Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: McNeil Products Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK
Pharmacotherapeutic group: Other Analgesics and Antipyretics (Anilides)
ATC Code: N02BE01
Paracetamol has analgesic and antipyretic effects that do not differ significantly from those of aspirin. However it has only weak anti-inflammatory effects. It is only a weak inhibitor of prostaglandin biosynthesis although there is some evidence to suggest it may be more effective against enzymes in the central nervous system than in the periphery. This may in part account for its activity profile.
Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract with peak plasma concentrations occurring 0.5-2 hours after dosing. The plasma half-life is approximately 2 hours after therapeutic doses in adults but is increased in neonates to about 5 hours.
It is widely distributed through the body.
Metabolism is principally by the hepatic microsomal enzymes and urinary excretion accounts for over 90% of the dose within 1 day. Virtually no paracetamol is excreted unchanged, the bulk being conjugated with glucoronic acid (60%), sulphuric acid (35%) or cysteine (3%).
Children have less capacity for glucuronidation of the drug than adults.
Following therapeutic doses 90-100% of the drug is recovered in the urine within 24 hours.
Preclinical data reveal no special hazard for humans based on conventional studies of single and repeated dose toxicity, genotoxicity, and carcinogenicity.
Conventional studies using the currently accepted standards for the evaluation of toxicity to reproduction and development are not available.
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