Due to the theoretical possibility of ergotism, the concurrent use of azithromycin with ergot derivatives is not recommended see section 4. Astemizole, alfentanil There are no known data on interactions with astemizole or alfentanil. Caution is advised in the co-administration of these medicines with Azithromycin because of the known enhancing effect of these medicines when used concurrently with the macrolid antibiotic erythromycin. Atorvastatin Coadministration of atorvastatin 10 mg daily and azithromycin 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. Carbamazepine 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.

Because macrolides inhibit this enzyme, concomitant administration of cisapride may cause the increase of QT interval prolongation, ventricular arrhythmias and torsades de pointes. Cimetidine 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.

Coumarin-Type Oral Anticoagulants In a pharmacokinetic interaction study, azithromycin did not alter the anticoagulant effect of a single 15 mg dose of warfarin administered to healthy volunteers.

There have been reports received in the post-marketing period of potentiated anticoagulation subsequent to coadministration of azithromycin and coumarin-type oral anticoagulants. Although a causal relationship has not been established, consideration should be given to the frequency of monitoring prothrombin time when azithromycin is used in patients receiving coumarin-type oral anticoagulants.

Consequently, caution should be exercised before considering concurrent administration of these drugs. If coadministration of these drugs is necessary, cyclosporin levels should be monitored and the dose adjusted accordingly. Efavirenz Coadministration of a mg single dose of azithromycin and mg efavirenz daily for 7 days did not result in any clinically significant pharmacokinetic interactions.

Fluconazole Coadministration of a single dose of mg azithromycin did not alter the pharmacokinetics of a single dose of mg fluconazole. Indinavir Coadministration of a single dose of mg azithromycin had no statistically significant effect on the pharmacokinetics of indinavir administered as mg three times daily for 5 days. Methylprednisolone In a pharmacokinetic interaction study in healthy volunteers, azithromycin had no significant effect on the pharmacokinetics of methylprednisolone.

Nelfinavir Coadministration of azithromycin mg and nelfinavir at steady state mg three times daily resulted in increased azithromycin concentrations. No clinically significant adverse effects were observed and no dose adjustment is required. Rifabutin Coadministration of azithromycin and rifabutin did not affect the serum concentrations of either drug. Neutropenia was observed in subjects receiving concomitant treatment of azithromycin and rifabutin.

Although neutropenia has been associated with the use of rifabutin, a causal relationship to combination with azithromycin has not been established see Section 4. Sildenafil In normal healthy male volunteers, there was no evidence of an effect of azithromycin mg daily for 3 days on the AUC and Cmax of sildenafil or its major circulating metabolite.

Terfenadine Pharmacokinetic studies have reported no evidence of an interaction between azithromycin and terfenadine. There have been rare cases reported where the possibility of such an interaction could not be entirely excluded; however there was no specific evidence that such an interaction had occurred.

Theophylline There is no evidence of a clinically significant pharmacokinetic interaction when azithromycin and theophylline are co-administered to healthy volunteers. Triazolam In 14 healthy volunteers, coadministration of azithromycin mg on Day 1 and mg on Day 2 with 0. Azithromycin serum concentrations were similar to those seen in other studies. Substances that prolong the QT interval Azithromycin should not be used concurrently with other active substances that prolong the QT interval see section 4.

In reproduction toxicity studies in animals azithromycin was shown to pass the placenta, but no teratogenic effects were observed. Therefore, inform your veterinarian of any and all medications your pet may be taking. This is especially important if your pet is currently taking cisapride or oral antacids.

Finally, if you notice any behavioral or physiological changes in your pet while administering this medication, contact your veterinarian immediately. Possible Side Effects Azithromycin should not be used in animals with known hypersensitivity or allergy to it or other macrolide antibiotics.

In addition, it should be used with great caution if at all when there is preexisting liver disease. Gastrointestinal side effects may include vomiting, diarrhea, or abdominal pain. Angioedema and cholestatic jaundice have been reported rarely in treated humans. Cardiac arrhythmias, including ventricular tachycardia, may be precipitated by azithromycin.

Renal dysfunction, including interstitial nephritis and acute renal failure, may occur secondary to azithromycin treatment and liver function may be affected. Although a dose adjustment of azithromycin is not recommended when administered in combination with nelfinavir, close monitoring for known adverse reactions of azithromycin, such as liver enzyme abnormalities and hearing impairment, is warranted.

Prothrombin times should be carefully monitored while patients are receiving azithromycin and oral anticoagulants concomitantly Potential Drug-Drug Interactions with Macrolides Interactions with digoxin or phenytoin have not been reported in clinical trials with azithromycin; however, no specific drug interaction studies have been performed to evaluate potential drug-drug interactions.

However, drug interactions have been observed with other macrolide products. Until further data are developed regarding drug interactions when digoxin or phenytoin are used concomitantly with azithromycin careful monitoring of patients is advised.

Reproduction studies have been performed in rats and mice at doses up to moderately maternally toxic dose concentrations i. These daily doses in rats and mice, based on body surface area, are estimated to be 4 and 2 times, respectively, an adult daily dose of mg. In the animal studies, no evidence of harm to the fetus due to azithromycin was found. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, azithromycin should be used during pregnancy only if clearly needed.

Nursing Mothers Azithromycin has been reported to be excreted in human breast milk in small amounts. Caution should be exercised when azithromycin is administered to a nursing woman. Pediatric Use [see Clinical Pharmacology Use of azithromycin for the treatment of acute bacterial sinusitis and community-acquired pneumonia in pediatric patients 6 months of age or greater is supported by adequate and well-controlled trials in adults. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in response between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Elderly patients may be more susceptible to development of torsades de pointes arrhythmias than younger patients. In the event of overdosage, general symptomatic and supportive measures are indicated as required.

AZITHROMYCIN 200MG/5ML ORAL SUSPENSION

Methylprednisolone In a pharmacokinetic interaction study in healthy volunteers, azithromycin had no significant effect on the pharmacokinetics of methylprednisolone. Fluconazole Coadministration of a single dose of mg azithromycin did not alter the pharmacokinetics of a single dose of mg fluconazole. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. However, 5ml of azithromycin increased the concentrations of phosphorylated zidovudine, azithromycin 200mg 5ml suspension, the clinically active metabolite, in suspension blood 200mg cells. Substances that prolong the QT interval Azithromycin should not be used concurrently with other active substances that prolong the QT interval see section 4. Drug Interactions Nelfinavir Co-administration of nelfinavir at steady-state with a single oral dose of azithromycin resulted in increased azithromycin serum concentrations. If an allergic reaction occurs, the drug should be discontinued and appropriate therapy should be instituted. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, azithromycin 200mg 5ml suspension, and other reported clinical experience has not identified differences in response between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Azithromycin should be aware that reappearance of the allergic symptoms may occur when symptomatic therapy is discontinued.

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