almotriptan 6.25 MG Oral Tablet
1 INDICATIONS AND USAGE 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 ( 1.1 ) • 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 ( 1.1 ) Important Limitations: • Use only after a clear diagnosis of migraine has been established ( 1.2 ) • In adolescents age 12 to 17 years, efficacy of almotriptan tablets on migraine-associated symptoms was not established ( 1.2 ) • Not intended for the prophylactic therapy of migraine ( 1.2 ) • Not indicated for the treatment of cluster headache ( 1.2 ) 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 [see Contraindications (4.7) ] . Safety and effectiveness of almotriptan tablets have not been established for cluster headache which is present in an older, predominantly male population.
Mylan Pharmaceuticals Inc.
ROUND WHITE M AL1
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almotriptan 12.5 MG Oral Tablet
Mylan Pharmaceuticals Inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING
ALMOTRIPtan Tablets, USP are available containing 8.75 mg or 17.50 mg of
ALMOTRIPtan malate, USP equivalent to 6.25 mg or 12.5 mg of
ALMOTRIPtan, respectively. The 6.25 mg tablets are white to off-white, film-coated, round, unscored tablets debossed with M on one side of the tablet and AL1 on the other side. They are available as follows: NDC 0378-5245-85 carton of 6 unit-dose tablets (1 x 6) The 12.5 mg tablets are white to off-white, film-coated, round, unscored tablets debossed with M on one side of the tablet and AL2 on the other side. They are available as follows: NDC 0378-5246-85 carton of 12 unit-dose tablets (2 x 6) Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
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