ZITHROMAX (azithromycin dihydrate) for oral administration is indicated for treatment of mild to moderate infections caused by susceptible strains of the designated microorganisms in the following diseases and specific conditions. As recommended dosages, durations of therapy and applicable patient populations vary among these infections, see 4 DOSAGE AND ADMINISTRATION for specific dosing recommendations.
Because some strains are resistant to azithromycin, when applicable, appropriate culture and susceptibility tests should be initiated before treatment to determine the causative organism and its susceptibility to azithromycin. Therapy with ZITHROMAX may be initiated before results of these tests are known; once the results become available, antibiotic treatment should be adjusted accordingly.
Pharyngitis and tonsillitis caused by Streptococcus pyogenes (group A β-hemolytic streptococci) occurring in individuals who cannot use first line therapy.
NOTE: Penicillin is the usual drug of choice in the treatment of Streptococcus pyogenes pharyngitis, including the prophylaxis of rheumatic fever. ZITHROMAX is often effective in the eradication of susceptible strains of streptococci from the oropharynx. However, data establishing the efficacy of ZITHROMAX in the subsequent prevention of rheumatic fever are not available at present.
Acute bacterial exacerbations of chronic obstructive pulmonary diseases caused by Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae.
Community-acquired pneumonia caused by Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae or Chlamydia pneumoniae in patients for whom oral therapy is appropriate.
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 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).
Uncomplicated skin and skin structure infections caused by Staphylococcus aureus, Streptococcus pyogenes or Streptococcus agalactiae.
Urethritis and cervicitis due to Neisseria gonorrhoeae or Chlamydia trachomatis. 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.
Patients 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.
ZITHROMAX, taken at a dose of 1200 mg weekly, alone or in combination with rifabutin at its approved dose, is indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in persons with advanced HIV infections (see 14 CLINICAL TRIALS).
ZITHROMAX for Injection is indicated for the treatment of patients with infections caused by susceptible strains of the designated microorganisms in the conditions listed below.
ZITHROMAX for Injection should be followed by oral administration of ZITHROMAX as required (see 4 DOSAGE AND ADMINISTRATION).
Community-acquired pneumonia (CAP) due to Chlamydia pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, Legionella pneumophila, Mycoplasma pneumoniae or Streptococcus pneumoniae in patients who require initial intravenous therapy.
Pelvic inflammatory disease (PID) due to Chlamydia trachomatis, Neisseria gonorrhoeae or Mycoplasma hominis in patients who require initial intravenous therapy. If anaerobic organisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with ZITHROMAX.
Patients should have a serologic test for syphilis performed at the time of diagnosis. Appropriate antimicrobial therapy and follow-up tests for this disease should be initiated if infection is confirmed.
Because some strains are resistant to azithromycin, appropriate culture and susceptibility tests should be initiated before treatment to determine the causative organism and its susceptibility to azithromycin. Therapy with ZITHROMAX may be initiated before results of these tests are known; once the results become available, antibiotic treatment should be adjusted accordingly.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZITHROMAX and other antibacterial drugs, ZITHROMAX 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.
Acute otitis media caused by Haemophilus influenzae (β-lactamase positive and negative strains), Moraxella catarrhalis or Streptococcus pneumoniae.
Pediatrics (<6 months): Safety and efficacy have not been established.
Pharyngitis and tonsillitis caused by Streptococcus pyogenes (group A β-hemolytic streptococci) occurring in individuals who cannot use first line therapy.
NOTE: Penicillin is the usual drug of choice in the treatment of Streptococcus pyogenes pharyngitis, including the prophylaxis of rheumatic fever. ZITHROMAX is often effective in the eradication of susceptible strains of streptococci from the oropharynx. However, data establishing the efficacy of ZITHROMAX in the subsequent prevention of rheumatic fever are not available at present.
Pediatrics (< 2 years): Safety and efficacy have not been established.
Community-acquired pneumonia caused by Haemophilus influenzae, Streptococcus pneumoniae, Mycoplasma pneumoniae or Chlamydia pneumoniae in patients for whom oral therapy is appropriate.
Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for outpatient oral therapy because of moderate to severe illness or risk factors such as any of the following: patients with cystic fibrosis, patients with nosocomial 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).
Safety and effectiveness for pneumonia due to Haemophilus influenzae and Streptococcus pneumoniae were not documented bacteriologically in the pediatric clinical trial due to difficulty in obtaining specimens. Use of azithromycin for these two microorganisms is supported, however, by evidence from adequate and well-controlled studies in adults.
Pediatrics (< 6 months): Safety and efficacy have not been established.
See 4.2 Recommended Dose and Dosage Adjustment; 7.1.3 Pediatrics
ZITHROMAX for Injection
Pediatrics (< 16 years): The safety and effectiveness of ZITHROMAX for Injection have not been established.
See 7.1.3 Pediatrics
Geriatrics: Evidence from clinical studies and experience suggests that use in the geriatric population is not associated with differences in safety or effectiveness. However, elderly patients may be more susceptible to development of torsade de pointes arrhythmias. (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular; 7.1.4 Geriatrics; 10 CLINICAL PHARMACOLOGY)
)ZITHROMAX (azithromycin dihydrate) for oral administration is indicated for treatment of mild to moderate infections caused by susceptible strains of the designated microorganisms in the following diseases and specific conditions. As recommended dosages, durations of therapy and applicable patient populations vary among these infections, see 4 DOSAGE AND ADMINISTRATION for specific dosing recommendations.
Because some strains are resistant to azithromycin, when applicable, appropriate culture and susceptibility tests should be initiated before treatment to determine the causative organism and its susceptibility to azithromycin. Therapy with ZITHROMAX may be initiated before results of these tests are known; once the results become available, antibiotic treatment should be adjusted accordingly.
Pharyngitis and tonsillitis caused by Streptococcus pyogenes (group A β-hemolytic streptococci) occurring in individuals who cannot use first line therapy.
NOTE: Penicillin is the usual drug of choice in the treatment of Streptococcus pyogenes pharyngitis, including the prophylaxis of rheumatic fever. ZITHROMAX is often effective in the eradication of susceptible strains of streptococci from the oropharynx. However, data establishing the efficacy of ZITHROMAX in the subsequent prevention of rheumatic fever are not available at present.
Acute bacterial exacerbations of chronic obstructive pulmonary diseases caused by Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae.
Community-acquired pneumonia caused by Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae or Chlamydia pneumoniae in patients for whom oral therapy is appropriate.
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 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).
Uncomplicated skin and skin structure infections caused by Staphylococcus aureus, Streptococcus pyogenes or Streptococcus agalactiae.
Urethritis and cervicitis due to Neisseria gonorrhoeae or Chlamydia trachomatis. 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.
Patients 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.
ZITHROMAX, taken at a dose of 1200 mg weekly, alone or in combination with rifabutin at its approved dose, is indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in persons with advanced HIV infections (see 14 CLINICAL TRIALS).
ZITHROMAX for Injection is indicated for the treatment of patients with infections caused by susceptible strains of the designated microorganisms in the conditions listed below.
ZITHROMAX for Injection should be followed by oral administration of ZITHROMAX as required (see 4 DOSAGE AND ADMINISTRATION).
Community-acquired pneumonia (CAP) due to Chlamydia pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, Legionella pneumophila, Mycoplasma pneumoniae or Streptococcus pneumoniae in patients who require initial intravenous therapy.
Pelvic inflammatory disease (PID) due to Chlamydia trachomatis, Neisseria gonorrhoeae or Mycoplasma hominis in patients who require initial intravenous therapy. If anaerobic organisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with ZITHROMAX.
Patients should have a serologic test for syphilis performed at the time of diagnosis. Appropriate antimicrobial therapy and follow-up tests for this disease should be initiated if infection is confirmed.
Because some strains are resistant to azithromycin, appropriate culture and susceptibility tests should be initiated before treatment to determine the causative organism and its susceptibility to azithromycin. Therapy with ZITHROMAX may be initiated before results of these tests are known; once the results become available, antibiotic treatment should be adjusted accordingly.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZITHROMAX and other antibacterial drugs, ZITHROMAX 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.
Acute otitis media caused by Haemophilus influenzae (β-lactamase positive and negative strains), Moraxella catarrhalis or Streptococcus pneumoniae.
Pediatrics (<6 months): Safety and efficacy have not been established.
Pharyngitis and tonsillitis caused by Streptococcus pyogenes (group A β-hemolytic streptococci) occurring in individuals who cannot use first line therapy.
NOTE: Penicillin is the usual drug of choice in the treatment of Streptococcus pyogenes pharyngitis, including the prophylaxis of rheumatic fever. ZITHROMAX is often effective in the eradication of susceptible strains of streptococci from the oropharynx. However, data establishing the efficacy of ZITHROMAX in the subsequent prevention of rheumatic fever are not available at present.
Pediatrics (< 2 years): Safety and efficacy have not been established.
Community-acquired pneumonia caused by Haemophilus influenzae, Streptococcus pneumoniae, Mycoplasma pneumoniae or Chlamydia pneumoniae in patients for whom oral therapy is appropriate.
Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for outpatient oral therapy because of moderate to severe illness or risk factors such as any of the following: patients with cystic fibrosis, patients with nosocomial 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).
Safety and effectiveness for pneumonia due to Haemophilus influenzae and Streptococcus pneumoniae were not documented bacteriologically in the pediatric clinical trial due to difficulty in obtaining specimens. Use of azithromycin for these two microorganisms is supported, however, by evidence from adequate and well-controlled studies in adults.
Pediatrics (< 6 months): Safety and efficacy have not been established.
See 4.2 Recommended Dose and Dosage Adjustment; 7.1.3 Pediatrics
ZITHROMAX for Injection
Pediatrics (< 16 years): The safety and effectiveness of ZITHROMAX for Injection have not been established.
See 7.1.3 Pediatrics
Geriatrics: Evidence from clinical studies and experience suggests that use in the geriatric population is not associated with differences in safety or effectiveness. However, elderly patients may be more susceptible to development of torsade de pointes arrhythmias. (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular; 7.1.4 Geriatrics; 10 CLINICAL PHARMACOLOGY)
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