Important Safety Information on SUBOXONE (buprenorphine and naloxone)… — recall 61988

Reported risk: Health Canada has authorized 2 dosage forms of SUBOXONE (buprenorphine and naloxone), a sublingual tablet and soluble film, that are not bioequivalent at all doses and routes of administration. Switching between dosage forms or routes of administration could result in variations in buprenorphine or naloxone blood plasma concentrations, which could lead to inadvertent overdosing or underdosing, including opioid withdrawal. SUBOXONE will be available in 2 dosage forms: SUBOXONE Soluble Film and SUBOXONE Sublingual Tablet. Both dosage forms are used for substitution treatment in adults with problematic opioid drug dependence. SUBOXONE Soluble Film may be administered sublingually (for both induction and maintenance therapy) or buccally (for maintenance therapy). SUBOXONE Sublingual Tablet can only be administered sublingually. SUBOXONE Soluble Film and Sublingual Tablet are not bioequivalent at all doses and routes of administration. In several pharmacokinetic studies following the administration of different dosages, a dose of one or two 2 mg / 0.5 mg SUBOXONE films administered sublingually or buccally showed comparable buprenorphine and naloxone bioavailability to the same total dose of SUBOXONE tablets. In contrast, one 8 mg / 2 mg and one 12 mg / 3 mg SUBOXONE film administered sublingually or buccally showed higher relative bioavailability for both buprenorphine and naloxone compared to the same total dose of SUBOXONE tablets. A combination of one 8 mg / 2 mg and two 2 mg / 0.5 mg SUBOXONE films (total dose of 12 mg / 3 mg) administered sublingually showed comparable buprenorphine and naloxone bioavailability to the same total dose of SUBOXONE tablets, while buccally administered SUBOXONE film showed higher relative bioavailability. For more information regarding the relative increase in exposure to buprenorphine and naloxone associated with SUBOXONE Soluble Film compared to SUBOXONE Sublingual Tablet, including the effect of route of administration, healthcare professionals should refer to Table 6 of the SUBOXONE Canadian Product Monograph, which can be found on Health Canada's Drug Product Database .