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TS-1 combination OD tablet T20/T25(替吉奥配合口腔崩解片)

2017-02-12 08:00:17  作者:新特药房  来源:互联网  浏览次数:1  文字大小:【】【】【
简介: 部份中文TS-1 combination OD处方资料(仅供参考)TS-1 combination OD tablet T20/T25(Tegafur/Gimeracil/Oteracil Potassium)TS-1是一种氟尿嘧啶衍生物口服抗癌剂,它包括替加氟(FT)和以下两类调 ...

部份中文TS-1 combination OD处方资料(仅供参考)
TS-1 combination OD tablet T20/T25(Tegafur/Gimeracil/Oteracil Potassium)
TS-1是一种氟尿嘧啶衍生物口服抗癌剂,它包括替加氟(FT)和以下两类调节剂:吉美嘧啶(CDHP)及奥替拉西(Oxo)。
其三种组分的作用如下:FT是 5-Fu的前体药物,具有优良的口服生物利用度,能在活体内转化为5-Fu。CDHP能够抑制在二氢嘧啶脱氢酶作用下从FT释放出来的5-Fu的分解代谢,有助于长时间血中和肿瘤组织中5-Fu有效深度,从而取得与5-Fu持续静脉输注类似的疗效。Oxo能够阻断5-Fu的磷酸化,口服给药之后,Oxo在胃肠组织中具有很高的分布浓度,从而影响5-Fu在胃肠道的分布,进而降低5-Fu毒性的作用。
TS-1与5-Fu相比具有以下优势:
①能维持较高的血药浓度并提高抗癌活性;
②明显减少药毒性;
③给药方便。
在日本,TS-1于1999年被批准用来治疗晚期胃癌,2001年被批准用来治疗头颈部癌症,2003年被批准用来治疗结直肠癌,2004年被批准用来治疗非小细胞肺癌。
多年的临床应用证明,TS-1是安全有效的抗癌药物。据统计,日本目前晚期胃癌的化疗,有80%以上的病例使用TS-1,治疗有效率(CR+PR)可达44.6%。
TS-1简要说明: 
成分:
呋喃脲嘧啶+5-氯-2,4-二羟吡啶,氧晴镁钾(OXO植物生长抑制素),替加氟
作用机理:TS-1其中的替加氟通过抑制胸苷酸合成酶,阻止脱氧尿苷酸转变为脱氧胸苷酸,从而干扰DNA的合成。而其中的吉莫斯特通过抑制胃肠道的氟尿嘧啶降解酶,达到延长药物的作用时间。TS-1其中的氧嗪酸钾是胃黏膜保护剂。
适应症:
复发性乳腺癌胃癌,大肠癌,头颈部癌,非小细胞肺癌,或不能工作,胰腺癌,胆道癌
用法用量
下面的参考量,根据体表面积的初始剂量(1剂量)为成人,后一天两次晚餐和早餐后,口服每日给药28天,14天,然后停药为一疗程。
此外,根据患者的条件来调整到40毫克,50毫克,60毫克,75毫克和/转增加的阶段或减少的量。胃肠道症状(血液测试,肝和肾功能检查),并且不表达的实验室异常判定体重增加由于药剂的施用,存在安全性没有问题,并在第一时间时判定它可以增加从基准量的最多一个步骤被设定为限制为75mg/次;此外,通常,体重减轻进行一步一步的最低剂量为40mg/次。
包装规格
口腔崩解
配合OD片T20
PTP包装:56片(14片×2×2),140片(14粒×2×5)


配合OD片T25
PTP包装:56片(14片×2×2),140片(14粒×2×5)


制造厂商
大鹏药业有限公司
完整处方资料附件:http://www.info.pmda.go.jp/go/pack/4229101F1026_1_03/
Anti-malignant tumor agent "TIS Eswan®-containing OD tablet T20 · T25"
Taiho Pharmaceutical Industry Co., Ltd. (Headquarters: Tokyo, President: Masayuki Kobayashi, hereinafter "Taiho Pharmaceutical") is in the dosage form of the antitumor agent "TIS Esan®" (general name: tegafur, gimeracil, oteracil potassium compound) In addition, we will inform you that the drug price was listed on Tuesday, 21st today, "TIS Eswan® Ingredient OD Tablets T20 · T25" (hereafter this product). Release is scheduled for June 27 (Thursday).
This product is the world's first anticancer drug orally disintegrating tablet. With saliva in the mouth promptly
Because it collapses and can be taken without water, it is difficult to take capsules, there are restrictions on water intake, etc. We can respond to the needs of various patients. We made it as a nucleated-type orally disintegrating tablet that reliably contains the anticancer agent ingredient, and made it a preparation that prevents scattering of anticancer drug ingredients and promptly disintegrates. We believe that together with conventional formulated capsules and compounded granules, it will be possible to select three dosage forms according to the patient's condition, thereby improving continuity of treatment and leading to higher outcome.
Taiho Pharmaceutical Co., Ltd. "Tea Esuan ®" can contribute to more patients and medical staff
We hope to become a drug, we will continue to provide information in the future.
About Tea Esplan®
Tea ES One, a fluorinated pyrimidine antineoplastic agent, is an antimetabolite of tegafur, which is converted to the anticancer agent fluorouracil (5-FU) after absorption, and gimeracil inhibiting 5-FU degradation in the body (5 -chloro-2,4-dihydroxypyridine, or CDHP), and oteracil (Oxo) which inhibits the phosphorylation of 5-FU in the gastrointestinal tract. It was developed as a remedy for stomach cancer, first approved in Japan in 1999, and now it is a standard treatment for stomach cancer. In Japan, we have acquired six additional efficacies such as colon · rectal cancer, head and neck cancer, non small cell lung cancer, inoperable or recurrent breast cancer, pancreatic cancer and biliary tract cancers. Overseas, it is marketed in Asia (7 countries) and Europe (15 countries) for gastric cancer indication. (As of May 15, 2013)
About nucleated-type orally disintegrating tablets
By enclosing the anticancer agent component in the nucleus with an outer shell rich in disintegrating property although it has sufficient strength against external force, prevention of scattering of anticancer drug ingredients and prompt disintegration in the oral cavity It is a compatible tablet.
-Product overview-
product name  
Tea Esan® Injection OD Tablets T20 · T25
common name 
Tegafur, gimeracil, oteracil potassium compound
Indication
Gastric cancer, colon/rectal cancer, head and neck cancer, non small cell lung cancer, inoperable or recurrent breast cancer, pancreatic cancer, biliary tract cancer
Dosage regimen
Ordinarily, for adults, the initial dose (single dose) is adjusted to the body surface area as the next reference amount, orally administered for 28 consecutive days twice a day after breakfast and after dinner for 14 days. Repeat administration with this as one course.
Body surface area initial reference amount (equivalent to tegafur)
Less than 1.25 square meters 40 mg/times
1.25 square meters or more to less than 1.50 square meters 50 mg / times
1.50 m 2 or more 60 mg/times
Incidentally, it should be increased or decreased according to the condition of the patient. The increment / decrement stage is set to 40 mg, 50 mg, 60 mg, 75 mg / times. Increase in dosage will be judged to be due to the administration of this drug No abnormal clinical laboratory test (blood test, liver / renal function test) and digestive symptoms do not develop, there is no safety problem, It is limited to one step from the reference amount and is limited to 75 mg / time. In addition, weight reduction is usually carried out step by step, and the minimum dose is 40 mg / times.
Manufacture and sale approval date
February 15, 2013
Drug Price Listing Date
June 21, 2013
Expected release date
June 27, 2013
Packaging
Tea Esuan® Injection OD Tablet T20 PTP Packing: 56 Tablets (14 Tablets * 2 * 2) 140 Tablets (14 Tablets * 2 * 5)
Tea Esan® Ingredients OD Tablets T25 PTP Packing: 56 Tablets (14 Tablets * 2 * 2) 140 Tablets (14 Tablets * 2 * 5)
Manufacturer selling agency
Taiho Pharmaceutical Co., Ltd.
This article Department of pharmacists/medical experts original translation finishing, welcome to reprint! At the same time the procurement of domestic scientific research institutions can contact us: 2363244352.3330889895
 

责任编辑:p53


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