SUMATRIPTAN SUCCINATE tablet, film coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

NuCare Pharmaceuticals,Inc.

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Sumatriptan succinate tablets are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: - Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan succinate tablets, reconsider the diagnosis of migraine before sumatriptan succinate tablets are administered to treat any subsequent attacks. - Sumatriptan succinate tablets are not indicated for the prevention of migraine attacks. - Safety and effectiveness of sumatriptan succinate tablets have not been established for cluster headache. Sumatriptan succinate tablets are contraindicated in patients with: - Ischemic coronary artery disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including Prinzmetal's angina [see Warnings and Precautions ( 5.1)] - Wolff-Parkinson-White syndrome or arrhythmias assoc

Povzetek izdelek:

Sumatriptan succinate tablets, 50 mg are white, triangular-shaped, film-coated tablets debossed with S on one side and 50 on the other side. NDC 68071-4389-9 BOX OF 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.)

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

SUMATRIPTAN SUCCINATE- SUMATRIPTAN SUCCINATE TABLET, FILM COATED
NUCARE 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:
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)
DOSAGE AND ADMINISTRATION
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)
DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg, 50 mg, and 100 mg ( 3)
CONTRAINDICATIONS
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)
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)
WARNINGS AND PRECAUTIONS
Myocardial ischemia/infarction and Prinzmetal’s angina: Perform
cardiac evaluation in patients with
multi