托瑞米芬柠檬片Fareston Tablets 60mg(toremifene citrate)

药店国别： 产地国家：美国 处方药：是 所属类别： 60毫克/片 30片/盒 包装规格： 60毫克/片 30片/盒 计价单位：盒 生产厂家中文参考译名： 生产厂家英文名：PROSTRAKAN INC 原产地英文商品名：FARESTON 60MG TAB 30/EA 原产地英文药品名：TOREMIFENE CITRATE 中文参考商品译名：FARESTON 60毫克/片 30片/盒 中文参考药品译名：盐酸托瑞米芬柠檬

简介

部份中文盐酸托瑞米芬柠檬处方资料(仅供参考) 英文名：toremifene citrate 商品名：FARESTON Tablets 中文名：盐酸托瑞米芬柠檬片 生产商：KYOWA KIRIN INC 药品介绍 FARESTON(托瑞米芬柠檬酸盐【toremifene citrate】60mg片剂口服给药美国最初批准：[1997] 警告： QT延长FARESTON已显示以剂量和浓度相关的方式延长QTC间隔[见临床药理学]。 QT间期的延长可导致一种心室心动过速的TORSADE DE POINT，这可能导致同步，癫痫和/或死亡。对于患有先天性/获得性QT延长，未经检查的低血糖症或不明原因的低血糖症的患者，不应给予TOREMIFENE。应该避免延长QT间期和强CYP3A4抑制剂的药物[见警告和预防措施]。最近的重大变化警告和注意事项：肝毒性：05/2017 警告和注意事项： 子宫恶性肿瘤风险 作用机制 托瑞米芬是一种非甾族三苯乙烯衍生物。 托瑞米芬与雌激素受体结合并可以发挥雌激素，抗雌激素或两者的活性，这取决于治疗的持续时间，动物种类，性别，靶器官或所选择的终点。 然而，一般而言，非甾体三苯乙烯衍生物在大鼠和人中主要是抗雌激素的并且在小鼠中是雌激素的。在大鼠中，托瑞米芬导致已建立的二甲基苯并蒽(DMBA)诱导的乳腺肿瘤消退。认为托瑞米芬在乳腺癌中的抗肿瘤作用主要是由于其抗雌激素作用，即其与雌激素竞争癌症中结合位点的能力，阻断雌激素在肿瘤中的生长刺激作用。 适应症和用法 FARESTON®是一种雌激素激动剂/拮抗剂，适用于治疗雌激素受体阳性或未知肿瘤的绝经后妇女的转移性乳腺癌。 剂量和给药 每日一次60毫克，口服剂量形式和强度60毫克片剂是圆形，凸形，未刻痕，未涂层，白色或几乎白色，一侧用TO 60压花。禁忌症对药物过敏QT延长，低钾血症，低镁血症 警告和注意事项 延长QT间隔Heptatotoxicty高钙血症和肿瘤发作子宫恶性肿瘤的风险一般实验室测试怀孕：给孕妇服用时可能会发生胎儿伤害。建议女性在服用FARESTON时不要怀孕。育龄妇女：在FARESTON治疗期间使用有效的非激素避孕药。 不良反应 最常见的不良反应是潮热，出汗，恶心和阴道分泌物。 药物相互作用 减少肾钙排泄的药物，例如噻嗪类利尿剂，可能会增加接受FARESTON的患者的高钙血症风险。应避免使用延长QT的药剂。与强CYP3A4诱导剂共同给药可能导致FARESTON暴露相关减少，应该避免。与强CYP3A4抑制剂共同给药可导致FARESTON暴露相关增加，应予以避免。应谨慎使用具有较窄治疗指数的CYP2C9底物，如华法林或含有FARESTON的苯妥英，并需要仔细监测。 用于特定人群护理母亲： 考虑到药物对母亲的重要性，停止使用药物或护理。 供应/储存和处理 ARESTON含有相当于60mg托瑞米芬的托瑞米芬柠檬酸盐的片剂是圆形，凸形，未刻痕，未涂层，白色或几乎白色。

英文版说明书

Fareston(toremifene citrate) 60 mg Tablets isImportant Safety Information And Boxed WarningIndicationFareston® (toremifene citrate) 60 mg Tablets is an estrogen agonist/antagonist for the treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor-positive or unknown tumors.WARNING: QT PROLONGATIONFareston has been shown to cause a change in heart rhythm (QT prolongation). This change can lead to fainting, seizures, and/or death. Do not take Fareston if you were born with or have a history of irregular heartbeats. Do not take Fareston if you have low blood potassium levels or low blood magnesium levels that are currently not corrected by treatment. There are certain medicines that should not be taken with Fareston. Talk to your doctor about all the other medicines you are taking.Do not take Fareston if you are allergic to Fareston or any of its ingredients. You should not take Fareston if you have a history of abnormal heart rhythms (arrhythmias), are taking other medicines that can result in abnormal heart rhythms, or were born with or have had any condition that causes abnormal heart rhythms. Do not take Fareston if you have a salt imbalance in the blood, especially low concentrations of potassium (hypokalemia) or low concentrations of magnesium in the blood (hypomagnesemia) that are currently not corrected by treatment. Periodic complete blood counts, calcium levels, and liver function tests should be obtained.Talk to your doctor before taking Fareston if you have bone metastasis or increased concentration of calcium in the blood (hypercalcemia), which may occur at the beginning of your treatment. Also talk to your doctor if you have a history of thickening of the womb lining. If you are pregnant, nursing, or may become pregnant, do not take Fareston, as it may cause fetal harm. You should not take Fareston if you have had or are at risk for getting blood clots in the legs, lungs, or eyes, as it may increase the risk of blood clots. If you have leg pain or warmth; swelling of the legs, hands or feet; chest pain; shortness of breath; or a sudden vision change, stop taking Fareston and call your doctor, as these may be signs of a blood clot. The most common side effects of Fareston are hot flashes, sweating, nausea, and vaginal discharge.