Adverse Reactions (≥1%) after Multiple-Dose Regimens with Cefuroxime Axetil Tablets They do not treat viral infections (e.g., the common cold). To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefuroxime axetil and other antibacterial drugs, cefuroxime axetil should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. Although lifetime studies in animals have not been performed to evaluate carcinogenic potential, no mutagenic activity was found for cefuroxime axetil in a battery of bacterial mutation tests. Cefuroxime axetil tablets are indicated for the treatment of pediatric patients (who can swallow tablets whole) with acute bacterial otitis media caused by susceptible strains of The most common drug-related adverse experiences were diarrhea (10.6%), Jarisch-Herxheimer reaction (5.6%), and vaginitis (5.4%). Cefuroxime axetil and doxycycline were effective in prevention of the development of sequelae of late Lyme disease. Hepatic impairment including hepatitis and cholestasis, jaundice.Angioedema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria.Drugs that reduce gastric acidity may result in a lower bioavailability of cefuroxime axetil compared with administration in the fasting state. ( Table 1. The axetil moiety is metabolized to acetaldehyde and acetic acid.Cefuroxime is excreted unchanged in the urine; in adults, approximately 50% of the administered dose is recovered in the urine within 12 hours. Two multicenter trials assessed cefuroxime axetil tablets 500 mg twice a day for 20 days. Subjects were assessed at 1 month posttreatment for success in treating early Lyme disease (Part I) and at 1 year posttreatment for success in preventing the progression to the sequelae of late Lyme disease (Part II).A total of 355 adult subjects (181 treated with cefuroxime axetil and 174 treated with doxycycline) were randomized in the 2 trials, with diagnosis of early Lyme disease confirmed in 79% (281/355). Each tablet contains 500mg cefuroxime (as cefuroxime axetil). We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. 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.There may be an interaction between cefuroxime axetil and any of the following:All material copyright MediResource Inc. 1996 – 2020. 125 mg cefuroxime per 5 ml (as 150 mg cefuroxime axetil) Zinnat 250 mg/5 ml granules for oral suspension . Twenty (2.2%) subjects discontinued medication due to adverse reactions. It is also supported by postmarketing adverse events surveillance. Dosing in Adults with Renal Impairment [see Dosage and Administration ( These highlights do not include all the information needed to use CEFUROXIME AXETIL TABLETS safely and effectively. Cefuroxime 125 mg and 500 mg Tablets (cefuroxime axetil) Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Clinical Effectiveness of Cefuroxime Axetil Tablets Compared with Doxycycline in the Treatment of Early Lyme DiseasePart I (1 Month after 20 Days of Treatment) No data are available on the absorption kinetics of the suspension formulation when administered to fasted pediatric subjects.Cefuroxime is distributed throughout the extracellular fluids. In this trial and in a supporting maxillary puncture trial, 15 evaluable subjects had non β-lactamase–producing Haemophilus influenzae as the identified pathogen. The most common drug-related adverse experiences were diarrhea (10.6% of patients), Jarisch-Herxheimer reaction (5.6%), and vaginitis (5.4%). Multiple-Dose Dosing Regimens with 7 to 10 Days’ DurationTable 5. No overall differences in safety or effectiveness were observed between these subjects and younger adult subjects. Positive results were obtained in an in vitro chromosome aberration assay; however, negative results were found in an in vivo micronucleus test at doses up to 1.5 g/kg. Fertility studies in rats (males dosed for 70 days prior to and through mating; females dosed 21 days prior to mating through lactation) at doses up to 1,000 mg/kg/day (9 times the MRHD based on body surface area) have revealed no adverse effects on fertility.One adequate and well-controlled trial was performed in subjects with acute bacterial maxillary sinusitis. To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefuroxime axetil and other antibacterial drugs, cefuroxime axetil should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. 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