البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
SUMATRIPTAN SUCCINATE (UNII: J8BDZ68989) (SUMATRIPTAN - UNII:8R78F6L9VO)
Endo Pharmaceuticals, Inc.
SUMATRIPTAN SUCCINATE
SUMATRIPTAN 6 mg in 0.5 mL
PRESCRIPTION DRUG
New Drug Application
SUMAVEL DOSEPRO- SUMATRIPTAN INJECTION ENDO PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE SUMAVEL DOSEPRO SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SUMAVEL DOSEPRO. SUMAVEL DOSEPRO (SUMATRIPTAN INJECTION), FOR SUBCUTANEOUS USE INITIAL U.S. APPROVAL: 1992 INDICATIONS AND USAGE Sumavel DosePro is a serotonin (5-HT ) receptor agonist (triptan) indicated for: Acute treatment of migraine with or without aura in adults (1) Acute treatment of cluster headache in adults (1) Limitations of Use: Use only if a clear diagnosis of migraine or cluster headache has been established. (1) Not indicated for the prevention of migraine attacks. (1) DOSAGE AND ADMINISTRATION For subcutaneous use only. (2.1, 2.2) Acute treatment of migraine: 4 mg or 6 mg single dose. (2.1) Acute treatment of cluster headache: 6 mg single dose. (2.1) Maximum dose in a 24-hour period: 12 mg. Separate doses by at least 1 hour. (2.1) Administer dose only to the abdomen or thigh. (2.2) DO NOT USE SUMAVEL DOSEPRO IF THE TIP OF THE DEVICE IS TITLED OR BROKEN OFF UPON REMOVAL FROM PACKAGING. (2.2) DOSAGE FORMS AND STRENGTHS Sumavel DosePro: 4 mg or 6 mg prefilled, single-dose, needle-free subcutaneous delivery systems. CONTRAINDICATIONS History of coronary artery disease or coronary 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) Current or recent (past 2 weeks) use of monoamine oxidase-A inhibitor (4) Hypersensitivity to Sumavel DosePro (angioedema and anaphylaxis seen) (4) WARNINGS AND PRECAUTIONS Myocardial ischemia/infarction and Prinzmetal’s angina: Perform cardiac evaluation in patients with multi اقرأ الوثيقة كاملة