Product Description.:
2.5
tablet , film-coated , white , round round
Debossed
FROVA (frovatriptan succinate) tablets contain frovatriptan succinate, a selective 5-hydroxy-tryptamine1 (5-HT1B/1D) receptor subtype agonist, as the active ingredient.
The empirical formula is C14H17N3O.C4H6O4.H2O, representing a molecular weight of 379.4. Frovatriptan succinate is a white to off-white powder that is soluble in water. Each FROVA tablet for oral administration contains 3.91 mg frovatriptan succinate, equivalent to 2.5 mg of frovatriptan base. Each tablet also contains the inactive ingredients lactose NF, microcrystalline cellulose NF, colloidal silicon dioxide NF, sodium starch glycolate NF, magnesium stearate NF, hydroxypropylmethylcellulose USP, polyethylene glycol 3000 USP, triacetin USP, and titanium dioxide USP.
INDICATIONS
FROVA is indicated for the acute treatment of migraine attacks with or without aura in adults.
FROVA is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine (see CONTRAINDICATIONS). The safety and effectiveness of FROVA have not been established for cluster headache, which is present in an older, predominately male, population.
DOSAGE AND ADMINISTRATION
The recommended dose is a single tablet of FROVA (frovatriptan 2.5 mg) taken orally with fluids.
If the headache 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 frovatriptan should not exceed 3 tablets (3 x 2.5 mg per day).
There is no evidence that a second dose of frovatriptan 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.
SIDE EFFECTS
Serious cardiac events, including some that have been fatal, have occurred following use of 5-HT1 agonists. These events are extremely rare and most have been reported in patients with risk factors predictive of CAD. Events reported have included coronary artery vasospasm, transient myocardial ischemia, myocardial infarction, ventricular tachycardia and ventricular fibrillation (see CONTRAINDICATIONS, WARNINGS and PRECAUTIONS).
Incidence in Controlled Clinical Trials: Among 1554 patients treated with FROVA in four placebo-controlled trials (Trials 1, 3, 4 and 5 in Table 1), only 1% (16) patients withdrew because of treatment-emergent adverse events. In a long term, open-label study where patients were allowed to treat multiple migraine attacks with FROVA for up to 1 year, 5% (26/496) patients discontinued due to treatment-emergent adverse events.
The treatment-emergent adverse events that occurred most frequently following administration of frovatriptan 2.5 mg (i.e., in at least 2% of patients), and at an incidence > 1% greater than with placebo, in the four placebo-controlled trials were dizziness, paresthesia, headache, dry mouth, fatigue, flushing, hot or cold sensation and chest pain.
