Do not start, stop, or change the dosage of any medicines without your doctor's approval. Store the tablets at 20 to 25C (68 to 77F) [See USP Controlled Room Temperature]. Itcontains cefotaxime which belongs to the class of drugs known as cephalosporins. [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. 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. Yes, Cefuroxime can treat gonorrhea which is a sexually transmitted infection caused by bacteria Neisseria gonorrhoeae which provides relief to the patient from fever, painful urination and abnormal discharge from reproductive organs (penis or vagina). [4], Cefuroxime axetil is a second generation cephalosporin that, like penicillins antibiotics, contains a -lactam ring structure. Angioedema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria. Kaiser Permanente health plans around the country: Kaiser Foundation Health Plan, Inc., in Northern and Southern California and Hawaii Kaiser Foundation Health Plan of Colorado Kaiser Foundation Health Plan of Georgia, Inc., Nine Piedmont Center, 3495 Piedmont Road NE, Atlanta, GA 30305, 404-364-7000 Kaiser Foundation Health Plan of the Mid-Atlantic States, Inc., in Maryland, Virginia, and Washington, D.C., 2101 E. Jefferson St., 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 Foundation Health Plan of Washington Options, Inc.,1300 SW 27thSt., Renton, WA 98057. 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 . Do not share this medication with others. [3], Absorption: Once consumed, cefuroxime axetil is converted to the active compound cefuroxime by esterases of mucosal cells in the gastrointestinal tract. Abstract Cefuroxime axetil, a prodrug of the cephalosporin cefuroxime, has proven in vitro antibacterial activity against several Gram-positive and Gram-negative organisms, including those most frequently associated with various common community-acquired infections. National Library of Medicine These work by stopping the growth of bacteria that cause infections. 1996 Jul;52(1):125-58. doi: 10.2165/00003495-199652010-00009. Spain referred the reasons for disagreement to the EMEA on 25 September 2006. National Committee for Clinical Laboratory Standards. 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. Skin tissue fluid levels of cefotiam in healthy man following oral cefotiam hexetil. Language links are at the top of the page across from the title. The following serious and otherwise important adverse reaction is described in greater detail in the Warnings and Precautions section of the label: Anaphylactic Reactions [see WARNINGS AND PRECAUTIONS (5.1)]. It is an acetoxyethyl ester prodrug of cefuroxime which is effective orally. (, Administer cefuroxime axetil tablets as described in the dosage guidelines. Renal and Urinary Disorders: Bleeding/pain in urethra, kidney pain. Take your next dose at the regular time. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Overdosage of cephalosporins can cause cerebral irritation leading to convulsions or encephalopathy. In Canada - Call your doctor for medical advice about side effects. An opinion was adopted by consensus on 26 April 2007. Cardiac Disorders: Tightness/pain in chest, tachycardia. [4], It was discovered by Glaxo (now GlaxoSmithKline) and introduced in 1987. [8] It is available by GSK as Ceftin in US[9] and Ceftum in India.[10]. View Labeling Archives, It will not work for viral infections (such as common cold, flu). Clinical Effectiveness of Cefuroxime Axetil Tablets Compared to Beta-Lactamase Inhibitor-Containing Control Drug in the Treatment of Acute Bacterial Maxillary Sinusitis, Table 6. It is difficult to say anything about the effect of Cefuroxime Axetil 500 mg Tablet and alcohol. Therefore, the safety and effectiveness of both the tablet and oral suspension formulations were established in separate clinical trials. 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. . The following adverse reactions have been identified during post-approval use of cefuroxime axetil. Cefuroxime may cause some side . The Rapporteur was Dr Frits Lekkerkerker and Co-Rapporteur was Dr Gonzalo Calvo Rojas. 2001;61(10):1455-500. doi: 10.2165/00003495-200161100-00008. Cefuroxime axetil tablets are a cephalosporin antibacterial drug indicated for the treatment of the following infections due to susceptible bacteria: (1). Human Data: While available studies cannot definitively establish the absence of risk, published data from epidemiologic studies, case series, and case reports over several decades have not identified an association with cephalosporin use (including cefuroxime axetil) during pregnancy and major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Kaiser Permanente is not responsible for the content or policies of external websites. An official website of the United States government. (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. Acute Bacterial Exacerbations of Chronic Bronchitis and Secondary Bacterial Infections of Acute Bronchitis, Uncomplicated Skin and Skin-Structure Infections, CEFUROXIME AXETIL TABLETS AND CEFUROXIME AXETIL FOR ORAL SUSPENSION ARE NOT BIOEQUIVALENT AND ARE THEREFORE NOT SUBSTITUTABLE ON A MILLIGRAM-PER-MILLIGRAM BASIS (SEE, Table 2. Adverse Reactions (1%) after Multiple-Dose Regimens with Cefuroxime Axetil Tablets. of patients. Labels, All Index Anaphylaxis, serum sickness-like reaction, acute myocardial ischemia with or without, myocardial infarction may occur as part of an allergic reaction. Cefuroxime axetil in the treatment of uncomplicated UTI: a comparison with cefaclor and augmentin. Revised: July 2021 ID#: All Drug Sometimes after starting treatment with antibacterials, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as 2 or more months after having taken their last dose of the antibacterial. Many people using this medication do not have serious side effects. *95% Confidence interval around the success difference [-0.164, +0.029]. vomiting. a Most extended spectrum -lactamase (ESBL)-producing and carbapenemase-producing isolates are resistant to cefuroxime axetil. The list of the product names concerned is given in Annex I. Limit alcoholic beverages. Musculoskeletal and Connective Tissue Disorders: Muscle cramps, muscle stiffness, muscle spasm of neck, lockjaw-type reaction. Before initiating therapy with cefuroxime axetil, inquire about previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. Prescribing cefuroxime axetil either 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. Before taking cefuroxime, tell your doctor or pharmacist if you are allergic to it; or to penicillins or other cephalosporin antibiotics (such as cephalexin); or if you have any other allergies. Cefuroxime axetil is contraindicated in patients with a known hypersensitivity to cefuroxime axetil or other -lactam antibacterial drugs [see CONTRAINDICATIONS (4)]. 68180-303-20, Please be advised that this content is no longer actively maintained and may now contain outdated information. Musculoskeletal and Connective Tissue Disorders: Disease-Associated Maternal and/or Embryo/Fetal Risk: Table 8. New Delhi, India: Jaypee Brothers Medical Publishers; 2013: Page No 727, April Hazard Vallerand, Cynthia A. Sanoski. There are no well-done studies that have been done in humans with cefuroxime. Replace cap securely after each opening. What is the effect of Cefuroxime Axetil 500 mg Tablet on the Kidneys? A false-positive result for glucose in the urine may occur with copper reduction tests, and a false-negative result for blood/plasma glucose may occur with ferricyanide tests in subjects receiving cefuroxime axetil [see DRUG INTERACTIONS (7.3)]. Jarisch/Herxheimer reaction is a short-term reaction . Would you like email updates of new search results? Dosing in Adults with Renal Impairment, Multiple-Dose Dosing Regimens with 7 to 10 Days' Duration, Table 5. You can take Cefuroxime without any fear of damage to the heart. 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. The most common drug-related adverse experiences were diarrhea (10.6%), Jarisch-Herxheimer reaction (5.6%), and vaginitis (5.4%). 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. It will not work for viral infections (such as. Descriptions Cefuroxime is used to treat bacterial infections in many different parts of the body. Despite this difference in absorption, the clinical and bacteriologic responses of subjects were independent of food intake at the time of tablet administration in 2 trials where this was assessed. Drug information provided by: Merative, Micromedex Along with its needed effects, a medicine may cause some unwanted effects. PubMed, Tell your doctor if you are pregnant or plan to become pregnant. Reproductive System and Breast Disorders: General Disorders and Administration Site Conditions: Single-Dose Regimen for Uncomplicated Gonorrhea: Table 6. Postprandial Pharmacokinetics of Cefuroxime Administered as Cefuroxime Axetil Tablets to Adults*. Canada residents can call a provincial poison control center. Clinical comparison of cefuroxime axetil, cephalexin and cefadroxil in the treatment of patients with primary infections of the skin or skin structures. To help you remember, take this medication at the same time(s) every day. Is this Cefuroxime Axetil 500 mg Tablet habit forming or addictive? FDA Safety Recalls, Cefuroxime Axetil 500 mg Tablet should be used only after doctor's advice. Is it safe to drive or operate heavy machinery when consuming? Cefuroxime, Medline Plus: Current Medication Information; U.S. National Library of Medicine. 1990;39(1):33-6. doi: 10.1007/BF02657053. Set id: 9ccf0781-4fb3-496e-bd58-54381ea33510, Table 1. CEFUROXIME (cefuroxime sodium) injection, powder, for solution, DailyMed: Current Medication Information; U.S. National Library of Medicine. Adult Patients and Pediatric Patients Dosage Guidelines for Cefuroxime Axetil Tablets, Table 4. In the case of cefuroxime, there are no specific foods that you must exclude from your diet when receiving this medication. Biochemical Data Summary. 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. It should be taken with food because food promotes its absorption from the stomach. If you miss a dose, take it as soon as you remember. However, an antibiotic sensitivity test is recommended to confirm its resistance. US residents can call their local poison control center at 1-800-222-1222. It is an acetoxyethyl ester prodrug of cefuroxime which is effective orally. 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. Applies to the following strengths: 7.5 g; 750 mg; 1.5 g; 250 mg; 500 mg; 125 mg; 125 mg/5 mL; 750 mg/50 mL-5%; 1.5 g/50 mL-5%; 250 mg/5 mL Usual Adult Dose for: Bacterial Infection Bronchitis Pneumonia Urinary Tract Infection Skin or Soft Tissue Infection Skin and Structure Infection Septicemia Meningitis Forming a habit of Cefuroxime Axetil 500 mg Tablet has not been reported. The following in vitro data are available, but their clinical significance is unknown. The final opinion was converted into a Decision by the European Commission on 22 August 2007. Events, (What Properly discard this product when it is expired or no longer needed. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Cefuroxime is used to treat a wide variety of bacterial infections. Do not drive or operate heavy machinery until you know how cefuroxime affects you. Also, it has been reported that cefuroxime is resistant to hydrolysis by -lactamases produced by Gram-negative bacteria. Revised: July 2021 ID#:267748, Report Adverse https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=f799137f-9676-42d4-9130-a9685cc9302c, https://dailymed.nlm.nih.gov/dailymed/rss.cfm. Allowing for an infant milk consumption of 150 mL/kg/day, the estimated breastfed infant dose would be less than 1% of the adult dose. Cefuroxime axetil tablets are indicated for the treatment of adult patients and pediatric patients (aged 13 and older) with uncomplicated gonorrhea, urethral and endocervical, caused by penicillinaseproducing and non-penicillinaseproducing susceptible strains of Neisseria gonorrhoeae and uncomplicated gonorrhea, rectal, in females, caused by non-penicillinaseproducing susceptible strains of Neisseria gonorrhoeae. Cure or improvement was achieved in 51 of 55 (93%) evaluable patients treated with cefuroxime axetil and in 45 of 51 (88%) patients treated with doxycycline. Drug interactions may change how your medications work or increase your risk for serious side effects. It works by stopping the growth of bacteria. If you have any questions regarding previously published content, please contact support@rxwiki.com. Especially tell your doctor if you take: This is not a complete list of cefuroxime drug interactions. You should consult with a medical professional if you have any questions about your health. Find the right dosage based on disease and age. Existing Marketing Authorisations should be varied and pending Marketing Authorisation Applications should be granted to include these amendments. Careers. Overview Cefuroximaxetil and associated names, 125 mg, 250 mg and 500 mg, coated tablets is a cephalosporin ( [Beta] - lactam group of antibiotics), indicated for the treatment of mild to moderately severe infections caused by micro-organisms susceptible to cefuroxime, such as: Using any antibiotic when it is not needed can cause it to not work for future infections. Stopping the medication too early may allow bacteria to continue to grow, which may result in a relapse of the infection. A randomized, multicenter, investigator-blinded trial treated 123 patients with EM for 20 days with either cefuroxime axetil 500 mg twice daily (n=63) or doxycycline 100 mg twice daily (n=60). For the best effect, take this antibiotic at evenly spaced times. Before Precautions must be taken in patients with ahistory of penicillin allergy, colitis, and impaired kidney function. RxNorm, & Articles, All Files, All Mapping If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader. If you notice other effects not listed above, contact your doctor or pharmacist. Maryland. The crushed tablet has a strong, persistent, bitter taste and should not be administered to pediatric patients in this manner. All subjects presented with physician-documented erythema migrans, with or without systemic manifestations of infection. ), Adolescents and Adults (13 years and older), Pediatric Patients (who can swallow tablets whole), Table 5. Reproductive System and Breast Disorders: Vaginitis, vulvar itch. This medication may affect the results of certain lab tests. Cefuroxime axetil is a semisynthetic, cephalosporin antibacterial drug for oral administration. Cefuroxime Axetil 500 mg Tablet is used to treat the following -. Once the -lactam ring binds to PBPs, cross-linking between peptidoglycan units is inhibited. Insert into bacterial cell wall causing perforation and depolarization: This page was last edited on 27 May 2023, at 23:00. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Jacobs RF, Brown WD, Chartrand S, Darden P, Drehobl MA, Yetman R, Ossi MJ. Cefuroxime axetil is an antibacterial drug [see MICROBIOLOGY (12.4)]. No research has been done on this yet. nausea. Sydnor A Jr, Gwaltney JM Jr, Cocchetto DM, Scheld WM. If you miss a dose, take the missed dose as soon as you remember. * 95% confidence interval around the satisfactory difference for Part I (-0.08, +0.05). This refers to the safety and efficacy of cefuroximaxetil in uncomplicated gonorrhoea and riskbenefit balance for this sought indication and this was considered to be a serious public health concern. It is noted that 125 mg twice daily is not an approved dosage. Pseudomembranous colitis [see WARNINGS AND PRECAUTIONS (5.2)]. Serious side effects have been reported with cefuroxime including the following: Allergic reactions. ), 95% (cefuroxime axetil 500 mg b.i.d. this version. Pharmacokinetics of Cefuroxime Administered in the Postprandial State as Cefuroxime Axetil Tablets to Adults, Table 10. 1989 Dec;115(12):1430-3. doi: 10.1001/archotol.1989.01860360032012. It belongs to the class of medicines known as cephalosporin antibiotics. This information does not assure that this product is safe, effective, or appropriate for you. There are no well-done studies that have been done in humans with cefuroxime. Cefuroxime axetil was an effective antibacterial agent for treatment of common skin infections. Always seek the advice of a qualified doctor for medical examination and treatment. Consult your doctor before breast-feeding. This medication is also available in an injectable form to be given directly into a vein (IV) or a muscle (IM) by a healthcare professional. A very serious allergic reaction to this drug is rare. No, Cefuroxime does not penicillin. Tell your doctor if your condition lasts or gets worse. If this occurs, advise patients to contact their physician as soon as possible. Not all photos of the drug may be displayed. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Evaluation of cefuroxime axetil and cefadroxil suspensions for treatment of pediatric skin infections. Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including cefuroxime axetil, and may range in severity from mild diarrhea to fatal colitis. It works by killing bacteria or preventing their growth. You can take Cefuroxime Axetil 500 mg Tablet with food. Talk to your doctor if you are using marijuana (cannabis). Do not crush or chew because the tablets have a strong bitter taste. The pharmacokinetics of cefuroxime in pediatric subjects have not been studied. Cefuroxime is an antibiotic medicine that is used to treat bacterial infections of the lungs, nose, throat, ears, skin, soft tissue and urinary tract. Generic: 1.5 g (1 ea) Suspension Reconstituted, Oral, as axetil [strength expressed as base]: Ceftin: 125 mg/5 mL (100 mL [DSC]); 250 mg/5 mL (50 mL [DSC], 100 mL [DSC]) [contains aspartame; tutti-frutti flavor] Tablet, Oral, as axetil [strength expressed as base]: Ceftin: 250 mg [DSC], 500 mg [DSC] Other adverse experiences occurred with frequencies comparable to those reported with 7 to 10 days' dosing. Tell your health care professional that you are using cefuroxime before having any immunizations/vaccinations. The chemical name of cefuroxime axetil (1-(acetyloxy) ethyl ester of cefuroxime) is (RS)-1-hydroxyethyl (6R,7R)-7-[2-(2-furyl)glyoxyl-amido]-3-(hydroxymethyl)-8-oxo-5-thia-1- azabicyclo[4.2.0]-oct-2-ene-2-carboxylate, 72-(Z)-(O-methyl-oxime), 1-acetate 3-carbamate. Inform patients that cefuroxime axetil is a cephalosporin that can cause allergic reactions in some individuals [see WARNINGS AND PRECAUTIONS (5.1)]. Follow us on these external social media sites that will open in a new browser window. Cefuroxime axetil has been shown to be active against most isolates of the following bacteria, both in vitro and in clinical infections [see INDICATIONS AND USAGE (1)]: Staphylococcus aureus (methicillin-susceptible isolates only). Cefuroxime axetil and doxycycline were effective in prevention of the development of sequelae of late Lyme disease. Cefuroxime may be found in some form under the following brand names: Serious side effects have been reported with cefuroxime. Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Skin and Subcutaneous Tissue Disorders: Rash, itch. One patient discontinued cefuroxime axetil due to severe urticaria and one patient discontinued cefaclor due to a persistent headache and vomiting. Patients with a median age of 32 years were randomly allocated to treatment for 10 days with one of three treatments: cefuroxime axetil 250 mg b.i.d., cefuroxime axetil 500 mg b.i.d., or cefaclor 250 mg t.i.d. The following adverse reactions occurred in less than 1% but greater than 0.1% of subjects (n = 912) treated with cefuroxime axetil in multiple-dose clinical trials. 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. Early Lyme Disease with 20-Day Regimen: Two multicenter trials assessed cefuroxime axetil tablets 500 mg twice daily for 20 days. Cefuroxime is substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. Based on several published case reports describing multiple lactating women who received cefuroxime via intravenous, intramuscular, and oral routes, cefuroxime is present in human milk. Before using this medication, tell your doctor or pharmacist your medical history, especially of: This drug may make you dizzy or drowsy. or When cefuroxime axetil is prescribed to treat a 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. 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