1 INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin tablets USP and other antibacterial drugs, azithromycin tablets USP 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 tablets USP 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 USP 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 (
1.1,
1.2)
Pharyngitis/tonsillitis in adults and pediatric patients (
1.1,
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. (
1.3)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin tablets USP and other antibacterial drugs, azithromycin tablets USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.
1.1 Adult Patients
Acute bacterial exacerbations of chronic bronchitis due to
Haemophilus influenzae,
Moraxella catarrhalis, or
Streptococcus pneumoniae.
Acute bacterial sinusitis due to
Haemophilus influenzae,
Moraxella catarrhalis. or
Streptococcus pneumoniae.
Community-acquired pneumonia due to
Chlamydophila pneumoniae,
Haemophilus influenzae,
Mycoplasma pneumoniae, or
Streptococcus pneumoniae in patients appropriate for oral therapy.
Pharyngitis/tonsillitis caused by
Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy.
Uncomplicated skin and skin structure infections due to
Staphylococcus aureus,
Streptococcus pyogenes, or
Streptococcus agalactiae.
Urethritis and cervicitis due to
Chlamydia trachomatis or
Neisseria gonorrhoeae.
Genital ulcer disease in men due to
Haemophilus ducreyi (chancroid). Due to the small number of women included in clinical trials, the efficacy of azithromycin in the treatment of chancroid in women has not been established.
1.2 Pediatric Patients
[
See Use in Specific Populations (
8.4) and Clinical Studies (
14.2).
]
Acute otitis media ( 6 months of age) caused by
Haemophilus influenzae,
Moraxella catarrhalis, or
Streptococcus pneumoniae
Community-acquired pneumonia ( 6 months of age) due to
Chlamydophila pneumoniae,
Haemophilus influenzae,
Mycoplasma pneumonia, or
Streptococcus pneumoniae in patients appropriate for oral therapy.
Pharyngitis/tonsillitis ( 2 years of age) caused by
Streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy.
1.3 Limitations 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 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).