Information about Veroclude
Composition:
• Eachfilm coated tablet Veroclude 0.5 mg contains: Entecavir 0.5 mg.
• Eachfilm coated tablet Veroclude 1.0 mg contains: Entecavir 1 mg.
Pharmacological Properties:
Veroclude is a guanosine nucleoside analogue with selective activity against hepatitis B Virus (HBV). It is efficiently phosphorylated tothe active triphosphate form, which has an intracellular half-life of 15 hours.
By competing with the natural substrate deoxyguanosine triphosphate, it inhibits all three activities of the HBV polymerase. The coadministration of HIV nucleoside / nucleotide reverse transcriptase inhibitors with Veroclude is unlikely to reduce the antiviral efficacy of Veroclude against HBV or any of these agents against HIV.
Following oral administration, Veroclude peak plasma concentrations occurred between 0.5 and 1.5 hours. Cmax and area under curve (AUC) increase in proportion to dose. The bioavailability of the tablet was 100% relative to theoral solution. Food results in delay in absorption, a decrease in Cmax and adecrease in AUC. Binding of Veroclude to human serum proteins was approximately13%.
Veroclude is not a substrate, inhibitor or induce of the cytochrome P450 (CYP450) enzyme system.
Veroclude is predominantly eliminated by the kidney with urine (62% - 73%) of unchanged drug.
Indications:
Veroclude is indicated for the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication and eitherevidence of persistent elevations in serum amino transferases (ALT or AST) or histologically active disease.
The following points should be considered when initiating therapy with Veroclude
• This indication is based on histologic, virdogic, biodemical and serologic responses.
• Limited data are available in adults subjects with HIV/HBV co-infection who have received prior lamivudine therapy.
• Verocludehas not been evaluated in patients with decompensated liver disease.
Dosage & Administration:
Veroclude should be administered on an empty stomach (at least 2 hours after a meal and 2 hours before the next meal).
• Adults and adolescents 16 years of age and older: 0.5 mg once daily.
• Adults and adolescents (at least 16 years of age) with a history of hepatitis B viremia while receiving lamivudine or known lamivudine or telbivudine resistance mutation: 1.0 mg once daily.
Packaging:
A pack contains 30 Veroclude tablets 0.5 mg Entecavir.
A pack contains 30 Veroclude tablets 1.0 mg Entecavir.