米托坦片mitotane(Lysodren 500mg Tablets)

产地国家：美国

处方药：是

所属类别： 500毫克/片 100片/瓶

包装规格： 500毫克/片 100片/瓶

计价单位：瓶

生产厂家英文名：BRISTOL MYERS SQUIBB

原产地英文商品名：LYSODREN 500MG TAB 100/EA

原产地英文药品名：MITOTANE

中文参考商品译名：LYSODREN 500毫克/片 100片/瓶

中文参考药品译名：米托坦

简介：

Lysodren（mitotane 中文名：米托坦片）是目前唯一被美国FDA批准用于治疗肾上腺皮质癌（ACC）的药物用于治疗肾上腺癌批准日期：2009年6月1日，公司：Bristol-Myers SquibbLYSODREN（米托坦[mitotane]）片剂，用于口服最初的美国批准：1970年警告：在设置电击或严重创伤时出现肾上腺危象请参阅完整的警告信息。

在服用LYSODREN的患者中，肾上腺危象发生在休克或严重创伤的情况下，并且对休克的反应受损。给予氢化可的松，监测升高的休克迹象并停止LYSODREN直至恢复。最近的重大变化绝经前妇女的卵巢巨噬细胞：5/2017作用机制Mitotane是一种肾上腺细胞毒性剂，具有未知的作用机制。 Mitotane改变类固醇的外周代谢并直接抑制肾上腺皮质。 已经报道了在没有降低皮质类固醇浓度和增加6-β-羟基皮质醇形成的情况下17-羟基皮质类固醇的减少。

适应症和用法：LYSODREN是一种肾上腺细胞毒性剂，适用于治疗不能手术，功能性或非功能性肾上腺皮质癌。

剂量和给药：初始剂量，每日口服2g至6g，分三次或四次。逐渐增加剂量以达到血液浓度为14至20mg/L或耐受。

剂量形式和强度：片剂，500mg

禁忌症：没有

警告和注意事项：（1）中枢神经系统（CNS）毒性：血浆浓度超过20mcg/mL与毒性发生率增加有关。（2）肾上腺功能不全：根据临床指征进行类固醇替代治疗。测量游离皮质醇和促肾上腺皮质激素（ACTH）水平，以实现最佳的类固醇替代。（3）胚胎 - 胎儿毒性：可能导致胎儿伤害。向生育潜力的女性提供胎儿潜在风险和使用有效避孕措施的建议。（4）绝经前妇女的卵巢巨噬细胞：建议妇女在经历阴道出血和/或骨盆疼痛等妇科症状时寻求医疗建议。

不良反应：常见的不良反应（≥15％）包括：厌食，恶心，呕吐和腹泻；抑郁，头晕或眩晕;和皮疹。

药物相互作用：根据需要调整伴随的香豆素类抗凝剂的剂量。

用于特定人群：（1）哺乳期，不要母乳喂养。

存储：LYSODREN片剂以500毫克白色，圆形，双凸面，刻痕片形式提供，一面一分为二，另一面用“BL”压印“BL”。每瓶100粒：NDC 0015-3080-60将瓶子存放在25°C（77°F）; 允许的偏差在15°C至30°C（59°F至86°F）之间。

英文版说明书

LYSODREN(mitotane) tablets, for oral useIndication and Important Safety InformationLYSODREN® is an adrenal cytotoxic agent indicated for the treatment of inoperable, functional or nonfunctional, adrenal cortical carcinoma.Warning/Adrenal crisis in the setting of shock or severe trauma: In patients taking LYSODREN®, adrenal crisis occurs in the setting of shock or severe trauma and response to shock is impaired. Administer hydrocortisone, monitor for escalating signs of shock and discontinue LYSODREN® until recovery.CNS Toxicity: CNS toxicity, including sedation, lethargy, and vertigo, occurs with LYSODREN® treatment. Mitotane plasma concentrations exceeding 20 mcg/mL are associated with a greater incidence of toxicity.Adrenal Insufficiency: Treatment with LYSODREN® can cause adrenal insufficiency. Institute steroid replacement as clinically indicated.Measure free cortisol and corticotropin (ACTH) levels to achieve optimal steroid replacement.Embryo-Fetal Toxicity: LYSODREN® can cause fetal harm when administered to a pregnant woman. Abnormal pregnancy outcomes, such as preterm births and early pregnancy loss, can occur in patients exposed to mitotane during pregnancy. Advise females of reproductive potential to use effective contraception during treatment with LYSODREN® and after discontinuation of treatment for as long as mitotane plasma levels are detectable.Ovarian Macrocysts in Premenopausal Women: Ovarian macrocysts, often bilateral and multiple, have been reported in premenopausal patients receiving LYSODREN®. Complications from these cysts, including adnexal torsion and hemorrhagic cyst rupture, have been reported. In some cases, improvement after mitotane discontinuation has been described.Lactation: Mitotane is excreted in human milk; however, the effect of LYSODREN® on the breastfed infant, or effect on milk production is unknown.Because of the potential for serious adverse reactions in the breastfed infant, advise nursing women that breastfeeding is not recommended during treatment with LYSODREN® and after discontinuation of treatment for as long as mitotane plasma levels are detectable.Hepatic Impairment: Administer LYSODREN® with caution to patients with hepatic impairment.Common adverse reactions (³15%) include: anorexia, nausea, vomiting and diarrhea; depression, dizziness or vertigo; and rash. LYSODREN® is a cytotoxic drug. Follow applicable special handling and disposal procedures.