ST LOUIS (MD Consult) - On August 31, 2010, Reckitt Benckiser announced that the US Food and Drug Administration (FDA) has approved a sublingual film formulation of Suboxone (buprenorphine and naloxone), a drug indicated for the maintenance treatment of opioid dependence. Before this version of Suboxone was approved, it was only available in the form of sublingual tablets.

Suboxone is intended to be used as part of a complete treatment plan that includes counseling and psychosocial support. Prescription use of this product is limited to physicians certified under the Drug Addiction Treatment Act, 2000. Suboxone is considered a schedule C-III controlled substance.

Suboxone sublingual film can be abused in a manner similar to the way other opioids, legal or illicit, can be abused. The manufacturer cautions that clinical monitoring appropriate to a patient's level of stability is essential.

Physicians and patients should be aware that chronic use of buprenorphine can lead to physical dependence. A sudden or rapid decrease in the dose of Suboxone may result in an opioid withdrawal syndrome. The syndrome is typically milder than that seen with full agonists and may be delayed in onset.

Patients should be advised that it is extremely dangerous to self-administer nonprescribed benzodiazepines or other central nervous system (CNS) depressants while taking Suboxone sublingual film. Prescribers should consider reducing the doses of either CNS depressants or Suboxone sublingual film (or both) when these medications are being used concomitantly. Death has been reported in patients receiving Suboxone who were not opioid tolerant or dependent, especially when CNS depressants were also being administered.

Adverse events commonly observed with the administration of Suboxone sublingual film are numbness and/or redness of the mouth, tongue soreness, headache, nausea, vomiting, sweating, constipation, insomnia, pain, swelling of the limbs, disturbance of attention, palpitations, blurred vision, and signs and symptoms of withdrawal.

Suboxone sublingual film will appear on the market in early October 2010. It will be available in the same doses currently offered in Suboxone sublingual tablets.

圣路易斯(MD Consult)——2010年8月31日，利洁时(Reckitt Benckiser)公司宣布，美国食品药品管理局(FDA)已批准赛宝松(Suboxone，丁丙诺啡和纳洛酮复方制剂) 舌下薄膜衣片用作阿片类药物依赖的维持治疗。在这种剂型的赛宝松获准之前，该药仅有舌下含片一种剂型。

 

赛宝松预期成为包括心理咨询和社会心理支持在内的完整治疗计划中的一个组成部分。《药物成瘾治疗法》(2000年版)中明确规定此药品的处方权仅限于执业医师。赛宝松为C表III类受管制物质。

 

赛宝松舌下薄膜衣片被滥用的方式与其他合法或非法的阿片类药物相似。生产厂家警告：必须对患者的稳定水平进行适宜的临床监测。

 

医生和患者应了解，长期应用丁丙诺啡可产生躯体依赖。突然或快速减少赛宝松的剂量可产生阿片类药物戒断综合征。与完全激动剂的观察结果相比，此综合征通常较轻，发作也可能会延迟。

 

应告知患者，在服用赛宝松舌下薄膜衣片的同时自行应用未开处方的苯二氮卓类药物或其他中枢神经系统(CNS)抑制剂是极其危险的。在同时应用CNS抑制剂与赛宝松舌下薄膜衣片时，处方者应考虑减少其中一者的用量(或两者均减量)。在接受赛宝松治疗、对阿片类药物无耐药性或依赖性的患者中已有死亡的报告，尤其是在同时应用CNS抑制剂的情况下。

 

使用赛宝松舌下薄膜衣片常见的不良事件有口唇麻木和(或)发红、舌痛、头痛、恶心、呕吐、出汗、便秘、失眠、疼痛、肢体水肿、注意力不集中、心悸、视力模糊以及戒断综合征。

 

赛宝松舌下薄膜衣片将于2010年10月上市。届时将有与目前的赛宝松舌下含片剂量相同的药品出售。