Aurobindo Pharma


Concise Prescribing Info
Abacavir sulfate
Combination therapy of HIV in adults & childn.
Dosage/Direction for Use
Tab Adult, adolescent & childn at least 25 kg 2 tab once daily or 1 tab bd. Childn from 3 mth, 14 to <20 kg ½ tab bd, ≥20 to <25 kg ½ tab in the morning then 1 tab in the evening. Oral soln Adult & adolescent at least 30 kg 600 mg (30 mL) once daily or 300 mg (15 mL) bd. Childn from 3 mth, <30 kg 8 mg/kg bd up to max: 600 mg (30 mL) daily.
May be taken with or without food: Tab: For patients unable to swallow, tab may be crushed & added to a small amount of semi-solid food/liqd. Consume immediately.
Hypersensitivity. Severe hepatic impairment.
Special Precautions
Discontinue use if hypersensitivity reactions occur; in hyperlactatemia, metabolic/lactic acidosis, progressive hepatomegaly or rapidly elevating aminotransferase levels. Patients co-infected w/ hepatitis C; chronic active hepatitis B or C; obese. Risk for lactic acidosis; mitochondrial dysfunction; lipodystrophy; immune reactivation syndrome; autoimmune disorders; osteonecrosis; opportunistic infections; HIV transmission; MI. Screen for HLA B*5701 allele carriage prior to initiation. Concomitant use w/ other medicinal products inducing skin toxicity eg, NNRTIs; ribavirin; triple nucleoside therapy eg, abacavir, lamivudine, zidovudine. Hepatitis or other known risk factors for hepatic disease; significant underlying hepatic disease; moderate to severe hepatic impairment. Avoid use in ESRD. Not recommended during pregnancy. Not to be used during lactation. Childn <3 mth. Elderly >65 yr.
Adverse Reactions
Anorexia; headache; nausea, vomiting, diarrhoea; rash; fever, lethargy, fatigue.
Drug Interactions
Slightly decreased plasma conc w/ potent enzymatic inducers eg, rifampicin, phenobarb, phenytoin. Increased AUC w/ ethanol. Increased mean systemic clearance of methadone. Reduced intracellular phosphorylated metabolites of ribavirin. Retinoid compds.
MIMS Class
ATC Classification
J05AF06 - abacavir ; Belongs to the class of nucleoside and nucleotide reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.
Abacavex FC tab 300 mg
Abacavex oral soln 20 mg/mL
(strawberry-banana flavour) 240 mL x 1's
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