- Approval Id
- 9e9cfe77c300ba45
- Drug Name
- ISENTRESS® 400MG TABLET
- Product Name
- ISENTRESS® 400MG TABLET
- Approval Number
- SIN13568P
- Approval Date
- 2008-11-05
- Registrant
- MSD PHARMA (SINGAPORE) PTE. LTD.
- Licence Holder
- MSD PHARMA (SINGAPORE) PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>VI. DOSAGE AND ADMINISTRATION</strong></p>
<p>ISENTRESS is to be given in a combination regimen with other antiretroviral agents.</p>
<p>ISENTRESS Film-coated Tablets and Chewable Tablets can be administered with or without food (see VII. Clinical Pharmacology – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>ISENTRESS is available in the following dose strengths:</p>
<ul>
<li>600 mg film-coated tablet for once daily use</li>
<li>400 mg film-coated tablet for twice daily use</li>
<li>chewable tablet in 100 mg (scored) and 25 mg strengths for twice daily use.</li>
</ul>
<p>Because the formulations have different pharmacokinetic profiles, do not substitute the 400 mg tablet for the 600 mg tablet to create a 1200 mg once daily dose and do not substitute the chewable tablet for the 400 mg or 600 mg tablet.</p>
<p>The maximum dose of the chewable tablet is 300 mg twice daily.</p>
<p>For the treatment of patients with HIV-1 infection, the dosage of ISENTRESS is as follows:</p>
<p><strong>Adults:</strong></p>
<img src="/TGIF/Isentress-AdultDosingRecommendationsTable.png" alt="Isentress Adult Dosing Recommendations Table" /><br><br>
<p><strong>Children and adolescents:</strong></p>
<img src="/TGIF/Isentress-PediatricDosingRecommendationsTable.png" alt="Isentress Pediatric Dosing Recommendations Table" /><br><br>
<img src="/TGIF/Isentress-Table1.png" alt="Isentress Dosage Table 1" /><br><br>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>V. INDICATIONS</strong></p>
<p><strong>Adults</strong><br>
ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients.</p>
<p>This indication is based on analyses of plasma HIV-1 RNA levels in three double-blind controlled studies of ISENTRESS. Two of these studies were conducted in clinically advanced, 3-class antiretroviral (NNRTI, NRTI, PI) treatment-experienced adults through 96 weeks and one was conducted in treatment-naïve adults through 240 weeks.</p>
<p>The use of other active agents with ISENTRESS is associated with a greater likelihood of treatment response (see VIId. Clinical Studies – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>Pediatrics</strong><br>
ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in children and adolescents 2 years of age and older.</p>
<p>This indication is based on the evaluation of safety, tolerability, pharmacokinetic parameters and efficacy of ISENTRESS through at least 24-weeks in a multi-center, open-label, noncomparative study in HIV-1 infected, treatment-experienced children and adolescents 2 to 18 years of age (see VIId. Clinical Studies – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>The safety and efficacy of ISENTRESS 400 mg tablets have not been established in children less than 6 years of age. The safety and efficacy of ISENTRESS chewable tablets have not been established in children less than 2 years of age.</p>
- Contraindications
- <p><strong>VIII. CONTRAINDICATIONS</strong></p>
<p>ISENTRESS is contraindicated in patients who are hypersensitive to any component of this medicine.</p>
- Atc Code
- J05AX08
- Atc Item Name
- xj 05 ax 08
- Pharma Manufacturer Name
- MSD PHARMA (SINGAPORE) PTE. LTD.
