SUMATRIPTAN SUCCINATE- sumatriptan succinate injection, solution

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

SUMATRIPTAN SUCCINATE (UNII: J8BDZ68989) (SUMATRIPTAN - UNII:8R78F6L9VO)

Доступно од:

Teva Parenteral Medicines, Inc.

INN (Међународно име):

SUMATRIPTAN SUCCINATE

Састав:

SUMATRIPTAN 6 mg in 0.5 mL

Пут администрације:

SUBCUTANEOUS

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Sumatriptan Succinate Injection is indicated in adults for (1) the acute treatment of migraine, with or without aura, and (2) the acute treatment of cluster headache. Limitations of Use: - Use only if a clear diagnosis of migraine or cluster headache has been established. If a patient has no response to the first migraine or cluster headache attack treated with Sumatriptan Succinate Injection, reconsider the diagnosis before Sumatriptan Injection is administered to treat any subsequent attacks. - Sumatriptan Succinate Injection is not indicated for the prevention of migraine or cluster headache attacks. Sumatriptan succinate injection is contraindicated in patients with: - Ischemic coronary artery disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including Prinzmetal’s angina [see Warnings and Precautions (5.1)] . - Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders [see

Резиме производа:

Sumatriptan Succinate Injection 6 mg/0.5 mL containing sumatriptan 6-mg (base) as the succinate salt is supplied as a clear, colorless to pale yellow, sterile, nonpyrogenic solution as follows: 0703-7351-02 6-mg Single-dose vials in cartons of 5 vials. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature] . May be refrigerated. Protect from light.

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

SUMATRIPTAN SUCCINATE- SUMATRIPTAN SUCCINATE INJECTION, SOLUTION
TEVA PARENTERAL MEDICINES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SUMATRIPTAN INJECTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SUMATRIPTAN
SUCCINATE INJECTION.
SUMATRIPTAN SUCCINATE INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 1992
INDICATIONS AND USAGE
Sumatriptan Succinate Injection is a serotonin (5-HT
) receptor agonist (triptan) indicated for:
Acute treatment of migraine with or without aura in adults (1)
Acute treatment of cluster headache in adults (1)
Limitations of Use:
Use only if a clear diagnosis of migraine or cluster headache has been
established (1)
Not indicated for the prophylactic therapy of migraine or cluster
headache attacks (1)
DOSAGE AND ADMINISTRATION
For subcutaneous use only (2.1)
Acute treatment of migraine: single dose of 1 to 6 mg (2.1)
Acute treatment of cluster headache: single dose of 6 mg (2.1)
Maximum dose in a 24-hour period: 12 mg, separate doses by at least 1
hour (2.1)
Patients receiving doses other than 4 or 6 mg: Use the 6-mg
single-dose vial (2.3)
DOSAGE FORMS AND STRENGTHS
Injection: 6-mg single-dose vial (3)
CONTRAINDICATIONS
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-HT 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)
WARNINGS AND PRECAUTIONS
Myocardial ischemia/infarction and Prinzmetal’s angina: Perform
cardiac evaluation in patients with multiple
cardiovascular ri