Indication: Levofloxacin 1 12. 4 Pneumonia: Nosocomial ( 1. 3 Skin and Skin Structure Infections (SSSI): Complicated ( 1. 5 Chronic bacterial prostatitis ( 1. 6 Inhalational Anthrax, Post-Exposure in adult and pediatric patients ( 1. 7 Plague in adult and pediatric patients ( 1. 8 Urinary Tract Infections (UTI): Complicated ( 1. 12 Acute Pyelonephritis ( 1. 11 Acute Bacterial Exacerbation of Chronic Bronchitis ( 1. 13 Acute Bacterial Sinusitis ( 1. 14 Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin and other antibacterial drugs, levofloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria ( 1. 15 Levofloxacin tablet is indicated in adult patients for the treatment of nosocomial pneumonia due to methicillin-susceptible Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, Streptococcus pneumoniae Pseudomonas aeruginosa [see Clinical Studies ( 14. 1 Levofloxacin tablet is indicated in adult patients for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae Streptococcus pneumoniae Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae [see Dosage and Administration ( 2. 2 MDRSP isolates are isolates resistant to two or more of the following antibacterials: penicillin (MIC >= 2 mcg/mL), 2 nd Levofloxacin tablet is indicated in adult patients for the treatment of community-acquired pneumonia due to Streptococcus pneumoniae Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Dosage and Administration ( 2. 3 Levofloxacin tablet is indicated in adult patients for the treatment of complicated skin and skin structure infections due to methicillin-susceptible Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, Proteus mirabilis [see Clinical Studies ( 14. 5 Levofloxacin tablet is indicated in adult patients 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 Streptococcus pyogenes Levofloxacin tablet is indicated in adult patients for the treatment of chronic bacterial prostatitis due to Escherichia coli, Enterococcus faecalis, Staphylococcus epidermidis [see Clinical Studies ( 14. 6 Levofloxacin tablet is indicated for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis [see Dosage and Administration ( 2. 2 [see Clinical Studies ( 14. 9 Levofloxacin tablet is indicated for treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis Y. pestis [see Dosage and Administration ( 2. 2 Efficacy studies of levofloxacin tablets could not be conducted in humans with plague for ethical and feasibility reasons. Therefore, approval of this indication was based on an efficacy study conducted in animals [see Clinical Studies ( 14. 10 Levofloxacin tablet is indicated in adult patients for the treatment of complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis [see Clinical Studies ( 14. 7 Levofloxacin tablet is indicated in adult patients for the treatment of complicated urinary tract infections (mild to moderate) due to Enterococcus faecalis, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa [see Clinical Studies ( 14. 8 Levofloxacin tablet is indicated in adult patients for the treatment of acute pyelonephritis caused by Escherichia coli [see Clinical Studies ( 14. 8 Levofloxacin tablet Escherichia coli, Klebsiella pneumoniae, Staphylococcus saprophyticus Because fluoroquinolones, including levofloxacin, have been associated with serious adverse reactions [see Warnings and Precautions ( 5 Levofloxacin tablet is indicated in adult patients for the treatment of acute bacterial exacerbation of chronic bronchitis (ABECB) due to methicillin-susceptible Staphylococcus aureus Streptococcus pneumoniae Haemophilus influenzae Haemophilus parainfluenzae Moraxella catarrhalis Because fluoroquinolones, including levofloxacin, have been associated with serious adverse reactions [see Warnings and Precautions ( 5 Levofloxacin tablet is indicated in adult patients for the treatment of acute bacterial sinusitis (ABS) due to Streptococcus pneumoniae Haemophilus influenzae Moraxella catarrhalis [see Clinical Studies ( 14. 4 Because fluoroquinolones, including levofloxacin, have been associated with serious adverse reactions [see Warnings and Precautions ( 5 To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin and other antibacterial drugs, levofloxacin 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. 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 [see Microbiology ( 12. 4 As with other drugs in this class, some isolates of Pseudomonas aeruginosa.

Indication: Ciprofloxacin Injection (in 5% Dextrose Injection) is a fluoroquinolone antibacterial indicated in adults (>=18 years of age) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: 1. 1) 1. 9 o 1. 10 o o 1. 11 Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of ciprofloxacin and other antibacterial drugs, ciprofloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. 12 Ciprofloxacin Injection (in 5% Dextrose Injection) is indicated in adult patients for treatment of skin and skin structure infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Morganella morganii, Citrobacter freundii, Pseudomonas aeruginosa, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes. Ciprofloxacin Injection (in 5% Dextrose Injection) is indicated in adult patients for treatment of bone and joint infections caused by Enterobacter cloacae, Serratia marcescens, Pseudomonas aeruginosa. Ciprofloxacin Injection (in 5% Dextrose Injection) is indicated in adult patients for treatment of complicated intra-abdominal infections (used in combination with metronidazole) caused by Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, Bacteroides fragilis. Ciprofloxacin Injection (in 5% Dextrose Injection) is indicated in adult patients for treatment of nosocomial pneumonia caused by Haemophilus influenzae Klebsiella pneumoniae. Ciprofloxacin Injection (in 5% Dextrose Injection) is indicated in adult patients for the treatment of febrile neutropenia in combination with piperacillin sodium [see Clinical Studies (14. 1) Ciprofloxacin Injection (in 5% Dextrose Injection) is indicated in adults and pediatric patients from birth to 17 years of age for treatment of inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. Ciprofloxacin serum concentrations achieved in humans served as a surrogate endpoint reasonably likely to predict clinical benefit and provided the initial basis for approval of this indication. 1 [see Clinical Studies (14. 3) Ciprofloxacin Injection (in 5% Dextrose Injection) is indicated for treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis (Y. pestis) [see Clinical Studies (14. 4) Ciprofloxacin Injection (in 5% Dextrose Injection) is indicated in adult patients for treatment of chronic bacterial prostatitis caused by Escherichia coli Proteus mirabilis. Ciprofloxacin Injection (in 5% Dextrose Injection) is indicated in adult patients for treatment of lower respiratory tract infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, Streptococcus pneumoniae. Streptococcus pneumonia Ciprofloxacin Injection (in 5% Dextrose Injection) is indicated for the treatment of acute exacerbations of chronic bronchitis (AECB) caused by Moraxella catarrhalis Because fluoroquinolones, including ciprofloxacin, have been associated with serious adverse reactions [see Warnings and Precautions (5. 1 en dash 5. 16)] Urinary Tract Infection in Adults Ciprofloxacin Injection (in 5% Dextrose Injection) is indicated in adult patients for treatment of urinary tract infections caused by Escherichia coli Klebsiella pneumoniae Enterobacter cloacae Serratia marcescens Proteus mirabilis Providencia rettgeri Morganella morganii Citrobacter koseri Citrobacter freundii Pseudomonas aeruginosa Staphylococcus epidermidis Staphylococcus saprophyticus Enterococcus faecalis Complicated Urinary Tract Infections and Pyelonephritis in Pediatric Patients Ciprofloxacin Injection (in 5% Dextrose Injection) is indicated in pediatric patients one to 17 years of age for treatment of complicated urinary tract infections (cUTI) and pyelonephritis due to Escherichia coli [see Use in Specific Populations (8. 4) Although effective in clinical trials, Ciprofloxacin Injection (in 5% Dextrose Injection), is not a drug of first choice in the pediatric population due to an increased incidence of adverse reactions compared to controls, including reactions related to joints and/or surrounding tissues. Ciprofloxacin Injection (in 5% Dextrose Injection), like other fluoroquinolones, is associated with arthropathy and histopathological changes in weight-bearing joints of juvenile animals [see Warnings and Precautions (5. 13) Adverse Reactions (6. 1) Use in Specific Populations (8. 4) Nonclinical Toxicology (13. 2) Ciprofloxacin Injection (in 5% Dextrose Injection) is indicated in adult patients for treatment of acute sinusitis caused by Haemophilus influenzae Streptococcus pneumoniae, Moraxella catarrhalis Because fluoroquinolones, including Ciprofloxacin Injection (in 5% Dextrose Injection), have been associated with serious adverse reactions [see Warnings and Precautions (5. 16)] To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ciprofloxacin Injection (in 5% Dextrose Injection) and other antibacterial drugs, Ciprofloxacin Injection (in 5% Dextrose Injection) 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. If anaerobic organisms are suspected of contributing to the infection, appropriate therapy should be administered. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to ciprofloxacin. Therapy with Ciprofloxacin Injection (in 5% Dextrose Injection) may be initiated before results of these tests are known; once results become available appropriate therapy should be continued. As with other drugs, some isolates of Pseudomonas aeruginosa.

Indication: Levofloxacinare a fluoroquinolone antibacterial indicated in adults (>= 18 years of age) with infections caused by designated, susceptible bacteria ( 1 12. 12 1. 11 1. 13 1. 14 To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tabletsand other antibacterial drugs, levofloxacin tabletsshould 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. Levofloxacin tablets are indicated for the treatment of adults (>= 18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. 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 [see Microbiology ( 12. 4 As with other drugs in this class, some isolates of Pseudomonas aeruginosa Levofloxacin tablet is indicated for the treatment of nosocomial pneumonia due to methicillin-susceptible Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, Streptococcus pneumoniae Pseudomonas aeruginosa [see Clinical Studies ( 14. 1 Levofloxacin tablet is indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae Streptococcus pneumoniae Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae [see Dosage and Administration ( 2. 2 MDRSP isolates are isolates resistant to two or more of the following antibacterials: penicillin (MIC >= 2 mcg/mL), 2 nd Levofloxacin tablet is indicated for the treatment of community-acquired pneumonia due to Streptococcus pneumoniae Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Dosage and Administration ( 2. 3 Levofloxacin tablet is indicated for the treatment of acute bacterial sinusitis due to Streptococcus pneumoniae Haemophilus influenzae, Moraxella catarrhalis [see Clinical Studies ( 14. 4 Levofloxacin tablet is indicated for the treatment of acute bacterial exacerbation of chronic bronchitis due to methicillin-susceptible Staphylococcus aureus Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis Levofloxacin tablet is indicated for the treatment of complicated skin and skin structure infections due to methicillin-susceptible Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, Proteus mirabilis [see Clinical Studies ( 14. 5 Levofloxacin tablet 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 Streptococcus pyogenes Levofloxacin tablet is indicated for the treatment of chronic bacterial prostatitis due to Escherichia coli, Enterococcus faecalis, Staphylococcus epidermidis [see Clinical Studies ( 14. 6 Levofloxacin tablet is indicated for the treatment of complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis [see Clinical Studies ( 14. 7 Levofloxacin tablet 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, Pseudomonas aeruginosa [see Clinical Studies ( 14. 8 Levofloxacin tablet is indicated for the treatment of acute pyelonephritis caused by Escherichia coli [see Clinical Studies ( 14. 8 Levofloxacin tabletis indicated for the treatment of uncomplicated urinary tract infections (mild to moderate) due to Escherichia coli, Klebsiella pneumoniae, Staphylococcus saprophyticus Levofloxacin tabletis indicated for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. [see Dosage and Administration ( 2. 9 Levofloxacin tablet is indicated for treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis Y. pestis see Dosage and Administration ( 2. 2 ) and Clinical Studies ( 14.

Indication: Levofloxacin is a fluoroquinolone antibacterial indicated in adults (>=18 years of age) with infections caused by designated, susceptible bacteria ( 1 12. 12 1. 11 1. 13 (1. 14) To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets, USP and other antibacterial drugs, levofloxacin tablets, USP 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. Levofloxacin Tablets, USP is indicated for the treatment of adults (>=18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. 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 tablets, USP [see Microbiology ( 12. 4 As with other drugs in this class, some isolates of Pseudomonas aeruginosa Levofloxacin tablets, USP is indicated for the treatment of nosocomial pneumonia due to methicillin-susceptible Staphylococcus aureus Pseudomonas aeruginosa Serratia marcescens Escherichia coli Klebsiella pneumoniae Haemophilus influenzae Streptococcus pneumoniae Pseudomonas aeruginosa [see Clinical Studies ( 14. 1 ) Levofloxacin tablets, USP is indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus Streptococcus pneumoniae Streptococcus pneumoniae Haemophilus influenzae Haemophilus parainfluenzae Klebsiella pneumoniae Moraxella catarrhalis Chlamydophila pneumoniae Legionella pneumophila Mycoplasma pneumoniae [see Dosage and Administration ( 2. 1 ) and Clinical Studies ( 14. 2 ) MDRSP isolates are strains resistant to two or more of the following antibacterials: penicillin (MIC >=2 mcg/mL), 2nd generation cephalosporins, e. , cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole. Levofloxacin tablets, USP is indicated for the treatment of community-acquired pneumonia due to Streptococcus pneumoniae Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae Chlamydophila pneumoniae see Dosage and Administration ( 2. 3 Levofloxacin tablets, USP is indicated for the treatment of acute bacterial sinusitis due to Streptococcus pneumoniae Haemophilus influenzae Moraxella catarrhalis [see Clinical Studies ( 14. 4 ) Levofloxacin tablets, USP is indicated for the treatment of acute bacterial exacerbation of chronic bronchitis due to methicillin-susceptible Staphylococcus aureus Streptococcus pneumoniae Haemophilus influenzae Haemophilus parainfluenzae Moraxella catarrhalis Levofloxacin tablets, USP is indicated for the treatment of complicated skin and skin structure infections due to methicillin-susceptible Staphylococcus aureus Enterococcus faecalis Streptococcus pyogenes Proteus mirabilis [see Clinical Studies ( 14. 5 ) Levofloxacin tablets, USP 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 Streptococcus pyogenes Levofloxacin tablets, USP is indicated for the treatment of chronic bacterial prostatitis due to Escherichia coli Enterococcus faecalis Staphylococcus epidermidis [see Clinical Studies ( 14. 6 ) Levofloxacin tablets, USP is indicated for the treatment of complicated urinary tract infections due to Escherichia coli Klebsiella pneumoniae Proteus mirabilis [see Clinical Studies ( 14. 7 Levofloxacin tablets, USP 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 Pseudomonas aeruginosa [see Clinical Studies ( 14. 8 Levofloxacin tablets, USP is indicated for the treatment of acute pyelonephritis caused by Escherichia coli, including cases with concurrent bacteremia [see Clinical Studies ( 14. 8 Levofloxacin tablets, USP is indicated for the treatment of uncomplicated urinary tract infections (mild to moderate) due to Escherichia coli, Klebsiella pneumoniae, or Staphylococcus saprophyticus. Levofloxacin tablets, USP is indicated for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. [see Dosage and Administration ( 2. 2 ) and Clinical Studies ( 14. 9 ) Levofloxacin tablets, USP is indicated for treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis (Y. pestis) efficacy study conducted in animals [see Dosage and Administration ( 2.

Indication: Levofloxacin is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with infections caused by designated, susceptible bacteria and in pediatric patients where indicated ( 1 12. 15 Levofloxacin tablets are indicated in adult patients for the treatment of nosocomial pneumonia due to methicillin-susceptible Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, Streptococcus pneumoniae. Pseudomonas aeruginosa [see Clinical Studies ( 14. 1) Levofloxacin tablets are indicated in adult patients for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae Streptococcus pneumoniae Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae [see Dosage and Administration ( 2. nd Levofloxacin tablets are indicated in adult patients for the treatment of community-acquired pneumonia due to Streptococcus pneumoniae Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, Chlamydophila pneumoniae [see Dosage and Administration ( 2. Levofloxacin tablets are indicated in adult patients for the treatment of complicated skin and skin structure infections due to methicillin-susceptible Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, Proteus mirabilis [see Clinical Studies ( 14. Levofloxacin tablets are indicated in adult patients 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, Streptococcus pyogenes. Levofloxacin tablets are indicated in adult patients for the treatment of chronic bacterial prostatitis due to Escherichia coli, Enterococcus faecalis, Staphylococcus epidermidis [see Clinical Studies ( 14. 6 Levofloxacin tablets are indicated for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis [see Dosage and Administration ( 2. [see Clinical Studies ( 14. 9 Levofloxacin tablets are indicated for treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis Y. pestis [see Dosage and Administration ( 2. 2 [see Clinical Studies ( 14. Levofloxacin tablets are indicated in adult patients for the treatment of complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis [see Clinical Studies ( 14. 7 Levofloxacin tablets are indicated in adult patients for the treatment of complicated urinary tract infections (mild to moderate) due to Enterococcus faecalis, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa [see Clinical Studies (14. Levofloxacin tablets are indicated in adult patients for the treatment of acute pyelonephritis caused by Escherichia coli, [see Clinical Studies (14. 8 Levofloxacin tablets are indicated in adult patients for the treatment of uncomplicated urinary tract infections (mild to moderate) due to Escherichia coli, Klebsiella pneumoniae, Staphylococcus saprophyticus. [see Warnings and Precautions ( 5. 15 Levofloxacin tablets are indicated in adult patients for the treatment of acute bacterial exacerbation of chronic bronchitis (ABECB) due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis. 15 Levofloxacin tablets are indicated in adult patients for the treatment of acute bacterial sinusitis (ABS) due to Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis [see Clinical Studies ( 14. 15 To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets and other antibacterial drugs, levofloxacin tablets 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. Culture and susceptibility testing [see Microbiology ( 12. Pseudomonas aeruginosa.

Indication: Levofloxacin tablets are a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with infections caused by designated, susceptible bacteria and in pediatric patients where indicated ( 1 12. 4 Pneumonia: Nosocomial ( 1. 3 Skin and Skin Structure Infections (SSSI): Complicated ( 1. 5 Chronic bacterial prostatitis ( 1. 6 Inhalational Anthrax, Post-Exposure in adult and pediatric patients ( 1. 7 Plague in adult and pediatric patients ( 1. 8 Urinary Tract Infections (UTI): Complicated ( 1. 12 Acute Pyelonephritis ( 1. 11 Acute Bacterial Exacerbation of Chronic Bronchitis ( 1. 13 Acute Bacterial Sinusitis ( 1. 15 Levofloxacin tablets are indicated in adult patients for the treatment of nosocomial pneumonia due to methicillin-susceptible Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, Streptococcus pneumoniae Pseudomonas aeruginosa [see Clinical Studies (14. 1) Levofloxacin tablets are indicated in adult patients for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae Streptococcus pneumoniae Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae [see Dosage and Administration (2. 1) and Clinical Studies (14. MDRSP isolates are isolates resistant to two or more of the following antibacterials: penicillin (MIC >=2 mcg/mL), 2 nd Levofloxacin tablets are indicated in adult patients for the treatment of community-acquired pneumonia due to Streptococcus pneumoniae Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, Chlamydophila pneumoniae [see Dosage and Administration (2. Levofloxacin tablets are indicated in adult patients for the treatment of complicated skin and skin structure infections due to methicillin-susceptible Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, Proteus mirabilis [see Clinical Studies (14. Levofloxacin tablets are indicated in adult patients 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, Streptococcus pyogenes Levofloxacin tablets are indicated in adult patients for the treatment of chronic bacterial prostatitis due to Escherichia coli, Enterococcus faecalis, Staphylococcus epidermidis [see Clinical Studies (14. 6) Levofloxacin tablets are indicated for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis [see Dosage and Administration (2. 2) [see Clinical Studies (14. 9) Levofloxacin tablets are indicated for treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis Y. pestis [see Dosage and Administration (2. 2)] Efficacy studies of levofloxacin tablets could not be conducted in humans with plague for ethical and feasibility reasons. Therefore, approval of this indication was based on an efficacy study conducted in animals [see Clinical Studies (14. 10) Levofloxacin tablets are indicated in adult patients for the treatment of complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis [see Clinical Studies (14. Levofloxacin tablets are indicated in adult patients for the treatment of complicated urinary tract infections (mild to moderate) due to Enterococcus faecalis, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa [see Clinical Studies (14. 8) ] Levofloxacin tablets are indicated in adult patients for the treatment of acute pyelonephritis caused by Escherichia coli [see Clinical Studies (14. 8 Levofloxacin tablets are indicated in adult patients for the treatment of uncomplicated urinary tract infections (mild to moderate) due to Escherichia coli, Klebsiella pneumoniae, Staphylococcus saprophyticus Because fluoroquinolones, including levofloxacin tablets, have been associated with serious adverse reactions [see Warnings and Precautions (5. 15) Levofloxacin tablets are indicated in adult patients for the treatment of acute bacterial exacerbation of chronic bronchitis (ABECB) due to methicillin-susceptible Staphylococcus aureus Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis Because fluoroquinolones, including levofloxacin tablets, have been associated with serious adverse reactions [see Warnings and Precautions (5. 15) Levofloxacin tablets are indicated in adult patients for the treatment of acute bacterial sinusitis (ABS) due to Streptococcus pneumoniae Haemophilus influenzae, Moraxella catarrhalis [see Clinical Studies (14. 4) Because fluoroquinolones, including levofloxacin tablets, have been associated with serious adverse reactions [see Warnings and Precautions (5. 15) To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets and other antibacterial drugs, levofloxacin tablets 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. 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 [see Microbiology (12. 4) As with other drugs in this class, some isolates of Pseudomonas aeruginosa.