"Today, the U.S. Food and Drug Administration approved Topamax (topiramate) for prevention (prophylaxis) of migraine headaches in adolescents ages 12 to 17. This is the first FDA approval of a drug for migraine prevention in this age group. The me"...
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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 FROVA, reconsider the diagnosis of migraine before FROVA is administered to treat any subsequent attacks.
- FROVA is not indicated for the prevention of migraine attacks.
- Safety and effectiveness of FROVA have not been established for cluster headache.
DOSAGE AND ADMINISTRATION
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 x 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.
Dosage Forms And Strengths
2.5 mg Tablets: Round, white, film-coated tablets debossed with 2.5 on one side and “E” on the other side.
Storage And Handling
FROVA 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 63481-025-09)
Store FROVA tablets at controlled room temperature, 25°C (77°F) excursions permitted to 15 -30°C (59°F -86°F) [see USP Controlled Room Temperature]. Protect from moisture.
Manufactured for: Endo Pharmaceuticals Inc., Malvern, PA 19355 Manufactured by: Almac Pharma Services Limited, Craigavon, BT63 5UA, UK. Revised: Oct 2013.
Last reviewed on RxList: 10/28/2013
This monograph has been modified to include the generic and brand name in many instances.
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