Replivir

Generic Name: Entecavir
Dosage Form: Tablet
TG Name: Anti-infectives

1. What is REPLIVIR^®?
Replivir^® is the preparation of Entecavir Monohydrate USP.

2. How REPLIVIR^® works in our body?
Replivir^® (Entecavir) is a guanosine nucleoside analogue with activity against HBV polymerase. Replivir^® (Entecavir) functionally inhibits all activities of the HBV polymerase (reverse transcriptase).

3. What is the indication of REPLIVIR^®?
Entecavir is indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevation in serum aminotransferases (ALT or AST) or histologically active disease.

4. What are the dosage & administration of REPLIVIR^®?
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. For Lamivudine-refractory or known Lamivudine or Telbivudine resistance mutations, the recommended dose of Entecavir is 1 mg once daily. For patients with decompensated liver disease (adult) the recommended dose of Entecavir is 1 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).

5. What are the contraindications of REPLIVIR^®?
Replivir^® is contraindicated in patients with previously demonstrated hypersensitivity to Entecavir or any component of the ingredients.

6. What are the adverse effects of REPLIVIR^®?
The most common adverse events are headache, fatigue, dizziness and nausea.

7. What would be the storage condition of REPLIVIR^®?
Do not store above 30° C. Keep in a dry place. Protect from light & keep out of the reach of children.