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Zmax (azithromycin extended release) for oral suspension
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
WARNINGS AND PRECAUTIONS
Prolongation of the QT interval
- Cases of torsades de pointes have been spontaneously reported during postmarketing surveillance in patients receiving azithromycin. Although the absolute risk is unknown, it appears to be low with azithromycin likely due to the lack of appreciable drug interactions, and the observation that it is rarely reported as a postmarketing adverse event. However, it would be prudent to avoid use in patients with known prolongation of the QT interval, patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, and in patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents. Elderly patients may be more susceptible to drug-associated effects on the QT interval.
Cholestatic jaundice/hepatic dysfunction
- Zmax is contraindicated in patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin.
- Abnormal liver function, hepatitis, cholestatic jaundice, hepatic necrosis, and hepatic failure have been reported, some of which have resulted in death. Discontinue azithromycin immediately if signs and symptoms of hepatitis occur.
- Liver/Biliary: Adverse reactions related to hepatic dysfunction have been reported in postmarketing experience with azithromycin.