1 INDICATIONS AND USAGE
Azithromycin tablets, 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 is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria:
Acute bacterial exacerbationsofchronic bronchitisinadults(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/tonsillitisin adultsand 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 and other antibacterial drugs, azithromycin 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
AcutebacterialexacerbationsofchronicbronchitisduetoHaemophilusinfluenzae,Moraxellacatarrhalis,or Streptococcuspneumoniae.
AcutebacterialsinusitisduetoHaemophilusinfluenzae,MoraxellacatarrhalisorStreptococcuspneumoniae.
Community-acquiredpneumoniaduetoChlamydophilapneumoniae,Haemophilusinfluenzae,Mycoplasmapneumoniae,or Streptococcus pneumoniae in patients appropriatefororaltherapy.
Pharyngitis/tonsillitiscausedbyStreptococcuspyogenesasanalternativetofirst-linetherapyinindividualswhocannotusefirst-linetherapy.
UncomplicatedskinandskinstructureinfectionsduetoStaphylococcusaureus,Streptococcuspyogenes,orStreptococcusagalactiae.
Urethritis and cervicitis due to Chlamydia trachomatis orNeisseriagonorrhoeae.
GenitalulcerdiseaseinmenduetoHaemophilusducreyi(chancroid).Duetothesmallnumberofwomenincludedinclinicaltrials,the efficacy of azithromycin in the treatmentofchancroidinwomenhasnotbeenestablished.
1.2 Pediatric Patients
[seeUseinSpecificPopulations(8.4)and Clinical Studies (14.2)]
Acuteotitismedia(>6monthsofage)causedbyHaemophilusinfluenzae,Moraxellacatarrhalis,orStreptococcuspneumoniae
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).
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.