United States - English - NLM (National Library of Medicine)

sagent pharmaceuticals - cefepime hydrochloride (unii: i8x1o0607p) (cefepime - unii:807pw4vqe3) - cefepime 1 g - cefepime for injection is indicated in the treatment of pneumonia (moderate to severe) caused by susceptible strains of streptococcus pneumoniae , including cases associated with concurrent bacteremia, pseudomonas aeruginosa , klebsiella pneumoniae , or enterobacter species. cefepime for injection as monotherapy is indicated for empiric treatment of febrile neutropenic patients. in patients at high risk for severe infection (including patients with a history of recent bone marrow transplantation, with hypotension at presentation, with an underlying hematologic malignancy, or with severe or prolonged neutropenia), antimicrobial monotherapy may not be appropriate. insufficient data exist to support the efficacy of cefepime monotherapy in such patients [see clinical studies (14.1)] . cefepime for injection is indicated in the treatment of uncomplicated and complicated urinary tract infections (including pyelonephritis) caused by susceptible isolates of escherichia coli or klebsiella pneumoniae , when the infec

United States - English - NLM (National Library of Medicine)

wg critical care, llc - cefepime hydrochloride (unii: i8x1o0607p) (cefepime - unii:807pw4vqe3) - cefepime 1 g in 20 ml - cefepime for injection is indicated in the treatment of pneumonia (moderate to severe) caused by susceptible strains of streptococcus pneumoniae , including cases associated with concurrent bacteremia, pseudomonas aeruginosa , klebsiella pneumoniae , or enterobacter species. cefepime for injection as monotherapy is indicated for empiric treatment of febrile neutropenic patients. in patients at high risk for severe infection (including patients with a history of recent bone marrow transplantation, with hypotension at presentation, with an underlying hematologic malignancy, or with severe or prolonged neutropenia), antimicrobial monotherapy may not be appropriate. insufficient data exist to support the efficacy of cefepime monotherapy in such patients [see clinical studies (14.1)] . cefepime for injection is indicated in the treatment of uncomplicated and complicated urinary tract infections (including pyelonephritis) caused by susceptible isolates of escherichia coli or klebsiella pneumoniae , when the infection is severe, or caused by escherichia coli , klebsiella pneumoniae , or proteus mirabilis , when the infection is mild to moderate, including cases associated with concurrent bacteremia with these bacteria. cefepime for injection is indicated in the treatment of uncomplicated skin and skin structure infections caused by staphylococcus aureus (methicillin-susceptible isolates only) or streptococcus pyogenes . cefepime for injection is indicated in the treatment of complicated intra-abdominal infections (used in combination with metronidazole) in adults caused by susceptible isolates of escherichia coli , viridans group streptococci, pseudomonas aeruginosa , klebsiella pneumoniae , enterobacter species, or bacteroides fragilis [see clinical studies (14.2)] . to reduce the development of drug-resistant bacteria and maintain the effectiveness of cefepime for injection and other antibacterial drugs, cefepime for injection 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. cefepime for injection is contraindicated in patients who have shown immediate hypersensitivity reactions to cefepime or the cephalosporin class of antibacterial drugs, penicillins or other beta-lactam antibacterial drugs. risk summary there are no cases of cefepime exposure during pregnancy reported from postmarketing experience or from clinical trials. available data from published observational studies and case reports over several decades with cephalosporin use in pregnant women have not established drug-associated risks of major birth defects, miscarriage or adverse maternal or fetal outcomes (see data ). cefepime was not associated with adverse developmental outcomes in rats, mice, or rabbits when administered parenterally during organogenesis. the doses used in these studies were 1.6 (rats), approximately equal to (mice), and 0.3 times (rabbits) the recommended maximum human dose (see data ). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, 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. data human data while available studies cannot definitively establish the absence of risk, published data from case-control studies and case reports over several decades have not identified an association with cephalosporin use 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 cefepime was not embryocidal and did not cause fetal malformations when administered parenterally during the period of organogenesis to rats at doses up to 1000 mg/kg/day, to mice at doses up to 1200 mg/kg/day, or to rabbits at doses up to 100 mg/kg/day. these doses are 1.6 times (rats), approximately equal to (mice), and 0.3 times (rabbits) the maximum recommended clinical dose based on body surface area. risk summary cefepime is present in human breast milk at low concentrations (approximately 0.5 mcg/ml) following a single intravenous dose of 1000 mg. a nursing infant consuming approximately 1000 ml of human milk per day would receive approximately 0.5 mg of cefepime per day (see data ). there is no information regarding the effects of cefepime on the breastfed infant or on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for cefepime and any potential adverse effects on the breastfed child from cefepime or from the underlying maternal condition. data a pharmacokinetic study was conducted in 9 healthy lactating women to evaluate the concentrations of cefepime in plasma and breast milk following a single intravenous dose of 1000 mg. the mean breast milk concentrations of cefepime during the first 8 hours post-dose were approximately 0.5 mcg/ml and then declined and became undetectable between 12- and 24-hours post-dose. the mean cumulative breast milk excretion of cefepime over 24 hours was 0.01% of the administered dose. the pharmacokinetics of cefepime are similar between lactating and non-lactating women. the safety and effectiveness of cefepime in the treatment of uncomplicated and complicated urinary tract infections (including pyelonephritis), uncomplicated skin and skin structure infections, pneumonia, and as empiric therapy for febrile neutropenic patients have been established in the age groups 2 months up to 16 years. use of cefepime for injection in these age groups is supported by evidence from adequate and well-controlled studies of cefepime in adults with additional pharmacokinetic and safety data from pediatric trials [see clinical pharmacology (12.3)] . safety and effectiveness in pediatric patients below the age of 2 months have not been established. there are insufficient clinical data to support the use of cefepime for injection in pediatric patients for the treatment of serious infections in the pediatric population where the suspected or proven pathogen is h. influenzae type b. in those patients in whom meningeal seeding from a distant infection site or in whom meningitis is suspected or documented, an alternate agent with demonstrated clinical efficacy in this setting should be used. of the more than 6,400 adults treated with cefepime for injection in clinical studies, 35% were 65 years or older while 16% were 75 years or older. when geriatric patients received the usual recommended adult dose, clinical efficacy and safety were comparable to clinical efficacy and safety in non-geriatric adult patients. serious adverse events have occurred in geriatric patients with renal insufficiency given unadjusted doses of cefepime, including life-threatening or fatal occurrences of the following: encephalopathy, myoclonus, and seizures [see warnings and precautions (5.2), adverse reactions (6.2)] . this drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug 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 renal function should be monitored [see clinical pharmacology (12.3), warnings and precautions (5.2), dosage and administration (2.3)] . adjust the dose of cefepime for injection in patients with creatinine clearance less than or equal to 60 ml/min to compensate for the slower rate of renal elimination [see dosage adjustments in patients with renal impairment (2.3)] .

United States - English - NLM (National Library of Medicine)

apotex corp. - cefepime hydrochloride (unii: i8x1o0607p) (cefepime - unii:807pw4vqe3) - cefepime 1 g - cefepime for injection is indicated in the treatment of pneumonia (moderate to severe) caused by susceptible strains of streptococcus pneumoniae , including cases associated with concurrent bacteremia, pseudomonas aeruginosa , klebsiella pneumoniae , or enterobacter species. cefepime for injection as monotherapy is indicated for empiric treatment of febrile neutropenic patients. in patients at high risk for severe infection (including patients with a history of recent bone marrow transplantation, with hypotension at presentation, with an underlying hematologic malignancy, or with severe or prolonged neutropenia), antimicrobial monotherapy may not be appropriate. insufficient data exist to support the efficacy of cefepime monotherapy in such patients [see clinical studies (14.1) ]. cefepime for injection is indicated in the treatment of uncomplicated and complicated urinary tract infections (including pyelonephritis) caused by susceptible isolates of escherichia coli or klebsiella pneumoniae , when the infec

United States - English - NLM (National Library of Medicine)

apotex corp. - cefepime hydrochloride (unii: i8x1o0607p) (cefepime - unii:807pw4vqe3) - cefepime 1 g - cefepime for injection is indicated in the treatment of pneumonia (moderate to severe) caused by susceptible strains of streptococcus pneumoniae , including cases associated with concurrent bacteremia, pseudomonas aeruginosa , klebsiella pneumoniae , or enterobacter species. cefepime for injection as monotherapy is indicated for empiric treatment of febrile neutropenic patients. in patients at high risk for severe infection (including patients with a history of recent bone marrow transplantation, with hypotension at presentation, with an underlying hematologic malignancy, or with severe or prolonged neutropenia), antimicrobial monotherapy may not be appropriate. insufficient data exist to support the efficacy of cefepime monotherapy in such patients [see clinical studies (14.1) ]. cefepime for injection is indicated in the treatment of uncomplicated and complicated urinary tract infections (including pyelonephritis) caused by susceptible isolates of escherichia coli or klebsiella pneumoniae , when the infec

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - cefixime (unii: 97i1c92e55) (cefixime anhydrous - unii:xz7bg04gjx) - cefixime for oral suspension and cefixime capsule is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated urinary tract infections caused by susceptible isolates of escherichia coli and proteus mirabilis . cefixime for oral suspension and cefixime capsule is indicated in the treatment of adults and pediatric patients six months of age or older with otitis media caused by susceptible isolates of haemophilus influenzae , moraxella catarrhalis , and streptococcus pyogenes . (efficacy for streptococcus pyogenes in this organ system was studied in fewer than 10 infections.) note: for patients with otitis media caused by streptococcus pneumoniae , overall response was approximately 10% lower for cefixime than for the comparator [see clinical studies ( 14)] . cefixime for oral suspension and cefixime capsule is indicated in the treatment of adults and pediatric patients six months of age or older with pharyngitis and tonsillitis caused by susceptible isolates of streptococcus pyogenes. (note: penicillin is the usual drug of choice in the treatment of streptococcus pyogenes infections. cefixime for oral suspension and cefixime capsule is generally effective in the eradication of streptococcus pyogenes from the nasopharynx; however, data establishing the efficacy of cefixime for oral suspension and cefixime capsule in the subsequent prevention of rheumatic fever is not available.) cefixime for oral suspension and cefixime capsule is indicated in the treatment of adults and pediatric patients six months of age or older with acute exacerbations of chronic bronchitis caused by susceptible isolates of streptococcus pneumoniae and haemophilus influenzae . cefixime for oral suspension and cefixime capsule is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated gonorrhea (cervical/urethral) caused by susceptible isolates of neisseria gonorrhoeae (penicillinase-and non-penicillinase-producing isolates). to reduce the development of drug resistant bacteria and maintain the effectiveness of cefixime and other antibacterial drugs, cefixime for oral suspension and cefixime capsule should be used only to treat 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 antimicrobial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. cefixime is contraindicated in patients with known allergy to cefixime or other cephalosporins. pregnancy category b . reproduction studies have been performed in mice and rats at doses up to 40 times the human dose and have revealed no evidence of harm to the fetus due to cefixime. there are no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. cefixime has not been studied for use during labor and delivery. treatment should only be given if clearly needed. it is not known whether cefixime is excreted in human milk. consideration should be given to discontinuing nursing temporarily during treatment with this drug. safety and effectiveness of cefixime in children aged less than six months old have not been established. the incidence of gastrointestinal adverse reactions, including diarrhea and loose stools, in the pediatric patients receiving the suspension, was comparable to the incidence seen in adult patients receiving tablets. clinical studies did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently than younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. a pharmacokinetic study in the elderly detected differences in pharmacokinetic parameters [see clinical pharmacology ( 12.3)] . these differences were small and do not indicate a need for dosage adjustment of the drug in the elderly. the dose of cefixime should be adjusted in patients with renal impairment as well as those undergoing continuous ambulatory peritoneal dialysis (capd) and hemodialysis (hd). patients on dialysis should be monitored carefully [see dosage and administration ( 2.3)] .

United States - English - NLM (National Library of Medicine)

northstar rxllc - cefixime (unii: 97i1c92e55) (cefixime anhydrous - unii:xz7bg04gjx) - cefixime for oral suspension is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated urinary tract infections caused by susceptible isolates of escherichia coli and proteus mirabilis . cefixime for oral suspension is indicated in the treatment of adults and pediatric patients six months of age or older with otitis media caused by susceptible isolates of  haemophilus influenzae , moraxella catarrhalis , and streptococcus pyogenes . (efficacy for streptococcus pyogenes in this organ system was studied in fewer than 10 infections.) note: for patients with otitis media caused by streptococcus pneumoniae , overall response was approximately 10% lower for cefixime than for the comparator. [ s ee c

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - cefixime (unii: 97i1c92e55) (cefixime anhydrous - unii:xz7bg04gjx) - cefixime is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated urinary tract infections caused by susceptible isolates of escherichia coli and proteus mirabilis . cefixime capsules are indicated in the treatment of adults and pediatric patients six months of age or older with pharyngitis and tonsillitis caused by susceptible isolates of streptococcus pyogenes. (note: penicillin is the usual drug of choice in the treatment of streptococcus pyogenes infections. cefixime capsules are generally effective in the eradication of streptococcus pyogenes from the nasopharynx; however, data establishing the efficacy of cefixime capsules in the subsequent prevention of rheumatic fever is not available.) cefixime capsules is indicated in the treatment of adults and pediatric patients six months of age or older with acute exacerbations of chronic bronchitis caused by susceptible isolates of streptococcus pneumoniae and haemophilus influenzae. cefixime capsules is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated gonorrhea (cervical/urethral) caused by susceptible isolates of neisseria gonorrhoeae (penicillinase-and non-penicillinase-producing isolates). to reduce the development of drug resistant bacteria and maintain the effectiveness of cefixime capsules and other antibacterial drugs, cefixime capsules should be used only to treat 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 antimicrobial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.  cefixime capsules are contraindicated in patients with known allergy to cefixime or other cephalosporins. pregnancy category b pregnancy category b. reproduction studies have been performed in mice and rats at doses up to 40 times the human dose and have revealed no evidence of harm to the fetus due to cefixime. there are no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. cefixime has not been studied for use during labor and delivery. treatment should only be given if clearly needed. it is not known whether cefixime is excreted in human milk. consideration should be given to discontinuing nursing temporarily during treatment with this drug. safety and effectiveness of cefixime in children aged less than six months old have not been established. the incidence of gastrointestinal adverse reactions, including diarrhea and loose stools, in the pediatric patients receiving the suspension, was comparable to the incidence seen in adult patients receiving tablets. clinical studies did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently than younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. a pharmacokinetic study in the elderly detected differences in pharmacokinetic parameters [see clinical pharmacology ( 12.3)] . these differences were small and do not indicate a need for dosage adjustment of the drug in the elderly. the dose of cefixime should be adjusted in patients with renal impairment as well as those undergoing continuous ambulatory peritoneal dialysis (capd) and hemodialysis (hd). patients on dialysis should be monitored carefully [see dosage and administration ( 2.3)] .

United States - English - NLM (National Library of Medicine)

ascend laboratories, llc - cefixime (unii: 97i1c92e55) (cefixime anhydrous - unii:xz7bg04gjx) - cefixime is indicated in the treatment of adults and pediatric patients six months of age or older with uncomplicated urinary tract infections caused by susceptible isolates of escherichia coli and proteus mirabilis . cefixime capsules are indicated in the treatment of adults and pediatric patients six months of age or older with pharyngitis and tonsillitis caused by susceptible isolates of streptococcus pyogenes. (note: penicillin is the usual drug of choice in the treatment of streptococcus pyogenes infections. cefixime capsules are generally effective in the eradication of streptococcus pyogenes from the nasopharynx; however, data establishing the efficacy of cefixime capsules in the subsequent prevention of rheumatic fever is not available.) cefixime capsules is indicated in the treatment of adults and pediatric patients six months of age or older with acute exacerbations of chronic bronchitis caused by susceptible isolates of streptococcus pneumoniae and haemophilus influenzae. cefixime capsules is

Ireland - English - HPRA (Health Products Regulatory Authority)

nectar lifesciences uk limited - cefixime - powder for oral suspension - 100/5 milligram(s)/millilitre - cefaclor

Ireland - English - HPRA (Health Products Regulatory Authority)

neclife pt unipessoal lda - cefixime - powder for oral suspension - 100/5 milligram(s)/millilitre - cefaclor