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TARCEVA(Erlotinib Hydrochloride Tablets)盐酸厄洛替尼片

2014-12-14 23:42:43  作者:新特药房  来源:互联网  浏览次数:444  文字大小:【】【】【
简介: 部份中文盐酸厄洛替尼处方资料(仅供参考)英文商品名:Tavceva英文通用名:Erlotinib HCL Tablets 通用名:盐酸厄洛替尼片用药介绍适应证和用途特罗凯是一种激酶抑制剂适用于:(1)用基于铂类一线化疗 ...

部份中文盐酸厄洛替尼处方资料(仅供参考)
英文商品名:Tavceva
英文通用名:Erlotinib HCL Tablets
通用名:盐酸厄洛替尼片
用药介绍
适应证和用途
特罗凯是一种激酶抑制剂适用于:
(1)用基于铂类一线化疗4个疗程没有进展局部晚期或转移性非-小细胞肺癌(NSCLC)患者的维持治疗。
(2)局部晚期或转移性非-小细胞肺癌至少1种既往化疗方案失败后的治疗。
(3)与吉西他滨[gemcitabine]联用对局部晚期,不能切除或转移性胰腺癌患者的一线治疗。
剂量和给药方法
(1)对NSCLC剂量是150mg/天。 
(2)对胰腺癌剂量是100 mg/天。
(3)应空腹服用特罗凯所有剂量至少进食前1小时或后2小时。
(4)需要时减低50mg减量。
剂型和规格
片:25mg,100mg和150mg。
禁忌证
无。
警告和注意事项
(1)曾不常报道间质性肺疾病(ILD)-样事件,包括死亡。如发生急性发作新或不能解释进展性肺症状,例如呼吸困难,咳嗽和发热中断特罗凯,如诊断为ILD终止特罗凯。
(2)曾报道急性肾衰(包括死亡),和肾功能不全病例。脱水事件时中断特罗凯。监视脱水风险患者肾功能和电解质。
(3)曾报道肝衰竭和肝肾综合征(包括死亡)病例。定期监查肝功能试验。如肝功能变化严重中断或终止特罗凯。
(4)严密监查有肝受损患者。如如肝功能变化严重中断或终止特罗凯。
(5)曾报道胃肠道穿孔,包括死亡。终止特罗凯。
(6)曾报道大疱和剥脱性皮肤病,包括死亡。中断或终止特罗凯。
(7)在胰腺癌患者中曾报道心肌梗死/缺血,包括死亡。
(8)在胰腺癌患者中曾报道脑血管意外,包括死亡。
(9)在胰腺癌患者中曾报道微血管病溶血性贫血与血小板减少。
(10)曾报道角膜穿孔和溃疡。中断或终止特罗凯。
(11)伴随某些同时华法林[warfarin]给药时曾报道国际标准化比值(International Normalized Ratio, INR)升高和出血事件。监视用华法林或其它香豆素-衍生抗凝剂患者。
(12)当妊娠妇女给予特罗凯时可能引起胎儿危害。建议妇女用特罗凯是避免妊娠。
不良反应
(1)在维持治疗中最常见不良反应(>20%)是皮疹样事件和腹泻。
(2)在二线NSCLC治疗时最常见不良反应(>20%)是皮疹,腹泻,厌食,疲劳,呼吸困难,咳嗽,恶心,感染和呕吐。
(3)在胰腺癌中最常见不良反应(>20%)是疲劳,皮疹,恶心,厌食,腹泻,腹痛,呕吐,体重减轻,感染,水肿,发热,便秘,骨痛,呼吸困难,口腔炎和肌肉痛。
药物相互作用
(1)CYP3A4抑制剂可能增加埃罗替尼血浆浓度。
(2)CYP3A4诱导剂可能减低埃罗替尼血浆浓度。
(3)CYP1A2诱导剂可能减低埃罗替尼血浆浓度。
(4)埃罗替尼溶解度是pH依赖性。改变上GI道pH的药物可能改变埃罗替尼的溶解度因而其吸收。
(5)吸烟减低埃罗替尼血浆浓度。


TARCEVA Tablet 25mg 100mg 150mg
Brand name :
TARCEVA Tablet 25mg
 Active ingredient: Erlotinib hydrochloride
 Dosage form: white to yellowish white tablet (φ: approx. 6.5mm, thickness: approx. 3.3mm)
 Printings on wrapping: タルセバ25
---------------------------------------------------
Brand name : TARCEVA Tablet 100mg
 Active ingredient: Erlotinib hydrochloride
 Dosage form: white to yellowish white tablet (φ: approx. 8.9mm, thickness: approx. 4.9mm)
 Printings on wrapping: タルセバ100
---------------------------------------------------
Brand name : TARCEVA Tablet 150mg
 Active ingredient: Erlotinib hydrochloride
 Dosage form: white to yellowish white tablet (φ: approx. 10.5mm, thickness: approx. 5.4mm)
 Printings on wrapping: タルセバ150
---------------------------------------------------
Effects of this medicine
This medicine inhibits the growth of non-small cell lung cancer by suppressing selectively the function of EGFR, a protein necessary for cancer growth.
It is usually used to treat non-small cell lung cancer which is unresectable, recurrent and progressive, and got worse after cancer chemotherapy.
Before using this medicine, tell your doctor/pharmacist
If you ever experienced any allergic reaction (itch, rash etc.) to any medicine.
If you are a patient with interstitial lung disease (interstitial pneumonia, pneumonitis, irradiation pneumonitis, organized pneumonia, pulmonary fibrosis, acute respiratory distress syndrome, pulmonary infiltration, alveolitis, etc.), lung infection, gastrointestinal ulcer, or diverticulum of large intestine.
If you ever had any of those diseases mentioned above.
If you are a patient with hepatic disorder.
If you are pregnant or breastfeeding.
If you are using any other prescription or nonprescription (OTC) medicine. (It is important to reduce the risk of drug interactions.)
Dosage regimen (proper use of this medicine)
Your dosage regimen is:(order of your doctor)
General dosage regimen: For adults, take 1 tablet (150mg of erlotinib) once a day, either over 1 hour before meal or over 2 hours after meal. The dose may be decreased according to your symptoms. Strictly follow the instructions of your doctor/pharmacist.
Avoid taking the medicine from just 1 hour before the meal to 2 hours after meal. Otherwise, you may have serious side effects.
Missed dose: Take the missed dose on an empty stomach. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. DO NOT take double doses to make up for the missed dose.
Overdose: If you took too much of the medicine (more than ordered), check with your doctor/pharmacist. You may have serious diarrhea, rash, or elevation of ALT(GPT)/AST(GOT).
Others: Do not stop taking the medicine without the instructions of your doctor.
Precautions while using this medicine
You may have serious side effects by taking the medicine. You need to be informed of precautions and so on until you fully understand them.
The medicine may cause side effects such as interstitial lung disease, rash, diarrhea, and corneal perforation/ulcer. If you have symptoms such as shortness of breath, breathing difficulty, cough, fever, rash, diarrhea, and ocular pain, or if you feel that those symptoms get worse, go and see a doctor immediately.
Avoid pregnancy if you have the possibility of it.
Avoid breastfeeding.
Grapefruit juice, hypericum perforatum-contained food and tobacco (smoking) affect the medicine. Avoid them while taking the medicine.
Side effects of this medicine
Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: rash, diarrhea, dry skin, pruritus, etc.Symptoms described below may be the sign of side effects indicated in brackets [ ]. If they occur, stop taking your medicine and check with your doctor immediately.
shortness of breath, breathing difficulty, labored and frequent breathing, cough, dry cough, fever, weight loss, phlegm, loss of appetite, bluish lips and finger/toe nails.[interstitial lung disease (interstitial pneumonia, pneumonitis, irradiation pneumonitis, organized pneumonia, pulmonary fibrosis, acute respiratory distress syndrome, pulmonary infiltration, alveolitis, etc.)]
lassitude, loss of appetite, nausea, vomiting, itch, yellowness in the skin and/or the white of the eye, dark urine, flapping tremor in hands[hepatitis, hepatic failure, hepatic function disorder]
muddy/watery stool, severe abdominal pain, nausea, sweating[serious diarrhea]
decreased consciousness, swollen body/eyes, easy fatigability, decreased urinary volume, urinary retention, headache, lassitude, breathlessness[acute renal failure]
lassitude, loss of appetite, fever, high fever, joint pain, red rash with dropsical swelling in the center, red spots and breakable blisters (bullas) all over the body, rash and blister, inflamed eyelid/eye, conjunctival sore, severe stomatitis, lip/intraoral sore, pain in the genitalia[mucocutaneous ocular syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis (TEN), erythema multiforme]
nausea, vomiting, stomachache, vomiting of blood, abdominal pain, severe abdominal pain, bloody/black stool[perforation of the digestive tract, gastrointestinal ulcer, gastrointestinal bleeding]
sensitive to light, blurred vision, irritation in the eyes, ocular pain, teary eyes[corneal perforation, corneal ulcer]
Other side effects not listed here may occur. Check with your doctor/pharmacist if you have any worrisome symptom.
Storage and other information
Keep out of the reach of children. Store at room temperature (1-30℃), away from direct sunlight and moisture.
Discard the remainder. Do not store them. Ask the pharmacist how to discard.
Manufacturer's name : Chugai Pharmaceutical Co., Ltd.
http://www.info.pmda.go.jp/go/pack/4291016F1020_1_13/


---------------------------------------------------------
注:以下产品不同规格和不同价格,购买以咨询为准!
---------------------------------------------------------
产地国家: 日本
原产地英文商品名:
TARCEVA(タルセバ錠)25mg/tablet 100tablets/box
原产地英文药品名:
Erlotinib Hydrochloride
中文参考商品译名:
TARCEVA片(タルセバ錠)25毫克/片 14片/盒
中文参考药品译名:
盐酸厄洛替尼
生产厂家中文参考译名:
中外制药
生产厂家英文名:
Chugai Pharmaceutical Co., Ltd.
------------------------------------------------------------------
产地国家: 日本
原产地英文商品名:
TARCEVA(タルセバ錠)100mg/tablet 100tablets/box
原产地英文药品名:
Erlotinib Hydrochloride
中文参考商品译名:
TARCEVA片(タルセバ錠)100毫克/片 14片/盒
中文参考药品译名:
盐酸厄洛替尼
生产厂家中文参考译名:
中外制药
生产厂家英文名:
Chugai Pharmaceutical Co., Ltd.
------------------------------------------------------------------
产地国家: 日本
原产地英文商品名:
TARCEVA(タルセバ錠)150mg/tablet 100tablets/box
原产地英文药品名:
Erlotinib Hydrochloride
中文参考商品译名:
TARCEVA片(タルセバ錠)150毫克/片 14片/盒
中文参考药品译名:
盐酸厄洛替尼
生产厂家中文参考译名:
中外制药
生产厂家英文名:
Chugai Pharmaceutical Co., Ltd.

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