Vol.52 No.9 September 2004
Postmarketing study of cefcapene pivoxil tablet
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® Tablet 75 mg, Flomox® Tablet 100 mg), 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). After 6 years of reexamination period, we applied for reevaluation on July 18, 2003.
5,801 cases of collected from 951 medical institutes nationwide; we evaluated 5,766 for safety, 5,574 for clinical efficacy, and 607 for bacteriological efficacy, wiht the following results:
1) The incidence of adverse drug reactions, 2.58% (149 cases/5,766 cases), was lower than that obtained in studies before marketing approval, 9.45% (303 cases/3,207 cases). The most frequently observed adverse drug reaction was diarrhea, whose incidence was 0.61% (35 events/5,766 cases).
2) Clinical efficacy by infection type was from 90.9-100.0%, 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.
Key word
cefcapene pivoxil, postmarketing surveillance, safety, efficacy
Received
June 18, 2004
Accepted
August 17, 2004
Jpn. J. Chemother. 52 (9): 490-507, 2004
