Pharmacokinetic Monitoring of Levetiracetam in Portuguese Refractory Epileptic Patients: Effect of Gender, Weight and Concomitant Therapy

Silva, Rui; Almeida, Anabela; Bicker, Joana; Gonçalves, Joana; Carona, Andreia; Silva, Ana; Santana, Isabel; Sales, Francisco; Falcão, Amı́lcar

doi:10.3390/pharmaceutics12100943

Cited by 5 publications

(3 citation statements)

References 67 publications

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“…A recent popPK study by Silva et al. suggested doubling the maintenance dose of PER in adult patients coadministered with EIASMs 34 . In comparison, the present study found that the dose of PER in pediatric patients coadministered with OXC should be increased by 20%–50% to achieve the same exposure level as with monotherapy at the same dose.…”

Section: Discussioncontrasting

confidence: 48%

“…A recent popPK study by Silva et al suggested doubling the maintenance dose of PER in adult patients coadministered with EIASMs. 34 In comparison, the present study found that the dose of PER in pediatric patients coadministered with OXC should be increased by 20%-50% to achieve the same exposure level as with monotherapy at the same dose. The discrepancies between the dosing regimens proposed in these two studies mainly stem from the varying degrees of induction of enzyme activity by different EIASMs, as well as differences in the pharmacokinetic profiles of PER in diverse populations.…”

Section: F I G U R Ementioning

confidence: 53%

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Population pharmacokinetics and dosing optimization of perampanel in children with epilepsy: A real‐world study

Li,

Yi,

Tuo

et al. 2024

Epilepsia

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ObjectiveThe purposes of this study were to explore the pharmacokinetics of perampanel (PER) in children with epilepsy, identify factors that contribute to pharmacokinetic variations among subjects, evaluate the connection between PER exposure and clinical outcome, and establish an evidence‐based approach for tailoring individualized antiepileptic treatment in this specific population.MethodsIn this prospective study, PER plasma concentrations and genetic information on metabolic enzymes were obtained from 194 patients younger than 18 years. The disposition kinetics of PER in pediatric patients following oral dosing were characterized using nonlinear mixed effect models. The effective range for the plasma concentration of PER was determined by assessing the efficacy and safety of PER treatment and analyzing the relationship between drug exposure and clinical response. Monte Carlo simulations were then performed to evaluate and optimize the current dosing regimens.ResultsThe pharmacokinetic profile of PER was adequately described by a one‐compartment model with first‐order absorption and elimination. Body weight, total bilirubin level, and concomitant oxcarbazepine were found to have significant influences on PER pharmacokinetics. Model estimates of apparent clearance and volume of distribution were .016 ± .009 L/h/kg and 1.47 ± .78 L/kg, respectively. The effective range predicted from plasma concentration data in responders was 215–862 μg/L. Dosing scenarios stratified according to essential covariates were proposed through simulation analysis.SignificanceIn this study, we captured the pharmacokinetic/pharmacodynamic characteristics of PER in pediatric epilepsy patients through analysis of real‐world data and adopted a pharmacometric approach to support an individualized dosing strategy for PER in this specific population.

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Section: Discussioncontrasting

confidence: 48%

Section: F I G U R Ementioning

confidence: 53%

Population pharmacokinetics and dosing optimization of perampanel in children with epilepsy: A real‐world study

Li,

Yi,

Tuo

et al. 2024

Epilepsia

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“…Since, many patients don't share their experience while using CBZ therapy some cases of hyponatremia may be missed. 24,25,27…”

Section: Carbamazepine As An Effective Antiepileptic Drug (Aed)mentioning

confidence: 99%

Pharmaceutical and Clinical Assessment of Multi-source Tegretol Sold in Egypt

Amer,

Eldeeb,

Eshra

2023

IJPQA

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across generic Narrow therapeutic index (NTI) medications compared to brands. However, little attention has been given to possible inequality within the same brand due to transportation and storage conditions, production site, manufacturing condition, and product specification requested by different countries. Market surveys has shown that Egypt is one of the countries suffering from this problem, which consequently augments the need for comparing and evaluating brand products marketed under the same brand name, manufactured in different countries under its own licensing trademark™ and sold in Egypt. This work studies the drug carbamazepine (CBZ) available in Egypt as Tegretol® tablets used as an oral first-line anti-epileptic drug (AED). Objectives: The present work investigate and evaluate the pharmaceutical quality and clinical efficacy of Tegretol®, obtained from Egypt and Saudi Arabia and being marketed and sold in Egypt from 2020 to 21. Methods: In-vitro quality testing included potency and uniformity of content tests performed according to USP 2019 monograph. Dissolution rates were also carried by adopting USP dissolution test for the drug. Studies of stability were adjusted at 25°C/65% RH, 45°C/75% RH and 10°C/15% RH. The clinical efficacy was studied by evaluating the pharmacokinetics parameters and blood sodium level during six months of therapy. Results: Variability between multisource Tegretol® brand products were ensured. Potency results and uniformity of content revealed statistically significant difference between Tegretol® sources. Also, variations in dissolution rates were recognized in both Tegretol® sources when dissolved in HCL/KCL, Acetate and Phosphate Buffer dissolution media. Dissimilarities were obtained for hardness and friability testing. Furthermore, a pharmacokinetically and pharmacodynamically inequivalence was ensured. Hence, hyponatremia was more prominent in patients receiving Saudi Arabian Tegretol® compared to patients taking Egyptian Tegretol®. Conclusion: Interchangeability between multi-source Tegretol brand products should be limited.

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Seaweed carrageenans: Productions and applications

Nguyen

et al. 2022

Algae-Based Biomaterials for Sustainable Development

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Pharmacokinetic Monitoring of Levetiracetam in Portuguese Refractory Epileptic Patients: Effect of Gender, Weight and Concomitant Therapy

Cited by 5 publications

References 67 publications

Population pharmacokinetics and dosing optimization of perampanel in children with epilepsy: A real‐world study

Population pharmacokinetics and dosing optimization of perampanel in children with epilepsy: A real‐world study

Pharmaceutical and Clinical Assessment of Multi-source Tegretol Sold in Egypt

Seaweed carrageenans: Productions and applications

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