Usage Information
Azithromycin is 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.AdultsAcute 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.
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
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