HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use AZITHROMYCIN safely and effectively. See full prescribing information for AZITHROMYCIN.
AZITHROMYCIN 250 mg and 500 mg tablets, for oral use
AZITHROMYCIN for oral suspension
Initial U.S. Approval: 1991
INDICATIONS AND USAGE
AZITHROMYCIN is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria:
Limitation of Use:
Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors. (1.3)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. (1.4)
DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
WARNINGS AND PRECAUTIONS
Most common adverse reactions are diarrhea (5 to 14%), nausea (3 to 18%), abdominal pain (3 to 7%), or vomiting (2 to 7%). (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Greenstone LLC at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
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