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Antimicrobial Agents and Chemotherapy, March 2005, p. 1106-1112, Vol. 49, No. 3
0066-4804/05/$08.00+0     doi:10.1128/AAC.49.3.1106-1112.2005
Copyright © 2005, American Society for Microbiology. All Rights Reserved.

Pharmacokinetics of Gatifloxacin in Infants and Children

Pediatric Pharmacology Research Unit, University of California,¹ Pediatric Pharmacology Research Unit, Children's Hospital San Diego, San Diego, California,³ Pediatric Pharmacology Research Unit, Rainbow Babies and Children's Hospital, Cleveland, Ohio,² Pediatric Pharmacology Research Unit, Children's Mercy Hospital, Kansas City, Missouri,⁴ Pediatric Pharmacology Research Unit, Arkansas Children's Hospital, Little Rock, Arkansas,⁵ Clinical Discovery, Bristol-Myers Squibb Pharmaceutical Research Institute, Princeton, New Jersey⁶

Received 5 May 2004/ Returned for modification 4 August 2004/ Accepted 13 October 2004

Gatifloxacin is an 8-methoxy fluoroquinolone effective against a broad spectrum of pathogens common in pediatric infections. The safety and pharmacokinetics of a single dose of gatifloxacin were studied in pediatric patients from 6 months to 16 years of age. Seventy-six pediatric patients (average age, 6.7 ± 5.0 years) were administered a single oral dose of gatifloxacin suspension (5, 10, or 15 mg/kg of body weight; 600-mg maximum) in a dose-escalating manner. Subjects were stratified by age into 4 groups. An additional 12 children, greater than 6 years of age, received gatifloxacin as the tablet formulation at a dose of approximately 10 mg/kg. Gatifloxacin's apparent clearance and half-life were 5.5 ± 2.1 ml/min/kg and 5.1 ± 1.4 h. The maximum concentration of drug in plasma and area under the concentration-time curve (AUC) increased in a manner approximately proportional to the dose. At the 10-mg/kg dose, the bioavailability was similar between the suspension and tablet formulation. The apparent oral clearance of gatifloxacin, normalized for body weight, exhibited a small but statistically significant decrease with increasing age. In all subjects receiving gatifloxacin at 10 mg/kg, the AUC exceeded 20 µg · h/ml (estimated free AUC/MIC ratio of 34 for MIC of 0.5 µg/ml). These data suggest that gatifloxacin at a dose of 10 mg/kg every 24 h will achieve therapeutic concentrations in plasma in infants and children.