PK/PD breakpoints and clinical/bacteriological effects of cefcapene pivoxil fine granules for children at free drug concentrations in pediatric patients with respiratory infection

A post-marketing clinical study was previously conducted in pediatric patients with respiratory infection to evaluate the pharmacokinetics, efficacy and safety of cefcapene pivoxil (CFPN-PI) fine granules for children. Based on the results from this study, we evaluated PK/PD breakpoints and clinical...

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Bibliographic Details
Published in:Japanese journal of antibiotics 2008/06/25, Vol.61(3), pp.172-183
Main Authors: TOYONAGA, YOSHIKIYO, IWAI, NAOICHI, MOTOHIRO, TAKASHI, SUNAKAWA, KEISUKE, FUJII, RYOCHI
Format: Article
Language:Japanese
Subjects:
Bacteria - drug effects
Cephalosporins - administration & dosage
Cephalosporins - blood
Cephalosporins - pharmacokinetics
Cephalosporins - pharmacology
Child
Humans
Product Surveillance, Postmarketing
Respiratory Tract Infections - drug therapy
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Summary:A post-marketing clinical study was previously conducted in pediatric patients with respiratory infection to evaluate the pharmacokinetics, efficacy and safety of cefcapene pivoxil (CFPN-PI) fine granules for children. Based on the results from this study, we evaluated PK/PD breakpoints and clinical/bacteriological effects of CFPN-PI at free drug concentrations in pediatric patients with respiratory infection to determine an effective and safe dosage regimen of CFPN-PI. The following results were obtained from 61 pediatric patients evaluated in our research. 1) The response rate of pediatric respiratory infection to CFPN-PI was 100% for laryngopharyngitis, 84.6% for acute bronchitis, 100% for tonsillitis, 100% for pneumonia and 95.8% for all. 2) The bacteriological response (eradication rate of Haemophilus influenzae, Streptococcus pyogenes, Moraxella catarrhalis, Streptococcus pneumoniae, etc.) of pediatric respiratory infection to CFPN-PI was 87.5% for laryngopharyngitis, 66.7% for acute bronchitis, 75.0% for tonsillitis, 63.6% for pneumonia and 73.8% for all. 3) The blood concentration simulation demonstrated that the PK/PD breakpoint exceeding the time above MIC (TAM) of 40% after administration of CFPN-PI 3 mg/kg three times daily was 0.27μg/mL. 4) The pediatric patients with respiratory infection were stratified by the TAM (%) of CFPN-PI into 40% to 100% (TAM≥40% group) and 0% to 40% (TAM
ISSN:0368-2781
2186-5477
DOI:10.11553/antibiotics1968b.61.172