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Azithromycin Azithromycin Indications/Dosage expand all | collapse all Labeled bacterial conjunctivitis non-gonococcal urethritis (NGU) bronchitis otitis media chancroid pelvic inflammatory disease (PID) chlamydia infection pharyngitis community-acquired pneumonia pneumonia gonorrhea sinusitis Mycobacterium avium complex (MAC) skin and skin structure infections prophylaxis tonsillitis Mycobacterium avium complex infection Off-Label asthma maintenance † gonorrhea prophylaxis † babesiosis † granuloma inguinale † bartonellosis † Lyme disease † bartonellosis prophylaxis † lymphogranuloma venereum † campylobacteriosis † ophthalmia neonatorum † chlamydial infection prophylaxis † pertussis (whooping cough) † cholera † pertussis prophylaxis † coronavirus disease 2019 (COVID-19) † rheumatic fever prophylaxis † cystic fibrosis † severe acute respiratory syndrome coronavirus 2 dental abscess (apical) † (SARS-CoV-2) infection † dental abscess (periapical) † shigellosis † dental infection † syphilis † dentoalveolar infection † traveler's diarrhea † endocarditis prophylaxis † typhoid fever † † Off-label indication Per the manufacturer, this drug has been shown to be active against most strains of the following microorganisms either in vitro and/or in clinical infections: Bacteroides bivius, Bordetella pertussis, Borrelia burgdorferi, Campylobacter jejuni, CDC coryneform group G, Chlamydia trachomatis, Chlamydophila pneumoniae, Clostridium perfringens, Haemophilus ducreyi, Haemophilus influenzae (beta-lactamase negative), Haemophilus influenzae (beta-lactamase positive), Legionella pneumophila, Moraxella catarrhalis, Mycobacterium avium, Mycobacterium intracellulare, Mycoplasma hominis, Mycoplasma pneumoniae, Neisseria gonorrhoeae, Peptostreptococcus sp., Prevotella bivia, Staphylococcus aureus (MSSA), Streptococcus agalactiae (group B streptococci), Streptococcus mitis, Streptococcus pneumoniae, Streptococcus pyogenes (group A beta-hemolytic streptococci), Streptococcus sp., Treponema pallidum, Ureaplasma urealyticum, Viridans streptococci. NOTE: The safety and effectiveness in treating clinical infections due to organisms with in vitro data only have not been established in adequate and well-controlled clinical trials. This drug may also have activity against the following microorganisms: Bacillus anthracis, Gardnerella vaginalis, Helicobacter pylori, Klebsiella granulomatis, Mycoplasma genitalium, Rickettsia tsutsugamushi, Salmonella typhi, Staphylococcus epidermidis, Streptococcus sp. (Group C), Streptococcus sp. (Group F), Streptococcus sp. (Group G), Toxoplasma gondii, Vibrio cholerae. NOTE: Some organisms may not have been adequately studied during clinical trials; therefore, exclusion from this list does not necessarily negate the drug’s activity against the organism. INVESTIGATIONAL USE: For adjunctive use in the treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection†, the virus that causes coronavirus disease 2019 (COVID-19)† Oral dosage (immediate-release) Adults Data are limited and inconclusive. Due to the potential for toxicities, the National Institutes of Health (NIH) COVID-19 treatment guidelines recommend against the use of azithromycin in combination with hydroxychloroquine outside of clinical trials.[65314] Azithromycin is being used in some COVID-19 institutional protocols. 500 mg PO on day 1 then 250 mg PO once daily for 5 days was administered in combination with hydroxychloroquine in a small study. On day 6, all patients treated with hydroxychloroquine and azithromycin (n = 6) were virologically cured compared to 57.1% of patients treated with hydroxychloroquine alone (n= 20). [65147] Another small study (n = 11) reviewed the same azithromycin plus hydroxychloroquine regimen and found nasopharyngeal swabs were still positive for SARS-CoV-2 in 8 of 10 patients at 5 to 6 days after treatment initiation.[65198] In a retrospective analysis of a multicenter cohort study (n = 349) in patients with Middle East Respiratory Syndrome Coronavirus (MERS-CoV), 136 patients received macrolide therapy in combination with antiviral treatment. Macrolide therapy was not associated with a reduction in 90-day mortality compared to the control group (adjusted OR: 0.84; 95% CI: 0.47 to 1.51; p = 0.56).[65149] For the treatment of community-acquired pneumonia (CAP) Oral dosage (immediate-release) Outpatient Adults 500 mg PO on day 1, followed by 250 mg PO once daily for at least 5 days as monotherapy for patients without comorbidities or risk factors for MRSA or P. aeruginosa and as part of combination therapy for patients with comorbidities. Guide treatment duration by clinical stability.[28855] [34362] [64669] FDA-approved labeling recommends a 5-day treatment course.[28855] Hospitalized Adults 500 mg PO once daily for at least 5 days as part of combination therapy. Guide treatment duration by clinical stability.[34362] [64669] Adolescents 10 mg/kg/dose (Max: 500 mg/dose) PO for 1 day, followed by 5 mg/kg/dose (Max: 250 mg/dose) PO once daily for 4 days.[28855] Guidelines recommend azithromycin as oral step-down therapy or as initial oral therapy in patients with atypical pathogens and as part of combination therapy for HIV-infected patients.[34362] [46963] Infants and Children 6 months to 12 years 10 mg/kg/dose (Max: 500 mg/dose) PO for 1 day, followed by 5 mg/kg/dose (Max: 250 mg/dose) PO once daily for 4 days.[28855] Guidelines recommend azithromycin as oral step-down therapy or as initial oral therapy in patients with atypical pathogens and as part of combination therapy for hospitalized HIV-infected patients. [34361] [46963] Infants 3 to 5 months† 10 mg/kg/dose PO for 1 day, followed by 5 mg/kg/dose PO once daily for 4 days. Guidelines recommend azithromycin as oral step-down therapy or as initial oral therapy in patients with atypical pathogens and as part of combination therapy for hospitalized HIV-infected patients.[34361] [46963] Oral dosage (extended-release) Adults 2 g PO as a single dose. This dosage form is not recommended for patients with moderate or severe illness or those with other underlying risk factors for which oral therapy is inappropriate.[34473] Infants, Children, and Adolescents 6 months to 17 years 60 mg/kg/dose (Max: 2 g/dose) PO as a single dose. This dosage form is not recommended for patients with moderate or severe illness or those with other underlying risk factors for which oral therapy is inappropriate. [34473] Intravenous dosage Adults 500 mg IV once daily for at least 5 days as part of combination therapy for hospitalized patients. Guide treatment duration by clinical stability.[34362] [64669] FDA-approved labeling recommends IV therapy for at least 2 days then step-down to oral therapy to complete a 7- to 10-day treatment course. The switch to oral therapy should be done at the discretion of the physician and based on the clinical response of the patient. [43974] Adolescents 16 to 17 years 500 mg IV once daily for at least 2 days, followed by oral therapy to complete a 7- to 10-day treatment course. [43974] Guidelines recommend azithromycin as monotherapy for definitive atypical pneumonia and as part of combination therapy for hospitalized patients, including HIV-infected patients, when atypical pathogens are suspected.[34362] [46963] Infants, Children, and Adolescents 3 months to 15 years† 10 mg/kg/dose (Max: 500 mg/dose) IV once daily for 2 days, followed by oral therapy to complete a 5-day treatment course. Guidelines recommend azithromycin as monotherapy for definitive atypical pneumonia and as part of combination therapy for hospitalized patients, including HIV-infected patients, when atypical pathogens are suspected.[34361] [34362] [46963] For the treatment of acute bacterial exacerbations of chronic bronchitis Oral dosage (immediate-release) Adults 500 mg PO once daily for 3 days, or 500 mg PO once daily for 1 day followed by 250 mg PO once daily for 4 days.[28855] For the treatment of group A beta-hemolytic streptococcal (GAS) pharyngitis (primary rheumatic fever prophylaxis†) and tonsillitis NOTE: Guidelines recommend azithromycin for secondary rheumatic fever prophylaxis in patients allergic to penicillin or sulfadiazine, although no dosage recommendations are given. Secondary prophylaxis is recommended for 10 years or until age 40 (whichever is longer) in patients who have experienced rheumatic fever with carditis and have residual heart disease (persistent valvular disease); for 10 years or until age 21 (whichever is longer) in patients who have experienced rheumatic fever with carditis, but have no residual heart disease; and for 5 years or until age 21 (whichever is longer) in patients who have experienced rheumatic fever without carditis.[35507] Oral dosage (immediate-release) Adults 500 mg PO once daily for 5 days as an alternative in patients allergic to penicillin is recommended in guidelines.[35507] [52889] The FDA-approved dose is 500 mg PO once daily for 1 day, followed by 250 mg PO once daily for 4 days.[28855] Children and Adolescents 2 to 17 years 12 mg/kg/dose (Max: 500 mg/dose) PO once daily for 5 days as an alternative in patients allergic to penicillin. [28855] [35507] [52889] Infants† and Children 1 year† 12 mg/kg/dose PO once daily for 5 days as an alternative in patients allergic to penicillin.[35507] [52889] For the treatment of acute bacterial sinusitis Oral dosage (immediate-release) Adults 500 mg PO once daily for 3 days.[28855] Due to the high rate of resistance among S. pneumoniae isolates, macrolides are not recommended as empiric therapy.[49853]
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