Rizatriptan

• 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

• MAXALT Tablets: 10 mg
• MAXALT-MLT Orally Disintegrating Tablets: 10 mg
• MAXALT Tablets 10 mg tablets are pale pink, capsule-shaped, compressed tablets coded MAXALT on one side and MRK 267 on the other.
• MAXALT-MLT Orally Disintegrating Tablets 10 mg orally disintegrating tablets are white to off-white, round lyophilized tablets debossed with a modified square on one side.

• 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

• most common adverse reactions in adults were (incidence ≥5% and greater than placebo): asthenia/fatigue, somnolence, pain/pressure sensation and dizziness To report SUSPECTED ADVERSE REACTIONS, contact Organon LLC, a subsidiary of Organon & Co.
• most common adverse reactions during treatment with MAXALT (≥5% in either treatment group and greater than placebo) were asthenia/fatigue, somnolence, pain/pressure sensation and dizziness.

• 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

• 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.

• 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%. Ergot-Containing Drugs Ergot-containing drugs have been reported to cause prolonged vasospastic reactions.
• Because these effects may be additive, use of ergotamine-containing or ergot-type medications (like dihydroergotamine or methysergide) and MAXALT within 24 hours is contraindicated. Other 5-HT 1 Agonists Because their vasospastic effects may be additive, co-administration of MAXALT and other 5-HT 1 agonists within 24 hours of each other is contraindicated.
• A specific MAO-A inhibitor increased the systemic exposure of rizatriptan and its metabolite.
• Drug Interactions Monoamine oxidase inhibitors: Rizatriptan is principally metabolized via monoamine oxidase, 'A' subtype (MAO-A).
• Plasma concentrations of rizatriptan may be increased by drugs that are selective MAO-A inhibitors (e.g., moclobemide) or nonselective MAO inhibitors [type A and B] (e.g., isocarboxazid, phenelzine, tranylcypromine, and pargyline).
• In a drug interaction study, when MAXALT 10 mg was administered to subjects (n=12) receiving concomitant therapy with the selective, reversible MAO-A inhibitor, moclobemide 150 mg t.i.d., there were mean increases in rizatriptan AUC and C max of 119% and 41% respectively; and the AUC of the active N-monodesmethyl metabolite of rizatriptan was increased more than 400%.

Available human data on the use of MAXALT in pregnant women are not sufficient to draw conclusions about drug-associated risk for major birth defects and miscarriage. In animal studies, developmental toxicity was observed following oral administration of rizatriptan during pregnancy (decreased fetal body weight in rats) or throughout pregnancy and lactation (increased mortality, decreased body weight, and neurobehavioral impairment in rat offspring) at maternal plasma...