[Pharmacokinetic and clinical studies of cefprozil fine granules in children].
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 7.5 mg/kg and 10 mg/kg were, respectively, 3.65 +/- 0.24 micrograms/ml and 6.38 +/- 3.23 micrograms/ml at 1-2 hours. The average half-life with 7.5 mg/kg administration was 0.90 +/- 0.16 hours and that with 10 mg/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 assessment 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.
Nagano
K
K
Department of Pediatrics, School of Medicine, Nagasaki University.
Maeda
H
H
Yanagi
T
T
Tsuji
Y
Y
Imamura
H
H
Nakayama
N
N
Yanagishima
M
M
Fukuda
S
S
D000284:Administration, Oral; D000293:Adolescent; D000367:Age Factors; D002511:Cephalosporins / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D002648:Child; D005260:Female; D006801:Humans; D008199:Lymphadenitis / Q000188:drug therapy / Q000378:metabolism; D008297:Male; D010033:Otitis Media / Q000188:drug therapy / Q000378:metabolism; D012141:Respiratory Tract Infections / Q000188:drug therapy* / Q000378:metabolism; D014552:Urinary Tract Infections / Q000188:drug therapy* / Q000378:metabolism; D000097670:Cefprozil
D002511:Cephalosporins; D000097670:Cefprozil