Cefuroxime axetil is an orally active prodrug of cefuroxime. The axetil portion of cefuroxime axetil is metabolized to acetic acid and acetaldehyde. Axetil oral suspension was carried out by sreejith. Wo1999044614a1 pharmaceutical composition containing. When reconstituted as directed, it provides the equivalent of 125 mg or 250 mg of cefuroxime as cefuroxime axetil per 5 ml of suspension. In infants from the age of 3 months and children with a body mass of less than 40 kg, it may be preferable to adjust dosage according to weight or age. After oral administration, cefuroxime axetil, as ceftin, is absorbed from the gastrointestinal tract and rapidly hydrolyzed by nonspecific esterases in the intestinal mucosa and blood to release cefuroxime into the blood stream. Cefuroxime, sold under the brand name zinacef among others, is an antibiotic used to treat and prevent a number of bacterial infections. Cefuroxime axetil ca is an ester prodrug of cefuroxime with an unpleasant taste when administrated orally.
Development and evaluation of tastemasked dry suspension of cefuroxime axetil for enhancement of oral bioavailability. While diarrhea is a common side effect of cefuroxime axetil, bloody or watery diarrhea may be a sign of a serious reaction to cefuroxime axetil that can occur when certain bacteria clostridium difficile overgrow in the colon. These include pneumonia, meningitis, otitis media, sepsis, urinary tract infections, and lyme disease. Read the entire detailed patient monograph for ceftin cefuroxime axetil. It is used to treat certain kinds of bacterial infections.
New development method for determination of cefuroxime. Cefuroxime is the second generation cephalosporin, which its intravenous and oral dosage forms are available. Cefuroxime is then released for systematic circulation. Cefuroxime and clavulanic acid formulations, tablets. Cefuroxime axetil for oral suspension was not bioequivalent to cefuroxime.
To reduce the development of drugresistant bacteria and maintain the effectiveness of. The result for the assay of cua, cz is shown in table 4. Drug administered with milk or milk products comparative pharmacokinetic properties. Development and evaluation of taste masked dry syrup formulation of potassium chloride madhur kulkarni1, brijesh vishwakarma2, samik sen2, sandhya anupuram1 and abhijit a. This ed material has been downloaded from a licensed data provider and is not for distribution, except. R medical university, chennai in partial fulfillment for the requirement of the degree of master of pharmacy. Cefuroxime axetil is an acetoxyethyl ester prodrug of cefuroxime which is effective orally. Cefuroxime is an enteral secondgeneration cephalosporin antibiotic. Ceftin for oral suspension, when reconstituted with water, provides the equivalent of.
It will not work for colds, flu, or other viral infections. Cefuroxime has bactericidal activity against a wide range of common pathogens, including many betalactamaseproducing strains. Measure the dose out carefully with a medication spooncup. Cefuroxime is used to treat many kinds of bacterial infections, including severe or lifethreatening forms. Original research paper development and evaluation of tastemasked dry suspension of cefuroxime axetil for enhancement of oral bioavailability yuqian dua, yinglei zhaib, juhong zhangc, chunnuan wua, cong luoa, jin suna, zhonggui hea, aschool of pharmacy, shenyang pharmaceutical university, no. Cefuroxime axetil for oral suspension usp, when reconstituted with water, provides the equivalent of. Dry suspensions were prepared by means of wet granulation method and solid dispersion method. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. This work was to mask the bitter taste of ca and enhance its oral bioavailability. Substitutes and alternatives to ceftin cefuroxime axetil for uses like strep throat, tonsillitis and ear infection. Cefuroxime and clavulanic acid formulations in tablets, syrup and suspension in 500mg, 250mg, 125mg, 62. Cefuroxime axetil is in the amorphous form and has the following structural formula. Zinnat suspension is provided as dry, white to offwhite, tuttifrutti flavoured granule in laminated sachets. Structure of cefuroxime axetil hence in the work undertaken, an attempt was made to mask the taste of the cefuroxime axetil by dry suspension formulation using lipophilic vehicle 5 such as hydrogenated cottonseed oil.
Cefuroxime is a cephalosporin sef a low spor in antibiotic. Determination of cefuroxime axetil and cefixime trihydrate in pharmaceutical dosage forms by rphplc. The in vivo bactericidal activity of cefuroxime axetil is due to cefuroximes binding to essential target proteins and the resultant inhibition of cellwall synthesis. It was discovered by glaxo, now glaxosmithkline, and first marketed in 1978 as zinacef. Formulation development and evaluation of taste masked cefuroxime axetil oral suspension dissertation submitted to the tamilnadu dr.
Cefuroxime axetil oral suspension is approved to treat the following infections in children 3 months through 12 years of age. Formulation design and evaluation of cefuroxime axetil 125 mg. Cefuroxime axetil api dmfs us drug master file dmf. Material safety data sheet material cefuroxime axetil tablets, usp 250 mg or 500 mg manufacturer lupin limited mumbai 400 098 india distributor lupin pharmaceuticals, inc. Ceftin cefuroxime axetil dose, indications, adverse. Tablets contain the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hydrogenated vegetable oil, hypromellose, methylparaben, microcrystalline cellulose, propylene glycol, propylparaben, sodium benzoate, sodium lauryl sulfate, and titanium dioxide. Selected from data included with permission and ed by first databank, inc.
Cefuroxime axetil for oral suspension was not bioequivalent to cefuroxime axetil tablets when. It has been reported that after cefuroxime axetil administration, it can be found in tonsil tissue, sinus tissue, bronchial tissue and. Ceftin tablets and ceftin for oral suspension contain cefuroxime as cefuroxime axetil. Ceftin is a semisynthetic, broadspectrum cephalosporin antibiotic for oral administration. Cefuroxime axetil tablets and cefuroxime axetil granules for oral suspension are not bioequivalent and are not substitutable on a milligrampermilligram basis see section 5. The two different products are approved for different uses. More specifically, the present invention relates to a pharmaceutical composition which comprises amorphous cefuroxime axetil as an active ingredient and silicon dioxide or its hydrate as a micro. Development and evaluation of tastemasked dry suspension. Maxima occur at 266 nm and minima at 300 nm aliquot of working solutions of cefuroxime axetil 0. Cefuroxime axetil versus ofloxacin for shortterm therapy of acute uncomplicated lower urinary tract infections in women.
Cefuroxime axetil definition of cefuroxime axetil by. This is not a complete list of side effects and others may occur. List of drug master files dmf of cefuroxime axetil active pharmaceutical ingredient api submitted to the u. Chemically, cefuroxime axetil, the 1acetyloxy ethyl ester of cefuroxime, is rs 1. Tablets are filmcoated and contain the equivalent of 250 or 500 mg of cefuroxime as cefuroxime axetil. Since cefuroxime is not absorbed orally, the 1acetyloxyethyl axetil ester of cefuroxime was used to improve its gastrointestinal absorption. Cefuroxime may also be used for purposes not listed in this medication guide. Data sources include ibm watson micromedex updated 4 may 2020, cerner multum updated 4 may 2020. Formulation development and optimization of cefuroxime. Ceftin cefuroxime axetil tablets, for oral use ceftin cefuroxime axetil, for oral suspension initial u.
Side effects of ceftin cefuroxime axetil, warnings, uses. Singledose cefuroxime axetil versus multipledose cefaclor in the treatment of acute urinary tract infections. Conversion to cefuroxime, the microbiologically active. Development and evaluation of taste masked dry syrup. The present invention relates to a pharmaceutical composition containing cefuroxine axetil wherein the active ingredient is not gelled by moisture absorption and is thus stable during storage period. Cefuroxime is a bactericidal second generation cephalosporin antibiotics, which is effective against a wide range of grampositive and gramnegative organisms including many betalactamase producing strains. New development method for determination of cefuroxime axetil cua and cefprozil cz in pharmaceutical drugs by. What conditions does cefuroxime axetil suspension for. If cefuroxime axetil is given with food, absorption values can increase by 52% compared to fasting patients. Cefuroxime axetil has an extremely bitter taste which is long lasting and this remains a. Cefuroxime axetil cua is a secondgeneration of cephalosporin using as antibiotic for drug pharmaceutical. Pdf formulation of cefuroxime axetil oral suspension and.
Cefuroxime ceftin is an oral drug used to treat bacterial infections. Cefuroxime axetil immediate release tablets were formulated by direct compression method with. Harborplace tower, 21st floor 111, south calvert street baltimore, md 21202 united states tel. How to use cefuroxime axetil suspension for reconstitution. It is used by mouth or by injection into a vein or muscle common side effects include nausea, diarrhea, allergic reactions, and pain at the site of injection. Development and comparative bioavailability evaluation of. Date3 abstract potassium chloride kcl syrup is widely used for the oral treatment of the hypokalemia. A 250 mg5 ml dose of cefuroxime axetil for oral suspension is bioequivalent to 2 times 125 mg5 ml dose of cefuroxime axetil for oral suspension when administered with food see table 2. Evaluation of cefuroxime axetil oral suspension by.
Tablets contain the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hydrogenated vegetable oil, hypromellose, microcrystalline. Tablets are filmcoated and contain the equivalent of 250 mg or 500 mg of cefuroxime as cefuroxime axetil usp. Formulation of cefuroxime axetil oral suspension and. This severe reaction can occur long after you stop taking cefuroxime axetil and can cause lifethreatening complications. Learn about side effects, warnings, dosage, and more.
72 519 61 138 1218 1227 763 930 233 1156 752 1037 932 1525 66 1205 670 846 1603 866 81 458 28 902 168 663 761 1303 920 5 1116 1448 509 665 425 594 165 360 1450 1001 975 116 128 1165