SUMATRIPTAN SUCCINATE tablet, film coated

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Mylan Pharmaceuticals Inc.

INN (Kansainvälinen yleisnimi):

SUMATRIPTAN SUCCINATE

Koostumus:

SUMATRIPTAN 25 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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: 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 with migraine range

Tuoteyhteenveto:

Sumatriptan Tablets, USP are available containing 35 mg, 70 mg or 140 mg of sumatriptan succinate, USP equivalent to 25 mg, 50 mg or 100 mg of sumatriptan, respectively. The 25 mg tablets are white, film-coated, round, unscored tablets debossed with M on one side of the tablet and S4 on the other side. They are available as follows: NDC 0378-5630-59 bottles of 9 tablets The 50 mg tablets are white, film-coated, round, unscored tablets debossed with M over S7 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-5631-59 bottles of 9 tablets The 100 mg tablets are white, film-coated, round, unscored tablets debossed with M over S12 on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-5632-59 bottles of 9 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense the accompanying Patient Information Leaflet to each patient.

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

SUMATRIPTAN SUCCINATE- SUMATRIPTAN SUCCINATE TABLET, FILM COATED
MYLAN 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
pain/tightness/pressure, other sensations of
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 we