- Approval Id
- 858cb73d26c69fbf
- Drug Name
- ABACAR ABACAVIR TABLETS USP 300 MG
- Product Name
- ABACAR ABACAVIR TABLETS USP 300 MG
- Approval Number
- SIN16114P
- Approval Date
- 2021-03-03
- Registrant
- HETERO SINGAPORE PTE. LTD.
- Licence Holder
- HETERO SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>4.2 Posology and Method of Administration</strong></p>
<p>Therapy should be initiated by a physician experienced in the management of HIV infection.<br>
ABACAR can be taken with or without food.<br>
To ensure administration of the entire dose, the tablet(s) should ideally be swallowed without crushing.<br>
For patients who are unable to swallow tablets, ABACAR is available as an oral solution. Alternatively, the tablets may be crushed and added to a small amount of semi-solid food or liquid, all of which should be consumed immediately (see 5.2 Pharmacokinetic Properties – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>Adults, adolescents and children weighing at least 25 kg:</strong> The recommended dose of ABACAR Tablets is 600 mg daily. This may be administered as either 300 mg (one tablet) twice daily or 600 mg (two tablets) once daily.</p>
<p><strong>Children from three months and weighing less than 25 kg:</strong> A dosing regimen according to weight bands is recommended for ABACAR scored tablets.</p>
<p><strong>Tablets:</strong></p>
<p><strong>Children weighing 14 to < 20 kg:</strong> 150 mg (one-half of a scored abacavir tablet) twice daily or 300 mg (one whole tablet) taken once daily.</p>
<p><strong>Children weighing ≥ 20 kg to < 25 kg:</strong> 150 mg (one-half of a scored abacavir tablet) taken in the morning and 300 mg (one whole tablet) taken in the evening or 450 mg (one and a half tablets) taken once daily.</p>
<p><strong>Children weighing at least 25 kg:</strong> the adult dosage of 300 mg (one tablet) twice daily or 600 mg (two tablets) once daily should be taken.</p>
<p>Patients changing from the twice daily dosing regimen to the once daily dosing regimen should take the recommended once daily dose (as described above) approximately 12 hours after the last twice daily dose, and then continue to take the recommended once daily dose (as described above) approximately every 24 hours. When changing back to a twice daily regimen, patients should take the recommended twice daily dose approximately 24 hours after the last once daily dose.</p>
<p><strong>Renal impairment:</strong> No dosage adjustment of ABACAR is necessary in patients with renal dysfunction (see 5.2 Pharmacokinetic Properties – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>Hepatic impairment:</strong> Abacavir is metabolised primarily by the liver. ABACAR is contra-indicated in patients with moderate or severe hepatic impairment, as the pharmacokinetics have not been studied in these patient groups (see 5.2 Pharmacokinetic Properties – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>4.1. Therapeutic Indications</strong></p>
<p>ABACAR is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults and children.</p>
- Contraindications
- <p><strong>4.3 Contra-indications</strong></p>
<p>ABACAR is contra-indicated in patients with known hypersensitivity to abacavir or any ingredient of ABACAR tablets.<br>
ABACAR is contra-indicated in patients with moderate or severe hepatic impairment.</p>
- Atc Code
- J05AF06
- Atc Item Name
- abacavir
- Pharma Manufacturer Name
- HETERO SINGAPORE PTE. LTD.
