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2010年8月31日，一种新的丁丙诺啡/纳络酮舌下薄膜衣片已被美国食品药品监督管理局（FDA）批准用于治疗阿片类药物依赖（opioid dependence），该药商品名为赛宝松（Suboxone）。FDA曾于2002年批准丁丙诺啡/纳络酮舌下含片上市，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。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。这次新批准的舌下薄膜衣片最早将于2010年10月在美上市。
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，必须对患者进行适宜的临床监测。长期应用丁丙诺啡可产生躯体依赖，因此突然停药或快速减少用量可产生阿片类药物戒断综合征，但与完全激动剂相比，症状通常较轻，发作也可能会延迟。
常见的不良反应包括，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。
Generic Name for SUBOXONE 8mg/2mg
Buprenorphine (as HCl) 8mg, naloxone (as HCl dihydrate) 2mg; sublingual tabs (lemon-lime flavor) or sublingual films (lime-flavor).
Legal Classification:
CIII
Pharmacological Class for SUBOXONE 8mg/2mg
Opioid (partial agonist-antagonist) + opioid antagonist.
Manufacturer of SUBOXONE 8mg/2mg
Reckitt Benckiser Pharmaceuticals, Inc.
Indications for SUBOXONE 8mg/2mg
Opioid dependence.
Adult dose for SUBOXONE 8mg/2mg
Dissolve under tongue; do not swallow tabs or films. Place additional films sublingually on opposite side from the first film if needed; should minimize overlapping. Start when clear signs of withdrawal occur, at least 4 hours after last opioid use; individualize based on type and degree of opioid dependence. ≥16yrs: Supervised administration (induction phase): Subutex 8mg once on day 1 and Subutex 16mg once on day 2. Unsupervised administration (maintenance phase): target dose is Suboxone 16mg once daily; adjust in 2mg or 4mg increments; range 4–24mg once daily. Switching from tabs to films or vice versa: may need dose adjustments; monitor for over-medication or under-dosing.
Children's dosing for SUBOXONE 8mg/2mg
≤16yrs: not recommended.
Also:
SUBOXONE 2mg/0.5mg
SUBUTEX
Warnings/Precautions for SUBOXONE 8mg/2mg
Head injury. Increased intracranial pressure. Monitor hepatic function at baseline then periodically. Impaired pulmonary, renal, thyroid, or adrenocortical function. Coma. Toxic psychoses. CNS depression. Acute abdomen. Biliary tract dysfunction. GI or GU obstruction. Acute alcoholism. Delirium tremens. Kyphoscoliosis. Avoid abrupt cessation. Elderly. Debilitated. Neonatal withdrawal. Pregnancy (Cat.C). Nursing mothers: not recommended.
Interactions for SUBOXONE 8mg/2mg
Potentiated by CYP3A4 inhibitors (eg, azole antifungals, macrolides, HIV protease inhibitors): may need buprenorphine dose adjustment. Monitor with CYP3A4 inducers (eg, efavirenz, phenobarbital, carbamazepine, phenytoin, rifampin). Avoid benzodiazepines (esp. intravenous), alcohol, other CNS depressants. Monitor for atazanavir with/without ritonavir: may need buprenorphine dose reduction.
Adverse Reactions for SUBOXONE 8mg/2mg
Headache, withdrawal syndrome, pain, GI upset, insomnia, asthenia, sweating, orthostatic hypotension, constipation; anaphylactic shock; films: also oral hypoesthesia, glossodynia, oral mucosal erythema, hyperhidrosis, peripheral edema.
How is SUBOXONE 8mg/2mg supplied?
Tabs, films—30 | 
