It is contra indicated in patients with a known hypersensitivity to azithromycin or any macrolide antibiotics.
Precautions and Warnings: As with any antibiotic, observation for signs of superinfection with non-susceptible organisms, including fungi is recommended. As with erythromycin and other macrolide, serious allergic reactions, including angioneurotic oedema and anaphylaxis, have been reported. Some of these reactions with azithromycin have resulted in recurrent symptoms and required a long period of observations and treatment.
Use in renal impairment: No dosage adjustment is needed in patients with mild renal impairment (Creatinine Clearance > 40 mI/mm.) 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 not be used in patients with hepatic disease.
Dosage Forms:
Each capsule contains: Azithromycin dihydrate U.S.P. ….equivalent to 250 mg of azithromycin.
Each 5ml oral suspension contains: Azithromycin U.S.P……. 200 mg.