When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Rare serious allergic reactions, including angioedema and anaphylaxis, have been reported rarely in patients on azithromycin therapy.
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Despite initially successful symptomatic treatment of the allergic symptoms, when symptomatic therapy was discontinued, the allergic symptoms recurred soon thereafter in some patients without further azithromycin exposure. These patients required prolonged periods of observation and symptomatic treatment. The relationship of these episodes to the long tissue half-life of azithromycin and subsequent prolonged exposure to antigen is unknown at present. If an allergic reaction occurs, the drug should be discontinued and appropriate therapy should be instituted.
Physicians should be aware that reappearance of the allergic symptoms may occur when symptomatic therapy is discontinued. In the treatment of pneumonia, azithromycin has only been shown to be safe and effective in the treatment of community-acquired pneumonia of mild severity due to Streptococcus pneumoniae or Haemophilus influenzae in patients appropriate for outpatient oral therapy.
Azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for outpatient oral therapy because of moderate to severe illness or risk factors such as any of the following: patients with nosocomially acquired infections, patients with known or suspected bacteremia, patients requiring hospitalization, elderly or debilitated patients, or patients with significant underlying health problems that may compromise their ability to respond to their illness including immunodeficiency or functional asplenia.
Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range in severity from mild to life-threatening.
Azithromycin (Zithromax): Drug Whys
Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of "antibiotic-associated colitis. After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated.
Mild cases of pseudomembranous colitis usually respond to discontinuation of the drug alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against Clostridium difficile colitis. There are no data regarding azithromycin usage in patients with renal impairment; thus, caution should be exercised when prescribing azithromycin in these patients.
Prolonged cardiac repolarization and QT interval, imparting a risk of developing cardiac arrhythmia and torsades de pointes , have been seen in treatment with other macrolides. A similar effect with azithromycin cannot be completely ruled out in patients at increased risk for prolonged cardiac repolarization. Prescribing Zithromax azithromycin in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Azithromycin capsules should not be taken with food. However, increased tolerability has been observed when tablets are taken with food. Patients should also be cautioned not to take aluminum- and magnesium-containing antacids and azithromycin simultaneously. The patient should be directed to discontinue azithromycin immediately and contact a physician if any signs of an allergic reaction occur. Patients should be counseled that antibacterial drugs including Zithromax azithromycin should only be used to treat bacterial infections.
They do not treat viral infections e. When Zithromax azithromycin is prescribed to treat bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may 1 decrease the effectiveness of the immediate treatment and 2 increase the likelihood that bacteria will develop resistance and will not be treatable by Zithromax azithromycin or other antibacterial drugs in the future.
Administration of cimetidine mg two hours prior to azithromycin had no effect on azithromycin mg absorption. Mean Cmax of nelfinavir and its M8 metabolite were not significantly affected. No dosage adjustment of nelfinavir is required when nelfinavir is coadministered with azithromycin. Coadministration of nelfinavir mg tid at steady state with a single oral dose of mg azithromycin increased the mean AUC 0- infinity of azithromycin by approximately a factor of 2-times range of up to 4 times of that when azithromycin was given alone.
The mean Cmax of azithromycin was also increased by approximately a factor of 2-times range of up to 5 times of that when azithromycin was given alone.
Dose adjustment of azithromycin is not recommended. However, when administered in conjunction with nelfinavir, close monitoring for known side effects of azithromycin, such as liver enzyme abnormalities and hearing impairment, is warranted. Administration of a mg single oral dose of azithromycin had no effect on the pharmacokinetics of efavirenz given at mg doses for 7 days to healthy adult subjects.
Azithromycin mg Day 1, mg Days did not affect the plasma levels or pharmacokinetics of theophylline administered as a single intravenous dose.
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The effect of azithromycin on the plasma levels or pharmacokinetics of theophylline administered in multiple doses resulting in therapeutic steady-state levels of theophylline is not known. However, concurrent use of macrolides and theophylline has been associated with increases in the serum concentrations of theophylline.
Therefore, until further data are available, prudent medical practice dictates careful monitoring of plasma theophylline levels in patients receiving azithromycin and theophylline concomitantly. Azithromycin mg Day 1, mg Days did not affect the prothrombin time response to a single dose of warfarin. However, prudent medical practice dictates careful monitoring of prothrombin time in all patients treated with azithromycin and warfarin concomitantly. Concurrent use of macrolides and warfarin in clinical practice has been associated with increased anticoagulant effects.
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Dose adjustments are not indicated when azithromycin and zidovudine are coadministered. However, none of these changes were significantly different from those produced in a parallel placebo control group of subjects. Preliminary data suggest that coadministration of azithromycin and rifabutin did not markedly affect the mean serum concentrations of either drug. Mean concentrations 5 days after the last dose were 8.
The following drug interactions 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. Triazolam-decrease the clearance of triazolam and thus may increase the pharmacologic effect of triazolam. Drugs metabolized by the cytochrome P system-elevations of serum carbamazepine, cyclosporine, hexobarbital, and phenytoin levels. 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: mouse lymphoma assay, human lymphocyte clastogenic assay, and mouse bone marrow clastogenic assay. Pregnancy Category B: Reproduction studies have been performed in rats and mice at doses up to moderately maternally toxic dose levels i. No evidence of impaired fertility or 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.
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Because many drugs are excreted in human milk, caution should be exercised when azithromycin is administered to a nursing woman. In controlled clinical studies, azithromycin has been administered to pediatric patients ranging in age from 6 months to 12 years. Safety data are available for 72 children 5 months to 18 years of age mean 7 years who received azithromycin for treatment of opportunistic infections. Adverse events were similar to those observed in the adult population, most of which involved the gastrointestinal tract.
Treatment related reversible hearing impairment in children was observed in 4 subjects 5. Two 2. A third child discontinued due to a laboratory abnormality eosinophilia. Dosage adjustment does not appear to be necessary for older patients with normal renal and hepatic function receiving treatment with this dosage regimen. 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 responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
These patients were treated for a variety of opportunistic infections, including MAC. The side effect profile was generally similar to that seen in younger patients, except for a higher incidence of side effects relating to the gastrointestinal system and to reversible impairment of hearing. In clinical trials, most of the reported side effects were mild to moderate in severity and were reversible upon discontinuation of the drug. Approximately 0. Most of the side effects leading to discontinuation were related to the gastrointestinal tract, e.
What to know about azithromycin
Rarely but potentially serious side effects were angioedema and cholestatic jaundice. Five percent of patients experienced reversible hearing impairment in the pivotal clinical trial for the treatment of disseminated MAC in patients with AIDS. Hearing impairment has been reported with macrolide antibiotics, especially at higher doses. Cardiovascular: Arrhythmias including ventricular tachycardia, hypotension. There have been rare reports of QT prolongation and torsades de pointes.
Significant abnormalities irrespective of drug relationship occurring during the clinical trials were reported as follows:.