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Use of amlodipine oral solution for the treatment of hypertension in children

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Abstract

Background Amlodipine is a widely used antihypertensive agent for the treatment of paediatric hypertension, but the commercially available tablets are not suitable to treat young patients, who need lower, flexible dosages and a liquid formulation. Objective To determine the pharmacokinetic properties of amlodipine and the acceptability of a standardised, extemporaneous oral solution. Method A newly developed liquid formulation of amlodipine was administered to hypertensive children between the age of 6 months and 11 years. Using a limited sampling strategy, population PK analysis was performed using nonlinear mixed effects modelling. Results Nine children, with a median age of 2.9 years (IQR 1.8–8.4), receiving stable amlodipine therapy in a median dose of 0.15 mg kg−1 day−1 (IQR 0.11–0.18), were switched to study medication. The population pharmacokinetic model was able to accurately predict the clearance of amlodipine in the study population. Based on the final model, clearance was reduced by 31.2% (RSE: 10%) in females. Patient reported outcomes on taste from a five-point hedonic scale were available for five patients, who scored the taste from positive to slightly negative. Conclusion The results from the PK study and the acceptability assessment show that the amlodipine oral solution presented in this study offers an appropriate treatment option for young children.

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Acknowledgement

The authors would like to thank Mariëtte Las, research nurse at the Radboud University Medical Center, for her contributions to this study.

Funding

This research was supported by a ZonMW Grant (Project Number 113202004) as part of the Priority Medicines Children program.

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Author notes

  1. Lidwien M. Hanff

    Present address: Department of Hospital Pharmacy, Princess Maxima Center for Pediatric Oncology, Utrecht, The Netherlands

Authors and Affiliations

  1. Department of Hospital Pharmacy, Erasmus MC-Sophia Children’s Hospital, University Medical Center Rotterdam, PO Box 2040, 3000 CA, Rotterdam, The Netherlands

    Anna C. van der Vossen, Brenda C. M. de Winter, Arnold G. Vulto & Lidwien M. Hanff

  2. Department of Pediatric Nephrology, Erasmus MC-Sophia Children’s Hospital, University Medical Center Rotterdam, Rotterdam, The Netherlands

    Karlien Cransberg

  3. Department of Pediatric Nephrology, Amalia Children’s Hospital, Radboud Institute for Molecular Life Sciences, Radboud University Medical Center, Nijmegen, The Netherlands

    Michiel F. Schreuder

  4. Division of Pediatrics, Leiden University Medical Center, Leiden, The Netherlands

    Roos W. G. van Rooij-Kouwenhoven

Authors
  1. Anna C. van der Vossen
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  2. Karlien Cransberg
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  3. Brenda C. M. de Winter
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  4. Michiel F. Schreuder
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  5. Roos W. G. van Rooij-Kouwenhoven
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  6. Arnold G. Vulto
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  7. Lidwien M. Hanff
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Corresponding author

Correspondence to Brenda C. M. de Winter.

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van der Vossen, A.C., Cransberg, K., de Winter, B.C.M. et al. Use of amlodipine oral solution for the treatment of hypertension in children. Int J Clin Pharm 42, 848–852 (2020). https://doi.org/10.1007/s11096-020-01000-9

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  • DOI: https://doi.org/10.1007/s11096-020-01000-9

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