Rizatriptan Benzoate ODT
Drug Details
- Generic Name
- Rizatriptan Benzoate ODT
- Brand Names
- Rizatriptan Benzoate ODT
- Application Number
- ANDA203062
- Sponsor
- Direct Rx
- NDC Codes
- 2
- Dosage Forms
- TABLET, ORALLY DISINTEGRATING
- Routes
- ORAL
- Active Ingredients
- RIZATRIPTAN BENZOATE
Indications and Usage
Rizatriptan benzoate orally disintegrating 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 orally disintegrating 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 orally disintegrating tablets, the diagnosis of migraine should be reconsidered before rizatriptan benzoate tablets are administered to treat any subsequent attacks. • Rizatriptan benzoate orally disintegrating tablets are not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)]. • Rizatriptan benzoate orally disintegrating tablets are not indicated for the prevention of migraine attacks. • Safety and effectiveness of rizatriptan benzoate orally disintegrating tablets have not been established for cluster headache.