RiteMED Levofloxacin Indications/Uses

For the treatment of adults (≥18 years old) with mild, moderate, or severe infections caused by susceptible strains of the designated microorganisms for the following conditions: Acute bacterial sinusitis; Acute bacterial exacerbation of chronic bronchitis; Community-acquired pneumonia; Healthcare-associated pneumonia; Complicated skin and skin structure infections; Uncomplicated skin and skin structure infections (mild to moderate) including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections; Complicated urinary tract infections; Acute pyelonephritis; Chronic bacterial prostatitis; Uncomplicated urinary tract infections.
To reduce the incidence or progression of inhalational anthrax in adults and children ≥6 months old, following exposure to aerosolized Bacillus anthracis. The effectiveness of levofloxacin is based on plasma concentrations achieved in humans, a surrogate endpoint reasonably likely to predict clinical benefit. Levofloxacin has not been tested in humans for the post-exposure prevention of inhalation anthrax. The safety of levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
For the treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis and prophylaxis for plague in adults and children ≥6 months old. Efficacy studies of levofloxacin could not be conducted in humans with plague for ethical and feasibility reasons. The approval of this indication was based on an efficacy study done in animals.