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If an allergic reaction occurs, the drug should be discontinued and appropriate therapy should be instituted. In healthy volunteers, coadministration of a 5-day regimen of azithromycin with cetirizine 20 mg at steady-state resulted in no pharmacokinetic interaction and no significant changes in the QT interval.

CDAD must be considered in all patients who present with diarrhoea following antibiotic use. Other pharmaceutical forms of azithromycin may be used, such as suspensions. However, post-marketing cases of rhabdomyolysis in patients receiving azithromycin with statins have been reported. Physicians should be aware that reappearance of the allergic symptoms may occur when symptomatic therapy is discontinued.

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Azithromycin is not indicated for the treatment of infected burn wounds. After the use of macrolide antibiotics pseudomembranous colitis has been reported. The use of azithromycin is contraindicated in patients with hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic, or to any excipient listed in Section 6. Concomitant administration of macrolide antibiotics, including azithromycin, with P-glycoprotein substrates such as digoxin, has been reported to result in increased serum levels of the P-glycoprotein substrate. Azithromycin has been reported to be secreted into human breast milk, but there are no adequate and well-controlled clinical studies in nursing women that have characterized the pharmacokinetics of azithromycin excretion into human breast milk. 6 HIV-positive subjects did not appear to affect the steady-state pharmacokinetics of didanosine as compared with placebo.

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. In patients receiving both azithromycin and antacids, the drugs should not be taken simultaneously. However, administration of azithromycin increased the concentrations of phosphorylated zidovudine, the clinically active metabolite, in peripheral blood mononuclear cells. Hepatic cytochrome P450 induction or inactivation via cytochrome-metabolite complex does not occur with azithromycin. Often, azithromycin is not the substance of first choice for the treatment of sinusitis.

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MHRA Yellow Card in the Google Play or Apple App Store. Long-term studies in animals have not been performed to evaluate carcinogenic potential. In case of rapid recurrent infections, treatment with another antibiotic should be considered. Azithromycin tablets should only be administered to children weighing more than 45 kg when normal adult dose should be used. Azithromycin administration should be stopped if liver dysfunction has emerged. 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.

Azithromycin Tablets should be given as a single daily dose. In a pharmacokinetic study investigating the effects of a single dose of cimetidine, given 2 hours before azithromycin, on the pharmacokinetics of azithromycin, no alteration of azithromycin pharmacokinetics was seen. Often, azithromycin is not the substance of first choice for the treatment of acute otitis media.

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Azithromycin serum concentrations were similar to those seen in other studies. For a full list of excipients, see section 6. The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. As a consequence of this, RNA-dependent protein synthesis in sensitive organisms is prevented. To email a medicine you must be a registered user. 500 mg on the first day and 250 mg on the second to the fifth day.

Azithromycin should be used with caution in patients with neurological or psychiatric disorders. The main causative agent of soft tissue infections, Staphylococcus aureus, is frequently resistant to azithromycin. Therefore azithromycin should only be used during pregnancy if the benefit outweighs the risk.

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Each capsule contains azithromycin dihydrate equivalent to 250 mg of azithromycin. Azithromycin has been reported to be secreted into human breast milk, but there are no adequate and well-controlled clinical studies in nursing women that have characterized the pharmacokinetics of azithromycin excretion into human breast milk. Azithromycin is not indicated for the treatment of infected burn wounds. The same dosage as in adult patients is used for older people. For the full list of excipients, see section 6. Attention should be paid to possible symptoms of superinfections caused by non-sensitive causal agents such as fungi.

It is not believed to undergo the pharmacokinetic drug interactions as seen with erythromycin and other macrolides. Hepatic cytochrome P450 induction or inactivation via cytochrome-metabolite complex does not occur with azithromycin. The half-life of 36 h in the older children was within the expected range for adults. Physicians should be aware that reappearance of the allergic symptoms may occur when symptomatic therapy is discontinued. CDAD must be considered in all patients who present with diarrhoea following antibiotic use.

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Following a single oral dose of azithromycin 1 g, mean Cmax and AUC0-120 increased by 5. Consequently, caution should be exercised before considering concurrent administration of these drugs. In a pharmacokinetic interaction study in healthy volunteers, azithromycin had no significant effect on the pharmacokinetics of methylprednisolone. No clinically significant adverse effects were observed and no dose adjustment is required.

There have been reports received in the post-marketing period of potentiated anticoagulation subsequent to co-administration of azithromycin and coumarin-type oral anticoagulants. Azithromycin administration should be stopped if liver dysfunction has emerged. Azithromycin does not interact significantly with the hepatic cytochrome P450 system. Adverse reactions possibly or probably related to Mycobacterium Avium Complex prophylaxis and treatment based on clinical trial experience and post-marketing surveillance.

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There are no adequate and well controlled studies on the use of azithromycin by pregnant women. A risk to the suckling infant cannot be excluded. A superinfection may require an interruption of the azithromycin treatment and initiation of adequate measures. Pharmacokinetic studies have reported no evidence of an interaction between azithromycin and terfenadine. In animal studies this process appeared to contribute to the accumulation of azithromycin in the tissue. In experimental in vitro and in vivo studies azithromycin accumulates in the phagocytes, freeing is stimulated by active phagocytosis.

The relevance of this finding to humans is unknown. Concomitant administration of macrolide antibiotics, including azithromycin, with P-glycoprotein substrates such as digoxin, has been reported to result in increased serum levels of the P-glycoprotein substrate. In common with many other antibiotics, Azithromycin Capsules should be taken at least 1 hour before or 2 hours after food.

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Adverse reactions identified from post-marketing experience are included in italics. It is recommended to discard the milk during treatment and up until 2 days after discontinuation of treatment. Because it is not known whether azithromycin may have adverse effects on the breast-fed infant, nursing should be discontinued during treatment with azithromycin. Biliary excretion of azithromycin, predominantly in unchangedform, is a major route of elimination. Neutropenia was observed in subjects receiving concomitant treatment of azithromycin and rifabutin.

Peak plasma levels are reached after 2-3 hours. Reporting suspected adverse reactions after authorisation of the medicinal product is important. The tablets may be taken with food.

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Azithromycin does not interact significantly with the hepatic cytochrome P450 system. The relevance of this finding to humans receiving azithromycin in accordance with the recommendations is unknown. There is no experience regarding the safety and efficacy of long term use of azithromycin for the mentioned indications. In the event of overdosage genaral symptomatic and general supportive measures are indicated as required. MHRA Yellow Card in the Google Play or Apple App Store.

Should pseudomembranous colitis be induced by azithromycin, then anti-peristaltics should be contraindicated. Azithromycin is not the substance of first choice for the treatment of pharyngitis and tonsillitis caused by Streptococcus pyogenes. As with any antibiotic preparation, observation for signs of superinfection with non-susceptible organisms, including fungi is recommended. Cmax and AUC0-5 were found to be significantly elevated.

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Adverse events experienced in higher than recommended doses were similar to those seen at normal doses. There is no evidence to suggest that azithromycin may have an effect on a patient’s ability to drive or operate machinery. This medicine is not suitable for treatment of severe infections where a high concentration of the antibiotic in the blood is rapidly needed. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

The relevance of this finding to humans is unknown. 15 years taking capsules, granules or suspension. Cmax after a single dose of 500 mg orally was approximately 0. In fertility studies conducted in rat, reduced pregnancy rates were noted following administration of azithromycin.