腎機能障害者におけるgatifloxacinの体内動態の検討

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  • Pharmacokinetics of Gatifloxacin in Patients with Impaired Renal Function

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The pharmacokinetics of gatifloxacin (GFLX) were studied in patients with impaired renal function after a single oral administration of 100 mg of GFLX. Patients were classified into three groups according to creatinine clearance (Ccr): six patients in Group I (60<Ccr≤90 mL/min), five patients in Group II (30<Ccr≤60 mL/min), and seven patients in Group III (10≤Ccr≤30 mL/min). Blood and urine samples were collected at different times from 0 to 72 hours after administration, and serum and urinary concentrations of GFLX were determined by HPLC.<BR>Mean peak serum concentrations were 1.29 μg/mL at 1.0 hour in Group I, 1.22 μg/mL at 1.8 hours in Group II, and 1.37 μg/mL at 1.9 hours in Group III. Mean elimination half-lives (T1/2) were 9.0, 15.7, and 30.2 hours and the mean areas under the curve (AUC0-∞) were 13.4, 20.2, and 48.7 μg·h/mL, respectively. Cumulative urinary recovery within 72 hours was 62.7%, 50.8%, and 36.3%, respectively. Prolonged T1/2 increased AUC0-∞, and reduced urinary excretion were observed depending on the degree of renal impairment. No findings of clinical or laboratory adverse reactions were observed in any case.<BR>Based on the results of this study, we recommend the following dosages of GFLX for patients with impaired renal function: 100 mg every 12 hours for patients with Ccr of 30 to 90 mL/min, and 100 mg every 24 hours for patients with Ccr of 10 to 30 mL/min.

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