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Paracetamol overdose: Simplification of the use of intravenous acetylcysteine

Safety warnings and messages for medicines

3 September 2012

The Commission on Human Medicines (CHM) has reviewed the use of acetylcysteine for the treatment of acute paracetamol overdose and made the following recommendations

  • The licensed indication for acetylcysteine is now:
    - Paracetamol overdose irrespective of the plasma paracetamol level in circumstances where the overdose is staggered or there is doubt over the time of paracetamol ingestion; or
    - Paracetamol overdose with a timed plasma paracetamol concentration on or above a single treatment line joining points of 100 mg/L at 4 hours and 15 mg/L at 15 hours nomogramPDF file (opens in new window) (35Kb), regardless of risk factors of hepatotoxicity.
  • An increase in the duration of administration of the first dose of intravenous acetylcysteine from 15 minutes to one hour.
  • Removal of hypersensitivity as a contraindication to treatment with acetylcysteine.
  • The provision of weight-based acetylcysteine dosing tables for adults and children.
  • Provision of a Technical Information Leaflet (TIL) for healthcare professionals in every pack of acetylcysteine, which gives more detailed instructions on the preparation of acetylcysteine infusions for administration.

The following resources are available for healthcare professionals:

Direct Healthcare Professional CommunicationPDF file (opens in new window) (542Kb)

A Technical Information LeafletPDF file (opens in new window) (175Kb) with weight-based dosage tables and advice on how to prepare acetylcysteine for infusion

A question and answer documentPDF file (opens in new window) (125Kb)

A model patient discharge leaflet Word file (opens in new window) (32Kb) to provide to patients who have taken a paracetamol overdose but are not treated with acetylcysteine. This can be amended with a local contact number.

Patient information leaflet - TevaPDF file (opens in new window) (403Kb)

Patient information leaflet - UCBPDF file (opens in new window) (220Kb)

Patient information leaflet - AurumPDF file (opens in new window) (1019Kb)

Further information can be found in the following documents:

Paracetamol overdose: public and patient summaryPDF file (opens in new window) (16Kb)

Benefit Risk Profile of Acetylcysteine in the Management of Paracetamol OverdosePDF file (opens in new window) (2161Kb)1

Acetylcysteine summary of product characteristicsPDF file (opens in new window) (224Kb)

1 Please note text has been redacted where permission has not be given for data to be published by the MHRA

Page last modified: 21 October 2013