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 suppositories
中文名：盐酸丁丙诺非栓剂
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. 
 レペタン坐剤0.2mg／レペタン坐剤0.4mg
药用分类名称
止痛药
批准日期：1990年5月
商標名
Lepetan suppositories 0.2mg
Lepetan suppositories 0.4mg
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，在任何测试中使用化学刺激、热刺激、压力刺激和电刺激作为侵权刺激吗啡、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
手术后　
通常，成人在直肠中施用0.4mg作为丁丙诺啡一次。然后，如有必要，每8至12小时重复施用一次。然而，在手术后立即给剧烈疼痛施用丁丙诺啡注射剂，然后根据需要施用栓剂。
各种癌症
通常，成人一次施用0.2mg或0.4mg作为丁丙诺芬在直肠。然后，如有必要，每8至12小时重复施用一次。另外，最好从低剂量开始给药。
临床结果
全国64个设施进行术后疼痛和癌症疼痛的临床试验摘要如下。
（1） 术后疼痛
该剂0.2mg的中度至重度术后疼痛，在0.4mg单剂量试验中中中改善率以上分别为35.6%（16/45例）和52.6%（20/38例）。在中度至重度术后疼痛的双盲试验中，在肌肉内施用丁丙诺啡注射剂0.2mg，在6小时后每8小时施用0.4mg的疗效超过80.4%（78/97例）。
（2） 癌症疼痛
在轻度至中度癌症疼痛的双盲试验中，该剂0.2mg的有效效率为94.1%（32/34例）。在中度至重度癌症疼痛的双盲试验中，该剂0.4mg的中度改善率提高67.7%（44/65例）为6）。在癌症疼痛剂0.2至0.4mg的长期给药试验中也观察到疗效。
包装
坐剤
0.2mg：50個


0.4mg：50個
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/1149703J1020_1_11/?view=frame&style=SGML&lang=ja
Lepetan suppository 0.2mg（Buprenorphine hydrochloride）
Brand name :
Lepetan suppository 0.2mg
　Active ingredient:
Buprenorphine hydrochloride
　Dosage form:
White suppository, length: approx. 27 mm, diameter: approx. 8.7 mm
　Print on wrapping:
(face) 坐剤, レペタン坐剤0.2mg, (back) レペタン坐剤0.2mg, 坐剤, のまないこと (Do not swallow.)
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 and pains due to various cancers.
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, biliary tract disease, proctitis, rectal bleeding or hemorrhoid.
If you are 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 pain: In general, for adults, insert 2 suppositories(0.4 mg of active ingredient) into the rectum (anus) at a time. Use the medicine approximately every 8 to 12 hours as necessary. If you feel severe postoperative pain, tell your doctor. Strictly follow the instructions of your doctor and pharmacist.
For cancer-related pain: In general, for adults, insert 1 or 2 suppositories (0.2 or 0.4 mg of active ingredient) into the rectum (anus) at a time. Use the medicine approximately every 8 to 12 hours as necessary. You may be instructed to use a lower dose when first using this medicine. Strictly follow the instructions of your doctor and pharmacist.
This medicine must only be used for rectal administration. Whenever possible, insert the suppository after defecation. Never swallow this medicine. After removing the suppository from the package sheet, insert it into the rectum from the round (thinner) end of the suppository.
If you miss a dose, use the dose as soon as you remember it and consult with your doctor or pharmacist. You should use the next dose at the instructed dosing interval. You should never use two doses at one time.
If you accidentally use more than your prescribed dose, consult with your doctor or pharmacist.
Do not stop using this medicine unless your doctor instructs you to do so.
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 delusion 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.
Storage conditions and other information
Keep out of the reach of children. Store away from direct sunlight, heat and moisture(it is not necessary to store in a refrigerator).
Discard the remainder. Do not store them. Ask the pharmacist how to discard them.
External
Published: 11/2010
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.