Azithromycin

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)

• Serious (including fatal) allergic and skin reactions: Discontinue azithromycin 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)

• Clostridium