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泰索帝注射液TAXOTERE（DOCETAXEL）

2013-05-24 00:16:11 作者：新特药房来源：互联网浏览次数：332 文字大小：【大】【中】【小】

简介：部分中文TAXOTERE处方资料药品英文名 Docetaxei 药品别名多西紫杉、多西紫杉醇、泰索帝、艾素、多帕菲、多帕菲、多烯紫杉醇、紫杉特尔、Taxotere 药物剂型 1.多西他赛注射剂：20mg/支，80mg/支(各附有1.5ml、6 ...

关键字：泰索帝注射液多西他赛紫杉萜 TAXOTERE

部分中文TAXOTERE处方资料
药品英文名
Docetaxei
药品别名
多西紫杉、多西紫杉醇、泰索帝、艾素、多帕菲、多帕菲、多烯紫杉醇、紫杉特尔、Taxotere
药物剂型
1.多西他赛注射剂：20mg/支，80mg/支(各附有1.5ml、6ml溶剂)。避光贮藏，放置于2～8℃下保存。
2.多西他赛注射液：20mg/0.5ml，20mg/1ml，20mg/2ml，80mg/2ml，80mg/8ml。2～8℃，密闭，遮光贮存。
药理作用
本品为细胞周期特异性抗肿瘤药，可特异性作用于M期细胞。本品可促进小管聚合成为稳定的微管，并抑制其解聚，以显著减少小管的数量，也可通过破坏微管的网状结构，抑制细胞有丝分裂，从而达到抗肿瘤的目的。
药动学
静滴本品100mg/m2后(滴注时间为1h)，平均血药峰浓度(Cmax)为3.7µg/ml，稳态分布容积为113L。本品可分布于全身各脏器，以肝脏、胆汁、肠、胃中含量较高，中枢神经系统中含量极少。蛋白结合率高于95%。主要在肝脏代谢，三相半衰期(α、β、γ)分别为4min、36min及11.1h。本品主要以代谢产物形式随粪便排泄(占给药量的75%)，经尿液排出仅占6%，仅有小部分以药物原形排出体外。
适应证
用于治疗晚期乳腺癌、非小细胞肺癌。也有报道用于治疗头颈部癌、小细胞肺癌、胃癌、卵巢癌等肿瘤。
禁忌证
1.对本品有严重过敏史者禁用。
2.严重白细胞低下者禁用。
3.严重肝功能不全者禁用。
4.本品的妊娠安全性分级为D级，孕妇用药后，对其胎儿有潜在危害，并有流产的可能性，因此孕妇禁用。
5.本品注射液可能含有聚山梨酯80，对其有严重过敏史者不能使用。
注意事项
1.肝功能不全者、严重衰弱者、严重水潴留者、严重感觉神经疾病患者慎用。
2.本品用于儿童的安全性尚未确定。
3.尚不清楚本品能否分泌人乳汁，哺乳期妇女的用药安全性尚未确定，用药前应停止哺乳。
4.配制本品时，粉针剂应先以指定溶剂溶解，再以生理盐水或5%葡萄糖注射液稀释后使用(配制后浓度不超过0.74mg/ml)。工作台表面应覆盖可丢弃的塑料薄膜，操作者应穿戴防护衣服及手套。若皮肤接触了药液，应立即用肥皂和水彻底清洗；如眼睛或黏膜接触了药液，立即用水彻底清洗。配制好的药液应立即使用。
5.在使用本品的最初几分钟内，可能发生过敏反应，应具备相应的急救设施。为预防液体潴留和过敏反应，推荐在用药前1天开始口服地塞米松(每天16mg，连用4～5天)。
6.如用药后仅发生面部潮红或局部皮肤反应，则不需要停止治疗。如发生严重过敏反应(血压下降超过2.67kPa、支气管痉挛或全身皮疹/红斑)，则需立即停止给药，并给予对症治疗。已发生过严重不良反应者，不能再次使用本品。
7.使用本品治疗时如出现严重的周围神经病变、严重的或累积性皮肤反应，或严重的中性粒细胞减少(低于0.5×109/L，并持续7天或7天以上)，建议下1个疗程减量给药。
8.当血胆红素高于正常值上限、氨基转移酶高于正常上限1.5倍、ALP高于正常上限2.5倍时，应停用本品治疗。
9.药物过量时，可能表现为中性粒细胞减少、皮肤反应和感觉异常。目前尚无特效解毒药。
10.治疗过程中应定期检测血常规、肝功能、血电解质、血肌酐、神经系统及超声心动图。
不良反应
1.血液系统：可见贫血、白细胞减少及血小板减少，其中中性粒细胞减少为剂量限制性毒性。
2.消化系统：恶心、呕吐、腹泻、黏膜炎、便秘、肝功能损害。
3.代谢/内分泌系统：使用本品后，可见体重增加，发生率约为13%。当累积量达400mg/m2时，可出现下肢水肿，甚至发展为全身水肿，体重可增加3kg以上。极少数患者可出现胸腹腔积液、心包积液。停止治疗后，液体潴留一般可逐渐消失。
4.皮肤：部分患者可发生指(趾)甲改变、色素沉着，甚至指甲脱落。
5.过敏反应：轻度过敏反应表现为皮肤瘙痒及潮红、皮疹、发热、寒战等，皮疹主要见于手、足，亦可在手臂、面部和胸部出现，常于用药后1周内发生；严重过敏反应不多见，主要表现为支气管痉挛、呼吸困难和低血压。
6.其他：肌肉关节疼痛、感染、头痛、感觉障碍，尚可见溢泪、脱发、乏力、注射部位反应及心血管毒性报道。
用法用量
1.单药治疗：每次75～100mg/m2，静滴1h，每3周1次。
2.联合用药：一般每次75mg/m2，每3周1次。
药物相应作用
1.本品与环磷酰胺、依托泊苷、氟尿嘧啶联合给药有协同作用，对放疗也有增敏作用。
2.本品与紫杉醇之间具有不完全交叉耐药性，与顺铂和氟尿嘧啶无交叉耐药。
3.与顺铂合用，导致神经病变的危险性增加。
4.伊曲康唑可抑制本品代谢，增加本品毒性。
5.体外研究表明，细胞色素P450 3A4抑制剂可能干扰本品代谢，当与此类药物(如酮康唑、红霉素、环孢素等)合用时，应特别谨慎。
6.给予托泊替康治疗3天后再使用本品，可使本品的清除率降低达50%。两者合用时，建议在第1天给予本品，第1～4天给予托泊替康。
7.用药期间接种活疫苗，将增加感染活疫苗的危险，故用药期间不能接种活疫苗。化疗停止至少3个月后才能接种活疫苗。

Taxotere
Generic Name: docetaxel (doe se TAX el)
Brand Names: Taxotere
What is Taxotere?
Taxotere is a cancer medicine that slows the growth and spread of cancer cells in the body.
Taxotere is used to treat breast cancer, lung cancer, prostate cancer, stomach cancer, and head/neck cancer.
Taxotere may also be used for other purposes not listed in this medication guide.
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Important information about Taxotere
Do not use this medication without your doctor's consent if you are pregnant.
It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment. Before being treated with Taxotere, tell your doctor if you have ever been treated with cisplatin (Platinol), or if you have liver disease, congestive heart failure, fluid retention, swelling problems, or if you have ever had an allergic reaction to docetaxel.
Taxotere can be harmful if it gets on your skin during an IV infusion. If this happens, wash the skin thoroughly with soap and warm water.
Some people receiving a Taxotere injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, light-headed, warm, or itchy, or if you have chest tightness or trouble breathing during the injection.
Taxotere can lower the blood cells that help your body fight infections. This can make it easier for you to get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis.
Your liver function may also need to be tested. It is important that you not miss any scheduled visits to your doctor.
Avoid contact with people who have colds, the flu, or other contagious illnesses. Contact your doctor immediately if you develop signs of infection, especially fever.
There are many other drugs that can interact with Taxotere. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
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Before using Taxotere
Before being treated with Taxotere, tell your doctor if you have ever been treated with cisplatin (Platinol), or if you have:
liver disease;
congestive heart failure;
fluid retention or swelling problems; or
if you have ever had an allergic reaction to docetaxel.
If you have any of these conditions, you may need a dose adjustment or special tests to safely receive Taxotere.
FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not use Taxotere without telling your doctor if you are pregnant. It could harm the unborn baby.
Use effective birth control, and tell your doctor if you become pregnant during treatment.
It is not known whether Taxotere passes into breast milk or if it could harm a nursing baby. Do not receive Taxotere without telling your doctor if you are breast-feeding a baby.
Adults older than 65 may be more sensitive to the side effects of Taxotere.
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How is Taxotere used?
Taxotere is given as an injection through a needle placed into a vein. You will receive this medicine in a clinic or hospital setting.
Taxotere must be given slowly through an IV and it may take up to an hour to complete your dose.
Your doctor may prescribe a steroid medicine for you to take for a few days before your injection.
This will help prevent swelling or an allergic reaction to Taxotere. Do not miss any doses of the steroid.
Taxotere must be given slowly through an IV and it may take up to an hour to complete your dose.
Taxotere can be harmful if it gets on your skin during an IV infusion. If this happens, wash the skin thoroughly with soap and warm water.
Taxotere is usually given once every 3 weeks, and you may receive other cancer medicines at the same time. Your doctor will determine a treatment schedule for you based on the type of cancer being treated and other factors.
Taxotere can lower the blood cells that help your body fight infections. This can make it easier for you to get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis.
Your liver function may also need to be tested. Do not miss any scheduled
appointments.
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What happens if I miss a dose?
Call your doctor for instructions if you miss a dose of Taxotere or the steroid medicine.
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What happens if I overdose?
Seek emergency medical attention if you think you have received too much of this medicine.
Overdose symptoms may include fever, chills, body aches, flu symptoms, numbness, burning, pain, or tingly feeling, or white patches or sores inside your mouth or on your lips.
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What should I avoid while using Taxotere?
Avoid getting a flu shot or vaccine while you are being treated with Taxotere. Vaccines may not work as well or could make you sick while you are using Taxotere.
Avoid contact with people who have colds, the flu, or other contagious illnesses. Contact your doctor immediately if you develop signs of infection, especially fever.
Avoid allowing this medicine to get on your skin during an IV infusion. If this does happen, wash the skin thoroughly with soap and warm water.
-------------------------------------------------------------
Taxotere side effects
Some people receiving a Taxotere injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, light-headed, warm, or itchy, or if you have chest tightness or trouble breathing during the injection.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:
easy bruising or bleeding, unusual weakness;
feeling like you might pass out;
fever, chills, body aches, flu symptoms;
severe diarrhea;
skin changes or bruising where the IV was placed;
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
feeling short of breath, even with mild exertion;
swelling of your ankles or feet, weight gain;
a red, blistering, peeling skin rash; or
numbness, burning, pain, or tingly feeling.
Less serious side effects may include:
feeling weak or tired;
white patches or sores inside your mouth or on your lips;
mild nausea, vomiting, diarrhea, constipation, or loss of appetite;
watery eyes;
changes in menstrual periods;
temporary hair loss; or
fingernail or toenail changes.
This is not a complete list of side effects and others may occur.
Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
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What other drugs will affect Taxotere?
Do not receive "live" vaccines during treatment with Taxotere.
Administration of a live vaccine may be dangerous during treatment with Taxotere.
There are many other drugs that can interact with Taxotere. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
-------------------------------------------------------------
Where can I get more information?
Your doctor or pharmacist can provide more information about Taxotere.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect.
Drug information contained herein may be time sensitive. Multum information has been
compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides.
The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects.
If you have questions about the drugs you are taking, check with your doctor,
nurse or pharmacist.
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注：以下产品不同规格和不同价格，购买以咨询为准！
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产地国家: 德国
原产地英文商品名:
TAXOTERE 20mg/ml/Vial
原产地英文药品名:
DOCETAXEL
中文参考商品译名:
泰索帝 20毫克/毫升/瓶
中文参考药品译名:
多西他赛
中文参考化合物名称:
紫杉萜
生产厂家中文参考译名:
赛诺菲-安万特
生产厂家英文名:
Sanofi Aventis

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产地国家: 美国
原产地英文商品名:
TAXOTERE 20mg/ml/Vial
原产地英文药品名:
DOCETAXEL
中文参考商品译名:
泰索帝 20毫克/毫升/瓶
中文参考药品译名:
多西他赛
中文参考化合物名称:
紫杉萜
生产厂家中文参考译名:
赛诺菲-安万特
生产厂家英文名:
Sanofi Aventis

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产地国家: 美国
原产地英文商品名:
TAXOTERE 80mg/4mls/Vial
原产地英文药品名:
DOCETAXEL
中文参考商品译名:
泰索帝 80毫克/4毫升/瓶
中文参考药品译名:
多西他赛
中文参考化合物名称:
紫杉萜
生产厂家中文参考译名:
赛诺菲-安万特
生产厂家英文名:
Sanofi Aventis