Recommended Pediatric Dosage of RETROVIR

On November 6, 2009, the Food and Drug Administration (FDA) approved revised pediatric dosing recommendations that expand dosing to include children starting treatment at four weeks of age.
The revised label contains the following recommendation:
The recommended dosage in pediatric patients 4 weeks of age and older and weighing ≥4 kg is provided in Table 1. RETROVIR Syrup should be used to provide accurate dosage when whole tablets or capsules are not appropriate.

Table 1: Recommended Pediatric Dosage of RETROVIR
Body Weight (kg)/ Total Daily / Dose Dosage Regimen and Dose
b.i.d. t.i.d
Body Weight: 4 to < 9
Total Daily: 24 mg/kg/day
Dose Dosage Regimen and Dose
b.i.d. 12 mg/kg
t.i.d 8 mg/kg
.....................
Body Weight: ≥ 9 to < 30
Total Daily: 18 mg/kg/day
Dose Dosage Regimen and Dose
b.i.d. 9 mg/kg
t.i.d 6 mg/kg
.....................
Body Weight: ≥ 30
Total Daily: 600 mg/day
Dose Dosage Regimen and Dose
b.i.d. 300 mg
t.i.d 200 mg


Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration