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 tablets are 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 )
Mylan Pharmaceuticals Inc.
ROUND WHITE M FR 2 5
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16 HOW SUPPLIED/STORAGE AND HANDLING Frovatriptan Succinate Tablets are available containing 3.91 mg of frovatriptan succinate equivalent to 2.5 mg of frovatriptan. The 2.5 mg tablets are white to off-white, film-coated, round, unscored tablets debossed with M on one side of the tablet and FR over 2.5 on the other side. They are available as follows: NDC 0378-3140-85 carton of 9 unit-dose tablets (1 x 9) Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
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