Abstract
Cefprozil (CFPZ, BMY-28100) is a new oral cephem antibiotic without an ester linkage. Pharmacokinetic and clinical studies using CFPZ 10% fine granules were performed in pediatric patients.
1. Pharmacokinetic investigation
Peak serum concentrations of CFPZ after dose of 7.5mg/kg and 10mg/kg were, respectively, 3.65±0.24μg/ml and 6.38±3.23μg/ml at 1-2 hours. The average half-life with 7.5mg/kg administration was 0.90±0.16 hours and that with 10mg/kg was 1.29±0.50 hours. The urinary excretion of CFPZ was about 45% (35.3-50.0%) in 6 hours.
2. Clinical investigation
Enrolled in the study were 22 patients including 4 with pharyngitis, 3 with tonsillitis, 3 with bronchitis, 5 with pneumonia, 4 with urinary tract infection, and 1 each with pertussis, purulent lymphadenitis and otitis media. Responses were excellent in 14 patients, good in 5 patients and fair in 1 patient. In the assesment of the bacteriological efficacy, 8 out of 17 strains of organism identified previous to the treatment were eradicated, 5 strains were found replaced by other bacteria and 4 strains persisted, hence the eradication rate was 76.5%
3. No adverse reactions attributable to the drug were observed. From the above results, it has been concluded that CFPZ is a highly effective and safe agent for moderate respiratory and urinary tract infections in children.
