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Single‐Dose Pharmacokinetic Study of Diphenhydramine HCl in Children and Adolescents
Diphenhydramine pharmacokinetics were characterized following a single oral dose in children aged 2 to 17 years using a weight‐ and age‐based dosing schedule with more tiers than the current age‐based dosing schedule recommended by the nonprescription drug monograph. This study was conducted in 42 s...
Autores principales: | , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2017
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5947143/ https://www.ncbi.nlm.nih.gov/pubmed/28967696 http://dx.doi.org/10.1002/cpdd.391 |
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author | Gelotte, Cathy K. Zimmerman, Brenda A. Thompson, Gary A. |
author_facet | Gelotte, Cathy K. Zimmerman, Brenda A. Thompson, Gary A. |
author_sort | Gelotte, Cathy K. |
collection | PubMed |
description | Diphenhydramine pharmacokinetics were characterized following a single oral dose in children aged 2 to 17 years using a weight‐ and age‐based dosing schedule with more tiers than the current age‐based dosing schedule recommended by the nonprescription drug monograph. This study was conducted in 42 subjects, aged 2 to 17 years. Doses were based on a weight‐age dosing schedule, ranging from 6.25 to 50 mg. An oral dose was administered with water about 2 hours after a light breakfast. Plasma samples were obtained up to 48 hours after dosing and analyzed for diphenhydramine. Pharmacokinetic parameters were estimated using noncompartmental methods, and the relationship of oral clearance with age was assessed using linear regression. Over an 8‐fold range of doses, C(max) and AUC increased ∼90 % to ∼140% across age groups, with a similar T(max) (1.5 hours). Oral CL/F increased with age, but after allometric scaling, no maturation‐related change in CL/F was apparent. Mild somnolence was the most commonly reported adverse event (95% of the subjects). A weight‐age dosing schedule using an 8‐fold range of doses achieved C(max) and AUC that increased about 2‐fold across age groups. No effect of maturation on CL/F was observed after allometric scaling. |
format | Online Article Text |
id | pubmed-5947143 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-59471432018-05-17 Single‐Dose Pharmacokinetic Study of Diphenhydramine HCl in Children and Adolescents Gelotte, Cathy K. Zimmerman, Brenda A. Thompson, Gary A. Clin Pharmacol Drug Dev Articles Diphenhydramine pharmacokinetics were characterized following a single oral dose in children aged 2 to 17 years using a weight‐ and age‐based dosing schedule with more tiers than the current age‐based dosing schedule recommended by the nonprescription drug monograph. This study was conducted in 42 subjects, aged 2 to 17 years. Doses were based on a weight‐age dosing schedule, ranging from 6.25 to 50 mg. An oral dose was administered with water about 2 hours after a light breakfast. Plasma samples were obtained up to 48 hours after dosing and analyzed for diphenhydramine. Pharmacokinetic parameters were estimated using noncompartmental methods, and the relationship of oral clearance with age was assessed using linear regression. Over an 8‐fold range of doses, C(max) and AUC increased ∼90 % to ∼140% across age groups, with a similar T(max) (1.5 hours). Oral CL/F increased with age, but after allometric scaling, no maturation‐related change in CL/F was apparent. Mild somnolence was the most commonly reported adverse event (95% of the subjects). A weight‐age dosing schedule using an 8‐fold range of doses achieved C(max) and AUC that increased about 2‐fold across age groups. No effect of maturation on CL/F was observed after allometric scaling. John Wiley and Sons Inc. 2017-10-02 2018-05 /pmc/articles/PMC5947143/ /pubmed/28967696 http://dx.doi.org/10.1002/cpdd.391 Text en © 2017 The Authors. Clinical Pharmacology in Drug Development Published by Wiley Periodicals, Inc. on behalf of The American College of Clinical Pharmacology This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
spellingShingle | Articles Gelotte, Cathy K. Zimmerman, Brenda A. Thompson, Gary A. Single‐Dose Pharmacokinetic Study of Diphenhydramine HCl in Children and Adolescents |
title | Single‐Dose Pharmacokinetic Study of Diphenhydramine HCl in Children and Adolescents |
title_full | Single‐Dose Pharmacokinetic Study of Diphenhydramine HCl in Children and Adolescents |
title_fullStr | Single‐Dose Pharmacokinetic Study of Diphenhydramine HCl in Children and Adolescents |
title_full_unstemmed | Single‐Dose Pharmacokinetic Study of Diphenhydramine HCl in Children and Adolescents |
title_short | Single‐Dose Pharmacokinetic Study of Diphenhydramine HCl in Children and Adolescents |
title_sort | single‐dose pharmacokinetic study of diphenhydramine hcl in children and adolescents |
topic | Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5947143/ https://www.ncbi.nlm.nih.gov/pubmed/28967696 http://dx.doi.org/10.1002/cpdd.391 |
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