部分中文Suboxone处方资料(仅供参考) FDA批准丁丙诺啡/纳络酮舌下薄膜制剂 9月3日Medscape网站消息,一种新的丁丙诺啡/纳络酮舌下薄膜制剂已被美国食品药品监督管理局(FDA)批准用于治疗阿片依赖(opioid dependence),该药商品名为Suboxone,由利洁时公司(Reckitt Benckiser)负责销售。 丁丙诺啡/纳络酮舌下片(C-III)于2002年被批准用于治疗阿片依赖,但经评估,患者服用该药的依从率低于75%,且该药可能会被碾碎后从鼻孔吸入。 由于在这种新的薄膜制剂中所含的纳络酮可降低丁丙诺啡的作用,故在对于纯阿片受体激动剂成瘾的人群中,如通过注射滥用该药,则可引起急性撤药综合征。另外,该薄膜制剂的溶解时间较舌下片快2倍。 根据该公司发布的消息称,这种舌下薄膜制剂最早将于2010年10月上市,规格与目前丁丙诺啡/纳络酮舌下片(C-III)所提供的相同。 Suboxone(丁丙诺啡/纳络酮)舌下薄膜片(C-III)可作为包括辅导和社会心理支持在内的完整治疗方案的一部分,以用于阿片依赖的维持治疗。该药物的治疗应在具有通过《美国药物成瘾治疗法案》(Drug Addiction Treatment Act)而获得相关资质的医生指导下进行。 FDA Approves Sublingual Film Formulation of Buprenorphine/Naloxone September 3, 2010 — A new sublingual film formulation of buprenorphine/naloxone (Suboxone; Reckitt Benckiser) has been approved by the US Food and Drug Administration (FDA) for the treatment of opioid dependence. Buprenorphine/naloxone sublingual tablets (C-III) were approved in 2002 as a treatment for opioid dependence, but the compliance rate is estimated to be less than 75%, and the tablets can potentially be crushed and snorted. The new film formulation, if abused by injection, precipitates acute withdrawal symptoms in people dependent on full opioid agonists because the naloxone contained in the new film formulation attenuates the effects of the buprenorphine. In addition, the film formulation also has a dissolve time that is twice as fast as tablets. According to a company press release, the sublingual film will be available in early October
2010topatientsinthesamedosesascurrentlyofferedbybuprenorphine/naloxone sublingual tablets C-III. Suboxone (buprenorphine/naloxone) sublingual film (C-III) is indicated for maintenance treatment of opioid dependence as part of a complete treatment plan to include counseling and psychosocial support. Treatment should be initiated under the direction of physicians qualified under the Drug Addiction Treatment Act. 附件:
201262723551139.PDF
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产地国家: 加拿大 原产地英文商品名: SUBOXONE (2mg/0.5mg)/tab 7tabs/box 原产地英文药品名: BUPRENORPHINE HYDROCHLORIDE/NALOXONE HYDROCHLORIDE 中文参考商品译名: SUBOXONE (2毫克/0.5毫克)/片 7片/盒 中文参考药品译名: 盐酸丁丙诺啡/盐酸纳洛酮 生产厂家中文参考译名: 利洁时 生产厂家英文名: RECKITT BENCKISER
--------------------------------------------------- 产地国家: 加拿大 原产地英文商品名: SUBOXONE (8mg/2mg)/tab 7tabs/box 原产地英文药品名: BUPRENORPHINE HYDROCHLORIDE/NALOXONE HYDROCHLORIDE 中文参考商品译名: SUBOXONE (8毫克/2毫克)/片 7片/盒 中文参考药品译名: 盐酸丁丙诺啡/盐酸纳洛酮 生产厂家中文参考译名: 利洁时 生产厂家英文名: RECKITT BENCKISER |