Land: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
Almotriptan Malate (UNII: PJP312605E) (Almotriptan - UNII:1O4XL5SN61)
Patriot Pharmaceuticals, LLC
Almotriptan Malate
Almotriptan 6.25 mg
PRESCRIPTION DRUG
New Drug Application
ALMOTRIPTAN MALATE- ALMOTRIPTAN MALATE TABLET, COATED PATRIOT PHARMACEUTICALS, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ALMOTRIPTAN MALATE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ALMOTRIPTAN MALATE TABLETS. ALMOTRIPTAN MALATE TABLETS FOR ORAL USE INITIAL U.S. APPROVAL: 2001 INDICATIONS AND USAGE Almotriptan Malate is a 5HT 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 Malate 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) DOSAGE AND ADMINISTRATION Adults and adolescents age 12 to 17 years: 6.25 mg or 12.5 mg single dose; may repeat after 2 hours if headache returns; benefit of second dose in patients who have failed to respond to first dose has not been established; maximum daily dose 25 mg (2.1) Patients with hepatic or severe renal impairment: 6.25 mg starting dose; maximum daily dose 12.5 mg (2.2, 2.3) DOSAGE FORMS AND STRENGTHS Tablets: 6.25 mg and 12.5 mg (3) CONTRAINDICATIONS Ischemic heart disease, coronary artery vasospasm, or other significant underlying cardiovascular disease (4.1) Cerebrovascular syndromes (e.g., history of stroke or TIA) (4.2) Peripheral vascular disease (including ischemic bowel disease) (4.3) Uncontrolled hypertension (4.4) Do not use Almotriptan Malate tablets within 24 hours of an ergotamine-containing, or ergot-type medication, or of another 5-HT agonist, e.g., another triptan (4.5, 4.6) Hemiplegic or basil Lestu allt skjalið