国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
SUMATRIPTAN SUCCINATE (UNII: J8BDZ68989) (SUMATRIPTAN - UNII:8R78F6L9VO)
Proficient Rx LP
SUBCUTANEOUS
PRESCRIPTION DRUG
Sumatriptan injection, USP is indicated in adults for (1) the acute treatment of migraine, with or without aura, and (2) the acute treatment of cluster headache. Limitations of Use : Sumatriptan injection is contraindicated in patients with: Pregnancy Category C. There are no adequate and well-controlled trials of sumatriptan injection in pregnant women. In developmental toxicity studies in rats and rabbits, oral administration of sumatriptan to pregnant animals was associated with embryolethality, fetal abnormalities, and pup mortality. When administered by the intravenous route to pregnant rabbits, sumatriptan was embryolethal. Sumatriptan injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Oral administration of sumatriptan to pregnant rats during the period of organogenesis resulted in an increased incidence of fetal blood vessel (cervicothoracic and umbilical) abnormalities. The highest no-effect dose for embryofetal developmental toxicity in
Sumatriptan injection, USP contains sumatriptan (base) as the succinate salt and is supplied as a clear, colorless to pale yellow, sterile, nonpyrogenic solution as follows: Single-Dose Vial : NDC 71205-111-01 sumatriptan injection, USP single-dose vial (6 mg/0.5 mL) in cartons containing 1 vial. Store between 2° and 25°C (36° and 77°F). Protect from light.
Abbreviated New Drug Application
SUMATRIPTAN SUCCINATE- SUMATRIPTAN SUCCINATE INJECTION PROFICIENT RX LP ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE SUMATRIPTAN INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SUMATRIPTAN INJECTION. SUMATRIPTAN INJECTION, FOR SUBCUTANEOUS USE INITIAL U.S. APPROVAL: 1992 INDICATIONS AND USAGE Sumatriptan injection, USP is a serotonin (5-HT ) receptor agonist (triptan) indicated for: • • Limitations of Use: • • DOSAGE AND ADMINISTRATION • • • • • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS • • • • • • • • • • WARNINGS AND PRECAUTIONS • • • • • • • • 1B/1D Acute treatment of migraine with or without aura in adults (1) Acute treatment of cluster headache in adults (1) Use only if a clear diagnosis of migraine or cluster headache has been established (1) Not indicated for the prophylactic therapy of migraine or cluster headache attacks (1) For subcutaneous use only (2.1) Acute treatment of migraine: single dose of 1 mg to 6 mg (2.1) Acute treatment of cluster headache: single dose of 6 mg (2.1) Maximum dose in a 24-hour period: 12 mg, separate doses by at least 1 hour (2.1) Patients receiving doses other than 4 mg or 6 mg: Use the 6-mg single-dose vial (2.3) Injection: 6-mg single-dose vial (3) 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) 1 Concurrent or recent (past 2 weeks) use of monoamine oxidase-A inhibitor (4) Hypersensitivity to sumatriptan (angioedema and anaphylaxis seen) (4) Severe hepatic impairment (4) Myocardial ischemia/infarction and Prinzmetal's angi 完全なドキュメントを読む