rizatriptan benzoate

FDA Drug Profile — rizatriptan benzoate, RIZATRIPTAN BENZOATE, MAXALT, MAXALT-MLT

Drug Details

Generic Name
rizatriptan benzoate
Brand Names
rizatriptan benzoate, RIZATRIPTAN BENZOATE, MAXALT, MAXALT-MLT
Application Number
ANDA203146
Sponsor
Macleods Pharmaceuticals Limited
NDC Codes
16
Dosage Forms
TABLET, ORALLY DISINTEGRATING, TABLET
Routes
ORAL
Active Ingredients
RIZATRIPTAN BENZOATE

Indications and Usage

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 [see Contraindications (4)]. Rizatriptan benzoate tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of rizatriptan benzoate tablets has not been established for cluster headache.