INDICATIONS AND USAGE
Azithromycin tablets are indicated for the treatment of patients
with mild to moderate infections (pneumonia: see
WARNINGS
) caused by susceptible
strains of the designated microorganisms in the specific conditions listed
below. As recommended dosages, durations of therapy and
applicable patient populations vary among these infections, please see
DOSAGE AND
ADMINISTRATION
for specific dosing recommendations.
Adults
Acute bacterial exacerbations of chronic
obstructive pulmonary disease 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 Chlamydia pneumoniae, Haemophilus influenzae, Mycoplasma
pneumoniae or Streptococcus pneumoniae in
patients appropriate for oral therapy.
NOTE: 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 nosocomially acquired 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).
Pharyngitis/tonsillitis caused by Streptococcus pyogenes as an alternative to first-line
therapy in individuals who cannot use first-line therapy.
NOTE: Penicillin by the intramuscular route is the usual drug of choice in
the treatment of Streptococcus pyogenes infection and
the prophylaxis of rheumatic fever. Azithromycin is often effective in the
eradication of susceptible strains of Streptococcus
pyogenes from the nasopharynx. Because some strains are resistant to
azithromycin, susceptibility tests should be performed when patients are treated
with azithromycin. Data establishing efficacy of azithromycin in subsequent
prevention of rheumatic fever are not available.
Uncomplicated skin and skin structure infections due
to Staphylococcus aureus, Streptococcus pyogenes, or
Streptococcus agalactiae. Abscesses usually require
surgical drainage.
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.
Azithromycin, at the recommended dose, should not be relied upon to treat
syphilis. Antimicrobial agents used in high doses for short periods of time to
treat non-gonococcal urethritis may mask or delay the symptoms of incubating
syphilis. All patients with sexually-transmitted urethritis or cervicitis should
have a serologic test for syphilis and appropriate cultures for gonorrhea
performed at the time of diagnosis. Appropriate antimicrobial therapy and
follow-up tests for these diseases should be initiated if infection is
confirmed.
Appropriate culture and susceptibility tests should be performed before
treatment to determine the causative organism and its susceptibility to
azithromycin. Therapy with azithromycin may be initiated before results of these
tests are known; once the results become available, antimicrobial therapy should
be adjusted accordingly.
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 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.
Pediatric Patients(See
PRECAUTIONS:
Pediatric Use
and
CLINICAL STUDIES IN PEDIATRIC
PATIENTS
).
Acute otitis media caused by Haemophilus influenzae, Moraxella catarrhalis or Streptococcus pneumoniae. (For specific dosage
recommendation, see
DOSAGE AND ADMINISTRATION
).
Community-acquired pneumonia due to Chlamydia pneumoniae, Haemophilus influenzae, Mycoplasma
pneumoniae or Streptococcus pneumoniae in
patients appropriate for oral therapy. (For specific dosage recommendation, see
DOSAGE AND
ADMINISTRATION
).
NOTE: Azithromycin should not be used in pediatric 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 nosocomially acquired infections,
patients with known or suspected bacteremia,
patients requiring hospitalization, or
patients with significant underlying health problems that
may compromise their ability to respond to their illness (including
immunodeficiency or functional asplenia).
Pharyngitis/tonsillitis caused by Streptococcus pyogenes as an alternative to first-line
therapy in individuals who cannot use first-line therapy. (For specific dosage
recommendation, see
DOSAGE AND ADMINISTRATION
).
NOTE: Penicillin by the intramuscular route is the usual drug of choice in
the treatment of Streptococcus pyogenes infection and
the prophylaxis of rheumatic fever. Azithromycin is often effective in the
eradication of susceptible strains of Streptococcus
pyogenes from the nasopharynx. Because some strains are resistant to
azithromycin, susceptibility tests should be performed when patients are treated
with azithromycin. Data establishing efficacy of azithromycin in subsequent
prevention of rheumatic fever are not available. Appropriate culture and susceptibility tests should be performed before
treatment to determine the causative organism and its susceptibility to
azithromycin. Therapy with azithromycin may be initiated before results of these
tests are known; once the results become available, antimicrobial therapy should
be adjusted accordingly.