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英文药名：Takecab Tablets（(Vonoprazan,TAK-438)
中文药名：富马酸沃诺拉赞片
生产厂家：武田制药
タケキャブ錠10mg／タケキャブ錠20mg
治疗类别名称
钾竞争性酸阻断剂 - 质子泵抑制剂 -
上市情况：2014年12月26日，富马酸沃诺拉赞在日本成功上市
商標名称：Takecab Tablets
药品名称:富马酸沃诺拉赞及片剂
英文名：Vonoprazan fumarate
药理作用
Vonoprazan属于钾离子(K+)竞争性酸阻滞剂(P-CAB)，是一种可逆的质子泵抑制剂，本品进入人体后，在胃壁细胞泌酸的最后步骤，通过抑制K+与H+-K+-ATP酶(质子泵)的结合，终止胃酸的分泌，达到抑酸效果，本品具有强劲、持久的抑制胃酸分泌作用。
适应症：
○胃溃疡，十二指肠溃疡，反流性食道炎，在低剂量阿司匹林给药，胃溃疡或十二指肠溃疡的复发抑制的时间胃溃疡或十二指肠溃疡的非甾体抗炎药给药时间反复抑制。
○根除幽门螺杆菌在以下的辅助
胃溃疡，十二指肠溃疡，胃MALT淋巴瘤，特发性血小板减少性紫癜，内镜切除早期胃癌术后胃，幽门螺旋杆菌感染性胃炎。
剂量和给药方法
以原处方口服为准！
包装规格
10mg ： 100錠（10錠×10）、140錠（14錠×10）、500錠（バラ、10錠×50）、700錠（14錠×50）
20mg ： 100錠（10錠×10）、140錠（14錠×10）、500錠（バラ、10錠×50）、700錠（14錠×50）
製造商
武田薬品工業株式会社 [联盟]大冢制药有限公司
http://www.info.pmda.go.jp/go/pack/2329030F1020_1_04/
Takecab Tablets (Vonoprazan Fumarate TAK-438)
Takecab Tablets 10mg（タケキャブ錠10mg）
Brand name : Takecab Tablets 10mg [agents for killing Helicobacter pylori]
Active ingredient: Vonoprazan fumarate
Dosage form: faint yellow oval tablet, major axis: 8.2 mm, minor axis: 4.7 mm, thickness: 3.4 mm
Print on wrapping: (Face)タケキャブ10mg B217, (Back)タケキャブ 10
Takecab Tablets 20mg（タケキャブ錠20mg）
Brand name : Takecab Tablets 20mg [agents for digestive organ]
Active ingredient: Vonoprazan fumarate
Dosage form: faint red oval tablet, major axis: 11.2 mm, minor axis: 6.2 mm, thickness 3.9 mm
Print on wrapping: (Face)タケキャブ20mg B218, (Back)タケキャブ 20
Effects of this medicine
This medicine inhibits the proton pump in a potassium ion-competitive manner and increases pH in the stomach to enhance antibacterial effects of antibacterial agents.
It is usually used concomitantly with two antibacterial agents in the treatment of Helicobacter pylori infection in gastric ulcer, duodenal ulcer, gastric MALT lymphoma, idiopathic thrombocytopenic purpura or after endoscopic therapy for early gastric cancer and Helicobacter pylori gastritis.
Before using this medicine, be sure to tell your doctor and pharmacist
•If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
If you have: liver/renal disorder.
•If you are pregnant or breastfeeding.
•If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)
Dosing schedule (How to take this medicine)
•Your dosing schedule prescribed by your doctor is <<to be written by a healthcare professional>>
•In general, for adults, take 2 tablets (20 mg of vonoprazan) at a time, twice a day for 7 days. Take this medicine together with two antibacterial medicines. Strictly follow the instructions.
•If you miss a dose, take the missed dose as soon as possible. If there is less than 5 hours to the next dose, skip the missed dose and follow your regular dosing schedule. You should never take two doses at one time.
•If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
•Do not stop taking this medicine unless your doctor instructs you to do so.
Precautions while taking this medicine
• Possible adverse reactions to this medicine
The most commonly reported adverse reactions include diarrhea, taste abnormality, stomatitis, stomach discomfort, enlarged feeling of abdomen and rash. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
•abdominal pain, frequent diarrhea [serious colitis]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.
Storage conditions and other information
•Keep out of reach of children. Store away from direct sunlight, heat and moisture.
•Discard the remainder. Do not store them.
Takeda Chemical Industries, Ltd.Internal
Published: 2/2015
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
富马酸沃诺拉赞片(Vonoprazan,TAK-438)Takecab Tablets （タケキャブ錠）
富马酸沃诺拉赞片(Vonoprazan,TAK-438) 富马酸沃诺拉赞片(Vonoprazan,TAK-438)Takecab Tablets （Vonoprazan Fumarate）
2015年2月27日，武田制药口服抗胃酸新药vonoprazan(TAK-438)是一种新一类胃酸分泌抑制剂,武田制药已于2014年2月28日向日本劳动卫生福利部（MHLW）提交了vonoprazan(TAK-438)的新药申请（NDA）.此次新药申请的提交是基于III期临床试验的良好数据。武田制药在日本已开展了数个III期临床试验，旨在调查TAK-438用于糜烂性食管炎、胃溃疡、十二指肠溃疡、幽门螺杆菌根除适应证的疗效。在临床试验中，TAK-438不仅表现出一定的疗效，同时具有良好的耐受性和安全性。
Vonoprazan(TAK-438)是一种属于钾离子（K+）竞争性酸阻滞剂（P-CAB）的新一类抑制剂，能够在胃壁细胞胃酸分泌的最后一步中，通过抑制K+对H+-K+-ATP酶（质子泵）的结合作用，提前终止胃酸的分泌，具有强劲、持久的抑制胃酸分泌作用。
目前，在日本，质子泵抑制剂（PPIs）已被广泛处方用于胃酸相关疾病的一线治疗。但PPI并不总是能够提供足够的疗效，而且抑制胃酸分泌效果常因人而异，这缘于参与PPI代谢的一种蛋白CYP-2C19，其编码基因在不同个体中具有基因多态性。而武田制药的该产品具有全新的靶点。TAK-438并不主要由CYP2C19代谢，同时TAK-438对质子泵的抑制作用无需酸的激活，以高浓度进入胃中，首次给药便能产生最大的抑制效应，且可持续24小时。TAK-438在酸中稳定，而速效配方现成，无需优化配方设计（如肠溶包衣），药效及起效剂量在不同患者中的差异并不显著。基于此，武田制药的TAK-438有望成为一种新的治疗药物，以解决当前酸相关疾病治疗中存在的问题.
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