In patients receiving ergot derivatives, ergotism has been precipitated by co-administration of some macrolide antibiotics. Azithromycin administration should be stopped if liver dysfunction has emerged. In case of signs and symptoms of liver dysfunction, such as rapid developing asthenia associated with jaundice, dark urine, bleeding tendency or hepatic encephalopathy, liver function tests/ investigations should be performed immediately. Some patients may have had pre-existing hepatic disease or may have been taking other hepatotoxic medicinal products. Cases of fulminant hepatitis potentially leading to life-threatening liver failure have been reported with azithromycin (see section 4.8).
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. No studies have been conducted regarding treatment of such patients with azithromycin (see section 4.4). Since azithromycin is metabolised in the liver and excreted in the bile, the drug should not be given to patients suffering from severe liver disease. Caution should be exercised when azithromycin is administered to patients with severe renal impairment (GFR < 10 ml/min) (see section 4.4 and section 5.2). Since elderly patients can be patients with ongoing proarrhythmic conditions a particular caution is recommended due to the risk of developing cardiac arrhythmia and torsades de pointes (see section 4.4).ĭose adjustment is not required in patients with mild to moderate renal impairment (GFR 10-80 ml/min). Other dosage forms are available for this group of patients.įor elderly patients the same dose as for adults can be applied. For patients who are allergic to penicillin and/or cephalosporins, prescribers should consult local treatment guidelines.Ĭhildren and adolescents with a body weight below 45 kg:Īzithromycin tablets are not suitable for patients under 45 kg body weight.
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