The use of the drug is not recommended in children under 6 months.
Serious hypersensitivity reactions, including angioedema, anaphylaxis, and dermatologic reactions, have occurred rarely in patients receiving azithromycin.
Because azithromycin is eliminated principally via the liver, the drug should be used with caution in patients with impaired hepatic function.
Because of limited data regarding use of azithromycin in patients with renal impairment, the drug should be used with caution in patients with glomerular filtration rates less than 10 mL/minute.
Prolonged cardiac repolarization and QT interval with risk of cardiac arrhythmia and torsades de pointes has been reported rarely with macrolides. The possibility of such effects with azithromycin cannot be completely ruled out in patients at increased risk for prolonged cardiac repolarization.
To reduce development of drug-resistant bacteria and maintain effectiveness of azithromycin and other antibacterials, the drug should be used only for the treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.
Azicine 250 mg contains sucrose (saccharose). Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Azicine 250 mg contains aspartame. Aspartame is a source of phenylalanine. It may be harmful if the patient has phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.