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Axert

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Axert

Indications
Dosage
How Supplied

INDICATIONS

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].

HOW SUPPLIED

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.”

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

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

AXERT® Tablets are manufactured by: Janssen-Ortho, LLC Gurabo, Puerto Rico 00778. AXERT® Tablets are manufactured for: Janssen Pharmaceuticals, Inc. Titusville, NJ 08560. Licensed from: Almirall, S.A. Revised Aug 2014

Last reviewed on RxList: 8/21/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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Axert - User Reviews

Axert User Reviews

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