Sumatriptan and Naproxen Sodium
Drug Details
- Generic Name
- Sumatriptan and Naproxen Sodium
- Brand Names
- Sumatriptan and Naproxen Sodium
- Application Number
- ANDA207457
- Sponsor
- Aurobindo Pharma Limited
- NDC Codes
- 3
- Dosage Forms
- TABLET, FILM COATED
- Routes
- ORAL
- Active Ingredients
- NAPROXEN SODIUM, SUMATRIPTAN SUCCINATE
Indications and Usage
1 INDICATIONS AND USAGE Sumatriptan and naproxen sodium tablets are indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older. Limitations of Use Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan and naproxen sodium tablets, reconsider the diagnosis of migraine before sumatriptan and naproxen sodium tablets are administered to treat any subsequent attacks. Sumatriptan and naproxen sodium tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of sumatriptan and naproxen sodium tablets have not been established for cluster headache. Sumatriptan and naproxen sodium tablets are a combination of sumatriptan, a serotonin (5-HT) 1b/1d receptor agonist (triptan), and naproxen sodium, a non-steroidal anti-inflammatory drug, indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older. (1) Limitations of Use: Use only if a clear diagnosis of migraine headache has been established. (1) Not indicated for the prophylactic therapy of migraine attacks. (1) Not indicated for the treatment of cluster headache. (1)