Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
SUMATRIPTAN SUCCINATE (UNII: J8BDZ68989) (SUMATRIPTAN - UNII:8R78F6L9VO)
Bryant Ranch Prepack
ORAL
PRESCRIPTION DRUG
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
Product: 63629-8134 Product: 63629-8188 NDC: 63629-8188-1 9 TABLET in a BOTTLE
Abbreviated New Drug Application
Bryant Ranch Prepack ---------- 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 Lesen Sie das vollständige Dokument
SUMATRIPTAN - SUMATRIPTAN SUCCINATE TABLET BRYANT RANCH PREPACK ---------- 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. Lesen Sie das vollständige Dokument