部份中文盐酸伊立替康处方资料（仅供参考） 【中文品名】盐酸伊立替康 【药效类别】抗肿瘤药>喜树碱衍生物类 【通用药名】IRINOTECAN HYDROCHLORIDE 【别　　名】Campto, Camptosar, Capto, CPT-11, DQ-2805, Irkan, SN-38, Topotecin, U-101-440E 【化学名称】 [1,4'-Bipiperidine]-1'-carboxylic acid, 4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo-1H-pyrano[3',4':6,7]indolizino[1,2-b]quinolin-9-yl ester, monohydrochloride 【CA登记号】[100286-90-6] 【结 构 式】 【分 子 式】CHNOPS· 【分 子 量】 【收录药典】 【开发单位】Daiichi Pharmaceutical 【首次上市】1994年，日本 【性　　状】 【用　　途】本品是从喜树的树皮中提取，与物种有关。为拓扑异构酶I抑制剂，用于治疗各种癌症，包括结肠、直肠、胃癌，乳腺、淋巴癌，鳞状细胞癌和肺、子宫颈、卵巢癌等。 【用法用量】 1.推荐剂量为350mg/m2，加入生理盐水或5%葡萄糖溶液中静脉滴注30～90min，每3周1次；或100mg/2，每周1次；或125～150mg/2，每周1次，连续4周，休息2周。 2.若出现严重毒性反应(3～4级)时，本品剂量应减少15%～20%。 3.本药用于结直肠癌治疗多与5-FU、CF联合用药 伊立替康(irinotecan，Camptll,Topotecin)　由日本第一制药公司开发，1994年首先在日本上市，1995年在法国获准上市，上市剂型为注射剂，规格为40mg/2ml,100mg/5ml,适应证为小细胞和非小细胞肺癌及宫颈癌和卵巢癌，结直肠癌等适应证也在申请或临床研究中。它是一种毒性较小的水溶性半合成喜树碱衍生物类拓扑异构酶-I抑制剂，为一前体药物，在体内进行脱酯化形成一个在体外比母体化合物作用强1000倍的代谢物SN-38。其对实体瘤有较强的作用，与阿霉素、长春新碱、顺铂等具有相似的作用。由于本药作用于拓扑异构酶-Ⅰ，因而和作用于拓扑异构酶-Ⅱ的抗癌新药无交叉耐药性，甚至合用可产生协同作用。 临床研究表明，对标准治疗方案无效的卵巢癌、子宫癌和肺癌的总有效率为20%,对胰腺癌、胃癌、结直肠癌和非小细胞肺癌的有效率分别为19%，43%，50%和48% 。本品有骨髓抑制和强烈的胃肠道不良反应，因此使用时应注意。本品是近年来继紫杉烷类抗癌药紫杉醇和多西紫杉(docetaxel)之后开发的第二大类从植物中获得的抗癌药。 トポテシン点滴静注４０ｍｇ／トポテシン点滴静注１００ｍｇ 治疗类别名称 抗肿瘤药 批准日期：2009年9月 商標名 TOPOTECIN INTRAVENOUS DRIP INFUSION 1. 一般名 イリノテカン塩酸塩水和物(Irinotecan Hydrochloride Hydrate) 2. 化学名 (＋)-(4S )-4,11-diethyl-4-hydroxy-9-[(4-piperidinopiperidino)carbonyloxy]-1H -pyrano[3´,4´： 6,7]indolizino[1,2-b ]quinoline-3,14(4H ,12H )-dione hydrochloride trihydrate 包装 静脉滴注 40毫克（2毫升），1瓶 100毫克（5毫升），1瓶 制造厂商 第一三共有限公司 完整资料附件：http://www.info.pmda.go.jp/go/pack/4240404A1091_1_09/ The effectiveness and approval and additional doses and administration of anti-cancer agent "Ⓡ Topotecin intravenous infusion of 40 mg, 100 mg" Daiichi Sankyo Co., Ltd. (Headquarters: Chuo-ku, Tokyo, hereinafter "the Company"), an anti-cancer agent "Ⓡ Topotecin intravenous infusion 40mg, 100mg same": "curative resection (generic name irinotecan hydrochloride hydrate ) we have today approved the acquisition of some change in non-pancreatic cancer, "additional efficacy and dosage and administration in accordance with the manufacturing and marketing approval on domestic issues, will be announced. Regarding Topotecin Ⓡ intravenous drip, received results of the study took place on March 23, 2012 "drugs unapproved high medical need, off-label drug Review Conference 1)," the company addressed the Ministry of Health, Labor Welfare and development was requested, which were carried out this request for approval in May this year. We are, in terms of corporate social responsibility (CSR), aggressive efforts to continue to eliminate the need for highly unapproved drug off-label drugs will continue to contribute to health care. 1) organized by the Ministry of Health, Labour and Welfare, but the United States and Europe have been approved for use for pharmaceutical and adaptation, which has not been approved in Japan, it is installed in order to promote the development of off-label drugs non-approved drugs by pharmaceutical companies conference product Summary Brand Name Ⓡ Topotecin intravenous 40mg, 100mg same Manufacturing and marketing approval matters Some change the date of approval 2013 December 20 Effect-efficacy (Changes underlined)  lung cancer small cell lung cancer non-small cell cancer, cervical cancer, ovarian cancer, gastric cancer (recurrent, unresectable or), colorectal cancer (recurrent, unresectable or), breast cancer (recurrent, unresectable or) squamous cell carcinoma, malignant lymphomas (non Hodgkin's lymphoma) solid tumors pediatric malignant inoperable pancreatic cancer DOSAGE AND ADMINISTRATION (Changes underlined)  1. Small cell lung cancer, lung cancer, non-small cell cancer, breast cancer (unresectable or recurrent) and squamous cell carcinoma is a method, cervical cancer, ovarian cancer, gastric cancer (inoperable or recurrent) and Cancer colorectal (unresectable or relapsed) is to use the method a or method B. In addition, malignant lymphoma (NHL) is a method C. method D pediatric malignant solid tumors, inoperable pancreatic cancer is to use the method E. Method: as anhydrous irinotecan hydrochloride, usually once per day for an adult is 100 mg/m2 was partitioned three to four times the intravenous infusion at weekly intervals, followed by discontinuation of medication for at least two weeks. This cold as 1 repeat dosing. Method B: irinotecan hydrochloride as anhydrous usually once per day for an adult is 150 mg/m2 distributed intravenous infusion two or three times at 2-week intervals, followed by discontinuation of medication for at least 3 weeks. This cold as 1 repeat dosing. Method C: irinotecan hydrochloride as anhydrous usually once per day for adults, the daily intravenous infusion of 40 mg/m2 for three days. This is repeated two or three times a week, followed by discontinuation of medication for at least two weeks. This cold as 1 repeat dosing. It should be noted that the dose of A ~ C method, increase or decrease depending on the patient's age and symptoms. Method D: irinotecan hydrochloride as the hydrate, usually once daily, 20 mg/m2 for 5 consecutive days by intravenous infusion. This is repeated two times per week, followed by discontinuation of medication for at least one week. This cold as 1 repeat dosing. Method E: irinotecan hydrochloride as anhydrous usually once per day for adults, intravenous infusion of 180 mg / m2, followed by discontinuation of medication for at least two weeks. This cold as 1 repeat dosing. It should be noted that the dose of Method D and Method E is reduced in the patient's condition. 2.A method, Method B and Method E, while taking this drug, more than 500 ml of brine, in accordance with the amount of administration, and mixed in a glucose solution or a maintenance solution of the electrolyte, intravenous drip for 90 minutes. In Method C, the time of administration of the drug, 250 ml or more of a physiological salt solution, according to the amount of administration, and mixed