SUMATRIPTAN spray

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

SUMATRIPTAN (UNII: 8R78F6L9VO) (SUMATRIPTAN - UNII:8R78F6L9VO)

Доступна с:

Sandoz Inc

ИНН (Международная Имя):

SUMATRIPTAN

состав:

SUMATRIPTAN 5 mg in 100 uL

Администрация маршрут:

NASAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Sumatriptan Nasal Spray is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: Sumatriptan Nasal Spray is contraindicated in patients with: Risk Summary Data from a prospective pregnancy exposure registry and epidemiological studies of pregnant women have not detected an increased frequency of birth defects or a consistent pattern of birth defects among women exposed to sumatriptan compared with the general population (see Data) . In developmental toxicity studies in rats and rabbits, oral administration of sumatriptan to pregnant animals was associated with embryolethality, fetal abnormalities, and pup mortality. When administered by the intravenous route to pregnant rabbits, sumatriptan was embryolethal (see Data ). In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The reported rate of major birth defects among deliveries to women

Обзор продуктов:

Sumatriptan Nasal Spray 5 mg (NDC 0781-6524-86) and 20 mg (NDC 0781-6523-86) are each supplied in boxes of 6 nasal spray devices. Each unit dose spray supplies 5 mg and 20 mg, respectively, of sumatriptan. Store between 2°C and 30°C (36°F and 86°F). Protect from light.

Статус Авторизация:

New Drug Application Authorized Generic

Характеристики продукта

SUMATRIPTAN- SUMATRIPTAN SPRAY
SANDOZ INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SUMATRIPTAN NASAL SPRAY SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SUMATRIPTAN NASAL
SPRAY.
SUMATRIPTAN NASAL SPRAY
INITIAL U.S. APPROVAL: 1992
INDICATIONS AND USAGE
Sumatriptan is a serotonin (5-HT
) receptor agonist (triptan) indicated for acute treatment of migraine
with or without
aura in adults. (1)
Limitations of Use:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Nasal spray: 5 mg and 20 mg (3, 16)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions (≥1% and >placebo) were burning
sensation, disorder/discomfort of nasal cavity/sinuses,
throat discomfort, nausea and/or vomiting, bad/unusual taste, and
dizziness/vertigo. (6.1)
1B/1D
Use only if a clear diagnosis of migraine headache has been
established. (1)
Not indicated for the prophylactic therapy of migraine attacks. (1)
Not indicated for the treatment of cluster headache. (1)
Single dose of 5 mg, 10 mg, or 20 mg of nasal spray. (2)
A second dose should only be considered if some response to the first
dose was observed. Separate doses by at least
2 hours. (2)
Maximum dose in a 24-hour period: 40 mg. (2)
History of coronary artery disease or coronary artery vasospasm (4)
Wolff-Parkinson-White syndrome or other cardiac accessory conduction
pathway disorders (4)
History of stroke, transient ischemic attack, or hemiplegic or basilar
migraine (4)
Peripheral vascular disease (4)
Ischemic bowel disease (4)
Uncontrolled hypertension (4)
Recent (within 24 hours) use of another 5-HT1 agonist (e.g., another
triptan) or of an ergotamine-containing
medication. (4)
Concurrent or recent (past 2 weeks) use of monoamine oxidase-A
inhibitor. (4)
Hypersensitivity to sumatriptan (angioedema and anaphylaxis seen). (4)
Severe hepatic impairment (4)
Myocardial isch