英文药名：S-1Meiji Combination Capsules T20/T25（Tegafur/Gimeracil/Oteracil Potassium）

中文药名：替加氟/吉莫斯特/氧嗪酸钾配合胶囊

日文药名：エスワンメイジ配合カプセルT20／T25

生产厂家：明治制果制药
类别名称
代谢拮抗剂
1.替加氟
性　状
替加氟是一种白色结晶粉末。
此产品是易于微溶于甲醇或丙酮，难溶于水或乙醇（95）。
此产品可溶于稀氢氧化钠TS中。
这款产品的甲醇溶液（1→50）没有显示出旋光。
一般名
テガフール　Tegafur
化学名
5-Fluoro-1-［（2RS）-tetrahydrofuran-2-yl］uracil
分子式
C8H9FN2O3
分子量
200.17
構造式

融　点
166～171℃
2.吉莫斯特
性　状
吉莫斯特为白色结晶粉末。
此产品是N，N-二甲基甲酰胺，以容易难溶，难溶在甲醇中，在乙醇（99.5）微溶，在极微溶于水。
一般名
ギメラシル　Gimeracil
化学名
5-Chloro-2,4-dihydroxypyridine
分子式
C5H4ClNO2
分子量
145.54
構造式

融　点
約262℃（分解）
3.氧嗪酸钾
性　状
氧嗪酸钾为白色结晶粉末。
该产品是在水中微溶，几乎不溶于甲醇或乙醇（99.5）。
一般名
オテラシルカリウム　Oteracil Potassium
化学名
Monopotassium 1,2,3,4-tetrahydro-2,4-dioxo-1,3,5-triazine-6-carboxylate
分子式
C4H2KN3O4
分子量
195.17
構造式

操作注意事项
即使在到期日开盘后是要尽快使用会。
稳定性试验
使用结果的包装产品（40℃，相对湿度75％，6个月）加速试验，Esuwan明治制定胶囊T20和Esuwan明治制定胶囊T25，据估计，在正常的市场发行了3年稳定在。
条件批准
根据所提交的实施计划，对于有关代理人进行（专项调查和上市后的临床试验）等的血药浓度波动程度适当的上市后监测的因素和信息，并安全地进行数据的收集，它被尽快提交的结果。
适应病症
胃癌
用法与用量
通常情况下，按照初始剂量（量一次）体表面积作为下一个参考量，早餐后和两次晚饭后一天的成年人，每天连续28天口服给药，然后停药14天。重复给药，本为一疗程。
体表面积：小于1.25平方米
最初的参考量（替加氟相当数量）：40毫克/次
体表面积：1.25平方米以上且小于1.5平方米
最初的参考量（替加氟相当数量）：50毫克/次
体表面积：1.5平方米更多
最初的参考量（替加氟相当数量）：60毫克/次
所述剂量可根据病人的情况进行调整。以增加或减少阶段的量的40毫克，50毫克，60毫克和75毫克/次。初始如果延长临床实验室异常（验血，肝，肾功能检查）被确定为是由于这种药物和不表达消化系统症状的施用，存在安全性没有问题，则确定可以增加与从基准量的一个步骤，它被限制为75毫克/次。此外，通常进行一步一步的最低剂量和40毫克/次。
包装规格
配合胶囊：T20
PTP包装56胶囊（14粒×4板） 140胶囊（14粒×10片）
配合胶囊:T25
PTP包装56胶囊（14粒×4板） 140胶囊（14粒×10片)

制造厂商
明治制果制药社
S-1Meiji Combination Capsules T20/T25（Tegafur/Gimeracil/Oteracil Potassium）
S-1Meiji Combination Capsules T20（エスワンメイジ配合カプセルT20）
Brand name : S-1Meiji Combination Capsules T20
　Active ingredient: Tegafur
 Gimeracil
 Oteracil potassium
　Dosage form: white capsule, full length: 14.5 mm, diameter: 5.2 mm
　Print on wrapping: エスワンメイジ配合T20, MS058, S-1Meiji Combination T20
S-1Meiji Combination Capsules T25（エスワンメイジ配合カプセルT25）
Brand name : S-1Meiji Combination Capsules T25
　Brand name : S-1Meiji Combination Capsules T25
　Active ingredient: Tegafur
 Gimeracil
 Oteracil potassium
　Dosage form: orange/white capsule, full length: 14.5 mm, diameter: 5.2 mm
　Print on wrapping: エスワンメイジ配合T25, MS059, S-1Meiji Combination T25
Effects of this medicine
This medicine is biotransformed into fluorouracil (anticancer drug) in the body, enhances antitumor activity by increased concentration and relieves gastrointestinal toxicities (side effects).
It is usually used to treat gastric cancer.
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: marrow depression (including leukopenia), renal or hepatic disorder, infectious disease, diabetes mellitus, current/history of interstitial pneumonia, current/history of cardiac disease, gastrointestinal ulcers or bleeding.
If you are transferring the medicine from fluoropyrimidine-group anti-cancer medicine to this medicine.
•If you are pregnant, potentially 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>>
•For adults: In general, take this medicine twice a day after breakfast and dinner for 28 consecutive days, followed by 14-day rest. This is repeated as one course but it may change according to the condition. Initial standard dose of tegafur is determined based on body surface area (BSA) as follows: 40 mg per dose for patients with a BSA less than 1.25 m2; 50 mg per dose for patients with a BSA 1.25 m2 to less than 1.5 m2; 60 mg per dose for patients with a BSA equal to or greater than 1.5 m2. The dosage may be adjusted to 40 mg, 50 mg, 60 mg or 75 mg for single dose. The maximum single dose should not exceed 75 mg, with the minimum dose of 40 mg. This preparation contains 25 mg of tegafur in a capsule. Strictly follow the instructions.
•You should never take any fluorinated pyrimidine medicine together with this medicine.
•Take memos about your medication status, health condition, and any symptoms you have noticed, and show those memos to your doctor or pharmacist at visits.
•If you miss a 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
•During the treatment, laboratory tests (hematological, liver and renal function test, etc.) are performed regularly at least once every 2 weeks to detect asymptomatic adverse reactions as early as possible. Be sure to keep your visiting schedule.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include loss of appetite, nausea, vomiting, diarrhea, general malaise, stomatitis, pigmentation, rash and lacrimation. 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.
•prolonged bleeding, general malaise, fever, sore throat [marrow depression]
•yellowing of the skin, general malaise, yellowing of the white of eyes, loss of appetite [serious liver disorder]
•diarrhea, severe abdominal pain [serious enteritis]
•respiratory distress, fever, dry cough  [interstitial pneumonia]
•bloody stool, black stool, vomiting of blood, abdominal pain [serious stomatitis, gastrointestinal ulcer/bleeding/perforation]
•severe stomatitis, red rash, hyperemia of the eyelid and eyes  [toxic epidermal necrolysis, muco-cutaneo-ocular syndrome]
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 the reach of children. Store away from direct sunlight, heat and moisture.
•Discard the remainder. Do not store them. Seek advice of your pharmacy or medical institution about proper disposal of the unused medicines.
Meiji Seika Pharma Co., Ltd.Internal
Published: 12/2013
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.
http://www.info.pmda.go.jp/go/pack/4229101M1076_1_03/