Barcavir
Entecavir INN Tablet

Presentation
Barcavir : Each tablet contains Entecavir INN 0.5 mg.

Description
Entecavir is a guanosine nucleoside analogue with activity against HBV polymerase. Entecavir functionally inhibits all activities of the HBV polymerase (reverse transcriptase).

Indications and Uses
Barcavir is indicated for the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication and either evidence of persistent elevation in serum aminotransferases (ALT or AST) or histologically active disease.

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

Dosage And Administration
The recommended dose of Entecavir for chronic hepatitis B virus infection in nucleoside-treatment-naive adults and adolescents 16 years of age is 0.5 mg once daily. Entecavir should be administered on an empty stomach (at least 2 hours after a meal or 2 hours before the next meal).

Dose Adjustment in Renal impairment: Dose adjustment is recommended for patients with creatinine clearance <50 mL/min.


Precautions
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.

Side Effects
The most common adverse events are headache, fatigue, dizziness and nausea.

Use in pregnancy & lactation
Pregnancy: There are no data on the effect of Entecavir on transmission of HBV from mother to infant. Therefore, appropriate care should be taken.
Lactation: It is not known whether it is excreted in human milk. Mothers should be instructed not to breast feed if they are taking Entecavir.

Pediatric Use
Safety and effectiveness of Entecavir in pediatric patients below the age of 16 years have not been established.

Geriatric Use
Clinical studies of Entecavir did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. But care should be taken in dose selection, and it may be useful to monitor renal function.

Overdosage
There is no experience of Entecavir overdosage reported in patients.

Commercial Pack
Barcavir : Each box contains 1 blister strip of 10 tablets. ;

Other
Missed dose If it is almost time for next dose, skip the missed dose and take the next dose at the proper time. Nobody should take a double dose to make up for the missed dose.