Pharmacokinetics and tissue distribution of intravenous ofloxacin for antibiotic prophylaxis in biliary surgery.

The plasma levels and tissue penetration of ofloxacin were studied after prophylactic administration in 17 patients undergoing elective biliary surgery. A single dose of ofloxacin 400mg given intravenously as an infusion was administered 1 hour before surgery. Adequate drug plasma levels [>/= minimum inhibitory concentration (MIC(90)) for Escherichia coli] were found throughout the procedure. Mean peak (1 hour) and last-determined (36 hours) ofloxacin serum levels were 7.97 +/- 3.79 mg/L and 0.19 +/- 0.13 mg/L, respectively. The elimination half-life (t((1/2)lambda)) was 8.86 +/- 3.07 hours, and the clearance and steady-state volume of distribution were 0.17 +/- 0.05 L/h.kg and 112.90 +/- 37.09L, respectively. The area under the plasma concentration-time curve from zero to infinity (AUC(0-infinity)) was 41.60 +/- 12.51 mg/L.h. In bile, ofloxacin levels were higher than in plasma and showed great variability. Adequate ofloxacin levels in subcutaneous cell tissue and gallbladder wall tissue were observed during the surgical procedure. Patients were observed daily throughout their hospital stay. This included examination of the surgical wound and recording of body temperature. No cases of anaerobic infection were noted in the study patients. Other constants such as hospitalisation stay and time of recuperation were normal for this type of surgery.