sumatriptan

FDA Drug Profile — SUMATRIPTAN, IMITREX, sumatriptan, TOSYMRA, Sumatriptan

Drug Details

Generic Name
sumatriptan
Brand Names
SUMATRIPTAN, IMITREX, sumatriptan, TOSYMRA, Sumatriptan
Application Number
ANDA200183
Sponsor
GlaxoSmithKline LLC
NDC Codes
30
Dosage Forms
TABLET, FILM COATED, INJECTION, SPRAY, INJECTION, SOLUTION
Routes
SUBCUTANEOUS, NASAL, ORAL
Active Ingredients
SUMATRIPTAN SUCCINATE, SUMATRIPTAN

Indications and Usage

1 INDICATIONS AND USAGE Sumatriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. 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, reconsider the diagnosis of migraine before sumatriptan is administered to treat any subsequent attacks. • Sumatriptan is not indicated for the prevention of migraine attacks. • Safety and effectiveness of sumatriptan tablets have not been established for cluster headache. Sumatriptan is a serotonin (5-HT1B/1D) receptor agonist (triptan) indicated for acute treatment of migraine with or without aura in adults. 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)