meloxicam, rizatriptan

FDA Drug Profile — SYMBRAVO

Drug Details

Generic Name
meloxicam, rizatriptan
Brand Names
SYMBRAVO
Application Number
NDA215431
Sponsor
Axsome Therapeutics, Inc.
NDC Codes
1
Dosage Forms
TABLET
Routes
ORAL
Active Ingredients
MELOXICAM, RIZATRIPTAN BENZOATE

Indications and Usage

1 INDICATIONS AND USAGE SYMBRAVO is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use SYMBRAVO 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 SYMBRAVO, the diagnosis of migraine should be reconsidered before SYMBRAVO is administered to treat any subsequent attacks. SYMBRAVO is not indicated for the preventive treatment of migraine attacks. SYMBRAVO is not indicated for the treatment of cluster headache. SYMBRAVO is a combination of meloxicam (an NSAID) and rizatriptan (a serotonin (5-HT) 1B/1D receptor agonist (triptan)), indicated for the acute treatment of migraine with or without aura in adults ( 1 ). Limitations of Use SYMBRAVO should only be used where a clear diagnosis of migraine has been established ( 1 ). SYMBRAVO is not indicated for the preventive treatment of migraine ( 1 ). SYMBRAVO is not indicated for the treatment of cluster headache ( 1 ).