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  药店国别: 美国药房
产地国家: 美国
所属类别: 抗癌药物->治疗卵巢癌药物
处方药:处方药
包装规格: 150毫克/25毫升/瓶
计价单位:
  点击放大  
该药品相关信息网址1:
http://www.drugs.com/taxol.html
该药品相关信息网址2:
http://www.chemocare.com/bio/taxol.asp
原产地英文商品名:
PACLITAXEL(TAXOL GENERIC) 150mg/25ml/Vial
原产地英文药品名:
PACLITAXEL,SEMI-SYNTHETIC
中文参考商品译名:
紫杉醇(泰素仿制药) 150毫克/25毫升/瓶
中文参考药品译名:
紫杉醇,半合成
中文参考化合物名称:
5β,20-环氧-1,2α,4,7β,10β,13α-六羟基紫杉烷-11-烯-9-酮-4,10-二乙酸酯-2-苯甲酸酯-13-[(2’R,3’S)-N-苯甲酰-3-苯基异丝氨酸酯
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Ovarian cancer
英文适应病症2:
Cancer
英文适应病症3:
Breast cancer
临床试验期:
完成
中文适应病症参考翻译1:
卵巢癌
中文适应病症参考翻译2:
癌症
中文适应病症参考翻译3:
乳腺癌
药品信息:

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 详细处方信息以本药内容附件PDF文件(201161219095836.pdf)的“原文Priscribing Information”为准
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部分中文紫杉醇处方资料(仅供参考)

【药物名称】紫杉醇 Paclitaxel

【药物类别】抗肿瘤植物药

【药物别名】泰素 Taxol

【分子式成分】化学名:5β,20-环氧-1,2α,4,7β,10β,13α-六羟基紫杉烷-11-烯-9-酮-4,10-二乙酸酯-2-苯甲酸酯-13-[(2’R,3’S)-N-苯甲酰-3-苯基异丝氨酸酯。分子式:C47H51NO14。分子量:853.92。

【制剂规格】粉针剂:5ml:30mg。

【药理毒理】本品是新型抗微管药物,通过促进微管蛋白聚合抑制解聚,保持微管蛋白稳定,抑制细胞有丝分裂。体外实验证明紫杉醇具有显著的放射增敏作用,可能是使细胞中止于对放疗敏感的G2和M期。

【药 动 学】静脉注射后,平均t1/2α为16.2min,t1/2β为6.4h。组织分布广泛,肝、脾、肾、肺及大肠中药物浓度较高。
静脉给予紫杉醇,药物血浆浓度呈双相曲线。本品蛋白结合率89%~98%,紫杉醇在肝脏代谢。紫杉醇主要在肝脏代谢,随胆汁进入肠道,经粪便排出体外(>90%)。经肾清除只占总清除的1%~8%,肾功能不全者一般紫杉醇在肝肾功能不全的病人体内代谢尚不明确。

【适 应 证】卵巢癌、乳腺癌,对铂类等已有抗药性的顽固性卵巢癌亦有效,也可用于肺癌、头颈部癌、食管癌、生殖细胞肿瘤、子宫内膜癌、淋巴瘤、膀胱癌等。

【不良反应】
1、过敏反应:发生率为39%,其中严重过敏反应发生率为2%。多数为1型变态反应,表现为支气管痉挛性呼吸困难,荨麻疹和低血压。几乎所有的反应发生在用药后最初的10分钟。
2、骨髓抑制:为主要剂量限制性毒性,表现为中性粒细胞减少,血小板降低少见,一般发生在用药后8~10日。严重中性粒细胞发生率为47%,严重的血小板降低发生率为5%。贫血较常见。
3、神经毒性:周围神经病变发生率为62%,最常见的表现为轻度麻木和感觉异常,严重的神经毒性发生率为6%。
4、心血管毒性:可有低血压和无症状的短时间心动过缓。肌肉关节疼痛:发生率为55%,发生于四肢关节,发生率和严重程度呈剂量依赖性。
5、胃肠道反应:恶心,呕吐,腹泻和黏膜炎发生率分别为59%,43%和39%,一般为轻和中度。
6、肝脏毒性:为ALT,AST和AKP升高。
7、脱发:发生率为80%。
8、局部反应:输注药物的静脉和药物外渗局部的炎症。

【相互作用】与干扰素合用,对激活巨噬细胞溶解肿瘤有增强作用。不宜合用铂类药物,以免加重神经毒性。给药期间同服烟酰胺、维生素B6、维生素B1可预防神经毒性。
药代动力学资料证明顺铂后给予本品,本品清除率大约降低30%,骨髓毒性较为严重。
同时应用酮康唑影响本品的代谢。

【用法用量】静脉滴注,成人按体表面积135mg~250mg/m2,每3周~4周1次,2~3周期为一疗程。
为了预防发生过敏反应,在紫杉醇治疗前12小时口服地塞米松10mg,治疗前,6小时再囗服地塞米松10mg,治疗前30~60分钟给予苯海拉明肌注20mg,静注西咪替丁300mg或雷尼替丁50mg。
单药剂量为135~200mg/m2,在G-CSF支持下,剂量可达250mg/m2。将紫杉醇用生理盐水或5%葡萄糖盐水稀释,静滴3小时。联合用药剂量为135~175mg/m2,3~4周重复。

【药物过量】尚无相应的解毒药。用药过量最主要的,可预测的并发症包括骨髓抑制,外周神经毒性及黏膜炎。

【注意事项】妊娠、哺乳期妇女、对本品过敏者禁用。 对聚氧乙基代蓖麻油过敏者禁用。禁用于中性白细胞低于1500/MM者。年老体弱、肝肾功能异常、糖尿病者慎用。滴注期间宜监测心电图、血压、呼吸等。用药期间禁酒。
治疗前应用地塞米松,苯海拉明和H2受体拮抗剂进行预处理。未稀释的浓缩药液不要接触聚氯乙烯塑料器械或设备,且不能进行静脉滴注。稀释的药液应储藏在瓶内或塑料袋,采用聚氯乙烯给药设备滴注。给药期间应注意有无过敏反应及生命特征的变化。

【孕妇及哺乳期妇女用药】紫杉醇在动物实验中证实影响胚胎生长,故孕妇禁用。育龄妇女,治疗期不宜怀孕。

Taxol
Generic Name: paclitaxel (PAK li TAK sel)
Brand Names: Onxol, Taxol

What is Taxol?
Taxol is a cancer medication that interferes with the growth of cancer cells and slows their growth and spread in the body.

Taxol is used to treat breast cancer, lung cancer, and ovarian cancer. It is also used to treat AIDS-related Kaposi's sarcoma.

Taxol may also be used for other purposes not listed in this medication guide.

Important information about Taxol
Do not use Taxol 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. You should not be given Taxol if you are allergic to paclitaxel, or to other medications that contain an ingredient called Cremophor EL (polyoxyethylated castor oil). This includes cyclosporine (Gengraf, Neoral, Sandimmune) and teniposide (Vumon).
Before you receive Taxol, tell your doctor if you have liver disease, heart disease, or a severely weak immune system.

Taxol can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or 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. Do not miss any scheduled appointments.

There are many other medicines that can interact with Taxol. 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. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you. Before receiving Taxol
You should not be given Taxol if you are allergic to paclitaxel, or to other medications that contain an ingredient called Cremophor EL (polyoxyethylated castor oil). This includes cyclosporine (Gengraf, Neoral, Sandimmune) and teniposide (Vumon).

Before you receive Taxol, tell your doctor if you are allergic to any drugs, or if you have:
•liver disease;
•heart disease; or
•a severely weak immune system.

If you have any of these conditions, you may need a dose adjustment or special tests to safely receive Taxol.

FDA pregnancy category D. Taxol can cause harm to an unborn baby. Do not receive Taxol 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 Taxol passes into breast milk or if it could harm a nursing baby. Do not receive Taxol without telling your doctor if you are breast-feeding a baby.

How is Taxol given?
Taxol is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting. Taxol must be given slowly through an IV infusion, and can take up to 24 hours to complete.

Taxol is usually given every 3 weeks. Follow your doctor's instructions.

Before your injection, you may be given other medications to help prevent a serious allergic reaction to Taxol.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when the Taxol is injected.
If any of Taxol gets on your skin, wash the area with soap and warm water right away.

Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely while you are receiving Taxol.

Your heart rate may also be monitored through electrocardiograph or ECG (sometimes called an EKG). This machine measures electrical activity of the heart.

Taxol can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or 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. Do not miss any scheduled appointments.

What happens if I miss a dose?
Contact your doctor if you miss an appointment for your Taxol injection.

What happens if I overdose?
Seek emergency medical attention if you think you have received too much Taxol.
Overdose symptoms may include numbness or tingling, fever, chills, mouth sores, unusual bleeding or weakness, or any signs of infection.

What should I avoid while using Taxol?
Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are being treated with Taxol.

Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Taxol side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:
•slow heart rate;
•seizure (black-out or convulsions);
•pale skin, easy bruising or bleeding, unusual weakness;
•fever, chills, body aches, flu symptoms;
•white patches or sores inside your mouth or on your lips;
•numbness, tingling, or burning pain in your hands or feet;
•increased blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats); or
•warmth or redness under your skin.

Less serious side effects may include:
•pain, swelling, redness, or skin color changes where the Taxol was injected;
•joint or muscle pain;
•mild nausea, vomiting, diarrhea; or
•hair loss.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

What other drugs will affect Taxol?
There are many other medicines that can interact with Taxol. 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. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Where can I get more information?
•Your doctor or pharmacist can provide more information about Taxol.

What does my medication look like?
Taxol is available with a prescription under the brand names Onxol and Taxol. Other brand or generic formulations may also be available. Ask your healthcare provider or pharmacist any questions you have about Taxol, especially if it is new to you.
•Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. 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. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects.

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 详细处方信息以本药内容附件PDF文件(201161219095836.pdf)的“原文Priscribing Information”为准
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更新日期: 2011-6-13
附件:


201161219095836.PDF    

 
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