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HIV/AIDS Update – New dosing recommendations Retrovir (zidovudine) syrup for HIV-infected infants

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
4 to < 9
24 mg/kg/day
12 mg/kg
8 mg/kg
≥ 9 to < 30
18 mg/kg/day
9 mg/kg
6 mg/kg
≥ 30
600 mg/day
300 mg
200 m

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration


November 12, 2009 - Posted by | 1

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