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However, the efficacy of azithromycin in treating clinical infections caused by these bacteria has not been established in adequate and well-controlled clinical trials. Direct parents and caregivers to contact their physician if vomiting or irritability with feeding occurs.
Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. Call your doctor for medical advice about side effects.
The primary endpoint of this trial was prospectively defined as the clinical cure rate at Day 28. This Patient Information has been approved by the U.
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8 patients who vomited within 30 minutes of dosing were re-dosed at the same total dose. 2 Hepatic Dysfunction5 WARNINGS AND PRECAUTIONS5. Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. The disk diffusion breakpoints are provided in Table 3.
Interstitial nephritis and acute renal failure and vaginitis. Safety and effectiveness in the treatment of pediatric patients with acute otitis media, acute bacterial sinusitis and community-acquired pneumonia under 6 months of age have not been established. Do not give ZITHROMAX to other people, even if they have the same symptoms you have. ZITHROMAX is not for viral infections such as the common cold. The MIC values should be interpreted according to criteria provided in Table 3.
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Geriatric use: Elderly patients may be more susceptible to development of torsades de pointes arrhythmias. In clinical trials, most of the reported side effects were mild to moderate in severity and were reversible upon discontinuation of the drug. Stop taking ZITHROMAX at the first sign of a skin rash and call your healthcare provider. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. If you would like more information, talk with your healthcare provider.
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. Very occasionally, the antibiotic can affect a locomotive system or become the cause of a candidiasis emergence. This Patient Information leaflet summarizes the most important information about ZITHROMAX. 2H2O and a molecular weight of 785.
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How should I use this medication? In multiple-dose clinical trials involving more than 5000 patients, four patients discontinued therapy because of treatment-related liver enzyme abnormalities and one because of a renal function abnormality. Prothrombin times should be carefully monitored while patients are receiving azithromycin and oral anticoagulants concomitantly. In this study, azithromycin concentrations were determined over a 24 hr period following the last daily dose. ZITHROMAX may exacerbate muscle weakness in persons with myasthenia gravis. And unfortunately, one will not be able to correct these changes any more.
Reportedly, side effects of the geniture were not detected. The antibacterial activity of azithromycin is pH related and appears to be reduced with decreasing pH, However, the extensive distribution of drug to tissues may be relevant to clinical activity. CLSI document M02-A12, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015. Standard azithromycin powder should provide the following range of MIC values provided in Table 4.
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Direct parents or caregivers to contact their physician if vomiting and irritability with feeding occurs in the infant. Antibacterial agents used to treat non-gonococcal urethritis may mask or delay the symptoms of incubating syphilis. A side effect is an unwanted response to a medication when it is taken in normal doses. If drugs for reduction of acidity of the stomach are taken together with Azithromycin, one is to take the break of two hours between their intakes. Caution should be exercised when azithromycin is administered to a nursing woman. Bacterial resistance: Misuse of an antibiotic such as azithromycin may lead to the growth of resistant bacteria that will not be killed by the antibiotic.
Do not stop using this medication without consulting your doctor. No dosage adjustment is recommended based on gender. What side effects are possible with this medication? If any of these symptoms were detected, one should urgently consult a doctor.
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Cases of torsades de pointes have been spontaneously reported during postmarketing surveillance in patients receiving azithromycin. 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. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately. Do not use ZITHROMAX for a condition for which it was not prescribed. Stop taking ZITHROMAX and tell your healthcare provider right away if you have yellowing of your skin or white part of your eyes, or if you have dark urine.
Pediatric use: Safety and effectiveness in the treatment of patients under 6 months of age have not been established. 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. Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. Also tell them about any supplements you take.
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All patients with sexually transmitted urethritis or cervicitis should have a serologic test for syphilis and appropriate testing for gonorrhea performed at the time of diagnosis. Two azithromycin 250 mg tablets are bioequivalent to a single 500 mg tablet. Hepatotoxicity can happen in people who take ZITHROMAX. The most frequently encountered mechanism of resistance to azithromycin is modification of the 23S rRNA target, most often by methylation.
Abnormal liver function, hepatitis, cholestatic jaundice, hepatic necrosis, and hepatic failure. Microbiologic determinations were made at the pre-treatment visit. If you notice these symptoms, stop taking azithromycin and contact your doctor as soon as possible.
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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. 1 HypersensitivityZITHROMAX is contraindicated in patients with known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide drug. 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. This can cause other infections, such as yeast infections, to develop. 32 evaluations were considered the primary test of cure endpoint. Arrhythmias including ventricular tachycardia and hypotension.
14 data are provided for clinical guidance. ZITHROMAX 500 mg tablets are supplied as pink modified capsular shaped, engraved, film-coated tablets containing azithromycin dihydrate equivalent to 500 mg of azithromycin. What should I tell my healthcare provider before taking ZITHROMAX?
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Tell your healthcare provider about any side effect that bothers you or that does not go away. If you become pregnant while taking this medication, contact your doctor immediately. Treatment with antibacterial agents alters the normal flora of the colon, leading to overgrowth of C. These reports should aid the physician in selecting an antibacterial drug for treatment. If the regular intake of the drug was missed, it must be taken when you recall, but the next intake must take place only a day later.
A double-blind, controlled, randomized trial was performed at nine clinical centers. Kidney disease: If you have kidney disease or reduced kidney function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. The safety and efficacy of azithromycin tablets or suspension have not been established for treating children younger than 2 years of age who have throat infections or tonsillitis. Take ZITHROMAX exactly as your healthcare provider tells you to take it. 3 DOSAGE FORMS AND STRENGTHSZITHROMAX 250 mg tablets are supplied as pink modified capsular shaped, engraved, film-coated tablets containing azithromycin dihydrate equivalent to 250 mg of azithromycin.
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7 Use in Sexually Transmitted InfectionsZITHROMAX, at the recommended dose, should not be relied upon to treat syphilis. And at the same moment, her organism becomes more vulnerable to all diseases and infections, which, of course, can harm her baby. Side Effects ol Azithromycin in Pregnancy According to the instruction of the drug, its side effects can be the following: an eruption on the skin and itch, loose bowels or constipation, increased gas formation, nausea and vomiting, a headache. Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications.
Children: The safety and efficacy of azithromycin tablets or suspension have not been established for treating children younger than 6 months of age who have acute otitis media or community-acquired pneumonia. 3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS4. For the diffusion technique using the 15 mcg azithromycin disk the criteria provided in Table 4 should be achieved.