The mechanism of action of REVIA in alcoholism is not understood; however, involvement of the endogenous opioid system is suggested by preclinical data. REVIA, an opioid receptor antagonist, competitively binds to such receptors and may block the effects of endogenous opioids. Opioid antagonists have been shown to reduce alcohol consumption by animals, and REVIA has been shown to reduce alcohol consumption in clinical studies. REVIA is not aversive therapy and does not cause a disulfiram-like reaction either as a result of opiate use or ethanol ingestion.

REVIA is indicated in the treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids. REVIA has not been shown to provide any therapeutic benefit except as part of an appropriate plan of management for the addictions.

To reduce the risk of precipitated withdrawal in patients dependent on opioids, or exacerbation of a preexisting subclinical withdrawal syndrome, opioid-dependent patients, including those being treated for alcohol dependence, should be opioid-free (including tramadol) before starting REVIA treatment. An opioid-free interval of a minimum of 7 to 10 days is recommended for patients previously dependent on shortacting opioids. See package insert for complete information.

During two randomized, double-blind placebo-controlled 12-week trials to evaluate the efficacy of REVIA as an adjunctive treatment of alcohol dependence, most patients tolerated REVIA well. In these studies, a total of 93 patients received REVIA at a dose of 50 mg once daily. Five of these patients discontinued REVIA because of nausea. No serious adverse events were reported during these two trials. See package insert for complete information.

REVIA is contraindicated in: 1.Patients receiving opioid analgesics. 2.Patients currently dependent on opioids, including those currently maintained on opiate agonists (e.g., methadone) or partial agonists (e.g., buprenorphine). 3.Patients in acute opioid withdrawal (see WARNINGS). 4.Any individual who has failed the naloxone challenge test or who has a positive urine screen for opioids. 5.Any individual with a history of sensitivity to REVIA or any other components of this product. It is not known if there is any cross-sensitivity with naloxone or the phenanthrene containing opioids.

When Reversal of REVIA Blockade is Required for Pain Management In an emergency situation in patients receiving fully blocking doses of REVIA, a suggested plan of management is regional analgesia, conscious sedation with a benzodiazepine, use of non-opioid analgesics or general anesthesia. In a situation requiring opioid analgesia, the amount of opioid required may be greater than usual, and the resulting respiratory depression may be deeper and more prolonged. A rapidly acting opioid analgesic which minimizes the duration of respiratory depression is preferred. See package insert for complete information.