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Pharmacokinetics, Safety, and Dosing of Novel Pediatric Levofloxacin Dispersible Tablets in Children with Multidrug-Resistant Tuberculosis Exposure

A. Garcia-Prats, S. Purchase, M. Osman, H. Draper, H. S. Schaaf, L. Wiesner, P. Denti, A. Hesseling

Antimicrobial Agents and Chemotherapy, 2019

109 participants · 27 citations

Abstract

This study characterized the pharmacokinetics of novel 100-mg levofloxacin dispersible tablets in 24 children aged <5 years who had household multidrug-resistant tuberculosus (MDR-TB) exposure. The current data were pooled with previously published data from children (n = 109) with MDR-TB receiving adult (250-mg) levofloxacin tablets, using nonlinear mixed-effects modelling. ABSTRACT This study characterized the pharmacokinetics of novel 100-mg levofloxacin dispersible tablets in 24 children aged <5 years who had household multidrug-resistant tuberculosus (MDR-TB) exposure. The current data were pooled with previously published data from children (n = 109) with MDR-TB receiving adult (250-mg) levofloxacin tablets, using nonlinear mixed-effects modelling. The adult tablets had 41% lower bioavailability than the novel dispersible tablets, resulting in much higher exposures with the dispersible tablets with the same dose.

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