Food and Drug Administration - June 23, 2008
Richard Klein & Kimberly Struble

The Kaletra (lopinavir/ritonavir) Tablet and Oral Solution labels were updated to include dosing recommendations for pediatric patients 14 days to 6 months of age and from 12 to 18 years of age.

In addition, information regarding oral and parenterally administered midazolam was updated in the Contraindication and Drug Interactions section.

Please see the attached pdf file for specific package insert changes related to pediatric use and midazolam.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

080623
FD080605

SOURCE: Food and Drug Administration (FDA).

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