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In some individuals the use of opioid antagonists has been associated with a change in baseline levels of some hypothalamicpituitaryadrenalor gonadal hormonesThe clinical significance of such changes is not fully understood.

Cases of hepatitis and clinically significant liver dysfunction were observed in association with REVIA exposure during the clinical development program and in the postmarketing periodTransientasymptomatic hepatic transaminase elevations were also observed in the clinical trials and postmarketing periodWhen patients presented with elevated transaminasesthere were often other potential causative or contributory etiologies identifiedincluding pre-existing alcoholic liver diseasehepatitis B and/or C infectionand concomitant usage of other potentially hepatotoxic drugsAlthough clinically significant liver dysfunction is not typically recognized as a manifestation of opioid withdrawalopioid withdrawal that is precipitated abruptly may lead to systemic sequelaeincluding acute liver injury.

REVIA does not interfere with thin-layergas-liquidand high pressure liquid chromatographic methods which may be used for the separation and detection of morphinemethadone or quinine in the urineREVIA may or may not interfere with enzymatic methods for the detection of opioids depending on the specificity of the testPlease consult the test manufacturer for specific details.

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The mechanism of action of REVIA in alcoholism is not understoodhoweverinvolvement of the endogenous opioid system is suggested by preclinical dataREVIAan opioid receptor antagonistcompetitively binds to such receptors and may block the effects of endogenous opioidsOpioid antagonists have been shown to reduce alcohol consumption by animalsand REVIA has been shown to reduce alcohol consumption in clinical studies.

Patients with addictive disordersespecially opioid addictionare at risk for multiple numerous adverse events and abnormal laboratory findingsincluding liver function abnormalitiesData from both controlled and observational studies suggest that these abnormalitiesother than the dose-related hepatotoxicity described aboveare not related to the use of REVIA.

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REVIA is not aversive therapy and does not cause a disulfiram-like reaction either as a result of opiate use or ethanol ingestion.

The naloxone challenge test should not be performed in a patient showing clinical signs or symptoms of opioid withdrawalor in a patient whose urine contains opioidsThe naloxone challenge test may be administered by either the intravenous or subcutaneous routes.

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REVIA should be considered as only one of many factors determining the success of treatment of alcoholismFactors associated with a good outcome in the clinical trials with REVIA were the typeintensityand duration of treatmentappropriate management of comorbid conditionsuse of community-based support groupsand good medication complianceTo achieve the best possible treatment outcomeappropriate compliance-enhancing techniques should be implemented for all components of the treatment programespecially medication compliance.

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