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FDA Labeling Changes

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1.1 Acute Treatment of Migraine Attacks


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).

1.2 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 (4.7)].

Safety and effectiveness of AXERT® have not been established for cluster headache which is present in an older, predominantly male population.


There is currently no drug history available for this drug.

Other Information

AXERT® (almotriptan malate) Tablets contain almotriptan malate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Almotriptan malate is chemically designated as 1-[[[3-[2-(Dimethylamino)ethyl]-1H-indol-5-yl]methyl]sulfonyl]pyrrolidine (±)-hydroxybutanedioate (1:1) and its structural formula is:

Chemical Structure

Its empirical formula is C17H25N3O2S-C4H6O5, representing a molecular weight of 469.56. Almotriptan is a white to slightly yellow crystalline powder that is soluble in water. AXERT® for oral administration contains almotriptan malate equivalent to 6.25 or 12.5 mg of almotriptan. Each compressed tablet contains the following inactive ingredients: mannitol, cellulose, povidone, sodium starch glycolate, sodium stearyl fumarate, titanium dioxide, hypromellose, polyethylene glycol, propylene glycol, iron oxide (6.25 mg only), FD&C Blue No. 2 (12.5 mg only), and carnauba wax.

Axert Manufacturers

  • Physicians Total Care, Inc.
    Axert (Almotriptan Malate) Tablet, Coated [Physicians Total Care, Inc.]
  • Janssen Pharmaceuticals, Inc.
    Axert (Almotriptan Malate) Tablet, Coated [Janssen Pharmaceuticals, Inc.]

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