Prescribing Information for Prenoxad 1mg/ml Injection

Please refer to Summary of Product Characteristics before prescribing.

Presentation: A 2ml pre-filled syringe containing Naloxone Hydrochloride 1mg/ml.


Indications: Prenoxad 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 (dicetylemorphine (INN)) and certain other opioids such as dextropropoxyphene and certain mixed agonist/antagonist analgesics: nalbuphine and pentazocine. 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.


Dosage and Administration: : 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. Prenoxad Injection is for administration by intramuscular injection.


Adults and the Elderly: Opioid overdosage (known or suspected). For Use by individuals in the community.
In patients where breathing does not appear to be normal.
In patients where breathing does not appear to be normal administration of Prenoxad Injection should be preceded by calling emergency services and requesting an ambulance. Following this, 30 chest compressions and if possible 2 rescue breaths (Basic Life Support SINGLE CYCLE) should be given; 0.4ml Prenoxad Injection solution should then be administered by intramuscular injection into the outer thigh muscle or muscles of the upper arm, through clothing if necessary. A further 3 cycles of chest compressions and rescue breaths should then be given followed by administration of 0.4ml Prenoxad Injection. Three cycles of chest compression and rescue breaths should take approximately 2 minutes. This should be repeated until an ambulance arrives or the patient begins breathing normally / regains consciousness. The patient when breathing normally or has regained consciousness should be placed in the recovery position (lying on their side, mouth open pointing towards the ground) and observed continuously.


In patients were breathing is normal but the patient is unrousable or suspected to be unconscious. The patient should be placed in the recovery position. 0.4ml Prenoxad Injection solution should be administered by intramuscular injection into the outer thigh muscle or muscles of the upper arm, through clothing if necessary, and an ambulance should be called. 0.4ml Prenoxad Injection solution should then be administered every 2-3 minutes and continued until the ambulance arrives and or the patient regains consciousness.


Children and Neonates: The Prenoxad Injection presentation is not intended to be used for children in the home setting other than by an appropriately trained healthcare professional.


Contra-Indications: Known hypersensitivity to Naloxone or any of the ingredients.


Warnings And Precautions: Prenoxad Injection is intended as an emergency treatment and the patient should be advised to seek medical help immediately.It should be administered cautiously to patients who have received large doses of opioids or to those physically dependent on opioids since too rapid reversal of opioid effects by Prenoxad may precipitate an acute withdrawal syndrome in such patients. Patients who have responded satisfactorily to Prenoxad should be kept under medical observation for at least 2 hours. Repeated doses of Prenoxad may be necessary since the duration of action of some opioids may exceed that of Prenoxad. Use with caution in patients with pre-existing cardiac, hepatic or renal disease and in those receiving medications with potential adverse cardiovascular effects e.g. hypotension, ventricular tachycardia or fibrillation and pulmonary oedema. Caution should be exercised and patients monitored when Prenoxad Injection is administered to this patients with renal insufficiency/failure or liver disease.


Interactions: Administer cautiously to opioid dependent patients including newborns of mother’s dependant or those suspected of having received large doses and observe for signs of acute withdrawal.


Pregnancy and Lactation:Prenoxad should be used with caution in pregnancy. The neonate must also be monitored for signs of opioid withdrawal. Naloxone may be administered during the second stage of labour to correct any respiratory depression due opioid analgesics. It is not known whether Naloxone is excreted in human milk therefore use with caution in breastfeeding mothers.


Undesirable Effects:Common side effects include nausea, vomiting, dizziness, headache, ventricular tachycardia, hypotension and hypertension. Less common side effects: Tremor, sweating, arrhythmia, bradycardia, diarrhoea, dry mouth, hyperventilation, inflammation. Seizure tension, allergic recations, anaphylactic shock, fibrillation, cardiac arrest, erythema multiforme, fever, dyspnoea, runny nose, sneezing and yawning. Piloerection, weakness, shivering.


Product Licence Number: PL 12064/0125 Product Licence Holder: Aurum Pharmaceuticals Ltd, Bampton Road, Harold Hill, Romford, Essex RM3 8UG Basic NHS Price: £18.00 Legal Category: POM. Date of Preparation: April 2013


For more details contact: Aurum Pharmaceuticals ubert Road, Brentwood, Essex CM14 4LZ 01277 266600


Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Martindale Pharma Tel. 01277 266600 Fax 01708 382739 e-mail drugsafety@martindalepharma.co.uk