Zithracin Special Precautions

Hypersensitivity: In the event of severe acute hypersensitivity reactions, such as angioedema, 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)], Zithracin should be discontinued immediately and appropriate treatment should beurgently initiated.
Hepatotoxicity: Use of azithromycin should be undertaken with caution in patients with significant hepatic disease. Discontinue azithromycin immediately if signs and symptoms of hepatitis occur.
Infantile hypertrophic pyloric stenosis (IHPS): 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.
Ergot derivatives: 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 co-administered.
Superinfection: As with any antibiotic preparation, observation for signs of superinfection with non-susceptible organisms, including fungi, is recommended.
Clostridium difficile-associated diarrhea: Clostridium difficile-associated diarrhea (CDAD) has been reported with the use of nearly all antibacterial agents, including azithromycin, and may range in severity from mild diarrhea to fatal colitis. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents.
Renal impairment: In patients with severe renal impairment (GFR <10 ml/min), an increase in systemic exposure to azithromycin was observed.
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 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.
Myasthenia gravis: Exacerbations of the symptoms of myasthenia gravis have been reported in patients receiving azithromycin therapy.
Effects on Ability to Drive and Use Machines: There is no evidence to suggest that azithromycin may have an effect on a patient's ability to drive or operate machinery.
Use in the Elderly: elderly patients may be more susceptible to drug-associated effects on the QT interval.