frovatriptan 2.5 MG Oral Tablet
1 INDICATIONS AND USAGE Frovatriptan succinate 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 has been established. If a patient has no response for the first migraine attack treated with frovatriptan succinate tablets, reconsider the diagnosis of migraine before frovatriptan succinate tablets are administered to treat any subsequent attacks. Frovatriptan succinate tablets are not indicated for the prevention of migraine attacks. Safety and effectiveness of frovatriptan succinate tablets have not been established for cluster headache. Frovatriptan succinate is 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 Use only after a clear diagnosis of migraine has been established. ( 1 ) Not indicated for the prophylactic therapy of migraine. ( 1 ) Not indicated for the treatment of cluster headache. ( 1 )
amneal pharmaceuticals ny llc
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16 HOW SUPPLIED/STORAGE AND HANDLING
FROVATRIPtan SUCCINATE Tablets, 2.5 mg are supplied as white to off-white, round shaped, biconvex, film-coated tablets, debossed with ‘A5’ on one side and plain on other side. They are available as follows: Carton of 9 Tablets: NDC 69238-1539-9 (Packages of 9 unit doses, 1 card of 9 tablets each) Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.
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