SUMATRIPTAN SUCCINATE tablet, film coated

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Preferred Pharmaceuticals Inc.

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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

Tóm tắt sản phẩm:

Sumatriptan succinate tablets, 25 mg, 50 mg, and 100 mg of sumatriptan (base) as the succinate. Sumatriptan succinate tablets, 25 mg are white, triangular-shaped, film-coated tablets debossed with "S" on one side and "I" on the other side. Bottles of 30 (Child Resistant Cap).........................................NDC 62756-520-83 Bottles of 100 (Child Resistant Cap).........................................NDC 62756-520-88 Bottles of 100 ..................................................................................NDC 62756-520-08 Bottles of 1000 ..................................................................................NDC 62756-520-18 Unit-of-use blister pack of 9 (1x9) tablets...................................NDC 62756-520-69 Unit-of-use blister pack of 9 (3x3) tablets....................................NDC 62756-520-93 Sumatriptan succinate tablets, 50 mg are white, triangular-shaped, film-coated tablets debossed with "S" on one side and "50" on the other side. Unit-of-use blister pack of 9 (1x9) tablets.........................................NDC 68788-7157-9 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.)

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

SUMATRIPTAN SUCCINATE- SUMATRIPTAN SUCCINATE TABLET, FILM COATED
PREFERRED PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SUMATRIPTAN SUCCINATE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
SUMATRIPTAN SUCCINATE TABLETS .
SUMATRIPTAN SUCCINATE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1992
INDICATIONS AND USAGE
Sumatriptan succinate 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
Tablets: 25 mg, 50 mg, and 100 mg (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
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 sumatriptan succinate tablets (angioedema and
anaphylaxis seen). (4)
Severe hepatic impairment. (4)
My