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Abstract

Vol.59 No.5 September 2011

Postmarketing surveillance of garenoxacin tablets

Seiji Hori1) and Nobuko Maki2)

1)Department of Infectious Diseases and Infection Control, Jikei University School of Medicine, 3-25-8 Nishi-Shinbashi, Minato-ku, Tokyo, Japan
2)Pharmacovigilance & Surveillance Department, Toyama Chemical Co., Ltd.

Abstract

A survey of the efficacy and safety of garenoxacin(GRNX; Geninax® Tablets 200 mg), an oral quinolone antimicrobial, was conducted between May 2008 and March 2010, and data were obtained for 6,915 subjects from 1,259 medical facilities nationwide. Safety and efficacy were analyzed for 6,412 and 6,071 cases, respectively.
1. The incidence of adverse drug reactions(ADRs) including abnormal laboratory values was 3.45% (221/6,412 cases), and the main ADRs were gastrointestinal disorders (0.87%, 56 cases), abnormal laboratory values (0.72%, 46 cases) and skin or subcutaneous tissue disorders (0.62%, 40 cases). In addition, although underlying disorders/complications and history of ADRs were identified as factors affecting safety, there were no specific trends in this surveillance.
2. The incidence of abnormal changes in blood glucose was 1.70% (19/1,116 cases), and those of abnormal electrocardiogram and decreased blood pressure were 2.80% (8/286 cases) and 0.59% (11/1,862 cases), respectively. Pigmentation was not observed.
3. The efficacy of GRNX was 95.8% (5,711/5,964 cases), and exceeded 90% for all indications. In addition, the eradication rates for Streptococcus pneumoniae and Haemophilus influenzae, major pathogens of respiratory tract infections and otorhinolaryngological infections, were 98.5% and 100%, respectively.
These results suggest that both the clinical efficacy and safety profile of GRNX are excellent.

Key word

garenoxacin, postmarketing surveillance, clinical efficacy, safety

Received

June 27, 2011

Accepted

July 9, 2011

Jpn. J. Chemother. 59 (5): 495-511, 2011