Pharmacokinetics of oxycodone/naloxone and its metabolites in patients with end-stage renal disease during and between haemodialysis sessions

Leuppi-Taegtmeyer, Anne; Duthaler, Urs; Hammann, Felix; Schmid, Yasmin; Dickenmann, Michael; Amico, Patricia; Jehle, Andreas W.; Kalbermatter, Stefan; Lenherr, Christoph; Schwabedissen, Henriette E. Meyer zu; Haschke, Manuel; Liechti, Matthias E.; Krähenbühl, Stephan

doi:10.1093/ndt/gfy285

Cited by 9 publications

(6 citation statements)

References 43 publications

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“…Patients with renal and hepatic function deterioration are more prone to oxycodone accumulation and adverse events in chronic use. However, recent data indicate that the PK parameters for a single dose of CR oxycodone-naloxone tablets in patients with end-stage renal disease are similar to those reported in subjects with normal renal function [53].…”

Section: Oxycodone In Renal and Hepatic Insufficiencymentioning

confidence: 72%

Updated Clinical Pharmacokinetics and Pharmacodynamics of Oxycodone

et al. 2019

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Global oxycodone consumption has increased sharply during the last two decades, and, in 2008, oxycodone consumption surpassed that of morphine. As oxycodone was synthesized in 1916 and taken to clinical use a year later, it has not undergone the same approval process required by today's standards. Most of the basic oxycodone pharmacokinetic (PK) data are from the 1990s and from academic research; however, a lot of additional data have been published over the last 10 years. In this review, we describe the latest oxycodone data on special populations, including neonates, children, pregnant and lactating women, and the elderly. A lot of important drug interaction data have been published that must also be taken into account when oxycodone is used concomitantly with cytochrome P450 (CYP) 3A inducers and inhibitors and/or CYP2D6 inhibitors. In addition, we gathered data on abuse-deterrent oxycodone formulations, and the PK of alternate administration routes, i.e. transmucosal and epidural, are also described. Mari Kinnunen and Panu Piirainen contributed equally to this work.

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Section: Oxycodone In Renal and Hepatic Insufficiencymentioning

confidence: 72%

Updated Clinical Pharmacokinetics and Pharmacodynamics of Oxycodone

et al. 2019

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“…There are some recent examples in the literature where this impact on PKs was characterized for various drugs or drug combinations. 29 , 30 , 31 In addition, the FDA guidance 8 describes the need and approach for evaluating the PKs of critical care medications likely to be used in patients on continuous renal replacement therapy (CRRT). The findings from the IHD studies may not be sufficient for patients on CRRT and hence may require a specific study and study design.…”

Section: Clinical Ri Study Designmentioning

confidence: 99%

Design and conduct considerations for studies in patients with impaired renal function

Ravenstijn¹,

Chetty

Manchandani

2021

Clinical Translational Sci

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An impaired renal function, including acute and chronic kidney disease and end-stage renal disease (ESRD), can be the result of ageing, certain disease conditions, the use of some medications or as a result of smoking. In patients with renal impairment (RI), the pharmacokinetics (PK) of drugs or drug metabolites may change and result in increased safety risks or decreased efficacy. In order to make specific dose recommendations in the label of drugs for RI patients, a clinical trial may have to be conducted or, when not feasible, modelling and simulations approaches such as population PK modelling (PopPK) or physiologically-based PK (PBPK) modelling may be applied. This tutorial aims to provide an overview of the global regulatory landscape and a practical guidance for successfully designing and conducting clinical RI trials or, alternatively, on applying modelling and simulation tools to come to a dose recommendation for RI patient in the most efficient manner.

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“…Thus, naturally occurring opioids should be avoided and only semi‐synthetic or synthetic opioids should be prescribed. Although oxycodone is metabolized by the liver into active metabolites which may accumulate in ESKD, it may be used cautiously in these patients; however, sustained‐release formulations should be avoided due to the risk of accumulation and toxicity 68 . Buprenorphine has a lower risk profile and could be substituted, using split dosing every 6 hours or a continuous transdermal patch 69…”

Section: Introductionmentioning

confidence: 99%

“…This includes considering offering naloxone, an opioid antagonist, when risk factors for opioid overdose such as history of overdose, history of substance use disorder, higher opioid dosages (≥50 MME/d), or concurrent benzodiazepine use, are present 63 . Naloxone is not dialyzed out and does not need dose adjustment in ESKD 68 . Dialysis units should stock naloxone and dialysis staff should be trained how and when to use it.…”

Section: Introductionmentioning

confidence: 99%

When ESKD complicates the management of pain

Jhamb

Tucker

Liebschutz

2020

Seminars in Dialysis

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Pain is one of the most common symptoms reported by patients with end‐stage kidney disease (ESKD) and negatively impacts their health‐related quality of life (HRQOL), dialysis adherence, healthcare utilization, and mortality. There are a number of patient‐related and health system‐related barriers that make it very challenging to treat pain in these patients. Moreover, the limited availability of efficacious and safe nonopiate analgesic options has led to over‐use of opioids in this population. We propose a framework for pain assessment and tailored treatment using nonpharmacological and pharmacological approaches to optimize pain management and opioid use. Additionally, we recommend system‐level changes to improve care coordination and pain management in ESKD patients.

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Pharmacokinetics of oxycodone/naloxone and its metabolites in patients with end-stage renal disease during and between haemodialysis sessions

Cited by 9 publications

References 43 publications

Updated Clinical Pharmacokinetics and Pharmacodynamics of Oxycodone

Updated Clinical Pharmacokinetics and Pharmacodynamics of Oxycodone

Design and conduct considerations for studies in patients with impaired renal function

When ESKD complicates the management of pain

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