Ethanol Content of Medications and Its Effect on Blood Alcohol Concentration in Pediatric Patients

Abstract

OBJECTIVE Ethanol is a common excipient used in liquid medications to enhance solubility and inhibit bacterial growth. While the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have released guidance for how much ethanol is acceptable in medicines, many medications contain more than the recommended amount. The objective of this study was to determine what effect these medications would have on blood alcohol concentration (BAC) for pediatric patients, defined as those medications that would increase the BAC by ≥2.5 mg/dL. METHODS A list of medications dispensed to pediatric patients from a single hospital over a period of 4 months was obtained. The package inserts of these medications were reviewed to determine ethanol content. Typical doses were used to determine the amount of ethanol pediatric patients weighing 10, 20, and 40 kg would receive. The theoretical BAC was then calculated for each medication containing ethanol. RESULTS Seven hundred ninety-six medications were dispensed for pediatric patients during the study period, of which 33 contained ethanol. Seven medications would be projected to increase the BAC above 2.5 mg/dL with a normal pediatric dose. CONCLUSION While most medications do not contain ethanol, we found 7 that contained enough ethanol to potentially raise the BAC above 2.5 mg/dL. Health care practitioners should consider the ethanol content of medications prior to recommending them in children and when assessing overdoses. ABBREVIATIONS BAC, blood alcohol concentration; CYP, cytochrome P450; EMA, European Medicines Agency; FDA, US Food and Drug Administration; IV, intravenous; KIDs List, Key Potentially Inappropriate Drugs in Pediatrics List; NDC, National Drug Code; PI, package insert; Vd, volume of distribution.