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盐酸伊立替康注射液IRINOTECAN HCL(CAMPTOSAR GENERIC)

2012-08-09 18:28:40  作者:新特药房  来源:中国新特药网天津分站  浏览次数:172  文字大小:【】【】【
简介: 部分中文IRINOTECAN HCL信息资料(仅供参考)【药物功效】适用于治疗成人转移性大肠癌,也可用于其它肿瘤(如胃癌、胰腺癌、宫颈癌、卵巢上皮细胞癌等)。禁忌症(1)肝肾功能不全者或血胆红素超过正常值上 ...

 部分中文IRINOTECAN HCL信息资料(仅供参考)
【药物功效】
适用于治疗成人转移性大肠癌,也可用于其它肿瘤(如胃癌、胰腺癌、宫颈癌、卵巢上皮细胞癌等)。
禁忌症
(1)肝肾功能不全者或血胆红素超过正常值上限1.5倍的患者。
(2)有慢性肠炎和(或)肠梗阻的患者。
(3)对本药有严重过敏史者。
(4)严重骨髓抑制者。
(5)WHO行为状态评分(BaselinePerformance)大于2的患者。
(6)孕妇。
(7)哺乳期妇女。
【给药说明】:
1.本药配伍禁忌尚不清楚,但建议不要与其它药物混合。
2.本药应静脉滴注给药,不能静脉注射。静脉滴注时间一般为30-90分钟。
3.使用本药后24小时内,有可能出现头晕及视力障碍,因此用药后禁止驾车。
4.在配制本药时应戴眼镜、口罩、手套等。如皮肤接触药液,立即用肥皂和清水彻底冲洗。如粘膜接触药液,立即用清水冲洗。
5.所有用于稀释或输液的材料均需按照细胞毒性药物的标准处理程序进行处置。
6.本药溶液首次打开后在室温下可保存12小时,在2-8℃下可保存24小时,但稀释后应立即使用。
7.迟发性腹泻的处理:因腹泻治疗不当可能危及生命,患者用药后,一旦出现第一次稀便,需饮用大量含电解质的液体,并立即给予适当的抗腹泻治疗。
当出现以下情况时,患者应住院治疗腹泻:
(1)腹泻同时伴有发热。
(2)严重腹泻。
(3)已用大剂量洛哌丁胺治疗,但48小时后仍有腹泻。建议出院患者携带一定数量的抗腹泻药。
8.可用昂丹司琼和苯海拉明预防本药所致的胃肠道反应。为预防或减弱早期腹泻(使用本药后不久即出现的腹泻)和其它胆碱能症状,可在用药前静脉或皮下注射阿托品0.25-1mg。晚期腹泻(迟发性腹泻,通常使用本药24小时后)可给予洛哌丁胺治疗,在首次出现稀便或肠蠕动较正常频繁时给药:首次给予4mg,以后每2小时给予2mg,直至腹泻停止后至少12小时;夜间可每4小时给予4mg。不应预防性使用洛哌丁胺(即使是上一周期已出现过迟发性腹泻者)。
9.使用本药期间,应避免使用具有通便作用的药物,因为可能会加重腹泻。出现严重腹泻的患者,在下一周期用药时应减量。
10.中性粒细胞减少性发热(体温超过38℃,中性粒细胞计数低于1×10☆9☆/L)应立即住院静脉滴注广谱抗生素治疗。只有当中性粒细胞计数高于1.5×10☆9☆/L时,方可恢复本药治疗。
11.当出现急性胆碱能综合征时,如没有禁忌,可使用硫酸阿托品治疗(0.25mg皮下注射)治疗。以后使用本药时,应预防性给予硫酸阿托品。
12.如患者出现了严重中性粒细胞减少或严重胃肠道不良反应,必须推迟使用本药,直到这些症状(尤其是腹泻)完全消失为止。
13.目前尚无关于药物过量的报道。在Ⅰ期研究中,在严密观察下使用剂量曾高达750mg/m☆2☆,最显著的不良反应是严重中性粒细胞减少和腹泻。目前尚无本药的特效解毒剂。
【用法用量】:
成人
·常规剂量
·静脉滴注应根据中性粒细胞计数调整剂量。推荐剂量为一次350mg/m☆2☆,每3周1次,持续使用直至病情加重或出现了严重毒性。对于无症状的严重中性粒细胞减少(低于0.5×10☆9☆/L)、中性粒细胞减少伴发热或感染(体温超过38℃、中性粒细胞计数低于或等于1×10☆9☆/L)或严重腹泻(需静脉输液治疗)的患者,下周期治疗剂量应减至300mg/m☆2☆,如仍出现以上不良反应,下一周期剂量可进一步减至250mg/m☆2☆。
[国外用法用量参考]
成人
·常规剂量
·静脉滴注
1.胃癌、胰癌、宫颈癌:一次100-150mg/m☆2☆,每1-2周1次。
2.卵巢上皮细胞癌:一次200mg/m☆2☆,每3-4周1次。
3.结肠直肠癌:
(1)单药治疗:
①"每周治疗方案",对氟尿嘧啶治疗失败的患者,推荐本药初始剂量为一周125mg/m☆2☆,静脉滴注90分钟,使用4周后,停2周后可重复疗程,并根据毒性反应调整剂量。
②"3周治疗方案",推荐初始剂量为每3周给药350mg/m☆2☆,静脉滴注90分钟。如果用药有效且未出现不可耐受的毒性,可长期坚持治疗。70岁或70岁以上者和(或)曾接受了骨盆或腹部放疗的患者,初始剂量为300mg/m☆2☆。必要时根据毒性反应调整剂量。
(2)联合用药:
①甲酰四氢叶酸/氟尿嘧啶弹丸式注射方案:本药125mg/m☆2☆静脉滴注90分钟,之后立即先后静脉弹丸式注射甲酰四氢叶酸20mg/m☆2☆、氟尿嘧啶500mg/m☆2☆。以上药物均在每个疗程的第1、8、15、22日给予。下一疗程在第7周(第43日)开始。
②甲酰四氢叶酸/氟尿嘧啶静脉滴注方案:在第1、15、29日给予本药180mg/m☆2☆,静脉滴注90分钟;在第1、2、15、16、29、30日静脉给予甲酰四氢叶酸200mg/m☆2☆,给药时间不应低于2小时;在给予甲酰四氢叶酸后立即静脉快速弹丸式注入氟尿嘧啶400mg/m☆2☆,然后静脉滴注氟尿嘧啶600mg/m☆2☆,滴注时间不应低于22小时。下一疗程在第7周(第43日)开始。
4.非小细胞肺癌:与顺铂联用(80mg/m☆2☆,在每个疗程的第1日给药),本药初始剂量为30mg/m☆2☆,在第1、8、15日给予,每28日重复1次。以后按10mg/m☆2☆递增(直至出现严重毒性)。最大耐受剂量可达70mg/m☆2☆。
·肝功能不全时剂量
有肿瘤肝转移但肝功能尚正常的患者不必调整剂量。对肝功能不全者,目前尚无具体推荐剂量。
【贮法】密封,遮光保存。
【禁忌】
(1)肝肾功能不全者或血胆红素超过正常值上限1.5倍的患者。
(2)有慢性肠炎和(或)肠梗阻的患者。
(3)对本药有严重过敏史者。
(4)严重骨髓抑制者。
(5)WHO行为状态评分(BaselinePerformance)大于2的患者。
(6)孕妇。
(7)哺乳期妇女。
Camptosar
Generic Name: irinotecan (EYE ri noe TEE kan)
Brand Names: Camptosar
What is Camptosar?
Camptosar (irinotecan) is a cancer medication that interferes with the growth of cancer cells and slows their growth and spread in the body.
Camptosar is used to treat cancers of the colon and rectum. It is usually given with other cancer medicines in a combination chemotherapy.
Camptosar may also be used for other purposes not listed in this medication guide.
-------------------------------------------------------------------
Important information about Camptosar
Do not use Camptosar without telling your doctor 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. Camptosar can cause severe diarrhea, which can be life-threatening if it leads to dehydration. Diarrhea can occur soon after your injection or more than 24 hours later.
Your doctor may recommend you have an anti-diarrhea medicine such as loperamide (Imodium) available at all times while you are receiving Camptosar. Take the anti-diarrhea medication at the first sign of loose or frequent bowel movements.
Call your doctor if you still have diarrhea after 24 hours of taking anti-diarrhea medicine.
Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.
Do not receive a "live" vaccine while you are being treated with Camptosar, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you.
-------------------------------------------------------------------
Before receiving Camptosar
Do not receive Camptosar if you are allergic to irinotecan.
If you have any of these other conditions, you may need a dose adjustment or special tests to safely receive Camptosar:
liver disease;
an intestinal disorder or obstruction;
Gilbert's syndrome;
diabetes;
fructose intolerance (Camptosar contains sorbitol); or
if you are receiving radiation treatment to your abdomen or pelvic area.
FDA pregnancy category D. Camptosar can cause harm to an unborn baby. Do not receive this medicine without telling your doctor if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment. It is not known whether irinotecan passes into breast milk or if it could harm a nursing baby. Do not receive Camptosar without telling your doctor if you are breast-feeding a baby.
-------------------------------------------------------------------
How is Camptosar given?
Camptosar is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting. The medicine must be given slowly through an IV infusion, and can take up to 90 minutes to complete. The Camptosar injection is usually followed by infusions with other cancer medications. These combination chemotherapy treatments are usually given at weekly intervals for several weeks.
Before starting your Camptosar injection, you may be given medications to help prevent nausea, vomiting, diarrhea, and other side effects. You may also need to use some of these medications for at least a day after receiving your injection.
Camptosar can cause severe diarrhea, which can be life-threatening if it leads to dehydration. Diarrhea can occur soon after your injection or more than 24 hours later.
Your doctor may recommend you have an anti-diarrhea medicine such as loperamide (Imodium) available at all times while you are receiving Camptosar. Take the anti-diarrhea medication at the first sign of loose or frequent bowel movements.
Call your doctor if you still have diarrhea after 24 hours of taking anti-diarrhea medicine. Do not take loperamide for longer than 2 full days without your doctor's advice.
To be sure Camptosar is not causing harmful effects, your blood will need to be tested on a regular basis. Your kidney or liver function may also need to be tested. Do not miss any scheduled visits to your doctor.
-------------------------------------------------------------------
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment to receive your Camptosar injection.
-------------------------------------------------------------------
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, and severe diarrhea.
-------------------------------------------------------------------
What should I avoid while using Camptosar?
Do not use a laxative or stool softener during treatment with Camptosar. These products can worsen diarrhea that may be caused by this medicine.
Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.
Do not receive a "live" vaccine while you are being treated with Camptosar, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you.
Avoid getting this medicine on your skin. If this happens, wash the area thoroughly with soap and warm water.
Camptosar 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.
-------------------------------------------------------------------
Camptosar side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Camptosar: 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:
pale skin, easy bruising or bleeding, unusual weakness;
loose stools, watery diarrhea;
bloody or black stools;
runny nose, watery eyes, increased sweating, stomach cramps, and warmth, tingling, or redness under your skin;
fever, chills, body aches, flu symptoms;
white patches or sores inside your mouth or on your lips;
sudden numbness or weakness, headache, confusion, problems with vision, speech, or balance;
chest pain, pain or swelling in one or both legs;
swelling or irritation where the IV needle is placed;
nausea or vomiting that keeps you from drinking enough fluids; or
signs of dehydration, such as dry mouth, increased thirst, drowsiness, feeling light-headed, or fainting.
Less serious Camptosar side effects may include:
loss of appetite, constipation;
dizziness;
redness or peeling of the skin on your hands and feet;
cough,
temporary hair loss.
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 other drugs will affect Camptosar?
Before receiving Camptosar, tell your doctor if you are using any of the following drugs:
a diuretic (water pill);
atazanavir (Reyataz);
ketoconazole (Nizoral);
rifabutin (Mycobutin);
rifampin (Rifadin, Rifater, Rifamate, Rimactane);
St. John's wort; or
seizure medicine such as carbamazepine (Carbatrol, Tegretol), phenobarbital (Luminal, Solfoton), or phenytoin (Dilantin).
This list is not complete and there may be other drugs that can interact with Camptosar. 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 doctor or pharmacist can provide more information about Camptosar.
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.

-------------------------------------------------------------
产地国家:美国
所属类别:抗癌药物 ->治疗肠癌药物
原产地英文药品名:
IRINOTECAN HCL
中文参考药品译名:
未知
原产地英文商品名:
IRINOTECAN HCL(CAMPTOSAR GENERIC) 20mg/ml 500mg/25mls/Vial
中文参考商品译名:
盐酸依立替康(坎普土沙仿制
生产厂家英文名:
未知
生产厂家中文参考译名:
未知
该药品相关信息网址1:
http://www.drugs.com/camptosar.html
曾用名:
未知
该药品相关信息网址2:
http://www.pfizer.com/products/rx/rx_product_camptosar.jsp
-----------------------------------------------------------
原产地英文药品名:
IRINOTECAN HCL
中文参考药品译名:
盐酸伊立替康
原产地英文商品名:
IRINOTECAN HCL(CAMPTOSAR GENERIC) 20mg/ml 100mg/5mls/Vial 10Vials/box
中文参考商品译名:
盐酸伊立替康(坎普土沙仿制
生产厂家英文名:
未知
生产厂家中文参考译名:
未知
该药品相关信息网址1:
http://www.drugs.com/camptosar.html
曾用名:
未知
该药品相关信息网址2:
http://www.pfizer.com/products/rx/rx_product_camptosar.jsp

责任编辑:admin


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