Veroclude

Therapeutic Group: Anti-Viral Drugs Chemical Composition: Entecavir License by : Unipharma Dosage form: Film Coated Tablets
Information about Veroclude

Veroclude            FilmCoated Tablets

 

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 selectiveactivity 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 deoxyguanosinetriphosphate, it inhibits all three activities of the HBV polymerase. Thecoadministration of HIV nucleoside / nucleotide reverse transcriptaseinhibitors with Veroclude is unlikely to reduce the antiviral efficacy of Verocludeagainst HBV or any of these agents against HIV.

Following oral administration, Veroclude peak plasma concentrationsoccurred between 0.5 and 1.5 hours. Cmax and area under curve (AUC) increase inproportion 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 cytochromeP450 (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 Bvirus infection in adults with evidence of active viral replication and eitherevidence of persistent elevations in serum aminotransferases (ALT or AST) orhistologically active disease.

The following points should be considered when initiating therapywith Veroclude

•        Thisindication is based on histologic, virdogic, biodemical and serologic responses.

•        Limiteddata are available in adults subjects with HIV/HBV co-infection who havereceived 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 2hours after a meal and 2 hours before the next meal).

•        Adultsand adolescents 16 years of age and older: 0.5 mg once daily.

•        Adultsand adolescents (at least 16 years of age) with a history of hepatitis Bviremia while receiving lamivudine or known lamivudine or telbivudineresistance 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.

 

Manufactured by UniversalPharmaceutical Industries – UNIPHARMA – Damascus – Syria.