Azithromycin Capsule 250 mg Special Precautions

Because azithromycin is eliminated principally via the liver, the drug should be used with caution in patients with impaired hepatic function. Discontinue immediately if symptoms of hepatitis occur (malaise, nausea, vomiting, abdominal colic, fever). In addition, because of limited data regarding use of azithromycin in patients with renal impairment, the drug should be used with caution in patients with glomerular filtration rates less than 10 mL/minute.
Prolonged cardiac repolarization and QT interval with risk of cardiac arrhythmia and torsades de pointes has been reported with macrolides, including azithromycin. There have been reports of arrhythmias, ventricular tachycardia, hypotension, QT prolongation, and torsades de pointes in patients receiving azithromycin during post marketing surveillance. Use with caution in patients at risk of prolong cardiac repolarization. Consider avoiding use in patient with prolonged QT interval, uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, or concurrent use of Class IA (e.g. quinidine, procainamide) or Class III (e.g. amiodarone, dofetilide, sotalol) antiarrhythmic agents.
Prolong use antibiotics may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD). It should be considered in the differential diagnosis of patients who develop diarrhea during or following azithromycin therapy and manage accordingly. If CDAD is suspected or confirmed, azithromycin may need to be discontinued.
Serious allergic reactions, including angioedema, anaphylaxis, and dermatologic reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported rarely in patients on azithromycin therapy. Although rare, fatalities have occurred. If an allergic reaction occurs with azithromycin, discontinue and institute appropriate therapy.
Cautions in patients with myasthenia gravis. There have been reports that azithromycin may aggravate the weakness of patients with myasthenia gravis.