Source: Marketing Authorisation Holder Revision Year: 2023 Publisher: Oethmaan Biosims (Pty) Ltd, 207A Sherwood House, Greenacres Office Park, c/o Victory and Rustenberg Roads, Victory Park, Johannesburg, 2195
Pharmacological classification: A 2.7 Antipyretics or antipyretic and anti-inflammatory analgesics
ATC Code: N02BE01
Paracetamol has analgesic and antipyretic activity.
Paracetamol is readily absorbed from the gastrointestinal tract, with peak plasma concentrations occurring approximately 10-60 minutes after oral doses.
Paracetamol is distributed into most body tissues. It crosses the placenta and is present in breast milk.
Paracetamol is mainly metabolised in the liver, following two major hepatic pathways: glucuronic acid conjugation and sulphuric acid conjugation.
The metabolites of paracetamol are mainly excreted in the urine. Less than 5% is excreted as unchanged paracetamol. The elimination half-life of paracetamol varies from about 1-3 hours.
Conventional studies using the currently accepted standards for the evaluation of toxicity to reproduction and development are not available.
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