Azith Special Precautions

If an allergic reaction occurs, the drug should be discontinued and consult a physician immediately.
Since liver is the principal route of elimination for Azithromycin, the use of Azithromycin should be undertaken with caution in patients with significant hepatic disease. Discontinue Azithromycin immediately if signs and symptoms of hepatitis occur.
In patients receiving ergot derivatives, ergotism has been precipitated by co-administration of some macrolide antibiotics. Azithromycin and ergot derivatives should not be co-administered.
As with other anti-infective agents, use of Azithromycin may result in an overgrowth of non-susceptible bacteria or fungi. If superinfection occurs, appropriate therapy should be instituted.
Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Azithromycin and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon, leading to overgrowth of C. difficile. C. difficile produces toxin which contribute to the development of CDAD.
In patients with severe renal impairment (GFR < 10 mL/min) a 33% increase in systemic exposure to Azithromycin was observed. Azithromycin should be used with caution in patients with severe renal impairment.
Prolonged cardiac repolarization and QT interval, imparting a risk of developing cardiac arrhythmia and torsades de pointes, have been seen in treatment with macrolides, including Azithromycin. Prescribers should consider the risk of QT prolongation which can be fatal when weighing the risks and benefits of Azithromycin 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 hypokalaemia and hypomagnesemia; Patients with clinically relevant bradycardia, cardiac arrhythmia or cardiac insufficiency.
Exacerbation of the symptoms of myasthenia gravis have been reported in patients receiving Azithromycin therapy.
Azithromycin for injection should be reconstituted and diluted as directed and administered as an IV infusion over not less than 60 minutes. Do not administer as an IV bolus or an intramuscular injection.
Use in Children: The use of Azithromycin in neonates may cause infantile hypertrophic pyloric stenosis (IHPS). Parents should be informed to contact the physician if vomiting or irritability with feeding occurs.
Use in the Elderly: Elderly patients may be more susceptible to drug-associated effects on the QT interval.