Vol.54 No.4 July 2006
Safety of coadministration of levofloxacin, a new quinolone, with nonsteroidal anti-inflammatory agents
PMS & Product Planning, Daiichi Pharmaceutical Co., Ltd, 1-8 Nihonbashi-Koamicho, Chuo-ku, Tokyo, Japan
Abstract
Of 8,856 patients enrolled in a special survey on levofloxacin (LVFX) therapy for pharyngitis, tonsillitis, and acute bronchitis associated with fever (≥38°C), 7,597 free of complications or underlying disease were studied to determine the safety of LVFX used in combination with nonsteroidal anti-inflammatory drugs (NSAIDs). LVFX was coadministered with NSAIDs in 64.4% of patients (4,890/7,597). Phenylacetic acid and propionic acid derivatives, which require "coadministration with care", were used in 37.2% (2,828/7,597). The incidence of adverse central nervous system (CNS) effects in the presence or absence of NSAIDs therapy was 0.04% (1/2,707) in the non-NSAIDs group, 0.07% (2/2,828) in the group receiving phenylacetic acid or propionic acid derivatives, and 0.10% (2/2,062) in the group using other NSAIDs. No significant difference was seen between groups. CNS symptoms included dizziness in two patients and wobbling, insomnia, and drowsiness in one patient each, but no convulsions. The incidence of adverse CNS effects related to the daily dose of LVFX was 0% (0/458) in patients given 200 mg/day (100 mg b.i.d.), 0.07% (4/5,716) in patients given 300 mg/day (100 mg t.d.s.), 0.10% (1/1,031) in patients receiving 400 mg/day (200 mg b.i.d.), and 0% (0/65) in patients receiving 600 mg/day (200 mg t.d.s.). No significant difference was seen between groups, nor when patients were stratified by the presence or absence of concomitant NSAIDs therapy. The incidence of adverse CNS effects was 0.06% (4/7,088) in patients <65 years old, 0.28% (1/358) in those from 65 to 74 years old, and 0% (0/151) in those ≥75 years, showing no significant difference. No significant difference was seen when patients were stratified by the presence or absence of concomitant NSAIDs therapy.
These results suggest that NSAIDs have very little influence on adverse CNS reactions to LVFX in patients without underlying disease.
Key word
levofloxacin, non-steroidal anti-inflammatory drug, adverse effect, safety
Received
April 17, 2006
Accepted
May 30, 2006
Jpn. J. Chemother. 54 (4): 321-329, 2006
