- Approval Id
- cec5360cf1e7ecfa
- Drug Name
- COMBIVIR TABLETS
- Product Name
- COMBIVIR TABLETS
- Approval Number
- SIN10795P
- Approval Date
- 1999-03-09
- Registrant
- GLAXOSMITHKLINE PTE LTD
- Licence Holder
- GLAXOSMITHKLINE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>Dosage and Administration</strong></p>
<p>Pharmaceutical Form: Film-coated tablets.</p>
<p><em>COMBIVIR</em> therapy should be initiated and monitored by a physician experienced in the management of HIV infection.</p>
<p><em>COMBIVIR</em> may be administered with or without food.</p>
<p><strong>Populations</strong></p>
<p>Adults and children over the age of 12 years:</p>
<p>The recommended dose of <em>COMBIVIR</em> is one tablet twice daily.</p>
<p>If a reduction in dose of <em>COMBIVIR</em> appears clinically indicated, or if one of the components of <em>COMBIVIR</em> (lamivudine or zidovudine) requires reduction or discontinuation, separate preparations of lamivudine (<em>EPIVIR</em>) and zidovudine (<em>RETROVIR</em>) are available in tablets/capsules and oral solution.</p>
<ul>
<li><strong>Elderly</strong>
<p>No specific data are available, however special care is advised in this age group due to age associated changes such as the decrease in renal function and alteration of haematological parameters.</p></li>
<li><strong>Renal impairment</strong>
<p>Dosage adjustment of lamivudine is required in patients with a creatinine clearance of less than 30 mL/min (<em>see Pharmacokinetics and Warnings and Precautions</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). It is therefore recommended that separate preparations of lamivudine and zidovudine should be administered to these patients.</p></li>
<li><strong>Hepatic impairment</strong>
<p>Dosage adjustments for zidovudine may be necessary in patients with hepatic impairment (<em>see Pharmacokinetics</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). It is therefore recommended that separate preparations of lamivudine and zidovudine should be administered to patients with severe hepatic impairment.</p></li>
<li><strong>Dosage adjustments in patients with haematological adverse reactions</strong>
<p>Dosage adjustment of zidovudine may be necessary if the haemoglobin level falls below 9 g/dL or 5.59 mmol/L or the neutrophil count falls below 1.0 x 10<sup>9</sup> /L (<em>see Contraindications and Warnings and Precautions</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). As dosage adjustment of <em>COMBIVIR</em> is not possible, separate preparations of zidovudine and lamivudine should be used. Physicians should refer to the individual prescribing information for these drugs.</p></li>
</ul>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>Indications</strong></p>
<p><em>COMBIVIR</em> is indicated for the treatment of HIV-infected adults and adolescents > 12 years, with progressive immunodeficiency (CD4+ Count =< 500 cells/mm<sup>3</sup>).</p>
<p>Lamivudine in combination with zidovudine reduces HIV-1 viral load and increases CD4+ cell count. Clinical endpoint data indicate that lamivudine in combination with zidovudine alone, or in combination with zidovudine containing treatment regimens result in a significant reduction in the risk of disease progression and mortality.</p>
- Contraindications
- <p><strong>Contraindications</strong></p>
<p>The use of <em>COMBIVIR</em> is contraindicated in patients with known hypersensitivity to lamivudine, zidovudine or to any ingredient of the preparation.</p>
<p>Zidovudine is contraindicated in patients with abnormally low neutrophil counts (less than 0.75 x 10<sup>9</sup>/L), or abnormally low haemoglobin levels (less than 7.5 g/dL or 4.65 mmol/L). <em>COMBIVIR</em> is therefore contraindicated in these patients (<em>see Warnings and Precautions</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Atc Code
- J05AR01
- Atc Item Name
- zidovudine and lamivudine
- Pharma Manufacturer Name
- GLAXOSMITHKLINE PTE LTD
