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Naltrexone at low doses upregulates a unique gene expression not seen with normal doses implications for its use in cancer therapy.

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Naltrexone may cause liver damage when taken in large dosesIt is not likely that naltrexone will cause liver damage when taken in recommended dosesTell your doctor if you have or have ever had hepatitis or liver diseaseIf you experience any of the following symptomsstop taking naltrexone and call your doctor immediatelyexcessive tiredness,unusual bleeding or bruisingloss of appetitepain in the upper right part of your stomach that lasts more than a few dayslight-colored bowel movements,dark urineor yellowing of the skin or eyes.

The clinical use of REVIA as adjunctive pharmacotherapy for the treatment of alcoholism was also evaluated in a multicenter safety studyThis study of 865 individuals with alcoholism included patients with comorbid psychiatric conditionsconcomitant medicationspolysubstance abuse and HIV diseaseResults of this study demonstrated that the side effect profile of REVIA appears to be similar in both alcoholic and opioid dependent populationsand that serious side effects are uncommon.

To reduce the risk of precipitated withdrawal in patients dependent on opioidsor exacerbation of a preexisting subclinical withdrawal syndromeopioid-dependent patientsincluding those being treated for alcohol dependenceshould be opioid-freeincluding tramadolbefore starting REVIA treatmentAn opioid-free interval of a minimum of 7 to 10 days is recommended for patients previously dependent on short-acting opioids.

REVIA has fewif anyintrinsic actions besides its opioid blocking propertiesHoweverit does produce some pupillary constrictionby an unknown mechanism.

There was limited evidence of a weak genotoxic effect of naltrexone in one gene mutation assay in a mammalian cell linein the Drosophila recessive lethal assayand in non-specific DNA repair tests with EcoliHoweverno evidence of genotoxic potential was observed in a range of other in vitro testsincluding assays for gene mutation in bacteriayeastor in a second mammalian cell linea chromosomal aberration assayand an assay for DNA damage in human cellsNaltrexone did not exhibit clastogenicity in an in vivo mouse micronucleus assay.

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