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ABACAR ABACAVIR TABLETS USP 300 MG [SIN16114P]
Active ingredients: ABACAR ABACAVIR TABLETS USP 300 MG
Last updated 26 October 2025
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Product Info
ABACAR ABACAVIR TABLETS USP 300 MG
[SIN16114P]
Product information
Active Ingredient and Strength | ABACAVIR SULFATE EQV ABACAVIR - 300 MG |
Dosage Form | TABLET, FILM COATED |
Manufacturer and Country | HETERO LABS LIMITED - INDIA |
Registration Number | SIN16114P |
Licence Holder | HETERO SINGAPORE PTE. LTD. |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | J05AF06 |
4.1. Therapeutic Indications
ABACAR is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults and children.
4.2 Posology and Method of Administration
Therapy should be initiated by a physician experienced in the management of HIV infection.
ABACAR can be taken with or without food.
To ensure administration of the entire dose, the tablet(s) should ideally be swallowed without crushing.
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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Adults, adolescents and children weighing at least 25 kg: 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.
Children from three months and weighing less than 25 kg: A dosing regimen according to weight bands is recommended for ABACAR scored tablets.
Tablets:
Children weighing 14 to < 20 kg: 150 mg (one-half of a scored abacavir tablet) twice daily or 300 mg (one whole tablet) taken once daily.
Children weighing ≥ 20 kg to < 25 kg: 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.
Children weighing at least 25 kg: the adult dosage of 300 mg (one tablet) twice daily or 600 mg (two tablets) once daily should be taken.
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.
Renal impairment: No dosage adjustment of ABACAR is necessary in patients with renal dysfunction (see 5.2 Pharmacokinetic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Hepatic impairment: 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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
4.3 Contra-indications
ABACAR is contra-indicated in patients with known hypersensitivity to abacavir or any ingredient of ABACAR tablets.
ABACAR is contra-indicated in patients with moderate or severe hepatic impairment.