Safety and efficacy not established for management of cluster headaches.
Dosage and Administration
Administration
Oral Administration
Administer orally as conventional or orally disintegrating tablets without regard to meals.
Just prior to administration of orally disintegrating tablet, remove blister from aluminum pouch; with dry hands, peel open blister package, place tablet on tongue to dissolve, and swallow with saliva.
Administration of orally disintegrating tablet with liquid is not necessary.
Dosage
Available as rizatriptan benzoate; dosage is expressed in terms of rizatriptan.
Adults
Vascular Headaches
Migraine
Oral
5 or 10 mg as a single dose; individualize dosage selection, weighing the possible benefit (greater effectiveness) and risks (increased adverse effects) of the 10-mg dose.
Additional doses may be administered at intervals of ≥2 hours, up to a maximum dosage of 30 mg in any 24-hour period.
Following failure to respond to first dose, reconsider diagnosis of migraine prior to administration of a second dose.
Prescribing Limits
Adults
Vascular Headaches
Migraine
Oral
Maximum 30 mg in any 24-hour period.
Safety of treating an average of >4 headaches per 30-day period has not been established.
Cautions
Contraindications
Known or suspected ischemic heart disease (e.g., angina pectoris, history of MI, documented silent ischemia).
Treatment within previous 24 hours with another 5-HT1 agonist or an ergot alkaloid. (See Specific Drugs under Interactions.)
Concurrent or recent (within 2 weeks) treatment with an MAO inhibitor. (See Specific Drugs under Interactions.)
Known hypersensitivity to rizatriptan or any ingredient in the formulation.
Warnings/Precautions
Warnings
Use only in patients in whom a clear diagnosis of migraine has been established.
Exclude other potentially serious neurologic disorders before administering rizatriptan to patients not previously diagnosed with migraine or to those with atypical symptoms.
Cardiac Effects
Possible myocardial ischemia and/or infarction, coronary vasospasm, life-threatening cardiac rhythm disturbances, and death.
Use not recommended in patients with known or suspected ischemic or vasospastic heart disease or in patients in whom unrecognized CAD is likely (e.g., postmenopausal women; men >40 years of age; patients with risk factors such as hypertension, hypercholesterolemia, smoking, obesity, diabetes, or family history of CAD) unless there is satisfactory evidence from prior cardiovascular evaluation that patient does not have CAD, ischemic heart disease, or other underlying cardiovascular disease.
Administer initial dose to patients with risk factors for CAD who have completed satisfactory cardiovascular evaluation under medical supervision (e.g., in clinician’s office, possibly followed by ECG) unless patient previously received the drug.
Periodic cardiovascular evaluation recommended in patients with risk factors for CAD if receiving intermittent long-term therapy.
Patients with symptoms suggestive of angina after receiving rizatriptan should be evaluated for presence of CAD or predisposition to Prinzmetal variant angina before receiving additional doses; if administration resumed and such signs or symptoms recur, ECG evaluation recommended.
Risk of certain cerebrovascular events (e.g., stroke, hemorrhage, TIA) may be increased in patients with migraine.
Other Cardiovascular or Vasospastic Effects
Peripheral vascular ischemia and colonic ischemia with abdominal pain and bloody diarrhea reported with use of 5-HT1 receptor agonists. Further evaluation recommended if signs or symptoms of decreased arterial flow (e.g., ischemic colitis, Raynaud’s phenomenon) occur following administration.
Substantial increases in BP, including hypertensive crises, reported rarely with 5-HT1 receptor agonists in patients with or without history of hypertension.
Increases in mean pulmonary artery pressure observed following administration of a 5-HT1 receptor agonist to patients with suspected CAD who were undergoing cardiac catheterization.
Serotonin Syndrome
Potentially life-threatening serotonin syndrome reported during concurrent therapy with 5-HT1 receptor agonists (“triptans”) and SSRIs or selective serotonin- and norepinephrine-reuptake inhibitors (SNRIs). Symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile BP, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination), and/or GI symptoms (e.g., nausea, vomiting, diarrhea).
General Precautions
Ocular Effects
Possible accumulation of rizatriptan in melanin-rich tissues (e.g., eye) over time, resulting in potential toxicity in these tissues with extended use.
Phenylketonuria
Advise individuals who must restrict phenylalanine intake that each 5- or 10-mg Maxalt-MLT® orally disintegrating tablet contains aspartame, which is metabolized in GI tract to provide 1.05 or 2.1 mg of phenylalanine, respectively. Conventional tablets do not contain aspartame.
Distributed into milk in rats; not known whether distributed into milk in humans. Caution advised if rizatriptan is used.
Pediatric Use
Safety and efficacy not established in children <18 years of age; use not recommended.
Geriatric Use
No substantial differences in efficacy, safety, or pharmacokinetic profile relative to younger adults; however, limited clinical experience in patients ≥65 years of age.
Hepatic Impairment
Use with caution in patients with moderate hepatic impairment. (See Special Populations under Pharmacokinetics.)
Not studied in patients with severe hepatic impairment.
Renal Impairment
Use with caution in patients undergoing dialysis. (See Special Populations under Pharmacokinetics.)
Common Adverse Effects
Pain/pressure sensations (i.e., chest pain [tightness/pressure/heaviness], pain/tightness/pressure in neck/throat/jaw, regional pain [tightness/pressure/heaviness], pain at location not specified), asthenia/fatigue, dizziness, somnolence, dry mouth, nausea, paresthesia.
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