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This medicine is not suitable for treatment of severe infections where a high concentration of the antibiotic in the blood is rapidly needed. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable. Some patients may have had pre-existing hepatic disease or may have been taken other hepatotoxic medicinal products. However, administration of azithromycin increased the concentrations of phosphorylated zidovudine, the clinically active metabolite, in peripheral blood mononuclear cells.

There is no evidence of a clinically significant pharmacokinetic interaction when azithromycin and theophylline are co-administered to healthy volunteers. Therefore azithromycin should only be used during pregnancy if the benefit outweighs the risk. To email a medicine you must be a registered user. Single 1000 mg doses and multiple 1200 mg or 600 mg doses of azithromycin had little effect on the plasma pharmacokinetics or urinary excretion of zidovudine or its glucuronide metabolite.

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Therefore, if azithromycin and P-gp substrates such as digoxin are administered concomitantly, the possibility of elevated serum concentrations of the substrate should be considered. Co-administration of a single dose of 1200 mg azithromycin had no statistically significant effect on the pharmacokinetics of indinavir administered as 800 mg three times daily for 5 days. Physicians should be aware that reappearance of the allergic symptoms may occur when symptomatic therapy is discontinued. If an allergic reaction occurs, the drug should be discontinued and appropriate therapy should be instituted. In patients receiving both azithromycin and antacids, the drugs should not be taken simultaneously. Azithromycin administration should be stopped if liver dysfunction has emerged.

In the event of overdosage, general symptomatic and supportive measures are indicated as required. Each capsule contains azithromycin dihydrate equivalent to 250 mg of azithromycin. Adverse events experienced in higher than recommended doses were similar to those seen at normal doses.

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Azithromycin should not be used in the treatment of a lactating woman unless the potential benefits justify the potential risks to the infant. Long-term studies in animals have not been performed to evaluate carcinogenic potential. Caution should be exercised with concomitant use of these agents and azithromycin in view of the described potentation of its effect during concomitant use of the macrolide antibiotic erythromycin.

The molecule is constructed by adding a nitrogen atom to the lactone ring of erythromycin A. The induction of significant resistance in both in vitro and in vivo models is Streptococcus pyogenes, Haemophilus influenzae, and Enterobacterciae after nine sub lethal passages of active substance and three dilution increase for Staphylococcus aureus and development of in vitro resistance due to mutation is rare. 125 mg triazolam on Day 2 had no significant effect on any of the pharmacokinetic variables for triazolam compared to triazolam and placebo. 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.

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Hepatic cytochrome P450 induction or inactivation via cytochrome-metabolite complex does not occur with azithromycin. Azithromycin Capsules are for oral administration only. In 14 healthy volunteers, co-administration of azithromycin 500 mg on Day 1 and 250 mg on Day 2 with 0. In patients with mild to moderate hepatic impairment, there is no evidence of a marked change in serum pharmacokinetics of azithromycin compared to normal hepatic function.

The clinical significance of this finding is unclear, but it may be of benefit to patients. The terminal plasma elimination half-life follows the tissue depletion half-life of 2 to 4 days. Attention should be paid to possible symptoms of superinfections caused by non-sensitive causal agents such as fungi. Other pharmaceutical forms of azithromycin may be used, such as suspensions. In a pharmacokinetic interaction study, azithromycin did not alter the anticoagulant effect of a single 15-mg dose of warfarin administered to healthy volunteers.

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After the use of macrolide antibiotics pseudomembranous colitis has been reported. Azithromycin should be administered with caution to patients suffering from neurological or psychiatric diseases. Co-administration of azithromycin and rifabutin did not affect the serum concentrations of either drug. Co-administration of a single dose of 1200 mg azithromycin did not alter the pharmacokinetics of a single dose of 800 mg fluconazole. In common with many other antibiotics, Azithromycin Capsules should be taken at least 1 hour before or 2 hours after food.

Target modification is controlled by erm encoded methylases. The relevance of this finding to humans is unknown. AUC and Cmax of sildenafil or its major circulating metabolite. 3 days did not cause clinically significant changes in the pharmacokinetics and pharmacodynamics of a single 15 mg dose of midazolam.

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Azithromycin is a macrolide antibiotic belonging to the azalide group. 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 case of sexually transmitted diseases a concomitant infection by T. Azithromycin does not interact significantly with the hepatic cytochrome P450 system. Because macrolides inhibit this enzyme, concomitant administration of cisapride may cause the increase of QT interval prolongation, ventricular arrhythmias and torsade de pointes. Pharmacokinetic studies have been conducted between azithromycin and the following drugs known to undergo significant cytochrome P450 mediated metabolism.

To bookmark a medicine you must be a registered user. Capsules are not indicated for these patients. There is no experience regarding the safety and efficacy of long term use of azithromycin for the mentioned indications. The selection of azithromycin to treat an individual patient should take into account the appropriateness of using a macrolide antibacterial agent based on adequate diagnosis to ascertain the bacterial etiology of the infection in the approved indications and the prevalence of resistance to azithromycin or other macrolides. In these patients, urinary recovery of azithromycin appears to increase perhaps to compensate for reduced hepatic clearance.

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Consideration should be given to official guidance on the appropriate use of antibacterial agents. CDAD must be considered in all patients who present with diarrhoea following antibiotic use. Penicillin susceptible Streptococcus pneumoniae are more likely to be susceptible to azithromycin than are penicillin resistant strains of Streptococcus pneumoniae. Electrophysiological investigations have shown that azithromycin prolongs the QT interval. However, post-marketing cases of rhabdomyolysis in patients receiving azithromycin with statins have been reported. Teratogenic effects were not observed in rat reproductive toxicity studies.

Consequently, caution should be exercised before considering concurrent administration of these drugs. The relevance of this finding to humans receiving azithromycin in accordance with the recommendations is unknown. Peak plasma levels are reached after 2-3 hours. The mechanism of action of azithromycin is based upon the suppression of bacterial protein synthesis, by binding to the ribosomal 50S sub-unit and thus inhibiting the translocation of peptides. 7 days with azithromycin 1200 mg on Day 7 had no significant effect on peak concentrations, total exposure or urinary excretion of either trimethoprim or sulfamethoxazole. There are no adequate and well controlled studies on the use of azithromycin by pregnant women.

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Reporting suspected adverse reactions after authorisation of the medicinal product is important. A complete cross resistance exists among erythromycin, azithromycin, other macrolides and lincosamides for Streptococcus pneumoniae, beta-haemolytic streptococcus of group A, Enterococcus spp. There is no evidence to suggest that azithromycin may have an effect on a patient’s ability to drive or operate machinery. At slight maternally toxic doses retardation in foetal ossification was seen. No data are available on interactions with astemizol, and alfentanil.

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. The same dosage as in adult patients is used in the elderly. There was no evidence of a potential for genetic and chromosome mutations in in-vivo and in-vitro test models. 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. Adverse reactions identified from post-marketing experience are included in italics.

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15 years taking capsules, granules or suspension. Azithromycin serum concentrations were similar to those seen in other studies. Co-administration of a 600 mg single dose of azithromycin and 400 mg efavirenz daily for 7 days did not result in any clinically significant pharmacokinetic interactions. PD parameter correlating best with the efficacy of azithromycin. No clinically significant adverse effects were observed and no dose adjustment is required.

A and B which contribute to the development of CDAD. This should be taken into account when treating infections caused by Streptococcus pneumoniae. It is not believed to undergo the pharmacokinetic drug interactions as seen with erythromycin and other macrolides.

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Cmax and AUC0-5 were found to be significantly elevated. A superinfection may require an interruption of the azithromycin treatment and initiation of adequate measures. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. In a pharmacokinetic interaction study in healthy volunteers, azithromycin had no significant effect on the pharmacokinetics of methylprednisolone.

In the case of uncomplicated genital infections due to Chlamydia trachomatis, the dose is 1000 mg as a single oral dose. Adverse reactions possibly or probably related to Mycobacterium Avium Complex prophylaxis and treatment based on clinical trial experience and post-marketing surveillance. In bacterial pharyngitis the use of azithromycin is recommended only in cases where first line therapy with beta-lactams is not possible. 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. 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 case of rapid recurrent infections, treatment with another antibiotic should be considered.