Buprenorphine and Naloxone Sublingual Tablets, a CIII controlled substance, is indicated for the treatment of opioid dependence. It combines buprenorphine, an opioid (partial agonist-antagonist), and naloxone, an opioid antagonist. Buprenorphine is a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor. Naloxone is a potent antagonist at mu-opioid receptors and produces opioid withdrawal signs and symptoms in individuals physically dependent on full opioid agonists when administered parenterally.
Buprenorphine and Naloxone Sublingual Tablets was approved under a Risk Evaluation and Mitigation Strategy (REMS) and will be distributed according to the FDA and Drug Enforcement Administration (DEA) regulations governing CIII controlled substances. It will be available as 2mg/0.5mg and 8mg/2mg strength tablets.
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