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: Ertapenem for injection is a penem antibacterial indicated in adult patients and pediatric patients (3 months of age and older) for the treatment of the following moderate to severe infections caused by susceptible bacteria: Complicated intra-abdominal infections. 1 Complicated skin and skin structure infections, including diabetic foot infections without osteomyelitis. 2 Community-acquired pneumonia. 3 Complicated urinary tract infections including pyelonephritis. 4 Acute pelvic infections including postpartum endomyometritis, septic abortion and post-surgical gynecologic infections. 5 Ertapenem for injection is indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery. 6 To reduce the development of drug-resistant bacteria and maintain the effectiveness of ertapenem for injection and other antibacterial drugs, ertapenem for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. 7 Ertapenem for injection is indicated for the treatment of adult patients and pediatric patients (3 months of age and older) with complicated intra-abdominal infections due to Escherichia coli Clostridium clostridioforme Eubacterium lentum Peptostreptococcus Bacteroides fragilis Bacteroides distasonis Bacteroides ovatus Bacteroides thetaiotaomicron Bacteroides uniformis Ertapenem for injection is indicated for the treatment of adult patients and pediatric patients (3 months of age and older) with complicated skin and skin structure infections, including diabetic foot infections without osteomyelitis due to Staphylococcus aureus Streptococcus agalactiae Streptococcus pyogenes Escherichia coli Klebsiella pneumoniae Proteus mirabilis Bacteroides fragilis Peptostreptococcus Porphyromonas asaccharolytica Prevotella bivia [see Clinical Studies (14) Ertapenem for injection is indicated for the treatment of adult patients and pediatric patients (3 months of age and older) with community acquired pneumonia due to Streptococcus pneumoniae Haemophilus influenzae Moraxella catarrhalis Ertapenem for injection is indicated for the treatment of adult patients and pediatric patients (3 months of age and older) with complicated urinary tract infections including pyelonephritis due to Escherichia coli Klebsiella pneumoniae Ertapenem for injection is indicated for the treatment of adult patients and pediatric patients (3 months of age and older) with acute pelvic infections including postpartum endomyometritis, septic abortion and post-surgical gynecological infections due to Streptococcus agalactiae, Escherichia coli Bacteroides fragilis, Porphyromonas asaccharolytica, Peptostreptococcus Prevotella bivia Ertapenem for injection is indicated in adults for the prevention of surgical site infection following elective colorectal surgery. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ertapenem for injection and other antibacterial drugs, ertapenem for 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.

Indication: Levofloxacin tablet 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. 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 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 bacteria ( 1. 15 ) Levofloxacin tablets are indicated in adult patients for the treatment of nosocomial pneumonia due to methicillin-susceptible S taphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, or 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 (including multi-drug-resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae see Dosage and Administration (2. 1) Clinical Studies (14. 2) 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 (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or 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, or Proteus mirabilis see Clinical Studies (14. 5) 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, or Streptococcus pyogenes. Levofloxacin tablets are indicated in adult patients for the treatment of chronic bacterial prostatitis due to Escherichia coli, Enterococcus faecalis, or methicillin-susceptible 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 Dosage and Administration ( 2. 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 of therapy beyond 14 days has not been studied. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk [see Clinical Studies ] 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, or Proteus mirabilis 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, or Pseudomonas aeruginosa Clinical Studies ( 14. 8 Levofloxacin tablets are indicated in adult patients for the treatment of acute pyelonephritis caused by Escherichia coli, 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, or 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, or Moraxella catarrhalis. 15 Levofloxacin tablets are indicated in adult patients for the treatment of acute bacterial sinusitis (ABS) due to Streptococcus pneumoniae, Haemophilus influenzae, or 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 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. As with other drugs in this class, some isolates of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with levofloxacin tablets. 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.

Indication: Azithromycin tablets are a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: Acute bacterial exacerbations of chronic bronchitis in adults ( 1. 1 Acute bacterial sinusitis in adults ( 1. 1 Uncomplicated skin and skin structure infections in adults ( 1. 1 Urethritis and cervicitis in adults ( 1. 1 Genital ulcer disease in men ( 1. 1 Acute otitis media in pediatric patients (6 months of age and older) ( 1. 2 Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) ( 1. 2 Pharyngitis/tonsillitis in adults and pediatric patients (2 years of age and older) ( 1. 2 Limitation of Use: Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors. 3 To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin tablets and other antibacterial drugs, azithromycin tablets should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. 4 Azithromycin tablets are a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see DOSAGE AND ADMINISTRATION ( 2 Acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae Moraxella catarrhalis, Streptococcus pneumoniae Acute bacterial sinusitis due to Haemophilus influenzae Moraxella catarrhalis Streptococcus pneumoniae Community-acquired pneumonia due to Chlamydophila pneumoniae Haemophilus influenzae Mycoplasma pneumoniae, Streptococcus pneumoniae Pharyngitis/tonsillitis caused by Streptococcus pyogenes Uncomplicated skin and skin structure infections due to Staphylococcus aureus Streptococcus pyogenes Streptococcus agalactiae Urethritis and cervicitis due to Chlamydia trachomatis Neisseria gonorrhoeae Genital ulcer disease in men due to Haemophilus ducreyi [see USE IN SPECIFIC POPULATIONS ( 8. 2 Acute otitis media ( >6 months of age) Haemophilus influenzae Moraxella catarrhalis, Streptococcus pneumoniae. Community-acquired pneumonia ( >6 months of age) Chlamydophila pneumoniae Haemophilus influenzae Mycoplasma pneumoniae Streptococcus pneumoniae Pharyngitis/tonsillitis (>2 years of age) Streptococcus pyogenes Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following: patients with cystic fibrosis, patients with nosocomial infections, patients with known or suspected bacteremia, patients requiring hospitalization, elderly or debilitated patients, or patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia). To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat 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.

Indication: Azithromycin tablets are a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications [see Dosage and Administration ( 2 Azithromycin tablets are a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: Acute bacterial exacerbations of chronic bronchitis in adults ( 1. 1 Acute bacterial sinusitis in adults ( 1. 1 Uncomplicated skin and skin structure infections in adults ( 1. 1 Urethritis and cervicitis in adults ( 1. 1 Genital ulcer disease in men ( 1. 1 Acute otitis media in pediatric patients ( 1. 2 Community-acquired pneumonia in adults and pediatric patients ( 1. 2 Pharyngitis/tonsillitis in adults and pediatric patients ( 1. 2 Limitation of Use: Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors. 3 To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin tablets and other antibacterial drugs, azithromycin tablets should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. 4 Acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae Moraxella catarrhalis, Streptococcus pneumoniae Acute bacterial sinusitis due to Haemophilus influenzae Moraxella catarrhalis, Streptococcus pneumoniae Community-acquired pneumonia due to Chlamydophila pneumoniae Haemophilus influenzae Mycoplasma pneumoniae, Streptococcus pneumoniae Pharyngitis/tonsillitis caused by Streptococcus pyogenes Uncomplicated skin and skin structure infections due to Staphylococcus aureus Streptococcus pyogenes Streptococcus agalactiae Urethritis and cervicitis due to Chlamydia trachomatis Neisseria gonorrhoeae Genital ulcer disease in men due to Haemophilus ducreyi [see Use in Specific Populations ( 8. 2 Acute otitis media (> 6 months of age) Haemophilus influenzae Moraxella catarrhalis, Streptococcus pneumoniae Community-acquired pneumonia (> 6 months of age) Chlamydophila pneumoniae Haemophilus influenzae Mycoplasma pneumonia Streptococcus pneumoniae Pharyngitis/tonsillitis (> 2 years of age) Streptococcus pyogenes Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following: patients with cystic fibrosis, patients with nosocomial infections, patients with known or suspected bacteremia, patients requiring hospitalization, elderly or debilitated patients, or patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia). To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin tablets and other antibacterial drugs, azithromycin tablets should be used only to treat 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.

Indication: Azithromycin is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2) Azithromycin is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: Acute bacterial exacerbations of chronic bronchitis in adults ( 1. 1 Acute bacterial sinusitis in adults ( 1. 1 Uncomplicated skin and skin structure infections in adults ( 1. 1 Urethritis and cervicitis in adults ( 1. 1 Genital ulcer disease in men ( 1. 1 Acute otitis media in pediatric patients (6 months of age and older) ( 1. 2 Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) ( 1. 2 Pharyngitis/tonsillitis in adults and pediatric patients (2 years of age and older) ( 1. 2 Limitation of Use: Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors. 3 To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. 4 Acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae Moraxella catarrhalis, Streptococcus pneumoniae Acute bacterial sinusitis due to Haemophilus influenzae Moraxella catarrhalis. Streptococcus pneumoniae Community-acquired pneumonia due to Chlamydophila pneumoniae Haemophilus influenzae Mycoplasma pneumoniae, Streptococcus pneumoniae Pharyngitis/tonsillitis caused by Streptococcus pyogenes Uncomplicated skin and skin structure infections due to Staphylococcus aureus Streptococcus pyogenes Streptococcus agalactiae Urethritis and cervicitis due to Chlamydia trachomatis Neisseria gonorrhoeae Genital ulcer disease in men due to Haemophilus ducreyi [see Use in Specific Populations (8. 4) Clinical Studies (14. 2) Acute otitis media ( > 6 months of age Haemophilus influenzae Moraxella catarrhalis, Streptococcus pneumoniae Community-acquired pneumonia ( > 6 months of age Chlamydophila pneumoniae Haemophilus influenzae Mycoplasma pneumonia Streptococcus pneumoniae Pharyngitis/tonsillitis ( > 2 years of age Streptococcus pyogenes Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following: patients with cystic fibrosis, patients with nosocomial infections, patients with known or suspected bacteremia, patients requiring hospitalization, elderly or debilitated patients, or patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia). To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat 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.

Indication: Azithromycin is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2) Azithromycin is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: Acute bacterial exacerbations of chronic bronchitis in adults ( 1. 1 Acute bacterial sinusitis in adults ( 1. 1 Uncomplicated skin and skin structure infections in adults ( 1. 1 Urethritis and cervicitis in adults ( 1. 1 Genital ulcer disease in men ( 1. 1 Acute otitis media in pediatric patients (6 months of age and older) ( 1. 2 Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) ( 1. 2 Pharyngitis/tonsillitis in adults and pediatric patients (2 years of age and older) ( 1. 2 Limitation of Use: 1. 4 Acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae Moraxella catarrhalis, Streptococcus pneumoniae Acute bacterial sinusitis due to Haemophilus influenzae Moraxella catarrhalis. Streptococcus pneumoniae Community-acquired pneumonia due to Chlamydophila pneumoniae Haemophilus influenzae Mycoplasma pneumoniae, Streptococcus pneumoniae Pharyngitis/tonsillitis caused by Streptococcus pyogenes Uncomplicated skin and skin structure infections due to Staphylococcus aureus Streptococcus pyogenes Streptococcus agalactiae Urethritis and cervicitis due to Chlamydia trachomatis Neisseria gonorrhoeae Genital ulcer disease in men due to Haemophilus ducreyi [see Use in Specific Populations (8. 4) Clinical Studies (14. 2) Acute otitis media (>6 months of age) Haemophilus influenzae, Moraxella catarrhalis Streptococcus pneumoniae. Community-acquired pneumonia (>6 months of age) Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae Streptococcus pneumoniae Pharyngitis/tonsillitis (>2 years of age) Streptococcus pyogenes Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following: patients with cystic fibrosis, patients with nosocomial infections, patients with known or suspected bacteremia, patients requiring hospitalization, elderly or debilitated patients, or patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia). To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin tablets and other antibacterial drugs, azithromycin tablets should be used only to treat 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.

Indication: Levofloxacin tablet 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. 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 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 bacteria ( 1. 15 ) Levofloxacin tablets are indicated in adult patients for the treatment of nosocomial pneumonia due to methicillin-susceptible S taphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, or 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 (including multi-drug-resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae see Dosage and Administration (2. 1) Clinical Studies (14. 2) 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 (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or 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, or Proteus mirabilis see Clinical Studies (14. 5) 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, or Streptococcus pyogenes. Levofloxacin tablets are indicated in adult patients for the treatment of chronic bacterial prostatitis due to Escherichia coli, Enterococcus faecalis, or methicillin-susceptible 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 Dosage and Administration ( 2. 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 of therapy beyond 14 days has not been studied. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk [see Clinical Studies ] 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, or Proteus mirabilis 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, or Pseudomonas aeruginosa Clinical Studies ( 14. 8 Levofloxacin tablets are indicated in adult patients for the treatment of acute pyelonephritis caused by Escherichia coli, 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, or 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, or Moraxella catarrhalis. 15 Levofloxacin tablets are indicated in adult patients for the treatment of acute bacterial sinusitis (ABS) due to Streptococcus pneumoniae, Haemophilus influenzae, or 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 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 may develop resistance fairly rapidly during treatment with levofloxacin tablets. 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.

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: Azithromycin tablets are a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications [see Dosage and Administration (2)]. Azithromycin tablets are a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: Acute bacterial exacerbations of chronic bronchitis in adults (1. 1) Limitation of Use: Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors. 3) To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin tablets and other antibacterial drugs, azithromycin tablets should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. 4) · Acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae Moraxella catarrhalis, Streptococcus pneumoniae · Acute bacterial sinusitis due to Haemophilus influenzae Moraxella catarrhalis. Streptococcus pneumoniae · Community-acquired pneumonia due to Chlamydophila pneumoniae Haemophilus influenzae Mycoplasma pneumoniae, Streptococcus pneumoniae · Pharyngitis/tonsillitis caused by Streptococcus pyogenes · Uncomplicated skin and skin structure infections due to Staphylococcus aureus Streptococcus pyogenes Streptococcus agalactiae · Urethritis and cervicitis due to Chlamydia trachomatis Neisseria gonorrhoeae · Genital ulcer disease in men due to Haemophilus ducreyi [see Use in Specific Populations (8. 4) and Clinical Studies (14. 2)] Acute otitis media ( >6 months of age) Haemophilus influenzae Moraxella catarrhalis, Streptococcus pneumoniae. Community-acquired pneumonia (>6 months of age) Chlamydophila pneumoniae Haemophilus influenzae Mycoplasma pneumoniae Streptococcus pneumoniae Pharyngitis/tonsillitis (>2 years of age Streptococcus pyogenes Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following: · patients with cystic fibrosis, · patients with nosocomial infections, · patients with known or suspected bacteremia, · patients requiring hospitalization, · elderly or debilitated patients, or · patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia). To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin tablets and other antibacterial drugs, azithromycin tablets should be used only to treat 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.