复方替加氟/吉莫斯特/氧嗪酸钾崩解片TS-1 combination OD tablet T20说明书

药店国别: 产地国家:日本 处方药:所属类别: 20毫克/片 56片/盒 包装规格: 20毫克/片 56片/盒 计价单位:盒 生产厂家中文参考译名: 生产厂家英文名:Taiho 原产地英文商品名:TS-1 combination OD tablet T20 20mg/tablet 56tablet/box 原产地英文药品名:Tegafur/Gimeracil/Oteracil Potassium 中文参考商品译名:替吉奥崩解片 20毫克/片 56片/盒 中文参考药品译名:替加氟/吉莫斯特/氧嗪酸钾 曾用名: 简介: 英文药名:TS-1 combination OD tablet T20(Tegafur/Gimeracil/Oteracil Potassium)中文药名:替吉奥配合崩解片T20生产厂家:大鹏药业药品介绍TS-1 combination OD tablet T20(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) 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 配合OD錠T20 PTP包装:56錠(14錠×2×2)、140錠(14錠×2×5)ティーエスワン配合OD錠T25 PTP包装:56錠(14錠×2×2)、140錠(14錠×2×5) 制造厂商 大鹏药业有限公司 英文版说明书 TS-1 combination OD tablet T20(Tegafur/Gimeracil/Oteracil Potassium)Effects of this medicineTS-1 enhances the antitumor activity in proportion to the increase in the concentration of 5-fluorouracil (5-FU) in the body via the biotransformation of FT to 5-FU. Also, this medicine relieves gastrointestinal toxicities (side effects) through the effects of oteracil pottasium.This drug is commonly used in the treatment of gastric cancer, colorectal cancer, head and neck cancer, non-small cell lung cancer, unresectable or recurrent breast cancer, pancreatic cancer, or biliary tract cancer.Before using this medicine, tell your doctor/pharmacistIf you ever experienced any allergic reaction (itch, rash etc.) to any medicine.If you present a condition indicative of bone marrow suppression (including leukopenia).If you have renal or hepatic dysfunction.If you have an infectious disease or diabetes.If you have a current or past history of interstitial pneumonia.If you have a heart disease or a history of heart disease.If you have gastrointestinal ulcers or hemorrhage.If you are using fluoropyrimidine-group anti-cancer drugs. (TS-1 and these medicines may interact strongly with each other and cause serious side effects.)If you use TS-1 after withdrawal of other fluoropyrimidine-group anti-cancer drugs. (An appropriate washout period must be provided in consideration of the influence of these prior agents.)If you are pregnant or breastfeeding.If you are using any other prescription or nonprescription (OTC) medicine. (It is important to reduce the risk of drug interactions.)Dosage regimen (proper use of this medicine)Your dosage regimen is:(order of your doctor)General dosage regimen: For adults, the initial dose is determined based on body surface area. This medicine is administered 40 mg of Tegafur for patients with under 1.25 m2 of body surface area; 50 mg of Tegaful for patients with 1.25 to 1.5 m2 of body surface area; 60 mg of Tegaful for patients with over 1.5 m2 of body surface area; twice daily after breakfast and dinner, for 28 consecutive days (4 weeks), followed by a 14-day (2 weeks) rest. This 6-week period is regarded as one course, which is repeated. The dose can be decreased or increased according to the patient's condition. Adjustment of the dose is determined 40, 50, 60, or 75 mg in incremental steps. The maximum dose is limited to 75 mg at a time, and the minimum dose is 40 mg at a time. This medicine contains 20 mg of Tegafur in a capsule. Strictly follow the instructions of your doctor/pharmacist.TS-1 must NOT be taken with other fluoropyrimidine-group anti-cancer drugs.Record your drug consumption, your physical condition and symptoms and show your records to your physician or pharmacist on your next visit.Missed dose: Proceed with the prescribed schedule of medication starting from the next dose. DO NOT take a double dose to make up for the missed dose.Overdose: If you took too much of this medicine (more than ordered), check with your doctor/pharmacist.Others: Do not change your dose and schedule of your chemotherapy without the instructions of your doctor.Precautions while using this medicineDuring the treatment, laboratory tests (hematological, liver and renal function tests) are performed regularly at least once every 2 weeks to detect asymptomatic side effects as early as possible. Be sure to consult your doctor.Side effects of this medicineCommon side effects are reported as below. If any of them occurs, check with your doctor/pharmacist:anorexia, nausea, vomiting, diarrhea, tiredness, stomatitis, pigmentation, rash, lacrimation, etc.In rare cases, symptoms described below may be the sign of side effects indicated in brackets [ ]. If they occur, stop taking your medicine and check with your doctor immediately.bleeding tendency, tiredness, fever, sore throat[bone marrow suppression]yellowing of the skin, tiredness, yellowing of the whites of the eyes, anorexia[severe hepatic dysfunction]diarrhea, severe abdominal pain[severe enteritis]difficult breathing, fever, dry cough[interstitial pneumonia]blood in stool, darkened stool, hematemesis, abdominal pain[gastrointestinal ulcer / gastrointestinal hemorrhage / gastrointestinal perforation]severe stomatitis, red rash, eyelid or eye redness[muco-cutaneo-ocular syndrome]Other side effects not listed here may occur. Check with your doctor/pharmacist if you have any worrisome symptom.Storage and other informationKeep the medicine out of the reach of babies, infants, and children. Store away from direct sunlight, heat, and humidity.Discard the remainder. Do not store them. Check with the pharmacy regarding how to discard.For further information, ask your doctor/pharmacist. "Kanjamuke Iyakuhin Guide" and Japanese package insert information (for medical professionals) is available on the website of Pharmaceuticals and Medical Devices Agency.
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