SINGLE-DOSE AND STEADY-STATE PHARMACOKINETICS OF A NEW ORAL SUSPENSION OF CIPROFLOXACIN IN CHILDREN

Objective. Quinolones are used ever increasingly in pediatrics, althou gh officially they are still contraindicated. Lack of evidence of arth ropathic effects in human offspring favors their use, but little is kn own about the pharmacokinetics of oral or parenteral ciprofloxacin in children, especially those without cystic fibrosis. Design. We studied 16 non-cystic fibrosis patients ranging in age from 0.3 to 7.1 years to whom the new suspension formulation of ciprofloxacin (10 mg/kg body weight) was given orally three times daily. Single-dose and steady-st ate pharmacokinetic parameters were elucidated. Results. Ciprofloxacin was rapidly absorbed. The maximum plasma concentrations, with the mea ns varying from 1.7 to 3.6 mg/L, were reached within 1 hour, almost re gardless of whether single-dose administration or steady state. The me an oral clearance was lower in children <6 years of age than in those greater than or equal to 6 years. Terminal half-life values, with the means varying only between 4.2 and 5.1, suggest that dosing recommenda tions based on body weight are pertinent, although caution should be e xercised in small infants. No arthropathic or other adverse events att ributable to ciprofloxacin suspension were observed. Conclusion. A dos e of the suspension form of ciprofloxacin of 10 mg/kg body weight give n orally three times daily seems appropriate in children, provided the drug is clearly indicated.