ALMOTRIPTAN MALATE tablet coated

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

Almotriptan Malate (UNII: PJP312605E) (Almotriptan - UNII:1O4XL5SN61)

Доступно од:

Patriot Pharmaceuticals, LLC

INN (Међународно име):

Almotriptan Malate

Састав:

Almotriptan 6.25 mg

Тип рецептора:

PRESCRIPTION DRUG

Статус ауторизације:

New Drug Application

Карактеристике производа

ALMOTRIPTAN MALATE- ALMOTRIPTAN MALATE TABLET, COATED
PATRIOT PHARMACEUTICALS, LLC
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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