INTRODUCTION:

 

Ofloxacin is widely used for the treatment of multidrug-resistant tuberculosis (MDR-TB). Data on its pharmacokinetics and safety in children are limited. It is not known whether the current internationally recommended pediatric dosage of 15-20 mg/kg achieves exposures reached in adults with tuberculosis after a standard 800mg dose (adult median area under the concentration-time curve [AUC0-24]: 103 μg*h/mL).

 

MATERIALS AND METHODS:

 

We assessed the pharmacokinetics and safety of ofloxacin in children <15 years routinely receiving ofloxacin for MDR-TB treatment or preventive therapy. Plasma samples were collected pre-dose and at 1, 2, 4, 8 and either 6 or 11 hours after a 20mg/kg dose. Pharmacokinetic parameters were calculated using non-compartmental analysis. Children with MDR-TB disease underwent long-term safety monitoring.

 

(후략)