Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
SUMATRIPTAN SUCCINATE (UNII: J8BDZ68989) (SUMATRIPTAN - UNII:8R78F6L9VO)
Proficient Rx LP
SUMATRIPTAN SUCCINATE
SUMATRIPTAN 100 mg
ORAL
PRESCRIPTION DRUG
Sumatriptan tablets, USP are indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use: Sumatriptan tablets are contraindicated in patients with: Teratogenic Effects Pregnancy Category C: There are no adequate and well-controlled trials 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 tablets 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 rats was 60 mg/kg/day, or approximately 3 times
Sumatriptan Tablets USP, 100 mg of sumatriptan (base) as the succinate. Sumatriptan Tablets USP, 100 mg are white to off-white, capsule shaped, biconvex uncoated tablets, debossed with ‘C’ on one side and ‘34’ on other side. Unit-dose package of 9 Tablets NDC 63187-931-09 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
SUMATRIPTAN- SUMATRIPTAN SUCCINATE TABLET PROFICIENT RX LP ---------- 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, USP are a serotonin (5-HT ) receptor agonist (triptan) indicated for acute treatment of migraine with or without aura in adults. (1) Limitations of Use: • • • DOSAGE AND ADMINISTRATION • • • • DOSAGE FORMS AND STRENGTHS Tablets: 25 mg, 50 mg, and 100 mg (3) CONTRAINDICATIONS • • • • • • • • • • WARNINGS AND PRECAUTIONS • • • • • • • • ADVERSE REACTIONS MOST COMMON ADVERSE REACTIONS (≥2% AND >PLACEBO) WERE PARESTHESIA, WARM/COLD SENSATION, CHEST PAIN/TIGHTNESS/PRESSURE AND/OR HEAVINESS, NECK/THROAT/JAW 1B/1D 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) 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) 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 sumatrip Прочетете целия документ