This is an Ethypharm UK only website EN

Prescribing Information and Adverse Event Reporting

ONLY for
Healthcare Professionals
or a person authorised
to supply Naloxone

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Martindale Pharma, an Ethypharm Group Company. Tel: 01277 266 600. e-mail: drugsafety.uk@ethypharm.com

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, 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

Drug overdose continues to be the main cause of death among problem drug users. Heroin or other opioids — often consumed alongside other central nervous system depressants such as benzodiazepines and alcohol — are present in the majority of reported fatal overdoses. Overdose is common among opioid users: many of them have experienced a non-fatal overdose and most have witnessed one. Death from opioid overdose is caused primarily by respiratory depression leading to cardiac arrest [2].

Opioid overdose deaths can be prevented through timely administration of naloxone, a potent opioid antagonist drug that rapidly reverses the effects of opioid analgesics by binding to the opioid receptors in the central nervous system. Because of its effectiveness, naloxone is used by emergency personnel worldwide.[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 effects 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, UK regulations added naloxone to the list of specified medicines in respect of which parenteral administration is permitted 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.[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, Topic overviews, Take-home naloxone. Page last updated 2020. Page last reviewed Oct 23VIEW
  3. Sporer, KA and Kral, AH. Prescription naloxone: a novel approach to heroin overdose prevention. Ann Emerg Med 2007;49(2):172-177. Page last updated May 2006. Page last reviewed Oct 23.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 2009;15(2):211–218. Page last reviewed Oct 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. Page last reviewed Oct 23.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. Page last reviewed Oct 23.VIEW
  7. Advisory Council on the Misuse of Drugs. Considerations of naloxone. May 2012. Page last reviewed Oct 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. Page last reviewed Oct 23.VIEW