Posted on 24.08.2018 in the General category
Safety and efficacy of epivir-hbv have not been established in the presence of decompensated liver disease see indications and usage 1 .
Animal DataLamivudine was administered orally to pregnant ratsat 90600and 4,000 mg per kg per dayand rabbitsat 90300and 1,000 mg per kg per day and at 1540and 90 mg per kg per dayduring organogenesison gestation Days 7 through 16ratand 8 through 20rabbitNo evidence of fetal malformations due to lamivudine was observed in rats and rabbits at doses producing plasma concentrationsC maxapproximately 53 or more times higher than human exposure at the recommended daily doseEvidence of early embryolethality in the absence of maternal toxicity was seen in the rabbit at systemic exposuresAUCsimilar to those observed in humansbut there was no indication of this effect in the rat at plasma concentrationsC max60 times higher than human exposure at the recommended daily doseStudies in pregnant rats showed that lamivudine is transferred to the fetus through the placentaIn the fertility/pre-and postnatal development study in ratslamivudine was administered orally at doses of 180900and 4,000 mg per kg per dayfrom prior to mating through postnatal Day 20In the studydevelopment of the offspringincluding fertility and reproductive performancewas not affected by maternal administration of lamivudine at plasma concentrationsC max104 times higher than human exposure.
Discontinue immediately if signs or symptoms of pancreatitis occur in patients with history of pancreatitis.
This medication should not be used if you have certain medical conditionsBefore using this medicineconsult your doctor or pharmacist if you havepancreatitis.
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.
MetabolismMetabolism of lamivudine is a minor route of eliminationIn humansthe only known metabolite of lamivudine is the trans-sulfoxide metaboliteapproximately 5of an oral dose after 12 hoursSerum concentrations of this metabolite have not been determinedLamivudine is not significantly metabolized by cytochrome P450 enzymes.
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epivir-hbv dosage and administration.
