Levofloxacin indications and usage

# INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of LEVAQUIN and other antibacterial drugs, LEVAQUIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
LEVAQUIN Tablets/Injection and Oral Solution are indicated for the treatment of adults (18 years of age) with mild, moderate, and severe infections caused by susceptible strains of the designated microorganisms in the conditions listed in this section. LEVAQUIN Injection is indicated when intravenous administration offers a route of administration advantageous to the patient (e.g., patient cannot tolerate an oral dosage form).

## Culture and susceptibility testing
Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin . Therapy with LEVAQUIN may be initiated before results of these tests are known; once results become available, appropriate therapy should be selected.
As with other drugs in this class, some strains of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with LEVAQUIN. Culture and susceptibility testing performed periodically during therapy will provide information about the continued susceptibility of the pathogens to the antimicrobial agent and also the possible emergence of bacterial resistance.

## Nosocomial Pneumonia
LEVAQUIN is indicated for the treatment of nosocomial pneumonia due to methicillin-susceptible Staphylococcus aureus,Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, or Streptococcus pneumoniae. Adjunctive therapy should be used as clinically indicated. Where Pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal -lactam is recommended .

## Community-Acquired Pneumonia: 714 day Treatment Regimen
LEVAQUIN is indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant Streptococcus pneumoniae ), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae .
MDRSP isolates are strains resistant to two or more of the following antibacterials: penicillin (MIC 2mcg/mL), 2nd generation cephalosporins, e.g., cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole.

## Community-Acquired Pneumonia: 5-day Treatment Regimen
LEVAQUIN is indicated for the treatment of community-acquired pneumonia due to Streptococcus pneumoniae (excluding multi-drug-resistant strains ), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae .

## Acute Bacterial Sinusitis: 5-day and 1014 day Treatment Regimens
LEVAQUIN is indicated for the treatment of acute bacterial sinusitis due to Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis .

## Acute Bacterial Exacerbation of Chronic Bronchitis
LEVAQUIN is indicated for the treatment of acute bacterial exacerbation of chronic bronchitis due to methicillin-susceptible Staphylococcus aureus,Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis.

## Complicated Skin and Skin Structure Infections
LEVAQUIN is indicated for the treatment of complicated skin and skin structure infections due to methicillin-susceptible Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, or Proteus mirabilis .

## Uncomplicated Skin and Skin Structure Infections
LEVAQUIN is indicated for the treatment of uncomplicated skin and skin structure infections (mild to moderate) including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to methicillin-susceptible Staphylococcus aureus, or Streptococcus pyogenes.

## Chronic Bacterial Prostatitis
LEVAQUIN is indicated for the treatment of chronic bacterial prostatitis due to Escherichia coli, Enterococcus faecalis, or methicillin-susceptibleStaphylococcus epidermidis .

## Complicated Urinary Tract Infections: 5-day Treatment Regimen
LEVAQUIN is indicated for the treatment of complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis .

## Complicated Urinary Tract Infections: 10-day Treatment Regimen
LEVAQUIN is indicated for the treatment of complicated urinary tract infections (mild to moderate) due to Enterococcus faecalis, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa .

## Acute Pyelonephritis: 5 or 10-day Treatment Regimen
LEVAQUIN is indicated for the treatment of acute pyelonephritis caused by Escherichia coli, including cases with concurrent bacteremia .

## Uncomplicated Urinary Tract Infections
LEVAQUIN is indicated for the treatment of uncomplicated urinary tract infections (mild to moderate) due to Escherichia coli, Klebsiella pneumoniae, orStaphylococcus saprophyticus.

## Inhalational Anthrax (Post-Exposure)
LEVAQUIN is indicated for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolizedBacillus anthracis. The effectiveness of LEVAQUIN is based on plasma concentrations achieved in humans, a surrogate endpoint reasonably likely to predict clinical benefit. LEVAQUIN has not been tested in humans for the post-exposure prevention of inhalation anthrax. The safety of LEVAQUIN in adults for durations of therapy beyond 28 days or in pediatric patients for durations of therapy beyond 14 days has not been studied. Prolonged LEVAQUIN therapy should only be used when the benefit outweighs the risk [see Dosage and Administration (2.1), (2.2) and Clinical Studies