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The epivir-hbv brand of lamivudine for treating hepatitis b should not be taken together with any other medication that contains lamivudine, which includes combivir, epivir, epzicom, and trizivir.

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Epivir-HBV is indicated for the treatment of chronic hepatitis B virus infection in pediatric patients aged 2 to 17 yearssee Indications and Usage1Clinical Pharmacology12.3Clinical Studies14.2The safety and efficacy of Epivir-HBV in pediatric patients younger than 2 years have not been established.

Lactic acidosis and severe hepatomegaly with steatosisincluding fatal casesreported with use of nucleoside analoguesincluding lamivudinea majority of these cases have been in womenfemale sex and obesity may be risk factors for development of lactic acidosis and severe hepatomegaly with steatosis in patients treated with antiretroviral nucleoside analoguessuspend treatment in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicitywhich may include hepatomegaly and steatosis even in the absence of marked transaminase elevations.

Epivir-HBV is indicated for the treatment of chronic hepatitis B virusHBVinfection associated with evidence of hepatitis B viral replication and active liver inflammationsee Clinical Studies14.114.2

Risk of immune reconstitution syndrome if used in combination with other antiretroviral drugs.

Patients should be monitored regularly during treatment by a physician experienced in the management of chronic hepatitis BDuring treatmentcombinations of events such as return of persistently elevated ALTincreasing levels of HBV DNA over time after an initial decline below assay limitprogression of clinical signs or symptoms of hepatic diseaseand/or worsening of hepatic necroinflammatory findings may be considered as potentially reflecting loss of therapeutic responseSuch observations should be taken into consideration when determining the advisability of continuing therapy with Epivir-HBV.

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