VIR 0.5 mg Tablet

VIR 0.5 mg Tablet

DESCRIPTION

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

COMPOSITION

Each film-coated tablet contains Entecavir INN 0.5 mg.

INDICATION

VIR 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 aminnotransferases (ALT or AST) or histologically active disease.

DOSAGE AND ADMINISTRATION

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

Dose Adjustment in Renal impairment: Dose adjustment is recommended for patients with creatinine clearance <50 mL/min, including patients on hemodialysis or continuous ambulatory peritoneal dialysis (CAPD) as shown in below –

SIDE EFFECT

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

CONTRAINDICATION

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

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.

USE IN PREGNANCY AND 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.

DRUG INTERACTION

Coadministration of Entecavir with Lamivudine or Adefovir dipivoxil did not result in significant drug interactions. The effects of co administration of Entecavir with other drugs that are renally eliminated or are known to affect renal function have not been evaluated.

OVER DOSE

There is no experience of Entecavir over dosage reported in patients.

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.

SUPPLY

Each box contains 1×10 tablets in blister strip