Paracetamol, widely used hardly understood

Abstract

Paracetamol (APAP), in the USA known as acetaminophen, is widely used both in hospital settings and at home for antipyresis and mild (postoperative) pain. Although APAP is available over the counter and is ranked on the third place, following nystatin and cisapride, when looking at the most commonly prescribed drugs in our Pediatric Surgical Intensive Care Unit (PSICU), it is surprising that there are still little data available concerning the pharmacokinetics (i.e. absorption, distribution, metabolism and elimination) and pharmacodynamics (i.e. effects) of APAP in children. Off label prescription of APAP is common, since prescription is often outside the terms of the product license with regards to the age of the patient, the indication and the dose and frequency of administration. Product license does not account for children < 3 months of age and prolonged use in children < 4 years of age for more than 2 days is advised against, since studies investigating the effects of prolonged use in children are lacking. Although APAP is considered as a safe drug, when administered within the therapeutic dosing range, concern exists about the maximum daily doses and the prolonged use of APAP, as overdoses of APAP (> 150 mg/kg in children2) might be associated with severe toxic effects, i.e. liver necrosis, which might lead to death if not treated adequately or in time with acetylcysteine.