Indication: Cefadroxil capsules are indicated for the treatment of patients with infection caused by susceptible strains of the designated organisms in the following diseases: Urinary tract infections caused by E. coli P. mirabilis Klebsiella Skin and skin structure infections caused by staphylococci and/or streptococci. Pharyngitis and/or tonsillitis caused by Streptococcus pyogenes Note: Note: To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefadroxil capsules and other antibacterial drugs, cefadroxil capsules 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: 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: To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefdinir capsules and other antibacterial drugs, cefdinir capsules 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. Cefdinir capsules are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below. Adults and Adolescents Community-Acquired Pneumonia Caused by Haemophilus influenzae Haemophilus parainfluenzae Streptococcus pneumoniae Moraxella catarrhalis CLINICAL STUDIES Acute Exacerbations of Chronic Bronchitis Caused by Haemophilus influenzae Haemophilus parainfluenzae Streptococcus pneumoniae Moraxella catarrhalis Acute Maxillary Sinusitis Caused by Haemophilus influenzae Streptococcus pneumoniae Moraxella catarrhalis NOTE: Pediatric Use DOSAGE AND ADMINISTRATION Pharyngitis/Tonsillitis Caused by Streptococcus pyogenes CLINICAL STUDIES NOTE: S. pyogenes S. pyogenes Uncomplicated Skin and Skin Structure Infections Caused by Staphylococcus aureus Streptococcus pyogenes Pediatric Patients Acute Bacterial Otitis Media Caused by Haemophilus influenzae Streptococcus pneumoniae Moraxella catarrhalis Pharyngitis/Tonsillitis Caused by Streptococcus pyogenes CLINICAL STUDIES NOTE: S. pyogenes S. pyogenes Uncomplicated Skin and Skin Structure Infections Caused by Staphylococcus aureus Streptococcus pyogenes

Indication: Azithromycin for oral suspension 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 for oral suspension 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 for oral suspension and other antibacterial drugs, azithromycin for oral suspension 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: ZITHROMAX (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) ZITHROMAX 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 ZITHROMAX (azithromycin) and other antibacterial drugs, ZITHROMAX (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 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 ZITHROMAX (azithromycin) and other antibacterial drugs, ZITHROMAX (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 (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 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 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 for oral suspension 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 for oral suspension 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 for oral suspension and other antibacterial drugs, azithromycin for oral suspension 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 (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 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 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: 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. 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 ( 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 and other antibacterial drugs, azithromycin should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. 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).