Safety warnings and messages for medicines
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 nomogram (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:
A Technical Information Leaflet (173Kb)1 with weight-based dosage tables and advice on how to prepare acetylcysteine for infusion
A question and answer document (125Kb)
A model patient discharge leaflet (32Kb)1 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 - Teva (403Kb)1
Patient information leaflet - UCB (220Kb)1
Patient information leaflet - Aurum (1019Kb)1
Further information can be found in the following documents:
1 Subject to user testing
2 Please note text has been redacted where permission has not be given for data to be published by the MHRA