替莫唑胺胶囊Temozolomide(Temodal Capsules 20mg)

产地国家日本

处方药

所属类别 20毫克/胶囊 5胶囊/瓶

包装规格 20毫克/胶囊 5胶囊/瓶

计价单位

生产厂家英文名MSD Co. Ltd.

原产地英文商品名TEMODAL Capsules(テモダール®カプセル)20mg/cap 5caps/bottle

原产地英文药品名Temozolomide

中文参考商品译名TEMODAL(テモダール®カプセル)20毫克/胶囊 5胶囊/瓶

中文参考药品译名替莫唑胺

简介

部份中文替莫唑胺处方资料(仅供参考)

英文名Dexamethasone

商标名:TEMODAL

中文名:替莫唑胺胶囊

生产商:MSD公司テモダールカプセル20mg/テモダールカプセル100mg

药用类别名称:抗恶性肿瘤药物

批准日期:2006年9月

商标名:TEMODAL Capsules 20mgTEMODAL Capsules 100mg

一般名:テモゾロミド(JAN)Temozolomide(JAN)

化学名:3-Methyl-4-oxo-3,4-dihydroimidazo[5,1-d][1,2,3,5]tetrazine-8-carboxamide

分子式:C6H6N6O2

分子量:194.15

性状:白色到细红色或淡黄色棕色粉末, 几乎不溶于二甲基亚硫酸、水、甲醇、丙酮, 或几乎不溶于乙腈, 很难溶于乙醇(95)。熔点约 206°c (拆卸)分布系数(1-辛醇/水)20.8 至22。40.1 mol磷酸盐缓冲液 (pH 值 7.0)2。00.1 moll盐酸盐试剂20。8水22。4

药用药理学:替莫唑胺是一种单价烷基化剂, 在生理pH条件下分解为非酶MTIC, 成为甲基二氮离子, 通过甲基化 DNA 显示出抗肿瘤作用。抗肿瘤活性替莫唑胺在体外对人恶性胶质细胞培养细胞的抑制作用。此外, Temozomido在人恶性胶质细胞颅内移植小鼠 (体内) 延长了存活天数。

作用机制:替莫唑胺通过鸟嘌呤 DNA 的6位氧原子甲基化导致 DNA 损伤, 通过诱导细胞周期 (体外) 停止和凋亡显示细胞静力抑制作用。

适应病症:恶性胶质瘤复发性或难治性尤因肉瘤

用法与用量:(1)在恶性胶质瘤的情况下, 最初与辐射相结合, 通常, 在成人中, 每天一次75Mg/2(体表面积), 每天42天作为替莫胺, 口服, 并休息4周。此后, 一次每天 150mgm 2作为 Temozomido 5天, 口服, 其余23天。28天和一个冷却, 下一个冷却可以增加到200mg/M 一次。(2)在复发性恶性胶质瘤的情况下通常, 在成人一次 150Mg/2(体表面积) 每天5天, 每天5天, 口服为Temozomido, 并离开23天。28天和一个凉爽, 可能的增加一次200Mg/2。在复发或难治性尤因肉瘤的情况下与伊里诺泰康联合使用, 通常, 每天一次 100mg/M 作为Temozomido 每天5天, 口服, 休息16天以上。另外, 根据患者的病情酌情用药。

英文版说明书:

Temozolomide: New drugs related to brain tumors for the first time in 19 yearsOn July 26, 2006, temozolomide (trade name: Temodar Capsel) of the antineoplastic agent was approved. Temozolomide is an oral preparation that has indication for malignant glioma, was listed on the drug price on September 15 and released on the same day. As a new drug with brain tumor-related indication, it will be released for the first time in 19 years in Japan.Glioma (glioma) is a brain tumor arising from neuroglia that fills between neurons, accounting for about 30% of primary brain tumors. Also, it is known that “malignant glioma” which is an indication of temozolomide invasively grows in the brain among gliomas and causes severe tumor-related complications such as neurological symptoms and cerebral hernia . Malignant gliomas include anaplastic astrocytoma, glioblastoma, anaplastic oligodendroglioma, anaplastic oligodendroglioma and the like, but both have very poor prognosis. The annual number of malignant gliomas in Japan is estimated to be about 2,500.Traditionally, a multidisciplinary approach combining surgery, postoperative radiation, and postoperative adjuvant chemotherapy has been used to treat malignant glioma. Of these, postoperative adjuvant chemotherapy includes nimustine hydrochloride (trade name: Nidolan), ranimustine (trade name: Cimelin), interferon beta (trade name: Feron, IFN beta motida) that have indications for brain tumor and glioblastoma . In addition, in 2005, three-drug combination therapy (PAV therapy) of nimustine hydrochloride, procarbazine hydrochloride (trade name: procarbazine hydrochloride), vincristine sulfate (trade name: Oncovin) was found to be a neurogenic astrocytoma, a nerve with an oligodendroglioma component It is recognized in glioma.Temozolomide that was approved this time is available internationally in 78 countries including the EU (European Union) and the United States in combination with radiation therapy of glioblastoma and treatment for subsequent maintenance therapy, treatment of relapsed/advanced glioblastoma etc. It is approved as a medicine. In July 2005, the Ministry of Health, Labor and Welfare’s “Study Committee on Utilization of Unapproved Drugs” proposal was made to apply early approval application and safety confirmation test by using radiation together.Temozolomide belongs to the alkylating agent in the classification of anti-neoplastic drugs. It becomes methyldiazonium ion in vivo, methylation of DNA causes DNA damage, and suppresses cell proliferation by inducing cell cycle arrest and apoptosis. Temozolomide is an oral capsule preparation, but it also passes through the blood brain barrier and has good migration to the cerebrospinal fluid. Even in clinical trials, the combination of temozolomide and radiation therapy showed a significant improvement in survival compared to radiation therapy aloneAs for safety, bone marrow suppression such as leucopenia decrease and thrombocytopenia is problematic like other antineoplastic agents. For this reason, during temozolomide administration, it is required to always observe the condition of the patient, such as blood tests. In addition, side effects such as loss of appetite, headache, constipation, nausea, vomiting, hair dropouts, convulsions, fatigue, diarrhea, stomatitis, blurred vision, etc. are also recognized, so care must be taken when using it.Physicochemical knowledge on active ingredientsName of drug classificationAntineoplastic agentEuropean trademark nameTEMODAL CapsulesGeneric name temozolomideCommon name (European name) TemozolomideChemical name 3-Methyl-4-oxo-3,4-dihydroimidazo [5,1-d] [1,2,3,5] tetrazine-8-carboxamideMolecular formula C 6 H 6 N 6 O 2Molecular weight 194.15Melting point about 206 ° C (decomposition)It is slightly soluble in dimethylsulfoxide, hardly soluble in water, methanol, acetone, or acetonitrile, and it is extremely insoluble in ethanol (95), because it is a white to fine blackish or fawn-brown powder.Partition coefficient (1 – octanol/water system): 20.8 – 22.40.1 mol/L phosphate buffer (pH 7.0): 22.00.1 mol/L hydrochloric acid reagent solution: 20.8Water: 22.4KEGG DRUGApproval conditionSince the clinical trial cases in the country are extremely limited, by conducting a usage result survey for all cases until data of a certain number of cases are accumulated after manufacture and sales, Grasp the background information of the patient to be used, collect data on the safety and efficacy of Ezetimiba at an early stage and take necessary measures for the proper use of bevacizumab.PackagingTemodar capsule 20 mg5 capsules (roses), 20 capsules (roses)5 capsules (1 capsule × 5 packs)Temodar capsule 100 mg5 capsules (roses), 20 capsules (roses)5 capsules (1 capsule × 5 packs)

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