Uses of Barcavir: - Chronic hepatitis B virus (HBV) infection Chronic hepatitis B Barcavir is contraindicated in patients with previously demonstrated hypersensitivity to Entecavir or any component of the product.

Hepatic viral infections (Hepatitis B)

Entecavir is a guanosine nucleoside analogue with potent and selective activity against HBV polymerase. For pharmacological action it is phosphorylated to the active triphosphate (TP) form. Entecavir triphosphate functionally inhibits all 3 activities of the viral polymerase- Priming of the HBV polymerase, Reverse transcription of the negative strand from the pregenomic messenger RNA Synthesis of the positive strand HBV DNA.

How to use Entecavir: Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Entecavir is to be taken empty stomach. Administration: Should be taken on an empty stomach. Take at least 2 hr after a meal & 2 hr before the next meal. Use oral solution when needed for renal impairment dosage adjustments. Adult Dose: Chronic Hepatitis B Indicated for treatment of CHB with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease Nucleoside inhibitor treatment-naïve with compensated liver disease (adults and adolescents ?16 yr): 0.5 mg PO qDay Lamivudine-refractory or known lamivudine or telbivudine resistance substitutions (adults and adolescents ?16 yr): 1 mg PO qDay Decompensated liver disease (adults): 1 mg PO qDay Child Dose: Chronic Hepatitis B Indicated for treatment of CHB with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease in children ?2 years and weigh at least 10 kg <2 years: Safety and efficacy not established >16 years: As adult Renal Dose: Renal Impairment Usual daily dose (0.5 mg) CrCl ?50 mL/min: No dosage adjustment required CrCl 30-49 mL/min: Reduce to 0.25 mg/day or 0.5 mg q48hr CrCl 10-29 mL/min: Reduce to 0.15 mg/day or 0.5 mg q72hr CrCl <10 mL/min, hemodialysis, or CAPD: 0.05 mg/day or 0.5 mg q7days Lamivudine-refractory/decompensated liver disease daily dose (1 mg) CrCl ?50 mL/min: No dosage adjustment required CrCl 30-49 mL/min: Reduce to 0.5 mg/day or 1 mg q48hr CrCl 10-29 mL/min: Reduce to 0.3 mg/day or 1 mg q72hr CrCl <10 mL/min, hemodialysis, or CAPD: 0.1 mg/day or 1 mg q7days

Drugs that reduce renal function or compete for active tubular secretion may increase serum conc of either entecavir or co-administered drug.

Entecavir is contraindicated in patients with previously demonstrated hypersensitivity to Entecavir or any component of the product.

Common - Headache - Dizziness - Tiredness - Nausea 1-10% Fatigue (1-3%),Headache (2-4%),Dizziness,Nausea <1% Diarrhea,Dyspepsia,Vomiting,Somnolence,Insomnia

Use in pregnancy: There are no adequate and well-controlled studies in pregnant women. Entecavir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.Use in lactation: It is not known whether Entecavir is excreted in human milk. Mothers should be instructed not to breast-feed if they are taking Entecavir.

Precaution: Lactic acidosis: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases have been reported with the use of nucleoside analogues alone or in combination with antiretrovirals.Exacerbations of hepatitis after discontinuation of treatment: Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including Entecavir. Lactation: excretion in milk unknown/not recommended

There is no experience of Entecavir overdosage reported in patients. Healthy subjects who received up to 20 mg daily for up to 14 days and single doses up to 40 mg had no unexpected adverse events. If overdosage occurs, the patient must be monitored for evidence of toxicity and standard supportive treatment as necessary.

Keep in a dry place and store below 30°C. Protect from light and keep out of the reach of children.

Hepatic viral infections (Hepatitis B)

Selective HBV DNA polymerase inhibitor; inhibition blocks reverse transcriptase activity, which in turn reduces viral DNA synthesis

Pregnancy Prospective pregnancy data from the APR are not sufficient to adequately assess the risk of birth defects, miscarriage or adverse maternal or fetal outcomes; use during pregnancy has been evaluated in a limited number of individuals reported to APR and number of exposures to entecavir is insufficient to make a risk assessment compared to a reference population; rate of miscarriage is not reported in APR; all pregnancies have a background risk of birth defect, loss, or other adverse outcomes Lactation Not known whether drug is present in human breast milk, affects human milk production, or has effects on the breastfed infant; when administered to lactating rats, entecavir was present in milk; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from drug or from underlying maternal condition