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[Pharmacokinetic and clinical studies on isepamicin in chronic complicated urinary tract infection using daily single dose treatment].

To assess the usefulness of single dose treatment with isepamicin (ISP) against chronic complicated urinary tract infection (CC-UTI), laboratory and clinical studies were carried out. The results are summarised as follows. 1. Serum concentrations. Serum concentrations of the drug were assayed for patients after the administration of ISP at a dose of 400 mg by intravenous drip infusion for 30 or 60 minutes. Patients tested consisted of 3 groups with different degrees of renal functions (Ccr: ml/min); 1) normal, 130.8, 2) slightly impaired, 70.8, 3) moderately impaired, 45.9. When the peak/trough concentrations in the 3 groups were compared on 1st-2nd day/5th-6th day of the administration, no significantly different values were recognized among the 3 groups in the peak/trough concentrations. 2. Clinical efficacy Twenty three patients including 18 (78%) patients over 61 years of age were treated at a dose of 400 mg once a day for 4-10 days. Of 21 evaluable cases, 15 (71%) were evaluated as excellent or moderate according to the Japanese UTI criteria. Against the clinical isolates, 21 (68%) out of 31 strains were eradicated after the treatment. 3. Safety Neither subjective side reactions nor clinical abnormal values were encountered throughout the treatment. 4. Conclusions The clinical effectiveness of daily single dose treatment with ISP (400 mg once a day, i.v.d.) was considered to be almost comparable to the treatment with 200 mg twice a day. Furthermore, since no problems on safety were noted even in treating aged patients with slight to moderate renal impairments, the drug appears to be evaluated as highly useful.