Vol.59 No.S-1 May 2011
Safety profile of intravenous levofloxacin (500 mg once a day)
1)Department of Pharmacology, Jikei University School of Medicine, 3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo, Japan
(Present: Department of Infectious Diseases and Infection Control, Jikei University School of Medicine)
2)Nagasaki University Hospital
Abstract
We evaluated the intravenous levofloxacin safety profile (N=342), integrating two clinical studies in which intravenous levofloxacin at 500 mg once a day was administered to Japanese subjects with pneumonia and secondary infection of chronic respiratory disease. Furthermore, we compared the safety profile of intravenous levofloxacin to that of oral levofloxacin, reported elsewhere. Adverse events were observed in 72.8% and adverse drug reactions in 48.0%. Major adverse drug reactions (over 5%) were injection site erythema (15.2%), alanine aminotransferase increased (10.2%), aspartate aminotransferase increased (8.5%), injection site pruritus (6.7%), diarrhea (5.0%), and gamma-glutamyltransferase increased (5.0%). The incidence of adverse events and adverse drug reactions was slightly higher in intravenous levofloxacin. Systemic allergic reactions such as anaphylaxis were not observed. Excluding injection site reactions such as erythema or pruritis, the adverse event and adverse drug reaction incidence were 63.2% and 33.6%, similar to those reported for oral levofloxacin.
Our results suggest that the intravenous levofloxacin safety profile, excluding injection site reactions, resembled that of oral levofloxacin and that intravenous levofloxacin can be used to treat of infectious diseases without special additional attention to adverse drug reactions.
Key word
levofloxacin injection, safety profile, respiratory tract infection
Received
November 10, 2010
Accepted
February 15, 2011
Jpn. J. Chemother. 59 (S-1): 46-54, 2011
