Usual Adult Dose for Otitis Media

Immediate release: 500 mg orally on the first day followed by 250 mg orally once a day on days 2 through 5

Usual Adult Dose for Upper Respiratory Tract Infection

Immediate release: 500 mg orally on the first day followed by 250 mg orally once a day on days 2 through 5

Usual Adult Dose for Bronchitis

Immediate release: 500 mg orally on the first day followed by 250 mg orally once a day on days 2 through 5

Usual Adult Dose for Pneumonia

Community acquired: Oral: Immediate release: 500 mg orally on the first day followed by 250 mg orally once a day on days 2 through 5 for mild infections Extended release suspension: 2 g orally once for mild to moderate infections IV: 500 mg IV once a day for at least 2 days followed by 500 mg (immediate release formulation) orally once a day to complete a 7- to 10-day course of therapy The IV dose should be reconstituted and diluted according to the manufacturer's recommendations, and administered as an infusion over not less than 60 minutes.

Usual Adult Dose for Tonsillitis/Pharyngitis

Immediate release: 500 mg orally on the first day followed by 250 mg orally once a day on days 2 through 5 Recommended as an alternative (second line therapy) in patients who cannot use first line therapy

Usual Adult Dose for Sinusitis

Acute bacterial sinusitis: Immediate release: 500 mg orally once a day for 3 days Extended release suspension: 2 g orally once for mild to moderate infections

Usual Adult Dose for Skin or Soft Tissue Infection

Uncomplicated: Immediate release: 500 mg orally on the first day followed by 250 mg orally once a day on days 2 through 5

Usual Adult Dose for Gonococcal Infection - Uncomplicated

Immediate release: 2 g orally once

Usual Adult Dose for Chancroid

Immediate release: 1 g orally once

Usual Adult Dose for Nongonococcal Urethritis

Immediate release: 1 g orally once

Usual Adult Dose for Cervicitis

Immediate release: 1 g orally once

Usual Adult Dose for Pelvic Inflammatory Disease

500 mg IV once a day for at least 2 days followed by 250 mg (immediate release formulation) orally once a day to complete a 7-day course of therapy The IV dose should be reconstituted and diluted according to the manufacturer's recommendations, and administered as an infusion over not less than 60 minutes.

Usual Adult Dose for Granuloma Inguinale

Immediate release: 1 g orally once a week for at least 3 weeks and until all lesions have completely healed This regimen is recommended by the Centers for Disease Control and Prevention as an alternative to doxycyline.

Usual Adult Dose for Legionella Pneumonia

500 mg IV once a day for at least 2 days followed by 500 mg (immediate release formulation) orally once a day to complete a 7- to 10-day course of therapy The IV dose should be reconstituted and diluted according to the manufacturer's recommendations, and administered as an infusion over not less than 60 minutes.

Usual Adult Dose for Mycoplasma Pneumonia

Immediate release: 500 mg orally on the first day followed by 250 mg orally once a day on days 2 through 5 Severe infection: 500 mg IV once a day can be administered for at least 2 days followed by 500 mg (immediate release formulation) orally once a day to complete a 7- to 10-day course of therapy The IV dose should be reconstituted and diluted according to the manufacturer's recommendations, and administered as an infusion over not less than 60 minutes.

Usual Adult Dose for Chronic Obstructive Pulmonary Disease - Acute

Acute bacterial exacerbations (mild to moderate): Immediate release: 500 mg orally once daily for 3 days or 500 mg orally on the first day followed by 250 mg orally once a day on days 2 through 5

Usual Adult Dose for Mycobacterium avium-intracellulare - Prophylaxis

Patients with advanced HIV infection: Immediate release: 1200 mg orally once a week alone or with rifabutin

Usual Adult Dose for Mycobacterium avium-intracellulare - Treatment

Patients with advanced HIV infection: Immediate release: 500 mg orally once a day plus ethambutol, with or without rifabutin

Usual Adult Dose for Bacterial Infection

Pertussis: Immediate release: 500 mg orally on the first day followed by 250 mg orally once a day on days 2 through 5

Usual Adult Dose for Lyme Disease - Erythema Chronicum Migrans

Immediate release: 500 mg orally once a day

Usual Adult Dose for Bacterial Endocarditis Prophylaxis

Immediate release: 500 mg orally once 30 to 60 minutes prior to the procedure

Usual Adult Dose for Toxoplasmosis

Immediate release: 1200 to 1500 mg orally once a day

Usual Adult Dose for Typhoid Fever

Immediate release: 1000 mg orally on the first day followed by 500 mg orally once a day for 6 days Alternatively, a dosage of 1000 mg orally once a day for 5 days may also be used.

Usual Pediatric Dose for Pneumonia

Community acquired: 6 months or older: Immediate release: 10 mg/kg (maximum: 500 mg/dose) orally as a single dose on the first day followed by 5 mg/kg (maximum: 250 mg/dose) orally once a day on days 2 thru 5 or 30 mg/kg orally once or 10 mg/kg orally once a day for 3 days Extended release suspension: Less than 34 kg: 60 mg/kg orally once for mild to moderate infections 34 kg or more: 2 g orally once for mild to moderate infections

Usual Pediatric Dose for Sinusitis

Acute bacterial sinusitis: 6 months or older: Immediate release: 10 mg/kg orally once a day for 3 days 16 years or older: Immediate release: 500 mg orally once a day for 3 days Extended release suspension: 2 g orally once for mild to moderate infections

Usual Pediatric Dose for Otitis Media

Acute: 6 months or older: Immediate release: 30 mg/kg (maximum: 1500 mg/dose) orally once or 10 mg/kg (maximum: 500 mg/dose) orally once a day for 3 days or 10 mg/kg (maximum: 500 mg/dose) orally as a single dose on the first day followed by 5 mg/kg (maximum: 250 mg/dose) orally once a day on days 2 thru 5

Usual Pediatric Dose for Tonsillitis/Pharyngitis

2 years or older: Immediate release: 12 mg/kg (maximum: 500 mg/dose) orally once a day for 5 days Recommended as an alternative (second line therapy) in patients who cannot use first line therapy

Usual Pediatric Dose for Skin or Soft Tissue Infection

Uncomplicated: 16 years or older: Immediate release: 500 mg orally on the first day followed by 250 mg orally once a day on days 2 through 5

Usual Pediatric Dose for Bacterial Infection

Pertussis: Immediate release: Neonates: 10 mg/kg orally once a day for 5 days. Less than 6 months: 10 mg/kg orally once a day for 5 days. 6 months or older: 10 mg/kg (maximum: 500 mg/dose) orally as a single dose on the first day followed by 5 mg/kg (maximum: 250 mg/dose) orally once a day on days 2 thru 5.

Usual Pediatric Dose for Upper Respiratory Tract Infection

Immediate release: 6 months or older: 10 mg/kg (maximum: 500 mg/dose) orally as a single dose on the first day followed by 5 mg/kg (maximum: 250 mg/dose) orally once a day on days 2 thru 5

Usual Pediatric Dose for Mycobacterium avium-intracellulare - Prophylaxis

Unlabeled use: Primary prevention: Children: 20 mg/kg (maximum: 1200 mg/dose) once a week (preferred) or 5 mg/kg (maximum: 250 mg/dose) orally once a day. Secondary prevention:

Children: 5 mg/kg (maximum: 250 mg/dose) orally once a day plus ethambutol, with or without rifabutin.

Usual Pediatric Dose for Mycobacterium avium-intracellulare - Treatment

Unlabeled use: Children: 10-12 mg/kg/day (maximum dose: 500 mg/day) orally once daily.

Usual Pediatric Dose for Typhoid Fever

6 months or older: Immediate release: 10 mg/kg orally once a day for 7 days

Usual Pediatric Dose for Chancroid

Immediate release: 20 mg/kg (maximum: 1 g/dose) orally once

Usual Pediatric Dose for Nongonococcal Urethritis

Uncomplicated: Immediate release: Less than 8 years and less than 45 kg: 20 mg/kg (maximum: 1 g/dose) orally once. 8 years or older and 45 kg or more: 1 g orally once.

Usual Pediatric Dose for Cervicitis

Uncomplicated: Immediate release: Less than 8 years and less than 45 kg: 20 mg/kg (maximum: 1 g/dose) orally once. 8 years or older and 45 kg or more: 1 g orally once.

Usual Pediatric Dose for Gonococcal Infection - Uncomplicated

16 years or older: Immediate release: 2 g orally once

Usual Pediatric Dose for Chronic Obstructive Pulmonary Disease - Acute

Acute bacterial exacerbations (mild to moderate): 16 years or older: Immediate release: 500 mg orally once a day for 3 days or 500 mg orally on the first day followed by 250 mg orally once a day on days 2 through 5

Usual Pediatric Dose for Babesiosis

Immediate release: 12 mg/kg (maximum: 600 mg/dose) orally once a day for 7 to 10 days plus oral atovaquone

Usual Pediatric Dose for Bacterial Endocarditis Prophylaxis

Immediate release: 15 mg/kg (maximum: 500 mg) orally once 30 to 60 minutes prior to procedure

Usual Pediatric Dose for Cystic Fibrosis

Chronic Pseudomonas aeruginosa infection: Children 6 years or older and adolescents: 25 to less than 40 kg: 250 mg orally on Mondays, Wednesdays, Fridays 40 kg or more: 500 mg orally on Mondays, Wednesdays, Fridays If side effects are intolerable, the dose should be decreased to twice a week, or if necessary, once a week.

Renal Dose Adjustments

No adjustment recommended. The manufacturer recommends caution when administering this drug to patients with severe renal dysfunction.

Liver Dose Adjustments

No adjustment recommended. The manufacturer recommends caution when administering this drug to patients with liver dysfunction.

Precautions
Azithromycin is contraindicated in patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin. Abnormal liver function, hepatitis, cholestatic jaundice, hepatic necrosis, and hepatic failure have been reported, some of which have resulted in death. Azithromycin should be discontinued immediately if signs and symptoms of hepatitis occur. Serious allergic reactions, including angioedema, anaphylaxis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported rarely in patients on azithromycin therapy. Rarely, fatalities have been reported. Reappearance of allergic symptoms may occur without further azithromycin exposure when symptomatic therapy is discontinued, which may be related to the long tissue half-life of the drug. Patients experiencing allergic symptoms generally require prolonged periods of observation and symptomatic treatment. In the treatment of pneumonia, azithromycin oral formulation should not be used in patients who are inappropriate candidates for oral therapy due to severe illness. Patients are also inappropriate candidates for oral therapy if they have the following risk factors: cystic fibrosis; nosocomially acquired infections; bacteremia; need for hospitalization; elderly or debilitated; or a significant underlying health problem that compromises their ability to respond to illness (e.g., immunodeficiency or functional asplenia). Clostridium difficile associated diarrhea (CDAD) has been reported with almost all antibacterial agents and may potentially be life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea following azithromycin therapy. Mild cases generally improve with discontinuation of the drug, while severe cases may require supportive therapy and treatment with an antimicrobial agent effective against C difficile. Hypertoxin producing strains of C difficile cause increased morbidity and mortality; these infections can be resistant to antimicrobial treatment and may necessitate colectomy. Physicians should consider additional antibiotic therapy in patients who vomit within 5 minutes after taking the extended release suspension. Alternative therapy should be considered for patients who vomit between 5 and 60 minutes after administration. Patients with normal gastric emptying who vomit 60 minutes or more following administration do not need a second dose of the extended release suspension or alternative therapy; however, alternative therapy should be considered for patients with delayed gastric emptying. To reduce the risk of development of drug-resistant organisms, antibiotics should only be used to treat or prevent proven or suspected infections caused by bacteria. Culture and susceptibility information should be considered when selecting treatment. If no data are available, local epidemiology and susceptibility patterns may be considered when selecting empiric therapy. Patients should be advised to avoid missing doses and to complete the entire course of therapy.

Dialysis
Data not available

Other Comments
Azithromycin immediate release tablets and oral suspension may be given without regard to meals. Azithromycin extended release suspension should be given 1 hour before or 2 hours after a meal. The extended release suspension is not interchangeable with immediate release formulations. Mycobacterium avium infections are usually treated with a combination of two to four drugs for a duration of 2 years to lifetime.