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Population Pharmacokinetic Analysis for Imipenem-Relebactam in Healthy Volunteers and Patients With Bacterial Infections.
- Source :
-
CPT: pharmacometrics & systems pharmacology [CPT Pharmacometrics Syst Pharmacol] 2019 Oct; Vol. 8 (10), pp. 748-758. Date of Electronic Publication: 2019 Oct 04. - Publication Year :
- 2019
-
Abstract
- Relebactam is a small-molecule β-lactamase inhibitor developed as a fixed-dose combination with imipenem/cilastatin. The pharmacokinetics of relebactam and imipenem across 10 clinical studies were analyzed using data from adult healthy volunteers and patients with bacterial infections. Renal function estimated by creatinine clearance significantly affected the clearance of both compounds, whereas weight and health status were of less clinical significance. Simulations were used to calculate probability of joint target attainment (ratio of free drug area under the curve from 0 to 24 hours to minimum inhibitory concentration (MIC) for relebactam and percentage of time the free drug concentration exceeded the MIC for imipenem) for the proposed imipenem/relebactam dose of 500/250 mg, with adjustments for patients with renal impairment, administered as a 30-minute intravenous infusion four times daily. These dosing regimens provide sufficient antibacterial coverage (MIC ≤ 4 μg/mL) for all renal groups.<br /> (© 2019 Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc. CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals, Inc. on behalf of the American Society for Clinical Pharmacology and Therapeutics.)
- Subjects :
- Administration, Intravenous
Adult
Aged
Aged, 80 and over
Anti-Bacterial Agents administration & dosage
Azabicyclo Compounds administration & dosage
Bacterial Infections urine
Case-Control Studies
Clinical Trials as Topic
Creatinine urine
Drug Combinations
Female
Humans
Imipenem administration & dosage
Male
Middle Aged
Models, Biological
Renal Elimination
Young Adult
Anti-Bacterial Agents pharmacology
Azabicyclo Compounds pharmacokinetics
Bacterial Infections drug therapy
Imipenem pharmacokinetics
Subjects
Details
- Language :
- English
- ISSN :
- 2163-8306
- Volume :
- 8
- Issue :
- 10
- Database :
- MEDLINE
- Journal :
- CPT: pharmacometrics & systems pharmacology
- Publication Type :
- Academic Journal
- Accession number :
- 31508899
- Full Text :
- https://doi.org/10.1002/psp4.12462