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Children and pharmacokinetics

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https://www.readbyqxmd.com/read/28445697/influence-of-maturation-on-in-vivo-tissue-to-plasma-partition-coefficients-for-cis-and-trans-permethrin
#1
Manoj Amaraneni, Jing Pang, James V Bruckner, Srinivasa Muralidhara, Tanzir B Mortuza, Darren Gullick, Shirin Hooshfar, Catherine A White, Brian S Cummings
Permethrin, the most widely used household insecticide in the U.S., is marketed as a mixture of its cis (CIS) and trans (TRANS) isomers. The major objective of this investigation was to develop and utilize a reliable approach to determine in vivo partition coefficients (PCs) for CIS and TRANS in immature and adult Sprague-Dawley rats. Adult, postnatal day (PND) 21 and PND 15 rats were infused with environmentally relevant concentrations of CIS or TRANS via a s.c. osmotic pump for 48 or 72 h. The adult and PND 21 rats also received an oral loading dose...
April 23, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28444856/pharmacokinetics-after-a-single-dose-of-naloxone-administered-as-a-nasal-spray-in-healthy-volunteers
#2
E Vanky, L Hellmundt, U Bondesson, S Eksborg, S Lundeberg
BACKGROUND: There is increasing interest in the use of intranasal naloxone to reverse adverse opioid effects during management of procedural pain in children and in adults after overdose. There are limited data on the pharmacokinetics of intranasal naloxone so in this study we aimed to detail the pharmacokinetic profile of the commercially marketed injectable solution of naloxone 0.4 mg/ml when administered as an intranasal spray. METHODS: Twenty healthy volunteers received naloxone as an intranasal spray at a dose of 10 μg/kg...
April 25, 2017: Acta Anaesthesiologica Scandinavica
https://www.readbyqxmd.com/read/28444427/population-pharmacokinetic-modelling-of-doxorubicin-and-doxorubicinol-in-children-with-cancer-is-there-a-relationship-with-cardiac-troponin-profiles
#3
Kuhan Kunarajah, Stefanie Hennig, Ross L G Norris, Michael Lobb, Bruce G Charles, Ross Pinkerton, Andrew S Moore
PURPOSE: Anthracyclines are a mainstay of the treatment of several childhood malignancies, but their utility is limited by dose-related cardiotoxicity. This study is aimed to explore the link between exposure of paediatric cancer patients to doxorubicin and its metabolite doxorubicinol, and cardiac troponin I (cTnI). METHODS: In a prospective pilot study plasma doxorubicin, doxorubicinol, and cTnI concentrations were measured in samples from children undergoing cancer chemotherapy...
April 25, 2017: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/28438661/systematic-review-of-the-potential-adverse-effects-of-caffeine-consumption-in-healthy-adults-pregnant-women-adolescents-and-children
#4
Daniele Wikoff, Brian T Welsh, Rayetta Henderson, Gregory P Brorby, Janice Britt, Esther Myers, Jeffrey Goldberger, Harris R Lieberman, Charles O'Brien, Jennifer Peck, Milton Tenebein, Connie Weaver, Seneca Harvey, Jonathan Urban, Candace Doepker
To date, one of the most heavily cited assessments of caffeine safety in the peer-reviewed literature is that issued by Health Canada (Nawrot et al., 2003). Since then, >10,000 papers have been published related to caffeine, including hundreds of reviews on specific human health effects; however, to date, none have compared the wide range of topics evaluated by Nawrot et al. (2003). Thus, as an update to this foundational publication, we conducted a systematic review of data on potential adverse effects of caffeine published from 2001 to June 2015...
April 7, 2017: Food and Chemical Toxicology
https://www.readbyqxmd.com/read/28429653/clinical-development-of-fenretinide-as-an-antineoplastic-drug-pharmacology-perspectives
#5
Jason P Cooper, C Patrick Reynolds, Hwangeui Cho, Min H Kang
Fenretinide (4-HPR) is a synthetic retinoid that has cytotoxic activity against cancer cells. Despite substantial in vitro cytotoxicity, response rates in early clinical trials with 4-HPR have been less than anticipated, likely due to the low bioavailability of the initial oral capsule formulation. Several clinical studies have shown that the oral capsule formulation at maximum tolerated dose (MTD) achieved <10 µmol/L concentrations in patients. To improve bioavailability of 4-HPR, new oral powder (LYM-X-SORB®, LXS) and intravenous lipid emulsion (ILE) formulations are being tested in early-phase clinical trials...
January 1, 2017: Experimental Biology and Medicine
https://www.readbyqxmd.com/read/28426519/toward-a-universal-antiretroviral-regimen-special-considerations-of-pregnancy-and-breast-feeding
#6
Amy L Slogrove, Polly Clayden, Elaine J Abrams
PURPOSE OF REVIEW: As optimized antiretroviral therapy (ART) regimens are prepared for introduction in low-income and middle-income countries (LMIC), we consider the current evidence related to dosing, efficacy and safety during pregnancy and breastfeeding of next-generation first-line and second-line ART regimens proposed for imminent introduction in the global marketplace. RECENT FINDINGS: Pregnancy pharmacokinetic considerations include potentially insufficient efavirenz exposure if dosed at 400 mg/day, the need for twice daily darunavir dosing and the paucity of data related to tenofovir alafenamide and dolutegravir dosing, safety and efficacy...
April 19, 2017: Current Opinion in HIV and AIDS
https://www.readbyqxmd.com/read/28421383/pharmacokinetics-safety-and-tolerability-of-single-and-multiple-doses-of-guanfacine-extended-release-formulation-in-healthy-japanese-and-caucasian-male-adults
#7
Yumiko Matsuo, Masafumi Okita, James Ermer, Toshihiro Wajima
BACKGROUND AND OBJECTIVE: Guanfacine extended-release (guanfacine XR) could be a useful treatment option for children and adolescent patients with attention-deficit/hyperactivity disorder (ADHD). As an initial step in the development in Japan, the pharmacokinetics, safety and tolerability were assessed in healthy Japanese and non-Hispanic Caucasian adults. METHODS: A Phase 1, double-blind, randomized, placebo-controlled, single- and multiple-oral dose escalation study of guanfacine XR was conducted...
April 18, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28419277/prevention-of-tb-using-rifampicin-plus-isoniazid-reduces-nevirapine-concentrations-in-hiv-exposed-infants
#8
Helen McIlleron, Paolo Denti, Silvia Cohn, Fildah Mashabela, Jennifer D Hoffmann, Saba Shembe, Regina Msandiwa, Lubbe Wiesner, Sithembiso Velaphi, Sanjay G Lala, Richard E Chaisson, Neil Martinson, Kelly E Dooley
Background: Newborns of HIV-infected mothers are given daily doses of nevirapine to prevent HIV-1 acquisition. Infants born to mothers with TB should also receive TB preventive therapy. TB preventive regimens include isoniazid for 6 months or rifampicin plus isoniazid for 3 months (RH preventive therapy). The effect of concomitant RH preventive therapy on nevirapine concentrations in infants is unknown. Patients and methods: Tshepiso was a prospective case-control cohort study of pregnant HIV-infected women with and without TB whose newborn infants received standard doses of nevirapine for HIV prophylaxis...
April 16, 2017: Journal of Antimicrobial Chemotherapy
https://www.readbyqxmd.com/read/28419164/population-pharmacokinetic-modelling-of-rupatadine-solution-in-6-11-year-olds-and-optimisation-of-the-experimental-design-in-younger-children
#9
Eva Santamaría, Javier Alejandro Estévez, Jordi Riba, Iñaki Izquierdo, Marta Valle
AIMS: To optimise a pharmacokinetic (PK) study design of rupatadine for 2-5 year olds by using a population PK model developed with data from a study in 6-11 year olds. The design optimisation was driven by the need to avoid children's discomfort in the study. METHODS: PK data from 6-11 year olds with allergic rhinitis available from a previous study were used to construct a population PK model which we used in simulations to assess the dose to administer in a study in 2-5 year olds...
2017: PloS One
https://www.readbyqxmd.com/read/28412445/methylphenidate-effects-in-the-young-brain-friend-or-foe
#10
REVIEW
Sara Loureiro-Vieira, Vera Marisa Costa, Maria de Lourdes Bastos, Félix Carvalho, João Paulo Soares Capela
Attention deficit hyperactivity disorder (ADHD) is one of the most prevalent neuropsychiatry disorders in children and adolescents, and methylphenidate (MPH) is a first-line stimulant drug available worldwide for its treatment. Despite the proven therapeutic efficacy, concerns have been raised regarding the possible consequences of chronic MPH exposure during childhood and adolescence. Disturbances in the neurodevelopment at these crucial stages are major concerns given the unknown future life consequences...
April 12, 2017: International Journal of Developmental Neuroscience
https://www.readbyqxmd.com/read/28410277/use-of-population-pharmacokinetics-and-electronic-health-records-to-assess-piperacillin-tazobactam-safety-in-infants
#11
Sara Salerno, Christoph P Hornik, Michael Cohen-Wolkowiez, P Brian Smith, Lawrence C Ku, Matthew S Kelly, Reese Clark, Daniel Gonzalez
BACKGROUND: Piperacillin, in combination with tazobactam, is frequently used in infants for treating nosocomial infections, although safety data in this population are limited. Electronic health record (EHR) data can be used to evaluate drug safety in infants, but measures of drug exposure are lacking. METHODS: To relate simulated piperacillin exposure with adverse events (AEs) in infants using EHR data, we identified infants discharged from 333 neonatal intensive care units managed by the Pediatrix Medical Group between 1997 and 2012...
April 13, 2017: Pediatric Infectious Disease Journal
https://www.readbyqxmd.com/read/28407118/voriconazole-dosing-in-children-younger-than-3-years-undergoing-cancer-chemotherapy-or-hematopoietic-stem-cell-transplantation
#12
Shirley Qiong Yan, Brian Seyboth, Rachel Kobos, Anne Eaton, Susan K Seo, Nina Cohen
There are limited pediatric population pharmacokinetic data for voriconazole dosing, particularly in younger children. In a cohort of 34 patients younger than 3 years receiving voriconazole, the majority (n = 23, 68%) had a low initial serum concentration <1 mg/L. Among 23 children <2 years old, 19 (83%) had an initial trough <1 mg/L. There was large intra- and interindividual variability in trough levels. Dosing also varied from 3.3 to 19.6 mg/kg per dose. Only 2 of 34 patients had a documented adverse drug reaction attributable to voriconazole...
April 12, 2017: Journal of the Pediatric Infectious Diseases Society
https://www.readbyqxmd.com/read/28399577/drug-development-concepts-as-guides-for-optimizing-clinical-trials-of-supplemental-zinc-for-populations-at-risk-of-deficiency-or-diarrhea
#13
David H Alpers, Graeme P Young, Cuong D Tran, Elissa K Mortimer, Geetha L Gopalsamy, Nancy F Krebs, Mark J Manary, Balakrishnan S Ramakrishna, Henry J Binder, Ian L Brown, Leland V Miller
Studies on the efficacy of zinc supplementation for treatment or prevention of diarrhea have shown an inconsistent effect in populations at risk for zinc deficiency. Unlike drugs, which have no preexisting presence in the body, endogenous zinc must be assessed pharmacokinetically by isotope tracer studies. Although such methods have produced much data, very few studies have estimated the dose and the timing of dosing of zinc supplementation. This review examines drug kinetics used to establish the best dose, the timing of such doses, and the mechanism of action through pharmacodynamic markers and applies them, where possible, to zinc supplements...
March 1, 2017: Nutrition Reviews
https://www.readbyqxmd.com/read/28399519/pharmacokinetic-and-pharmacodynamic-modeling-of-mod-4023-a-long-acting-human-growth-hormone-in-growth-hormone-deficiency-children
#14
Dennis M Fisher, Ron G Rosenfeld, Michal Jaron-Mendelson, Leanne Amitzi, Ronit Koren, Gili Hart
BACKGROUND/AIMS: MOD-4023 is a long-acting human growth hormone (hGH) in clinical trials for the treatment of growth hormone deficiency (GHD). A key goal is maintenance of serum concentrations of insulin-like growth factor (IGF) 1 within normal range throughout GH dosing. The study aimed to develop a pharmacokinetic model for MOD-4023 and a pharmacodynamic model for the effect of MOD-4023 on IGF-1 to allow estimation of peak and mean IGF-1 and to identify the optimal IGF-1 sampling day...
April 11, 2017: Hormone Research in Pædiatrics
https://www.readbyqxmd.com/read/28399040/a-new-enzyme-linked-immunosorbent-assay-elisa-for-a-total-anti-t-lymphocyte-globulin-determination-development-analytical-validation-and-clinical-application
#15
M Montagna, G La Nasa, M E Bernardo, E Piras, M A Avanzini, M Regazzi, F Locatelli
BACKGROUND: Anti-T lymphocyte globulin (ATLG) modulates the alloreactivity of T lymphocytes, reducing the risk of immunological post-transplant complications, in particular rejection and graft-versus-host disease (GvHD), after allogeneic hematopoietic stem cell transplantation (HSCT).We developed and validated a new enzyme-linked immunosorbent assay (ELISA) method to measure serum levels of total ATLG and evaluate the pharmacokinetics (PK) of the drug in children with β-Thalassemia, receiving allogeneic HSCT...
April 7, 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28395551/use-of-tigecycline-in-pediatric-clinical-practice
#16
Maria Vincenza Mastrolia, Luisa Galli, Maurizio de Martino, Elena Chiappini
INTRODUCTION: Tigecycline, a derivative of minocycline, is an extended-spectrum antimicrobial agent. It has a restricted approval field in children and the experience of its adoption in clinical practice is reserved for cases of challenging infections. The aim of this review was to summarize evidence regarding the use of tigecycline in infants and children, focusing on the drug's clinical efficacy data and tolerability profile. AREAS COVERED: We have conducted a literature search of the Cochrane Library, EMBASE, and MEDLINE databases, from their inception through January 5, 2017, using the following terms: tigecycline, newborn, infant, child, pediatrics, adolescent, human, clinical trial, and case report...
April 11, 2017: Expert Review of Anti-infective Therapy
https://www.readbyqxmd.com/read/28387840/dose-optimization-of-piperacillin-tazobactam-in-critically-ill-children
#17
Pieter A J G De Cock, Sven C van Dijkman, Annick de Jaeger, Jef Willems, Mieke Carlier, Alain G Verstraete, Joris R Delanghe, Hugo Robays, Johan Vande Walle, Oscar E Della Pasqua, Peter De Paepe
Objectives: To characterize the population pharmacokinetics of piperacillin and tazobactam in critically ill infants and children, in order to develop an evidence-based dosing regimen. Patients and methods: This pharmacokinetic study enrolled patients admitted to the paediatric ICU for whom intravenous piperacillin/tazobactam (8:1 ratio) was indicated (75 mg/kg every 6 h based on piperacillin). Piperacillin/tazobactam concentrations were measured by an LC-MS/MS method...
April 6, 2017: Journal of Antimicrobial Chemotherapy
https://www.readbyqxmd.com/read/28383392/valganciclovir-dosing-for-cytomegalovirus-prophylaxis-in-pediatric-solid-organ-transplant-recipients-a-prospective-pharmacokinetic-study
#18
Orit Peled, Matitiahu Berkovitch, Eran Rom, Efraim Bilavsky, Yael Bernfeld, Lev Dorfman, Adi Pappo, Tomer Ziv-Baran, Nurit Brandriss, Adina Bar-Haim, Jacob Amir, Liat Ashkenazi-Hoffnung
BACKGROUND: Valganciclovir is extensively used for prophylaxis and treatment of CMV infection in solid-organ transplant recipients. However, pharmacokinetic data in children are scarce, and the pediatric dosing regimen is uncertain. This study sought to prospectively evaluate the pharmacokinetic profile, the clinical efficacy and safety of oral valganciclovir in pediatric transplant recipients and compare different dosing regimens. METHODS: The cohort included solid-organ transplant recipients treated with valganciclovir for CMV prophylaxis in 2014-2015 at a tertiary pediatric medical center...
April 5, 2017: Pediatric Infectious Disease Journal
https://www.readbyqxmd.com/read/28382572/current-clinical-trials-on-the-use-of-ceftaroline-in-the-pediatric-population
#19
REVIEW
Adam Corey, Tsz-Yin So
The rate of antibiotic resistance in children continues to rise requiring the use of new antibiotics. Ceftaroline fosamil, a newer-generation cephalosporin, was recently approved for the treatment of acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia in children aged >2 months. Ceftaroline provides coverage against staphylococcal and streptococcal infections, including methicillin-resistant Staphylococcus aureus and penicillin-resistant Streptococcus pneumoniae...
April 5, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28377723/multiple-psychopharmacological-effects-of-the-traditional-japanese-kampo-medicine-yokukansan-and-the-brain-regions-it-affects
#20
REVIEW
Kazushige Mizoguchi, Yasushi Ikarashi
Yokukansan (YKS), a traditional Japanese Kampo medicine, has indications for use in night crying and irritability in children, as well as neurosis and insomnia. It is currently also used for the remedy of the behavioral and psychological symptoms of dementia (BPSD), such as aggressiveness, agitation, and hallucinations. In parallel with clinical evidence, a significant amount of fundamental researches have been undertaken to clarify the neuropsychopharmacological efficacies of YKS, with approximately 70 articles, including our own, being published to date...
2017: Frontiers in Pharmacology
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