Clinical adverse reactions a reported in greater than or equal to 10 of subjects who received epivir-hbv for 52 to 68 weeks and at an incidence greater than placebo trials 1-3 .

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There is no known specific treatment for overdose with Epivir-HBVIf overdose occursthe patient should be monitoredand standard supportive treatment appliedas requiredBecause a negligible amount of lamivudine was removed via4-hourhemodialysiscontinuous ambulatory peritoneal dialysisand automated peritoneal dialysisit is not known if continuous hemodialysis would provide clinical benefit in a lamivudine overdose event.

The following points should be considered when initiating therapy with Epivir-HBV:

Do not stop taking this medication without consulting your doctorWorsening of your conditiondecreased response to medicationor development of drug-resistant types of the virus may occur during or after treatmentPromptly report any new symptoms that occur during or after treatment to your doctor.

There is no information available regarding the effects of the drug on the breastfed infant or on milk production.

Pharmacokinetic parameters of lamivudine are not altered by diminishing hepatic functionthereforeno dosage adjustment is required with impaired hepatic functionSafety and efficacy have not been established in patients with decompensated hepatic diseaseTreatment should be discontinued in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity.

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the safety and efficacy of epivir-hbv were evaluated in a double-blind clinical trial in 286 subjects aged 2 to 17 years, who were randomized 2 1 to receive 52 weeks of epivir-hbv 3 mg per kg once daily to a maximum of 100 mg once daily or placebo.