Source: FDA, National Drug Code (US) Revision Year: 2018
FROVA is indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use:
The recommended dose is a single tablet of FROVA (frovatriptan 2.5 mg) taken orally with fluids.
If the migraine recurs after initial relief, a second tablet may be taken, providing there is an interval of at least 2 hours between doses. The total daily dose of FROVA should not exceed 3 tablets (3 × 2.5 mg per 24 hour period).
There is no evidence that a second dose of FROVA is effective in patients who do not respond to a first dose of the drug for the same headache.
The safety of treating an average of more than 4 migraine attacks in a 30-day period has not been established.
The elimination half-life of frovatriptan is 26 hours [see Clinical Pharmacology (12.3)]. Therefore, monitoring of patients after overdose with frovatriptan should continue for at least 48 hours or while symptoms or signs persist. There is no specific antidote to frovatriptan. It is unknown what effect hemodialysis or peritoneal dialysis has on the serum concentrations of frovatriptan.
Store FROVA tablets at controlled room temperature, 25ºC (77ºF) excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature]. Protect from moisture.
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