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Most commonly observed adverse reactions in the pediatric trials were similar . to those in adult trialsPosttreatment transaminase elevations were observed in some subjects followed after cessation of Epivir-HBV.

Epivir-HBV is contraindicated in patients with a previous hypersensitivity reaction to lamivudine.

Pediatric subjects who received lamivudineEpiviroral solution concomitantly with other antiretroviral oral solutions at any time in the ARROW trial had lower rates of virologic suppressionlower plasma lamivudine exposureand developed viral resistance more frequently than those receiving lamivudineEpivirtabletslamivudineEpivirscored tablet is the preferred formulation for HIV-1-infected pediatric patients who weigh at least 14 kg and for whom a solid dosage form is appropriateconsider more frequent monitoring of HIV-1 viral load when treating with lamivudineEPIVIRoral , . solution.

Lamivudine is administered orallyIt distributes into extravascular spacesWhen administered to pregnant womendrug concentrations in cord blood are similar to those observed in maternal blood at deliveryThe volume of distribution is independent of dose and does not correlate with body weightPlasma protein binding is less than 36Hepatic . metabolism is a minor route of eliminationmost of an oral dose71is excreted unchanged in the urine by active organic cationic secretionThe only known metabolite in humans is the trans-sulfoxide metabolitewhich accounts for approximately 5of a dose appearing in the urineThe mean elimination half-life after a single dose ranges from 5 to 7 hours.

Peritoneal dialysis After corrections for renal impairmentno additional dose modifications are required after routine4-hourperitoneal dialysisCAPDAlternatively in adult patientsa dose of 50 mg PO once then 25 to 50 mg PO every 24 hours has been suggestedFor pediatric patientsreducing the dose to 25of the normal dose and extending the dosing interval to every 24 hours has been recommended based on a twice daily dosage regimen in patients with normal renal function being treated for HIVEpivir

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