SUMATRIPTAN- sumatriptan succinate tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Bryant Ranch Prepack

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Sumatriptan 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 tablets, reconsider the diagnosis of migraine before sumatriptan tablets are administered to treat any subsequent attacks. - Sumatriptan tablets are not indicated for the prevention of migraine attacks. - Safety and effectiveness of sumatriptan tablets have not been established for cluster headache. Sumatriptan 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 associated with other cardiac accessory conduction pathway disorders [see Warnings and Precautions (5.2)] - H

Produktsammanfattning:

Product: 63629-8134 Product: 63629-8188 NDC: 63629-8188-1 9 TABLET in a BOTTLE

Bemyndigande status:

Abbreviated New Drug Application

Bipacksedel

Bryant Ranch Prepack
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Sumatriptan Succinate Tablets
Revised: 8/2019
Document Id: d68f0ce2-d6e0-4901-ba43-f33a43186440
34391-3
Set id: a6a4e17a-7841-43cb-b435-e4eb11105a80
Version: 2
Effective Time: 20190807
Bryant Ranch Prepack

Produktens egenskaper

SUMATRIPTAN - SUMATRIPTAN SUCCINATE TABLET
BRYANT RANCH PREPACK
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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:
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 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
multiple cardiovascular risk factors. (5.1)
Arrhythmias: Discontinue sumatriptan if occurs. (5.