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Levofloxacin Pharmacokinetics in Children

From Johnson & Johnson Pharmaceutical Research & Development, LLC, Raritan, New Jersey (S. Chien, Dr Natarajan, Dr Maldonado, Dr Noel); University of Arkansas for Medical Sciences and the Arkansas Children's Hospital PPRU, Little Rock, Arkansas (Dr Wells); Rainbow Babies and Children's Hospital PPRU, Cleveland, Ohio (Dr Blumer); University of Missouri–Kansas City and the Children's Mercy Hospitals and Clinics PPRU, Kansas City, Missouri (Dr Kearns); Children's Hospital and Health Center and the UCSD/Children's Hospital PPRU, San Diego, California (Dr Bradley); Louisiana State University Health Sciences Center–Shreveport and the Louisiana State University Health Sciences Center–Shreveport PPRU, Shreveport, Louisiana (Dr Bocchini); and University of Medicine and Dentistry of New Jersey, Newark, New Jersey (Dr Noel).

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 <2 years, 2 to <5 years, 5 to <10 years, 10 to <12 years, and 12 to 16 years. Each child received a single 7-mg/kg dose of levofloxacin (not to exceed 500 mg) intravenously or orally. Plasma and urine samples were collected through 24 hours after dose. Pharmacokinetic parameters were estimated and compared among the 5 age groups and to previously collected adult data. Levofloxacin absorption (as indicated by C_max and t_max) and distribution in children are not age dependent and are comparable to those in adults. Levofloxacin elimination (reflected by t 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.

Key Words: Levofloxacin • pediatrics • pharmacokinetics

Address for reprints: Shuchean Chien, MS, Johnson & Johnson Pharmaceutical Research & Development, LLC, 920 Route 202 South, PO Box 300, Raritan, NJ 08869-0602.

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