国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
GRANISETRON (UNII: WZG3J2MCOL) (GRANISETRON - UNII:WZG3J2MCOL)
Physicians Total Care, Inc.
GRANISETRON
GRANISETRON 3.1 mg in 24 h
TRANSDERMAL
PRESCRIPTION DRUG
Sancuso® (Granisetron Transdermal System) is indicated for the prevention of nausea and vomiting in patients receiving moderately and/or highly emetogenic chemotherapy regimens of up to 5 consecutive days duration. Sancuso is contraindicated in patients with known hypersensitivity to granisetron or to any of the components of the patch. Pregnancy Category B Reproduction studies with granisetron hydrochloride have been performed in pregnant rats at intravenous doses up to 9 mg/kg/day (54 mg/m2 /day, about 24 times the recommended human dose delivered by the Sancuso patch, based on body surface area) and oral doses up to 125 mg/kg/day (750 mg/m2 /day, about 326 times the recommended human dose with Sancuso based on body surface area). Reproduction studies have been performed in pregnant rabbits at intravenous doses up to 3 mg/kg/day (36 mg/m2 /day, about 16 times the human dose with Sancuso based on body surface area) and at oral doses up to 32 mg/kg/day (384 mg/m2 /day, about 167 times the human dose with San
Sancuso (Granisetron Transdermal System) is supplied as a 52 cm2 patch containing 34.3 mg of granisetron. Each patch is printed on one side with the words "Granisetron 3.1 mg/24 hours". Each patch is packaged in a separate sealed foil-lined plastic pouch. Sancuso is available in packages of 1 (NDC 54868-5985-0 ) patch. Store at 20°-25°C (68°-77°F); excursions permitted between 15°-30°C (59°-86°F). [see USP Controlled Room Temperature]. Sancuso should be stored in the original packaging.
New Drug Application
SANCUSO - GRANISETRON PATCH PHYSICIANS TOTAL CARE, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE SANCUSO (GRANISETRON TRANSDERMAL SYSTEM) SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SANCUSO. SANCUSO (GRANISETRON TRANSDERMAL SYSTEM) INITIAL U.S. APPROVAL: 2008 INDICATIONS AND USAGE Sancuso is a serotonin subtype 3 (5-HT3) receptor antagonist indicated for the prevention of nausea and vomiting in patients receiving moderately and/or highly emetogenic chemotherapy for up to 5 consecutive days. (1) DOSAGE AND ADMINISTRATION Apply a single transdermal system (patch) to the upper outer arm a minimum of 24 hours before chemotherapy. The patch may be applied up to a maximum of 48 hours before chemotherapy as appropriate. Remove the patch a minimum of 24 hours after completion of chemotherapy. The patch can be worn for up to 7 days depending on the duration of the chemotherapy regimen. (2) DOSAGE FORMS AND STRENGTHS 52 cm patch containing 34.3 mg of granisetron delivering 3.1 mg per 24 hours (3) CONTRAINDICATIONS Known hypersensitivity to granisetron or to any of the components of the patch (4) WARNINGS AND PRECAUTIONS Granisetron may mask a progressive ileus and/or gastric distention caused by the underlying condition. (5.1) Mild application site reactions have occurred; remove patch if severe reactions or a generalized skin reaction occur. (5.2) Avoid direct exposure of application site to natural or artificial sunlight by covering with clothing while wearing the patch and for 10 days after removing it. (5.3) ADVERSE REACTIONS The most common adverse reaction is constipation. (6) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PROSTRAKAN INC. AT 1-800-SANCUSO AND WWW.SANCUSO.COM, OR FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH_. DRUG INTERACTIONS No clinically relevant drug interactions have been reported in clinical studies with Sancuso. (7) USE IN SPECIFIC POPULATIONS Use during pregnancy only if clearly needed. (8.1) Use cauti 阅读完整的文件