Omeprazole Disposition in Children following Single‐Dose Administration

Abstract

(1) in children ages 2 to 16 years receiving 10 or 20 mg of omeprazole as a single oral dose, the PK are quite comparable to values reported for adults, and (2) in pediatric patients who are CYP2C19 extensive metabolizers, there was no association between genotype and the pharmacokinetics of omeprazole.

Impact of the CYP2C19*17 Allele on the Pharmacokinetics of Omeprazole and Pantoprazole in Children: Evidence for a Differential Effect

“…The current investigation was enabled by a reassessment of data and samples available from previous pharmacokinetic studies of omeprazole (Kearns et al, 2003b) and pantoprazole (Kearns et al, 2008) conducted in pediatric populations for the purpose of product labeling. The Institutional Review Boards at participating institutions approved both investigations, and subjects were enrolled by parental permission and patient assent, as appropriate.…”

“…The approvals contained provisions for data reanalysis and expanded genotype analysis of stored DNA specimens. Study designs, complete methods, and results were previously described in detail (Kearns et al, 2003b(Kearns et al, , 2008, and therefore only pertinent information is recapitulated in this brief communication.…”

“…The approvals contained provisions for data reanalysis and expanded genotype analysis of stored DNA specimens. Study designs, complete methods, and results were previously described in detail (Kearns et al, 2003b(Kearns et al, , 2008, and therefore only pertinent information is recapitulated in this brief communication.The omeprazole study comprised 37 subjects, 23 of whom yielded evaluable pharmacokinetic data (Kearns et al, 2003b); these subjects were further investigated for CYP2C19*17. Ten or 20 mg of omeprazole was administered as a single solid oral dose to subjects aged 9.5 Ϯ 3.8 years (mean Ϯ S.D.…”

Pharmacokinetics of two formulations of omeprazole administered through a gastrostomy tube in patients with severe neurodevelopmental problems

“…Considerable interindividual variability, particularly in area under the plasma concentration-time curve (AUC) data, has been described before for both intravenous and oral administration of omeprazole in children [6,7] and adults [8,9]. This high variability can be largely attributed to genetic polymorphism of the cytochrome P450 (CYP) isoform CYP2C19 [4,10].…”

In vitro evaluation of natural and methylated cyclodextrins as buccal permeation enhancing system for omeprazole delivery

“…Omeprazole (OME) a substituted benzimidazole, has been shown to effectively suppress gastric acid secretion by inhibiting the H + K + -ATPase (proton pump), in the parietal cells [16,17]. The bioavailability of OME following oral administration is usually very low, since it degrades quickly in the acidic environment of the stomach and undergoes hepatic first-pass metabolism.…”