Ziagen

Ziagen Dosage/Direction for Use

abacavir

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig Pharma
Full Prescribing Info
Dosage/Direction for Use
Therapy should be initiated by a physician experienced in the management of HIV infection.
ZIAGEN 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, ZIAGEN 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 Pharmacology: Pharmacokinetics under Actions).
Adults, adolescents and children weighing at least 25kg: FC tablet: The recommended dose of ZIAGEN tablets is 600 mg daily. This may be administered as either 300 mg (one tablet) twice daily or 600 mg (two tablets) once daily.
Oral solution: The recommended dose of ZIAGEN oral solution is 300 mg (15 ml) twice daily or 600 mg (30 ml) once daily.
Children from three months and weighing less than 25 kg: FC tablet: Children weighing 14 to < 20 kg: one-half of a scored abacavir tablet twice daily.
Children weighing ≥ 20 kg to < 25 kg: one-half of a scored abacavir tablet taken in the morning and one whole tablet taken in the evening.
Children weighing at least 25 kg: the adult dosage of 300 mg twice daily or 600 mg once daily should be taken.
The oral solution may be administered to children weighing less than 14 kg or those who are unable to swallow tablets.
Oral solution: The recommended dose is 8 mg/kg twice daily or 16 mg/kg once daily up to a maximum dose of 300 mg twice daily or 600 mg once daily.
Children less than three months: The data available on the use of ZIAGEN in this age group are very limited (see Pharmacology: Pharmacokinetics under Actions).
Renal impairment: No dosage adjustment of ZIAGEN is necessary in patients with renal dysfunction (see Pharmacology: Pharmacokinetics under Actions).
ZIAGEN should be avoided in patients with end-stage renal disease.
Hepatic impairment: Abacavir is metabolised primarily by the liver. The recommended dose of ZIAGEN in patients with mild hepatic impairment (Child-Pugh score 5 to 6) is 200 mg (10 ml) twice a day. To enable dose reduction ZIAGEN oral solution should be used for the treatment of these patients.
Pharmacokinetic and safety data on the use of abacavir in patients with moderate and severe hepatic impairment are not available (see Pharmacology: Pharmacokinetics under Actions). Therefore the use of ZIAGEN is not recommended in patients with moderate or severe hepatic impairment, unless the benefit of use outweighs the risk.
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