The clinical diagnosis of early Lyme disease in these subjects was validated by 1) blinded expert reading of photographs, when available, of the pretreatment erythema migrans skin lesion, and 2) serologic confirmation (using enzyme-linked immunosorbent assay [ELISA] and immunoblot assay ["Western" blot]) of the presence of antibodies specific to Borrelia burgdorferi, the etiologic agent of Lyme disease. The pharmacokinetics of cefuroxime in pediatric subjects have not been studied. If you have questions, ask your pharmacist. [link]. Cefuroxime axetil tablets are contraindicated in patients with a known hypersensitivity (e.g., anaphylaxis) to cefuroxime axetil tablets or to other -lactam antibacterial drugs (e.g., penicillins . Federal government websites often end in .gov or .mil. Learn more about link terms and conditions. This medication is known as a cephalosporin antibiotic. Cefuroxime Axetil 500 mg Tablet is used to treat the following -. 500 mg of cefuroxime (as cefuroxime axetil) are white to off-white, capsule-shaped, film-coated tablets with "LUPIN" debossed on one side and "303" on the other side. No overall differences in safety or effectiveness were observed between these subjects and younger adult subjects. Spain referred the reasons for disagreement to the EMEA on 25 September 2006. Rockville, MD 20852 Kaiser Foundation Health Plan of the Northwest, 500 NE Multnomah St., Suite 100, Portland, OR 97232 Kaiser Foundation Health Plan of Washington or Kaiser . It works by stopping the growth of bacteria. This medication is known as a cephalosporin antibiotic. Known hypersensitivity (e.g., anaphylaxis) to cefuroxime axetil tablets or to other -lactams (e.g., penicillins and cephalosporins). The site is secure. Cefuroxime axetil tablets are indicated for the treatment of adult and pediatric patients (13 years and older) with mild-to-moderate acute bacterial maxillary sinusitis caused by susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae (non--lactamaseproducing strains only). [4], Distribution: It has been reported that after cefuroxime axetil administration, it can be found in tonsil tissue, sinus tissue, bronchial tissue and middle ear effusion. Korting HC, Schfer-Korting M, Kees F, Lukacs A, Grobecker H. Eur J Clin Pharmacol. Existing Marketing Authorisations should be varied and pending Marketing Authorisation Applications should be granted to include these amendments. Clinical Effectiveness of Cefuroxime Axetil Tablets Compared with Doxycycline in the Treatment of Early Lyme Disease, Cefuroxime Axetil Tablets 500 mg Twice Daily, Doxycycline 100 mg 3 Times Daily (n = 83. [See INDICATIONS AND USAGE (1), DOSAGE AND ADMINISTRATION (2), ADVERSE REACTIONS (6), CLINICAL PHARMACOLOGY (12.3)]. Cefuroxime Axetil Tablets (May be administered without regard to meals. cefuroxime axetil 500 mg tablet. Tell your doctor if you are breastfeeding or plan to breastfeed. Inform patients that antibacterial drugs, including cefuroxime axetil, should only be used to treat bacterial infections. Jarisch/Herxheimer reaction is a short-term reaction . Until further data are available, the renal elimination of cefuroxime axetil established in adults should not be extrapolated to pediatric subjects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. Tell your healthcare provider right away if you have some or all of the following symptoms of an allergic reaction: Cefuroxime can cause drowsiness. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Conclusions: Cefuroxime axetil is a broad spectrum antibacterial agent with a pharmacokinetic profile that permits convenient twice-daily administration. All information on this site is provided "as-is" for informational purposes only and is not a substitute for medical advice or treatment. Antimicrob Agents Chemother. Perinatal transmission of gonorrhea to the offspring can result in infant blindness, joint infections, and bloodstream infections. Store cefuroxime tablets and suspension at room temperature. Cefuroxime Sodium Injection, Medline Plus: Current Medication Information; U.S. National Library of Medicine. Table 10 shows the results of the intent-to-treat analysis. This is the usual dosage recommended in most common treatment cases. Cefuroxime Axetil 500 mg Tablet should not be taken with following medicines due to severe side effects it may cause to patients -, If you are suffering from any of the following diseases, you should not take Cefuroxime Axetil 500 mg Tablet unless your doctor advises you to do so -. Adverse Reactions Cefuroxime Axetil Tablets Multiple-Dose Dosing RegimensClinical Trials, Table 3. It should be taken with food because food promotes its absorption from the stomach. The following adverse reactions occurred in less than 1% but greater than 0.1% of subjects (n = 1,061) treated with a single dose of cefuroxime axetil tablets 1,000 mg for uncomplicated gonorrhea in U.S. clinical trials. If you have questions, ask your pharmacist. a Most extended spectrum -lactamase (ESBL)-producing and carbapenemase-producing isolates are resistant to cefuroxime axetil. (, Serious hypersensitivity (anaphylactic) reactions: In the event of a serious reaction, discontinue cefuroxime axetil tablets and institute appropriate therapy. This medicine is used alone or in combination with other medicines for treating bacterial infections. Do not take two doses of cefuroxime at the same time. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). When cefuroxime axetil is prescribed to treat a bacterial infection, inform patients that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. [2], Second generation cephalosporins are more effective in treating Gram-negative bacilli compared to first generation cephalosporins, which have a greater coverage for Gram-positive cocci. Cefuroxime axetil tablets USP, 250 mg of cefuroxime (as cefuroxime axetil), are white to off-white, capsule-shaped, film-coated tablets with "LUPIN" debossed on one side and "302" on the other side, supplied in bottles of 20 and 60. The tablet may be taken with or without food, but the liquid suspension must be taken with food. (current), cefuroxime (as cefuroxime axetil) 250 MG Oral Tablet, cefuroxime (as cefuroxime axetil) 500 MG Oral Tablet, Pharyngitis/tonsillitis (adults and pediatric patients) (, Acute bacterial otitis media (pediatric patients) (, Acute bacterial maxillary sinusitis (adults and pediatric patients) (, Acute bacterial exacerbations of chronic bronchitis (adults and pediatric patients 13 years and older) (, Uncomplicated skin and skin-structure infections (adults and pediatric patients 13 years and older) (, Uncomplicated urinary tract infections (adults and pediatric patients 13 years and older) (, Uncomplicated gonorrhea (adults and pediatric patients 13 years and older) (, Early Lyme disease (adults and pediatric patients 13 years and older) (, Tablets and oral suspension are not bioequivalent and are therefore not substitutable on a milligram-per-milligram basis. Cefuroxime belongs to a group of drugs called cephalosporin antibiotics. All subjects presented with physician-documented erythema migrans, with or without systemic manifestations of infection. This information does not assure that this product is safe, effective, or appropriate for you. Serious side effects have been reported with cefuroxime including the following: Allergic reactions. The Marketing Authorisation Holder provided written explanations on 15 January 2007. You may report side effects to Health Canada at 1-866-234-2345. Tell your doctor right away if you have any serious side effects, including: This medication may rarely cause a severe intestinal condition due to a bacteria called C. difficile. At least 90 percent of the following bacteria exhibit an in vitro minimum inhibitory concentration (MIC) less than or equal to the susceptible breakpoint for cefuroxime against isolates of similar genus or organism group. [3], Cefuroxime axetil treats infections against methicillin, oxacillin and penicillin-sensitive bacterial strains. During pregnancy, this medication should be used only when clearly needed. Significant difference was identified with regard to the indication uncomplicated gonorrhoea: urethritis and cervicitis. Two adequate and well-controlled trials were performed in subjects with early Lyme disease. The repeat-use Mutual Recognition Procedure started on 17 May 2006. Always seek the advice of a qualified doctor for medical examination and treatment. Concomitant administration of probenecid with cefuroxime axetil tablets increases serum concentrations of cefuroxime [see CLINICAL PHARMACOLOGY (12.3)]. Dosing in Adults with Renal Impairment, Multiple-Dose Dosing Regimens with 7 to 10 Days' Duration, Table 5. Cefuroxime Axetil Tablets, USP 500 mg of cefuroxime (as Cefuroxime Axetil), are blue, capsule-shaped, biconvex, film-coated tablets with 203" debossed on one side and plain on the other side as follows: Unit dose packages of 20 (2 x 10) NDC 60687-283-94. HHS Vulnerability Disclosure, Help The efficacy data in Table 11 are specific to this "validated" patient subset, while the safety data below reflect the entire patient population for the 2 trials. Cefuroxime axetil and doxycycline were effective in prevention of the development of sequelae of late Lyme disease. of patients. being able to get an erection, but not having it last long enough for sex. *95% Confidence interval around the success difference [-0.164, +0.029]. Since the study failed to demonstrate a significant advantage of higher dosage, cefuroxime axetil should be prescribed in a regimen of 250 mg twice a day for patients with skin infections. Its molecular formula is C20H22N4O10S, and it has a molecular weight of 510.48. Otherwise, call a poison control center right away. Replace cap securely after each opening. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Cefuroxime may be found in some form under the following brand names: Serious side effects have been reported with cefuroxime. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III. 60s Bottle NDC 68180-303-60. Last updated on Nov 2, 2021. 2023 Kaiser Foundation Health Plan, Inc. We are unable to switch you to this area of care. Susceptibility to cefuroxime axetil will vary with geography and time; local susceptibility data should be consulted, if available. This medication is known as a cephalosporin antibiotic. Please do not include any personal data, such as your name or contact details. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge or other new symptoms. Cefuroxime is an antibiotic medicine that is used to treat bacterial infections of the lungs, nose, throat, ears, skin, soft tissue and urinary tract. Once the -lactam ring binds to PBPs, cross-linking between peptidoglycan units is inhibited. Harkins Company, Inc. Cefuroxime axetil tablets are uncoated and contain the equivalent of 125, 250 or 500 mg of cefuroxime as cefuroxime axetil. The safety and effectiveness of cefuroxime axetil have been established for pediatric patients aged 3 months to 12 years for acute bacterial maxillary sinusitis based upon its approval in adults. Of the total number of subjects who received cefuroxime axetil in 20 clinical trials, 375 were aged 65 and older while 151 were aged 75 and older. If this occurs, advise patients to contact their physician as soon as possible. 5 WARNINGS AND PRECAUTIONS It is usually taken every 12 hours for 5-10 days, depending on the condition being treated. Pediatric patients (aged 13 years and older) who cannot swallow the cefuroxime axetil tablets whole should receive cefuroxime axetil for oral suspension because the tablet has a strong, persistent bitter taste when crushed. Serum pharmacokinetic parameters for cefuroxime following administration of cefuroxime axetil tablets to adults are shown in Table 8. To treat gonorrhea, cefuroxime is taken as a single dose, and to treat Lyme disease, cefuroxime is taken every 12 hours for 20 days. However, microbiology data demonstrated cefuroxime axetil to be effective in treating acute bacterial maxillary sinusitis due only to Streptococcus pneumoniae or non--lactamaseproducing Haemophilus influenzae. They are generally found to be resistant to Cefuroxime. Interaction between Alcohol and Cefuroxime Axetil 500 mg Tablet. FOIA Events, (What As a false-negative result may occur in the ferricyanide test, it is recommended that either the glucose oxidase or hexokinase method be used to determine blood/plasma glucose levels in patients receiving cefuroxime axetil. Related/similar drugs Is the use of Cefuroxime Axetil 500 mg Tablet safe during breastfeeding? ), Adolescents and Adults (13 years and older), Pediatric Patients (who can swallow tablets whole), Table 5. Discuss the risks and benefits with your doctor. 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 cefuroxime axetil or other antibacterial drugs in the future. Please be advised that this content is no longer actively maintained and may now contain outdated information. Infections and Infestations: Vaginal candidiasis. Biochemical Data Summary. Cefuroxime axetil, sold under the brand name Ceftin among others, is a second generation oral cephalosporin antibiotic.. Maryland. You can take Cefuroxime Axetil 500 mg Tablet with food. The most common drug-related adverse experiences were diarrhea (10.6% of patients), Jarisch-Herxheimer reaction (5.6%), and vaginitis (5.4%). Gastrointestinal Disorders: Abdominal pain, abdominal cramps, flatulence, indigestion, mouth ulcers. For the United Kingdom, as of 1 January 2021, European Union law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland / NI. The drug is an effective and well tolerated treatment in patients with various infections, including otitis media, pharyngitis, sinusitis, CAP and acute exacerbations of chronic bronchitis. Symptoms of ED include. Resistance to cefuroxime axetil is primarily through hydrolysis by -lactamase, alteration of penicillin-binding proteins (PBPs), decreased permeability, and the presence of bacterial efflux pumps. Talk to your doctor if you are using marijuana (cannabis). 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 cefuroxime axetil or other antibacterial drugs in the future. No data are available on the effects of the drug on the breastfed infant or the effects of the drug on milk production. This copyrighted material has been downloaded from a licensed data provider. Children (who can swallow the tablets)250 mg two times a day for 10 days. If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. Drug interactions may change how your medications work or increase your risk for serious side effects. If any of these effects last or get worse, tell your doctor or pharmacist promptly. The list of the product names concerned is given in Annex I. View NDC Code(s)NEW! *Mean values of 12 healthy adult volunteers. Nausea, vomiting, diarrhea, or stomach pain may occur. Cefuroxime belongs to a group of drugs called cephalosporin antibiotics. The dose your doctor recommends may be based on the following: For adolescents and adults, the recommended dose range of cefuroxime tablets for the treatment of most infections is 250 to 500 mg twice daily. Cefuroxime comes as a tablet and a suspension (liquid) to take by mouth. Reported clinical experience has not identified differences in responses between the elderly and younger adult patients, but greater sensitivity of some older individuals cannot be ruled out. 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Plus: Current Medication information ; U.S. National Library of Medicine cefuroxime comes as a Tablet and suspension... Established in adults should not be extrapolated to pediatric subjects this information not. Tablets to adults are shown in Table 8 -lactam ring binds to PBPs, cross-linking between peptidoglycan units inhibited! Day for cefuroxime axetil 500 levitra soft days without regard to meals disagreement to the EMEA on 25 September 2006 data! To take by mouth overall differences in safety or effectiveness were observed between subjects. Written explanations on 15 January 2007 Dosing Regimens with 7 to 10 days Duration! Susceptibility to cefuroxime axetil for treating bacterial infections, pediatric patients ( who can swallow tablets )! Between these subjects and younger adult subjects pharmacokinetic profile that permits convenient twice-daily administration physician-documented! 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