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Children and pharmacokinetics

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https://www.readbyqxmd.com/read/28819726/population-pharmacokinetics-of-stiripentol-in-paediatric-patients-with-dravet-syndrome-treated-with-stiripentol-valproate-and-clobazam-combination-therapy
#1
Sophie Peigné, Stéphanie Chhun, Michel Tod, Elisabeth Rey, Christelle Rodrigues, Catherine Chiron, Gérard Pons, Vincent Jullien
AIM: The aim of this study was to describe the pharmacokinetics of stiripentol in children with Dravet syndrome and to determine the concentrations of stiripentol achieved in this population for the usual 25 mg/kg twice-daily dose. METHODS: Thirty-five children with epilepsy were included in a prospective population pharmacokinetic study (using MONOLIX software). Four blood samples were drawn per patient. Stiripentol area under the plasma concentration-time curve (AUC) values and trough concentrations were simulated for 7000 theoretical children weighing between 10 and 70 kg for the 25 mg/kg twice-daily dose...
August 17, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28816644/cyp2b6-haplotype-predicts-efavirenz-plasma-concentration-in-black-south-african-hiv-1-infected-children-a-longitudinal-pediatric-pharmacogenomic-study
#2
Riaan Reay, Collet Dandara, Michelle Viljoen, Malie Rheeders
South Africa has the highest burden of the human immunodeficiency virus (HIV) infection globally. Efavirenz (EFV), a frequently used drug against HIV infection, displays a relationship between drug concentration and pharmacodynamics effects clinically. However, haplotype-based genetic variation in drug metabolism in a pediatric sample has been little considered in a longitudinal long-term context. CYP2B6 plays a key role in variation of EFV plasma concentration through altered drug metabolism. We report here on a prospective clinical pharmacogenomics/pharmacokinetic study of Bantu-speaking children, importantly, over a period of 24 months post-initiation of EFV-based treatment in South Africa...
August 2017: Omics: a Journal of Integrative Biology
https://www.readbyqxmd.com/read/28815754/pharmacokinetic-interactions-and-dosing-rationale-for-antiepileptic-drugs-in-adults-and-children
#3
S C van Dijkman, W M Rauwé, M Danhof, O Della Pasqua
AIM: Population pharmacokinetic modelling has been widely used across many therapeutic areas to identify sources of variability, which are incorporated into models as covariate factors. Despite numerous publications on pharmacokinetic (PK) drug-drug interactions (DDIs) between antiepileptic drugs (AEDs), such data are not used to support the dose rationale for polytherapy in the treatment of epileptic seizures. Here we assess the impact of DDIs on plasma concentrations and evaluate the need for AED dose adjustment...
August 16, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28814674/rilonacept-maintains-long-term-inflammatory-remission-in-patients-with-deficiency-of-the-il-1-receptor-antagonist
#4
Megha Garg, Adriana A de Jesus, Dawn Chapelle, Paul Dancey, Ronit Herzog, Rafael Rivas-Chacon, Theresa L Wampler Muskardin, Ann Reed, James C Reynolds, Raphaela Goldbach-Mansky, Gina A Montealegre Sanchez
BACKGROUND: Deficiency of IL-1 receptor antagonist (DIRA) is a rare autoinflammatory disease that presents with life-threatening systemic inflammation, aseptic multifocal osteomyelitis, and pustulosis responsive to IL-1-blocking treatment. This study was performed (a) to investigate rilonacept, a long-acting IL-1 inhibitor, in maintaining anakinra-induced inflammatory remission in DIRA patients, (b) to determine doses needed to maintain remission, and (c) to evaluate the safety and pharmacokinetics of rilonacept in young children (<12 years)...
August 17, 2017: JCI Insight
https://www.readbyqxmd.com/read/28807770/gsta1-genetic-variants-and-conditioning-regimen-missing-key-factors-in-dosing-guidelines-of-busulfan-in-pediatric-hematopoietic-stem-cell-transplantation
#5
T Nava, M A Rezgui, Crs Uppugunduri, P Huezo-Diaz Curtis, Y Théoret, M Duval, L E Daudt, M Ansari, M Krajinovic, H Bittencourt
Busulfan (Bu) is a key component of conditioning regimens used prior to hematopoietic stem cell transplantation (SCT) in children. Different predictive methods have been used to calculate the Bu first-dose. To evaluate the necessity of further improvements, we retrospectively analyzed the currently available weight- and age-based guidelines to calculate the first doses in 101 children who underwent allogenic SCT in CHU Sainte-Justine, Montreal, following an intravenous Bu-containing conditioning regimen according to genetic and clinical factors...
August 11, 2017: Biology of Blood and Marrow Transplantation
https://www.readbyqxmd.com/read/28805964/therapeutic-drug-monitoring-of-voriconazole-for-treatment-and-prophylaxis-of-invasive-fungal-infection-in-children
#6
Sarah Allegra, Giovanna Fatiguso, Silvia De Francia, Fabio Favata, Elisa Pirro, Chiara Carcieri, Amedeo De Nicolò, Jessica Cusato, Giovanni Di Perri, Antonio D'Avolio
Voriconazole therapeutic drug monitoring is not consistently recommended due to its high interpatients and intrapatients variability. Here, we aimed to describe our experience with voriconazole for treatment and prophylaxis of invasive fungal infections, in paediatric patients. A fully validated HPLC-MS method was used to quantify voriconazole concentration in plasma, at the end of dosing interval. A high interindividual variability was shown. We enrolled 237 children, 83 receiving intravenous and 154 oral voriconazole...
August 14, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28800382/suboptimal-cotrimoxazole-prophylactic-concentrations-in-hiv-infected-children-according-to-the-who-guidelines
#7
C Pressiat, V Mea-Assande, C Yonaba, J-M Treluyer, D-L Dahourou, M Amorissani-Folquet, S Blanche, F Eboua, D Ye, G Lui, K Malateste, Y Zheng, V Leroy, D Hirt
AIMS: A clinical study was conduct in HIV-infected children to evaluate the prophylactic doses of cotrimoxazole (sulfamethoxazole (SMX) and trimethoprim (TMP)) advised by WHO. METHODS: Children received lopinavir-based antiretroviral therapy with cotrimoxazole prophylaxis (200 mg of SMX/ 40 mg of TMP once daily). Nonlinear mixed effects modelling approach was used to analyze plasma concentrations. Factors that could impact the pharmacokinetic profile were investigate...
August 11, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28794069/phase-i-study-of-the-anti-cd22-immunotoxin-moxetumomab-pasudotox-for-childhood-acute-lymphoblastic-leukemia
#8
Alan S Wayne, Nirali N Shah, Deepa Bhojwani, Lewis B Silverman, James A Whitlock, Maryalice Stetler-Stevenson, Weili Sun, Meina Liang, Jie Yang, Robert J Kreitman, Mark C Lanasa, Ira Pastan
Novel therapies are needed to overcome chemotherapy resistance for children with relapsed/refractory acute lymphoblastic leukemia (ALL). Moxetumomab pasudotox is a recombinant anti-CD22 immunotoxin. A multicenter, phase I study was conducted to determine the maximum tolerated cumulative dose (MTCD) and evaluate safety, activity, pharmacokinetics, and immunogenicity of moxetumomab pasudotox in children, adolescents, and young adults with ALL (n=55). Moxetumomab pasudotox was administered as a 30-minute intravenous infusion at doses of 5 to 50 µg/kg every other day (QOD) for six (Cohorts A and B) or 10 (Cohort C) doses, on 21-day cycles...
August 9, 2017: Blood
https://www.readbyqxmd.com/read/28791666/clinical-pharmacokinetics-and-pharmacodynamics-of-micafungin
#9
REVIEW
Roeland E Wasmann, Eline W Muilwijk, David M Burger, Paul E Verweij, Catherijne A Knibbe, Roger J Brüggemann
Micafungin is a selective inhibitor of the synthesis of fungal 1,3-β-D-glucan, an essential component of the fungal cell wall. It is available as a powder for infusion only and is registered for the treatment of invasive and esophageal candidiasis in addition to prophylaxis of Candida infections in both adults and children. Average exposure after a single intravenous 100 mg dose in healthy adults is 133 mg h/L. Both exposure and maximum plasma concentration show linear dose proportional pharmacokinetics (PK) over a 0...
August 8, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28791664/pharmacokinetics-of-sildenafil-in-children-with-pulmonary-arterial-hypertension
#10
Hugo Juárez Olguín, Hector Osnaya Martínez, Carmen Flores Pérez, Blanca Ramírez Mendiola, Liliana Rivera Espinosa, Juan Luis Chávez Pacheco, Janett Flores Pérez, Ignacio Mora Magaña
BACKGROUND: Recently, sildenafil was introduced to treat pulmonary arterial hypertension (PAH); however, there are currently few studies on the pharmacokinetics of sildenalfil in children. Therefore, we aimed to carry out a pharmacokinetic study of sildenafil in children with PAH using a single dose. METHODS: Twelve children diagnosed with PAH, consisting of with ten males and two females, were recruited for the study after obtaining written consent from their parents or guardians...
August 8, 2017: World Journal of Pediatrics: WJP
https://www.readbyqxmd.com/read/28782097/interactions-between-cannabidiol-and-commonly-used-antiepileptic-drugs
#11
Tyler E Gaston, E Martina Bebin, Gary R Cutter, Yuliang Liu, Jerzy P Szaflarski
OBJECTIVE: To identify potential pharmacokinetic interactions between the pharmaceutical formulation of cannabidiol (CBD; Epidiolex) and the commonly used antiepileptic drugs (AEDs) through an open-label safety study. Serum levels were monitored to identify interactions between CBD and AEDs. METHODS: In 39 adults and 42 children, CBD dose was started at 5 mg/kg/day and increased every 2 weeks by 5 mg/kg/day up to a maximum of 50 mg/kg/day. Serum AED levels were obtained at baseline prior to CBD initiation and at most study visits...
August 6, 2017: Epilepsia
https://www.readbyqxmd.com/read/28776198/determining-the-optimal-vancomycin-daily-dose-for-pediatrics-a-meta-analysis
#12
REVIEW
Geisa Cristina da Silva Alves, Samuel Dutra da Silva, Virginia Paula Frade, Danielle Rodrigues, André de Oliveira Baldoni, Whocely Victor de Castro, Cristina Sanches
OBJECTIVE: The objective of this study was to check which initial dose of vancomycin is needed to achieve the therapeutic target that is currently used in pediatrics. METHODS: The search was conducted in the following data sources: Pubmed (1980-2017), the Cochrane Library, and Embase (1986-2017) and the references of the published studies; searches were performed using the key terms: child, children, pediatrics, infants and adolescents, vancomycin, pharmacokinetics, and pharmacodynamics...
August 4, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28771787/population-pharmacokinetics-of-oxcarbazepine-and-its-monohydroxy-derivative-in-epileptic-children
#13
Christelle Rodrigues, Catherine Chiron, Elisabeth Rey, Olivier Dulac, Emmanuelle Comets, Gérard Pons, Vincent Jullien
AIMS: Oxcarbazepine is an antiepileptic drug with an activity mostly due to its monohydroxy derivative metabolite (MHD). A parent-metabolite population pharmacokinetic model in children was developed in order to evaluate the consistency between the recommended pediatric doses and the reference range for trough concentration (Ctrough ) of MHD (3-35 mg/L). METHODS: A total of 279 plasma samples were obtained from 31 epileptic children (2-12y) after a single dose of oxcarbazepine...
August 3, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28770451/pharmacotherapy-for-seizures-in-neonates-with-hypoxic-ischemic-encephalopathy
#14
REVIEW
Elissa Yozawitz, Arthur Stacey, Ronit M Pressler
Seizures are common in neonates with moderate and severe hypoxic ischemic encephalopathy (HIE) and are associated with worse outcomes, independent of HIE severity. In contrast to adults and older children, no new drugs have been licensed for treatment of neonatal seizures over the last 50 years, because of a lack of controlled clinical trials. Hence, many antiseizure medications licensed in older children and adults are used off-label for neonatal seizure, which is associated with potential risks of adverse effects during a period when the brain is particularly vulnerable...
August 2, 2017: Paediatric Drugs
https://www.readbyqxmd.com/read/28763744/genetic-polymorphisms-and-valproic-acid-plasma-concentration-in-children-with-epilepsy-on-valproic-acid-monotherapy
#15
Shenghui Mei, Weixing Feng, Leting Zhu, Yazhen Yu, Weili Yang, Baoqin Gao, Xiaojuan Wu, Zhigang Zhao, Fang Fang
PURPOSE: The aim of the study is to evaluate the association between genetic polymorphisms and valproic acid (VPA) concentration to dose ratio in children with epilepsy on VPA monotherapy. METHODS: A total of 137 children, aged 3.5-18 years, (89 males and 48 females) with epilepsy on sustained-release VPA monotherapy were enrolled. Trough plasma concentrations of VPA at steady-state were measured using an AXSYM automatic immunity analyzer. The values were divided by body weight and total daily dose to calculate concentration to dose ratio of VPA (CDRV)...
July 20, 2017: Seizure: the Journal of the British Epilepsy Association
https://www.readbyqxmd.com/read/28762136/predicting-cortisol-exposure-from-paediatric-hydrocortisone-formulation-using-a-semi-mechanistic-pharmacokinetic-model-established-in-healthy-adults
#16
Johanna Melin, Zinnia P Parra-Guillen, Niklas Hartung, Wilhelm Huisinga, Richard J Ross, Martin J Whitaker, Charlotte Kloft
BACKGROUND AND OBJECTIVE: Optimisation of hydrocortisone replacement therapy in children is challenging as there is currently no licensed formulation and dose in Europe for children under 6 years of age. In addition, hydrocortisone has non-linear pharmacokinetics caused by saturable plasma protein binding. A paediatric hydrocortisone formulation, Infacort(®) oral hydrocortisone granules with taste masking, has therefore been developed. The objective of this study was to establish a population pharmacokinetic model based on studies in healthy adult volunteers to predict hydrocortisone exposure in paediatric patients with adrenal insufficiency...
July 31, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28758800/dosing-antibiotics-in-neonates-review-of-the-pharmacokinetic-data
#17
Nazario D Rivera-Chaparro, Michael Cohen-Wolkowiez, Rachel G Greenberg
Antibiotics are often used in neonates despite the absence of relevant dosing information in drug labels. For neonatal dosing, clinicians must extrapolate data from studies for adults and older children, who have strikingly different physiologies. As a result, dosing extrapolation can lead to increased toxicity or efficacy failures in neonates. Driven by these differences and recent legislation mandating the study of drugs in children and neonates, an increasing number of pharmacokinetic studies of antibiotics are being performed in neonates...
July 31, 2017: Future Microbiology
https://www.readbyqxmd.com/read/28755452/extrapolating-evidence-of-antiepileptic-drug-efficacy-in-adults-to-children-%C3%A2-2%C3%A2-years-of-age-with-focal-seizures-the-case-for-disease-similarity
#18
John M Pellock, Alexis Arzimanoglou, O'Neill D'Cruz, Gregory L Holmes, Douglas Nordli, Shlomo Shinnar
Expediting pediatric access to new antiseizure drugs is particularly compelling, because epileptic seizures are the most common serious neurological symptom in children. Analysis of antiepileptic drug (AED) efficacy outcomes of randomized controlled trials, conducted during the past 20 years in different populations and a broad range of study sites and countries, has shown considerable consistency for each drug between adult and pediatric populations. Historically, the majority of regulatory approvals for AEDs have been for seizure types and not for specific epilepsy syndromes...
July 29, 2017: Epilepsia
https://www.readbyqxmd.com/read/28754601/magnesium-sulfate-infusion-for-acute-asthma-in-the-emergency-department
#19
REVIEW
Jose Enrique Irazuzta, Nicolas Chiriboga
OBJECTIVES: To describe the role of intravenous magnesium sulfate (MgSO4) as therapy for acute severe asthma in the pediatric emergency department (ED). SOURCE: Publications were searched in the PubMed and Cochrane databases using the following keywords: magnesium AND asthma AND children AND clinical trial. A total of 53 publications were retrieved using this criteria. References of relevant articles were also screened. The authors included the summary of relevant publications where intravenous magnesium sulfate was studied in children (age <18 years) with acute asthma...
July 26, 2017: Jornal de Pediatria
https://www.readbyqxmd.com/read/28751444/pediatric-phase-1-trial-and-pharmacokinetic-study-of-trebananib-in-relapsed-solid-tumors-advl1115-a-children-s-oncology-group-phase-1-consortium-report
#20
Sarah E S Leary, Julie R Park, Joel M Reid, Andrew T Ralya, Sylvain Baruchel, Bing Wu, Timothy P L Roberts, Xiaowei Liu, Charles G Minard, Elizabeth Fox, Brenda J Weigel, Susan Blaney
Trebananib is a first-in-class anti-angiogenic peptibody (peptide-Fc fusion protein) that inhibits Angiopoietin 1 and 2. A pediatric phase 1 trial was performed to define trebananib dose limiting toxicities (DLT), recommended phase 2 dose (RP2D) and pharmacokinetics (PK).<br /><br />Experimental Design: Trebananib was administered by weekly infusion. Three dose levels (10, 15 or 30 mg/kg/dose) were evaluated using a rolling-six design. Part 2 evaluated a cohort of subjects with primary central nervous system (CNS) tumors...
July 27, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
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