Vol.57 No.5 September 2009
Overview of new dosage and administration of levofloxacin, 500 mg once a day
1)Department of Infectious Diseases, Tokyo Women's Medical University, 8-1 Kawada, Shinjuku-ku, Tokyo, Japan
2)Nagasaki University Hospital
3)Department of Urology, University of Occupational and Environmental Health
4)Laboratory of Infectious Diseases Science, Graduate School of Infection Control Sciences, Kitasato University
5)Jikei University School of Medicine
Abstract
Basic and clinical studies were conducted to determine the feasibility of new dosage and administration of levofloxacin(LVFX) 500 mg once a day based on pharmacokinetic and pharmacodynamic theory.
A basic study to determine bactericidal effects and the appearance of drug-resistant bacteria was conducted using an in vitro human blood drug concentration simulation model. New dosage and administration were assumed to inhibit drug-resistant bacteria more potently than the existing dosage and administration of LVFX, which is 100 mg three times a day.
Clinical studies in Japan and China showed that the clinical response (efficacy) when treatment was completed was 95.1% (136/143) in Japan and 97.3% (747/768) in China for respiratory tract infection (RTI) and 83.4% (131/157) in Japan and 86.1% (253/294) in China for urinary tract infection (UTI), indicating similar efficacy. In terms of safety, adverse drug reaction incidence was 29.1% (460/1,582). Major adverse reactions included dizziness in 3.7%, nausea in 3.5%, leucopenia in 3.2%, and insomnia in 2.3%. These events had been previously reported as LVFX-related adverse drug reactions, and their incidence was similar to that reported.
These findings indicate that new dosage and administration inhibit drug-resistant bacteria and are as effective and safe as the existing dosage and administration.
Key word
levofloxacin, PK-PD, once-a-day
Received
June 8, 2009
Accepted
August 12, 2009
Jpn. J. Chemother. 57 (5): 411-422, 2009
