Almotriptan Malate label

Almotriptan Malate

Almotriptan Malate Recall

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Uses

1.1 Acute Treatment of Migraine Attacks

Adults

Almotriptan Malate tablets are 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

Almotriptan Malate tablets are 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

Almotriptan Malate tablets 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 Almotriptan Malate tablets, the diagnosis of migraine should be reconsidered before Almotriptan Malate tablets are administered to treat any subsequent attacks.

In adolescents age 12 to 17 years, efficacy of Almotriptan Malate tablets on migraine-associated symptoms (nausea, photophobia, and phonophobia) was not established. Almotriptan Malate tablets are 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 Almotriptan Malate tablets have not been established for cluster headache which is present in an older, predominantly male population.

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History

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Other Information

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. Almotriptan Malate tablets for oral administration contain almotriptan malate equivalent to 6.25 or 12.5 mg of almotriptan. Each compressed tablet contains the following inactive ingredients: carnauba wax, cellulose, FD&C Blue No. 2 (12.5 mg only), hypromellose, iron oxide (6.25 mg only), mannitol, polyethylene glycol, povidone, propylene glycol, sodium starch glycolate, sodium stearyl fumarate and titanium dioxide.

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Almotriptan Malate Manufacturers

  • Patriot Pharmaceuticals, Llc
    Almotriptan Malate | Patriot Pharmaceuticals, Llc
    No Recall

    Almotriptan Malate | Patriot Pharmaceuticals, Llc

    Almotriptan Malate | Patriot Pharmaceuticals, Llc
    2.1 Acute Treatment of Migraine Attacks

    The recommended dose of Almotriptan Malate tablets 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 Almotriptan Malate tablets, the choice of dose should be made on an individual basis.

    If the headache is relieved after the initial Almotriptan Malate tablets 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.

    2.2 Hepatic Impairment

    The recommended starting dose of Almotriptan Malate tablets 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 (5.9) and Clinical Pharmacology (12.3)].

    2.3 Renal Impairment

    The recommended starting dose of Almotriptan Malate tablets 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 (5.9) and Clinical Pharmacology (12.3)].

  • Teva Pharmaceuticals Usa Inc
    Almotriptan Malate | Pfizer Animal Health
    No Recall

    Almotriptan Malate | Pfizer Animal Health

    Almotriptan Malate | Pfizer Animal Health

    Initial Dose: 25 mg/lb (55 mg/kg) of animal body weight.

    Subsequent Daily Doses: 12.5 mg/lb (27.5 mg/kg) of animal body weight.

    For ease of administration in animals of varying weights, 3 tablet sizes are provided. The following table indicates how dosage may be adjusted depending on tablet size and body weight. Subsequent doses should be given at 24-hour intervals.

    Tablet Size Approximate Animal Weight Initial Dose
    25 mg/lb
    (55 mg/kg) Subsequent Daily Doses
    12.5 mg/lb
    (27.5 mg/kg)  125 mg  5 lb (2.2 kg)  1 tablet  1/2 tablet  250 mg  10 lb (4.5 kg)  1 tablet  1/2 tablet  500 mg  20 lb (9.1 kg)  1 tablet  1/2 tablet

    Treatment may be initiated with Albon Injection 40% to obtain effective blood levels almost immediately or to facilitate treatment of the fractious animal.

    Length of treatment depends on the clinical response. In most cases treatment for 3–5 days is adequate. Treatment should be continued until the animal is asymptomatic for 48 hours.

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