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Lepetan 0.2mg 10ampoule×1.ml(Buprenorphine 盐酸丁丙诺啡注射液)
药店国别  
产地国家 日本 
处 方 药: 是 
所属类别 0.2毫克 10安瓿×1.毫升 
包装规格 0.2毫克 10安瓿×1.毫升 
计价单位: 盒 
生产厂家中文参考译名:
大冢制药
生产厂家英文名:
Otsuka Pharmaceutical
该药品相关信息网址1:
http://www.info.pmda.go.jp/go/pack/1149403A1050_1_08/
该药品相关信息网址2:
该药品相关信息网址3:
原产地英文商品名:
Lepetan(レペタン注)0.2mg 10ampoule×1ml
原产地英文药品名:
Buprenorphine Hydrochloride
中文参考商品译名:
Lepetan(レペタン注)0.2毫克 10安瓿×1.毫升
中文参考药品译名:
盐酸丁丙诺啡
曾用名:
简介:

 

部份中文盐酸丁丙诺非处方资料(仅供参考)
英文名:Buprenorphine Hydrochloride
商品名:Lepetan injection
中文名:盐酸丁丙诺非注射液
生产商:大冢制药
药品简介
Lepetan(Buprenorphine)是一种止痛药,通过神经信号传导大脑,阻止疼痛,从而达到止痛效果. 
レペタン注0.2mg/レペタン注0.3mg
药用分类名称
止痛药
批准日期:2005年12月
商標名
Lepetan injection 0.2mg
Lepetan injection 0.3mg
一般名
ブプレノルフィン塩酸塩〔Buprenorphine Hydrochloride(JAN)〕
化学名
(2S)-2-[(5R,6R,7R,14S)-17-(Cyclopropylmethyl)-4,5-epoxy-3-hydroxy-6-methoxy-6,14-ethanomorphinan-7-yl]-3,3-dimethylbutan-2-ol monohydrochloride
構造式
分子式
C29H41NO4・HCl
分子量
504.10
性状
它是白色到带状黄白色晶体或结晶粉末。
容易溶于甲醇或醋酸(100),不易溶于水或乙醇(99.5)。
熔点
约268°C(分解)
药效药理
镇痛作用
丁丙诺啡通过抑制中枢神经系统的疼痛传导系统表现出镇痛效应,化学刺激、热刺激、压力刺激和电刺激在任何测试中都用作侵权刺激吗啡、五氯辛强,并表现出更长的镇痛效果。另外,对吗啡的拮抗作用与盐酸纳罗酮相当弱。
适应症
以下疾病和情况的镇痛
术后,各种癌症
用法与用量
当用于镇痛时
术后,各种癌症
通常成人,一次0.2mg~0.3mg作为丁丙诺芬(每体重4μg/kg~6μg/kg)注射到肌肉中。另外,初始量最好为0.2mg。然后根据需要每6-8小时重复注射一次。根据症状适当增加或减少。
心肌梗死
通常,在成人中,一次0.2毫克作为丁丙诺啡逐渐注射到静脉中。根据症状适当增加或减少。
用于麻醉辅助目的
通常,在引入麻醉时,将0.2mg~0.4mg(每体重4μg/kg~8μg/kg)作为丁丙诺啡,逐渐注射到静脉中。症状,手术时间,适当增加或减少,根据组合药物等。
临床结果
在日本151个设施中共进行了1652例,临床试验结果摘要包括3个多设施联合双盲比较试验。
术后疼痛
当0.2mg或0.3mg作为术后疼痛的丁丙诺芬注射肌肉时,效率分别为88.5%(170/192例),90.6%(58/64例)。此外,通过双盲比较试验,也观察到了该剂的有用性。
癌症疼痛
当0.2mg或0.3mg作为癌症疼痛的丁丙诺芬在肌肉内注射时,效率分别为71.1%(64/90例),91.7%(22/24例)。此外,通过双盲比较试验,也观察到了该剂的有用性。
心肌梗死疼
当静脉注射0.2mg作为丁丙诺芬作为心肌梗死疼痛的疗效为90.0%(153/170例)。此外,通过比较试验(信封法),承认了该剂的有用性。
麻醉辅助
4μg /kg作为压合剂在麻醉辅助应用试验中,6μg/kg,8μg/kg静脉注射时的效率分别为50.0%(32/64例)、83.3%(80/96例)、83.9%(73/87例)。
包装
注射液
0.2mg:1mL×10 管(带玻璃安培)
0.3mg:1.5mL×10管 (带玻璃安培)
制造供应商
大塚制药有限公司
注:以上中文处方资料不够完整,使用者以原处方资料为准。
完整说明资料附件:
http://www.info.pmda.go.jp/go/pack/1149403A1050_1_08/
Lepetan injection 0.2mg(Buprenorphine hydrochloride)
Brand name :Lepetan injection 0.2mg
 Active ingredient:
Buprenorphine hydrochloride
 Dosage form:
injection
 Print on wrapping:
Effects of this medicine
This medicine suppresses pain conduction in the central nervous system, providing a strong analgesic action.
It is usually used to relieve postoperative pain, pains due to various cancers or myocardial infarction, and used as an adjunct to anesthesia in the surgery.
Before using this medicine, be sure to tell your doctor and pharmacist
If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
If you have respiratory dysfunction, pulmonary function impairment, hepatic disorder, renal disorder, narcotic dependence, drug dependence, consciousness clouding due to head injury or brain lesion, increased intracranial pressure, or biliary tract disease.
If you are pregnant, possibly pregnant or breastfeeding.
If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)
Dosing schedule (How to take this medicine)
Your dosing schedule prescribed by your doctor is((to be written by a healthcare professional))
For postoperative or cancer-related pain: In general, for adults, this medicine is administered intramuscularly. Then, it is administered approximately every 6 to 8 hours as necessary. If you feel severe postoperative pain, tell your doctor.
For pains due to myocardial infarction: In general, for adults, this medicine is administered intravenously.
For adjunct to anesthesia: In general, for adults, this medicine is administered intravenously during the induction of anesthesia.
Precautions while taking this medicine
Remain at rest whenever possible after using this medicine because it may cause nausea, vomiting, dizziness or light-headedness when standing or walking after use. If you are administered this medicine at an outpatient visit to a hospital or clinic, rest for a while before returning home.
This medicine may cause sleepiness, dizziness, light-headedness or decreased attention, concentration and reflex movement. Do not drive a car, work at heights or engage in dangerous activities after using this medicine.
Refrain from consuming alcohol while using this medicine (alcohol may enhance the therapeutic effect of this medicine or cause adverse effects).
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include itching, rash, dizziness, nausea and vomiting. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
shallow and rapid breathing leading to breathing difficulty, and breathing difficulty shortly after moving [respiratory depression, breathing difficulty]
abnormal downward or back placement of the tongue [glossoptosis]
facial pallor, breathing difficulty, skin or mucosa (especially in lips and nails) turns blue to dark violet[shock]
mild consciousness disorder with illusion and hallucination, subjective unfounded beliefs[delirium, delusion]
continuous use of a certain substance regardless of trying to stop using it[dependence]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.
Injection
Published: 5/2014
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment. 

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