Elimination is prolonged in patients with compromised renal function. Cefepime has in vitro activity against many bacterial isolates resistant to. Pharmacokinetics and pharmacodynamics of continuous. Despite its extensive use, its presence in multiple clinical guidelines, and numerous indications for its use 1, 16, 20, 26, a recent metaanalysis found treatment with cefepime to be associated with an increase in the patient. Cefepime pharmacokinetics have been investigated in patients with various degrees of renal impairment n30. Pharmacodynamic parameters of two different doses of cefepime. T1 pharmacokinetics of cefepime in patients with cancer and febrile neutropenia in the setting of hematologic malignancies or hematopoeitic cell transplantation. Maxipime cefepime hydrochloride dose, indications, adverse. Cefepime pharmacokinetics 1887 0 e 3 0 0 i3 a 0 2 4 6 8 10 12 time hrs fig. Steady state pharmacokinetics, absolute bioavailability, and dose proportionality of cefepime were evaluated in healthy male subjects after single 250, 500, or 2000 mg and multiple mg every 12 hours for 10 days intramuscular injections. Pdf pharmacokinetics of cefepime in subjects with renal.
Highlights of prescribing information the usual recommended. This prospective, multicenter study aims to determine the pharmacokinetics and pharmacodynamics of extendedinfusion cefepime in crrt. Clinical pharmacology cefepime is an antibacterial agent belonging to the cephalosporin class of antibacterials with in vitro antibacterial activity against facultative grampositive and gramnegative bacteria. Listing a study does not mean it has been evaluated by the u. Pharmacokinetics and clinical response in patients.
It is 16 to 19% proteinbound and is primarily renally eliminated. Pharmacokinetics following im administration the pharmacokinetics of cefepime following single and repeated im administration in 340 healthy volunteers barbhaiya et al. Indications and usage cefepime for injection is a cephalosporin antibacterial indicated for the treatment of the following infections. We investigated the pharmacokinetics and tolerability of cefepime given as a subcutaneous infusion. Stability of cefepime and ceftazidime 12% wv at 25 and 30c. Stability and compatibility study of cefepime in comparison. The pharmacokinetics, safety, and tolerance of cefepime. To measure firstdose and steadystate plasma, urine, and sputum concentrations of cefepime and make preliminary assessments of the clinical efficacy of cefepime in patients with cystic fibrosis. Cefepime pharmacokinetics and clinical response in patients with cystic fibrosis adriano g. A total daily dose of 150 mgkg of body weightday was administered as a single injection every 24 h for 4 days.
Cefepime pharmacokinetics in cystic fibrosis hamelin. This novel route of administration is proposed as an alternative to intravenous and intramuscular administration for patients treated outside an institutional setting, such as home hospice. The pharmacokinetics of cefepime do not change to a clinically significant. The average plasma concentrations of cefepime observed in healthy adult male volunteers. The average plasma concentrations of cefepime and its derived. The pharmacokinetics of cefepime have been well described in adults with normal and impaired renal function. Pharmacokinetics of cefepime after single and multiple. Clinical uses are similar to those of the thirdgeneration cephalosporins. Dosage and administration cefepime for injection, usp. Cefepimes maximum concentration was approximately 150.
A translational pharmacokinetic rat model of cerebral spinal. The pharmacokinetics of cefepime in 31 young, healthy volunteers were assessed after the administration of single and multiple 250, 500, 1,000, or 2,000mg intravenous doses. Baxter healthcare corporation cefepime cefepime injection. Cefepime was absorbed rapidly over the 250 to 2000 mg dose range and cmax was generally obtained between 10 and 16 h after. Sep 24, 2019 ten critically ill adults who were receiving cefepime 2 g intravenously every 8 hours as a 4. In patients with cystic fibrosis the pharmacokinetics of cefepime do not change to a clinically significant degree in. Steady state pharmacokinetics, absolute bioavailability, and dose proportionality of cefepime were evaluated in healthy male subjects after single 250, 500, or 2000 mg and multiple mg every 12 hours for 10 days intramuscular. Safety, tolerance, and pharmacokinetics of cefepime. Antibiotic pharmacokinetics and pharmacodynamics for. A single 2 g iv dose of cefepime alphapharm as a 30minute infusion, see section. Plasma, urine and skin pharmacokinetics of cefepime in. A translational pharmacokinetic rat model of cerebral.
Tthe pharmacokinetics of cefepime in he pharmacokinetics. Maxipime cefepime hydrochloride, usp for injection fda. In addition the pharmacokinetics pk of cefepime was assessed and pharmacodynamics pd of ci were compared with traditional intermittent administration. Pharmacodynamic parameters of two different doses of cefepime the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Pharmacokinetics of cefepime was studied after single dose intravenous administration at the dose rate. Pdf pharmacokinetics of cefepime following intravenous.
Pharmacokinetics and dosage regimen of cefepime following. Pharmacokinetics of cefepime during continuous venovenous hemodiafiltration article pdf available in antimicrobial agents and chemotherapy 4111. Limited data exist on the effects of extracorporeal membrane oxygenation on pharmacokinetics of cefepime in critically ill pediatric patients. Each subject received a single dose of cefepime via a 30min intravenous infusion on day 1. The pharmacokinetics of cefepime were unaltered in patients with hepatic impairment who received a single 1 g dose n11. Cefepime pharmacokinetics in cystic fibrosis hamelin 1993. Three studies encompassing 88 patients ages 2 months to 16 years examined the pharmacokinetics of. Pharmacokinetics of cefepime in patients with respiratory. No statistically significant difference was seen in any of the pharmacokinetic values between the groups, except for the mean residence time 2. Pharmacokinetics of cefepime in subjects with renal. Total drug clearance and renal clearance are similar. Cefepime pharmacokinetics are linear over the range 250 mg to 2 g.
Cefepime cefepime hydrochloride for injection for intravenous or intramuscular use cefepime initial u. Cefepime concentrations in plasma, urine, and hemodialysate were assayed using reverse. Pharmacokinetics is the study of the disposition of drugs in the body, while pharmacodynamics considers the interaction of the drug at the site of infection over time. Two sets of five serum cefepime concentrations were collected for each patient to assess pharmacokinetics before and during presumed steady state. Cefepime is a broadspectrum fourthgeneration cephalosporin with in vitro activity similar to that of cefotaxime or ceftriaxone against the common meningeal pathogens h. This study assessed the pharmacokinetics and pharmacodynamics of cefepime administered by intermittent and continuous infusion against clinical isolates of pseudomonas aeruginosa, enterobacter cloacae, and staphylococcus aureus.
Tmpsmx rash piptazo rash levofloxacin rash, anxiety patient tolerated cefepime. Data from four clinical cefepime pk studies representing unique. Management of symptomatic infections can aid in palliation. Pharmacokinetic studies have indicated that cefepime exhibits linear pharmacokinetic behaviour. Subcutaneous administration of cefepime journal of pain. Pharmacokinetics and pharmacodynamics of continuous infusion. Cefepime monograph paediatric champ manual page 4 of 5 care should be taken and renal function monitored when used with other nephrotoxic drugs e. Pharmacokinetic characteristics of cefepime were not affected by the time of infusion and were on average. Pediatric pharmacotherapy university of virginia school. It acts against members of the enterobacteriaceae and pseudomonas aeruginosa but maintains activity against grampositive isolates that is similar to that of first or secondgeneration cephalosporins. Cefepime, is a parenteral semisynthetic bactericidal cephalosporin having excellent activity against a broad spectrum of clinically important pathogens, including. It acts against the enterobacteriaceae family, and pseudomonas aeruginosa, but maintains grampositive activity similar to that of first or secondgeneration cephalosporins. Pharmacokinetics of cefepime in patients with cancer and febrile neutropenia in the setting of hematologic malignancies or hematopoeitic cell transplantation laura whited, meagan grove, dusten rose, nathaniel j. Oct 02, 2018 the pharmacokinetics of cefepime were unaltered in patients with hepatic impairment who received a single 1 g dose n11.
Ten critically ill adults who were receiving cefepime 2 g intravenously every 8 hours as a 4. A population pharmacokinetic analysis to study the effect. However, modification of the dosing regimen based on renal impairment should also take into consideration pharmacodynamic parameters predicting clinical. Pharmacokinetics and pharmacodynamics of extendedinfusion. Cefepime is a new parenteral cephalosporin with antimicrobial activity similar to thirdgeneration cephalosporins. Jun 01, 2015 this prospective, multicenter study aims to determine the pharmacokinetics and pharmacodynamics of extendedinfusion cefepime in crrt. Plasma, urine and skin pharmacokinetics of cefepime in burns. Cefepime 16 r ceftazidime 16 r ciprofloxacin 1 s gentamicin 2 s levofloxacin 2 s meropenem 8 r tobramycin 2 s 100,000 cfuml p. Male spraguedawley rats received cefepime intravenously. Cefepime is a commonly used broadspectrum cephalosporin with potent activity against a wide variety of gramnegative bacteria, including pseudomonas aeruginosa. Patients on crrt who are being initiated on cefepime 2000 mg iv every eight hours with a. Pharmacokinetics of cefepime in patients with cancer and. Cefepime population pharmacokinetics 1 development of.
Pdf pharmacokinetics of cefepime during continuous. Three studies encompassing 88 patients ages 2 mont. Dec 28, 2009 cefepime is a commonly used broadspectrum cephalosporin with potent activity against a wide variety of gramnegative bacteria, including pseudomonas aeruginosa. Comparison of cefepime pharmacokinetics in neonatal foals. Maximum concentration c max increased with decreasing time of infusion and was similar to reference values of c max.
Cefepime pharmacokinetics have been investigated in elderly 65 years of age and older men n12 and women n12 whose mean sd creatinine clearance was 74 15 mlmin. Nicholas odonnell, jessica neeb, kelli thoele, david r. A population pharmacokinetic analysis to study the effect of. The pharmacokinetics of cefepime were unaltered in patients with impaired hepatic function who received a single 1g dose. The pharmacokinetics of intravenously administered cefepime mg over 30 minutes were studied in 5 healthy volunteers and 20 patients with various degrees of renal impairment. Pharmacokinetics of cefepime in subjects with renal insufficiency. This study sought to define the transit of cefepime between plasma and cerebral spinal fluid csf in a rat model. Population pharmacokinetics of cefepime in neonates with. Cefepime has in vitro activity against many bacterial isolates resistant to ceftazidime and cefotaxime, is. The pharmacokinetics of cefepime, a new fourth generation cephalosporin with enhanced antibacterial activity, was examined in neonatal foals and adult dogs. Pharmacokinetics and pharmacodynamics of cefepime in patients.
Tthe pharmacokinetics of cefepime in he pharmacokinetics of cefepime in ee. This is done by investigating both the stability and the antimicrobial effect of cefepime during continuous infusion ci. The fine dotted line corresponds to the lowest limit of drug content for drug powders, based on the specifications of the 2000 edition of the pharmacopee europeenne38 and the corresponding recommendations of the european agency for evaluation of the. In a further study of severe communityacquired pneumonia, clinical cure rates were 87% in the cefepime group and 86% in the ceftazidime group 54. Pharmacokinetics of intravenously and intramuscularly administered. The pharmacokinetics of cefepime in burns patients is not well documented.
Pharmacokinetics and spectrum of activity similar to ceftazidime. Patients on crrt who are being initiated on cefepime 2000 mg iv every eight hours with a fourhour infusion will be considered for enrollment. The average halflife in patients requiring hemodialysis was. Clinical pharmacodynamics of cefepime in patients infected. A unified cefepime population pharmacokinetic model has been developed. Therefore, dosage adjustments are not required in patients with hepatic impairment. Plasma samples were obtained via a second dedicated intravenous catheter. Review of the pharmacokinetics of cefepime in children. Data in pediatric patients with impaired renal function are not available.
Mathematical models of antibiotic pharmacodynamics are sometimes used to predict if antibiotic doses are sufficient to treat infection with organisms of different minimal. Cefepime fda prescribing information, side effects and uses. To define the pharmacokinetic behaviour of cefepime in neonates with severe nosocomial infections using a mixed effects model. Cefepime total body clearance decreased proportionally with en3082 page 3 of 24. Cefepime is cleared primarily by urinary excretion 85%. Maxipime cefepime hydrochloride, usp for injection for. Cefepime hydrochloride monograph for professionals. Cefepime hydrochloride pharmacokinetics absorption bioavailability. Data are insufficient to support the efficacy of cefepime monotherapy in patients at high risk for severe. Despite its extensive use, its presence in multiple clinical guidelines, and numerous indications for its use 1, 16, 20, 26, a recent metaanalysis found treatment with cefepime to be associated with an. Cefepime is an antibacterial agent belonging to the cephalosporin class of antibacterials with.
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