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. Elderly patients may be more susceptible to drug-associated effects on the QT interval. Treatment with antibacterial agents alters the normal flora of the colon , leading to overgrowth of C.
Hypertoxin-producing strains of C. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. 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 co-administration of these two drugs. If co-administration is necessary, ciclosporin levels should be monitored and the dose adjusted accordingly. Co-administration of a single dose of mg azithromycin and mg efavirenz daily for 7 days did not result in any clinically significant pharmacokinetic interactions.
Co-administration of a single dose of mg azithromycin did not alter the pharmacokinetics of a single dose of mg fluconazole. Co-administration 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. In a pharmacokinetic interaction study in healthy volunteers, Zithromax had no significant effect on the pharmacokinetics of methylprednisolone.
Co-administration 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 was required. 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.
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. Pharmacokinetic studies have reported no evidence of an interaction between azithromycin and terfenadine. Do not dispose of medications in wastewater e.
Ask your pharmacist how to dispose of medications that are no longer needed or have expired. Who should NOT take this medication? Do not take azithromycin if you: Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication.
Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.
Measure your dose correctly with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid. Measure the extended-release oral liquid with a marked measuring spoon, syringe, or cup. You or your child must take this medicine within 12 hours after it has been mixed with water.
It is best to take the extended-release oral liquid on an empty stomach or at least 1 hour before or 2 hours after a meal. No dosage adjustment of either drug is recommended when azithromycin is co-administered with any of the above agents.
Interactions with the drugs listed below have not been reported in clinical trials with azithromycin; however, no specific drug interaction studies have been performed to evaluate potential drug-drug interaction. Nonetheless, they have been observed with macrolide products. Until further data are developed regarding drug interactions when azithromycin and these drugs are used concomitantly; careful monitoring of patients is advised: Ergotamine or dihydroergotamine—acute ergot toxicity characterized by severe peripheral vasospasm and dysesthesia.
Terfenadine, cyclosporine, hexobarbital and phenytoin concentrations. Laboratory Test Interactions There are no reported laboratory test interactions. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been performed to evaluate carcinogenic potential.
Azithromycin has shown no mutagenic potential in standard laboratory tests: No evidence of impaired fertility due to azithromycin was found. Pregnancy Teratogenic Effects Pregnancy Category B Reproduction studies have been performed in rats and mice at doses up to moderately maternally toxic dose concentrations i.
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 It is not known whether azithromycin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when azithromycin is administered to a nursing woman.
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