Abstract
Imipenem (Im) (thienamycin, MKO787/MKO791), a new β-lactam antibiotic, has outstanding potency against gram positive, gram negative, aerobic and anaerobic bacteria, including Pseudomonas aeruginosa. Selected pharmacokinetic and safety parameters were studied in children in anticipation of clinical therapeutic trials. A single dose (10 or 25 mg/kg) of Im was given intravenously to eight children aged 2-12 years hospitalized and receiving conventional intravenous antibiotics for suspected or proven infection. Plasma samples were obtained at 1 min, 30 min, 1, 2, 4, and 6 hours after the completion of the Im infusion. Random urine samples were also obtained. Im concentrations were measured by high performance liquid chromatography. Interpretation of the data was based on a one compartment open model. Selected parameters (means ± S.D.) are as follows:
No adverse clinical or laboratory effects were noted. Based on these data and Im's in vitro activity, a dose of 25 mg/kg, intravenously every 4-6 hours, would likely be safe and provide therapeutic serum and urine concentrations in clinical trials in pediatric patients.
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Engelhard, D., Shalit, I., Stutman, H. et al. IMIPENEM PHARMACOKINETICS IN CHILDREN. Pediatr Res 18 (Suppl 4), 152 (1984). https://doi.org/10.1203/00006450-198404001-00355
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DOI: https://doi.org/10.1203/00006450-198404001-00355