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Because animal reproduction studies are not always predictive of human response, azithromycin should be used during pregnancy only if clearly needed. 14 were considered on-therapy evaluations because of the extended half-life of azithromycin.
Direct parents and caregivers to contact their physician if vomiting or irritability with feeding occurs. 6 Exacerbation of Myasthenia Gravis Exacerbation of symptoms of myasthenia gravis and new onset of myasthenic syndrome have been reported in patients receiving azithromycin therapy.
Adverse reactions identified from post-marketing experience are included in italics. Sharing our faith is the foundation of the Village.
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Constituting instructions for ZITHROMAX Oral Suspension 300, 600, 900, 1200 mg bottles. Quantitative methods that require measurement of zone diameters can also provide reproducible estimates of the susceptibility of bacteria to antibacterial compounds. 2 years of age have not been established. Prothrombin times should be carefully monitored while patients are receiving azithromycin and oral anticoagulants concomitantly. Rifabutin: Co-administration of azithromycin and rifabutin did not affect the serum concentrations of either drug.
Zithromax capsules should be given as a single daily dose. You may report side effects to FDA at 1-800-FDA-1088. Treatment with antibacterial agents alters the normal flora of the colon, leading to overgrowth of C. The most frequently encountered mechanism of resistance to azithromycin is modification of the 23S rRNA target, most often by methylation. PVC blister strips, 4 capsules per strip, 1 strip in a carton box. The disk diffusion breakpoints are provided in Table 3.
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Indinavir: 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. Direct parents or caregivers to contact their physician if vomiting and irritability with feeding occurs in the infant. 5 days, of whom 31 patients were evaluated for azithromycin pharmacokinetics following a low fat breakfast. Patients should also be cautioned not to take aluminum- and magnesium-containing antacids and azithromycin simultaneously.
Not all pack sizes may be marketed. You can ask your pharmacist or healthcare provider for information about ZITHROMAX that is written for health professionals. It is not known if ZITHROMAX will harm your unborn baby.
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In the event of overdose, the administration of medicinal charcoal and general symptomatic treatment and supportive measures are indicated as required. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Each capsule contains azithromycin dihydrate 262. Discontinue azithromycin immediately if signs and symptoms of hepatitis occur. 500 mg once daily for 3 days. ZITHROMAX 500 mg tablets are engraved with “Pfizer” on one side and “ZTM500” on the other.
The effects of co-administration of azithromycin on the pharmacokinetics of other drugs are shown in Table 1 and the effects of other drugs on the pharmacokinetics of azithromycin are shown in Table 2. ZITHROMAX tablets and oral suspension can be taken with or without food. Cough, pharyngitis, pleural effusion, and rhinitis. Zidovudine: 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. In animal tests, high concentrations of azithromycin have been found in phagocytes.
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It is not known if ZITHROMAX is safe and effective for children with ear infections, sinus infections, and community-acquired pneumonia under 6 months of age. Long-term studies in animals have not been performed to evaluate carcinogenic potential as the drug is indicated for short-term treatment only and there were no signs indicative of carcinogenic activity. HIV-positive subjects did not appear to affect the steady-state pharmacokinetics of didanosine as compared to placebo.
In uncomplicated genital infections due to Chlamydia trachomatis, the dose is 1000 mg as a single oral dose. Keep ZITHROMAX and all medicines out of the reach of children. CLSI document M02-A12, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015.
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Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. 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. However, administration of azithromycin increased the concentrations of phosphorylated zidovudine, the clinically active metabolite, in peripheral blood mononuclear cells. There are no data concerning the possibility of an interaction between ergot and azithromycin.
These patients required prolonged periods of observation and symptomatic treatment. Since azithromycin is metabolised in the liver and excreted in the bile, the drug should not be given to patients suffering from severe liver disease. In these studies, no evidence of harm to the foetus due to azithromycin was found. ZITHROMAX for oral suspension can be taken with or without food. For more information, go to www. The typical symptoms of an overdose with macrolide antibiotics include reversible loss of hearing, severe nausea, vomiting and diarrhoea.
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Potentially serious adverse reactions of angioedema and cholestatic jaundice were reported. Pruritus serious skin reactions including erythema multiforme, AGEP, Stevens-Johnson Syndrome, toxic epidermal necrolysis, and DRESS. Considerations should be given to official guidance regarding the appropriate use of antibacterial agents.
This could happen after you have finished your ZITHROMAX. 2 Hepatic Dysfunction5 WARNINGS AND PRECAUTIONS5. Single and Multiple-dose regimens: The types of adverse reactions in pediatric patients were comparable to those seen in adults, with different incidence rates for the dosage regimens recommended in pediatric patients. Co-administration of azithromycin at therapeutic doses had a modest effect on the pharmacokinetics of the drugs listed in Table 1.
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Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine. Antibacterial agents used to treat non-gonococcal urethritis may mask or delay the symptoms of incubating syphilis. This Patient Information leaflet summarizes the most important information about ZITHROMAX. Do not skip any doses of ZITHROMAX or stop taking it, even if you begin to feel better, until you finish your prescribed treatment unless you have a serious allergic reaction or your healthcare provider tells you to stop taking ZITHROMAX. Neutropenia was observed in subjects receiving concomitant treatment of azithromycin and rifabutin. Take ZITHROMAX exactly as your healthcare provider tells you to take it.
Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. Co-administration of azithromycin with efavirenz or fluconazole had a modest effect on the pharmacokinetics of azithromycin.
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As there are no data from adequate and well-controlled studies of azithromycin treatment of infections in these additional body sites, the clinical significance of these tissue concentration data is unknown. Pharmacokinetic studies have been conducted between azithromycin and the following drugs known to undergo significant cytochrome P450 mediated metabolism. Physicians should be aware that allergic symptoms may reappear when symptomatic therapy has been discontinued.
3 days did not cause clinically significant changes in the pharmacokinetics and pharmacodynamics of a single dose of 15mg midazolam. Diarrhea is a common problem caused by antibacterials which usually ends when the antibacterial is discontinued. Zithromax Capsules are for oral administration only.
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2H2O and a molecular weight of 785. In children under 45 kg body weight: Zithromax Capsules are not suitable for children under 45 kg. In animal studies for embryotoxic effects of the substance, no teratogenic effect was observed in mice and rats. For current full prescribing information, please visit www.
4 QT Prolongation Prolonged cardiac repolarization and QT interval, imparting a risk of developing cardiac arrhythmia and torsades de pointes, have been seen with treatment with macrolides, including azithromycin. Cases of torsades de pointes have been spontaneously reported during postmarketing surveillance in patients receiving azithromycin. No clinically significant adverse effects were observed and no dose adjustment was required.