1 INDICATIONS AND USAGE
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) (
1.1,
1.2)
Pharyngitis/tonsillitis
in adults and pediatric patients (2 years of age and older) (
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 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. (
1.4)
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) c
aused by
Haemophilus influenzae ,
Moraxella catarrhalis, or
Streptococcus pneumoniae.
Community-acquired pneumonia
(
>6 months of age)
due to
Chlamydophila pneumoniae ,
Haemophilus influenzae ,
Mycoplasma pneumoniae , 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).
1.4 Usage
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.