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.

About naloxone in opioid overdose

Opioid-related overdose deaths represent a significant public health issue worldwide, rising in recent years. In Europe, the majority of drug-related deaths feature opioid drugs like heroin, as well as other opioids like morphine, methadone, buprenorphine, fentanyl and tramadol.[2]

Prenoxad Injection in a pre-filled syringe contains 2ml naloxone hydrochloride 1mg/ml. Naloxone is a competitive antagonist of μ, δ and κ-opioid receptors, and is most potent at the μ-receptor. Naloxone, given on its own, produces very little effect. However, if it is given in higher doses it rapidly reverses the effect of morphine and other opioids, including pentazocine and nalorphine.[1] Therefore, it may be used as an antagonist drug to reverse opioid and opioid-related overdose.[2]

Following overdose by heroin injection, death occurs within 1 to 3 hours, limiting the window of opportunity to intervene.[3] Furthermore, most drug overdose deaths occur in the company of others,[3] with up to one in five overdoses being witnessed by others.[4,5] Naloxone is well established in reversing opioid or opioid-related overdoses 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.[6]

In 2005, naloxone was made available under UK law to be administered by anyone for the purpose of saving life in an emergency.[7]

Prenoxad Injection is the first presentation of naloxone to be licensed in the UK 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. 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 how to supply Prenoxad Injection, as well as how Prenoxad Injection should be used.

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. European Drug Report Trends and Developments. June 2019. VIEW
  3. Sporer, KA and Kral, AH. Prescription naloxone: a novel approach to heroin overdose prevention. Ann Emerg Med 2007;49(2):172-177. VIEW
  4. 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. 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. 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. VIEW
  7. Advisory Council on the Misuse of Drugs. Considerations of naloxone. May 2012. 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