Avelox Tablets and I.V. have been used in over 40 million patients worldwide. Comprehensive safety data collected from >7000 patients treated with Avelox in clinical trials and >46,000 patients treated with Avelox in postmarketing and phase IV studies demonstrate that Avelox is generally well tolerated with a frequency of side effects comparable to comparator antibiotics.
The most common (incidence ≥3%) adverse drug reactions observed with Avelox in clinical studies are nausea and diarrhea.
Please see the following tables for complete adverse drug reaction information based on all clinical studies with Avelox 400 mg (oral and sequential therapy; overall n=11,464; including n=2239 for sequential therapy studies; status: December 2004). ADRs derived from post marketing reports (status: December 2004) are printed in bold italic.
The following undesirable effects have a higher frequency in the subgroup of IV/oral sequentially treated patients:
Common: Increased gamma-glutamyl-transferase
Uncommon: Ventricular tachyarrythmias, hypotension, vasodilation, pseudomembranous colitis (in very rare cases associated with life-threatening complications), seizures of various clinical manifestations (including grand mal convulsions), hallucination, renal impairment (which in some cases due to dehydration can lead to renal failure especially in elderly patients with pre-existing renal disorders)
Effects on the intestinal flora in humans
In two volunteer studies, the following changes in the intestinal flora were seen following oral dosing with Avelox. E. coli, Bacillus spp., Bacteroides vulgatus, Enterococci and Klebsiella spp. were reduced, as were the anaerobes Bifidobacterium, Eubacterium, and Peptostreptococcus. These changes returned to normal within two weeks. Clostridium difficile toxin was not found.
Effects on ability to drive and use machines
In clinical trials a low incidence of CNS reactions was observed. However, patients should be cautioned to see how they react before driving or operating machinery.
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