Levofloxacin Pharmacokinetics in Children

Abstract

Levofloxacin is a broad‐spectrum fluoroquinolone antibiotic with activity against many pathogens that cause bacterial infections in children, including penicillin‐resistant pneumococci. To provide dosing guidance for children, 3 single‐dose, multicenter pharmacokinetic studies were conducted in 85 children in 5 age groups: 6 months to max and t_max) and distribution in children are not age dependent and are comparable to those in adults. Levofloxacin elimination (reflected by t_1/2 and clearance), however, is age dependent. Children younger than 5 years of age clear levofloxacin nearly twice as fast (intravenous dose, 0.32 ± 0.08 L/h/kg; oral dose, 0.28 ± 0.05 L/h/kg) as adults and, as a result, have the total systemic exposure (area under the plasma drug concentration‐time curve) approximately one half that of adults. The levofloxacin area under the plasma drug concentration‐time curve (dose normalized) in children receiving a single dose of the oral liquid formulation is comparable to that in children receiving the intravenous formulation. To provide compatible levofloxacin exposures associated with clinical effectiveness and safety in adults, children <5 years need a daily dose of 10 mg/kg, whereas children 6 months to <5 years should receive 10 mg/kg every 12 hours.