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 )
par pharmaceutical
ROUND WHITE E 2 5
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16 HOW SUPPLIED/STORAGE AND HANDLING
FROVATRIPtan SUCCINATE tablets, containing 2.5 mg of frovatriptan (base) as the succinate salt, are available as round, white, film-coated tablets debossed with 2.5 on one side and “E” on the other side. The tablets are available in: Blister card of 9 tablets, 1 blister card per carton (NDC 0603-3718-34) Store
FROVATRIPtan SUCCINATE tablets at controlled room temperature, 25°C (77°F) excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.
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