Carrier solvents in pharmaceuticals should be excipient. Ethanol in liquid preparations intended for children is an industry decision but it is a metabolically active substrate, sometimes found in subtherapeutic or subtoxic doses. Worst offenders in this respect are prescription drugs for long-term treatment which inevitably subject patients to chronic passive exposure. 103 such preparations were identified from the Italian pharmacopoeia with more than 20mg/dL ethanol. OTCs and homeopathic remedies were also found to contain large amounts (up to 60% vol.) of ethanol with even less clinical need or benefit. Domestic sources other than medicinals were found to account for neglegible amounts (>2mg/dL). Hepatic and extrahepatic enzyme route switching, hepatic blood flow and plasma clearance are all age-dependent and the growth process itself is increasingly thought to impact on drug pharmacokinesis. The implications for paediatric prescribers are that trademarks for the same active ingredient should be differentially assessed against expected length of treatment and ethanol amounts, preferring non- alcoholic alternatives whenever possible. Yet the medical literature has paradoxically ignored the need for a toxicological re-assessment of ethanol in children medications and acceptable risk thresholds have not been determined.
- Chronic passive exposure
- Paediatric guidelines
ASJC Scopus subject areas
- Endocrinology, Diabetes and Metabolism