Safety of paracetamol and paracetamol-containing preparations
Safety of paracetamol and paracetamol-containing preparations
Paracetamol (acetaminophen) – one of the most popular drugs from the group of non-steroidal anti-inflammatory drugs (NSAIDs) for symptomatic treatment of SARS and influenza. Until recently, paracetamol is considered safe drugs, their small number and a rare incidence of adverse reactions.
In recent years, data on the hepatotoxic effect of paracetamol when it is moderate overdose of paracetamol in the appointment of a high therapeutic doses, and the simultaneous admission of inducers of liver microsomal enzyme system, P-450 (antihistamines, glucocorticoids, phenobarbital, ethacrynic acid), as well as in alcoholics [1 ]. Even when receiving therapeutic doses (2,5-4 g / day), acetaminophen can cause serious liver damage in alcoholics, as well as by persons regularly consume alcohol (for men – a daily intake of over 700 ml to 200 ml of beer or wine for women – dose 2 times less), especially if paracetamol occurred within a short period of time after drinking alcohol [2]. With chronic administration of paracetamol more than 1 tablet per day (1000 or more pills for life) doubles the risk of developing severe analgesic nephropathy, leading to terminal renal insufficiency [3].
After the accident, poisoning by paracetamol in Ireland had introduced new rules for its sale. Leave with a prescription drug made in the case of the appointment of more than 50 tablets, pharmacies allowed OTC sales package containing not more than 24 tablets of paracetamol, other institutions may not sell more than 12 tablets of 500 mg or equivalent dose of paracetamol in combined preparations used for catarrhal diseases. All acetaminophen-containing products sold in Ireland, should contain the following label: “Contains paracetamol, as well as warnings -” Do not take other paracetamol-containing products “,” In case of overdose seek immediate medical help, even if you feel normal, due to the high risk of irreversible liver damage. Please read carefully the instructions on the application “[4]. Less stringent rules imposed sale of paracetamol in the UK, where a prescription is required only if you buy more than 100 tablets [5].
In Russia, paracetamol before the end of 1998 was resolved as a prescription drug in a daily dose of 2 g, whereas in many European countries and the United States paracetamol was used as OTC drugs in a daily dose for adults 4 g [6]. In September 1998, Moscow hosted an international symposium, “The efficacy and safety of paracetamol, in which it was decided to apply to the State Pharmacological Committee (PGA) to consider changing the OTC daily dose of paracetamol in the direction of its increase to 4, the Special Commission PGA of Toxicology, Pediatric Gastroenterology and consider the use of paracetamol as a prescription drug. Based on the findings of the commissions recommended the PGA in the instructions on paracetamol-containing products following additions:
a) The maximum dose of paracetamol for a non-prescription medicines in children – 10-15 mg / kg every 8 hours, taking as a febrifuge no more than 3 days, as a painkiller – not more than 5 days;
b) The maximum daily dose of paracetamol for prescription medicines in adults 4 g;
c) All known contraindications and warnings for paracetamol;
g) “abusers of alcohol before taking this medication should consult a doctor. Paracetamol may have a damaging effect on the liver “[7].
It should be borne in mind that acetaminophen is contained not only in the preparations of the same name or business analogs, but also part of the combined drugs. Therefore always necessary to consider the dose of paracetamol in the appointment of combined paracetamol-containing preparations to avoid overdose.
