Treating disorders of the neonatal central nervous system: pharmacokinetic and pharmacodynamic considerations with a focus on antiepileptics
A major consideration in the treatment of neonatal disorders is that the selected drug, dose and dosage frequency is safe, effective and appropriate for the intended patient population. Thus, a thorough knowledge of the pharmacokinetics and pharmacodynamics of the chosen drug within the patient popu...
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| Published in: | British journal of clinical pharmacology Vol. 81; no. 1; pp. 62 - 77 |
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| Main Authors: | , , , , |
| Format: | Journal Article |
| Language: | English |
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England
John Wiley and Sons Inc
01.01.2016
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| ISSN: | 0306-5251, 1365-2125, 1365-2125 |
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| Abstract | A major consideration in the treatment of neonatal disorders is that the selected drug, dose and dosage frequency is safe, effective and appropriate for the intended patient population. Thus, a thorough knowledge of the pharmacokinetics and pharmacodynamics of the chosen drug within the patient population is essential. In paediatric and neonatal populations two additional challenges can often complicate drug treatment – the inherently greater physiological variability, and a lack of robust clinical evidence of therapeutic range. There has traditionally been an overreliance in paediatric medicine on extrapolating doses from adult values by adjusting for bodyweight or body surface area, but many other sources of variability exist which complicate the choice of dose in neonates. The lack of reliable drug dosage data in neonates has been highlighted by regulatory authorities, as only ~50% of the most commonly used paediatric medicines have been examined in a paediatric population. Moreover, there is a paucity of information on the pharmacokinetic parameters which affect drug concentrations in different body tissues, and pharmacodynamic responses to drugs in the neonate. Thus, in the present review, we draw attention to the main pharmacokinetic factors that influence the unbound brain concentration of neuroactive drugs. Moreover, the pharmacodynamic differences between neonates and adults that affect the activity of centrally‐acting therapeutic agents are briefly examined, with a particular emphasis on antiepileptic drugs. |
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| AbstractList | A major consideration in the treatment of neonatal disorders is that the selected drug, dose and dosage frequency is safe, effective and appropriate for the intended patient population. Thus, a thorough knowledge of the pharmacokinetics and pharmacodynamics of the chosen drug within the patient population is essential. In paediatric and neonatal populations two additional challenges can often complicate drug treatment – the inherently greater physiological variability, and a lack of robust clinical evidence of therapeutic range. There has traditionally been an overreliance in paediatric medicine on extrapolating doses from adult values by adjusting for bodyweight or body surface area, but many other sources of variability exist which complicate the choice of dose in neonates. The lack of reliable drug dosage data in neonates has been highlighted by regulatory authorities, as only ~50% of the most commonly used paediatric medicines have been examined in a paediatric population. Moreover, there is a paucity of information on the pharmacokinetic parameters which affect drug concentrations in different body tissues, and pharmacodynamic responses to drugs in the neonate. Thus, in the present review, we draw attention to the main pharmacokinetic factors that influence the unbound brain concentration of neuroactive drugs. Moreover, the pharmacodynamic differences between neonates and adults that affect the activity of centrally‐acting therapeutic agents are briefly examined, with a particular emphasis on antiepileptic drugs. A major consideration in the treatment of neonatal disorders is that the selected drug, dose and dosage frequency is safe, effective and appropriate for the intended patient population. Thus, a thorough knowledge of the pharmacokinetics and pharmacodynamics of the chosen drug within the patient population is essential. In paediatric and neonatal populations two additional challenges can often complicate drug treatment - the inherently greater physiological variability, and a lack of robust clinical evidence of therapeutic range. There has traditionally been an overreliance in paediatric medicine on extrapolating doses from adult values by adjusting for bodyweight or body surface area, but many other sources of variability exist which complicate the choice of dose in neonates. The lack of reliable drug dosage data in neonates has been highlighted by regulatory authorities, as only ~50% of the most commonly used paediatric medicines have been examined in a paediatric population. Moreover, there is a paucity of information on the pharmacokinetic parameters which affect drug concentrations in different body tissues, and pharmacodynamic responses to drugs in the neonate. Thus, in the present review, we draw attention to the main pharmacokinetic factors that influence the unbound brain concentration of neuroactive drugs. Moreover, the pharmacodynamic differences between neonates and adults that affect the activity of centrally-acting therapeutic agents are briefly examined, with a particular emphasis on antiepileptic drugs.A major consideration in the treatment of neonatal disorders is that the selected drug, dose and dosage frequency is safe, effective and appropriate for the intended patient population. Thus, a thorough knowledge of the pharmacokinetics and pharmacodynamics of the chosen drug within the patient population is essential. In paediatric and neonatal populations two additional challenges can often complicate drug treatment - the inherently greater physiological variability, and a lack of robust clinical evidence of therapeutic range. There has traditionally been an overreliance in paediatric medicine on extrapolating doses from adult values by adjusting for bodyweight or body surface area, but many other sources of variability exist which complicate the choice of dose in neonates. The lack of reliable drug dosage data in neonates has been highlighted by regulatory authorities, as only ~50% of the most commonly used paediatric medicines have been examined in a paediatric population. Moreover, there is a paucity of information on the pharmacokinetic parameters which affect drug concentrations in different body tissues, and pharmacodynamic responses to drugs in the neonate. Thus, in the present review, we draw attention to the main pharmacokinetic factors that influence the unbound brain concentration of neuroactive drugs. Moreover, the pharmacodynamic differences between neonates and adults that affect the activity of centrally-acting therapeutic agents are briefly examined, with a particular emphasis on antiepileptic drugs. |
| Author | Murray, Deirdre M. Donovan, Maria D. Griffin, Brendan T. Boylan, Geraldine B. Cryan, John F. |
| AuthorAffiliation | 4 Irish Centre for Fetal and Neonatal Translational Research University College Cork and Cork University Maternity Hospital Cork Ireland 1 Pharmacodelivery Group, School of Pharmacy University College Cork Cork Ireland 2 Department of Anatomy and Neuroscience University College Cork Cork Ireland 3 Department of Paediatrics and Child Health University College Cork Cork Ireland 5 Alimentary Pharmabiotic Centre University College Cork Cork Ireland |
| AuthorAffiliation_xml | – name: 1 Pharmacodelivery Group, School of Pharmacy University College Cork Cork Ireland – name: 2 Department of Anatomy and Neuroscience University College Cork Cork Ireland – name: 4 Irish Centre for Fetal and Neonatal Translational Research University College Cork and Cork University Maternity Hospital Cork Ireland – name: 3 Department of Paediatrics and Child Health University College Cork Cork Ireland – name: 5 Alimentary Pharmabiotic Centre University College Cork Cork Ireland |
| Author_xml | – sequence: 1 givenname: Maria D. surname: Donovan fullname: Donovan, Maria D. organization: University College Cork – sequence: 2 givenname: Geraldine B. surname: Boylan fullname: Boylan, Geraldine B. organization: University College Cork and Cork University Maternity Hospital – sequence: 3 givenname: Deirdre M. surname: Murray fullname: Murray, Deirdre M. organization: University College Cork – sequence: 4 givenname: John F. surname: Cryan fullname: Cryan, John F. organization: University College Cork – sequence: 5 givenname: Brendan T. surname: Griffin fullname: Griffin, Brendan T. organization: University College Cork |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/26302437$$D View this record in MEDLINE/PubMed |
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| CitedBy_id | crossref_primary_10_1080_17425255_2016_1203900 crossref_primary_10_1016_j_pediatrneurol_2019_02_012 crossref_primary_10_1038_s41390_018_0242_2 crossref_primary_10_1080_13543784_2025_2462615 crossref_primary_10_1016_j_clp_2025_02_005 |
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| Keywords | pharmacokinetics neonate antiepileptics patient-specific computational modeling pharmacodynamics |
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| SubjectTerms | Anticonvulsants - pharmacokinetics Anticonvulsants - pharmacology antiepileptics Blood-Brain Barrier Brain - metabolism Central Nervous System Diseases - drug therapy Humans Infant, Newborn Infant, Newborn, Diseases - drug therapy Models, Biological neonate patient‐specific computational modeling pharmacodynamics pharmacokinetics Review Reviews |
| Title | Treating disorders of the neonatal central nervous system: pharmacokinetic and pharmacodynamic considerations with a focus on antiepileptics |
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