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Prescribing Information and Adverse Event Reporting

Therapeutic indication:[1]

Prenoxad Injection (naloxone hydrochloride 1mg/ml solution for injection) is intended for emergency use in the home or other non-medical setting by appropriate individuals or in a health facility setting for the complete or partial reversal of respiratory depression induced by natural and synthetic opioids, including methadone, diamorphine (diacetylmorphine [INN]) and certain other opioids such as dextropropoxyphene and certain mixed agonist/antagonist analgesics: nalbuphine and pentazocine. For this reason Prenoxad Injection should be carried by persons at risk of such events. It may also be used for the diagnosis of suspected acute opioid overdose.

Use of Naloxone in Opioid Overdose

Naloxone is a competitive antagonist of opioid receptors, that rapidly reverses the effect of morphine and other opioids.[1] Therefore, it may be used as an antagonist drug to reverse opioid overdose.[1,2]

Naloxone has been used worldwide, and for many years, to reverse opioid-induced CNS depression in the context of routine post-operative use in the hospital setting as well as in emergency settings for users of illegal opiates, when administered by physicians, ambulance crews and anaesthesiologists.[3]

Following overdose by heroin injection, death occurs within 1 to 3 hours, limiting the window of opportunity to intervene.[4] Furthermore, most drug overdose deaths occur in the company of others,[4] with up to one in five overdoses being witnessed by others.[5,6] Since the late 1990s there have been successful initiatives in many countries to provide naloxone for administration by individuals who have received instruction in how to reverse opioid overdose while waiting for an ambulance to arrive and medical attention to be provided.[4,5,7] Naloxone use in the community therefore provides an opportunity to save lives and plays a role in harm reduction strategies for opiate misusers.[8]

In 2005, naloxone was made available under UK law to be administered by anyone for the purpose of saving life in an emergency.[9]

Prenoxad Injection is the first presentation of naloxone licensed for emergency use in the home or other non-medical setting by appropriate individuals for the complete or partial reversal of respiratory depression induced by opioids. It should be carried by persons at risk of opioid overdose or their representatives.[1]

Prenoxad Injection may only be made available once the prescriber has assessed the suitability and competence of a client or representative to administer naloxone in the appropriate circumstances.[1]

On this website you will find further information on when and how Prenoxad Injection should be used and a resource to train clients or their representatives on using Prenoxad Injection.

For further details on the provision of naloxone, please view the UK Guidance on the availability of naloxone.[8]

References

  1. Prenoxad Injection. Summary of Product Characteristics. VIEW
  2. European Monitoring Centre for Drugs and Drug Addiction, Topic overviews, Take-home naloxone. Page last reviewed May 23 VIEW
  3. Wermeling, DP. Review of naloxone safety for opioid overdose: practical considerations for new technology and expanded public access. Ther Adv Drug Saf 2015;6(1):20–31. Page last reviewed May 23.VIEW
  4. Sporer, KA and Kral, AH. Prescription naloxone: a novel approach to heroin overdose prevention. Ann Emerg Med 2007;49(2):172-177. Page last reviewed May 23.VIEW
  5. Strang J, et al. Preventing opiate overdose fatalities with take-home naloxone: pre-launch study of possible impact and acceptability. Addiction 1999;94:199–204. VIEW
  6. Strang J, et al. Family carers and the prevention of heroin overdose deaths: Unmet training need and overlooked intervention opportunity of resuscitation training and supply of naloxone. Drugs: education, prevention and policy 2008;15(2):211–218. Page last reviewed May 23.VIEW
  7. Strang J, et al. Heroin overdose: the case for take home naloxone. BMJ 1996;312;(7044):1435. Page last reviewed May 23.VIEW
  8. Department of Health and Social Care, Medicines and Healthcare Products Regulatory Agency and Public Health England. Guidance: widening the availability of naloxone. Updated 18 February 2019. VIEW
  9. Advisory Council on the Misuse of Drugs. Considerations of naloxone. May 2012. Page last reviewed May 23.VIEW