- Fpizithro is contraindicated in patients with a known hypersensitivity to azithromycin or any of the macrolide or ketoIide antibiotics, erythromycin, or to any other excipients in the product.
- Epizithro is contraindicated in patients with a history of cholestatic jaundice, hepatic dysfunction associated with prior use of Epizithro.
pregnancy and lactation :
- There are no adequate and well-controlled studies in pregnant women Because animal reproduction studies are not always predictive of human response, azithromycin should be used during pregnancy only if clearly needed There are no data on secretion in breast milk.
- As many drugs are excreted in human milk, azithromycin should not be used in the treatment of a lactating woman unless the physician feels that the potential benefits justify the potential risks to the infant
use in renal impairment :
- In patients with severe renal impairment (GFR <10 ml/minj a 33- increase in systemic exposure to azithromycin was observed.
- Exacerbations of the symptoms of myasthenia gravis and new onset of myasthenia syndrome have been reported in patients receiving azithromycin therapy.
- Sa few and efficacy for prevention or treatment of MAC in children have not been established.
- Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency 01 qlucose-galactose malabsorption should not take this medicine.
- Consult your doctor in the following cases If you are allergic to any of the components of the product In cases of pregnancy and lactation If you are taking any other medicines with the drug If you have other diseases
Special Warnings and Precautions for use:
- As with erythromycin and other macrolides, rare serious allergic reactions including angioneurotic oedema 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.
- Hepatotoxicity: Abnormal liver function, hepatitis, cholestatic jaundice, hepatic necrosis, and hepatic failure have been reported, some of which have resulted in death. Discontinue Epizithro immediately if signs and symptoms of hepatitis occur.
- Since the liver is the principal route of elimination for azithromycin, the use of azithromycin should be undertaken with caution in patients with significant hepatic disease.
- Cases of fulminant hepatitis potentially leading to life-threatening liver failure have been reported with azithromycin (see Section Undesirable effects)
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