Consumer medicine information

Nyxoid

Naloxone

BRAND INFORMATION

Brand name

Nyxoid

Active ingredient

Naloxone

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Nyxoid.

What is in this leaflet

This leaflet answers some common questions about NYXOID nasal spray. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor or pharmacist has weighed the risks of you being given NYXOID against the benefits they expect it will have for you.

If you have any concerns about being given this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What NYXOID is used for

This medicine contains the active substance naloxone. Naloxone belongs to a group of medicines that cause temporary reversal of the effects of opioids such as methadone or heroin.

Nyxoid is a nasal spray used as part of the emergency treatment of opioid overdose or possible opioid overdose.

Signs of overdose include:

  • breathing problems,
  • severe sleepiness
  • not responding to a loud noise or touch.

If you are at risk of an opioid overdose you should always carry your NYXOID with you. It is designed as an emergency rescue treatment only; you must get emergency medical attention as soon as possible after its use.

Ask your doctor or pharmacist if you have any questions about this medicine.

This medicine is available from your pharmacy.

This medicine is not addictive.

Before you are given NYXOID

When you must not be given NYXOID nasal spray

You should not be given NYXOID nasal spray if you have an allergy to:

  • any medicine containing naloxone
  • any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include;

  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin.

You should not be given this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should be given this medicine, talk to your doctor or pharmacist.

Before you are given NYXOID nasal spray

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

  • heart disease
  • lung disease
  • kidney disease
  • liver disease
  • drug addiction (including an addiction to alcohol)

Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding. Your doctor can discuss with you the risks and benefits involved.

If you have received NYXOID close to giving birth or during labour, tell your midwife or doctor. Your baby could suffer from sudden opioid withdrawal syndrome, which could be life-threatening if not treated.

If you have not told your doctor about any of the above, tell them before you are given NYXOID.

NYXOID will only be made available after you or your carer have been instructed how to use it.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket, health food shop, naturopath or herbalist.

These include but are not limited to:

  • pain killers
  • cough and cold remedies
  • alcohol
  • heart or blood pressure medications.

Alcohol will not stop NYXOID from working. However, if alcohol has been taken in addition to opioids there may be a delay in the action of naloxone. The nasal spray can be used at any time that it is needed.

If you take opioids to control chronic pain, you may experience pain when you receive NYXOID.

Talk to your doctor before being given NYXOID if you are physically dependent on opioids or if you have received high doses of opioids (for example methadone or heroin). You may get strong withdrawal symptoms if the effects of this medicine occur too quickly.

Talk to your doctor if you use buprenorphine. NYXOID may not fully reverse breathing problems.

These medicines may be affected by NYXOID nasal spray or may affect how well NYXOID nasal spray works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor or pharmacist will have more information on medicines to be careful with or avoid while taking this medicine.

How NYXOID nasal spray is given

Follow all directions given by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

If you or your carer do not understand the instructions on the leaflet, ask your doctor or pharmacist for help.

It is likely that you will be given this medicine by your carer who is trained to do so.

Your carer must call for emergency help immediately before administering the first NYXOID dose.

NYXOID is to be given right away following a suspected overdose and does not take the place of emergency medical care.

Signs of an opioid overdose include breathing problems, severe sleepiness or not being able to respond to a loud noise or touch.

How much NYXOID nasal spray to give

One spray of NYXOID is given into one nostril.

Each Nyxoid nasal spray contains one single dose of naloxone and cannot be reused.

The signs and symptoms of an opioid overdose can return after this nasal spray is given. If this happens, or there is no response to treatment, another dose after 2 to 3 minutes using a new nasal spray may be administered.

How NYXOID nasal spray is given

  1. Call for an ambulance before giving Nyxoid.

  1. Lay the patient on their back. Support the back of the neck and allow the head to tilt back.
  2. It’s best to check that the nose is clear before giving Nyxoid. Should the nose be blocked, a tissue, or piece of material may be used to clear the obstruction before giving Nyxoid.

Peel off the back of the blister from the corner to remove the device from the container.

Hold the nasal spray with your thumb on the bottom of the plunger and your first and middle fingers on either side of the nozzle. Do not prime or test the device before you give it.

Gently insert the device nozzle in one nostril of the patient. Press firmly on the plunger until it clicks to give the dose. Remove the nozzle from the nostril after giving the dose. Each Nyxoid nasal spray contains one single dose of naloxone and cannot be reused.

  1. Place the patient into the recovery position on their side with mouth open pointing towards the ground and stay with them until the emergency services arrive. Watch for an improvement in the patient’s breathing level, alertness and response to noise and touch.

  1. If the patient is no better within 2 - 3 minutes, a second dose can be given. Repeat steps 3-4 in the other nostril using a new Nyxoid nasal spray. However, the patient need not be moved from the recovery position to administer additional doses of Nyxoid, Once the patient is breathing normally, do not administer further does of Nyxoid.
  2. Further doses may be given every 2 -3 minutes, if needed, until the emergency services arrive.

In patients who are unconscious and not breathing normally additional life-saving support can be given if possible, e.g. CPR if you are trained to do so.

If you take too much (overdose)

NYXOID is designed as an emergency rescue treatment only, and you should still get medical attention as soon as possible after its use.

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much NYXOID nasal spray. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Symptoms of a NYXOID overdose are called 'withdrawal symptoms' which may include:

  • restlessness or irritability
  • change in mood
  • increased skin sensitivity or goosebumps
  • vomiting, nausea, stomach or muscle cramps
  • sleeping difficulty, anxiety
  • sweating, fast heartbeat, high blood pressure, yawning or fever.

While you are being given NYXOID nasal spray

Things you must do

If you are about to be started on any new medicine, advise your doctor and pharmacist that you have been given NYXOID nasal spray.

Tell any other doctors, dentists, who treat you that you have been given NYXOID nasal spray.

If you are going to have surgery, tell the surgeon or anaesthetist that you have been given NYXOID nasal spray. It may affect other medicines used during surgery.

If you become pregnant while being given NYXOID nasal spray medicine, tell your doctor immediately.

If you are about to have any blood tests, tell your doctor that you have been given this medicine. It may interfere with the results of some tests.

Things you must not do

Do not drive or operate machinery after you have been given NYXOID nasal spray for at least 24 hours (1 day), since the effects of opioids may recur.

Do not use this medicine after the expiry date which is stated on the carton, blister pack and the label after EXP. The expiry date refers to the last day of that month.

Things to be careful of

If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly. Standing up slowly, especially when you get up from a bed or a chair, will help your body get used to the change in position and blood pressure. If this problem continues or gets worse, talk to your doctor.

Sudden opioid withdrawal syndrome may be life-threatening if not treated properly in children. They should be monitored for at least 24 hours for the signs and symptoms of withdrawal syndrome which include: seizures, crying more than usual and increased reflexes.

Side effects

Tell your doctor, or nurse as soon as possible if you do not feel well after being given NYXOID nasal spray.

This medicine helps most people reverse a life threatening opioid overdose, but it may have unwanted side effects in a few people.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor or nurse to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • dizziness
  • headache
  • nausea and vomiting
  • high blood pressure, low blood pressure

The above list includes the more common side effects of your medicine.

Tell your doctor as soon as possible if you notice any of the following:

  • sweating
  • tremor
  • increased heart rate
  • nervousness or restlessness
  • irritability or restlessness
  • violent behaviour or agitation

The above list includes serious side effects that may require medical attention.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

  • shortness of breath
  • life-threatening irregular heartbeat or heart attack
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • build up of fluid in the lungs
  • rash, redness, swelling, severe flaking or peeling, itching or hives on the skin.

The above list includes very serious side effects. You may need urgent medical attention or further hospitalisation.

Tell your doctor or healthcare professional if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people.

After being given NYXOID

Storage

Keep your unused NYXOID devices in the pack.

Keep NYXOID in a cool dry place where the temperature stays below 30°C.

Do not store NYXOID or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

This medicine is provided in a pre filled nasal spray device and contains naloxone in 0.1 ml of a clear, colourless to pale yellow solution.

NYXOID is packed in a box containing 2 nasal sprays individually sealed in blisters. Each nasal spray contains one single dose of naloxone.

Ingredients

NYXOID contains 1.8 mg of naloxone (as naloxone hydrochloride dihydrate) as the active ingredient.

The other ingredients are:

  • sodium citrate dihydrate
  • sodium chloride
  • hydrochloric acid
  • sodium hydroxide
  • purified water

This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo dye.

Sponsor

NYXOID is sponsored in Australia by:

Mundipharma Pty Limited
ABN 87 081 322 509
88 Phillip Street
SYDNEY NSW 2000

This leaflet was prepared in September 2018

NYXOID nasal spray: AUST R 309381

® NYXOID is a trade mark of MUNDIPHARMA

RA-0205

Published by MIMS September 2019

BRAND INFORMATION

Brand name

Nyxoid

Active ingredient

Naloxone

Schedule

S3

 

Name of the medicine

Naloxone hydrochloride dihydrate nasal spray.

Description

Naloxone hydrochloride is an off-white powder soluble in water. The chemical name is 17-allyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride dihydrate (CAS No: 51481-60-8). It is a synthetic congener of oxymorphone, with molecular formula C19H21NO4.HCl.2H2O and molecular weight 399.87. The pKa is 7.9 and the Partition Coefficient Log P is 1.5.
Nyxoid nasal spray is a clear, colourless to pale yellow solution in glass vials in a single dose nasal spray device. Each dose of 100 microliter contains 1.8 mg naloxone (as hydrochloride dihydrate). The solution also contains sodium citrate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide and purified water.

Pharmacology

Pharmacotherapeutic group: Antidotes, ATC code: V03AB15.

Mechanism of action and pharmacodynamic effects.

Naloxone, a semisynthetic morphine derivative (N-allyl-nor-oxymorphone), is a specific opioid antagonist that acts competitively at opioid receptors. It reveals very high affinity for the opioid receptor sites and therefore displaces both opioid agonists and partial antagonists. Naloxone does not possess the "agonistic" or morphine-like properties characteristic of other opioid antagonists. In the absence of opioids or agonistic effects of other opioid antagonists, it exhibits essentially no pharmacologic activity. Naloxone has not been shown to produce tolerance or cause physical or mental dependence. In the presence of physical dependence on opioids Nyxoid may produce withdrawal symptoms.
The fastest onset of action (apparent within 2 minutes) is provided by intravenous administration. Administration via subcutaneous (SC) and intramuscular route result in a slightly slower onset of action, although it was found that for SC administration, the slower onset of action was offset by not having to gain intravenous access first.
As the duration of action of some opioid agonists may be longer than that of naloxone, the effects of the opioid agonist may return as the effects of naloxone disappear. This may necessitate repeat doses of naloxone - though the need for repeat naloxone doses is dependent on the quantity, type and route of administration of the opioid agonist that is being treated.
A study demonstrated mean absolute bioavailability of 47% and mean half-lives of 1.4 h from the intranasal (IN) doses of 2 mg.

Absorption.

Intranasal administration of naloxone has demonstrated naloxone to be rapidly absorbed, as evidenced by very early appearance (as early as 1 minute after administration) of the active substance in systemic circulation, with peak plasma concentrations being attained as early as 8 minutes (median 30 minutes) after dosing.
A study investigating intranasal naloxone at doses of 1, 2, 4 mg (MR903-1501) shows that the median tmax associated with intranasal administration of naloxone is between 15-30 minutes, with individuals attaining peak concentrations as early as 8 minutes. Onset of action following intranasal administration can reasonably be expected to occur in each individual before the tmax is reached.
The half value duration (HVD) values for IN administration were longer than for IM administration (IN, 2 mg, 1.27 h, IM, 0.4 mg 1.09 h) from which we can infer a longer duration of action of naloxone given by the IN rather than the IM route. If the duration of action of the opioid agonist exceeds that of IN naloxone, the effects of the opioid agonist may return, necessitating a second IN naloxone administration.

Distribution.

Distribution following administration via the nasal spray has not been studied. Following parenteral administration, naloxone is rapidly distributed in the body. It is metabolised in the liver primarily by glucuronide conjugation and the metabolites are excreted in the urine. It is 50% protein bound. The elimination half-life in adults is 60-90 minutes and 180 minutes in neonates.

Metabolism.

Naloxone is rapidly metabolized in the liver and excreted in the urine. It undergoes extensive hepatic metabolism mainly by glucuronide conjugation. The principal metabolites are naloxone-3-glucuronide, 6-beta-naloxol and its glucuronide.

Excretion.

There are no data available on the excretion of naloxone following IN administration, however, the disposition of labelled naloxone following IV administration was studied in healthy volunteers and opioid-dependent patients. Following an IV dose of 125 microgram, 38% of the dose was recovered in the urine within 6 hours in healthy volunteers compared with 25% of the dose being recovered in opioid-dependent patients in the same time period. After a period of 72 hours, 65% of the injected dose was recovered in urine in the healthy volunteers compared with 68% of the dose in opiate-dependent patients.

Clinical Trials

No clinical trials have been conducted with Nyxoid. Efficacy has been inferred based on pharmacokinetic studies.

Indications

Nyxoid is intended as part of the emergency treatment for known or suspected opioid overdose as manifested by respiratory and/or central nervous system depression in:
the home or other non-medical setting;
a health facility setting.
For this reason, Nyxoid should be carried by persons at risk of, or likely to witness such events.
Nyxoid is indicated in adults and children.

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Precautions

General.

Instructing patients/ users on the proper use of Nyxoid.

Patients or any other person who might be in a position to administer this product must be instructed in the proper use of Nyxoid.
Nyxoid is not a substitution for emergency medical care and cannot replace intravenous injection. It is administered as a part of a resuscitation intervention in emergency settings, including the home or other non-medical settings in suspected overdose casualties, where opioids may be involved or suspected. The prescriber should describe the symptoms which allow presumptive diagnosis of CNS/respiratory depression, the indication and the instructions for use with the patient and/or person who might be in a position to administer this product to a patient experiencing a known or suspected opioid overdose event. This should be performed in accordance with the educational plan for Nyxoid. Therefore, patients at risk of experiencing an opioid overdose event and/or any other person who might be in a position to administer Nyxoid to a patient experiencing such an event should be carefully instructed in regard to the circumstances under which this potentially life-saving medicinal product should be used.

The importance of seeking medical assistance.

Nyxoid is intended as part of an emergency treatment and the patient/carer should be advised to seek medical help immediately. Therefore patients at risk or likely to witness an opioid overdose should be carefully instructed in regard to the circumstances under which this potentially life-saving medicinal product should be used.
The duration of action of most opioids may exceed that of Nyxoid nasal spray resulting in a return of respiratory and/or central nervous system depression after an initial improvement in symptoms.

Monitoring of the patient for a response.

Patients who respond satisfactorily to naloxone must be closely monitored. The effect of some opioids can be longer than the effect of naloxone which could lead to reoccurrence of respiratory depression and therefore further doses of naloxone may be required.

Opioid withdrawal syndrome.

Receiving naloxone can lead to a rapid reversal of the opioid effect which can cause an acute withdrawal syndrome in such patients (see Adverse Effects). Patients who are receiving opioids for the relief of chronic pain may experience pain and opioid withdrawal symptoms when naloxone is administered.
The use of Nyxoid nasal spray in patients who are opioid-dependent may bring about opioid withdrawal characterised by the following signs and symptoms; body aches, diarrhoea, tachycardia, fever, runny nose, sneezing, piloerection, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness and increased blood pressure. If these signs and symptoms occur no further Nyxoid should be given.

Effectiveness of naloxone.

Reversal of buprenorphine-induced respiratory depression may be incomplete. If an incomplete response occurs respiration should be mechanically assisted.
Reversal of respiratory depression by partial agonists or mixed agonist/antagonists such as buprenorphine may be incomplete. Larger or repeat doses of naloxone hydrochloride may be required for patients who have taken buprenorphine because it has a long duration of action. Buprenorphine antagonism is characterised by a gradual onset of the reversal effects and a decreased duration of action of the normally prolonged respiratory depression.

Effects on fertility.

No clinical data on effects of naloxone on fertility are available, however data from rat studies indicate no effects.
Naloxone had no effect on fertility and reproduction in the rat or on early embryonic development of the rat. In peri-post natal rat studies, naloxone produced increased pup deaths in the immediate post-partum period at the high doses that also caused significant maternal toxicity in rats (e.g. bodyweight loss, convulsions). Naloxone did not affect development or behaviour of surviving pups. Naloxone is therefore not teratogenic in rats or rabbits.

Use in pregnancy.

(Category B1)
Naloxone hydrochloride crosses the placenta and may precipitate withdrawal in the foetus as well as in the opioid-dependent mother. The foetus should be evaluated for signs of distress after Nyxoid nasal spray is used. Careful monitoring is needed until the foetus and mother are stabilised.
There are no adequate data from the use of naloxone in pregnant women. Studies in animals do not show any concerns on reproductive toxicity. The potential risk for humans is unknown. The benefit risk of the medicinal product must be considered before use.
In pregnant women who are opioid dependent, naloxone administration can cause withdrawal symptoms in new-born infants.

Use in lactation.

It is unknown whether naloxone is excreted in human breast milk and it has not been established whether infants who are breast-fed are affected by naloxone. However, as naloxone is practically not orally bioavailable, its potential to affect a breast-fed infant is negligible. Caution should be exercised when naloxone is administered to a nursing mother but there is no need to discontinue breast-feeding.

Paediatric use.

Absorption of naloxone following intranasal administration in paediatric patients may be erratic or delayed. Monitor the paediatric patients for at least 24 hours for the development of the signs and symptoms of opioid withdrawal syndrome even when the patient responds appropriately to naloxone.
Where it is preferable to avoid the abrupt precipitation of opioid withdrawal symptoms, consider use of alternative naloxone-containing dosage forms that can be titrated to effect and, where applicable, dosed according to weight.
Opioid withdrawal may be life-threatening in neonates if not recognised and properly treated and may include the following signs and symptoms: convulsions, excessive crying and hyperactive reflexes.

Genotoxicity and carcinogenicity.

Naloxone was not mutagenic in the bacterial reverse mutation assay, but was positive in mouse lymphoma assay and was clastogenic in vitro, however, naloxone was not clastogenic in vivo. Naloxone was not carcinogenic following oral administration in a rat 2-year study or in a 26-week study in Tg-rasH2 mice. Overall, the weight of evidence indicates that naloxone poses minimal, if any, risk for human genotoxicity and carcinogenicity.

Effects on ability to drive or operate machinery.

Patients who have received naloxone to reverse the effects of opioids should be warned not to drive, to operate machinery or to engage in other activities demanding physical or mental exertion for at least 24 hours, since the effect of the opioids may return.

Interactions

No interaction studies have been performed with Nyxoid. The effect of naloxone is based on the interaction with opioids and opioid agonists, reversing effects of opioids; rapid reversal may precipitate acute withdrawal syndrome in opioid dependence. At the usual naloxone dose there is no interaction with barbiturates and tranquillisers. Data on the interaction with alcohol are not uniform. In patients with multiple intoxication with opioids and sedatives or alcohol, the result of naloxone administration may be delayed, dependent on the cause of intoxication.
Complete analgesia can be restored following administration of naloxone hydrochloride to patients that had buprenorphine as analgesic. It is assumed that this effect is caused by the arched form of the dose-response curve of buprenorphine with decreasing analgesia at (too) high doses. However, reversal of respiratory depression caused by buprenorphine is limited.
Serious hypertension has been reported following administration of naloxone hydrochloride to patients in a coma caused by clonidine-overdosing.
Naloxone reverses the analgesic and other effects of opioid agonist/ antagonists such as pentazocine, so may precipitate withdrawal symptoms if used concurrently with these medicines in physically dependent patients.
Naloxone reverses the analgesic and other effects of opioid agonist analgesics, and may precipitate withdrawal symptoms if used concurrently with these medicines in physically dependent patients, including patients receiving methadone to treat opioid dependence.
When naloxone is used postoperatively to reverse the central depressive effects of opioid agonists used as anaesthesia adjuncts, the dose of naloxone must be carefully titrated to achieve the desired effect without interfering with control of postoperative pain, or causing other adverse effects.

Adverse Effects

Summary of the safety profile.

The most common adverse drug reaction (ADR) seen with naloxone administration is nausea (frequency of very common). Typical opioid withdrawal syndrome is expected with naloxone which may be caused by the abrupt withdrawal of opioid in persons physically dependent on them.

Tabulated list of adverse reactions.

The following adverse reactions have been reported with Nyxoid and/or other naloxone-containing products during clinical studies and post marketing experience. ADRs are listed below by system organ class and frequency. See Table 1.

Description of selected adverse reactions.

Drug withdrawal syndrome.

Signs and symptoms of drug withdrawal syndrome include restlessness, irritability, hyperaesthesia, nausea, vomiting, gastrointestinal pain, muscle spasms, dysphoria, insomnia, anxiety, hyperhidrosis, piloerection, tachycardia, increased blood pressure, yawning, pyrexia.

Reporting of suspected adverse reactions.

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.

Paediatric population.

The frequency, type and severity of adverse reactions in paediatrics are expected to be the same as in adults.
Monitor the paediatric patients for at least 24 hours for the development of the signs and symptoms of opioid withdrawal syndrome even when the patient responds appropriately to naloxone. Opioid withdrawal may be life-threatening in neonates if not recognised and properly treated and may include the following signs and symptoms: convulsions, excessive crying and hyperactive reflexes.

Dosage and Administration

Nyxoid is administered as a part of a resuscitation intervention in emergency settings, including the home or other non-medical settings in suspected overdose casualties, where opioids may be involved or suspected.
The prescriber should review in detail, the indications, the instructions and operation of the nasal spray with the patient or any other person who might be in a position to administer this product to a patient experiencing a known or suspected opioid overdose event.
How to identify an opioid overdose (symptoms of respiratory depression):
breathing problems;
severe sleepiness;
not responding to a loud noise or touch.

Dosage.

One spray of Nyxoid into a nostril. Re-administer Nyxoid, using a new Nyxoid container, into the other nostril after 2 to 3 minutes if the patient does not respond or responds and then relapses into respiratory depression. Further doses may be given every 2 to 3 minutes if needed until further assistance is available.

Method of administration.

Nasal use only.
The device is ready for use. No further assembly or priming is required.
If an overdose is suspected, call for emergency medical assistance immediately. Nyxoid is not a substitute for emergency medical care.

How to use Nyxoid.

Nyxoid should be administered as quickly as possible to avoid damage to the central nervous system or death. Nyxoid is a single dose nasal spray. Do not test the device as it cannot be reused. See Table 2.
If no improvement is seen in the patient and the person administering Nyxoid is appropriately trained, CPR can be given as an additional resuscitation measure.

Dosing modifications due to partial agonists or mixed agonist/ antagonists.

Reversal of respiratory depression by partial agonists or mixed agonist/antagonists, such as buprenorphine and pentazocine, may be incomplete and require higher doses of naloxone.

Overdosage

There is limited clinical experience with Nyxoid overdosage in humans. Patients who experience a Nyxoid overdose should be treated symptomatically in a closely-supervised environment.
For information on the management of overdose, contact the Poisons Information Centre on 131 126 (Australia).

Presentation

The container consists of a type I Ph.Eur. glass vial with chlorobutyl stopper and polypropylene applicator. Nyxoid 1.8 mg nasal spray: unit dose spray device containing 0.1 ml solution. Each pack contains two single dose nasal sprays.

Storage

Do not store above 30°C. Do not freeze.

Poison Schedule

S3.