Overall clinical evaluation of cefpodoxime proxetil against infections in pediatric fields

: Dry syrup and tablet of newly developed cefpodoxime proxetil (CS-807, CPDX-PR) was investigated in the departments of pediatrics of 17 institutes and their related hospitals. 1. Pharmacokinetics of CPDX-PR in pediatrics were investigated. Peak blood levels of CPDX at dose levels of 3 mg/kg and 6 mg/kg were 2.24 +/- 0.21 and 4.68 +/- 0.54 micrograms/ml, respectively, in fasting and 1.65 +/- 0.07 and 3.71 +/- 0.41 micrograms/ml, respectively, after meal. Urinary recovery rates in 6 hours were 31.2 +/- 2.2% of dose in average. 2. Clinical efficacies of CPDX-PR on various infectious diseases were studied in 748 cases. Clinical efficacy rate in 499 cases with causative bacteria isolated was 94.6%: efficacy rates for individual infections were 96.8% (120/124) for tonsillitis, 96.0% (96/100) for urinary tract infection, 93.5% (58/62) for pneumonia, 92.4% (61/66) for impetigo, 100% (32/32) for scarler fever and 93.2% for pharyngitis or laryngitis. Bacteriological eradication rate for Gram-positive organisms was 91.0% (244/268); and for Gram-negative organisms, 89.7% (210/234). The clinical efficacy rate for cases which were non-responsive to previous antibiotic therapy was 88.1% (74/84). 3. Side effects and clinical laboratory findings were investigated in 779 cases. Two each of vomiting, loose stool and rash, 10 of diarrhea and 1 of diarrhea associated with candidiasis were reported, but no serious side effects were noted. There was no serious laboratory test abnormality except slight elevations of eosinophile, platelet, transaminase or prolongation of prothrombin time, totalling 34 occurrences.