Version May 2024
Note: With oral therapy, monitor for infantile hypertrophic pyloric stenosis (IHPS).
General dosing: Limited data available: Preterm and term neonates: Oral, IV: 10 mg/kg/dose once daily; higher doses may be needed for some indications; see indication-specific dosing (Ref).
Chlamydia trachomatis congenital infection (conjunctivitis or pneumonia), treatment (alternative): Limited data available: Preterm and term neonates: Oral: 20 mg/kg/dose once daily for 3 days (Ref).
Pertussis, treatment or postexposure prophylaxis: Limited data available: Preterm and term neonates: Oral, IV: 10 mg/kg/dose once daily for 5 days (Ref).
Ureaplasma spp., respiratory eradication in extremely low gestation newborns: Limited data available: GA 24 to <29 weeks, PNA <72 hours: IV: 20 mg/kg/dose every 24 hours for 3 doses. Dosing based on a prospective, multicenter study of preterm neonates randomized to receive azithromycin or placebo (total n=121; azithromycin group n=60); all patients were cultured for Ureaplasma prior to the first dose of study drug. Ureaplasma-positive patients (total n=44; azithromycin group n=19) receiving azithromycin had successful elimination following treatment and had a significantly higher rate of Ureaplasma-free survival, defined as survival to NICU discharge with 3 negative cultures post-treatment, compared to Ureaplasma-positive patients receiving placebo (84% vs 12%). Bronchopulmonary dysplasia occurred less in the Ureaplasma-positive azithromycin group vs placebo (38% vs 75%), but the difference was not statistically significant. At 2-year follow-up, overall survival and pulmonary and neurodevelopmental outcomes were similar between treatment groups; however, Ureaplasma-positive patients receiving azithromycin experienced more serious respiratory morbidity than patients in the placebo group (45% vs 15%) (Ref).
General dosing:
Infants, Children, and Adolescents:
Oral: 5 to 12 mg/kg/dose; typically administered as 10 to 12 mg/kg/dose on day 1 (usual maximum dose: 500 mg/dose) followed by 5 to 6 mg/kg once daily (usual maximum dose: 250 mg/dose) for remainder of treatment duration (Ref).
IV: 10 mg/kg once daily; maximum dose: 500 mg/dose (Ref).
Babesiosis: Limited data available:
Infants, Children, and Adolescents:
Mild to moderate disease: Oral: 10 mg/kg once on day 1 (maximum dose: 500 mg/dose), then 5 mg/kg/dose once daily (maximum dose: 250 mg/dose) in combination with atovaquone; in immunocompromised patients, higher doses (eg, adolescents: 500 to 1,000 mg daily) have been used. Typically treat for a total duration of 7 to 10 days; longer duration may be necessary in some patients with severe or persistent symptoms until parasitemia is cleared (eg, ≥6 weeks with ≥2 weeks of negative blood smears in severely immunocompromised patients) (Ref).
Severe disease : IV: 10 mg/kg/dose once daily; maximum dose: 500 mg. In immunocompromised patients, higher doses (eg, adolescents: 500 to 1,000 mg daily) have been used. Transition to oral azithromycin therapy once symptoms abate for a total duration of 7 to 10 days; longer duration may be necessary in some patients with severe or persistent symptoms until parasitemia is cleared (eg, ≥6 weeks with ≥2 weeks of negative blood smears in severely immunocompromised patients) (Ref).
Cat scratch disease (Bartonella henselae) (lymphadenitis) (Ref): Limited data available:
Infants, Children, and Adolescents weighing ≤45 kg: Oral: 10 mg/kg once on day 1 (maximum dose: 500 mg/dose), then 5 mg/kg/dose once daily for 4 additional days (maximum dose: 250 mg/dose).
Children and Adolescents weighing >45 kg: Oral: 500 mg as a single dose on day 1, then 250 mg once daily for 4 additional days.
Chlamydia trachomatis infection:
Urogenital/anogenital tract or oropharyngeal infection (eg, cervicitis [including presumptive treatment], urethritis): Children <8 years weighing ≥45 kg or Children ≥8 years and Adolescents: Oral: 1,000 mg as a single dose (Ref). For presumptive treatment of cervicitis, if the patient is at risk for gonorrhea or lives in a community where gonorrhea prevalence is high, consider also treating for gonococcal infection (Ref).
Pneumonia, congenital: Infants: Oral, IV: 20 mg/kg/dose once daily for 3 days (Ref).
Cholera (Vibrio cholerae), treatment: Limited data available: Infants, Children, and Adolescents: Oral: 20 mg/kg as a single dose in combination with hydration; maximum dose: 1,000 mg/dose (Ref).
Cystic fibrosis; chronic lung maintenance: Limited data available; dosing regimen variable: Note: Recommended for use in patients with a history of Pseudomonas aeruginosa; may also be considered in patients without Pseudomonas who experience frequent exacerbations (Ref). Patients should be screened for nontuberculous mycobacterial infection prior to treatment (if able) and azithromycin should not be used if present (Ref).
Weight-directed dosing:
Infants ≥6 months, Children, and Adolescents: Oral: 10 mg/kg/dose 3 times weekly; maximum dose: 500 mg/dose (Ref).
Fixed dosing:
Children ≥6 years and Adolescents (Ref):
18 to <36 kg: Oral: 250 mg 3 times weekly (Monday, Wednesday, Friday).
≥36 kg: Oral: 500 mg 3 times weekly (Monday, Wednesday, Friday).
Diarrhea, infectious:
Campylobacter infection:
Infants, Children, and Adolescents: Oral: 10 mg/kg/dose once daily for 3 days; patients with HIV should receive treatment for 5 days; maximum dose: 500 mg/dose (Ref).
Shigellosis:
Patients without HIV: Infants, Children, and Adolescents:
5-day regimen: Oral: 12 mg/kg once on day 1 (maximum dose: 500 mg/dose), followed by 5 mg/kg/dose once daily on days 2 to 5 (maximum dose: 250 mg/dose) (Ref).
3-day regimen: Oral: 10 mg/kg/dose once daily for 3 days; maximum dose: 500 mg/dose (Ref).
Patients with HIV: Adolescents: Oral: 500 mg once daily for 5 days (Ref).
Endocarditis, prophylaxis before invasive dental procedures (alternative agent): Limited data available:
Note: Alternative agent for use in patients with penicillin or ampicillin allergy. Recommended only in patients who are at highest risk for infective endocarditis (IE) or adverse outcomes (eg, history of IE, cardiac valve repair using prosthetic valves or material, unrepaired cyanotic congenital heart disease [CHD], left ventricular assist device or implantable heart, repaired CHD with prosthetic material or device during first 6 months after procedure, pulmonary artery valve or conduit placement [eg, Melody valve, Contegra conduit], repaired CHD with residual defects at the site or adjacent to site of prosthetic patch or device, heart transplant recipients with cardiac valvulopathy) (Ref).
Infants, Children, and Adolescents: Oral: 15 mg/kg as a single dose administered 30 to 60 minutes before dental procedure; maximum dose: 500 mg/dose (Ref).
Gonococcal infection, uncomplicated infections of the cervix, urethra, or rectum (alternative agent): Limited data available: Note: Only for use if ceftriaxone is not available or not feasible.
Children >45 kg and Adolescents: Oral: 2,000 mg as a single dose in combination with IM gentamicin (Ref). Note: For treatment failure, consult an infectious diseases specialist and report to the CDC through state and local health departments within 24 hours of diagnosis (Ref).
Lyme disease (Borrelia spp. infection), erythema migrans (alternative agent): Limited data available:
Infants, Children, and Adolescents: Oral: 10 mg/kg/dose once daily for 7 days; maximum dose: 500 mg/dose. Note: Due to lower efficacy, should only be used when first-line agents cannot be used (Ref).
Meningococcal disease, chemoprophylaxis for high-risk contacts (alternative agent): Infants, Children, and Adolescents: Oral: 10 mg/kg as a single dose; maximum dose: 500 mg/dose (Ref).
Mycobacterium avium complex (MAC) infection (HIV-exposed/-infected):
Infants and Children (Ref):
Primary prophylaxis (patients who meet age-specific CD4 count thresholds): Oral: 20 mg/kg once weekly (maximum dose: 1,200 mg/dose) (preferred regimen) or alternatively, 5 mg/kg/dose once daily (maximum dose: 250 mg/dose); may be discontinued in children ≥2 years of age receiving stable antiretroviral therapy (ART) for ≥6 months and experiencing sustained (>3 months) CD4 count recovery well above age-specific targets.
Treatment (alternative to clarithromycin): Oral: 10 to 12 mg/kg/dose once daily as part of an appropriate combination regimen; maximum dose: 500 mg/dose; continue therapy for at least 12 months; following completion of treatment, initiate long-term suppression (secondary prophylaxis).
Long-term suppression (secondary prophylaxis) (alternative to clarithromycin): Oral: 5 mg/kg/dose once daily as part of an appropriate combination regimen; consideration can be given to discontinuation of therapy in children ≥2 years when patient has completed ≥12 months of therapy, has no signs/symptoms of MAC disease, and has sustained (≥6 months) CD4 count recovery meeting age-specific thresholds in response to stable ART.
Adolescents (Ref):
Primary prophylaxis (patients with CD4 count <50 cells/mm3 who are not initiated on fully suppressive ART): Oral: 1,200 mg once weekly (preferred) or 600 mg twice weekly; may discontinue prophylaxis when patient is initiated on effective ART.
Treatment and long-term suppression (secondary prophylaxis): Oral: 500 to 600 mg daily as part of an appropriate combination regimen; may discontinue when patient has completed ≥12 months of therapy, has no signs or symptoms of MAC disease, and has sustained (≥6 months) CD4 count >100 cells/mm3 in response to ART.
Otitis media, acute (AOM) (alternative agent for patients who cannot tolerate beta-lactam antibiotics): Note: Not recommended for routine empiric use due to limited efficacy against Streptococcus pneumoniae and Haemophilus influenzae (Ref).
Infants ≥6 months, Children, and Adolescents:
Single-dose regimen: Oral: 30 mg/kg once as a single dose; maximum dose: 1,500 mg/dose; if patient vomits within 30 minutes of dose, repeat dosing has been administered, although limited safety data are available (Ref).
Three-day regimen: Oral: 10 mg/kg/dose once daily for 3 days; maximum dose: 500 mg/dose (Ref). Note: For recurrent or persistent infections, doses of 20 mg/kg/dose once daily for 3 days have been described in patients ≥6 months to <6 years of age (Ref).
Five-day regimen: Oral: 10 mg/kg once on day 1 (maximum dose: 500 mg/dose), followed by 5 mg/kg/dose (maximum dose: 250 mg/dose) once daily on days 2 to 5 (Ref).
Peritonitis (peritoneal dialysis), prophylaxis for patients receiving peritoneal dialysis who require dental procedures:
Infants, Children, and Adolescents: Oral: 15 mg/kg administered 30 to 60 minutes before dental procedure; maximum dose: 500 mg/dose (Ref).
Pertussis (Ref):
Infants 1 to <6 months: Oral, IV: 10 mg/kg/dose once daily for 5 days.
Infants ≥6 months, Children, and Adolescents: Oral, IV: 10 mg/kg once on day 1 (maximum dose: 500 mg/dose), followed by 5 mg/kg/dose once daily on days 2 to 5 (maximum dose: 250 mg/dose).
Pneumonia, community-acquired (presumed atypical pneumonia or proven C. pneumoniae or M. pneumoniae infection) (Ref):
Mild infection or step-down therapy: Infants >3 months, Children, and Adolescents: Oral: 10 mg/kg once on day 1 (maximum dose: 500 mg/dose), followed by 5 mg/kg/dose (maximum dose: 250 mg/dose) once daily on days 2 to 5 (Ref).
Severe infection: Infants >3 months, Children, and Adolescents: IV: 10 mg/kg/dose once daily for at least 2 days (maximum dose: 500 mg/dose); when able transition to the oral route with a single daily dose of 5 mg/kg/dose (maximum dose: 250 mg/dose) to complete a 5-day course of therapy (Ref).
Recurrent asthma-like symptoms, reduction in duration: Limited data available: Children ≤3 years: Oral: 10 mg/kg/dose once daily for 3 days; dosing based on a randomized placebo-controlled trial (n=72; episodes of recurrent asthma-like symptoms analyzed=148; mean age: 2 ± 0.6 years); patients were diagnosed with recurrent troublesome lung symptoms (asthma-like episodes) and included in the study if they had ≥5 episodes in 6 months, persistent symptoms for ≥4 weeks, or previously experienced a severe acute episode requiring an oral steroid or hospital admission; patients presenting with ≥3 days of consecutive symptoms were randomized to azithromycin or placebo. Patients received a beta-2 agonist, with the potential to receive inhaled corticosteroids (82%), montelukast (60%), and/or oral prednisolone as well. Children who received azithromycin experienced fewer days of symptoms (3.4 days) as compared to those who received placebo (7.7 days; p<0.0001); the biggest impact was noted when azithromycin was given before day 6 of symptoms (Ref).
Rhinosinusitis, bacterial: Infants ≥6 months, Children, and Adolescents: Oral: 10 mg/kg/dose once daily for 3 days; maximum dose: 500 mg/dose; Note: Although FDA approved, macrolides are not recommended for empiric therapy due to high rates of resistance (Ref).
Streptococcus, group A; pharyngitis/tonsillitis (alternative agent for severe penicillin allergy):
Five-day regimen: Children and Adolescents: Oral: 12 mg/kg/dose once daily for 5 days; maximum dose: 500 mg/dose (Ref).
Three-day regimen: Limited data available: Children and Adolescents: Oral: 20 mg/kg/dose once daily for 3 days; maximum dose: 1,000 mg/dose (Ref).
Typhoid fever (Salmonella typhi or Salmonella paratyphi infection), treatment: Limited data available:
Children and Adolescents: Oral: 10 mg/kg/dose (maximum dose: 500 mg/dose) once daily for 7 days or 20 mg/kg/dose (maximum dose: 1,000 mg/dose) once daily for 5 to 7 days (Ref).
Altered kidney function: Infants, Children, and Adolescents: Oral, IV:
Mild to severe impairment: There are no dosage adjustments provided in the manufacturer's labeling; however, some experts suggest that no dosage adjustment is necessary (Ref).
Hemodialysis: There are no dosage adjustments provided in the manufacturer's labeling; however, some experts suggest no dosage adjustment or supplemental doses are necessary (Ref).
Peritoneal dialysis: There are no dosage adjustments provided in the manufacturer's labeling; however, some experts suggest no dosage adjustment or supplemental doses are necessary (Ref). Based on adult information, azithromycin is not removed with continuous ambulatory peritoneal dialysis (Ref).
Continuous renal replacement therapy (CRRT): There are no dosage adjustments provided in the manufacturer's labeling; however, some experts suggest no dosage adjustment or supplemental doses are necessary (Ref).
Azithromycin is predominantly hepatically eliminated; however, there is no dosage adjustment provided in the manufacturer's labeling. Use with caution due to potential for hepatotoxicity (rare); discontinue immediately for signs or symptoms of hepatitis.
(For additional information see "Azithromycin (systemic): Drug information")
Acne vulgaris, inflammatory, moderate to severe (alternative agent) (off-label use):
Note: Use in combination with topical acne therapy. Reserve use for patients who cannot use preferred agents (Ref).
Oral: Optimal dose uncertain; clinical trials have used varied pulse-dosing regimens: 500 mg once daily for 4 consecutive days per month for 3 months (Ref) or 500 mg once daily for 3 days in the first week, followed by 500 mg once weekly until week 10 (Ref) or 500 mg once daily for 3 consecutive days each week in month 1, followed by 500 mg once daily for 2 consecutive days each week in month 2, then 500 mg once daily for 1 day each week in month 3 (Ref). Treatment should ideally be limited to 3 to 4 months to minimize the risk of resistance (Ref).
Babesiosis (off-label use):
Mild to moderate disease: Oral: 500 mg on day 1, followed by 250 mg once daily in combination with atovaquone (Ref); higher doses of azithromycin (up to 1 g daily) may be used in patients who are highly immunocompromised (Ref).
Severe disease, initial therapy: IV: 500 mg once daily in combination with atovaquone; may switch to oral azithromycin once symptoms improve (Ref).
Severe disease, oral step-down therapy: Oral: 250 to 500 mg once daily in combination with atovaquone (Ref). Note: Higher doses of azithromycin (up to 1 g daily) may be used in patients who are immunocompromised (Ref).
Duration of therapy: 7 to 10 days; a longer duration of ≥6 weeks, including 2 weeks after resolution of parasitemia, may be necessary for patients at high risk of relapse (eg, patients who are highly immunocompromised) (Ref).
Bartonella spp. infection (off-label use):
Patients with HIV:
Treatment: Note: Not for treatment of endocarditis or CNS infections (Ref).
Bacillary angiomatosis, cat scratch disease, peliosis hepatitis, bacteremia, or osteomyelitis (alternative agent): IV, Oral: 500 mg once daily for ≥3 months (Ref).
Suppressive therapy: Note: For patients who experience a relapse after receiving a ≥3-month course of primary treatment (Ref).
Oral: 500 mg once daily. Continue until patient has received ≥3 months of therapy and CD4 count is >200 cells/mm3 for ≥6 months; some experts discontinue only if Bartonella titers have also decreased 4-fold (Ref).
Patients without HIV:
Cat scratch disease:
Lymphadenitis: Oral: 500 mg as a single dose, then 250 mg once daily for 4 additional days (Ref).
Hepatosplenic disease, prolonged systemic illness: IV, Oral: 500 mg as a single dose, then 250 mg once daily in combination with rifampin for 10 to 14 days (Ref). For patients unable to tolerate rifampin, may give azithromycin monotherapy: 500 mg once daily for 5 days (Ref).
CNS infection, neuroretinitis (alternative agent): IV, Oral: 500 mg as a single dose, then 250 mg once daily, in combination with rifampin. Duration is 10 to 14 days for CNS infection and 4 to 6 weeks for neuroretinitis (Ref).
Bronchiectasis (noncystic fibrosis), prevention of pulmonary exacerbations (off-label use): Oral: 500 mg 3 times weekly (Ref) or 250 mg once daily (Ref). An initial dose of 250 mg 3 times weekly, with subsequent titration according to patient response, may be considered to minimize adverse effects (Ref). Note: Recommended for patients with ≥2 (Ref) or ≥3 (Ref) exacerbations per year; for those who do not have Pseudomonas aeruginosa infection, have P. aeruginosa but cannot take an inhaled antibiotic, or continue to have exacerbations despite an inhaled antibiotic. Screen patients for nontuberculous mycobacterial infection prior to treatment, and azithromycin should not be given if present (Ref).
Bronchiolitis obliterans (off-label use):
Bronchiolitis obliterans syndrome in lung transplant recipients, treatment: Oral: 250 mg 3 times weekly (Ref); some experts recommend an initial dose of 250 mg daily for the first 5 days (Ref). Usually given for a 3-month trial period (Ref), but some experts continue indefinitely, regardless of response to therapy (Ref). Note: When studied to prevent bronchiolitis obliterans syndrome in patients with hematologic malignancy who underwent allogeneic hematopoietic cell transplantation, rates of cancer relapse and mortality were increased among patients receiving long-term azithromycin, leading to early trial termination (Ref).
Diffuse panbronchiolitis or symptomatic cryptogenic bronchiolitis obliterans, treatment: Oral: 250 to 500 mg once daily or 3 times weekly (Ref). After a 3- to 6-month trial, long-term therapy may be continued based on response (Ref).
Cesarean delivery (intrapartum or after rupture of membranes), preoperative prophylaxis (off-label use): IV: 500 mg as a single dose 1 hour prior to surgical incision; use in combination with standard preoperative antibiotics (Ref).
Chronic obstructive pulmonary disease, acute exacerbation:
Acute exacerbation , treatment: Note: Avoid use in patients with risk factors for Pseudomonas infection or poor outcomes (eg, ≥65 years of age with major comorbidities, FEV1 <50% predicted, frequent exacerbations) (Ref).
Oral: 500 mg in a single loading dose on day 1, followed by 250 mg once daily on days 2 to 5 (Ref) or 500 mg once daily for 3 days (Ref).
Prevention of exacerbations (off- label use): Note: Consider for patients with frequent exacerbations despite optimal medical management (eg, >3 exacerbations per year [at least 1 of which required hospital admission]) (Ref) or (eg, ≥2 exacerbations per year or ≥1 hospital admission per year) (Ref).
Oral: 250 to 500 mg 3 times weekly (Ref) or 250 mg once daily (Ref).
Cystic fibrosis, anti-inflammatory (off-label use):
Note: Reserve for patients with chronic pseudomonal infection or frequent exacerbations despite other therapies (Ref).
Oral: 250 mg (<40 kg) or 500 mg (≥40 kg) 3 times weekly (Ref) or 250 mg once daily (Ref). Note: Screen patients for nontuberculous mycobacterial infection prior to treatment and azithromycin should not be given if present (Ref).
Diarrhea, infectious (off-label use):
Campylobacter gastroenteritis:
Patients with HIV: Mild to moderate disease (without bacteremia): Oral: 500 mg once daily for 5 days. For patients with recurrent infection (particularly when CD4 <200 cells/mm3), may extend therapy for 2 to 6 weeks (Ref).
Patients without HIV: Oral: 1 g as a single dose (if nausea is a concern, 500 mg in 2 divided doses on same day (Ref)) or 500 mg once daily for 3 days (Ref). If symptoms have not resolved after 24 hours following single-dose therapy, continue with 500 mg once daily for 2 more days (Ref).
Cholera (alternative agent): Oral: 1 g as a single dose (Ref).
Shigella gastroenteritis: Note: Confirm susceptibility if possible (Ref).
Patients with HIV (without bacteremia): Oral: 500 mg once daily for 5 days. For patients with recurrent infection (particularly when CD4 <200 cells/mm3), may extend therapy for up to 6 weeks (Ref).
Patients without HIV: Oral: 500 mg once daily for 3 days; for Shigella dysenteriae type 1 infection, treat for a total of 5 to 7 days (Ref).
Travelers' diarrhea , empiric treatment:
Note: Most cases are self-limited and may not warrant antimicrobial therapy. Some experts reserve antimicrobial therapy for severe diarrhea (eg, fever with blood, pus, or mucus in stool) (Ref) or certain high-risk travelers (eg, those with an immunocompromising condition) (Ref).
Oral: 1 g as a single dose or 500 mg once daily for 3 days (Ref). If symptoms have not resolved after 24 hours following single-dose therapy, continue with 500 mg once daily for 2 more days. A 3-day course of 500 mg once daily is the preferred regimen for dysentery or febrile diarrhea (Ref). Increased nausea may occur with the 1 g single-dose regimen (Ref), which may be reduced by administering azithromycin as 2 divided doses on the same day (Ref).
Endocarditis, prophylaxis (invasive dental procedure) (alternative agent for penicillin-allergic patients) (off-label use):
Note: Reserve for select situations (cardiac condition with the highest risk of adverse endocarditis outcomes and procedure likely to result in bacteremia with an organism that can cause endocarditis) (Ref).
Oral: 500 mg 30 to 60 minutes prior to procedure; if inadvertently not given prior to the procedure, may be administered up to 2 hours after the procedure.
Lyme disease (Borrelia spp. infection), erythema migrans (alternative agent) (off-label use): Oral: 500 mg once daily for 7 days (range: 5 to 10 days). Note: Use with caution and only when recommended agents cannot be used (due to decreased efficacy compared to other agents) (Ref).
Mycobacterial (nontuberculous) infection:
Mycobacterium avium complex (MAC) infection:
Disseminated disease in patients with HIV:
Treatment: Oral: 500 to 600 mg daily as part of an appropriate combination regimen (Ref).
Primary prophylaxis (patients with CD4 count <50 cells/mm3 who are not initiated on fully suppressive antiretroviral therapy [ART]): Oral: 1.2 g once weekly (preferred) or 600 mg twice weekly; may discontinue prophylaxis when patient is initiated on effective ART (Ref).
Secondary prophylaxis: Oral: 500 to 600 mg daily as part of an appropriate combination regimen; may discontinue when patient has completed ≥12 months of therapy, has no signs/symptoms of MAC disease, and has sustained (>6 months) CD4 count >100 cells/mm3 in response to ART (Ref).
Pulmonary disease (nodular/bronchiectatic disease) (off-label use): Oral: 500 mg 3 times weekly as part of an appropriate combination regimen; continue treatment until patient is culture negative on therapy for ≥1 year (Ref).
Pulmonary disease (severe nodular/bronchiectatic or cavitary disease) (off-label use): Oral: 250 to 500 mg once daily as part of an appropriate combination regimen (Ref); continue treatment until patient is culture negative on therapy for ≥1 year (Ref). Preliminary data suggest a relationship between peak concentration and clinical outcome among patients receiving daily therapy for pulmonary MAC (Ref); as such, some experts recommend checking levels and/or using the higher dose (eg, 500 mg once daily) of azithromycin (Ref).
Pulmonary disease in patients with cystic fibrosis (off-label use): Oral: 250 to 500 mg once daily as part of an appropriate combination regimen; continue treatment until patient is culture negative on therapy for ≥1 year. Note: Intermittent dosing (3 times weekly) is not recommended for patients with cystic fibrosis (Ref).
Mycobacterial (nontuberculous, rapidly growing) infection (off-label use):
Note: Presence of inducible erm gene can result in decreased susceptibility even with a “susceptible” MIC result; perform susceptibility testing before and after ≥14 days of clarithromycin incubation to evaluate for the presence of an active erm gene, which may preclude use of azithromycin (Ref).
Pulmonary, skin and soft tissue, or bone infection: Oral: 250 to 500 mg once daily as part of an appropriate combination regimen and continued for ≥6 to 12 months for pulmonary and bone infections, and ≥4 months for skin and soft tissue infections (Ref). Note: Patients should be under the care of a clinician with expertise in managing mycobacterial infection (Ref).
Pneumonia, community-acquired:
Outpatient: Oral: 500 mg on day 1, followed by 250 mg once daily for 4 days or 500 mg once daily for 3 days (Ref). Note: May use as monotherapy (alternative agent) for outpatients without comorbidities or risk factors for antibiotic-resistant pathogens only if local pneumococcal resistance is <25%. Must be used as part of an appropriate combination regimen in outpatients with comorbidities (Ref); some experts prefer to use as part of an appropriate combination regimen in all outpatients, regardless of comorbidities (Ref).
Inpatient: Oral, IV: 500 mg once daily for a minimum of 3 days, as part of an appropriate combination regimen (Ref).
Rhinosinusitis, acute bacterial:
Note: In uncomplicated acute bacterial rhinosinusitis, initial observation and symptom management without antibiotic therapy is appropriate in most patients. Reserve antibiotic therapy for poor follow-up or lack of improvement over the observation period (Ref). Given increased resistance in S. pneumoniae, macrolides, including azithromycin, are not recommended for empiric treatment of acute bacterial rhinosinusitis (Ref).
Oral: 500 mg once daily for 3 days (Ref).
Sexually transmitted infections:
Cervical infection, empiric therapy for cervicitis or pathogen-directed therapy for Chlamydia trachomatis (alternative agent): Oral: 1 g as a single dose, preferably under direct observation; give in combination with ceftriaxone if the patient is at high risk for gonorrhea, if follow-up is a concern, or if the local prevalence of gonorrhea is high (eg, >5%) (Ref).
Chancroid (due to Haemophilus ducreyi ): Oral: 1 g as a single dose. Note: Data are limited concerning efficacy in HIV infected patients (Ref).
Gonococcal infection, uncomplicated (infection of the cervix, rectum [off-label use], or urethra ) (alternative agent):
Note: Reserve for patients who cannot use a cephalosporin (Ref).
Oral: 2 g as a single dose in combination with IM gentamicin (preferred) or oral gemifloxacin (Ref). When treatment failure is suspected (eg, detection of N. gonorrhoeae after treatment without additional sexual exposure), consult an infectious diseases specialist. Report failures to the CDC through state and local health departments (Ref).
Granuloma inguinale (donovanosis) (off-label use): Oral: 1 g once weekly or 500 mg once daily for >3 weeks and until resolution of lesions. Note: If symptoms do not improve within the first few days of therapy, the addition of a second agent may be considered (Ref).
Lymphogranuloma venereum (alternative agent) (off-label use): Oral: 1 g once weekly for 3 weeks. Note: Consider a test of cure for C. trachomatis 4 weeks after therapy completion (Ref).
Mycoplasma genitalium (alternative agent) (off-label use):
Note: Azithromycin resistance is rapidly emerging; the CDC only recommends azithromycin for documented susceptible infection, but susceptibility testing is not widely available (Ref).
Oral: 1 g on day 1, followed by 500 mg once daily on days 2 through 4 (Ref).
Pelvic inflammatory disease, mild to moderate (alternative agent):
Note: Reserve for patients who cannot use first-line options and are unlikely to have infection caused by N. gonorrhoeae (Ref).
Oral, IV: 500 mg IV once daily for 1 to 2 days, then 250 mg orally once daily to complete a 7-day course, in combination with metronidazole (Ref).
Urethral infection, empiric therapy for urethritis or pathogen-directed therapy for Chlamydia trachomatis (alternative agent): Oral: 1 g as a single dose, preferably under direct observation or 500 mg on day 1 then 250 mg once daily for 4 days (some experts prefer this dose for urethritis if adherence is not a concern (Ref)); give in combination with ceftriaxone if there is microscopic evidence of gonococcal urethritis or if there is high clinical suspicion of gonococcal infection (Ref).
Streptococcus, group A (alternative agent for patients with severe penicillin allergy):
Pharyngitis: Oral: 12 mg/kg (maximum: 500 mg) on day 1, followed by 6 mg/kg (maximum: 250 mg) once daily on days 2 through 5 (Ref) or 12 mg/kg (maximum: 500 mg) once daily for 5 days (Ref).
Secondary prophylaxis in patients with rheumatic fever (prevention of recurrent attacks) (off-label use): Note: Optimal dose not well defined (Ref).
Oral: 250 mg once daily (Ref). Duration depends on risk factors, age, and presence of valvular disease (Ref).
Surgical prophylaxis, uterine evacuation (induced abortion or pregnancy loss) (alternative agent) (off-label use): Oral: 500 mg as a single dose 1 hour before the procedure; may be administered up to 24 hours before the procedure (Ref). Note: The optimal dosing regimen has not been established; various protocols are in use (Ref).
Typhoid and paratyphoid fever (S. typhi or S. paratyphi infection), uncomplicated, treatment (off-label use): Oral: 1 g once daily or 1 g once on day 1, followed by 500 mg once daily; total duration: 5 to 7 days (Ref).
The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.
Oral, IV:
Mild to severe impairment: No dosage adjustment necessary (Ref).
Hemodialysis: No dosage adjustment or supplemental dose necessary (Ref).
Peritoneal dialysis: Minimally dialyzed (Ref): No dosage adjustment or supplemental dose necessary (Ref).
CRRT: No dosage adjustment or supplemental dose necessary (Ref).
Azithromycin is predominantly hepatically eliminated; however, there is no dosage adjustment provided in the manufacturer's labeling. Use with caution due to potential for hepatotoxicity (rare); discontinue immediately for signs or symptoms of hepatitis.
Azithromycin is associated with altered cardiac conduction, including prolonged QT interval on ECG (Ref) and polymorphic ventricular tachycardia (Ref). May be associated with increased cardiac risk and/or death; however, data are conflicting (Ref).
Mechanism: Inhibits the delayed rectifier potassium channel, which is encoded by the human ether-à-go-go related gene 1 (hERG1) with much less affinity than erythromycin, causing prolonging of the action potential of cardiac myocytes, prolonging the QT interval (Ref).
Onset: Variable; altered cardiac conduction reported to occur within minutes after the administration of the first dose up to 7 days after initiation (Ref).
Risk factors:
• Females (Ref)
• Older patients (Ref)
• Heart disease (Ref)
• High baseline cardiovascular disease risk (Ref)
• History of drug-induced torsades de pointes (Ref)
• Congenital long QT syndrome (LQTS) (Ref)
• Baseline QTc interval prolongation (eg, >500 msec) or lengthening of the QTc by ≥60 milliseconds (Ref)
• Coadministration of medications that prolong the QT interval or drug interactions that increase serum drug concentrations of QT prolonging medications (Ref)
• Hypokalemia and hypomagnesemia (Ref)
• Bradycardia (Ref)
Clostridioides difficile infection (CDI) has been reported with azithromycin, including Clostridioides difficile associated diarrhea and Clostridioides difficile colitis.
Onset: Variable; may start on the first day of antibiotic therapy or up to 3 months postantibiotic (Ref).
Risk factors:
• Antibiotic exposure (highest risk factor) (Ref).
• Type of antibiotic (azithromycin considered moderate risk) (Ref)
• Long durations in a hospital or other healthcare setting (recent or current) (Ref)
• Older adults (Ref)
• Immunocompromised conditions (Ref)
• A serious underlying condition (Ref)
• GI surgery/manipulation (Ref)
• Antiulcer medications (eg, proton pump inhibitors and H2 blockers) (Ref)
• Chemotherapy (Ref)
Azithromycin is associated with drug-induced liver injury, including cholestatic hepatitis, hepatocellular hepatitis, and mixed cholestatic/hepatocellular hepatitis. Most patients fully recover; however, severe cutaneous reactions, chronic liver injury, and serious complications leading to death or liver transplantation may occur (Ref).
Mechanism: Non-dose-related; not fully understood. An in vitro study was unable to predict if the mechanism was related to bile acid transporter inhibition, mitochondrial dysfunction, or oxidative stress and concluded that hepatotoxicity could be caused by a mechanism that was not evaluated or could be due to unknown metabolite effects (Ref). May be related to hypersensitivity (Ref).
Onset: Intermediate; typically occurs within 1 to 3 weeks after initiation (Ref)
Risk factors:
• Underlying chronic liver disease (Ref)
• Hypersensitivity to azithromycin; cross-reactivity among macrolides may occur (Ref)
Delayed hypersensitivity reactions have been reported with azithromycin, ranging from maculopapular skin rash and fixed drug eruption to severe cutaneous adverse reactions (SCARs). SCARs include acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms, Stevens-Johnson syndrome and toxic epidermal necrolysis (Ref). Azithromycin has also been associated with development of a maculopapular rash in patients with concurrent infectious mononucleosis (Ref).
Mechanism: Non-dose-related; immunologic; delayed hypersensitivity reactions, including SCARs, involve a T-cell mediated drug-specific immune response (Ref). The mechanism for the development of a nonspecific rash in patients with infectious mononucleosis may be a transient virus-mediated immune alteration that leads to the development of a reversible hypersensitivity reaction (Ref).
Onset: Variable; type IV reactions are delayed hypersensitivity reactions that typically occur days to weeks after drug exposure but may occur more rapidly (usually within 1 to 4 days) upon reexposure (Ref).
Risk factors:
• Limited information regarding cross-reactivity among macrolides (Ref)
Immediate hypersensitivity reactions, including angioedema, urticaria and anaphylaxis, have been reported with azithromycin (Ref).
Mechanism: Non-dose-related; immunologic. Although IgE has not been identified in relationship to immediate hypersensitivity reactions to azithromycin, most immediate hypersensitivity reactions are IgE-mediated, with specific antibodies formed against a drug allergen following initial exposure (Ref).
Onset: Rapid; generally occurs within 1 hour of administration but may occur up to 6 hours after exposure (Ref).
Risk factors:
• Limited information regarding cross-reactivity among macrolides (Ref)
Azithromycin is associated with ototoxicity, including hearing loss and tinnitus. Ototoxicity usually manifests in bilateral symmetrical hearing loss of 40 to 50 dB. In most cases, ototoxicity is reversible and resolves within 1 to 5 weeks after discontinuation (Ref). Irreversible hearing loss has been reported, albeit rarely (Ref).
Mechanism: Dose- and time-related; linked to cumulative doses of azithromycin. Azithromycin may exert temporary ototoxic effects on outer hair cells via reversible reduction in transient evoked otoacoustic emissions (Ref).
Onset: Varied; reported cases of tinnitus have occurred as early as 24 hours; however, the majority of hearing loss cases have occurred with prolonged durations of therapy (ie, ≥4 weeks) (Ref).
Risk factors:
• Generally greater with higher doses (ie, 500 to 600 mg) (Ref)
• Prolonged durations of therapy (ie, ≥4 weeks) (Ref)
• Serum azithromycin levels of ≥0.8 +/- 0.4 µg/mL (Ref)
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%: Gastrointestinal: Diarrhea (≤14%; high single-dose regimens tend to be associated with increased incidence), nausea (≤7%; high single-dose regimens: 5% to 18%)
1% to 10%:
Cardiovascular: Chest pain (≤1%), facial edema (children: ≤1%), palpitations (adults: ≤1%)
Dermatologic: Diaphoresis (children: ≤1%), eczema (children: ≤1%), fungal dermatitis (children: ≤1%), pruritus (≤2%), skin photosensitivity (adults: ≤1%), skin rash (≤2%; single-dose regimens tend to be associated with increased incidence), urticaria (≤1%), vesiculobullous dermatitis (children: ≤1%)
Endocrine & metabolic: Increased lactate dehydrogenase (1% to 3%)
Gastrointestinal: Abdominal pain (1% to 7%; single-dose regimens tend to be associated with increased incidence), anorexia (≤2%), constipation (≤1%), dysgeusia (adults: ≤1%), dyspepsia (≤1%), enteritis (children: ≤1%), flatulence (≤1%), gastritis (≤1%), melena (adults: ≤1%), oral candidiasis (≤1%), stomatitis (≤1%), vomiting (adults: ≤2%; adults, single 2 g dose: 2% to 7%; children, single-dose regimens tend to be associated with increased incidence: 1% to 6%)
Genitourinary: Genital candidiasis (adults: ≤1%), vaginitis (adults: ≤3%)
Hypersensitivity: Angioedema (≤1%)
Infection: Fungal infection (children: ≤1%)
Local: Local inflammation (adults, IV: 3%), pain at injection site (adults, IV: 7%)
Nervous system: Agitation (≤1%), dizziness (≤1%), drowsiness (≤1%), fatigue (≤1%), headache (≤1%), insomnia (children: ≤1%), malaise (children: ≤1%), nervousness (children: ≤1%), pain (children: ≤1%), vertigo (≤1%)
Neuromuscular & skeletal: Hyperkinetic muscle activity (children: ≤1%), increased creatine phosphokinase in blood specimen (1% to 2%)
Respiratory: Bronchospasm (≤1%), cough (children: ≤1%), pleural effusion (children: ≤1%)
Miscellaneous: Fever (children: ≤1%)
Postmarketing:
Cardiovascular: Prolonged QT interval on ECG (rare: <1%) (Russo 2006), syncope (Cocco 2015), torsades de pointes (rare: <1%) (Kezerashvili 2007), ventricular tachycardia (rare: <1%) (Kim 2005)
Dermatologic: Acute generalized exanthematous pustulosis (rare: <1%) (Campanón-Toro 2017), erythema multiforme (Isik 2007), Stevens-Johnson syndrome (rare: <1%) (Xu 2018), toxic epidermal necrolysis
Gastrointestinal: Ageusia (Schiffman 2018), Clostridioides difficile associated diarrhea (rare: <1%) (Brown 2013), Clostridioides difficile colitis (rare: <1%) (Brown 2013), pancreatitis, pyloric stenosis (infantile hypertrophic) (Smith 2015), tongue discoloration
Hematologic & oncologic: Thrombocytopenia (Butt 2019)
Hepatic: Cholestatic hepatitis (rare: <1%) (Martinez 2015), hepatic failure (rare: <1%) (Martinez 2015), hepatic necrosis (rare: <1%) (Martinez 2015), hepatocellular hepatitis (rare: <1%) (Martinez 2015)
Hypersensitivity: Anaphylaxis (rare: <1%) (Ünal 2018)
Immunologic: Drug reaction with eosinophilia and systemic symptoms (rare: <1%) (Sriratanaviriyakul 2014)
Nervous system: Aggressive behavior, altered sense of smell (Schiffman 2018), anosmia (Schiffman 2018), anxiety (Adachi 2003), exacerbation of myasthenia gravis (Pradhan 2009), hyperactive behavior, paresthesia, seizure (Schiff 2010)
Neuromuscular & skeletal: Arthralgia, asthenia
Otic: Deafness (Etminan 2017), hearing loss (Li 2014), tinnitus (Tseng 1997)
Renal: Acute kidney injury, interstitial nephritis (Woodruff 2015)
Hypersensitivity to azithromycin, erythromycin, other macrolide (eg, azalide or ketolide) antibiotics, or any component of the formulation; history of cholestatic jaundice/hepatic dysfunction associated with prior azithromycin use
Note: The manufacturer does not list concurrent use of pimozide as a contraindication; however, azithromycin is listed as a contraindication in the manufacturer's labeling for pimozide.
Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Concerns related to adverse effects:
• Superinfection: Prolonged use may result in fungal superinfection.
Disease-related concerns:
• Bronchiolitis obliterans: When studied to prevent bronchiolitis obliterans syndrome in patients with hematologic malignancy who underwent allogeneic hematopoietic cell transplantation, rates of cancer relapse and mortality were increased among patients receiving long-term azithromycin, leading to early trial termination (Bergeron 2017; FDA Drug Safety Communication 2018).
• Gonorrhea/syphilis: May mask or delay symptoms of incubating gonorrhea or syphilis, so appropriate culture and susceptibility tests should be performed prior to initiating a treatment regimen.
• Myasthenia gravis: Use with caution in patients with myasthenia gravis; exacerbation and new onset of symptoms have occurred.
Special populations:
• Infants: Use of azithromycin in neonates and infants <6 weeks of age has been associated with infantile hypertrophic pyloric stenosis (IHPS); the strongest association occurred with exposure during the first 2 weeks of life; observe for nonbilious vomiting or irritability with feeding (Eberly 2015). The risks and benefits of azithromycin use should be carefully considered in neonates; some experts recommend avoidance except for in the treatment of pertussis or C. trachomatis pneumonia; specific risk-benefit ratio should be considered before use for Ureaplasma spp. eradication (Meyers 2020).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Packet, Oral:
Zithromax: 1 g (3 ea, 10 ea) [cherry-banana flavor]
Generic: 1 g (1 ea, 3 ea, 10 ea)
Solution Reconstituted, Intravenous [preservative free]:
Zithromax: 500 mg (1 ea)
Generic: 500 mg (1 ea)
Suspension Reconstituted, Oral:
Zithromax: 100 mg/5 mL (15 mL) [cherry-vanilla-banana flavor]
Zithromax: 200 mg/5 mL (15 mL, 22.5 mL, 30 mL) [cherry flavor]
Generic: 100 mg/5 mL (15 mL); 200 mg/5 mL (15 mL, 22.5 mL, 30 mL)
Tablet, Oral:
Zithromax: 250 mg, 500 mg, 600 mg [DSC]
Zithromax Tri-Pak: 500 mg
Zithromax Z-Pak: 250 mg
Generic: 250 mg, 500 mg, 600 mg
Yes
Pack (Azithromycin Oral)
1 g (per each): $29.13
Pack (Zithromax Oral)
1 g (per each): $29.64
Solution (reconstituted) (Azithromycin Intravenous)
500 mg (per each): $3.60 - $17.30
Solution (reconstituted) (Zithromax Intravenous)
500 mg (per each): $7.31
Suspension (reconstituted) (Azithromycin Oral)
100 mg/5 mL (per mL): $2.33
200 mg/5 mL (per mL): $1.16
Suspension (reconstituted) (Zithromax Oral)
100 mg/5 mL (per mL): $2.12
200 mg/5 mL (per mL): $2.71
Tablets (Azithromycin Oral)
250 mg (per each): $7.77 - $7.78
500 mg (per each): $15.54 - $15.57
600 mg (per each): $8.05 - $18.68
Tablets (Zithromax Oral)
250 mg (per each): $2.59
500 mg (per each): $3.57
Tablets (Zithromax Tri-Pak Oral)
500 mg (per each): $83.62
Tablets (Zithromax Z-Pak Oral)
250 mg (per each): $2.59
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Intravenous:
Zithromax: 500 mg (5 mL)
Generic: 500 mg (1 ea)
Suspension Reconstituted, Oral:
Zithromax: 100 mg/5 mL (15 mL); 200 mg/5 mL (15 mL, 22.5 mL)
Generic: 100 mg/5 mL (15 mL, 22.5 mL); 200 mg/5 mL (15 mL, 22.5 mL, 37.5 mL)
Tablet, Oral:
Zithromax: 250 mg
Generic: 250 mg, 600 mg
Oral: May administer without regard to food; do not administer with antacids that contain aluminum or magnesium.
Oral suspension bottle: Shake well before use.
Oral suspension 1,000 mg packet for a single dose: Mix the entire contents of the packet with approximately 60 mL of water. Administer the entire contents immediately after mixing; add an additional 60 mL of water, mix, and drink. Do not use to administer any other dose except 1,000 mg.
Parenteral: Do not give IM or by IV bolus. Administer IV infusion at a final concentration of 1 mg/mL over 3 hours; for a 2 mg/mL concentration, infuse over 1 hour; do not infuse over a period of less than 60 minutes.
IV: Infuse over 1 hour (2 mg/ml infusion) or over 3 hours (1 mg/ml infusion). Not for IM or IV bolus administration.
Oral: Suspension and tablet may be taken without regard to food. Shake suspension well before each use.
Injection: Store intact vials of injection at room temperature. Reconstituted solution is stable for 24 hours when stored below 30°C (86°F). The diluted solution D5W, D5LR, D51/4NS, D51/3NS, D51/2NS (with or without 20 mEq/L KCl), Normosol-M in D5, Normosol-R in D5, LR, NS, or 1/2NS is stable for 24 hours at or below room temperature (30°C [86°F]) and for 7 days if stored under refrigeration (5°C [41°F]).
Suspension: Store dry powder below 30°C (86°F). Store reconstituted suspension at 5°C to 30°C (41°F to 86°F) and use within 10 days.
Tablet: Store between 15°C to 30°C (59°F to 86°F).
Oral:
Oral suspension (100 mg per 5 mL; 200 mg per 5 mL), tablets (250 and 500 mg): Treatment of acute otitis media due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae (FDA approved in pediatric patients ages ≥6 months); treatment of community-acquired pneumonia due to Chlamydia (Chlamydophila) pneumoniae, Mycoplasma pneumoniae, H. influenzae, or S. pneumoniae in patients appropriate for oral therapy (FDA approved in ages ≥6 months and adults); treatment of pharyngitis/tonsillitis due to Streptococcus pyogenes in individuals who cannot use first-line therapy (FDA approved in ages ≥2 years and adults); treatment of acute bacterial sinusitis or acute exacerbations of chronic bronchitis due to H. influenzae, M. catarrhalis, or S. pneumoniae (FDA approved in adults); treatment of uncomplicated skin and skin structure infections due to Staphylococcus aureus, S. pyogenes, or Streptococcus agalactiae (FDA approved in adults); treatment of urethritis and cervicitis due to Chlamydia trachomatis or Neisseria gonorrhoeae (FDA approved in adults); treatment of chancroid (FDA approved in adult males). Has also been used for treatment of babesiosis, bartonellosis, cholera, cystic fibrosis lung disease, infectious diarrhea, pertussis, typhoid fever, endocarditis prophylaxis in penicillin allergic patients, prophylaxis of peritonitis in patients undergoing invasive dental procedures, and chemoprophylaxis for meningococcal disease in high-risk contact.
Oral suspension (1,000 mg per 5 mL packet), tablet (600 mg): Treatment of urethritis and cervicitis due to C. trachomatis; prevention of disseminated Mycobacterium avium complex (MAC) disease; treatment of disseminated MAC disease in combination with ethambutol (All indications: FDA approved in adults).
Parenteral: Treatment of community-acquired pneumonia due to susceptible C. pneumoniae, Legionella pneumophila, M. pneumoniae, H. influenzae, S. aureus, S. pneumoniae; treatment of pelvic inflammatory disease due to susceptible C. trachomatis, N. gonorrhoeae, or Mycoplasma hominis (All indications: FDA approved in ≥16 years and adults).
Azithromycin may be confused with azathioprine, erythromycin
Zithromax may be confused with Fosamax, Zinacef, Zovirax
KIDs List: Azithromycin (systemic), when used in neonates, is identified on the Key Potentially Inappropriate Drugs in Pediatrics (KIDs) list and should be avoided due to risk of hypertrophic pyloric stenosis, unless treating Bordetella pertussis or Chlamydia trachomatis pneumonia; risk vs benefit should be assessed when using for Ureaplasma spp.(strong recommendation; high quality of evidence) (PPA [Meyers 2020]).
Substrate of CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential; Inhibits P-glycoprotein/ABCB1
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Afatinib: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Afatinib. Management: If combined, administer the P-gp inhibitor simultaneously with, or after, the dose of afatinib. Monitor closely for signs and symptoms of afatinib toxicity and if the combination is not tolerated, reduce the afatinib dose by 10 mg. Risk D: Consider therapy modification
Aliskiren: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Aliskiren. Risk C: Monitor therapy
Amisulpride (Oral): May enhance the QTc-prolonging effect of QT-prolonging Agents (Moderate Risk). Risk C: Monitor therapy
Bacillus clausii: Antibiotics may diminish the therapeutic effect of Bacillus clausii. Management: Bacillus clausii should be taken in between antibiotic doses during concomitant therapy. Risk D: Consider therapy modification
BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination
BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Risk C: Monitor therapy
Berotralstat: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Berotralstat. Management: Decrease the berotralstat dose to 110 mg daily when combined with P-glycoprotein (P-gp) inhibitors. Risk D: Consider therapy modification
Bilastine: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Bilastine. Risk X: Avoid combination
Cardiac Glycosides: Macrolide Antibiotics may increase the serum concentration of Cardiac Glycosides. Risk C: Monitor therapy
Celiprolol: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Celiprolol. Risk C: Monitor therapy
Chloroquine: QT-prolonging Miscellaneous Agents (Moderate Risk) may enhance the QTc-prolonging effect of Chloroquine. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy
Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Risk X: Avoid combination
Clofazimine: QT-prolonging Miscellaneous Agents (Moderate Risk) may enhance the QTc-prolonging effect of Clofazimine. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy
Colchicine: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Colchicine. Colchicine distribution into certain tissues (e.g., brain) may also be increased. Management: This combination is often contraindicated, but combined use may be permitted with dose adjustment and monitoring. Recommendations vary based on brand, indication, use of CYP3A4 inhibitors, and hepatic/renal function. See interaction monograph for details. Risk D: Consider therapy modification
CycloSPORINE (Systemic): Azithromycin (Systemic) may increase the serum concentration of CycloSPORINE (Systemic). Risk C: Monitor therapy
Dabigatran Etexilate: P-glycoprotein/ABCB1 Inhibitors may increase serum concentrations of the active metabolite(s) of Dabigatran Etexilate. Risk C: Monitor therapy
Dabrafenib: QT-prolonging Miscellaneous Agents (Moderate Risk) may enhance the QTc-prolonging effect of Dabrafenib. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy
Domperidone: QT-prolonging Agents (Moderate Risk) may enhance the QTc-prolonging effect of Domperidone. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider therapy modification
DOXOrubicin (Conventional): P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of DOXOrubicin (Conventional). Risk X: Avoid combination
DOXOrubicin (Liposomal): P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of DOXOrubicin (Liposomal). Risk C: Monitor therapy
Edoxaban: Azithromycin (Systemic) may increase the serum concentration of Edoxaban. Management: In patients treated for DVT/PE, reduce the edoxaban dose to 30mg daily when combined with azithromycin. No dose adjustment is recommended for patients treated for atrial fibrillation. Monitor for increased edoxaban toxicities (ie, bleeding) when combined. Risk D: Consider therapy modification
Etoposide: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Etoposide. Risk C: Monitor therapy
Etoposide Phosphate: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Etoposide Phosphate. Risk C: Monitor therapy
Everolimus: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Everolimus. Risk C: Monitor therapy
Fecal Microbiota (Live) (Oral): May diminish the therapeutic effect of Antibiotics. Risk X: Avoid combination
Fecal Microbiota (Live) (Rectal): Antibiotics may diminish the therapeutic effect of Fecal Microbiota (Live) (Rectal). Risk X: Avoid combination
Fexinidazole: May enhance the QTc-prolonging effect of QT-prolonging Miscellaneous Agents (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy
Fluorouracil Products: QT-prolonging Miscellaneous Agents (Moderate Risk) may enhance the QTc-prolonging effect of Fluorouracil Products. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy
Gadobenate Dimeglumine: QT-prolonging Miscellaneous Agents (Moderate Risk) may enhance the QTc-prolonging effect of Gadobenate Dimeglumine. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy
Glecaprevir and Pibrentasvir: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Glecaprevir and Pibrentasvir. Risk C: Monitor therapy
Halofantrine: QT-prolonging Miscellaneous Agents (Moderate Risk) may enhance the QTc-prolonging effect of Halofantrine. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy
Haloperidol: QT-prolonging Miscellaneous Agents (Moderate Risk) may enhance the QTc-prolonging effect of Haloperidol. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy
Hydroxychloroquine: Azithromycin (Systemic) may enhance the cardiotoxic effect of Hydroxychloroquine. Risk C: Monitor therapy
Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Antibiotics may diminish the therapeutic effect of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor therapy
Inotuzumab Ozogamicin: QT-prolonging Miscellaneous Agents (Moderate Risk) may enhance the QTc-prolonging effect of Inotuzumab Ozogamicin. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy
Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Risk C: Monitor therapy
Lapatinib: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Lapatinib. Risk C: Monitor therapy
Larotrectinib: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Larotrectinib. Risk C: Monitor therapy
Lefamulin: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Lefamulin. Management: Avoid concomitant use of lefamulin tablets with P-glycoprotein/ABCB1 inhibitors. If concomitant use is required, monitor for lefamulin adverse effects. Risk D: Consider therapy modification
Levoketoconazole: QT-prolonging Agents (Moderate Risk) may enhance the QTc-prolonging effect of Levoketoconazole. Risk X: Avoid combination
Lofexidine: QT-prolonging Miscellaneous Agents (Moderate Risk) may enhance the QTc-prolonging effect of Lofexidine. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy
Lovastatin: Azithromycin (Systemic) may enhance the myopathic (rhabdomyolysis) effect of Lovastatin. Risk C: Monitor therapy
Midostaurin: QT-prolonging Miscellaneous Agents (Moderate Risk) may enhance the QTc-prolonging effect of Midostaurin. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy
Mizolastine: Macrolide Antibiotics may increase the serum concentration of Mizolastine. Risk X: Avoid combination
Morphine (Systemic): P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Morphine (Systemic). Risk C: Monitor therapy
Nadolol: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Nadolol. Risk C: Monitor therapy
Naldemedine: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Naldemedine. Risk C: Monitor therapy
Naloxegol: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Naloxegol. Risk C: Monitor therapy
Nelfinavir: May increase the serum concentration of Azithromycin (Systemic). Risk C: Monitor therapy
Ondansetron: QT-prolonging Miscellaneous Agents (Moderate Risk) may enhance the QTc-prolonging effect of Ondansetron. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy
PAZOPanib: Azithromycin (Systemic) may enhance the QTc-prolonging effect of PAZOPanib. Azithromycin (Systemic) may increase the serum concentration of PAZOPanib. Risk X: Avoid combination
Pentamidine (Systemic): QT-prolonging Miscellaneous Agents (Moderate Risk) may enhance the QTc-prolonging effect of Pentamidine (Systemic). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy
Pimozide: May enhance the QTc-prolonging effect of QT-prolonging Agents (Moderate Risk). Risk X: Avoid combination
Piperaquine: QT-prolonging Miscellaneous Agents (Moderate Risk) may enhance the QTc-prolonging effect of Piperaquine. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy
Pralsetinib: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Pralsetinib. Management: If this combo cannot be avoided, decrease pralsetinib dose from 400 mg daily to 300 mg daily; from 300 mg daily to 200 mg daily; and from 200 mg daily to 100 mg daily. Risk D: Consider therapy modification
Probucol: QT-prolonging Miscellaneous Agents (Moderate Risk) may enhance the QTc-prolonging effect of Probucol. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy
QT-prolonging Agents (Highest Risk): May enhance the QTc-prolonging effect of Azithromycin (Systemic). Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider therapy modification
QT-prolonging Antidepressants (Moderate Risk): May enhance the QTc-prolonging effect of QT-prolonging Miscellaneous Agents (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy
QT-prolonging Antipsychotics (Moderate Risk): Azithromycin (Systemic) may enhance the QTc-prolonging effect of QT-prolonging Antipsychotics (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy
QT-prolonging Class IC Antiarrhythmics (Moderate Risk): QT-prolonging Miscellaneous Agents (Moderate Risk) may enhance the QTc-prolonging effect of QT-prolonging Class IC Antiarrhythmics (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy
QT-Prolonging Inhalational Anesthetics (Moderate Risk): QT-prolonging Miscellaneous Agents (Moderate Risk) may enhance the QTc-prolonging effect of QT-Prolonging Inhalational Anesthetics (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy
QT-prolonging Kinase Inhibitors (Moderate Risk): May enhance the QTc-prolonging effect of Azithromycin (Systemic). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy
QT-prolonging Miscellaneous Agents (Moderate Risk): May enhance the QTc-prolonging effect of Azithromycin (Systemic). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy
QT-prolonging Moderate CYP3A4 Inhibitors (Moderate Risk): May enhance the QTc-prolonging effect of QT-prolonging Miscellaneous Agents (Moderate Risk). QT-prolonging Moderate CYP3A4 Inhibitors (Moderate Risk) may increase the serum concentration of QT-prolonging Miscellaneous Agents (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy
QT-prolonging Quinolone Antibiotics (Moderate Risk): QT-prolonging Miscellaneous Agents (Moderate Risk) may enhance the QTc-prolonging effect of QT-prolonging Quinolone Antibiotics (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy
QT-prolonging Strong CYP3A4 Inhibitors (Moderate Risk): May enhance the QTc-prolonging effect of QT-prolonging Miscellaneous Agents (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy
Ranolazine: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Ranolazine. Risk C: Monitor therapy
Red Yeast Rice: Azithromycin (Systemic) may enhance the myopathic (rhabdomyolysis) effect of Red Yeast Rice. Risk C: Monitor therapy
Relugolix: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Relugolix. Management: Avoid coadministration of relugolix with oral P-gp inhibitors whenever possible. If combined, take relugolix at least 6 hours prior to the P-gp inhibitor and monitor patients more frequently for adverse reactions. Risk D: Consider therapy modification
Relugolix, Estradiol, and Norethindrone: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Relugolix, Estradiol, and Norethindrone. Management: Avoid use of relugolix/estradiol/norethindrone with P-glycoprotein (P-gp) inhibitors. If concomitant use is unavoidable, relugolix/estradiol/norethindrone should be administered at least 6 hours before the P-gp inhibitor. Risk D: Consider therapy modification
Repotrectinib: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Repotrectinib. Risk X: Avoid combination
RifAXIMin: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of RifAXIMin. Risk C: Monitor therapy
Rimegepant: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Rimegepant. Management: Avoid administration of another dose of rimegepant within 48 hours if given concomitantly with a P-glycoprotein (P-gp) inhibitor. Risk D: Consider therapy modification
RisperiDONE: Azithromycin (Systemic) may enhance the QTc-prolonging effect of RisperiDONE. Azithromycin (Systemic) may increase the serum concentration of RisperiDONE. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy
RomiDEPsin: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of RomiDEPsin. Risk C: Monitor therapy
Ruxolitinib (Systemic): Azithromycin (Systemic) may increase the serum concentration of Ruxolitinib (Systemic). Risk C: Monitor therapy
Saquinavir: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Saquinavir. Risk C: Monitor therapy
Sertindole: May enhance the QTc-prolonging effect of QT-prolonging Agents (Moderate Risk). Risk X: Avoid combination
Silodosin: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Silodosin. Risk C: Monitor therapy
Simvastatin: Azithromycin (Systemic) may enhance the myopathic (rhabdomyolysis) effect of Simvastatin. Risk C: Monitor therapy
Sincalide: Drugs that Affect Gallbladder Function may diminish the therapeutic effect of Sincalide. Management: Consider discontinuing drugs that may affect gallbladder motility prior to the use of sincalide to stimulate gallbladder contraction. Risk D: Consider therapy modification
Sirolimus (Conventional): P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Sirolimus (Conventional). Management: Avoid concurrent use of sirolimus with P-glycoprotein (P-gp) inhibitors when possible and alternative agents with lesser interaction potential with sirolimus should be considered. Monitor for increased sirolimus concentrations/toxicity if combined. Risk D: Consider therapy modification
Sirolimus (Protein Bound): P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Sirolimus (Protein Bound). Risk X: Avoid combination
Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Risk D: Consider therapy modification
Tacrolimus (Systemic): Azithromycin (Systemic) may increase the serum concentration of Tacrolimus (Systemic). Risk C: Monitor therapy
Talazoparib: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Talazoparib. Risk C: Monitor therapy
Tegaserod (Withdrawn from US Market): P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Tegaserod (Withdrawn from US Market). Risk C: Monitor therapy
Teniposide: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Teniposide. Risk C: Monitor therapy
Tenofovir Disoproxil Fumarate: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Tenofovir Disoproxil Fumarate. Risk C: Monitor therapy
Topotecan: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Topotecan. Risk X: Avoid combination
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Avoid use of live attenuated typhoid vaccine (Ty21a) in patients being treated with systemic antibacterial agents. Postpone vaccination until 3 days after cessation of antibiotics and avoid starting antibiotics within 3 days of last vaccine dose. Risk D: Consider therapy modification
Ubrogepant: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Ubrogepant. Management: Use an initial ubrogepant dose of 50 mg and second dose (at least 2 hours later if needed) of 50 mg when used with a P-gp inhibitor. Risk D: Consider therapy modification
VinCRIStine (Liposomal): P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of VinCRIStine (Liposomal). Risk X: Avoid combination
Vitamin K Antagonists (eg, warfarin): Macrolide Antibiotics may enhance the anticoagulant effect of Vitamin K Antagonists. Risk C: Monitor therapy
Some products may contain sodium and/or sucrose.
Oral suspension may be administered with or without food.
Tablet may be administered with food to decrease GI effects.
Azithromycin crosses the placenta and is present in amniotic fluid (Boelig 2021; Ramsey 2003; Sutton 2015).
Outcome data following maternal use of azithromycin during pregnancy are available (Andersson 2021; Hume-Nixon 2021; Keskin-Arslan 2023; Leke 2021; Mallah 2020).
Some pharmacokinetic properties of azithromycin may be altered during pregnancy (Fischer 2012; Ramsey 2003; Saiman 2010; Sutton 2015). High concentrations of azithromycin are sustained in the myometrium and adipose tissue when given as a single dose prior to cesarean delivery (Ramsey 2003; Sutton 2015). Following a single dose in patients with preterm premature rupture of membranes, azithromycin amniotic fluid concentrations may fall below the MIC for common pathogens within 7 days (Boelig 2021).
Azithromycin may be used as an alternative or adjunctive prophylactic antibiotic in patients undergoing unplanned cesarean delivery (ACOG 2018b). Azithromycin may also be administered to patients with preterm prelabor rupture of membranes (ACOG 2020; SOGC [Ronzoni 2022]). Azithromycin is recommended for the treatment of several infections, including chlamydia, and granuloma inguinale, and prophylaxis of Mycobacterium avium complex in select pregnant patients (consult current guidelines) (CDC [Workowski 2021]; HHS [OI adult] 2023). Azithromycin may also be used in certain situations prior to vaginal delivery in patients at high risk for endocarditis (ACOG 2018a; ACOG 2018b). Azithromycin may be useful for lymphogranuloma venereum during pregnancy; however, dosing and duration of therapy have not been specifically studied in pregnant patients. The treatment of cervicitis in pregnancy is the same as nonpregnant patients (CDC [Workowski 2021]).
Azithromycin is used as an alternative treatment of Lyme disease. Vertical transmission from mother to fetus is not well documented; it is unclear if infection increases the risk of adverse pregnancy outcomes. When treatment for Lyme disease in pregnancy is needed, the indications and dosing of azithromycin are the same as in nonpregnant patients (IDSA/AAN/ACR [Lantos 2021]; Lambert 2020; SOGC [Smith 2020]).
LFTs, CBC with differential; ECG for QT prolongation. Monitor for signs and symptoms of infantile hypertrophic pyloric stenosis (eg, post-prandial nonbilious vomiting, feeding intolerance) in patients <6 weeks of age (Eberly 2015).
Inhibits RNA-dependent protein synthesis at the chain elongation step; binds to the 50S ribosomal subunit resulting in blockage of transpeptidation
Absorption: Oral: Rapid from the GI tract.
Distribution: Extensive tissue; distributes well into skin, lungs, sputum, tonsils, and cervix; penetration into CSF is poor; Vd: 31 to 33 L/kg.
Protein binding (concentration dependent and dependent on alpha1-acid glycoprotein concentrations): Oral, IV: 7% to 51%.
Metabolism: Hepatic to inactive metabolites.
Bioavailability: Oral: Tablet, oral suspension: 34% to 52%; variable effect with food (increased with oral suspension, unchanged with tablet).
Half-life elimination: Terminal: Oral, IV:
Infants and Children 4 months to 15 years: 54.5 hours.
Adults: 68 to 72 hours.
Time to peak, serum: Oral: ~2 to 3 hours.
Excretion: Oral, IV: Biliary (major route 50%, unchanged); urine (6% to 14% unchanged).
Altered kidney function: Cmax and AUC increased 61% and 35%, respectively, in subjects with severe renal impairment.
Older adult: In elderly women, a higher Cmax was observed but there was no change in drug accumulation.
Anti-infective considerations:
Parameters associated with efficacy: Concentration and time dependent, associated with AUC24/minimum inhibitory concentration; goal: ≥25 (Bauernfeind 1995; Craig 1998; Craig 2001; den Hollander 1998; Van Bambeke 2001).
Expected drug exposure in normal renal function:
AUC:
Pediatric patients:
Oral suspension: Multiple dose: 10 mg/kg/dose (maximum dose: 500 mg/dose) on day 1, followed by 5 mg/kg/dose (maximum dose: 250 mg/dose) daily on days 2 to 5.
Infants ≥6 months of age and children ≤5 years of age: AUC24: 1.841 ± 0.651 mg•hour/L (Nahata 1995).
Children ≥6 years of age and adolescents <16 years of age: AUC24: 3.109 ± 1.033 mg•hour/L (Nahata 1993).
IV: Infants ≥6 months of age, children, and adolescents <16 years of age: Single dose: 10 mg/kg (maximum dose: 500 mg): AUC0-72: 8.2 ± 1.7 mg•hour/L (Jacobs 2005).
Adults:
Oral tablet:
Single dose, 500 mg: AUC0-72: 4.3 ± 1.2 mg•hour/L.
Multiple dose (steady state): 500 mg once daily for 3 days: AUC0-∞: 17.4 ± 6.2 mg•hour/L; 500 mg day 1,250 mg once daily on days 2 to 5: AUC0-∞: 14.9 ± 3.1 mg•hour/L.
IV: Single dose, 500 mg: AUC24: 8.03 ± 0.86 mg•hour/L.
Postantibiotic effect: Gram-positive/gram-negative respiratory pathogens: ~2 to 4 hours, varies based on organism (Debbia 1990; Ferrara 1996; Ramadan 1995).
Parameters associated with toxicity: Serum azithromycin levels of ≥0.8 ± 0.4 mg/L have been associated with ototoxicity (Brown 1997).
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