Efficacy, safety, and pharmacokinetics of cefcapene pivoxil in children

• Sunakawa Keisuke

  Department of Infectious Diseases, Kitasato University of Medicine

• Nishimura Tadafumi

  Hokusetsu General Hospital

• Motohiro Takashi

  Social Welfare Corporation, Yukari-gakuen

• Iwai Naoichi

  Department of Pediatrics, Meitetsu Hospital

• Yano Yoshitaka

  Statistical Analytic Department, Shionogi & Co., Ltd.

• Wajima Yasuhiro

  Statistical Analytic Department, Shionogi & Co., Ltd.

• Fujii Ryochi

  Teikyo University of Medicine

Bibliographic Information

Other Title

• 小児感染症患者におけるｃｅｆｃａｐｅｎｅ　ｐｉｖｏｘｉｌ小児用細粒の有効性，安全性および薬物動態の検討

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.<BR>1. Population Pharmacokinetics<BR>CL/F and Vd/F were in proportion to body weight, and there were no differences in pharmacokinetic data between patients under 10kg and patients over 10kg (110 evaluated patients).<BR>2. Efficacy<BR>The efficacy rate against respiratory infections and urology infections were very high (88.1% and 100%, respectively).<BR>3. Bacteriological Efficacy<BR>CFPN-PI displayed potent antibacterial activity against various bacteria, including Penicillin-resistant Streptococcus pneumoniae (PRSP).<BR>4. Safety<BR>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.<BR>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.

Journal

• Japanese Journal of Chemotherapy

  Japanese Journal of Chemotherapy 54 (5), 465-477, 2006

  Japanese Society of Chemotherapy

Keywords

• cefcapene pivoxil
• clinical trial
• pediatric infection
• pharmacokinetic

Details

• CRID: 1390282681262421760
• NII Article ID: 130004298306
• NII Article ID: 10018041011
• NII Book ID: AN10472127
• DOI: 10.11250/chemotherapy1995.54.465
• ISSN: 18845886
• ISSN: 13407007
• Web Site: https://search.jamas.or.jp/link/ui/2007015752
• Text Lang: ja
• Data Source:
  • JaLC
  • CiNii Articles
• Abstract License Flag: Disallowed