FDA Approves New Zidovudine (Retrovir) Dosing Recommendation for Infants

SUMMARY: The U.S. Food and Drug Administration (FDA) this week announced the approval of new dosing recommendations for the liquid formulation of zidovudine (AZT, Retrovir) for the treatment of infants with HIV starting at 4 weeks of age.

Below is the text of the FDA announcement describing the changes.

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
Body Weight (kg)	Total Daily Dose	b.i.d.	t.i.d
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

11/13/09

Source
R Klein and K Struble, Food and Drug Administration. HIV/AIDS Update -- New dosing recommendations Retrovir (zidovudine) syrup for HIV-infected infants. November 9, 2009.