Axert 12.5 MG Oral Tablet
1 INDICATIONS AND USAGE AXERT ® is 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 AXERT ® 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 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.
Ortho-McNeil-Janssen Pharmaceuticals, Inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING AXERT ® (almotriptan malate) Tablets are available as follows: 6.25 mg : white, coated, circular, biconvex tablets with red code imprint "2080." Unit Dose (aluminum blister pack) 6 tablets NDC 0062-2080-06 12.5 mg : white, coated, circular, biconvex tablets with blue stylized imprint "A." Unit Dose (aluminum blister pack) 12 tablets NDC 0062-2085-12 Store at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F) [see USP Controlled Room Temperature].
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