Azithromycin

Warnings and Precautions, Cardiovascular Death (5.5)                  06/2021

Azithromycin tablets are a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below.

Azithromycin can be taken with or without food. However, increased tolerability has been observed when tablets are taken with food.

Azithromycin tablets USP, 600 mg are supplied as white to off white, oval shaped, film-coated tablet debossed with “592” on one side and “L” on the other side containing azithromycin dihydrate equivalent to 600 mg azithromycin, USP. These are packaged in bottles of 30 tablets and unit dose packages of 100 tablets.

·        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)