Axert (Almotriptan Malate) - Indications and Dosage

INDICATIONS AND USAGE

Acute Treatment of Migraine Attacks

Adults

AXERT^® (almotriptan malate) is indicated for the acute treatment of migraine attacks in patients with a history of migraine with or without aura.

Adolescents Age 12 to 17 Years

AXERT^® is indicated for the acute treatment of migraine headache pain in patients with a history of migraine attacks with or without aura usually lasting 4 hours or more (when untreated).

Important Limitations

AXERT^® should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with AXERT^®, the diagnosis of migraine should be reconsidered before AXERT^® is administered to treat any subsequent attacks.

In adolescents age 12 to 17 years, efficacy of AXERT^® on migraine-associated symptoms (nausea, photophobia, and phonophobia) was not established. 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.

DOSAGE AND ADMINISTRATION

Acute Treatment of Migraine Attacks

The recommended dose of AXERT^® (almotriptan malate) in adults and adolescents age 12 to 17 years is 6.25 mg to 12.5 mg, with the 12.5 mg dose tending to be a more effective dose in adults. As individuals may vary in their response to different doses of AXERT^®, the choice of dose should be made on an individual basis.

If the headache is relieved after the initial AXERT^® dose but returns, the dose may be repeated after 2 hours. The effectiveness of a second dose has not been established in placebo-controlled trials. The maximum daily dose should not exceed 25 mg. The safety of treating an average of more than four migraines in a 30-day period has not been established.

Hepatic Impairment

The recommended starting dose of AXERT^® in patients with hepatic impairment is 6.25 mg. The maximum daily dose should not exceed 12.5 mg over a 24-hour period [see Warnings and Precautions and Clinical Pharmacology].

Renal Impairment

The recommended starting dose of AXERT^® in patients with severe renal impairment is 6.25 mg. The maximum daily dose should not exceed 12.5 mg over a 24-hour period [see Warnings and Precautions and Clinical Pharmacology].

DOSAGE FORMS AND STRENGTHS

AXERT^® (almotriptan malate) Tablets are available as white, coated, circular, biconvex tablets in the following dosage strengths:

6.25 mg tablet with red code imprint "2080"

12.5 mg tablet with blue stylized imprint "A."

HOW SUPPLIED/STORAGE AND HANDLING

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 50458-211-01

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

•  Unit Dose (aluminum blister pack)
   
•  12 tablets NDC 50458-210-01