- Approval Id
- ba2ed2c93f71c728
- Drug Name
- HOVID-ENTECAVIR FILM COATED TABLET 1 MG
- Product Name
- HOVID-ENTECAVIR FILM COATED TABLET 1 MG
- Approval Number
- SIN16724P
- Approval Date
- 2023-03-02
- Registrant
- GOLDPLUS UNIVERSAL PTE LTD
- Licence Holder
- GOLDPLUS UNIVERSAL PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>DOSAGE AND ADMINISTRATION</strong></p>
<ol>
<li><p><strong>Recommended Dosage</strong><br>
<strong>Compensated Liver Disease</strong><br>
The recommended dose of HOVID ENTECAVIR for chronic hepatitis B virus infection in nucleosidetreatment-naïve adults and adolescents 16 years of age and older is 0.5 mg once daily, with or without food.</p>
<p>The recommended dose of HOVID ENTECAVIR in adults and adolescents (≥16 years of age) with a history of hepatitis B viremia while receiving lamivudine or known lamivudine resistance mutations is 1 mg once daily, which must be taken on an empty stomach (at least 2 hours after a meal and 2 hours before the next meal).</p>
<p><strong>Decompensated Liver Disease</strong><br>
The recommended dose of HOVID ENTECAVIR for chronic hepatitis B virus infection in adults with decompensated liver disease is 1 mg once daily, which must be taken on an empty stomach (at least 2 hours after a meal and 2 hours before the next meal).</p></li>
<li><p><strong>Renal Impairment</strong><br>
In subjects with renal impairment, the apparent oral clearance of entecavir decreased as creatinine clearance decreased. Dosage adjustment is recommended for patients with creatinine clearance less than 50 mL/min, including patients on hemodialysis or continuous ambulatory peritoneal dialysis (CAPD), as shown in Table 2. The once-daily dosing regimens are preferred.</p>
<img src="/TGIF/HovidEntecavir-Table2.png" alt="Hovid Entecavir Dosage Table 2" /><br><br></li>
<li><p><strong>Hepatic Impairment</strong><br>
No dosage adjustment is necessary for patients with hepatic impairment.</p></li>
<li><p><strong>Duration of Therapy</strong><br>
The optimal duration of treatment with HOVID ENTECAVIR for patients with chronic hepatitis B virus infection and the relationship between treatment and long-term outcomes such as cirrhosis and hepatocellular carcinoma are unknown.</p></li>
</ol>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>INDICATIONS</strong><br>
ENTECAVIR is indicated for the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.</p>
<p>The following points should be considered when initiating therapy with ENTECAVIR:</p>
<p>This indication is based on histologic, virologic, biochemical, and serologic responses in nucleoside-treatment-naïve and lamivudine-resistant adult subjects with HBeAg-positive or HBeAg-negative chronic HBV infection with compensated liver disease.</p>
<p>Virologic, biochemical, serologic, and safety data are available from a controlled study in adult subjects with chronic HBV infection and decompensated liver disease [see Adverse Reactions and clinical studies – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>].</p>
<p>Virologic, biochemical, serologic, and safety data are available for a limited number of adult subjects with HIV/HBV co-infection who have received prior lamivudine therapy [see Warnings and Precautions and clinical studies – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>].</p>
- Contraindications
- <p><strong>CONTRAINDICATIONS</strong><br>
ENTECAVIR is contraindicated in patients with previously demonstrated hypersensitivity to entecavir or any component of the product.</p>
- Atc Code
- J05AF10
- Atc Item Name
- entecavir
- Pharma Manufacturer Name
- GOLDPLUS UNIVERSAL PTE LTD
- Company Detail Path
- /organization/goldplus-universal-pte-ltd
