Verenigde Staten - Engels - NLM (National Library of Medicine)

ranbaxy pharmaceuticals inc - cefuroxime axetil (unii: z49qdt0j8z) (cefuroxime - unii:o1r9fj93ed) - cefuroxime 125 mg in 5 ml - note: cefuroxime axetil tablets and cefuroxime axetil for oral suspension are not bioequivalent and are not substitutable on a milligram-per-milligram basis (see clinical pharmacology). cefuroxime axetil for oral suspension is indicated for the treatment of pediatric patients 3 months to 12 years of age with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below. the safety and effectiveness of cefuroxime axetil for oral suspension in the treatment of infections other than those specifically listed below have not been established either by adequate and well-controlled trials or by pharmacokinetic data with which to determine an effective and safe dosing regimen. - pharyngitis/tonsillitis caused by streptococcus pyogenes. note: the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever, is penicillin given by the intramuscular route. cefuroxime axetil for oral suspensio

Verenigde Staten - Engels - NLM (National Library of Medicine)

medvantx, inc. - cefuroxime axetil (unii: z49qdt0j8z) (cefuroxime - unii:o1r9fj93ed) - cefuroxime 500 mg - to reduce the development of drug-resistant bacteria and maintain the effectiveness of cefuroxime axetil tablets and other antibacterial drugs, cefuroxime axetil tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. note: cefuroxime axetil tablets and cefuroxime axetil for oral suspension are not bioequivalent and are not substitutable on a milligram-per-milligram basis (see clinical pharmacology) cefuroxime axetil tablets are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below:  1. pharyngitis/tonsillitis caused by streptococcus pyogenes. note: the usual dr

Australië - Engels - Department of Health (Therapeutic Goods Administration)

aspen pharmacare australia pty ltd - cefuroxime axetil -

Verenigde Staten - Engels - NLM (National Library of Medicine)

wg critical care, llc - cefuroxime sodium (unii: r8a7m9my61) (cefuroxime - unii:o1r9fj93ed) - cefuroxime 750 mg - cefuroxime for injection, usp is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases: - lower respiratory tract infections, including pneumonia, caused by streptococcus pneumoniae, haemophilus influenzae (including ampicillin-resistant strains), klebsiella spp., staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), streptococcus pyogenes , and escherichia coli . - urinary tract infections caused by escherichia coli and klebsiella spp. - skin and skin structure infections caused by staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), streptococcus pyogenes , escherichia coli, klebsiella spp., and enterobacter spp. - septicemia caused by staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), streptococcus pneumoniae, escherichia coli, haemophilus influenzae (including ampicillin-resistant strains), and klebsiella spp. - meningitis

Malta - Engels - Medicines Authority

dr. friedrich eberth arzneimittel gmbh am bahnhof 2, ursensollen 92289, germany - cefuroxime sodium - powder for solution for infusion or injection - cefuroxime sodium 750 mg - antibacterials for systemic use

Malta - Engels - Medicines Authority

dr. friedrich eberth arzneimittel gmbh am bahnhof 2, ursensollen 92289, germany - cefuroxime sodium - powder for solution for infusion or injection - cefuroxime sodium 1500 mg - antibacterials for systemic use

Verenigde Staten - Engels - NLM (National Library of Medicine)

ranbaxy pharmaceuticals inc. - cefuroxime axetil (unii: z49qdt0j8z) (cefuroxime - unii:o1r9fj93ed) - tablet - 125 mg - note: cefuroxime axetil tablets and cefuroxime axetil for oral suspension are not bioequivalent and are not substitutable on a milligram-per-milligram basis (see clinical pharmacology). cefuroxime axetil tablets: cefuroxime axetil tablets are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below: 1. pharyngitis/tonsillitis caused by streptococcus pyogenes. note: the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever, is penicillin given by the intramuscular route. cefuroxime axetil tablets are generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefuroxime in the subsequent prevention of rheumatic fever are not available. please also note that in all clinical trials, all isolates had to be sensitive to both penicillin and cefuroxime. there are

Verenigde Staten - Engels - NLM (National Library of Medicine)

remedyrepack inc. - cefuroxime axetil (unii: z49qdt0j8z) (cefuroxime - unii:o1r9fj93ed) - cefuroxime axetil tablets are indicated for the treatment of adult patients and pediatric patients (13 years and older) with mild-to-moderate pharyngitis/tonsillitis caused by susceptible strains of streptococcus pyogenes . limitations of use - the efficacy of cefuroxime axetil in the prevention of rheumatic fever was not established in clinical trials. - the efficacy of cefuroxime axetil in the treatment of penicillin-resistant strains of streptococcus pyogenes has not been demonstrated in clinical trials. 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 streptococcus pneumoniae, haemophilus influenzae (including β-lactamase–producing strains), moraxella catarrhalis (including β-lactamase–producing strains), or streptococcus pyogenes . 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 -β -lactamase–producing strains only). limitations of use the effectiveness of cefuroxime axetil for sinus infections caused by β-lactamase–producing haemophilus influenzae or moraxella catarrhalis in patients with acute bacterial maxillary sinusitis was not established due to insufficient numbers of these isolates in the clinical trials [see clinical studies ( 14.1)] . cefuroxime axetil tablets are indicated for the treatment of adult patients and pediatric patients (aged 13 and older) with mild-to-moderate acute bacterial exacerbations of chronic bronchitis caused by susceptible strains of streptococcus pneumoniae , haemophilus influenzae (β-lactamase–negative strains), or haemophilus parainfluenzae (β-lactamase–negative strains). cefuroxime axetil tablets are indicated for the treatment of adult patients and pediatric patients (aged 13 and older) with uncomplicated skin and skin-structure infections caused by susceptible strains of staphylococcus aureus (including β - lactamase–producing strains) or streptococcus pyogenes. cefuroxime axetil tablets are indicated for the treatment of adult patients and pediatric patients (aged 13 and older) with uncomplicated urinary tract infections caused by susceptible strains of escherichia coli or klebsiella pneumoniae . 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 penicillinase-producing and non-penicillinase–producing susceptible strains of neisseria gonorrhoeae and uncomplicated gonorrhea, rectal, in females, caused by non-penicillinase–producing susceptible strains of neisseria gonorrhoeae . cefuroxime axetil tablets are indicated for the treatment of adult patients and pediatric patients (aged 13 and older) with early lyme disease (erythema migrans) caused by susceptible strains of borrelia burgdorferi. 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. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. cefuroxime axetil is contraindicated in patients with a known hypersensitivity (e.g., anaphylaxis) to cefuroxime axetil or to other β-lactam antibacterial drugs (e.g., penicillins and cephalosporins). risk summary available data from published epidemiologic studies, case series, and case reports over several decades with cephalosporin use, includingcefuroxime axetil, in pregnant women have not established drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data) . in studies in pregnant mice and rats administered oral cefuroxime axetil during organogenesis at 14 and 9 times the maximum recommended human dose (mrhd) based on body surface area, respectively, there were no adverse developmental outcomes (see data). the estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. all pregnancies have a background risk of birth defects, loss, or other adverse outcomes. 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. clinical considerations disease-associated maternal and/or embryo/fetal risk: maternal gonorrhea may be associated with preterm birth, low neonatal birth weight, chorioamnionitis, intrauterine growth restriction, small for gestational age, and premature rupture of membranes. perinatal transmission of gonorrhea to the offspring can result in infant blindness, joint infections, and bloodstream infections. data 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 (includingcefuroxime axetil) during pregnancy and major birth defects, miscarriage, or other adverse maternal or fetal outcomes. available studies have methodologic limitations, including small sample size, retrospective data collection, and inconsistent comparator groups. animal data: studies performed with oral cefuroxime axetil administered to pregnant mice during organogenesis (gestation days 7 through 16) at doses up to 3,200 mg/kg/day (14 times the mrhd based on body surface area); and in rats dosed during organogenesis and lactation (gestation days 7 through 16 and gestation days 17 through lactation day 21, respectively) at doses up to 1,000 mg/kg/day (9 times the mrhd based on body surface area) have revealed no adverse developmental outcomes. risk summary 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. the highest maternal milk concentration described occurred in lactating women 8 hours after an intramuscular administration of cefuroxime 750 mg. 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 . no data are available on the effects of the drug on the breastfed infant or the effects of the drug on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for cefuroxime and any potential adverse effects on the breastfed infant from cefuroxime or from the underlying maternal condition. 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. use of cefuroxime axetil in pediatric patients is supported by pharmacokinetic and safety data in adults and pediatric patients, and by clinical and microbiological data from adequate and well-controlled trials of the treatment of acute bacterial maxillary sinusitis in adults and of acute otitis media with effusion in pediatric patients. it is also supported by postmarketing adverse events surveillance. [see indications and usage ( 1), dosage and administration ( 2), adverse reactions (6), clinical pharmacology ( 12.3).] 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. no overall differences in safety or effectiveness were observed between these subjects and younger adult subjects. 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. cefuroxime is substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. 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. reducing the dosage of cefuroxime axetil is recommended for adult patients with severe renal impairment (creatinine clearance <30 ml/min) [see dosage and administration ( 2.5), clinical pharmacology ( 12.3)] .

Verenigd Koninkrijk - Engels - MHRA (Medicines & Healthcare Products Regulatory Agency)

teva uk ltd - cefuroxime axetil - oral tablet - 250mg

Australië - Engels - Department of Health (Therapeutic Goods Administration)

aspen pharmacare australia pty ltd - cefuroxime axetil, quantity: 300 mg (equivalent: cefuroxime, qty 250 mg) - suspension, powder for - excipient ingredients: povidone; sucrose; stearic acid; flavour - zinnat suspension is indicated for the treatment of the following mild to moderately severe infections caused by sensitive bacteria in paediatric patients aged 3 months to 12 years: tonsillitis and pharyngitis, acute bacterial otitis media. penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. cefuroxime axetil appears to be as effective as phenoxymethylpenicillin in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefuroxime axetil in the subsequent prevention of rheumatic fever are not available at present.