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Frova (Frovatriptan Succinate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

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.

HOW SUPPLIED

FROVA tablets, containing 2.5 mg of frovatriptan (base) as the succinate, 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 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.

U.S. Patent Nos 5,962,501, 5,827,871, 5,637,611 and 5,464,864 and 5,616,603.


Rx Only

Manufactured for:
Endo Pharmaceuticals Inc.
Chadds Ford, PA 19317

Manufactured by:
Almac Pharma Services Limited
Craigavon, BT63 5UA, UK

FROVA is a registered trademark of Vernalis Development Limited.


© 2007 Endo Pharmaceuticals Inc.                                                            PX544-3 / April, 2007

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