SUMATRIPTAN SUCCINATE injection

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Proficient Rx LP

Начин на приложение:

SUBCUTANEOUS

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Sumatriptan injection, USP 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 : Sumatriptan injection is contraindicated in patients with: Pregnancy Category C. There are no adequate and well-controlled trials of sumatriptan injection in pregnant women. 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. Sumatriptan injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Oral administration of sumatriptan to pregnant rats during the period of organogenesis resulted in an increased incidence of fetal blood vessel (cervicothoracic and umbilical) abnormalities. The highest no-effect dose for embryofetal developmental toxicity in

Каталог на резюме:

Sumatriptan injection, USP contains sumatriptan (base) as the succinate salt and is supplied as a clear, colorless to pale yellow, sterile, nonpyrogenic solution as follows: Single-Dose Vial : NDC 71205-111-01 sumatriptan injection, USP single-dose vial (6 mg/0.5 mL) in cartons containing 1 vial. Store between 2° and 25°C (36° and 77°F). Protect from light.

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

SUMATRIPTAN SUCCINATE- SUMATRIPTAN SUCCINATE INJECTION
PROFICIENT RX LP
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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
INJECTION.
SUMATRIPTAN INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 1992
INDICATIONS AND USAGE
Sumatriptan injection, USP is a serotonin (5-HT
) receptor agonist (triptan) indicated for:
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Limitations of Use:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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1B/1D
Acute treatment of migraine with or without aura in adults (1)
Acute treatment of cluster headache in adults (1)
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)
For subcutaneous use only (2.1)
Acute treatment of migraine: single dose of 1 mg 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 mg or 6 mg: Use the 6-mg
single-dose vial (2.3)
Injection: 6-mg single-dose vial (3)
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)
1
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 ischemia/infarction and Prinzmetal's angi