Pharmacokinetics of a fluoronaphthyridone, trovafloxacin (CP 99,219), in infants and children following administration of a single intravenous dose of alatrofloxacin

The pharmacokinetics of trovafloxacin following administration of a single intravenous dose of alatrofloxacin, equivalent to 4 mg of trovafloxacin per kg of body weight, were determined in 6 infants (ages 3 to 12 months) and 14 children (ages, 2 to 12 years). There was rapid conversion of alatroflox acin to trovafloxacin, with an average +/- standard deviation (SD) peak tro vafloxacin concentration determined at the end of the infusion of 4.3 +/- 1 .4 mu g/ml. The primary pharmacokinetic parameters (average +/- SD) analyze d were volume of distribution at steady state (1.6 +/- 0.6 liters/kg), clea rance (151 +/- 82 ml/h/kg), and half-life (9.8 +/- 2.9 h). The drug was wel l tolerated by all children. There were no age-related differences in any o f the pharmacokinetic parameters studied. Less than 5% of the administered dose was excreted in the urine over 24 h. On the basis of the mean area und er the concentration-time curve of 30.5 +/- 10.1 mu g . h/ml and the suscep tibility (less than or equal to 0.5 mu g/ml) of common pediatric bacterial pathogens to trovafloxacin, dosing of 4 mg/kg/day once or twice daily shoul d be appropriate.