Cases of fulminant hepatitis potentially leading to life-threatening liver failure have been reported with azithromycin (see section 4.8). Since elderly people 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).Azithromycin tablets should only be administered to children weighing more than 45 kg when normal adult dose should be used. For azithromycin the AUC/MIC is the major PK/PD parameter correlating best with the efficacy of azithromycin.Following the assessment of studies conducted in children, the use of azithromycin is not recommended for the treatment of malaria, neither as monotherapy nor combined with chloroquine or artemisinin based drugs, as non-inferiority to anti-malarial drugs recommended in the treatment of uncomplicated malaria was not established.Resistance to azithromycin may be inherent or acquired. No teratogenic effects were observed in animal studies of embryotoxicity in mice and rats. Co-administration of atorvastatin (10 mg daily) and azithromycin (500 mg daily) did not alter the plasma concentrations of atorvastatin (based on a HMG CoA-reductase inhibition assay).However, post-marketing cases of rhabdomyolysis in patients receiving azithromycin with statins have been reported.In a pharmacokinetic interaction study in healthy volunteers, no significant effect was observed on the plasma levels of carbamazepine or its active metabolite in patients receiving concomitant azithromycin.Cisapride is metabolized in the liver by the enzyme CYP 3A4. About 12% of an intravenously administered dose is excreted in the urine unchanged over a period of 3 days; the majority in the first 24 hours. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl) oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. When azithromycin is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of the therapy, the medication should be taken exactly as directed. Maternal toxicity (reduced food consumption and body weight gain; increased stress at parturition) was observed at the higher dose. For the 122 patients who were evaluated at the Day 30 visit, the clinical success rate was 70% for azithromycin.Microbiologic determinations were made at the pre-treatment visit. There have been reports received in the post-marketing period of potentiated anticoagulation subsequent to co-administration of azithromycin and coumarin-type oral anticoagulants. Despite initially successful symptomatic treatment of the allergic symptoms, when symptomatic therapy was discontinued, the allergic symptoms recurred soon thereafter in some patients without further azithromycin exposure. Drug interaction studies were performed with azithromycin and other drugs likely to be co-administered. 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg once daily on Days 2 through 5. Days 24 to 32 evaluations were considered the primary test of cure endpoint.In three double-blind controlled studies, conducted in the United States, azithromycin (12 mg/kg once a day for 5 days) was compared to penicillin V (250 mg three times a day for 10 days) in the treatment of pharyngitis due to documented Group A β-hemolytic In a double-blind, controlled clinical study of acute otitis media performed in the United States, azithromycin (10 mg/kg on Day 1 followed by 5 mg/kg on Days 2 to 5) was compared to amoxicillin/clavulanate potassium (4:1). "Azithromycin Tablets can cause serious side effects, including:Serious heart rhythm changes (QT prolongation and torsades de pointes).Worsening of myasthenia gravis (a problem that causes muscle weakness).Keep Azithromycin Tablets and all medicines out of the reach of children.General information about the safe and effective use of Azithromycin Tablets.This Patient Information has been approved by the U.S. Food and Drug Administration.We comply with the HONcode standard for trustworthy health information - Multiple-dose regimens: Overall, the most common treatment-related adverse reactions in adult patients receiving multiple-dose regimens of azithromycin were related to the gastrointestinal system with diarrhea/loose stools (4 to 5%), nausea (3%), and abdominal pain (2 to 3%) being the most frequently reported.No other adverse reactions occurred in patients on the multiple-dose regimens of azithromycin with a frequency greater than 1%. 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