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Consideration of these findings should be balanced with treatment benefits when prescribing azithromycin.Exacerbations of the symptoms of myasthenia gravis and new onset of myasthenia syndrome have been reported in patients receiving azithromycin therapy (see section 4.8).Safety and efficacy for the prevention or treatment of Azithromycin powder for oral suspension is not suitable for treatment of severe infections where a high concentration of the antibiotic in the blood is rapidly needed.Azithromycin is not the first choice for the empiric treatment of infections in areas where the prevalence of resistant isolates is 10% or more (see section 5.1).In areas with a high incidence of erythromycin A resistance, it is especially important to take into consideration the evolution of the pattern of susceptibility to azithromycin and other antibiotics.
Content of the bottle after reconstitution: 30 ml.Packs of powder equivalent to 1500 mg azithromycin. 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. After reconstitution the drug can be administered using a PE/PP syringe for oral use. It prevents bacterial growth. However, administration of azithromycin increased the concentrations of phosphorylated zidovudine, the clinically active metabolite, in peripheral blood mononuclear cells. Neither non-clinical nor clinical data are available to assess aspartame use in infants below 12 weeks of age. Or 500mg on day 1 followed by 250mg on days 2 to 5. 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, because of the theoretical possibility of ergotism, azithromycin and ergot derivatives should not be coadministered.As with any antibiotic preparation, observation for signs of superinfection with non- susceptible organisms, including fungi is recommended.In patients with severe renal impairment (GFR <10 ml/min) a 33% increase in systemic exposure to azithromycin was observed (see Section 5.2).Prolonged cardiac repolarization and QT interval, imparting a risk of developing cardiac arrhythmia and torsades de pointes, have been seen in treatment with macrolides including azithromycin (see section 4.8).
Although neutropenia has been associated with the use of rifabutin, a causal relationship to combination with azithromycin has not been established (see Section 4.8).In normal healthy male volunteers, there was no evidence of an effect of azithromycin (500 mg daily for 3 days) on the AUC and CPharmacokinetic studies have reported no evidence of an interaction between azithromycin and terfenadine. Content of the bottle after reconstitution 37.5 ml.Shake the dry powder loose. There are limited data on use in children younger than 1 year.The dose for the treatment of pharyngitis caused by Penicillin is however the drug of first choice in the treatment of pharyngitis caused by No dose adjustment is necessary in patients with mild to moderate renal impairment (GFR 10-80 ml/min) (see section 4.4).A dose adjustment is not necessary for patients with mild to moderately impaired liver function (see section 4.4).Before use the powder should be reconstituted with water into a white to off white, homogenous suspension, see section 6.6. Therefore Azithromycin should only be used during pregnancy if the benefit outweighs the risk.Azithromycin has been reported to be secreted into human breast milk, but there are no adequate and well-controlled clinical studies in breastfeeding women that have characterized the pharmacokinetics of azithromycin excretion into human breast milk.In fertility studies conducted in rat, reduced pregnancy rates were noted following administration of azithromycin. 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 establishedResistance to azithromycin may be inherent or acquired. The relevance of this finding to humans is unknown.There is no evidence to suggest that azithromycin may have an effect on a patient's ability to drive or operate machinery. In reproduction toxicity studies in animals azithromycin was shown to pass the placenta, but no teratogenic effects were observed.
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