Almotriptandrug info
almotriptan 12.5 MG Oral Tablet
What it is used for
Almotriptan tablets are a 5HT 1B/1D receptor agonist (triptan) indicated for:
Acute treatment of migraine attacks in adults with a history of migraine with or without aura
Acute treatment of migraine headache pain in adolescents age 12 to 17 years with a history of migraine with or without aura, and who have migraine attacks usually lasting 4 hours or more Important Limitations:
Use only after a clear diagnosis of migraine has been established
In adolescents age 12 to 17 years, efficacy of almotriptan tablets on migraine-associated symptoms was not established
Not intended for the prophylactic therapy of migraine
Not indicated for the treatment of cluster headache
1.1 Acute Treatment of
Migraine Attacks Adults Almotriptan tablets (almotriptan malate) 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 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 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 tablets, the diagnosis of migraine should be reconsidered before almotriptan tablets are administered to treat any subsequent attacks. In adolescents age 12 to 17 years, efficacy of almotriptan tablets on migraine-associated symptoms (nausea, photophobia, and phonophobia) was not established. Almotriptan tablets are not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine. Safety and effectiveness of almotriptan tablets have not been established for cluster headache which is present in an older, predominantly male population.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective May 9, 2017. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Description
Almotriptan tablets, USP contain almotriptan malate, a selective 5-hydroxytryptamine 1B/1D (5-HT 1B/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 molecular formula is C 17 H 25 N 3 O 2 S
C 4 H 6 O 5, representing a molecular weight of 469.56. Almotriptan malate, USP is a white to light yellow color crystalline powder that is soluble in water. Almotriptan tablets for oral administration contain 8.75 mg or 17.50 mg of almotriptan malate equivalent to 6.25 mg or 12.5 mg of almotriptan, respectively. Each compressed tablet contains the following inactive ingredients: hypromellose, mannitol, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate (potato), sodium stearyl fumarate and titanium dioxide. Almotriptan Malate Structural Formula
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective May 9, 2017. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
This page reproduces regulatory text for reference. It is not medical advice, and KenyRx is not a pharmacy or a prescriber. Talk to a doctor or pharmacist about whether a medicine is right for you.
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