Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
SUMATRIPTAN SUCCINATE (UNII: J8BDZ68989) (SUMATRIPTAN - UNII:8R78F6L9VO)
Carilion Materials Management
SUMATRIPTAN SUCCINATE
SUMATRIPTAN 25 mg
ORAL
PRESCRIPTION DRUG
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 - W
NDC:68151-1658-4 in a CUP of 1 TABLET, FILM COATEDS
Abbreviated New Drug Application
SUMATRIPTAN SUCCINATE - SUMATRIPTAN SUCCINATE TABLET, FILM COATED CARILION MATERIALS MANAGEMENT ---------- 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 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 ( ) Uncontrolled hypertension ( ) 44 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 evalua Đọc toàn bộ tài liệu