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Prescribing information for Prenoxad 1mg/ml Injection Always read the label. Models are for illustrative purposes only. Date of preparation: October 2016
Please refer to the Summary of Product Characteristics (SPC) 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 (diacetylmorphine (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 is for administration by intramuscular injection. 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 administered as a part of a resuscitation intervention in suspected overdose casualties, where opioid drugs may be involved or suspected. It may need to be used in a non-medical setting. Always call an ambulance. Adults and the Elderly: Opioid overdosage (known or suspected). Use by individuals in the community. 400 micrograms or 0.4ml of Prenoxad Injection solution by intramuscular injection into the outer thigh or muscles of the upper arm as part of the resuscitation intervention. The dose of 0.4ml can be repeated every 2-3 minutes in subsequent resuscitation cycles until an ambulance arrives or the patient begins breathing normally / regains consciousness. Children: The Prenoxad Injection presentation is not intended to be used for children in the home setting other than by an appropriately trained healthcare professional. Neonatal Use: Naloxone should only be used in Neonates under medical supervision. 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. Prenoxad Injection is not effective against respiratory depression caused by non-opioid drugs. Reversal of buprenorphine-induced respiratory depression may be incomplete. If an incomplete response occurs, respiration should be mechanically assisted. Abrupt postoperative reversal of opioid depression may result in
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nausea, vomiting, sweating, tremulousness, tachycardia, increased blood pressure, seizures, ventricular tachycardia and fibrillation, pulmonary oedema and cardiac arrest which may result in death. Use with caution in patients with pre-existing cardiac 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 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 respiratory rate and signs of opioid withdrawal. Naloxone may be administered during the second stage of labour to correct any respiratory depression due to opioid analgesics. It is not known if Naloxone affects the duration of labour and/or delivery. It is not known whether Naloxone is excreted in human milk therefore use with caution in breastfeeding mothers. Effects on ability to drive and use machines: Not Applicable. Undesirable Effects: Common side effects include nausea, vomiting, dizziness, headache, ventricular tachycardia, hypotension and hypertension and postoperative pain. Less common side effects: Tremor, sweating, arrhythmia, bradycardia, diarrhoea, dry mouth, hyperventilation, inflammation. Seizure tension, allergic reactions, anaphylactic shock, fibrillation, cardiac arrest, erythema multiforme, fever, dyspnoea, runny nose, sneezing, yawning, piloerection, weakness, shivering. Consult SPC for further information. Product Licence Number: PL 12064/0125 Product Licence Holder: Aurum Pharmaceuticals Ltd, Bampton Road, Harold Hill, Romford, Essex RM3 8UG. Basic NHS Price: £15.30 Legal Category: POM. Further information: Martindale Pharma, Bampton Road, Romford, RM3 8UG. Tel: 01277 266600. Date of Preparation: January 2016.
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
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