英文药名：XELODA(Capecitabine Tablet) 中文药名：卡培他滨片 生产厂家：中外制药 ゼローダ錠300 药品分类 -抗肿瘤药- 批准上市日期：2003年6月 商標名 XELODA 一般名 カペシタビン（Capecitabine）（JAN） 化学名 (+)-pentyl 1-(5-deoxy-β-D-ribofuranosyl)-5-fluoro-1,2-dihydro-2-oxo-4-pyrimidinecarbamate 構造式 分子式 C15H22FN3O6 分子量 359.35 性　状 白色粉末。它非常易溶于甲醇，易溶于乙醇或苄醇（99.5），和微溶于水。 熔点 约120℃（分解） 审批条件 在日本的临床试验中实施适当的后期营销，包括临床去氧氟尿苷定位这种药物，目的是进一步明确该药物的安全性和有效性。 药理作用 卡培他滨本身无细胞毒性，而是在体内经过三步酶促反应途径转化为活性分子5-FU后发挥抗肿瘤作用。 适应证 1.乳腺癌，目前主要用于对紫杉醇和含蒽环类方案耐药的晚期乳腺癌。 2.结、直肠癌。 用法用量 推荐剂量为单药每天2500mg/m2，分早、晚两次口服，连用2周，休息1周为1个周期。 完整资料附件：http://www.info.pmda.go.jp/go/pack/4223005F1022_1_22/ XELODA Tablet 300 Manufacturer's name : Chugai Pharmaceutical Co., Ltd. 610470009 Revised: 09/2011 Brand name : XELODA Tablet 300 　Active ingredient: Capecitabine 　Dosage form: white tablet (major axis: approx. 13.4 mm, minor axis: approx. 7.1 mm, thickness: approx. 4.8 mm) 　Printings on wrapping: NR450 ゼローダ300 Effects of this medicine This medicine is metabolized by enzymes which abound in malignant tumors, acts on the tumors effectively, and interferes with growth of the tumors. It is usually used for treatment of inoperable or recurrent breast cancer, for postoperative adjuvant chemotherapy for colon cancer, for treatment of advanced or recurrent colorectal cancer which is not amenable to curative resection, and for treatment of advanced or recurrent gastric cancer which is not amenable to curative resection. Before using this medicine, tell your doctor/pharmacist If you ever experienced any allergic reaction (itch, rash etc.) to any medicine. If you had been receiving treatment with combined ingredient of tegafur, gimeracil and oteracil potassium within the last 7 days. If you have renal or hepatic disorder, myelosuppression, or gastrointestinal ulcer/bleeding. If you have ever had a coronary artery disease. 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 treatment of inoperable or recurrent breast cancer: Take the medicine according to the following regimen A or B. -Regimen A: According to the body surface area, take 3 to 5 tablets (900 to 1,500 mg of the active ingredient) at a time, twice a day, within 30 minutes after breakfast and dinner. "Take the medicine for consecutive 21 days and after that discontinue taking the medicine for 7 days", and repeat this dosing schedule. Strictly follow the instructions of your doctor/pharmacist. -Regimen B: According to the body surface area, take 5 to 8 tablets (1,500 to 2,400 mg) at a time, twice a day, within 30 minutes after breakfast and dinner, however, the dosage may be decreased according to the symptoms. "Take the medicine for consecutive 14 days and after that discontinue taking the medicine for 7 days", and repeat this dosing schedule. Strictly follow the instructions of your doctor/pharmacist. For postoperative adjuvant chemotherapy for colon cancer: According to the body surface area, take 5 to 8 tablets (1,500 to 2,400 mg) at a time, twice a day, within 30 minutes after breakfast and dinner, however, the dosage may be decreased according to the symptoms. "Take the medicine for consecutive 14 days and after that discontinue taking the medicine for 7 days", and repeat this dosing schedule. Strictly follow the instructions of your doctor/pharmacist. For treatment of advanced or recurrent colorectal cancer, which is not amenable to curative resection: It is used along with other anti-malignant tumor medicines. According to the body surface area, take 4 to 7 tablets (1,200 to 2,100 mg) at a time, twice a day, within 30 minutes after breakfast and dinner, however, the dosage may be decreased according to the symptoms. "Take the medicine for consecutive 14 days and after that discontinue taking the medicine for 7 days", and repeat this dosing schedule. Strictly follow the instructions of your doctor/pharmacist. For treatment of advanced or recurrent gastric cancer, which is not amenable to curative resection: It is used along with a platinum-based regimen. According to the body surface area, take 4 to 7 tablets (1,200 to 2,100 mg) at a time, twice a day, within 30 minutes after breakfast and dinner, however, the dosage may be decreased according to the symptoms. "Take the medicine for consecutive 14 days and after that discontinue taking the medicine for 7 days", and repeat this dosing schedule. Strictly follow the instructions of your doctor/pharmacist. Missed dose: Skip the missed dose and continue your regular dosing schedule. DO NOT take double doses to make up for the missed dose. Overdose: If you took too much of the medicine (more than ordered), check with your doctor/pharmacist. The medicine may cause serious nausea, vomiting, diarrhea, mucositis, gastrointestinal stimulus or bleeding, or myelosuppression. Others: Do not stop taking the medicine without the instructions of your doctor. Precautions while using this medicine The medicine may decrease the immune system, and is likely to cause infections such as cold. Take enough care, such as to avoid being in crowd, to wash the hands and to gargle after returning home. Avoid breastfeeding. Side effects of this medicine Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: hand-foot syndrome, nausea, loss of appetite, diarrhea, stomatitis, peripheral sensory neuropathy, fatigue, pigmentation disorder, etc.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. lassitude, thirst, hyperventilation, shaky hands and fingers, decreased urinary volume, faint consciousness, impaired mind/judgment[dehydration] sensitivity or insensitivity, redness and swelling, pain, skin strip, blister, skin sore on the palms of the hands and/or the soles of the feet[hand-foot syndrome] lassitude, swollen body, cold sweat, dizziness, easy breathing in upright position, breathlessness, shortness of breath, palpitation, palpitation when moving, chest pain, anginal pain, chest pressured/constrictive feeling, strong chest oppressive feeling, sense of being compressed strongly on the chest suddenly, faint[cardiac disorder] lassitude, yellowness in the skin and/or the white of the eyes, itch, dark or brown urine, loss of appetite, nausea, vomiting[hepatic disorder, jaundice] headache, swollen face/eyelids, decreased urinary volume[renal disorder] lassitude, fever, gum/nose bleeding, shortness of breath, blue spot, prolonged bleeding, bleeding tendency[myelosuppression] mucosa irritation in the mouth[stomatitis] dry cough, breathlessness, shortness of breath, fever[interstitial pneumonia] severe abdominal pain, diarrhea, bloody stool, fever, feeling sick at the stomach, nausea, vomiting, enlarged feeling of abdomen[serious enteritis (hemorrhagic/ischemic/necrotizing enteritis, etc.)] memory loss, lightheadedness, absent-mindedness, difficulty memorizing, difficulty speaking, loss of consciousness, convulsion[serious psychoneurotic disorder (leukoencephalopathy, etc.)] paralysis/numbness of the limbs, difficulty speaking, chest pain, breathing difficulty, sudden pain/swelling in one leg, back pain[thrombosis] lassitude, loss of appetite, high fever, fever, red rash with dropsical swelling in the center, red rash, inflamed eye and eyelid, conjunctival sore, severe stomatitis, lip/intraoral sore, pain in the genitalia[mucocutaneous ocular syndrome (Stevens-Johnson syndrome)] Other side effects not listed here may occur. Check with your doctor/pharmacist if you have any worrisome symptom. Storage and other information Keep out of the reach of children. Store at room temperature (1 to 30℃), away from direct sunlight and moisture. Discard the remainder. Do not store them. Ask the pharmacist 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. 卡培他滨是一个新型氟尿嘧啶类药物，采用口服给药的方法，方便，患者不需住院。它能够模拟持续输注5-FU的抗肿瘤作用，并且由于其独特的代谢特点，使得药物在肿瘤部位优先活化，既增强疗效，又减少了毒性反应，治疗指数高于5-Fu及脱氧氟尿苷。一项随机研究(44名阿霉素治疗失败的乳腺癌)显示，卡培他滨组有效率为36%，包括3名CR；紫杉醇组有效率为21%，无一例CR。目前该药主要用于耐药的乳腺癌及结直肠癌，对其他恶性肿瘤的疗效及联合用药尚在观察中。 ----------------------------------------------------------- 产地国家: 日本 原产地英文商品名: XELODA（ゼローダ錠） 300mg/Tablet，140Tablets 原产地英文药品名: CAPECITABINE 中文参考商品译名: 希罗达（ゼローダ錠） 300毫克/片 140片/盒 中文参考药品译名: 卡培他滨 生产厂家中文参考译名: 中外制药 生产厂家英文名: Chugai Pharmaceutical ----------------------------------------------------------- 产地国家: 日本 原产地英文商品名: XELODA（ゼローダ錠）300mg/Tablet 56Tablets 原产地英文药品名: CAPECITABINE 中文参考商品译名: 希罗达（ゼローダ錠）300毫克/片 56片/瓶 中文参考药品译名: 卡培他滨 生产厂家中文参考译名: 中外制药 生产厂家英文名: Chugai Pharmaceutical