Hypersensitivity: In the event of severe acute hypersensitivity reactions, such as anaphylaxis, severe cutaneous adverse reactions (SCARs) [e.g. Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) & acute generalised exanthematous pustulosis (AGEP)], Azithro should be discontinued immediately and appropriate treatment should be urgently initiated. Some of these reactions with azithromycin have resulted in recurrent symptoms and required a longer period of observation and treatment.
Physicians should be aware that reappearance of the allergic symptoms may occur when symptomatic therapy is discontinued.
Prolongation of the QT Interval: 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 (see Effects on Ability to Drive and Use Machines as follows). 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 hypokalemia and hypomagnesemia.
Patients with clinically relevant bradycardia, cardiac arrhythmia or cardiac insufficiency.
Elderly patients: elderly patients may be more susceptible to drug associated effects on the QT interval.
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.
In patient receiving ergot derivative, ergotism has been precipitated by coadministration of some macrolide antibiotics. There are no data concerning the possibility of an interaction between ergot and azithromycin. However, because of the theoretical possibility of ergotism, azithromycin and ergot derivatives should not be coadministered.
As with antibiotics preparation for signs of superinfection with non-susceptible organisms, including fungi is recommended.
As with any severe renal impairment (GFR <10 ml/min) increase in systemic exposure to azithromycin was observed.
Infantile hypertrophic pyloric stenosis (IHPS) has been reported following the use of azithromycin in infants (treatment up to 42 days of life). Parents and caregivers should be informed to contact their physician if vomiting and/or irritability with feeding occurs.
Effects on Ability to Drive and Use Machines: There is no evidence to suggest that Azithro have an effect on a patient's ability to drive or operate machinery.