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Rare serious allergic reactions, including angioedema and anaphylaxis (rarely fatal), have been reported. Some of these reactions with Azithromycin have resulted in recurrent symptoms and required a longer period of observation and treatment.
Pseudomembranous colitis has been reported and may range in severity from mild to life threatening. Therefore, it is important to consider this diagnosis in patients with diarrhoea subsequent to administration of Azithromycin.
Observation for signs of superinfection with non-susceptible organisms, including fungi, is recommended.
Use in renal impairment: There are no data regarding Azithromycin usage in patients with renal impairment, thus caution should be exercised when prescribing Azithromycin in these patients.
Use in children under 1 year of age: The safety and efficacy of Azithromycin in children less than 1 year have not been established.
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