Vol.52 No.9 September 2004
Postmarketing study of cefcapene pivoxil fine granules for children
1)Drug Safety Management Dept., Shionogi &, Co., Ltd., 5-12-4 Sagisu, Fukushima-ku, Osaka, Japan
2)Institute of Medical Science, St. Marianna University School of Medicine
Abstract
Cefcapene pivoxil hydrochloride (CFPN-PI, Flomox® Fine granules 100 mg for children), an oral cephem antibiotic, was approved for marketing on April 22, 1997. For 2 years from approval, we studied the practical use in compliance with new Good Postmarketing Surveillance Practices (GPMSP). Then, after 6 years of reexamination period, we applied for reevaluation on July 18, 2003.
3,073 cases of collected from 566 medical institutes nationwide; we evaluated 3,047 for safety, 2,979 for clinical efficacy, and 326 for bacteriological efficacy, with the following results:
1) The incidence of adverse drug reactions, 4.30% (131 cases/3,047 cases), was lower than that obtained in studies before marketing approval, 6.63% (37 cases/558 cases). The most frequently observed adverse drug reaction was diarrhea, whose incidence was 3.74% (114 events/3,047 cases). The incidence of diarrhea tended to be higher in younger patients.
2) Clinical efficacy by infection type was 91.2-98.3%, and results were equivalent to those in studies before marketing approval.
3) In bacteriological evaluation, elimination was 90% or more in most strains, and results were equivalent to those in studies before marketing approval.
4) The drug could be taken "easily" or "without any difficulty" in 94.0% of patients.
Key word
Cefcapene pivoxil, postmarketing surveillance, safety, efficacy, pediatric use
Received
June 18, 2004
Accepted
July 29, 2004
Jpn. J. Chemother. 52 (9): 508-520, 2004
