SUMATRIPTAN tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

SUN PHARMACEUTICAL INDUSTRIES, INC.

Designación común internacional (DCI):

SUMATRIPTAN SUCCINATE

Composición:

SUMATRIPTAN 100 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Sumatriptan tablets, USP 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 w

Resumen del producto:

Sumatriptan tablets, USP, 25 mg, 50 mg, and 100 mg of sumatriptan (base) as the succinate. Sumatriptan tablets, USP, 25 mg, are white to off-white, round, biconvex, uncoated tablets, debossed with “ RI61 ” on one side and plain on the other side. NDC 63304-097-45 Bottles of 5 NDC 63304-097-13 Bottles of 120 NDC 63304-097-19 Blisters of 9 Sumatriptan tablets, USP, 50 mg, are white to off-white, round, biconvex, uncoated tablets, debossed with “ RI62 ” on one side and plain on the other side. NDC 63304-098-45 Bottles of 5 NDC 63304-098-13 Bottles of 120 NDC 63304-098-19 Blisters of 9 Sumatriptan tablets, USP, 100 mg, are white to off-white, capsule-shaped, biconvex, uncoated tablets, debossed with “ RB97 ” on one side and plain on the other side. NDC 63304-099-09 Bottles of 9 NDC 63304-099-13 Bottles of 120 NDC 63304-099-19 Blisters of 9 Store at 20° - 25° C (68° - 77° F) [See USP Controlled Room Temperature].

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

SUMATRIPTAN- SUMATRIPTAN TABLET
SUN PHARMACEUTICAL INDUSTRIES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SUMATRIPTAN TABLETS,
USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
SUMATRIPTAN TABLETS,
USP.
SUMATRIPTAN TABLETS, USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1992
INDICATIONS AND USAGE
Sumatriptan tablets, USP are a serotonin (5-HT
) receptor agonist (triptan) indicated for acute
treatment of migraine with or without aura in adults. (1) (1)
Limitations of Use: (1)
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg, 50 mg, and 100 mg (3) (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
pain/tightness/pressure, other sensations of
pain/pressure/tightness/heaviness, vertigo, and malaise/fatigue. (6.1)
(6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SUN PHARMACEUTICAL
INDUSTRIES, INC. AT
1-800-406-7984 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. (6)
USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, may cause fetal harm. (8.1) (8)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 1/2022
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 o