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Hypersensitivity: As with Erythromycin and other macrolides, rare serious allergic reactions, including angioedema and anaphylaxis (rarely fatal), dermatologic reactions including Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN) (rarely fatal), and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have been reported. Some of these reactions with Azithromycin have resulted in recurrent symptoms and required a longer period of observation and treatment.
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.
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. Prescribers should consider the risk 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 Class 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.
As with any antibiotic preparation, there is a possibility that superinfections could occur (e.g. fungal infection).
Streptococcal infection: Penicillin is usually the first choice for treatment of pharyngitis/ tonsillitis due to Streptococcus pyrogenes and also for prophylaxis of acute rheumatic fever.
Azithromycin is in general effective against streptococcus in oropharynx, but no data are available that demonstrate the efficacy of Azithromycin in preventing acute rheumatic fever. In patients with severe renal impairment (GFR <10 mL/min) a 33% 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.
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 generalized exanthematous pustulosis (AGEP), Floctil should be discontinued immediately and appropriate treatment should be urgently initiated.
