following adverse reactions are discussed in more detail in other sections of the labeling: Myocardial Ischemia, Myocardial Infarction, and Prinzmetal's Angina. Arrhythmias. Chest, Throat, Neck and/or Jaw Pain/Tightness/Pressure. Cerebrovascular Events. Other Vasospasm Reactions. Medication Overuse Headache. Serotonin Syndrome. Increase in Blood Pressure. The most common adverse reactions in adults were (incidence ≥5% and greater than placebo): asthenia/fatigue, somnolence, pain/pressure sensation and dizziness

Propranolol The dose of MAXALT should be adjusted in propranolol-treated patients, as propranolol has been shown to increase the plasma AUC of rizatriptan by 70%.

Store MAXALT Tablets at room temperature, 15°C-30°C (59°F-86°F). Store MAXALT-MLT Orally Disintegrating Tablets at room temperature, 15°C-30°C (59°F-86°F).