Almotriptan Malate Recall
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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).
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.
There is currently no drug history available for this drug.
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:
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.