PRENOXAD Solution for injection/infusion Ref.[27751] Active ingredients: Naloxone

Posology

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. Therefore, the prescriber should take appropriate steps to ensure that the patient thoroughly understands the indications and use of Prenoxad Injection. The prescriber should review with the patient or any other person who might be in a position to administer Prenoxad Injection to a patient experiencing a suspected opioid overdose event.

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

Patient should be placed in the recovery position (lying on their side, mouth open pointing towards the ground). 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. The patient should be continuously observed but particularly their breathing. If there is a decrease in breathing it is important that 0.4ml Prenoxad Injection solution is given every 2-3 minutes.

Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration whenever solution and container permit.

Adults

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 the contents of a syringe are used up.

N.B. The duration of action of certain opioids can outlast that of an IV bolus of Naloxone, e.g. dextropropoxyphene, dihydrocodeine and methadone. In situations where one of these opioids is known or suspected it is recommended that an infusion of Naloxone be used to produce sustained antagonism to the opioid without repeated injection.

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. In the event of a child being given or taking an opioid inappropriately an ambulance should be called and resuscitation started if required.

Neonatal Use

Naloxone should only be used in Neonates under medical supervision.

Elderly

Use as for adults.

Method of administration

Prenoxad Injection is for administration by intramuscular injection.

There is limited clinical experience with Naloxone overdosage in humans.

Adult Patients

In one study, volunteers and morphine-dependent subjects who received a single subcutaneous dose of 24mg/70kg did not demonstrate toxicity.

In another study, 36 patients with acute stroke received a loading dose of 4mg/kg (10mg/m²/min) of Naloxone followed immediately by 2mg/kg/hr for 24 hours. There were a few reports of serious adverse events: seizures (2 patients), severe hypertension (1) and hypotension and/or bradycardia (3).

At doses of 2 mg/kg in normal subjects, memory impairment has been reported.

Paediatric Patients

Up to 11 doses of 0.2mg of naloxone (2.2mg) have been administered to children following overdose of diphenoxylate hydrochloride with atropine sulphate. Paediatric reports include a 2½ year old child who inadvertently received a dose of 20mg of naloxone and a 4½ year old child who received 11 doses during a 12-hour period, both of whom had no adverse sequelae.

Patient Management

Patients who experience a Prenoxad Injection overdose should be treated symptomatically in a closely-supervised environment. Physicians should contact a poison control centre for the most up-to-date patient management information.

3 years.

This medicinal product does not require any special temperature storage conditions.

Keep the syringe in the plastic box in order to protect from light.

Store in the original container.

Sterile solution for injection presented in a Glass (Type I) 2ml prefilled syringe. The pack contains two 23G x 1¼" needles.

Discard any unused solution immediately after use. Any unused product or waste material (including needles) should be disposed of in accordance with local requirements.