英文药名：NKS-1 combination capsule T20/T25（Tegafur/Gimeracil/Oteracil Potassium）
中文药名：复方替加氟/吉莫斯特/氧嗪酸钾胶囊
生产厂家：日本化药有限公司
エヌケーエスワン配合カプセルT20／エヌケーエスワン配合カプセルT25
治疗类别名称
代谢拮抗剂
商標名
NKS-1 combination capsule T20
NKS-1 combination capsule T25
1. 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
性状
它是一种白色结晶粉末。微溶于甲醇或丙酮，难溶于水或乙醇（95）。溶于稀氢氧化钠TS中。甲醇溶液（1→50）示出了没有旋光性。
2. 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
性状
它是一种白色结晶粉末。易溶于二甲亚砜，N，N-二甲基甲酰胺，以容易难溶，难溶在甲醇，乙醇（99.5），微溶于1,3-二甲基-2-咪唑啉酮或水。
3. 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
性状
它是一种白色结晶粉末。微溶于水，并在乙醇（99.5），甲醇几乎不溶。
操作注意事项
稳定性试验
使用的结果，外观和内容等的最终包装产品（40℃，相对湿度75％，6个月）的加速试验是标准的范围内，NTT电缆Esuwan配制胶囊T20和NTT电缆Esuwan配制胶囊T25是正常的市场在一个稳定的三岁以下的分布被推测。
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，它被尽快提交结果尽可能。
适应病症
用于治疗胃癌
用法用量
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，减肥通常进行一步一步的最低剂量和40毫克/次。
包装规格
T20：56胶囊（14cap×4张），84胶囊（14cap×6片），140胶囊（14cap×10片）
T25：56胶囊（14cap×4张），140胶囊（14cap×10片）
制造商
日本化药有限公司
NKS-1 combination capsule T20/T25（Tegafur/Gimeracil/Oteracil Potassium）
NKS-1 combination capsule T20（エヌケーエスワン配合カプセルT20）
Brand name : NKS-1 combination capsule T20
Active ingredient: Tegafur
Gimeracil
Oteracil potassium
Dosage form: white capsule (No. 4 capsule), total length 14.5 mm, long diameter 5.2 mm, short diameter 5.0 mm, weight about 179 mg
Print on wrapping:
NKS-1 combination capsule T25（エヌケーエスワン配合カプセルT25）
Brand name : NKS-1 combination capsule T25
Active ingredient: Tegafur
Gimeracil
Oteracil potassium
Dosage form: white/orange capsule (No. 4 capsule), total length 14.5 mm, long diameter 5.2 mm, short diameter 5.0 mm, weight about 214 mg
Print on wrapping:
Effects of this medicine
This medicine is biotransformed into fluorouracil (anti-cancer drug), 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 bone marrow suppression (including leukopenia), renal/hepatic disorder, infectious disease, diabetes, gastrointestinal ulcers or hemorrhage.
If you have a current or past history of interstitial pneumonia or heart disease.
If you are using fluoropyrimidine-group drugs. (NKS-1 and fluropyrimidine-group drugs may interact strongly with each other and cause serious side effects.)
If your medicine was switched from fluropyrimidine-group drugs to this medicine (NKS-1). (An appropriate washout period must be provided in consideration of the influence of these prior agents.)
•If you are pregnant, breastfeeding or possibly pregnant.
•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, the initial dose is determined based on body surface area as follows: 40 mg of Tegafur for patients with under 1.25 m2 of body surface area; 50 mg of Tegafur for patients with 1.25 to 1.5 m2 of body surface area; 60 mg of Tegafur for patients with over 1.5 m2 of body surface area. The medicine is administered twice daily after breakfast and dinner, for 28 consecutive days, followed by a 14-day rest. This is regarded as one course, which is repeated. The dose can be decreased or increased according to the patient's condition in stages of: 40, 50, 60, or 75 mg. The maximum dose is limited to 75 mg at a time, and the minimum dose is 40 mg at a time. This medicine contains 25 mg of Tegafur in a capsule. Strictly follow the instructions.
•This medicine must NOT be taken with other fluoropyrimidine-group anticancer drugs.
•Record your drug consumption, your physical condition and symptoms, and show your records to your physician or pharmacist on your next visit.
•If you miss a dose, skip the missed dose and continue 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 tests) are performed regularly at least once every 2 weeks to detect asymptomatic side effects 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, dullness, 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.
•bleeding tendency, dullness, fever, sore throat [bone marrow depression, haemolytic anaemia]
•yellowness in the skin, dullness, yellowness in the whites of the eyes, loss of appetite [serious liver disorder]
•diarrhea, severe stomachache [serious enteritis]
•breathlessness, fever, dry cough [interstitial pneumonia]
•sore in the mouth, blood in stool, darkened stool, hematemesis, stomachache [serious stomatitis, gastrointestinal ulceration, gastrointestinal hemorrhage, gastrointestinal perforation]
•severe stomatitis, red rash, redness of the eyelid/eye [toxic epidermal necrolysis, oculomucocutaneous 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. Ask the pharmacist or healthcare facility how to discard them.
NIPPON KAYAKUInternal
Published: 6/2013
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/4229101M1050_1_03/