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New pediatric dosing information for Kaletra, patients 14 days to 6 months and 12-18 years of age and update information on coadministration with midazolam
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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
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