Abstract
BackgroundPhenobarbital (PB) is commonly used as elixir and powder formulations in pediatric care. Its dose adjustment is performed based on individual drug concentration monitoring. Few studies have comprehensively analyzed the variation factors for serum PB concentration. In this study, we retrospectively investigated the factors that influence serum PB concentration and assessed the impacts of dosage formulation and administration route.MethodsThis retrospective cohort study covered clinical data from January 2007 to September 2019 at Mie University Hospital. The present study included 60 pediatric patients administered the elixir and powder of PB through oral route and enteral tube. Simple and multiple linear regression analyses were performed to identify the risk factors that affect the weight-corrected PB serum concentration/dose (C/D) ratio in pediatric patients. Six subgroups were also established according to the concomitant use of drugs that potentially inhibit PB metabolism, dosage formulation, and administration route to investigate the difference in the PB C/D ratio among the subgroups.ResultsA significant regression equation to predict the PB C/D ratio was found through simple and multiple linear regression analyses, with an adjusted coefficient of determination of 0.53 (p < 0.001). Further, the concomitant uses of valproic acid (VPA) or amiodarone, which were the only two drugs seen in this study as potential inhibitors of PB, was found to have the greatest effect on the PB C/D ratio (standardized partial regression coefficient (β) = 0.543, p < 0.001). Furthermore, a significant difference in the PB C/D ratio was found between the subgroups classified by the concomitant use of VPA or amiodarone (p = 0.002). However, there were no significant correlations between the PB C/D ratio, dosage formulation, and administration route.ConclusionsThe most influential factor on the PB C/D ratio was the concomitant use of VPA or amiodarone with PB. This result could provide an important perspective in pediatric drug therapy where elixir and powder formulations are administered via the oral route and enteral tube.
Highlights
Phenobarbital (PB) is commonly used as elixir and powder formulations in pediatric care
Previous investigations have demonstrated that serum PB concentration increased after the dosage formulation was switched from powder to elixir without a change in dose
Patients were excluded if their serum PB concentration was not at a steady state (n = 10), which was attained by repeated constant PB dose for more than 10 days based on the elimination half time of 2.5 days in the pediatric population [6]
Summary
Phenobarbital (PB) is commonly used as elixir and powder formulations in pediatric care. Few studies have comprehensively analyzed the variation factors for serum PB concentration. We retrospectively investigated the factors that influence serum PB concentration and assessed the impacts of dosage formulation and administration route. In 1912, phenobarbital (PB) was developed and released by Hauptmann [1] for the treatment of epileptic seizures [2, 3] It remains one of the first-line drugs for the treatment of suspected neonatal seizures [4]. Dosage formulation is often switched between elixir and powder for several reasons, such as nonadherence and easy handling of dose adjustment with growth in pediatric patients. Few studies have comprehensively analyzed the variation factors for serum PB concentration, including the dosage formulation and administration route
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