- Approval Id
- 8d1a9fcc3e4e5fe4
- Drug Name
- TRUVADA TABLET 200MG/300MG
- Product Name
- TRUVADA TABLET 200MG/300MG
- Approval Number
- SIN14147P
- Approval Date
- 2012-05-14
- Registrant
- GILEAD SCIENCES SINGAPORE PTE. LTD.
- Licence Holder
- GILEAD SCIENCES SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>2 DOSAGE AND ADMINISTRATION</strong></p>
<p><strong>2.1 Recommended Dose</strong></p>
<p>The recommended dose of TRUVADA is one tablet (containing 200 mg of emtricitabine and 300 mg of tenofovir DF) once daily taken orally with or without food.</p>
<p><strong>2.2 Dose Adjustment for Renal Impairment</strong></p>
<p>Significantly increased drug exposures occurred when emtricitabine or tenofovir were administered to subjects with moderate to severe renal impairment <em>[See Warnings and Precautions (5.3) and Clinical Pharmacology (11.2)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>. Therefore, adjust the dosing interval of TRUVADA in patients with baseline creatinine clearance 30–49 mL/min using the recommendations in Table 1. These dosing interval recommendations are based on modeling of single-dose pharmacokinetic data in non-HIV infected subjects. The safety and effectiveness of these dosing interval adjustment recommendations have not been clinically evaluated in patients with moderate renal impairment, therefore clinical response to treatment and renal function should be closely monitored in these patients <em>[See Warnings and Precautions (5.3)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>.</p>
<p>No dose adjustment is necessary for patients with mild renal impairment (creatinine clearance 50–80 mL/min).</p>
<img src="/TGIF/Truvada-Table1.png" alt="Truvada Dosage Table 1" /><br><br>
<p>Routine monitoring of estimated creatinine clearance, serum phosphorus, urine glucose, and urine protein should be performed in all individuals with mild renal impairment <em>[See Warnings and Precautions (5.3)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>1 INDICATIONS AND USAGE</strong></p>
<p>TRUVADA®, a combination of emtricitabine and tenofovir disoproxil fumarate (tenofovir DF) is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.</p>
<p>The demonstration of the benefit of the combination emtricitabine and tenofovir DF in antiretroviral therapy is based solely on studies performed in treatment-naïve patients <em>[See Clinical Studies (13)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>.</p>
<p>The following points should be considered when initiating therapy with TRUVADA for the treatment of HIV-1 infection:</p>
<ul>
<li>It is not recommended that TRUVADA be used as a component of a triple nucleoside regimen.</li>
<li>TRUVADA should not be coadministered with COMPLERA®, STRIBILD®, VIREAD®, GENVOYA®, DESCOVY® , VEMLIDY® or products containing tenofovir alafenamide, tenofovir DF, emtricitabine and lamivudine <em>[See Warnings and Precautions (5.4)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>.</li>
<li>In treatment experienced patients, the use of TRUVADA should be guided by laboratory testing and treatment history <em>[See Clinical Pharmacology (11.3)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>.</li>
</ul>
- Contraindications
- <p><strong>4 CONTRAINDICATIONS</strong></p>
<p>None.</p>
- Atc Code
- J05AR03
- Atc Item Name
- tenofovir disoproxil and emtricitabine
- Pharma Manufacturer Name
- GILEAD SCIENCES SINGAPORE PTE. LTD.
