Ziagen

Ziagen

abacavir

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Abacavir sulfate
Indications/Uses
Combination antiretroviral therapy (CART) for the treatment of HIV infection in adults, adolescents & childn.
Dosage/Direction for Use
Adult, adolescent & childn weighing at least 25 kg 600 mg daily [either 300 mg (1 tab or 15 mL) bd or 600 mg (2 tab or 30 mL) once daily]. FC tab Childn weighing ≥20 to <25 kg 450 mg daily [either 150 mg (½ tab) in the morning & 300 mg (1 tab) in the evening, or 450 mg (1½ tab) once daily], 14 to <20 kg 300 mg daily [either 150 mg (½ tab) bd or 300 mg (1 tab) once daily]. Oral soln Childn weighing <25 kg, ≥1 yr 8 mg/kg bd or 16 mg/kg once daily. Max: 600 mg (30 mL) daily, 3 mth to 1 yr 8 mg/kg bd, if not feasible, consider 16 mg/kg once daily.
Administration
May be taken with or without food: For patients unable to swallow, crush tab & add to a small amount of semi-solid food or liqd then, consume immediately.
Contraindications
Special Precautions
High risk for abacavir hypersensitivity reactions (HSR) in patients who test +ve for HLA-B*5701 allele. Do not initiate treatment in patients w/ +ve HLA-B*5701 status, nor in patients w/ -ve HLA-B*5701 status who had suspected abacavir HSR on previous abacavir-containing regimen. Discontinue treatment if HSR is suspected. Reports of mitochondrial dysfunction in HIV -ve infants following exposure in utero &/or postnatally to nucleoside analogues. Increase in wt & blood lipid & glucose levels may occur. Reports of pancreatitis. Reports of virological failure & emergence of resistance at an early stage when combined w/ tenofovir disoproxil fumarate & lamivudine as a once daily regimen. Increased frequency of liver function abnormalities in patients w/ pre-existing liver dysfunction, including chronic active hepatitis. Consider interruption or discontinuation of treatment if there is evidence of worsening liver disease. Increased risk of severe & potentially fatal hepatic adverse reactions in HIV patients co-infected w/ chronic HBV or HCV. Risk of immune reactivation syndrome. Reports of osteonecrosis, particularly in patients w/ advanced HIV disease &/or long-term exposure to CART. Opportunistic infections & other HIV complications may still develop. Residual risk of HIV transmission. Observational studies have shown an association between MI & abacavir use. Not recommended in patients w/ ESRD, & moderate or severe hepatic impairment. Pregnancy. HIV-infected women should not breast-feed to avoid HIV transmission. Elderly >65 yr. Limited experience in childn <3 mth. Oral soln: Contains sorbitol. Patients w/ rare hereditary problems of fructose intolerance should not take this medicine. Contains methyl parahydroxybenzoate & propyl parahydroxybenzoate.
Adverse Reactions
Anorexia; headache; nausea, vomiting, diarrhoea; rash (w/o systemic symptoms); fever, lethargy, fatigue.
Drug Interactions
Slightly decreased plasma conc w/ potent enzymatic inducers (eg, rifampicin, phenobarb, phenytoin). Reduced Cmax & delayed tmax w/ methadone. Possible interaction w/ retinoids. Riociguat dose may need to be reduced.
MIMS Class
Antivirals
ATC Classification
J05AF06 - abacavir ; Belongs to the class of nucleoside and nucleotide reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.
Presentation/Packing
Form
Ziagen oral soln 20 mg/mL
Packing/Price
240 mL x 1's
Form
Ziagen FC tab 300 mg
Packing/Price
60's
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