Vol.54 No.5 September 2006
Efficacy, safety, and pharmacokinetics of cefcapene pivoxil in children
1)Department of Infectious Diseases, Kitasato University of Medicine, 1-15-1 Kitasato, Sagamihara, Kanagawa, Japan
2)Hokusetsu General Hospital
3)Social Welfare Corporation, Yukari-gakuen
4)Department of Pediatrics, Meitetsu Hospital
5)Statistical Analytic Department, Shionogi & Co., Ltd.
6)Honorary Professor, Teikyo University of Medicine
Abstract
An oral cephalosporin antibiotic, cefcapene pivoxil (CFPN-PI), was administered to 128 pediatric patients in a multi-centered post-marketing clinical trial, and its pharmacokinetics efficacy, and safety were investigated. The results obtained are described below.
1. Population Pharmacokinetics
CL/F and Vd/F were in proportion to body weight, and there were no differences in pharmacokinetic data between patients under 10 kg and patients over 10 kg (110 evaluated patients).
2. Efficacy
The efficacy rate against respiratory infections and urology infections were very high (88.1% and 100%, respectively).
3. Bacteriological Efficacy
CFPN-PI displayed potent antibacterial activity against various bacteria, including Penicillin-resistant Streptococcus pneumoniae (PRSP).
4. Safety
Adverse drug reactions manifested as clinical symptoms were observed in 18 of the 128 cases (18 events). All events except 1 rash consisted of gastrointestinal symptoms. Adverse drug reactions in the form of abnormal laboratory test values were observed in 11 of 116 cases (15 events), including 4 cases each AST elevation and ALT elevation.
The above results, confirmed that CFPN-PI is efficacious, safe and yields favorable pharmacokinetic data when administered to pediatric patients, including infants (except for newborns), at the approved dosage and administration method.
Key word
cefcapene pivoxil, clinical trial, pediatric infection, pharmacokinetic
Received
February 27, 2006
Accepted
May 29, 2006
Jpn. J. Chemother. 54 (5): 465-477, 2006
