Recommended Topic Related To:

Axert

"Migraine medications overview

Migraine is a serious, potentially life-threatening neurological disease that affects nearly 32 million Americans, the majority of whom are women. The hallmark symptom of migraine is an escalating, often "...

Axert

Axert

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 (almotriptan malate) 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 (almotriptan malate) 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 (almotriptan malate) , the diagnosis of migraine should be reconsidered before AXERT (almotriptan malate) is administered to treat any subsequent attacks.

In adolescents age 12-17 years, efficacy of AXERT (almotriptan malate) on migraine associated symptoms (nausea, photophobia and phonophobia) was not established. AXERT (almotriptan malate) 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 (almotriptan malate) 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 (almotriptan malate) , the choice of dose should be made on an individual basis.

If the headache is relieved after the initial AXERT (almotriptan malate) 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 (almotriptan malate) 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 (almotriptan malate) 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.”

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 imprint “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) [see USP Controlled room temperature].

AXERT (almotriptan malate) Tablets are manufactured by: Janssen-Ortho, LLC Gurabo, Puerto Rico 00778. AXERT (almotriptan malate) Tablets are manufactured for: Ortho-McNeil Neurologics, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. Raritan, NJ 08869. Licensed from: Laboratorios Almirall, S.A.

Last reviewed on RxList: 5/29/2009
This monograph has been modified to include the generic and brand name in many instances.

A A A

Axert - User Reviews

Axert User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Axert sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Living Better

Find the secrets to longer life.

advertisement
advertisement
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations