米托坦片Mitotane(Lysodren 500mg tablets)

产地国家：法国

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：HRA Pharma UK and Ireland Limited

原产地英文商品名：Lysodren 500mg/tablets 100tablets

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

部份中文米托坦处方资料（仅供参考）

别 名：氯苯二氯乙烷、曼托坦、密妥坦 (米托坦) 解腺瘤片,解腺瘤、Chloditan、Chlonlithane。

商品牌子名：LYSODREN TAB 500MG

药物制造商：Bristol-Myers Squibb

剂型：药片

孕妇用药分级：C

药理：本品结构与杀虫药DDT和DDD相似，可使肾上腺皮质萎缩和坏死。给予本品后可使体内肾上腺皮质激素及其代谢产物水平迅速下降，可用于肾上腺瘤或肾上腺增生引起的枯氏综合征。口服约40%由胃肠道吸收，其余60%以原型随粪便排出。每日5～10g，血药浓度可达10～90μg/ml，代谢物浓度30～50。停药6～9μg/ml周后，血浆中仍可测到邻氯烷。本品脂溶性高，主要储存于脂肪中。从尿中排出的水溶性代谢物约占给药量的25%。

适应证：无法手术的、功能性和非功能性肾上腺皮质癌、肾上腺皮质增生以及肿瘤所致的皮质醇增多症。

剂量：对於18岁以下的儿童，此药的疗效及安全性尚未完全确定，医生会视乎患者的体重或身体表面面积来决定每日服用的剂量成人每日剂量為1至6克(可分3至4次服)，及后可逐步递增至每日8至10克。一般建议每日最高剂量為18克,5-10周为一疗程.

用药禁忌：对此药有过敏反应者不宜服用。

用药注意：对於轻微至中等程度的肝臟或肾臟受损的患者，剂量可能需要根据药物的血液浓度相应下调；对於严重程度的肝臟或肾臟受损的患者则不建议服用此药。

常见副作用：抑制中枢神经系统、眩晕、嗜睡、皮肤出疹、食慾不振、噁心、呕吐、腹泻等其他副作用：头痛、高血压、体位性低血压、抑鬱、神志不清、肌肉震颤、出血性膀胱炎等

药物相互作用：

1. Spironolactone (螺内酯)可降低此药的疗效，故不建议同时使用

2. 酒精、第一代抗组织胺药物(sedative antihistamine)、镇静安眠药、吗啡类止痛药、抗癲癇症药等具中枢神经系统抑制的作用，合併使用可增加相关的副作用如嗜睡、眩晕等

3. 此药可增加肝臟对某些药物(如部份抗癲癇症药物、巴比妥类药物、Warfarin华法林等)的代谢，合併使用可使后者的药效下降，故需特别监察

4. 服药者在使用其他药物前请先征询医生意见

病患及家属注意事项：

a. 此药乃化疗药物，在处理及弃置药物时须小心谨慎

b. 接触药物时最好配戴可弃置的手套，避免由孕妇处理药物

c. 饱肚服用此药可增加吸收

d. 此药可抑制中枢神经系统，引致嗜睡、眩晕等，故在服药期间儘量避免驾驶或操作机械等需要高度精神集中力的活动

e.服药期间可能出视肾上腺皮质功能不全 (adrenocortical insufficiency)，需要时医生会為个别病人处方适当剂量的皮质激素作补充

f. 服药者如出现感染、创伤或其他疾病，应立即找医生诊治，以避免出现急性肾上腺皮质功能不全

储存：贮法密闭、干燥，于阴凉处保存。

英文版说明书

mitotane (Lysodren)What is mitotane (Lysodren)?Mitotane is a cancer medication. That interferes with the growth of cancer cells and slows their growth and spread in the body.Mitotane is used to treat cancer of the adrenal gland (adrenal cortical carcinoma).Mitotane may also be used for other purposes not listed in this medication guide.Lysodren 500 mground, white, imprinted with BL L1Prev 1 NextWhat are the possible side effects of mitotane (Lysodren)?Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.Call your doctor at once if you have a serious side effect such as:•feeling like you might pass out;•fast or pounding heartbeats;•warmth, redness, or tingly feeling under your skin;•sweating, cold or clammy skin;•high fever, chills, uncontrolled shaking;•blurred or double vision;•confusion, problems with speech, balance, or walking;•pain or burning when you urinate;•blood in your urine; or•unexpected weight loss.Less serious side effects may include:•dizziness, spinning sensation;•drowsiness, tired feeling;•depressed mood;•mild skin rash;•nausea, vomiting, diarrhea; or•loss of appetite.This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.What is the most important information I should know about mitotane (Lysodren)?You may receive your first few doses of mitotane in a hospital setting where you can be monitored in case the medication causes serious side effects.You should not use this medication if you are allergic to mitotane.Before taking mitotane, tell your doctor if you have liver disease, or if you have had a recent infection, surgery, or trauma.Always wear rubber gloves when handling mitotane tablets. The medicine from a crushed or broken tablet can be dangerous if it gets on your skin.You may need to take steroid medication along with mitotane to best treat your condition. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor.If you have any type of infection, serious injury or medical emergency, you may need to stop taking this medication for a short time. Your doctor will determine when you can start taking mitotane again.Carry an ID card or wear a medical alert bracelet stating that you are taking mitotane, in case of an emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are using mitotane.You must remain under the care of a doctor while taking mitotane. Do not miss any scheduled appointments.It may take up to several months of using mitotane before your symptoms improve. Talk with your doctor if your symptoms do not improve or if they get worse.What should I discuss with my healthcare provider before taking mitotane (Lysodren)?You should not use this medication if you are allergic to mitotane.If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:•recent infection, surgery, or trauma;•liver disease.FDA pregnancy category C. It is not known whether mitotane is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment.It is not known whether mitotane passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.How should I take mitotane (Lysodren)?You may receive your first few doses of mitotane in a hospital setting where you can be monitored in case the medication causes serious side effects.Take mitotane exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.You may take mitotane with or without food.Always wear rubber gloves when handling mitotane tablets. Do not crush or break a tablet, or use a tablet that has been accidentally broken. The medicine from a crushed or broken tablet can be dangerous if it gets on your skin. If skin contact occurs, wash the area with soap and water. Ask your doctor or pharmacist how to safely dispose of the broken tablet.Your doctor may occasionally change your dose to make sure you get the best results from this medication. You may also need to take steroid medication to best treat your condition. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor.Contact your doctor at once if you develop signs of infection such as fever, chills, sore throat, flu symptoms, loss of appetite, nausea and vomiting, mouth sores, or unusual weakness.If you have any type of infection, serious injury or medical emergency, you may need to stop taking this medication for a short time. Your doctor will determine when you can start taking mitotane again.Carry an ID card or wear a medical alert bracelet stating that you are taking mitotane, in case of an emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are using mitotane.To be sure this medication is helping your condition and is not causing harmful effects, your doctor will need to check your progress on a regular basis. You must remain under the care of a doctor while taking mitotane. Do not miss any scheduled appointments.It may take up to several months of using mitotane before your symptoms improve. For best results, keep using your medications as directed. Talk with your doctor if your symptoms do not improve or if they get worse.Store mitotane at room temperature away from moisture and heat.What happens if I miss a dose (Lysodren)?Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.What happens if I overdose (Lysodren)?Seek emergency medical attention if you think you have used too much of this medicine.Symptoms of a mitotane overdose are not known.What should I avoid while taking mitotane (Lysodren)?Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.Avoid activities that may increase your risk of trauma or injury.Mitotane can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.What other drugs will affect mitotane (Lysodren)?Before using mitotane, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by mitotane.Tell your doctor about all other medications you use, especially:•a blood thinner such as warfarin (Coumadin);•spironolactone (Aldactone).This list is not complete and there may be other drugs that can interact with mitotane. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.Where can I get more information?Your pharmacist can provide more information about mitotane.