Ziagen

Ziagen Dosage/Direction for Use

abacavir

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig
/
Agencia Lei Va Hong
Full Prescribing Info
Dosage/Direction for Use
Ziagen should be prescribed by physicians experienced in the management of HIV infection.
Ziagen can be taken with or without food.
Ziagen is available as a tablet formulation.
Ziagen is also available as an oral solution for use in children over three months of age and weighing less than 14 kg and for those patients for whom the tablets are inappropriate.
To ensure administration of the entire dose, the tablet(s) should ideally be swallowed without crushing.
Alternatively, for patients who are unable to swallow tablets, the tablet(s) 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 25 kg): The recommended dose of Ziagen is 600 mg daily (30 ml). This may be administered as either 300 mg (15 ml) twice daily or 600 mg (30 ml) once daily (see Precautions and Pharmacology: Pharmacodynamics under Actions).
Children (weighing less than 25 kg): Tablet: Dosing according to weight bands is recommended for Ziagen tablets.
Children weighing ≥ 20 kg to < 25 kg: The recommended dose is 450 mg daily. This may be administered as either one 150 mg (one half of a 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 14 to < 20 kg: The recommended dose is 300 mg daily. This may be administered as either 150 mg (one half of a tablet) twice daily or 300 mg (one whole tablet) once daily.
Children less than three months of age: The clinical experience in children aged less than three months is limited and are insufficient to propose specific dosage recommendations (see Pharmacology: Pharmacokinetics under Actions).
Oral solution: Children from one year of age: The recommended dose is 8 mg/kg twice daily or 16 mg/kg once daily, up to a maximum total daily dose of 600 mg (30 ml).
Children from three months to one year of age: The recommended dose is 8 mg/kg twice daily. If a twice daily regimen is not feasible, a once daily regimen (16 mg/kg/day) could be considered. It should be taken into account that data for the once daily regimen are very limited in this population (see Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions).
Children less than three months of age: the experience in children aged less than three months is limited (see Pharmacology: Pharmacokinetics under Actions).
Patients changing from the twice daily dosing regimen to the once daily dosing regimen should take the recommended once daily dose (as described as follows) approximately 12 hours after the last twice daily dose, and then continue to take the recommended once daily dose (as described as follows) 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.
Special populations: Renal impairment: No dosage adjustment of Ziagen is necessary in patients with renal dysfunction. However, Ziagen is not recommended for patients with end-stage renal disease (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: Abacavir is primarily metabolised by the liver. No definitive dose recommendation can be made in patients with mild hepatic impairment (Child-Pugh score 5-6). In patients with moderate or severe hepatic impairment, no clinical data are available, therefore the use of abacavir is not recommended unless judged necessary. If abacavir is used in patients with mild hepatic impairment, then close monitoring is required, including monitoring of abacavir plasma levels if feasible (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Elderly: No pharmacokinetic data are currently available in patients over 65 years of age.
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