- Approval Id
- 6cf440618aaa9ce5
- Drug Name
- BARACLUDE TABLET 0.5mg
- Product Name
- BARACLUDE TABLET 0.5mg
- Approval Number
- SIN13165P
- Approval Date
- 2006-01-16
- Registrant
- BRISTOL-MYERS SQUIBB (SINGAPORE) PTE. LTD.
- Licence Holder
- BRISTOL-MYERS SQUIBB (SINGAPORE) PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>2 DOSAGE AND ADMINISTRATION</strong></p>
<p><strong>2.1 Recommended Dosage</strong></p>
<p><strong>Compensated Liver Disease</strong></p>
<p>The recommended dose of BARACLUDE for chronic hepatitis B virus infection in nucleoside-treatment-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 BARACLUDE 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><em><strong>Decompensated Liver Disease</strong></em></p>
<p>The recommended dose of BARACLUDE 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>
<p><strong>Oral Solution</strong></p>
<p>BARACLUDE (entecavir) Oral Solution contains 0.05 mg of entecavir per milliliter. Therefore, 10 mL of the oral solution provides a 0.5 mg dose and 20 mL provides a 1 mg dose of entecavir.</p>
<p><strong>2.2 Renal Impairment</strong></p>
<p>In subjects with renal impairment, the apparent oral clearance of entecavir decreased as creatinine clearance decreased [see <em>Clinical Pharmacology (10.2)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>]. 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 1. The once-daily dosing regimens are preferred.</p>
<img src="/TGIF/Baraclude-Table1.png" alt="Baraclude Dosage Table 1" /><br><br>
<p><strong>2.3 Hepatic Impairment</strong></p>
<p>No dosage adjustment is necessary for patients with hepatic impairment.</p>
<p><strong>2.4 Duration of Therapy</strong></p>
<p>The optimal duration of treatment with BARACLUDE 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>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>1 INDICATIONS AND USAGE</strong></p>
<p>BARACLUDE® (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 BARACLUDE:</p>
<ul>
<li><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 [see <em>Clinical Studies (12)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>].</p></li>
<li><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 <em>Adverse Reactions (5)</em> and <em>Clinical Studies (12.1)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>].</p></li>
<li><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 <em>Warnings and Precautions (4.2)</em> and <em>Clinical Studies (12.1)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>].</p></li>
</ul>
- Contraindications
- <p><strong>3 CONTRAINDICATIONS</strong></p>
<p>BARACLUDE 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
- BRISTOL-MYERS SQUIBB (SINGAPORE) PTE. LTD.
