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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:  06/20/2008
Trade Name:  Kaletra
Generic Name or Proper Name (*):  lopinavir/ ritonavir
Indications Studied:  Use in combination with other antiretroviral agents for HIV-1 infection
Label Changes Summary:  * Extended indication from 6 months  12 years to 14 days  18 years * The safety, efficacy, and pharmacokinetic profiles in pediatric patients < 14 days have not been established * Dose should be calculated based on body weight or body surface area not to exceed adult dose * Because no data exists for dosage when administered with efavirenz, nevirapine, (fos)amprenavir, or nelfinavir, it is recommended that lopinavir/ ritonavir not be administered in combination with these drugs in patients < 6 months of age * Infants <6 months of age generally had lower lopinavir AUC12 than children 6 months  12 years of age * Information on dose, PK parameters, clinical studies, and AEs
Product Labeling:  Labeling  Opens a new window
BPCA(B) and PREA(P):  B, P
Sponsor:  Abbott
Pediatric Exclusivity Granted Date:  03/07/2008
Therapeutic Category:  Antiviral