甲磺酸多拉司琼注射剂ANZEMET Injection

药店国别： 产地国家：美国 处方药：是 所属类别： 500毫克/25毫升(20毫克/毫升)/瓶 1瓶/盒 包装规格： 500毫克/25毫升(20毫克/毫升)/瓶 1瓶/盒 计价单位：盒 生产厂家中文参考译名： 生产厂家英文名：sanofi-aventis 原产地英文商品名：ANZEMET Injection 500mg/25mL(20mg/mL)/vial 1vial/box 原产地英文药品名：Dolasetron Mesylate 中文参考商品译名：ANZEMET 500毫克/25毫升(20毫克/毫升)/瓶 1瓶/盒 中文参考药品译名：甲磺酸多拉司琼 曾用名： 简介：部份中文甲磺酸多拉司琼处方资料(仅供参考) 【药品名称】甲磺酸多拉司琼注射液 【英文名称】Dolasetron Mesylate Injection 【汉语拼音】Jiahuangsuan Duolasiqiong Zhusheye 【化学名称】本品主要成份为甲磺酸多拉司琼，其化学名称为1H-吲哚-3-羧酸，八氢-3-氧-2，6-亚甲基-2H-喹嗪-8-(2α，6α，8α，9αβ)-单甲烷磺酸盐一水合物。 【化学结构式】 【分子式】C19H20N2O3•CH3SO3H•H2O 【分子量】438.50 【规格】5ml:100mg和1ml:12.5mg 【剂型】原料、注射剂 【商品名】原研商品名：ANZEMET;国内商品名：立必复 【处方组成】本品为甲磺酸多拉司琼的灭菌水溶液。含有辅料：甘露醇、盐酸 【适应症】本品适用于肿瘤治疗药物引起的恶心或呕吐，也可用于预防和治疗手术后的恶心或呕吐。 【用法用量】甲磺酸多拉司琼注射液可以100mg/30秒的速度快速静注或用相容的注射溶媒(0.9%氯化钠注射液或5%葡萄糖注射液)稀释至50ml输注15分钟以上。稀释后的溶液在正常光照条件下室温24小时或冷藏48小时内稳定。 【原研情况】甲磺酸多拉司琼(dolasetron mesilate)，由德国Hoechst Marion Roussel 公司研发，1997年由Sanofi-Aventis(赛诺菲-安万特)公司首次在澳大利亚上市，1998年在美国上市。本品为5-HT3受体拮抗剂，临床主要用于治疗由化疗、放疗引起的术后恶心及呕吐，止吐作用较盐酸阿扎司琼(azasetronhydrochloride)和盐酸格拉司琼(granisetron hydrochloride) 等其他5-HT3 受体拮抗剂作用更强。 甲磺酸多拉司琼注射剂英文版说明书 Injection FDA Drug Safety CommunicationAbnormal Heart Rhythms Associated with Use of Anzemet (dolasetron mesylate)This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.FDA is informing patients and healthcare professionals that the injection form of Anzemet (dolasetron mesylate) should no longer be used to prevent nausea and vomiting associated with cancer chemotherapy (CINV) in pediatric and adult patients. New data demonstrate that Anzemet injection can increase the risk of developing an abnormal heart rhythm (torsade de pointes), which in some cases can be fatal. Patients at particular risk are those with underlying heart conditions or those who have existing heart rate or rhythm problems. Anzemet causes a dose-dependant prolongation in the QT, PR, and QRS intervals on an electrocardiogram (ECG).A contraindication against this use (CINV) is being added to the product label for Anzemet injection. Anzemet injection may still be used for the prevention and treatment of postoperative nausea and vomiting (PONV) because the lower doses used for PONV are less likely to affect the electrical activity of the heart and result in abnormal heart rhythms.Anzemet tablets may still be used to prevent CINV because the risk of developing an abnormal heart rhythm with the oral form of this drug is less than that seen with the injection form. However, a stronger warning about this potential risk is being added to the Warnings and Precautions sections of the Anzemet tablet label. Anzemet tablets may also still be used for prevention of PONV.Healthcare professionals should be aware that:- Hypokalemia and hypomagnesemia should be corrected before administering Anzemet. These electrolytes should be monitored after administration as clinically indicated.- Use electrocardiogram (ECG) monitoring in patients with congestive heart failure, patients with bradycardia, patients with underlying heart disease, the elderly and in patients who are renally impaired who are taking Anzemet.- No dose adjustment is necessary for renal-impaired patients, hepatic-impaired patients, or the elderly.- Anzemet also causes dose-dependent PR and QRS prolongation. Drugs known to prolong the PR interval (such as verapamil) or QRS interval (such as flecainide or quinidine) should be avoided in patients taking Anzemet.