Pharmacokinetic and clinical studies of balofloxacin on respiratory infectious diseases

Balofloxacin (BLFX: development code Q-35) was orally administered at 200 mg once a day for 7 days to 3 elderly patients with varying degrees of renal dysfunction. The curve simulated from the plasma concentration of BLFX on the first day was generally consistent with the subsequent changes in plasma concentration, showing no accumulation. As renal dysfunction progressed, T(1/2) was prolonged, and the area under the curve (AUC) increased. In contrast, the rate of recovery front urine accumulated tip to 168 hours was decreased. Clinical efficacy was investigated in 27 patients: 22 with various respiratory infectious diseases, 4 with cholecystocholangitis and 1 with urinary tract infection. BLFX was administered to the patients with respiratory infectious diseases at a dose of 200 mg once a day for 7 days. BLFX was administered to the patients with cholecystocholangitis at a dose of 100 mg twice a day for 11~14 days. BLFX was administered to the patient with urinary tract infection at a dose of 100 mg once a day for 7 days. Clinical efficacy was good in 26 patients, for an efficacy rate of 96.3%. Although no particular side effects were observed, slight elevations of GOT and GPT were observed in 1, a slight elevation of GPT in 1, and a slight elevation of BUN in 1 on clinical laboratory tests.