As with any antibiotic, observation for signs of superinfection with non susceptible organisms, including fungi is recommended. As with erythromycin and other macrolides, serious allergic reactions, including angioneurotic oedema and anaphylaxis, have been reported. Some of these reactions with Azomax have resulted in recurrent symptoms and required a long period of observation and treatment.
Use in renal impairment
No dosage adjustment is needed in patients with mild renal impairment (Creatinine Clearance >40 ml/min.) but there are no data regarding azithromycin usage in patients with more severe renal impairment, thus caution should be exercised in using azithromycin in these patients.
Use in hepatic impairment
As liver is the principal route of excretion of azithromycin, it should not be used in patients with hepatic disease.
Use in pregnancy
Animal reproduction studies have demonstrated that azithromycin crosses the placenta, but have revealed no evidence of harm to the foetus. There are no adequate and well controlled studies in pregnant women. Since animal reproduction studies are not always predictive of human response, azithromycin should be used during pregnancy only if adequate alternatives are not available.
Use in lactation
No data on secretion of azithromycin in breast milk are available, so azithromycin should only be used in lactating women where adequate alternatives are not available.
