AXERT® (almotriptan malate) Tablets are indicated for the acute treatment of migraine with or without aura in adults.

AXERT® is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine (see CONTRAINDICATIONS).Safety and effectiveness of AXERT® have not been established for cluster headache, which is present in an older, predominantly male population.

In controlled clinical trials, single doses of 6.25 mg and 12.5 mg of AXERT® (almotriptan malate) Tablets were effective for the acute treatment of migraines in adults, with the 12.5 mg dose tending to be a more effective dose (see Clinical Studies).Individuals may vary in response to doses of AXERT®.The choice of dose should therefore be made on an individual basis.

If the headache returns, the dose may be repeated after 2 hours, but no more than two doses should be given within a 24-hour period. Controlled trials have not adequately established the effectiveness of a second dose if the initial dose is ineffective.

The safety of treating an average of more than four headaches in a 30-day period has not been established.

Hepatic Impairment

The pharmacokinetics of almotriptan have not been assessed in this population. The maximum decrease expected in the clearance of almotriptan due to hepatic impairment is 60%.Therefore, the maximum daily dose should not exceed 12.5 mg over a 24-hour period, and a starting dose of 6.25 mg should be used (see CLINICAL PHARMACOLOGY, Pharmacokinetics).

Renal Impairment

In patients with severe renal impairment, the clearance of almotriptan was decreased.Therefore, the maximum daily dose should not exceed 12.5 mg over a 24-hour period, and a starting dose of 6.25 mg should be used (see CLINICAL PHARMACOLOGY, Pharmacokinetics).

AXERT® (almotriptan malate) Tablets are available as follows:

6.25 mg: White, coated, circular, biconvex tablets with red code imprint "2080."

Unit Dose (aluminum blister pack)
6 tablets..........NDC 0062-2080-06

12.5 mg: White, coated, circular, biconvex tablets with blue stylized "A."

Unit Dose (aluminum blister pack)
12 tablets........NDC 0062-2085-12

Store at 25°C (77°F);excursions permitted to 15°- 30°C (59° - 86°F). r only.

AXERT® Tablets are manufactured by: JOLLC Gurabo, Puerto Rico 00778. AXERT® Tablets are distributed by: Ortho-McNeil Pharmaceutical, Inc. Raritan, NJ 08869. Revised May 2007. FDA rev date: 6/1/2004

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