阿那曲唑(瑞宁得仿制药)ANASTROZOLE

药店国别:

产地国家:美国

处方药:

所属类别: 1毫克/片 90片/瓶

包装规格: 1毫克/片 90片/瓶

计价单位:

生产厂家中文参考译名:

生产厂家英文名:

原产地英文商品名:ANASTROZOLE(ARIMIDEX GENERIC) 1mg/Tablet 90Tablets/bottle

原产地英文药品名:ANASTROZOLE

中文参考商品译名:阿那曲唑(瑞宁得仿制药) 1毫克/片 90片/瓶

中文参考药品译名:阿那曲唑

简介

英文名:Anastrozole Tablets

主要成份:阿那曲唑片

适应证:适用于绝经后妇女的晚期乳腺癌的治疗。对雌激素受体阴性的病人,若其对他莫昔芬呈现阳性的临床反应,可考虑使用本品。适用于绝经后妇女雌激素受体阳性的早期乳腺癌的辅助治疗

用法用量:

成年人(包括老年人):每日一次,每次1片。儿童:本药不推荐儿童服用。肾功障碍:轻度至中度肾损害不用调整剂量。肝功障碍:轻度肝损害不用调整剂量。不良反应:本品通常容易为病人所耐受,副作用通常为轻度或中度,由于副作用导致的中断治疗很少见。

药理作用

可引起一些可预料的症状,包括皮肤潮红,阴道干涩和头发油脂过度分泌。本品还可引起胃肠功能紊乱(厌食恶心呕吐和腹泻)、乏力、忧郁、头痛或皮疹。阴道出血现象偶见报告,主要出现在患者从现有的激素疗法改为阿那曲唑治疗的前几周。如有持续出血现象,需进行一步的评价。阿那曲唑与血栓栓塞的发生无因果关系,在临床试验中用阿那曲唑1mg时血栓栓塞的发生率和醋酸甲地孕酮无明显差异,而用阿那曲唑10mg时血栓栓塞的发生率较醋酸甲地孕酮低。

在应用本品的晚期乳腺癌患者中有肝功能改变的报道(如转肽酶及碱性磷酸酶升高),但这些患者中许多人都已经有肝脏转移或骨转移。这些变化起因的研究尚未进行。临床观察表明本品可以轻微提高血浆总胆固醇水平。瑞宁得Arimidex(anastrozole)是第一种既可用于基础辅助治疗–直接用于乳癌术后—也可作为Tamoxifen跟进疗法的芳香酶抑制剂。瑞宁得Arimidex先前已被广泛用于基础辅助疗法。

对这一补充适应症的批准主要以三项试验数据为基础,据悉,这些临床试验结果显示,患者从Tamoxifen转为Aanstrozole后,疾病无进展存活率有显著提高。按照欧盟的相互承认程序,目前英国,德国,奥地利,葡萄牙,意大利及西班牙都批准了Arimidex的这一新适应症。

禁忌症:

本品禁用于以下情况:绝经前妇女。有严重肾损害的病人(肌酐清除率小于20ml/min) 。有中到重度肝损害的病人。已知对阿那曲唑及其包装合上所标示的各组份高敏的患者。与其它含有雌激素的疗法伍用,可降低本品之药效,所以禁止与其伍用。

注意事项:

有患者出现闭经应怀疑是激素水平生化学平衡破坏所致。对中度到重度肝损害病人及重度肾损害的病人(肌酐清除率小于20ml/min),尚无有关瑞宁得应用的安全性方面的资料。

药物之间相互作用:

安替匹林和甲氰脒胍药物临床相互作用的研究表明:瑞宁得同其他药物合用时不易引起由细胞色素P-450所介导的药物反应。临床试验尚未发现瑞宁得同其他临床常用药物之间有显著的相互影响。尚无证据表明瑞宁得是否应同其他抗肿瘤药物合用。含有雌激素的疗法可降低瑞宁得之疗效,故不宜同瑞宁得合用。

贮藏:

30度以下保存。效期:5年

英文版说明书

ARIMIDEXIMPORTANT NOTE:THE FOLLOWING INFORMATION IS INTENDED TO SUPPLEMENT, NOT SUBSTITUTE FOR, THE EXPERTISE AND JUDGMENT OF YOUR PHYSICIAN, PHARMACIST OROTHER HEALTHCARE PROFESSIONAL. IT SHOULD NOT BE CONSTRUED TO INDICATE THAT USE OF THE DRUG IS SAFE, APPROPRIATE, OR EFFECTIVE FOR YOU. CONSULT YOUR HEALTHCARE PROFESSIONAL BEFORE USING THIS DRUG.ANASTROZOLE – ORAL (ann-uh-STROW-zole)COMMON BRAND NAME(S):ArimidexUSES:This medication is used in the treatment of post-menopausal breast cancer in women.HOW TO TAKE THIS MEDICATION:Take this by mouth exactly as directed usually once a day. This is a potent medication. Do not increase your dose or take this more oftenthan directed.SIDE EFFECTS:Diarrhea, constipation, nausea, vomiting, loss of appetite, headache, hot flashes, dizziness, dry mouth, back pain, vaginal dryness and cough may occur. Changes in diet such as eating several small meals or limited activity may help lessen nausea and vomiting.In some cases, therapy with another drug may be necessary to prevent or relieve nausea. Notify your doctor if you experience:breathing trouble, rash, vaginal bleeding, shortness of breath, chest pain, pain or swelling in the legs, swelling of the feet or ankles, weight gain, tingling of the hands or feet, depression. If you notice other effects not listed above, contact your doctor or pharmacist.PRECAUTIONS:Before taking this, tell your doctor if you have: other illnesses, liver disease, any allergies. Use of this medication is notrecommended during pregnancy. Contraceptive (birth control) measures are recommended during therapy and for one month following.Discuss risks and benefits with your doctor. It is not known if this drug is excreted into breast milk. Consult your doctor before breast-feeding. This medication is not recommended for use in children.DRUG INTERACTIONS:Tell your doctor of any nonprescription or prescription medication you may take. Do not start or stop any medicine without doctor or pharmacist approval.OVERDOSE:If overdose is suspected, contact your local poison control center or emergency room immediately.NOTES:Keep all doctor appointments and scheduled laboratory tests as your condition will be closely monitored.MISSED DOSE:If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not “double-up” the dose to catch up.STORAGE:Store at room temperature between 59 and 86 degrees F (15 to 30 degrees C) away from heat and moisture as directed. Keep this and all medications out of the reach of children

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