Important note: Information in this article was accurate in 2009. The state of the art may have changed since the publication date.
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Food and Drug Administration - November 10, 2009
Richard Klein & Kimberly Struble
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
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Body Weight (kg)
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Total Daily Dose
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Dosage Regimen and Dose
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|---|---|---|---|
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b.i.d.
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t.i.d
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||
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4 to < 9
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24 mg/kg/day
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12 mg/kg
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8 mg/kg
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≥ 9 to < 30
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18 mg/kg/day
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9 mg/kg
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6 mg/kg
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≥ 30
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600 mg/day
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300 mg
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200 mg
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Richard Klein
Office of Special Health Issues
Food and Drug Administration
Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration
091110
FD091102
SOURCE: Food and Drug Administration (FDA).
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