16571-696-13, Aunque su uso pediátrico es aconsejable basándose en los estudios realizados hasta el presente, se require de estudios adicionales a gran escala que demuestren su eficacia en la población adulta.Présenter les données concernant la pharmacologie, l'efficacité, et la sécurité de l'utilisation de l'azithromycine en dose unique dans le traitement des infections du tractus respiratoire chez les adultes et les enfants.Une recherche MEDLINE (1990–2003) a été réalisée pour identifier toutes les études et tous les articles de revue traitant du sujet. Long-term studies in animals have not been performed to evaluate carcinogenic potential. • • Adults, children and adolescents with a body weight of 45 kg or over: • The total dose is 1500 mg, administered as 500 mg once daily for 3 days.
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Azithromycin administered during the period of organogenesis did not cause fetal malformations in rats and mice at oral doses up to 200 mg/kg/day (moderately maternally toxic). Drug interaction studies were performed with azithromycin and other drugs likely to be co-administered.
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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. The safety of re-dosing azithromycin in pediatric patients who vomit after receiving 30 mg/kg as a single dose has not been established.
If you have the appropriate software installed, you can download article citation data to the citation manager of your choice. At the Day 11 and Day 30 visits, the following clinical success rates were obtained from the evaluable group:Efficacy using azithromycin given over 3 days (10 mg/kg/day).In a double-blind, controlled, randomized clinical study of acute otitis media in pediatric patients from 6 months to 12 years of age, azithromycin (10 mg/kg per day for 3 days) was compared to amoxicillin/clavulanate potassium (7:1) in divided doses q12h for 10 days. Microbiology was not reassessed at later visits. Spontaneous postmarketing reports suggest that concomitant administration of azithromycin may potentiate the effects of oral anticoagulants such as warfarin, although the prothrombin time was not affected in the dedicated drug interaction study with azithromycin and warfarin.
In adults given 500 mg/day for 3 days, the discontinuation rate due to treatment-related adverse reactions was 0.6%. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.Azithromycin tablets are macrolide antibiotic prescription medicine used in adults 18 years or older to treat certain infections caused by certain germs called bacteria. Pediatric patients from 6 months to 12 years of age were randomized 1:1 to treatment with either azithromycin (given at 30 mg/kg as a single dose on Day 1) or amoxicillin/clavulanate potassium (7:1), divided q12h for 10 days. Most of the adverse reactions leading to discontinuation were related to the gastrointestinal tract, e.g., nausea, vomiting, diarrhea, or abdominal pain. Antibacterial agents used to treat non-gonococcal urethritis may mask or delay the symptoms of incubating syphilis. Adverse reactions that occurred with a frequency of 1% or less included the following:Overall, the most common adverse reactions in patients receiving a single-dose regimen of 1 gram of azithromycin were related to the gastrointestinal system and were more frequently reported than in patients receiving the multiple-dose regimen.Adverse reactions that occurred in patients on the single 1 gram dosing regimen of azithromycin with a frequency of 1% or greater included diarrhea/loose stools (7%), nausea (5%), abdominal pain (5%), vomiting (2%), dyspepsia (1%), and vaginitis (1%).Overall, the most common adverse reactions in patients receiving a single 2 gram dose of azithromycin were related to the gastrointestinal system.
30 mg/kg PO as a single dose (Max: 1,500 mg/dose), OR 10 mg/kg/day PO once daily for 3 days (Max: 500 mg/day), OR 10 mg/kg PO as a single dose (Max: 500 mg/dose) on day 1, followed by 5 mg/kg/day on days 2 to 5 (Max: 250 mg/day). Based on body surface area, this dose is approximately 4 (rats) and 2 (mice) times an adult human daily dose of 500 mg. Azithromycin has shown no mutagenic potential in standard laboratory tests: mouse lymphoma assay, human lymphocyte clastogenic assay, and mouse bone marrow clastogenic assay. In clinical studies involving 487 patients with acute otitis media given a single 30 mg/kg dose of azithromycin, 8 patients who vomited within 30 minutes of dosing were re-dosed at the same total dose. For the 521 patients who were evaluated at the Day 30 visit, the clinical success rate was 73% for azithromycin and 71% for the control agent.
In this study, azithromycin concentrations were determined over a 24 hr period following the last daily dose. Infection of the urethra caused by Chlamydia.
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