Retrospective population pharmacokinetics of levocetirizine in atopic children receiving cetirizine: The ETAC® studyCitation formats

  • External authors:
  • Ziad Hussein
  • Maria Pitsiu
  • Oneeb Majid
  • Marc De Longueville
  • Armel Stockis

Standard

Retrospective population pharmacokinetics of levocetirizine in atopic children receiving cetirizine: The ETAC® study. / Hussein, Ziad; Pitsiu, Maria; Majid, Oneeb; Aarons, Leon; De Longueville, Marc; Stockis, Armel.

In: British Journal of Clinical Pharmacology, Vol. 59, No. 1, 01.2005, p. 28-37.

Research output: Contribution to journalArticle

Harvard

Hussein, Z, Pitsiu, M, Majid, O, Aarons, L, De Longueville, M & Stockis, A 2005, 'Retrospective population pharmacokinetics of levocetirizine in atopic children receiving cetirizine: The ETAC® study', British Journal of Clinical Pharmacology, vol. 59, no. 1, pp. 28-37. https://doi.org/10.1111/j.1365-2125.2005.02242.x

APA

Hussein, Z., Pitsiu, M., Majid, O., Aarons, L., De Longueville, M., & Stockis, A. (2005). Retrospective population pharmacokinetics of levocetirizine in atopic children receiving cetirizine: The ETAC® study. British Journal of Clinical Pharmacology, 59(1), 28-37. https://doi.org/10.1111/j.1365-2125.2005.02242.x

Vancouver

Hussein Z, Pitsiu M, Majid O, Aarons L, De Longueville M, Stockis A. Retrospective population pharmacokinetics of levocetirizine in atopic children receiving cetirizine: The ETAC® study. British Journal of Clinical Pharmacology. 2005 Jan;59(1):28-37. https://doi.org/10.1111/j.1365-2125.2005.02242.x

Author

Hussein, Ziad ; Pitsiu, Maria ; Majid, Oneeb ; Aarons, Leon ; De Longueville, Marc ; Stockis, Armel. / Retrospective population pharmacokinetics of levocetirizine in atopic children receiving cetirizine: The ETAC® study. In: British Journal of Clinical Pharmacology. 2005 ; Vol. 59, No. 1. pp. 28-37.

Bibtex

@article{8a2f86d4e9994d9fa7b10050b8b3ceda,
title = "Retrospective population pharmacokinetics of levocetirizine in atopic children receiving cetirizine: The ETAC{\circledR} study",
abstract = "Aims: To evaluate the population pharmacokinetics of levocetirizine in young children receiving long-term treatment with cetirizine. Methods: Data were available from a randomized, double-blind, parallel group and placebo-controlled study of cetirizine in 343 young children between 12 and 24 months of age at entry, who were at high risk of developing asthma, but were not yet affected (ETAC{\circledR} study). Infants received oral drops of cetirizine at 0.25 mg kg-1 twice daily for 18 months. Plasma concentration of the active enantiomer levocetirizine was determined in blood samples collected at months 3, 12 and 18 (1-3 samples per child). A one-compartment open model was fitted to the data using nonlinear mixed effects modelling (NONMEM). The influence of weight, age, gender, BSA and other covariates on CL/F and V/F was evaluated. Results: CL/F increased linearly with weight by 0.044 | h -1 kg-1 over an intercept of 0.244 | h-1, and V/F increased linearly with weight by 0.639 | kg-1. Population estimates in children with weights of 8 and 20 kg were 0.60 and 1.13 | h -1 for CL/F, and 5.1 and 12.8 | for V/F, respectively, with interpatient variabilities of 24.4{\%} and 14.7{\%}. Weight-normalized estimates of CL/F and V/F were higher than in adults. The estimated relative bioavailability was 0.28 in 12{\%} of instances of suspected noncompliance. Levocetirizine pharmacokinetics were not influenced by severe allergy or aeroallergen sensitization. Results on the effects of concomitant medications or diseases were inconclusive due to limited positive cases. AUC55, calculated in compliant subjects using posterior estimates of the final model, was 1952 (1227-3319) μg |-1 h (mean, min-max), a value similar to that in adults after intake of 5 mg oral solution (2036 (1414-2827) μg |-1 h. Conclusions: The model suggests that administration of levocetirizine 0.125 mg kg-1 twice daily in children 12-48 months of age or weighing 8-20 kg yields the same exposure as in adults taking the recommended dose of 5 mg once daily.",
keywords = "Antihistamine, Cetirizine, ETAC, Levocetirizine, Paediatric population pharmacokinetics",
author = "Ziad Hussein and Maria Pitsiu and Oneeb Majid and Leon Aarons and {De Longueville}, Marc and Armel Stockis",
year = "2005",
month = "1",
doi = "10.1111/j.1365-2125.2005.02242.x",
language = "English",
volume = "59",
pages = "28--37",
journal = "British Journal of Clinical Pharmacology",
issn = "0306-5251",
publisher = "John Wiley & Sons Ltd",
number = "1",

}

RIS

TY - JOUR

T1 - Retrospective population pharmacokinetics of levocetirizine in atopic children receiving cetirizine: The ETAC® study

AU - Hussein, Ziad

AU - Pitsiu, Maria

AU - Majid, Oneeb

AU - Aarons, Leon

AU - De Longueville, Marc

AU - Stockis, Armel

PY - 2005/1

Y1 - 2005/1

N2 - Aims: To evaluate the population pharmacokinetics of levocetirizine in young children receiving long-term treatment with cetirizine. Methods: Data were available from a randomized, double-blind, parallel group and placebo-controlled study of cetirizine in 343 young children between 12 and 24 months of age at entry, who were at high risk of developing asthma, but were not yet affected (ETAC® study). Infants received oral drops of cetirizine at 0.25 mg kg-1 twice daily for 18 months. Plasma concentration of the active enantiomer levocetirizine was determined in blood samples collected at months 3, 12 and 18 (1-3 samples per child). A one-compartment open model was fitted to the data using nonlinear mixed effects modelling (NONMEM). The influence of weight, age, gender, BSA and other covariates on CL/F and V/F was evaluated. Results: CL/F increased linearly with weight by 0.044 | h -1 kg-1 over an intercept of 0.244 | h-1, and V/F increased linearly with weight by 0.639 | kg-1. Population estimates in children with weights of 8 and 20 kg were 0.60 and 1.13 | h -1 for CL/F, and 5.1 and 12.8 | for V/F, respectively, with interpatient variabilities of 24.4% and 14.7%. Weight-normalized estimates of CL/F and V/F were higher than in adults. The estimated relative bioavailability was 0.28 in 12% of instances of suspected noncompliance. Levocetirizine pharmacokinetics were not influenced by severe allergy or aeroallergen sensitization. Results on the effects of concomitant medications or diseases were inconclusive due to limited positive cases. AUC55, calculated in compliant subjects using posterior estimates of the final model, was 1952 (1227-3319) μg |-1 h (mean, min-max), a value similar to that in adults after intake of 5 mg oral solution (2036 (1414-2827) μg |-1 h. Conclusions: The model suggests that administration of levocetirizine 0.125 mg kg-1 twice daily in children 12-48 months of age or weighing 8-20 kg yields the same exposure as in adults taking the recommended dose of 5 mg once daily.

AB - Aims: To evaluate the population pharmacokinetics of levocetirizine in young children receiving long-term treatment with cetirizine. Methods: Data were available from a randomized, double-blind, parallel group and placebo-controlled study of cetirizine in 343 young children between 12 and 24 months of age at entry, who were at high risk of developing asthma, but were not yet affected (ETAC® study). Infants received oral drops of cetirizine at 0.25 mg kg-1 twice daily for 18 months. Plasma concentration of the active enantiomer levocetirizine was determined in blood samples collected at months 3, 12 and 18 (1-3 samples per child). A one-compartment open model was fitted to the data using nonlinear mixed effects modelling (NONMEM). The influence of weight, age, gender, BSA and other covariates on CL/F and V/F was evaluated. Results: CL/F increased linearly with weight by 0.044 | h -1 kg-1 over an intercept of 0.244 | h-1, and V/F increased linearly with weight by 0.639 | kg-1. Population estimates in children with weights of 8 and 20 kg were 0.60 and 1.13 | h -1 for CL/F, and 5.1 and 12.8 | for V/F, respectively, with interpatient variabilities of 24.4% and 14.7%. Weight-normalized estimates of CL/F and V/F were higher than in adults. The estimated relative bioavailability was 0.28 in 12% of instances of suspected noncompliance. Levocetirizine pharmacokinetics were not influenced by severe allergy or aeroallergen sensitization. Results on the effects of concomitant medications or diseases were inconclusive due to limited positive cases. AUC55, calculated in compliant subjects using posterior estimates of the final model, was 1952 (1227-3319) μg |-1 h (mean, min-max), a value similar to that in adults after intake of 5 mg oral solution (2036 (1414-2827) μg |-1 h. Conclusions: The model suggests that administration of levocetirizine 0.125 mg kg-1 twice daily in children 12-48 months of age or weighing 8-20 kg yields the same exposure as in adults taking the recommended dose of 5 mg once daily.

KW - Antihistamine

KW - Cetirizine

KW - ETAC

KW - Levocetirizine

KW - Paediatric population pharmacokinetics

U2 - 10.1111/j.1365-2125.2005.02242.x

DO - 10.1111/j.1365-2125.2005.02242.x

M3 - Article

VL - 59

SP - 28

EP - 37

JO - British Journal of Clinical Pharmacology

JF - British Journal of Clinical Pharmacology

SN - 0306-5251

IS - 1

ER -