Ethanol in liquid preparations intended for children

• Published in: Pediatrics (Evanston) 1984-03, Vol.73 (3), p.405-407
• Main Authors: PRUITT, A. W, ANYAN, W. R. JR, NIEBYL, J, SMITH, D. L, LICATA, S. A, OAKLEY, G, SAWCHUK, S, FARCHIONE, L, BREWER, E. J, LEER, J. A, HILL, R. M, KAUFFMAN, R. E, MOFENSON, H. C, RUMACK, B. H, SINGER, H. S, SPIELBERG, S, BALLIN, J. C, FREEMAN, M. M
• Format: Article
• Language: English
• Subjects: Age Factors; Biological and medical sciences; Brain - drug effects; Child; Child, Preschool; Dose-Response Relationship, Drug; Drug Compounding; Drug Interactions; Drug Packaging; Ethanol - adverse effects; Ethanol - blood; General pharmacology; Humans; Kinetics; Medical sciences; Pharmaceutical technology. Pharmaceutical industry; Pharmacology. Drug treatments; Solvents
• ISSN: 0031-4005; 1098-4275
• DOI: 10.1542/peds.73.3.405

Ethanol is present in more than 700 pharmaceutical liquid preparations, ostensibly as an "inert" solvent on diluent.1 Despite recent voluntary efforts by several pharmaceutical companies to replace alcohol or reduce its content, there remain on the market an excessive number of liquid medications containing alcohol in concentrations ranging from 0.3% to 68%, eg, teething preparations, decongestants, and cough medicines. The presence of ethanol in children's medication is of major toxicologic interest with respect to both acute ingestion and passive exposure that occurs during therapy with ethanol-containing products. This commentary focuses upon the toxicology of ethanol in children and the determination of acceptable alcohol concentrations in children's medication. INTERACTION WITH OTHER DRUGS When taken in conjunction with other drugs, medicines containing alcohol may produce undesirable interactions. Acute ethanol administration may alter drug absorption2 or impair the degradation of other drugs.3 When taken with sedating drugs, it may result in enhanced psychomotor impairment.4,5 Chronic ethanol administration, which induces drug-metabolizing enzymes (such as P-450), may be of clinical importance by altering the clearance of several drugs (phenobarbital, phenytoin, meprobamate, and warfarin).3 Disulfiram (Antabuse) reactions, symptoms of which include flushing, tachycardia, nausea, vomiting, and, in severe forms, cardiac arrythmias, cardiovascular collapse, respiratory depression, and convulsions, may also be induced by alcohol-containing medicines. Of more direct importance to pediatricians are recent reports of disulfiram-like reactions that occur in some individuals after the simultaneous use of antibacterial drugs such as moxalactam, metronidazole, sulfonamides, chloramphenicol on cefamandole, and alcoholic beverages or medicinal elixirs.6-9 ESTABLISHING CRITERIA FOR ALCOHOL CONTENT IN CHILDREN'S MEDICATION