_† non-FDA-approved indication

Azithromycin (Zithromax) Indications and Dosage

NOTE: To reduce the development of drug-resistant bacteria and maintain the effectiveness of antibacterial drugs, this drug should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

The following organisms are generally considered susceptible to azithromycin in vitro: Bacillus anthracis; Bacteroides bivius; Bordetella pertussis; Campylobacter jejuni; Chlamydia pneumoniae; Chlamydia trachomatis; Clostridium perfringens; Gardnerella vaginalis; Haemophilus ducreyi; Haemophilus influenzae (beta-lactamase negative); Haemophilus influenzae (beta-lactamase positive); Helicobacter pylori _† ; Legionella pneumophila; Moraxella catarrhalis; Mycobacterium avium; Mycobacterium intracellulare; Mycoplasma pneumoniae; Neisseria gonorrhoeae; Peptostreptococcus sp.; Rickettsia tsutsugamushi _† , Staphylococcus aureus (MSSA); Staphylococcus epidermidis; Streptococcus agalactiae (group B streptococci); Streptococcus pneumoniae; Streptococcus pyogenes (group A beta-hemolytic streptococci); Toxoplasma gondii; Treponema pallidum; Ureaplasma urealyticum.

For the treatment of mild to moderate acute bacterial exacerbations of chronic bronchitis in patients with COPD caused by susceptible strains of Haemophilus influenza, Moraxella catarrhalis, or Streptococcus pneumoniae:
Oral dosage:
Adults and adolescents >= 16 years: The recommended dose is either 500 mg PO once daily for 3 days (e.g., Zithromax® Tri-Pak™) or 500 mg PO on first day of therapy, followed by 250 mg PO once daily for 4 days (e.g., Z-Pak®). Total cumulative dose 1.5 g.

Oral dosage (extended release oral suspension, e.g., Zmax™) _† :
Adults: 2 g PO as a single dose was reported to be as effective as a 7-day course of levofloxacin in a multicenter, randomized, double-blind, double-dummy study.

For the treatment of moderate upper respiratory tract infections due to susceptible strains of H. influenzae or S. pneumoniae:
Oral dosage (includes Z-pak® packaging):
Adults and adolescents: The recommended dose is 500 mg PO on first day of therapy, followed by 250 mg PO once daily for 4 days. Total cumulative dose 1.5 g.

Oral dosage (immediate-release oral suspension):
Children >= 2 years: The recommended dose is 12 mg/kg PO once daily for 5 days for a total course of 60 mg/kg azithromycin. Daily dose should not exceed 500 mg/day. A meta-analysis of randomized control trials reported that this 5-day regimen (total dose of 60 mg/kg azithromycin) was more effective in producing eradication and clinical cure of group A streptococcal tonsillopharyngitis than a 3-day regimen totalling 30 mg/kg of azithromycin.
Children < 2 years: Safe and effective use not established.

Oral dosage (immediate-release oral suspension):
Infants and Children >= 6 months to 12 years: 10 mg/kg PO once daily for 3 days.
Infants < 6 months: Safe and effective use not established.

Oral dosage (extended release oral suspension, e.g., Zmax™):
Adults: 2 g PO as a single dose.

For the treatment of acute otitis media:
Oral dosage (immediate-release oral suspension):
Children and infants >= 6 months: 30 mg/kg PO as a single dose or 10 mg/kg PO once daily (not to exceed 500 mg/day) for 3 days or 10 mg/kg PO as a single dose on day 1 followed by 5 mg/kg/day on days 2 - 5. The 30 mg/kg single dose regimen resulted in clinical cure rates similar to those seen with the 3- and 5-day regimens. A double-blind, double-dummy international study in children aged 6 to 30 months compared a single dose of azithromycin (30 mg/kg PO; n=158) and a 10-day regimen of high dose amoxicillin; clavulanic acid (45 mg/kg/day given twice daily; n=154) for treatment of uncomplicated acute otitis media. Azithromycin was shown to be as effective as amoxicillin; clavulanic acid and was associated with a lower rate of adverse reactions and better compliance.

For the treatment of community-acquired pneumonia (CAP) due to susceptible strains of Chlamydia pneumoniae, H. influenzae, Mycoplasma pneumoniae, or S. pneumoniae:

Oral dosage (includes Z-pak® packaging):
Adults and adolescents: 500 mg PO on first day of therapy, followed by 250 mg PO once daily.

Oral dosage (extended release oral suspension, e.g., Zmax™):
Adults: 2 g PO as a single dose.

Intravenous dosage:
Adults and adolescents >= 16 years: Initially, 500 mg IV as a single daily dose for at least 2 days followed by 500 mg PO once daily to complete a 7 - 10 day course of therapy. The switch to oral therapy should be done at the discretion of the physician and based on the clinical response of the patient.

Oral dosage (includes Z-pak® packaging):
Adults and adolescents: 500 mg PO on first day of therapy, followed by 250 mg PO once daily.

Oral dosage (extended release oral suspension, e.g., Zmax™):
Adults: 2 g PO as a single dose.

Intravenous dosage:
Adults and adolescents >= 16 years: Initially, 500 mg IV as a single daily dose for at least 2 days followed by 500 mg PO once daily. The switch to oral therapy should be done at the discretion of the physician and based on the clinical response of the patient.

Oral dosage (includes Z-pak® packaging):
Adults and adolescents: 500 mg PO on first day of therapy, followed by 250 mg PO once daily.

Oral dosage (extended release oral suspension, e.g., Zmax™):
Adults: 2 g PO as a single dose.

Intravenous dosage:
Adults and adolescents >= 16 years: Initially, 500 mg IV as a single daily dose for at least 2 days followed by 500 mg PO once daily. The switch to oral therapy should be done at the discretion of the physician and based on the clinical response of the patient.

Oral dosage (includes Z-pak® packaging):
Adults and adolescents: 500 mg PO on first day of therapy, followed by 250 mg PO once daily.

Oral dosage (extended release oral suspension, e.g., Zmax™):
Adults: 2 g PO as a single dose.

Intravenous dosage:
Adults and adolescents >= 16 years: Initially, 500 mg IV as a single daily dose for at least 2 days followed by 500 mg PO once daily. The switch to oral therapy should be done at the discretion of the physician and based on the clinical response of the patient.

Oral dosage (extended release oral suspension, e.g., Zmax™):
Adults: 2 g PO as a single dose.

Intravenous dosage:
Adults and adolescents >= 16 years: Initially, 500 mg IV as a single daily dose for at least 2 days followed by 500 mg PO once daily. The switch to oral therapy should be done at the discretion of the physician and based on the clinical response of the patient.

For the treatment of lower respiratory tract infections due to susceptible strains of Chlamydia pneumoniae, H. influenzae, Mycoplasma pneumoniae, or S. pneumoniae:
Oral dosage (includes Z-pak® packaging):
Adults and adolescents: 500 mg PO on first day of therapy, followed by 250 mg PO once daily for 4 days. Total cumulative dose 1.5 g.

Oral dosage (immediate-release oral suspension):
Children and infants >= 6 months: 10 mg/kg PO as a single dose on day 1 followed by 5 mg/kg/day on days 2 - 5. Maximum daily dose is 500 mg/day.

Oral dosage (extended release oral suspension, e.g., Zmax™):
Adults: 2 g PO as a single dose.

Intravenous dosage:
Adults and adolescents >= 16 years: Initially, 500 mg IV as a single daily dose for at least 2 days followed by 500 mg PO once daily to complete a 7 - 10 day course of therapy. The switch to oral therapy should be done at the discretion of the physician and based on the clinical response of the patient.

For secondary prevention of coronary heart disease _† in patients with Chlamydia pneumoniae infection:
Oral dosage:
Adults: Azithromycin was shown not to reduce the incidence of coronary heart disease events in stable patients who had a previous myocardial infarction and evidence of Chlamydia pneumoniae infection. The WIZARD (Weekly Intervention with Zithromax for Atherosclerosis and its Related Disorders) study was a randomized, placebo-controlled study of 7747 patients with previous MI that had occurred at least 6 weeks prior to the study and a C. pneumoniae IgG titer of 1:16 or more. Patients received either azithromycin 600 mg/day for 3 days during week 1, then 600 mg/week during weeks 2 - 12 or placebo. Primary endpoints were first occurrence of death from any cause, nonfatal reinfarction, coronary revascularization, or hospitalization for angina. The study concluded after 14 months and reported that there was no significant risk reduction associated with azithromycin therapy versus placebo.

For the treatment of uncomplicated skin and skin structure infections caused by Staphylococcus pyrogenes or S. agalactiae.
Oral dosage (includes Z-pak® packaging):
Adults and adolescents >= 16 years: The recommended dose is 500 mg PO on first day of therapy, followed by 250 mg PO once daily for 4 days. Total cumulative dose 1.5 g. In a comparative study (n=296), this dosing regimen for azithromycin was shown to be as effective as a 10-day course of cefadroxil (500 mg PO twice daily).

For the treatment of pelvic inflammatory disease (PID):
NOTE: Azithromycin is not included in the current CDC recommendations for the treatment of pelvic inflammatory disease, however, the manufacturer’s product literature offers the following dosage regimen.

Intravenous and oral dosage:
Adults: 500 mg IV as a single daily dose for 1 or 2 days followed by oral therapy at 250 mg PO once daily to complete a 7 day course of therapy. According to the manufacturer, an antimicrobial agent with anaerobic activity should be administered in combination with azithromycin if anaerobic microorganisms are suspected. One comparative study showed that azithromycin alone or in combination with metronidazole was as effective as two common regimens, doxycycline plus amoxicillin-clavulanate or metronidazole plus doxycycline, cefoxitin, and probenecid.

For the treatment of urethritis and cervicitis:

For the treatment of persons recently exposed, through sexual intercourse within the last 30 days, to sexual partners with infectious syphilis _† :
Oral dosage:
Adults and adolescents: 1 g PO as a single dose has been reported to be effective in preventing the disease. Because treatment failures have been reported, use of azithromycin in areas (i.e., San Francisco, CA) where macrolide resistance in T. pallidum is high should be avoided.

For the treatment of chancroid (genital ulcer disease) due to Haemophilus ducreyi:
Oral dosage:
Adults: The CDC recommends 1 g PO as a single dose. A longer course of therapy may be required in HIV-infected patients and uncircumcised men.

For the treatment of chronic prostatitis _† due to Ureaplasma urealyticum:
Oral dosage:
Adults: In a pilot study, azithromycin 500 mg PO daily for 3 days repeated every week for 3 weeks (total dose = 4500 mg) was compared to doxycycline 100 mg PO twice daily for 21 days. Patients were randomized to the doxycycline (n=31) or azithromycin (n=32) regimen; sexual partners were also treated at the same time. Eradication rates and clinical cure rates were similar between the groups.

For the treatment of Legionnaire’s disease _† :
Oral dosage:
Adults: A dose of 500 mg PO once daily has been recommended.

For the treatment of Mycobacterium avium complex (MAC) _† disease:
Oral dosage:
Adults: A dose of 500 - 1000 mg PO once daily has been used.
Children _† : Although definitive dosage recommendations have not been established, doses of 10 - 20 mg/kg PO once daily (max: 40 mg/kg/day) have been used in clinical trials.

For Mycobacterium avium complex (MAC) prophylaxis in HIV-infected patients:

For the treatment of shigellosis _† diarrhea in non-immunocompromised patients:
Oral dosage:
Adults: Both ciprofloxacin and azithromycin were found to be highly effective in the treatment of men in Bangladesh with shigellosis lasting less than 72 hours. The dose of azithromycin in this double-blind, randomized study was 500 mg PO on day 1, followed by 250 mg PO once daily for the next 4 days.

For the treatment of toxoplasmosis _† , including toxoplasmic encephalitis _† , in HIV-positive patients:
Oral dosage:
Adults: Only case reports are available describing the use of azithromycin for the treatment of toxoplasmosis in humans. In one case, a 30 year-old HIV-positive male, azithromycin 150 mg PO once daily was added to a regimen of clindamycin and doxycycline and success was observed. In another case, a 28 year-old HIV-positive male, azithromycin was substituted when the patient developed a rash while receiving clindamycin, pyrimethamine, and leucovorin. An initial azithromycin dose of 1500 mg PO was given, followed by 1000 mg PO once daily. After 6 weeks, the patient and a corresponding MRI were improved and the maintenance dose was lowered to 500 mg PO once daily. A final scan after 6 months of therapy showed no recurrence.

For the treatment of early Lyme disease _† :
Oral dosage:
Adults: A dose of 500 mg PO once daily for 5 - 10 days has been used.

For the treatment of dental infection _† , including dentoalveolar infection _† :

For bacterial endocarditis prophylaxis _† during dental, oral, respiratory tract, or esophageal procedures in amoxicillin-, ampicillin-, and penicillin-allergic patients:
Oral dosage:
Adults: A dose of 500 mg PO one hour before the procedure has been used.
Children: A dose of 15 mg/kg PO one hour before the procedure has been used. Dosage should not exceed 500 mg.

For the treatment of babesiosis _† in combination with atovaquone:
Oral dosage:
Adults: A prospective, unblinded, randomized trial compared the efficacy of an atovaquone/azithromycin regimen with the standard quinine/clindamycin regimen for treatment of babesiosis. Patients received either atovaquone (750 mg PO every 12 hours) plus azithromycin (500 mg PO on day 1, followed by 250 mg PO once daily for seven days) or the quinine/clindamycin regimen. The atovaquone/azithromycin regimen was as effective as the quinine/clindamycin regimen but with less adverse reactions.

For the treatment of granuloma inguinale _† (i.e., donovanosis):
Oral dosage:
Adults and adolescents: The CDC recommends 1 g PO once per week for a minimum of 3 weeks as an alternative to co-trimoxazole or doxycycline. The addition of an aminoglycoside (e.g., gentamicin) should be considered if lesions do not respond within the first few days of therapy or if the patient also has HIV infection. NOTE: Co-trimoxazole and doxycycline are considered first-line agents by the CDC.

For use in improving pulmonary function in cystic fibrosis _† patients chronically infected with Pseudomonas aeruginosa:
Oral dosage:
Adults, adolescents, and children >= 6 years: A randomized clinical trial evaluated whether azithromycin improves pulmonary function in patients with cystic fibrosis infected with Pseudomonas aeruginosa. Patients received either azithromycin 250 mg PO or placebo 3 days per week (Mon, Wed, Fri) for 168 days. At the end of the study, those receiving azithromycin showed greater improvements in FEV1 and had a decrease in pulmonary exacerbations. The azithromycin patient group also weighed an average of 0.7 kg more than placebo patients which suggests an improvement in nutritional status. The results of this study are consistent with 2 other studies suggesting benefits of azithromycin in CF patients.

For the treatment of mild scrub typhus due to Orientia tsutsugamushi _† (formerly Rickettsia tsutsugamushi _† ):
Oral dosage:
Adults: Azithromycin 500 mg PO as a single dose was as effective as a standard one week doxycycline regimen. A prospective, open-label, randomized study (n=93) compared azithromycin with doxycycline for treatment of mild scrub typhus which is an endemic infection in the Asia-Pacific region. All patients receiving azithromycin (n=47) were cured whereas 43 of 46 patients (93.5%) receiving doxycycline were cured. Azithromycin-treated patients were afebrile at a median time of 21 hours after initiation and those treated with doxycycline at 29 hours. Relapses did not occur in either of the groups during a 1-month follow-up.

For the treatment of pertussis (whooping cough) _† caused by Bordetella pertussis or for postexposure pertussis prophylaxis _† :
NOTE: For postexposure prophylaxis, administer to close contacts within 3 weeks of exposure, especially in high-risk patients (e.g., women in 3rd trimester, infants < 12 months).
Oral dosage:
Adults: 500 mg PO on day 1, followed by 250 mg PO once daily on days 2 - 5.
Children and infants >= 6 months: 10 mg/kg/day PO (maximum 500 mg) on day 1, then 5 mg/kg/day PO (maximum 250 mg) on days 2 - 5.
Infants < 6 months: 10 mg/kg/day PO for 5 days. Monitor for infantile hypertrophic pyloric stenosis (IHPS) in infants < 1 month old.

Maximum Dosage Limits:

Patients with hepatic impairment:
No dosage adjustment recommendations can be made in patients with impaired hepatic function; azithromycin has not been studied in these patients.

Patients with renal impairment:
CrCl > 80 ml/min: No dosage adjustment is needed.
CrCl 10 - 80 ml/min: No dosage adjustment is recommended.
CrCl < 10 ml/min: No dosage adjustment is recommended; however, the manufacturer recommends exercising caution in these patients since mean AUC is increased roughly 35%.

_† non-FDA-approved indication

[ Last revised: 3/1/2006 9:36:00 AM ]

References
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