Vol.62 No.6 November 2014
Safety and efficacy of intravenous levofloxacin 500 mg once a day
1)Department of Infectious Diseases and Infection Control, Jikei University School of Medicine, 3-25-8 Nishi-Shimbashi, Tokyo, Japan
2)Medical Affairs Department Business Intelligence Division, Daiichi Sankyo Company, Limited
3)Post-Marketing Regulatory Affairs Department, Daiichi Sankyo Company, Limited
4)Pharmacovigilance Department, Daiichi Sankyo Company, Limited
5)Clinical Data and Biostatistics Department, Daiichi Sankyo Company, Limited
Abstract
A use-results survey on intravenous levofloxacin (LVFX, Cravit® intravenous drip infusion 500 mg) was performed from October 2011 to September 2013. In total, 1,142 case cards were collected from 221 medical institutions and 1,118 cases were subjected to a safety evaluation and 952 were subjected to an efficacy evaluation.
The incidence of adverse drug reactions (ADRs) was 10.02% (112/1,118 cases). The major ADRs were investigations at 4.56% (51/1,118 cases), hepatobiliary disorders at 1.43% (16/1,118 cases) and general disorders and administration site conditions (such as injection site reactions) at 1.25% (14/1,118 cases). Serious ADRs were observed in 6 cases and the details were pneumonia, blood creatinine increased, interstitial lung disease, hepatic function abnormal, lung disorder and acute respiratory distress syndrome.
Nonsteroidal anti-inflammatory drugs (NSAIDs) of the phenyl acetate and propionate types, which require caution when coadministered with LVFX, were used concomitantly by 9.8% (110/1,118 cases) of patients but the incidence of ADRs in these patients did not increase. Furthermore, no central nervous system ADRs (such as nervous system disorder and psychiatric disorders) were observed among patients in whom NSAIDs of the phenyl acetate, propionate types and other types were coadministered with LVFX.
The overall efficacy rate was 90.7% (863/952 cases) and by types of indications, it was 90.5% (781/863 cases) for pneumonia, and 92.1% (82/89 cases) for secondary infection of chronic respiratory disease. By the classification of pneumonia, it was 93.8% (589/628 cases) for community-acquired pneumonia, 79.9% (123/154 cases) for nursing and healthcare-associated pneumonia, and 85.9% (67/78 cases) for hospital-acquired pneumonia.
The overall eradication rate was 93.0% (146/157 strains) including Gram-positive bacteria at 88.7% (55/62 strains), Gram-negative bacteria at 95.4% (83/87 strains), and atypical bacteria at 100.0% (8/8 strains).
In conclusion, this use-results survey confirmed that intravenous LVFX is a useful antibacterial agent with no serious problems in its safety profile and efficacy rate was more than 90% in all indications, pneumonia and secondary infection in chronic respiratory disease.
Key word
levofloxacin, safety, efficacy, injection
Received
August 8, 2014
Accepted
September 16, 2014
Jpn. J. Chemother. 62 (6): 687-702, 2014
