部份中文盐酸伊立替康处方资料（仅供参考）
商品名:TOPOTECIN INTRAVENOUS DRIP INFUSION
英文名：Irinotecan Hydrochloride Hydrate
中文名：盐酸伊立替康IV输注
生产商：第一三共制药
药效分类
抗恶性肿瘤药物
批准日期：2009年9月
商標名
TOPOTECIN INTRAVENOUS DRIP INFUSION
一般名
イリノテカン塩酸塩水和物(Irinotecan Hydrochloride Hydrate)
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
分子式
C33H38N4O6・HCl・3H2O
分子量
677.18
構造式
性状
微黄色—淡黄色的结晶或结晶性的粉末。
乙酸(100)容易溶化，甲醇中很难溶解，而且很难溶于水、无水醋酸或乙醇(95)。
.熔点
分解250 - 263码
处理上的注意
1.如果药水附着在皮肤上，应立即用大量水冲洗。
2.注意不要冻结。
药效药理
铱盐酸盐水和物是1983年由抗肿瘤性生物甲醛合成的抗恶性肿瘤剂。本药剂是在生物体内由甲氧酶分解在活性代谢物(sn- 38)中进行加水分解的专业毒品。
(1) 抗肿瘤作用
相对于移植肿瘤具有广泛的抗肿瘤光谱。对鼠s180肉瘤，metha纤维肉瘤，lewis肺癌，l1210和p388白血病，拉特宠物猫256癌肉瘤，裸体老鼠可移植人类肿瘤mx -1(乳房癌)，编码-4(大肠癌)，st-15(胃癌)，qg -56(肺癌)等显示出很强的抗肿瘤效果。另外，在in vitro试验中，抑制了人类胰腺癌由来的bxpc -3、panc -1、spa和suit -2细胞股的繁殖。
(2)作用机制
通过抑制i型dna热酶，从而妨碍dna合成。杀死细胞效果在细胞周期s期是特异性的，是在限制时间依存性上显示效果的药剂。
适应症
小细胞肺癌、非小细胞肺癌、子宫颈癌、卵巢癌、胃癌(不能手术或复发)、结肠癌和直肠癌癌(不能手术或复发)、乳腺癌(不能手术或复发),有棘细胞癌、恶性淋巴瘤(非霍奇金淋巴瘤),小儿恶性实体肿瘤无法切除的胰腺癌,治愈
用法与用量
1.子宫颈癌、卵巢癌、胃癌(不能手术或复发)和有刺细胞癌使用a法或b法;子宫颈癌、卵巢癌、胃癌(不能手术或复发)以及结肠和直肠癌(不能手术或复发)使用a法或b法。
另外，恶性淋巴瘤(非霍奇金淋巴肿瘤)使用c法，小儿恶性固体肿瘤使用d法，不能切除的胰腺癌使用e法。
a法:
通常，以1周为间隔，每周3 ~ 4次为单位，每次100mg/m2注水，并至少休药2周。把这个作为1酷，反复输入。
b法:
通常，每隔2周向成年人注射一次150毫克盐酸盐水，并至少休药3周。把这个作为1酷，反复输入。
c法:
通常，每天1次，每次40毫克左右的盐酸盐水和物，每天点滴输入，每次40毫克左右。每周重复2 ~ 3次，至少休息2周。把这个作为1酷，反复输入。另外，a ~ c法的输入量根据年龄、症状适当增减。
d法:
通常，每天1次，每次20毫克左右的盐酸盐水和物连续输液，每次20毫克左右。每周重复两次，至少要休一周假。把这个作为1酷，反复输入。
e法:
通常，每成人每天点滴180毫克/m2作为铱盐酸盐水和物，并至少休药两周。把这个作为1酷，反复输入。另外，d法和e法的输入量根据患者的状态，适当减少。2.用a
a法、b法和e法，在配药时，根据用量将盐水混和500毫升以上的生理食盐液、葡萄糖液或电解质维持液，用90分钟以上的时间注满水。
c法规定，注射本药剂时，根据用量将盐水混和250ml以上的生理食盐液、葡萄糖液或电解质维持液，用60分钟以上的时间注水。在d方法中，注射本药剂时，根据配药量，混和100毫升以上的生理食盐液、葡萄糖液或电解质维持液，用60分钟以上的时间注水。
包装
点滴注用
40mg (2毫升) 1瓶
100mg(5毫升)1瓶
制造商
制造商
第三共株式会社
注：以上中文处方资料不够完整，使用者以原处方资料为准。
完整说明书附件：http://www.info.pmda.go.jp/go/pack/4240404A1091_1_09/
Announcement of approval for addition of antitumor agent "Topotecin® intravenous drip infusion 40 mg, 100 mg" for additional indication related to addition of dosage and dosage
Daiichi Sankyo Co., Ltd. (Headquarters: Chuo-ku, Tokyo, hereinafter referred to as "the company") is a "curative resection" of generalized name: irinotecan hydrochloride hydrate) "40 mg of Topotecin® intravenously, We are pleased to inform you that we have approved partial change of domestic manufacturing and marketing approval matters concerning the indications and dosage addition and the indications and effects of "incapable pancreatic cancer".
Regarding intravenous drip infusion of topotecin Ⓡ, we received the results of examination at the "Medical Necessary Highly Approved Drugs/Adaptable Drug Consideration Conference 1" held on March 23, 2012, and received from the Ministry of Health, Labor and Welfare Development was requested, and we applied for approval in May this year.
From the perspective of corporate social responsibility (CSR), we will continue to actively address unapproved drugs and non-applicable drugs with high medical needs, and will contribute to medical care.
1) established by the Ministry of Health, Labor and Welfare for the purpose of promoting the development of unapproved drugs and non-applicable drugs by pharmaceutical companies for pharmaceuticals and indications that are approved for use in Europe and the US but not approved in Japan Conference
Product Summary
Sales name
Topotecin Ⓡ IV infusion 40 mg, same 100 mg
Manufacturing and marketing authorization matter
Partial change approval date
20th December 2013
Indication
(Change underlined part)
Small cell lung cancer, small cell lung cancer, cervical cancer, ovarian cancer, gastric cancer (inoperable or recurrent), colorectal cancer (inoperable or recurrent), breast cancer (inoperable or recurrent), squamous cell carcinoma, malignant lymphoma (Non-Hodgkin's lymphoma), pediatric malignant solid tumor, curative unresectable pancreatic cancer
Dosage regimen
(Change underlined part)
  1. Small cell lung cancer, non-small cell lung cancer, breast cancer (inoperable or recurrent) and squamous cell carcinoma can be classified as Method A by cervical cancer, ovarian cancer, gastric cancer (inoperable or recurrent) and colorectal cancer Or recurrence) use method A or method B. We also use method C for malignant lymphoma (non-Hodgkin's lymphoma), method D for pediatric malignant solid tumor, and method E for pancreatic cancer that is curative unresectable.
Method A: Irinotecan hydrochloride hydrate is usually administered intravenously to an adult three to four times at intervals of one week at intervals of 100 mg / m 2 once a day, followed by withdrawal for at least 2 weeks. Repeat administration with this as one course.
Method B: Irinotecan hydrochloride hydrate is usually administered intravenously to an adult 2 to 3 times at intervals of 2 weeks, once a day, once a day for at least 3 weeks withdrawal. Repeat administration with this as one course.
Method C: As an irinotecan hydrochloride hydrate, intravenous drip infusion should be given to adults on a daily basis at 40 mg / m 2 daily for 3 consecutive days. Repeat this 2 to 3 times every week for rest for at least 2 weeks. Repeat administration with this as one course.
The dose of methods A to C is appropriately increased or decreased depending on age and symptoms.
Method D: As an irinotecan hydrochloride hydrate, intravenous drip infusion of 20 mg / m 2 daily for 5 consecutive days, usually once a day. Repeat this twice a week for at least one week off. Repeat administration with this as one course.
Method E: Irinotecan hydrochloride hydrate is usually administered intravenously to an adult intravenously 180 mg/m 2 once daily for at least 2 weeks off. Repeat administration with this as one course.
The dose of D method and E method is appropriately reduced depending on the condition of the patient.
2. In method A, method B, and method E, administer it in 500 mL or more of physiological saline solution, glucose solution or electrolyte maintaining solution according to the dose at the time of administration of this product, and intravenously drop infused over 90 minutes.
In Method C, when this product is administered, it is mixed with physiological saline solution, dextrose solution or electrolyte maintenance solution of 250 mL or more according to the dose, and intravenous drip infusion over 60 minutes.
In method D, administer it to a physiological saline solution, glucose solution or electrolyte maintenance solution of 100 mL or more according to the dose at the time of administration of this drug, and intravenously drop infused over 60 minutes.