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Azithromycin

    Brands

    DEA Class; Rx

    Common Brand Names; Zithromax

    • Macrolides

    azithromycin ophthalmic (Rx)

    Brand and Other Names: AzaSite
    • Classes: Macrolides, Ophthalmic
     

    Macrolide antibiotic similar in structure to erythromycin, but can be dosed systemically once daily
    Used systemically for otitis media, pharyngitis, community-acquired pneumonia, sexually transmitted diseases, and Mycobacterium avium complex (MAC) prophylaxis and treatment in patients with advanced HIV disease; an ophthalmic solution is used for bacterial conjunctivitis
    Produces less GI intolerance and reaches higher intracellular concentrations than erythromycin

    Indicated for treatment of community-acquired pneumonia due to Chlamydophila pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, or Streptococcus pneumoniae in patients appropriate for oral therapy

    Indicated for treatment of pharyngitis/tonsillitis caused by Streptococcus pyogenes as an alternative therapy in individuals who cannot use first-line therapy

    Indicated for treatment of uncomplicated skin and skin structure infections due to Staphylococcus aureus, Streptococcus pyogenes, or Streptococcus agalactiae

    Indicated for treatment of acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae

    Indicated for treatment of acute bacterial sinusitis due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae

    Indicated for treatment of genital ulcer disease in men due to Haemophilus ducreyi (chancroid)

    Indicated for treatment of urethritis and cervicitis due to Chlamydia trachomatis or Neisseria gonorrhoeae

    Indicated for treatment of pelvic inflammatory disease due to Chlamydia trachomatis, Neisseria gonorrhoeae, or Mycoplasma hominis in patients who require initial IV therapy

    Bacterial Conjunctivitis

    Hypersensitivity to azithromycin, erythromycin, any macrolides or ketolides

    History of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin

    • Diarrhea (52.8%)
    • Nausea (32.6%)
    • Abdominal pain (27%)
    • Loose stool (19.1%)
    • Elevated ALT, AST, creatinine (4-6%)
    • Elevated LDH, bilirubin (1-3%)

    Community-acquired pneumonia

    • Pain at injection site (6.5%)
    • Diarrhea (4.3%)
    • Nausea (3.9%)
    • Local inflammation (3.1%)
    • Abdominal pain (2.7%)
    • Vomiting (1.4%)

    Pelvic inflammatory disease

    • Diarrhea (8.5%)
    • Nausea (6.6%)
    • Vaginitis (2.8%)
    • Abdominal pain (1.9%)
    • Anorexia (1.9%)
    • Rash and pruritus (1.9%)

    Abnormal liver function, hepatitis, cholestatic jaundice, hepatic necrosis, and hepatic failure have been reported, some of which have resulted in death; discontinue treatment immediately if signs and symptoms of hepatitis occur

    Infantile Hypertrophic Pyloric Stenosis (IHPS) has been reported; advise direct parents and caregivers if vomiting or irritability with feeding occurs

    Clostridium difficile associated diarrhea (CDAD) has been reported, and may range in severity from mild diarrhea to fatal colitis; if CDAD is suspected or confirmed, discontinue ongoing antibacterial use not directed against C. difficile; institute appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation as clinically indicated

    Exacerbations of symptoms of myasthenia gravis and new onset of myasthenic syndrome have been reported

    Antibacterial agents used to treat nongonococcal 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 testing for gonorrhea performed at the time of diagnosis; if infection confirmed, initiate appropriate antibacterial therapy and follow-up tests for these diseases

    Local IV site reactions have been reported with IV azithromycin

    Prescribing azithromycin in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria

    Available data on use in pregnant women have not identified any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes

    Present in human milk

    Adults

    500 mg/day PO is FDA-approved dosage; however, doses up to 1,200 mg/day PO are used off-label; 2 g PO when given as single dose; 500 mg/day IV infusion.

    Geriatric

    500 mg/day PO is FDA-approved dosage; however, doses up to 1,200 mg/day PO are used off-label; 2 g PO when given as single dose; 500 mg/day IV infusion.

    Adolescents

    16 to 17 years: 500 mg/day PO is FDA-approved dosage; however, doses up to 1,200 mg/day PO are used off-label; 2 g PO when given as single dose; 500 mg/day IV infusion.
    13 to 15 years: For the immediate-release oral suspension or tablets, 12 mg/kg/day PO (Max: 500 mg/dose) and single doses up to 30 mg/kg PO (Max: 1.5 g/dose) are the maximum FDA-approved dosages; however, doses up to 20 mg/kg/day PO (Max: 1,000 mg/day) or 1,200 mg/day are used off-label. For extended-release oral suspension, 60 mg/kg single dose PO (Max: 2 g/dose). Safety and efficacy have not been established for IV; however, doses up to 10 mg/kg/day (Max: 500 mg/dose) have been used off-label.

    Children

    2 to 12 years: For the immediate-release oral suspension or tablets, 12 mg/kg/day PO (Max: 500 mg/dose) and single doses up to 30 mg/kg PO (Max: 1.5 g/dose) are the maximum FDA-approved dosages; however, doses up to 20 mg/kg/day PO (Max: 1,000 mg/day) are used off-label. For extended-release oral suspension, 60 mg/kg single dose PO (Max: 2 g/dose). Safety and efficacy have not been established for IV; however, doses up to 10 mg/kg/day (Max: 500 mg/dose) have been used off-label.
    1 year: For the immediate-release oral suspension or tablets, 10 mg/kg/day PO and single doses up to 30 mg/kg PO are the maximum FDA-approved dosages; however, doses up to 20 mg/kg/day PO are used off-label. For extended-release oral suspension, 60 mg/kg single dose PO. Safety and efficacy have not been established for IV; however, doses up to 10 mg/kg/day have been used off-label.

    Infants

    6 to 11 months: For the immediate-release oral suspension or tablets, 10 mg/kg/day PO and single doses up to 30 mg/kg PO are the maximum FDA-approved dosages; however, doses up to 20 mg/kg/day PO are used off-label. For extended-release oral suspension, 60 mg/kg single dose PO. Safety and efficacy have not been established for IV; however, doses up to 10 mg/kg/day have been used off-label.
    3 to 5 months: Safety and efficacy have not been established; however, doses up to 20 mg/kg/day PO or 10 mg/kg/day IV have been used off-label.
    1 to 2 months: Safety and efficacy have not been established; however, doses up to 20 mg/kg/day PO have been used off-label.

    Neonates

    Safety and efficacy have not been established; however, doses up to 20 mg/kg/day PO have been used off-label.

    Azithromycin

    injection, lyophilized powder for reconstitution

    • 500mg/vial

    tablet

    • 250mg
    • 500mg

    oral suspension

    • 100mg/5mL
    • 200mg/5mL

    ophthalmic solution

    • 1% (2.5mL)