SUMATRIPTAN- sumatriptan succinate tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Preferred Pharmaceuticals, Inc.

INN (שם בינלאומי):

SUMATRIPTAN SUCCINATE

הרכב:

SUMATRIPTAN 100 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Sumatriptan tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: Sumatriptan tablets are 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

leaflet_short:

Sumatriptan Tablets USP, 25 mg, 50 mg, and 100 mg of sumatriptan (base) as the succinate.                                 Unit-dose package of 9 Tablets                      NDC 65862-147-36 Sumatriptan Tablets USP, 100 mg are white to off-white, capsule shaped, biconvex uncoated tablets, debossed with ‘C’ on one side and ‘34’ on other side.                                 Unit-dose package of 9 Tablets                      NDC 68788-6778-9 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

SUMATRIPTAN- SUMATRIPTAN SUCCINATE TABLET
PREFERRED PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SUMATRIPTAN TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
SUMATRIPTAN TABLETS.
SUMATRIPTAN TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1992
INDICATIONS AND USAGE
Sumatriptan tablets are 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
Tablets: 25 mg, 50 mg, and 100 mg (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
MOST COMMON ADVERSE REACTIONS (≥2% AND >PLACEBO) WERE PARESTHESIA,
WARM/COLD
SENSATION, CHEST PAIN/TIGHTNESS/PRESSURE AND/OR HEAVINESS,
NECK/THROAT/JAW
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 25 mg, 50 mg, or 100 mg tablet. (2.1)
A second dose should only be considered if some response to the first
dose was observed. Separate
doses by at least 2 hours. (2.1)
Maximum dose in a 24-hour period: 200 mg. (2.1)
Maximum single dose should not exceed 50 mg in patients with mild to
moderate hepatic
impairment. (2.2)
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-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