ZITHROMAX is a macrolide antibacterial indicated for mild to moderate infections caused by designated, susceptible bacteria:

• Sexually Transmitted Diseases (1.1)
• Mycobacterial Infections (1.2)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZITHROMAX and other antibacterial drugs, ZITHROMAX should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. (1.3)

• Sexually Transmitted Diseases (2.1)
• Mycobacterial Infections (2.2)

• ZITHROMAX 600 mg tablets (3)
• ZITHROMAX for oral suspension 1000 mg/5 mL (3)

• Patients with known hypersensitivity to azithromycin, erythromycin, any macrolide, or ketolide antibiotic. (4.1)
• Patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin. (4.2)

• Serious (including fatal) allergic and skin reactions. Discontinue ZITHROMAX and initiate appropriate therapy if reaction occurs. (5.1)
• Hepatotoxicity: Discontinue azithromycin immediately if signs and symptoms of hepatitis occur. (5.2)
• Infantile Hypertrophic Pyloric Stenosis (IHPS): Following the use of azithromycin in neonates (treatment up to 42 days of life), IHPS has been reported. Direct parents and caregivers to contact their physician if vomiting or irritability with feeding occurs. (5.3)
• Prolongation of QT interval and cases of torsades de pointes have been reported. This risk which can be fatal should be considered in patients with certain cardiovascular disorders including known QT prolongation or history torsades de pointes, those with proarrhythmic conditions, and with other drugs that prolong the QT interval. (5.4)
• Cardiovascular Death: Some observational studies have shown an approximately two-fold increased short-term potential risk of acute cardiovascular death in adults exposed to azithromycin relative to other antibacterial drugs, including amoxicillin. Consider balancing this potential risk with treatment benefits when prescribing ZITHROMAX. (5.5)
• Clostridioides difficile-Associated Diarrhea: Evaluate patients if diarrhea occurs. (5.6)
• ZITHROMAX may exacerbate muscle weakness in persons with myasthenia gravis. (5.7)

The most common adverse reactions are diarrhea (5%), nausea (3%), abdominal pain (3%), or vomiting, (no percent given). (6)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

• Nelfinavir: Close monitoring for known side effects of azithromycin, such as liver enzyme abnormalities and hearing impairment, is warranted. (7.1)
• Warfarin: Use with azithromycin may increase coagulation times; monitor prothrombin time. (7.2)

• Pediatric Use: Safety and effectiveness in the treatment of patients under 6 months of age have not been established. (8.4)
• Geriatric Use: Elderly patients may be more susceptible to development of torsades de pointes arrhythmias. (8.5)