Most recent update(s): National Institutes of Health (NIH) and Infectious Diseases Society of America COVID-19 guidelines recommend against the use of azithromycin (as monotherapy or in combination with hydroxychloroquine or chloroquine) for the treatment of COVID-19.
As part of our response to the evolving COVID-19 pandemic, published literature and guidelines from major health organizations are continuously monitored for potential content updates. At this time, only investigational medications with data determined to be of relatively high quality and/or consistently showing positive clinical outcomes to support dosing recommendations will be included in the monograph, outside of this Special Alert field.
Further information may be found at:
Clinicaltrials.gov: https://clinicaltrials.gov/ct2/results?cond=Covid19&term=azithromycin&cntry=&state=&city=&dist
IDSA: https://www.idsociety.org/COVID19guidelines
Note: Zmax suspension has been discontinued in the United States for >1 year.
Note: ER suspension (Zmax) is not interchangeable with IR formulations. Use should be limited to approved indications. All doses are expressed as IR azithromycin unless otherwise specified.
Acne vulgaris, inflammatory (moderate to severe) (off-label use):
Note: Use as an adjunct to topical acne therapy (AAD [Zaenglein 2016]).
Oral: Dosing regimens used in clinical trials have varied greatly. All trials used pulse-dosing regimens; regimens included: 500 mg once daily for 4 consecutive days per month for 3 consecutive months (Babaeinejad 2011; Parsad 2001) or 500 mg once daily for 3 days in the first week, followed by 500 mg once weekly until week 10 (Maleszka 2011) 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 (Kus 2005). The shortest possible duration should be used to minimize development of bacterial resistance; reevaluate at 3 to 4 months (AAD [Zaenglein 2016]).
Babesiosis (off-label use):
Mild to moderate disease: Oral: 500 mg on day 1, followed by 250 mg once daily in combination with atovaquone (IDSA [Krause 2021]; Krause 2000); higher doses of azithromycin (up to 1 g daily) may be used in highly immunocompromised patients (IDSA [Krause 2021]; Wormser 2010).
Severe disease, initial therapy: IV: 500 mg once daily in combination with atovaquone; may switch to oral azithromycin once symptoms improve (IDSA [Krause 2021]; Sanchez 2016).
Severe disease, oral step-down therapy: Oral: 250 to 500 mg once daily in combination with atovaquone (IDSA [Krause 2021]). Note: Higher doses of azithromycin (up to 1 g daily) may be used in immunocompromised patients (IDSA [Krause 2021]; Sanchez 2016; Wormser 2010).
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, highly immunocompromised patients) (IDSA [Krause 2021]; Krause 2008; Sanchez 2016).
Bronchiectasis (noncystic fibrosis), prevention of pulmonary exacerbations (off-label use): Oral: 500 mg 3 times weekly (BTS [Smith 2020]; Wong 2012) or 250 mg once daily (Altenburg 2013; BTS [Smith 2020]). An initial dose of 250 mg 3 times weekly, with subsequent titration according to patient response, may be considered to minimize adverse effects (BTS [Smith 2020]). Note: Recommended for patients with ≥2 (Barker 2021) or ≥3 (BTS [Smith 2020]; ERS [Polverino 2017]) 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. Patients should be screened for nontuberculous mycobacterial infection prior to treatment, and azithromycin should not be given if present (ERS [Polverino 2017]).
Bronchiolitis obliterans (off-label use):
Bronchiolitis obliterans syndrome in lung transplant recipients, treatment: Oral: 250 mg 3 times weekly (BTS [Smith 2020]; ISHLT/ATS/ERS [Meyer 2014]); some experts recommend an initial dose of 250 mg daily for the first 5 days (ISHLT/ATS/ERS [Meyer 2014]). Usually given for a 3-month trial period (BTS [Smith 2020]; ISHLT/ATS/ERS [Meyer 2014]), but some experts continue indefinitely, regardless of response to therapy (Pilewski 2021). 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 (Bergeron 2017; FDA Drug Safety Communication 2018).
Diffuse panbronchiolitis or symptomatic cryptogenic bronchiolitis obliterans, treatment: Oral: 250 to 500 mg once daily or 3 times weekly (Abtahi 2016; Hui 2013; King 2021b; Li 2011). After a 3- to 6-month trial, long-term therapy may be continued based on response (King 2021a; King 2021b).
Cat scratch disease (lymphadenitis) (off-label use): Oral: 500 mg as a single dose, then 250 mg once daily for 4 additional days (Bass 1998; IDSA [Stevens 2014]; Psarros 2012).
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 (ACOG 199 2018; Tita 2016).
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) (Sethi 2021).
Oral: 500 mg in a single loading dose on day 1, followed by 250 mg once daily on days 2 to 5 (Castaldo 2003) or 500 mg once daily for 3 days (Swanson 2005).
Prevention of exacerbations (off-label use): Oral: 250 to 500 mg 3 times weekly (Berkhof 2013; BTS [Smith 2020]; GOLD 2021; Uzun 2014) or 250 mg once daily (Albert 2011; GOLD 2021). Note: Consider for patients with frequent exacerbations (eg, ≥2 per year) despite optimal medical management (Sethi 2021) or >3 exacerbations per year (at least 1 of which required hospital admission) (BTS [Smith 2020]).
Cystic fibrosis, anti-inflammatory (off-label use):
Note: Some experts reserve for patients with chronic pseudomonal infection or frequent exacerbations despite other therapies (Mogayzel 2013; Simon 2021).
Oral: 250 mg (<40 kg) or 500 mg (≥40 kg) 3 times weekly (Saiman 2003) or 250 mg once daily (Wolter 2002). Note: Patients should be screened for nontuberculous mycobacterial infection prior to treatment and azithromycin should not be given if present (Mogayzel 2013; Saiman 2003).
Diarrhea, infectious (off-label use):
Campylobacter gastroenteritis: Oral: 1 g as a single dose or 500 mg once daily for 3 days (ACG [Riddle 2016]; Tribble 2007). If symptoms have not resolved after 24 hours following single-dose therapy, continue with 500 mg once daily for 2 more days (ACG [Riddle 2016]). For HIV-infected patients, 500 mg once daily for 5 days is recommended (HHS [OI adult] 2020). Note: Increased nausea may occur with the 1 g single-dose regimen (Tribble 2007), which may be reduced by administering azithromycin as 2 divided doses on the same day (CDC 2018; Riddle 2017).
Cholera (alternative agent): Oral: 1 g as a single dose (Saha 2006).
Shigella gastroenteritis: Note: Confirm susceptibility if possible (Agha 2021; HHS [OI adult] 2020; WHO 2005). Oral: 500 mg once daily for 3 days (ACG [Riddle 2016]); 5 days of therapy should be given for Shigella dysenteriae type 1 infection or for patients with HIV coinfection (Agha 2021; HHS [OI adult] 2020).
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) (LaRocque 2017; Riddle 2017) or certain high-risk travelers (eg, those with an immunocompromising condition) (LaRocque 2021).
Oral: 1 g as a single dose or 500 mg once daily for 3 days (ACG [Riddle 2016]; CDC 2018; Riddle 2017; Tribble 2007). 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 (ACG [Riddle 2016]). Increased nausea may occur with the 1 g single-dose regimen (Tribble 2007), which may be reduced by administering azithromycin as 2 divided doses on the same day (CDC 2018; Riddle 2017).
Endocarditis prophylaxis, dental or invasive respiratory tract procedure (alternative agent for penicillin-allergic patients) (off-label use): 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. 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) (AHA [Wilson 2007]; AHA [Wilson 2021]).
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) (IDSA/AAN/ACR [Lantos 2021]).
Mycobacterial (nontuberculous) infection:
Mycobacterium avium complex (MAC) infection:
Disseminated disease in patients with HIV:
Treatment: Oral: 500 to 600 mg daily as part of a combination therapy regimen (HHS [OI adult] 2020).
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 (HHS [OI adult] 2020; IAS-USA [Saag 2018]).
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 (HHS [OI adult] 2020).
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 (ATS/ERS/ESCMID/IDSA [Daley 2020]; BTS [Haworth 2017]).
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 (ATS/ERS/ESCMID/IDSA [Daley 2020]; BTS [Haworth 2017]; Deshpande 2016; van Ingen 2012); continue treatment until patient is culture negative on therapy for ≥1 year (ATS/ERS/ESCMID/IDSA [Daley 2020]; BTS [Haworth 2017]). Preliminary data suggest a relationship between peak concentration and clinical outcome among patients receiving daily therapy for pulmonary MAC (Jeong 2016); as such, some experts recommend checking levels and/or using higher doses of azithromycin (Kasperbauer 2020).
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 (CFF/ECFS [Floto 2016]).
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 (ATS/ERS/ESCMID/IDSA [Daley 2020]; CFF/ECFS [Floto 2016]; Griffith 2020).
Pulmonary, skin, 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/soft tissue infections (ATS/ERS/ESCMID/IDSA [Daley 2020]; CFF/ECFS [Floto 2016]; Griffith 2020). Note: Patients should be under the care of a clinician with expertise in managing mycobacterial infection (ATS/ERS/ESCMID/IDSA [Daley 2020]).
Pertussis (off-label use): Oral: 500 mg on day 1, followed by 250 mg once daily on days 2 to 5 (CDC [Tiwari 2005]).
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 (Amsden 1999; ATS/IDSA [Metlay 2019]; Schönwald 1991). 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 (ATS/IDSA [Metlay 2019]); some experts prefer to use as part of an appropriate combination regimen in all outpatients, regardless of comorbidities (File 2021).
Inpatient: Oral, IV: 500 mg once daily for a minimum of 3 days, as part of an appropriate combination regimen (ATS/IDSA [Metlay 2019]; File 2021).
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%) (CDC [Workowski 2021]; Powell 2021).
Chancroid (due to Haemophilus ducreyi ): Oral: 1 g as a single dose. Note: Data are limited concerning efficacy in HIV infected patients (CDC [Workowski 2021]).
Gonococcal infection, uncomplicated (infection of the cervix, rectum [off-label use], or urethra ) (alternative agent):
Note: Reserve for patients who cannot use ceftriaxone (CDC [Workowski 2021]).
Oral: 2 g as a single dose in combination with IM gentamicin (preferred) or oral gemifloxacin (CDC [Workowski 2021]; Seña 2022). 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 (CDC [Workowski 2021]).
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 (CDC [Workowski 2021]).
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 (CDC [Workowski 2021]).
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 (CDC [Workowski 2021]).
Oral: 1 g on day 1, followed by 500 mg once daily on days 2 through 4 (CDC [Workowski 2021]; Durukan 2020; Read 2019).
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 [Bachmann 2021]); give in combination with ceftriaxone if there is microscopic evidence of gonococcal urethritis or if there is high clinical suspicion of gonococcal infection (Bachmann 2021; CDC [Workowski 2021]).
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 (IDSA [Shulman 2012]) or 12 mg/kg (maximum: 500 mg) once daily for 5 days (Pichichero 2022).
Secondary prophylaxis in patients with rheumatic fever (prevention of recurrent attacks) (off-label use): Note: Optimal dose not well defined (AHA [Gerber 2009]).
Oral: 250 mg once daily (Pichichero 2022). Duration depends on risk factors, age, and presence of valvular disease (AHA [Gerber 2009]).
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 (Shih 2020). Note: The optimal dosing regimen has not been established; various protocols are in use (RCOG 2015; White 2018; White 2019).
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 (Höffler 1995).
Hemodialysis: No dosage adjustment or supplemental dose necessary (Aronoff 2007; Heintz 2009).
Peritoneal dialysis: Minimally dialyzed (Kent 2001): No dosage adjustment or supplemental dose necessary (Ma 2014).
CRRT: No dosage adjustment or supplemental dose necessary (Aronoff 2007; Heintz 2009).
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): Pediatric drug information")
Note: Extended-release suspension (Zmax) is not interchangeable with immediate-release formulations. All doses are expressed as immediate-release azithromycin unless otherwise specified. Zmax 2 g extended-release oral suspension has been discontinued in the US for >1 year.
General dosing, susceptible infection (Red Book [AAP 2018]): 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.
IV: 10 mg/kg once daily; maximum dose: 500 mg/dose.
Babesiosis: Limited data available: Infants, Children, and Adolescents: 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 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; in immunocompromised patients, higher doses (eg, adults: 600 to 1,000 mg daily) have been used (IDSA [Wormser 2006]; Red Book [AAP 2018]).
Cat scratch disease (Bartonella henselae) (lymphadenitis) (IDSA [Stevens 2014]): 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.
Cervicitis or urethritis, empiric treatment: Limited data available:
Infants and Children <45 kg: Optimal dose uncertain: Oral: 60 mg/kg as a single dose in combination with ceftriaxone; maximum dose: 1,000 mg/dose (Red Book [AAP 2018]).
Children ≥45 kg and Adolescents: Oral: 1,000 mg as a single dose in combination with ceftriaxone (CDC [Workowski 2015]; Red Book [AAP 2018]).
Chancroid (Haemophilus ducreyi)(CDC [Workowski 2015]; Red Book [AAP 2018]): Limited data available:
Infants and Children <45 kg: Oral: 20 mg/kg as a single dose; maximum dose: 1,000 mg/dose.
Children ≥45 kg and Adolescents: Oral: 1,000 mg as a single dose.
Chlamydia trachomatis infection:
Urogenital/anogenital tract or oropharyngeal infection (eg, cervicitis, urethritis): Oral: Children <8 years weighing ≥45 kg or Children ≥8 years and Adolescents: Oral: 1,000 mg as a single dose (CDC [Workowski 2015]; Red Book [AAP 2018]).
Pneumonia, congenital: Infants: Oral, IV: 20 mg/kg/dose once daily for 3 days (CDC [Workowski 2015]; Red Book [AAP 2018]).
Cystic fibrosis; improve lung function, reduce exacerbation frequency: Limited data available; dosing regimen variable (Mogayzel 2013; Saiman 2003; Saiman 2010):
Children ≥6 years and Adolescents: Oral:
18 to 35.9 kg: 250 mg three times weekly (Monday, Wednesday, Friday).
≥36 kg: 500 mg three times weekly (Monday, Wednesday, Friday).
Diarrhea, infectious:
Campylobacter infection:
Non-HIV-exposed/-infected: Infants, Children, and Adolescents: Oral: 10 mg/kg/dose once daily for 3 days (Red Book [AAP 2018]); maximum dose: 500 mg/dose (Riddle 2017).
HIV-exposed/-infected: Adolescents: Oral: 500 mg once daily for 5 days (HHS [adult OI 2020].
Shigellosis:
Non-HIV-exposed/-infected: Infants, Children, and Adolescents: Oral: 10 mg/kg/dose once daily for 3 days (Dupont 2009; Mackell 2005); maximum dose: 500 mg/dose (Riddle 2017); WHO Guidelines recommend up to 20 mg/kg/dose (usual adult dose: 1,000 to 1,500 mg/dose) and in some cases, a wider range of duration of therapy (eg, 1 to 5 days) (WHO 2005).
HIV-exposed/-infected: Adolescents: Oral: 500 mg once daily for 5 days (HHS [adult OI 2020].
Endocarditis; prophylaxis: Infants, Children, and Adolescents: Oral: 15 mg/kg/dose 30 to 60 minutes before procedure; maximum dose: 500 mg/dose (AHA [Wilson 2007]).
Gonococcal infection: Limited data available:
Uncomplicated gonococcal infections of the cervix, urethra, or rectum (alternative agent in severe cephalosporin allergy): Children >45 kg and Adolescents: Oral: 2,000 mg as a single dose in combination with IM gentamicin (CDC [St. Cyr 2020]; CDC [Workowski 2015]). 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 (CDC [St. Cyr 2020]; CDC [Workowski 2015]).
Disseminated gonococcal infection (arthritis, arthritis-dermatitis, meningitis, endocarditis): Children >45 kg and Adolescents: Oral: 1,000 mg as a single dose in combination with daily ceftriaxone (CDC [Workowski 2015]); Red Book [AAP 2018]).
Gonococcal conjunctivitis: Children >45 kg and Adolescents: Oral: 1,000 mg as a single dose in combination with ceftriaxone (CDC [Workowski 2015]); Red Book [AAP 2018]).
Group A streptococcal infection; treatment of streptococcal tonsillopharyngitis (alternative agent for severely penicillin-allergic patients) (IDSA [Shulman 2012]):
Manufacturer's labeling and AHA recommendations: Infants, Children, and Adolescents: Oral: 12 mg/kg/dose once daily for 5 days; maximum dose: 500 mg/dose (AHA [Gerber 2009]).
Alternate dosing:
IDSA recommendations: Infants, Children, and Adolescents: Oral: 12 mg/kg (maximum: 500 mg/dose) on day 1 followed by 6 mg/kg/dose (maximum: 250 mg/dose) once daily on days 2 through 5 (IDSA [Shulman 2012]).
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 (Cohen 2004; O'Doherty 1996).
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 (IDSA/AAN/ACR [Lantos 2021]).
Meningococcal disease, chemoprophylaxis of high-risk contacts: Infants, Children, and Adolescents: Oral: 10 mg/kg as a single dose; maximum dose: 500 mg/dose; Note: Not routinely recommended; may consider if fluoroquinolone resistance detected (Red Book [AAP 2018]).
Mycobacterium avium complex (MAC) infection (HIV-exposed/-infected):
Infants and Children (HHS [pediatric OI 2019]):
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 (HHS [adult OI 2020]):
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): Infants ≥6 months, Children, and Adolescents: Oral: Note: Due to increased S. pneumonia and H. influenzae resistance, azithromycin is not routinely recommended as a treatment option (AAP [Lieberthal 2013]).
Single-dose regimen: 30 mg/kg 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 data available on safety.
Three-day regimen: 10 mg/kg once daily for 3 days; maximum dose: 500 mg/dose.
Five-day regimen: 10 mg/kg once on day 1 (maximum dose: 500 mg/dose), followed by 5 mg/kg (maximum dose: 250 mg/dose) once daily on days 2 to 5.
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 (Warady [ISPD 2012]).
Pertussis (CDC 2005; Red Book [AAP 2018]): Oral, IV:
Infants 1 to 5 months: 10 mg/kg/dose once daily for 5 days.
Infants ≥6 months, Children, and Adolescents: 10 mg/kg once on day 1 (maximum dose: 500 mg/dose), followed by 5 mg/kg 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) (IDSA/PIDS [Bradley 2011]):
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 (IDSA/PIDS [Bradley 2011]).
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 (IDSA/PIDS [Bradley 2011]).
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 (Stokholm 2016).
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 (AAP [Wald 2013]); IDSA [Chow 2012]).
Sexual victimization, prophylaxis: Note: Consider administering hepatitis B or human papillomavirus vaccines if needed based on patient's immunization status (CDC [Workowski 2015]; Red Book [AAP 2018]).
Adolescents: Oral: 1,000 mg as a single dose in combination with ceftriaxone and either metronidazole or tinidazole (CDC [Workowski 2015]; Red Book [AAP 2018]).
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 (Aronoff 2007).
Hemodialysis: There are no dosage adjustments provided in the manufacturer's labeling; however, some experts suggest no dosage adjustment or supplemental doses are necessary (Aronoff 2007).
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 (Aronoff 2007). Based on adult information, azithromycin is not removed with continuous ambulatory peritoneal dialysis (Kent 2001).
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 (Aronoff 2007).
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.
Refer to adult dosing.
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
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
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, 600 mg
Generic: 250 mg, 500 mg [DSC], 600 mg
Zmax suspension has been discontinued in the US for more than 1 year.
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: Immediate release suspension and tablet may be taken without regard to food; extended release suspension should be taken on an empty stomach (at least 1 hour before or 2 hours following a meal), within 12 hours of reconstitution.
Oral:
Immediate release: May administer without regard to food; do not administer with antacids that contain aluminum or magnesium.
Oral suspension, multiple doses: 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.
Oral, IV:
Chancroid: Treatment of genital ulcer disease (in men) due to Haemophilus ducreyi (chancroid)
Chronic obstructive pulmonary disease, acute exacerbation: Treatment of acute bacterial exacerbations of chronic obstructive pulmonary disease (COPD) due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae
Mycobacterium avium complex: Prevention of Mycobacterium avium complex (MAC) in patients with advanced HIV infection; treatment of disseminated MAC (in combination with ethambutol) in patients with advanced HIV infection
Otitis media, acute: Treatment of acute otitis media due to H. influenzae, M. catarrhalis, or S. pneumoniae
Pneumonia, community-acquired: Treatment of community-acquired pneumonia (CAP) due to Chlamydophila pneumoniae, H. influenzae, Legionella pneumophila, M. catarrhalis, Mycoplasma pneumoniae, or S. pneumoniae
Skin and skin structure infection, uncomplicated: Treatment of uncomplicated skin and skin structure infections due to Staphylococcus aureus, Streptococcus pyogenes, or Streptococcus agalactiae
Streptococcal pharyngitis, group A: Treatment of pharyngitis/tonsillitis due to S. pyogenes as an alternative to first-line therapy
Urethritis/cervicitis: Treatment of urethritis and cervicitis due to Chlamydia trachomatis or Neisseria gonorrhoeae. Note: CDC sexually transmitted infections treatment guidelines only recommend azithromycin (in combination with gentamicin) for uncomplicated gonococcal infection of the cervix or urethra in patients who have a cephalosporin allergy (CDC [Workowski 2021]).
Acne vulgaris; Babesiosis; Bronchiectasis (noncystic fibrosis), prevention of pulmonary exacerbations; Bronchiolitis obliterans syndrome in lung transplant recipients; Bronchiolitis obliterans, diffuse panbronchiolitis and symptomatic cryptogenic bronchiolitis obliterans; Campylobacter gastroenteritis; Cat scratch disease; Cesarean delivery (intrapartum or after rupture of membranes), preoperative prophylaxis; Cholera; Chronic obstructive pulmonary disease, prevention of exacerbations; Cystic fibrosis, anti-inflammatory; Endocarditis prophylaxis; Gonococcal infection, uncomplicated (infection of the rectum); Granuloma inguinale (donovanosis); Lyme disease (Borrelia spp. infection), erythema migrans; Lymphogranuloma venereum; Mycobacterial (nontuberculous, rapidly growing) infection; Mycoplasma genitalium; Pertussis; Shigella gastroenteritis; Streptococcus (group A), secondary prophylaxis in patients with rheumatic fever (prevention of recurrent attacks); Surgical prophylaxis, uterine evacuation (induced abortion or pregnancy loss); Travelers' diarrhea, empiric treatment
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]).
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.
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).
Dosage form specific issues:
• Oral suspensions: Immediate release and extended release suspensions are not interchangeable.
Substrate of CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential; Inhibits P-glycoprotein/ABCB1
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
AtorvaSTATin: Azithromycin (Systemic) may enhance the myopathic (rhabdomyolysis) effect of AtorvaSTATin. Risk C: Monitor therapy
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: Colchicine is contraindicated in patients with impaired renal or hepatic function who are also receiving a P-gp inhibitor. In those with normal renal and hepatic function, reduce colchicine dose as directed. 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
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
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
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
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
Immune Checkpoint Inhibitors: Antibiotics may diminish the therapeutic effect of Immune Checkpoint Inhibitors. 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
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: P-glycoprotein/ABCB1 Inhibitors 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
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): QT-prolonging Miscellaneous Agents (Moderate Risk) 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 Kinase 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
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). QT-prolonging Strong CYP3A4 Inhibitors (Moderate Risk) may increase the serum concentration of QT-prolonging Miscellaneous Agents (Moderate Risk). Risk X: Avoid combination
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
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: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of RisperiDONE. Risk C: Monitor therapy
RomiDEPsin: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of RomiDEPsin. Risk C: Monitor therapy
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
Sodium Stibogluconate: QT-prolonging Miscellaneous Agents (Moderate Risk) may enhance the QTc-prolonging effect of Sodium Stibogluconate. 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
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: P-glycoprotein/ABCB1 Inhibitors may increase the serum concentration of Tegaserod. 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
Toremifene: Azithromycin (Systemic) may enhance the QTc-prolonging effect of Toremifene. Risk C: Monitor therapy
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 increase the serum concentration of Vitamin K Antagonists. Risk C: Monitor therapy
Rate and extent of GI absorption may be altered depending upon the formulation. Azithromycin suspension, not tablet form, has significantly increased absorption (46%) with food. Management: Immediate release suspension and tablet may be taken without regard to food; extended release suspension should be taken on an empty stomach (at least 1 hour before or 2 hours following a meal).
Azithromycin crosses the placenta (Ramsey 2003).
The maternal serum half-life of azithromycin is unchanged in early pregnancy and decreased at term; however, high concentrations of azithromycin are sustained in the myometrium and adipose tissue (Fischer 2012; Ramsey 2003).
Azithromycin may be used as an alternative or adjunctive prophylactic antibiotic in patients undergoing unplanned cesarean delivery (ACOG 2018). Azithromycin is recommended for the treatment of several infections, including chlamydia, granuloma inguinale, and Mycobacterium avium complex in pregnant patients (consult current guidelines) (CDC [Workowski 2021]; HHS [OI adult 2020]). Azithromycin may also be used in certain situations prior to vaginal delivery in patients at high risk for endocarditis (ACOG 2018). 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 non-pregnant patients (IDSA/AAN/ACR [Lantos 2021]; Lambert 2020; SOGC [Smith 2020]).
Azithromycin is present in breast milk.
Following administration of oral azithromycin 2 g as a single dose to 20 women during labor, azithromycin was measurable in breast milk for up to 28 days; adverse events were not observed in the breastfed infants (Salman 2015). In a different study, a woman was given oral azithromycin as a 1 g loading dose followed in 48 hours by azithromycin 500 mg for 3 days; milk concentrations increased over time and reached a peak 30 hours after the last oral dose (Kelsey 1994). In a third study, the median half-life in breast milk was 15.6 hours (Sutton 2015).
Decreased appetite, diarrhea, rash, and somnolence have been reported in nursing infants exposed to macrolide antibiotics (Goldstein 2009). In general, antibiotics that are present in breast milk may cause non-dose-related modification of bowel flora. Monitor infants for GI disturbances (WHO 2002). In addition, an increased risk for infantile hypertrophic pyloric stenosis (IHPS) may be present in infants who are exposed to macrolides via breast milk, especially during the first 2 weeks of life (Lund 2014); however, data are conflicting (Goldstein 2009). According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.
The CDC's Sexually Transmitted Diseases Treatment Guidelines state that azithromycin is one of the recommended agents for the treatment of granuloma inguinale in lactating patients (CDC [Workowski 2021]).
Some products may contain sodium and/or sucrose.
Oral suspension, immediate release, may be administered with or without food.
Oral suspension, extended release, should be taken on an empty stomach (at least 1 hour before or 2 hours following a meal).
Tablet may be administered with food to decrease GI effects.
LFTs, symptoms of hepatitis (malaise, nausea, vomiting, abdominal colic, fever), CBC with differential, audiogram with prolonged use, ECG for QTc prolongation (ATS/ERS/ESCMID/IDSA [Daley 2020]).
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, immediate release oral suspension: 34% to 52%; extended release oral suspension: 28% to 43%; variable effect with food (increased with immediate or delayed release oral suspension, unchanged with tablet)
Half-life elimination: Terminal: Oral, IV:
Infants and Children 4 months to 15 years: 54.5 hours
Adults: Immediate release: 68 to 72 hours; Extended release: 59 hours
Time to peak, serum: Oral: Immediate release: ~2 to 3 hours; Extended release: 3 to 5 hours
Excretion: Oral, IV: Biliary (major route 50%, unchanged); urine (6% to 14% unchanged)
Renal function impairment: Cmax and AUC increased 61% and 35%, respectively, in subjects with severe renal impairment.
Geriatric: 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 IR 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.
Oral ER tablet: Single dose, 2 g: AUC0-120: 14.8 ± 3.16 mg•hour/L (Liu 2007).
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).
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
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