Use with caution in patients with severe hepatic/renal impairment.
There were reports about:
- Rare serious allergic reactions. If an allergic reaction occurs, the drug should be discontinued and appropriate therapy should be instituted. Physicians should be aware that reappearance of the allergic symptoms may occur when symptomatic therapy is discontinued.
- 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.
- Acute exacerbations of the symptoms of myasthenia gravis.
- Infantile hypertrophic pyloric stenosis (IHPS) in neonates (treatment up to 42 days of life), contact physician if vomiting or irritability with feeding occurs.
- Clostridium difficile-associated diarrhea (CDAD) must be considered in all patients who present with diarrhea following antibiotic use. CDAD may range in severity from mild diarrhea to fatal colitis.
Observation for signs of super infection with non-susceptible organisms, including fungi is recommended.
Azithromycin and ergot derivatives should not be co-administered.
Consider the risk of QT prolongation, which can be fatal when prescribe for at-risk groups including:
- Patients with congenital or documented QT prolongation.
- Patients currently receiving treatment with other active substances known to prolong QT interval, such as antiarrhythmics of Classes IA and III, antipsychotic agents, antidepressants, and fluoroquinolones.
- Patients with electrolyte disturbance, particularly in cases of hypokalemia and hypomagnesemia.
- Patients with clinically relevant bradycardia, cardiac arrhythmia or cardiac insufficiency.
- Elderly patients.
Azithromycin should be used during pregnancy only if clearly needed. Caution should be exercised when azithromycin is administered to a nursing woman.
Patients should be aware of how they react to drug before driving or operating machinery.