Pharmacokinetics of Ertapenem in Patients With Varying Degrees of Renal Insufficiency and in Patients on Hemodialysis

Mistry, Goutam C.; Majumdar, Anup; Swan, Suzanne K.; Sica, Domenic A.; Fisher, Anita M.; Xu, Yang; Hesney, Michael; Xi, Liwen; Wagner, John A.; Deutsch, Paul

doi:10.1177/0091270006291839

Cited by 45 publications

(58 citation statements)

References 14 publications

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“…This might be explained by the parenteral route of administration of ertapenem, in which there is no loss of ertapenem due to absorption. Several studies looking at the level of exposure to ertapenem have shown that it varies greatly among patients (13,14). There was little variability in the values of the pharmacokinetic parameters among the MDR-TB patients (Table 3).…”

Section: Discussionmentioning

confidence: 98%

“…The pharmacokinetics of ertapenem have typically been studied in healthy volunteers (9), people with obesity (10,11), patients with renal failure (12)(13)(14), and critically ill patients with various pathologies (15)(16)(17). Lower levels of drug exposure were observed in obese individuals (11), and an increase in the dosing interval was needed in patients with renal insufficiency with an estimated glomerular filtration rate (eGFR) of less than 30 ml/min/1.73 m 2 (13), suggesting that the optimal dose of ertapenem is different in patients with different health conditions.…”

mentioning

confidence: 99%

“…Lower levels of drug exposure were observed in obese individuals (11), and an increase in the dosing interval was needed in patients with renal insufficiency with an estimated glomerular filtration rate (eGFR) of less than 30 ml/min/1.73 m 2 (13), suggesting that the optimal dose of ertapenem is different in patients with different health conditions. A recent study on the pharmacokinetics of drugs in MDR-TB patients suggested that there was substantial variability in these patients (7).…”

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confidence: 99%

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Pharmacokinetic Modeling and Limited Sampling Strategies Based on Healthy Volunteers for Monitoring of Ertapenem in Patients with Multidrug-Resistant Tuberculosis

Rijn

Zuur

Altena

et al. 2017

Antimicrob Agents Chemother

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Ertapenem is a broad-spectrum carbapenem antibiotic whose activity against Mycobacterium tuberculosis is being explored. Carbapenems have antibacterial activity when the plasma concentration exceeds the MIC at least 40% of the time (40% T MIC ). To assess the 40% T MIC in multidrug-resistant tuberculosis (MDR-TB) patients, a limited sampling strategy was developed using a population pharmacokinetic model based on data for healthy volunteers. A two-compartment population pharmacokinetic model was developed with data for 42 healthy volunteers using an iterative two-stage Bayesian method. External validation was performed by Bayesian fitting of the model developed with data for volunteers to the data for individual MDR-TB patients (in which the fitted values of the area under the concentrationtime curve from 0 to 24 h [AUC 0 -24, fit values] were used) using the population model developed for volunteers as a prior. A Monte Carlo simulation (n ϭ 1,000) was used to evaluate limited sampling strategies. Additionally, the 40% T MIC with the free fraction (f 40% T MIC ) of ertapenem in MDR-TB patients was estimated with the population pharmacokinetic model. The population pharmacokinetic model that was developed was shown to overestimate the area under the concentration-time curve from 0 to 24 h (AUC 0 -24 ) in MDR-TB patients by 6.8% (range, Ϫ17.2 to 30.7%). The best-performing limited sampling strategy, which had a time restriction of 0 to 6 h, was found to be sampling at 1 and 5 h (r 2 ϭ 0.78, mean prediction error ϭ Ϫ0.33%, root mean square error ϭ 5.5%). Drug exposure was overestimated by a mean percentage of 4.2% (range, Ϫ15.2 to 23.6%). When a free fraction of 5% was considered and the MIC was set at 0.5 mg/liter, the minimum f 40% T MIC would have been exceeded in 9 out of 12 patients. A population pharmacokinetic model and limited sampling strategy, developed using data from healthy volunteers, were shown to be adequate to predict ertapenem exposure in MDR-TB patients.

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Section: Discussionmentioning

confidence: 98%

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confidence: 99%

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confidence: 99%

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Pharmacokinetic Modeling and Limited Sampling Strategies Based on Healthy Volunteers for Monitoring of Ertapenem in Patients with Multidrug-Resistant Tuberculosis

Rijn

Zuur

Altena

et al. 2017

Antimicrob Agents Chemother

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“…Time above MIC [10,11] No specific interactions [10,12] LT Only in special populations [13] Y doripenem IV Y(R) [12], N(H)ᵠ ertapenem IV Y(R) [14],…”

Section: Carbapenemsmentioning

confidence: 99%

Role of Therapeutic Drug Monitoring in Pulmonary Infections: Use and Potential for Expanded Use of Dried Blood Spot Samples

et al. 2015

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Respiratory tract infections are among the most common infections in men. We reviewed literature to document their pharmacological treatments, and the extent to which therapeutic drug monitoring (TDM) is needed during treatment. We subsequently examined potential use of dried blood spots as sample procedure for TDM. TDM was found to be an important component of clinical care for many (but not all) pulmonary infections. For gentamicin, linezolid, voriconazole and posaconazole dried blood spot methods and their use in TDM were already evident in literature. For glycopeptides, beta-lactam antibiotics and fluoroquinolones it was determined that development of a dried blood spot (DBS) method could be useful. This review identifies specific antibiotics for which development of DBS methods could support the optimization of treatment of pulmonary infections

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“…While ertapenem pharmacokinetic (PK) parameters are well described in the general population, there are scant data on the PK properties of ertapenem in patients receiving renal replacement therapies (4,20). To date, there are no published studies evaluating the PK of ertapenem during PD, a dialysis modality used by 26,000 patients in the United States (27).…”

mentioning

confidence: 99%

Ertapenem Pharmacokinetics and Pharmacodynamics during Continuous Ambulatory Peritoneal Dialysis

Cardone

Grabe

Kulawy

et al. 2012

Antimicrob Agents Chemother

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Scant data exist for the pharmacokinetics (PK) of ertapenem in patients on continuous ambulatory peritoneal dialysis (CAPD).The goals of this study were to characterize the PK profile of ertapenem during CAPD, determine the extent of ertapenem penetration into the peritoneal cavity, and quantify the probability of the target attainment (PTA) profile in the serum and peritoneal cavity. A single-dose PK study was conducted in seven patients on CAPD. Population PK modeling and Monte Carlo simulation determined the probability that ertapenem at 500 mg intravenously (i.v.) every 24 h (q24h) would achieve concentrations in excess of the MIC for 40% of the dosing interval (40% T>MIC, where T is time) in the serum and peritoneal cavity. Monte Carlo simulation was also used to calculate the peritoneal cavity/serum mean and median penetration ratios by estimating the area under the concentration-time curve in the peritoneal cavity and serum (AUC Peritoneal and AUC Serum , respectively) from zero to infinity after a single simulated dose

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Pharmacokinetics of Ertapenem in Patients With Varying Degrees of Renal Insufficiency and in Patients on Hemodialysis

Cited by 45 publications

References 14 publications

Pharmacokinetic Modeling and Limited Sampling Strategies Based on Healthy Volunteers for Monitoring of Ertapenem in Patients with Multidrug-Resistant Tuberculosis

Pharmacokinetic Modeling and Limited Sampling Strategies Based on Healthy Volunteers for Monitoring of Ertapenem in Patients with Multidrug-Resistant Tuberculosis

Role of Therapeutic Drug Monitoring in Pulmonary Infections: Use and Potential for Expanded Use of Dried Blood Spot Samples

Ertapenem Pharmacokinetics and Pharmacodynamics during Continuous Ambulatory Peritoneal Dialysis

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