SUMMARY CMI

Naloxone Juno and Naloxone Juno Neonatal

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using Naloxone Juno and Naloxone Juno Neonatal?

Naloxone Juno and Naloxone Juno Neonatal contains the active ingredient naloxone hydrochloride dihydrate. Naloxone hydrochloride dihydrate is used to reverse the effects of opium-like substances such as morphine, heroin and codeine.

For more information, see Section 1. Why am I using Naloxone Juno and Naloxone Juno Neonatal? in the full CMI.

2. What should I know before I use Naloxone Juno and Naloxone Juno Neonatal?

You should not be given Naloxone Juno and Naloxone Juno Neonatal if you have ever had an allergic reaction to any medicine containing naloxone hydrochloride dihydrate, or any of the ingredients listed at the end of the CMI or any other similar medicines.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I use Naloxone Juno and Naloxone Juno Neonatal? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Naloxone Juno and Naloxone Juno Neonatal and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Naloxone Juno and Naloxone Juno Neonatal?

Naloxone Juno and Naloxone Juno Neonatal must only be given by a doctor or nurse. Your doctor will decide what dose of this medicine you will receive. This depends on your condition and other factors, such as your weight.

More instructions can be found in Section 4. How do I use Naloxone Juno and Naloxone Juno Neonatal? in the full CMI.

5. What should I know while using Naloxone Juno and Naloxone Juno Neonatal?

For more information, see Section 5. What should I know while using Naloxone Juno and Naloxone Juno Neonatal? in the full CMI.

6. Are there any side effects?

Naloxone Juno and Naloxone Juno Neonatal may cause dizziness, headache, nausea, vomiting, pain at the site of the injection, sweating, tremor, increase in heart rate, nervousness, irritability, or restlessness, violent behaviour or agitation, 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. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

Naloxone Juno and Naloxone Juno Neonatal

Active ingredient(s): Naloxone hydrochloride dihydrate

Consumer Medicine Information (CMI)

This leaflet provides important information about using Naloxone Juno and Naloxone Juno Neonatal naloxone hydrochloride dihydrate (referred to as Naloxone).

You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Naloxone Juno and Naloxone Juno Neonatal.

Where to find information in this leaflet:

1. Why am I using Naloxone Juno and Naloxone Juno Neonatal?
2. What should I know before I use Naloxone Juno and Naloxone Juno Neonatal?
3. What if I am taking other medicines?
4. How do I use Naloxone Juno and Naloxone Juno Neonatal?
5. What should I know while using Naloxone Juno and Naloxone Juno Neonatal?
6. Are there any side effects?
7. Product details

1. Why am I using Naloxone Juno and Naloxone Juno Neonatal?

Naloxone Juno and Naloxone Juno Neonatal contains the active ingredient naloxone hydrochloride dihydrate. Naloxone hydrochloride dihydrate belongs to a group of medicines called opioid antagonists.

Naloxone Juno and Naloxone Juno Neonatal is used to reverse the effects of opium-like substances such as morphine, heroin, and codeine.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Your doctor may have prescribed it for another reason.

2. What should I know before I use Naloxone Juno and Naloxone Juno Neonatal?

Warnings

Do not use Naloxone Juno and Naloxone Juno Neonatal if you:

• are allergic to any medicine containing naloxone hydrochloride dihydrate, or any of the ingredients listed at the end of this leaflet, or any other similar medicines.

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.

Always check the ingredients to make sure you can use this medicine.

Check with your doctor if you:

• have allergies to any other medicines, foods, preservatives or dyes
• have or have had any other medical conditions, especially the following:
  - heart disease
  - lung disease
  - kidney disease
  - liver disease
  - drug addiction (including and addiction to alcohol).

You should not be given Naloxone Juno and Naloxone Juno Neonatal if:

• the solution is discoloured, cloudy, turbid, or a precipitate is present. The injection is normally a clear and colourless solution, practically free from visible particles.

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

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

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

3. What if I am taking other medicines?

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

Some medicines may interfere with Naloxone Juno and Naloxone Juno Neonatal and affect how it works.

These include but are not limited to:

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

These medicines may be affected by Naloxone Juno and Naloxone Juno Neonatal or may affect how well Naloxone Juno and Naloxone Juno Neonatal works. You may need different amounts of your medicines, or you may need to take different medicines.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Naloxone Juno and Naloxone Juno Neonatal.

4. How do I use Naloxone Juno and Naloxone Juno Neonatal?

This medicine must only be given by a doctor or a healthcare professional.

How it is given

This medicine can be given:

• as an injection into a muscle (intramuscular)
• just under the skin (subcutaneous) or
• as a slow injection into a vein (intravenous).

How much is given

• Your doctor will decide what dose of this medicine you will receive and how long you will receive it for. This depends on your medical condition and other factors.
• Sometimes only a single dose of this medicine is required.

When to use Naloxone Juno and Naloxone Juno Neonatal

• to reverse the effects of opium-like substances such as morphine, heroin, and codeine.

If you are given too much (overdose)

As this medicine is always given to you in a hospital under the supervision of a doctor, an overdose is unlikely.

Symptoms of an overdose may be the same as side effects but may be more severe. The symptoms of a side effect are listed under 6. Are there any side effects? below.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using Naloxone Juno and Naloxone Juno Neonatal?

Things you should do

• If you are about to be started on any new medicine, tell your doctor, dentist and pharmacist that you have been given Naloxone Juno and Naloxone Juno Neonatal.
• Tell any doctors, dentists and pharmacists who treat you that you have been treated with this medicine.
• If you are going to have surgery, tell the surgeon or anaesthetist that you have been given this medicine. It may affect other medicines used during surgery.
• 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.
• If you are on a salt restricted diet, tell you doctor that you are taking this medicine. Your diet may need to be changed.

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 to get worse talk to your doctor.

Call your doctor straight away if you:

• become pregnant while being given Naloxone Juno and Naloxone Juno Neonatal.

Remind any doctor, dentist, pharmacist, or nurse you visit that you have been given Naloxone Juno and Naloxone Juno Neonatal.

Driving or using machines

Do not drive or operate machinery for at least 24 hours (1 day) after you have been given Naloxone Juno and Naloxone Juno Neonatal.

Drinking alcohol

Do not drink alcohol while you are given this medicine.

Looking after your medicine

This medicine will be stored in a hospital. The injection is kept in a cool dry place, protected from the light where the temperature stays below 25 degrees Celsius.

This medicine will only be opened when it is time for you to have the injection.

6. Are there any side effects?

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

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

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

Less serious side effects

Serious side effects

Very serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What NALOXONE Juno AND NALOXONE JUNO NEONATAL contains

Do not take this medicine if you are allergic to any of these ingredients.

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

What NALOXONE Juno AND NALOXONE JUNO NEONATAL looks like

The 1 mL ampoule (NALOXONE JUNO) contains 400 micrograms of naloxone hydrochloride (as dihydrate) and Water for Injections to 1 mL. It is available in packs of 1, 5 or 10 ampoules.

The 2 mL ampoule (NALOXONE JUNO NEONATAL) contains 40 micrograms of naloxone hydrochloride (as dihydrate) and Water for Injections to 2 mL. It is available in packs of 1, 5 or 10 ampoules.

Not all pack size is marketed.

Who distributes NALOXONE Juno AND NALOXONE JUNO NEONATAL

Juno Pharmaceuticals Pty Ltd
15 – 17 Chapel Street
Cremorne, VIC 3121
www.junopharm.com.au

NALOXONE JUNO AUST R 236005

NALOXONE JUNO NEONATAL AUST R 236003

This leaflet was prepared in November 2024.

Published by MIMS February 2025

1 Name of Medicine

The name of this medicine is naloxone hydrochloride dihydrate.

2 Qualitative and Quantitative Composition

Naloxone Juno and Naloxone Juno Neonatal are available as sterile solutions for intravenous, intramuscular and subcutaneous administration at a concentration of 400 micrograms of naloxone hydrochloride (as dihydrate) in 1 mL of water for injections, and 40 micrograms of naloxone hydrochloride (as dihydrate) in 2 mL water for injections. The pH is adjusted to 3.0 - 3.3 with hydrochloric acid.
Naloxone Juno and Naloxone Juno Neonatal, opioid antagonists, are synthetic congeners of oxymorphone. In structure they differ from oxymorphone in that the methyl group on the nitrogen atom is replaced by an allyl group.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Solution for injection.
Naloxone Juno and Naloxone Juno Neonatal are clear, colourless solutions.

4 Clinical Particulars

4.1 Therapeutic Indications

Naloxone hydrochloride dihydrate injection is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by opioids including natural and synthetic opioids, propoxyphene, methadone and the narcotic antagonist analgesics: nalbuphine, pentazocine and butorphanol. Naloxone hydrochloride dihydrate injection is also indicated for the diagnosis of suspected acute opioid overdosage.

4.2 Dose and Method of Administration

Naloxone Juno and Naloxone Juno Neonatal may be administered intravenously, intramuscularly, or subcutaneously. The most rapid onset of action is achieved by intravenous administration and it is recommended in emergency situations.
Since the duration of action of some opioids may exceed that of naloxone hydrochloride dihydrate the patient should be kept under continued surveillance, and repeated doses of naloxone hydrochloride dihydrate should be administered, as necessary.
Naloxone Juno and Naloxone Juno Neonatal contain no antimicrobial preservative, therefore are for use in one patient on one occasion only; after use, any remaining solution should be discarded.

Intravenous infusion.

Usage in adults.

Opioid overdose (known or suspected).

Postoperative opioid depression.

Opioid overdose (known or suspected).

Postoperative opioid depression.

Usage in neonates.

Opioid induced depression.

4.3 Contraindications

Naloxone Juno and Naloxone Juno Neonatal are contraindicated in patients known to be hypersensitive to naloxone hydrochloride dihydrate or to any other ingredients in Naloxone Juno and Naloxone Juno Neonatal.

4.4 Special Warnings and Precautions for Use

Naloxone hydrochloride (as dihydrate) should be administered cautiously to persons including newborns of mothers who are known or suspected to be physically dependent on opioids. In such cases an abrupt and complete reversal of opioid effects may precipitate an acute withdrawal syndrome.
The signs and symptoms of opioid withdrawal in patients physically dependent on opioids may include, but are not limited to, the following: body aches, diarrhoea, tachycardia, fever, runny nose, sneezing, piloerection, sweating, yawning, nausea and vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure. In the neonate opioid withdrawal may also include: convulsions, excessive crying and hyperactive reflexes.
The patient who has satisfactorily responded to naloxone hydrochloride dihydrate should be kept under continued surveillance and repeated doses of naloxone hydrochloride dihydrate should be administered, as necessary, since the duration of action of some opioids may exceed that of naloxone hydrochloride dihydrate. Large doses of naloxone hydrochloride dihydrate in postoperative patients may result in a clear reversal in analgesia, excitement and an elevation in blood pressure. A reversal of opioid effects achieved too rapidly may induce nausea, vomiting, sweating or tachycardia.
Naloxone hydrochloride dihydrate is not effective against respiratory depression due to nonopioid drugs.
Reversal of buprenorphine induced respiratory depression may be incomplete. If an incomplete response occurs, respiration should be mechanically assisted.
In addition to naloxone hydrochloride dihydrate, other resuscitative measures such as maintenance of a free airway, artificial ventilation, cardiac massage, and vasopressor agents should be available and employed when necessary to counteract acute opioid poisoning.
Abrupt postoperative reversal of opioid depression may result in nausea, vomiting, sweating, tremulousness, tachycardia, increased blood pressure, seizures, ventricular tachycardia and fibrillation, pulmonary oedema and cardiac arrest which may result in death.
Several instances of hypotension, hypertension, ventricular tachycardia and fibrillation, pulmonary oedema and cardiac arrest have been reported in postoperative patients following naloxone hydrochloride (as dihydrate) administration. Death, coma and encephalopathy have been reported as sequelae of these events. These have occurred in postoperative patients most of whom had pre-existing cardiovascular disorders or received other drugs which may have similar adverse cardiovascular effects. Although a direct cause and effect relationship has not been established, naloxone hydrochloride dihydrate should be used with caution in patients with pre-existing cardiac disease or patients who have received medications with potential adverse cardiovascular effects, such as hypotension, ventricular tachycardia or fibrillation and pulmonary oedema. It has been suggested that the pathogenesis of pulmonary oedema associated with the use of naloxone hydrochloride dihydrate is similar to neurogenic pulmonary oedema i.e. a centrally mediated massive catecholamine response leading to a dramatic shift of blood volume into the pulmonary vascular bed resulting in increased hydrostatic pressures.
Naloxone hydrochloride (as dihydrate) should also be used with caution in patients with pre-existing pulmonary disease, since sudden exacerbation of underlying pulmonary disease may occur.

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The effect of naloxone hydrochloride dihydrate 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 hydrochloride dihydrate dose there is no interaction with barbiturates and tranquillizers. Data on the interaction with alcohol are not uniform. In patients with multiple intoxication with opioids and sedatives or alcohol, the result of naloxone hydrochloride dihydrate administration may be delayed, dependent on the cause of intoxication.
Complete analgesia can be restored following administration of naloxone hydrochloride dihydrate 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 dihydrate to patients in a coma caused by clonidine overdosing, naloxone hydrochloride dihydrate 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 hydrochloride dihydrate 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 hydrochloride dihydrate is used postoperatively to reverse the central depressive effects of opioid agonists used as anaesthesia adjuncts, the dose of naloxone hydrochloride dihydrate must be carefully titrated to achieve the desired effect without interfering with control of postoperative pain, or causing other adverse effects.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

No studies on the effects on the ability to drive and use machines have been performed.
Patients who have received naloxone hydrochloride dihydrate to reverse the effect of opioids should be warned not to take part in road traffic, 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.

4.8 Adverse Effects (Undesirable Effects)

The following undesirable effects are ranked according to system organ class and to their frequency: within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).

Immune system disorders.

Nervous system disorders.

Cardiac disorders.

Vascular disorders.

Respiratory, thoracic and mediastinal disorders.

Gastrointestinal disorders.

Skin and subcutaneous tissue disorders.

General disorders and administration site conditions.

Postoperative.

Opioid depression.

Opioid dependence (see Section 4.4 Special Warnings and Precautions for Use).

Drug abuse and dependence.

Reporting suspected adverse effects.

4.9 Overdose

Symptoms and signs.

Treatment.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism and excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Hydrochloric acid, Water for Injections.

6.2 Incompatibilities

No drug or chemical agent should be added to Naloxone Juno or Naloxone Juno Neonatal unless its effect on the chemical and physical stability of the solution has first been established. Naloxone Juno and Naloxone Juno Neonatal should not be mixed with preparations containing sulfite, metabisulfite, long chain or high molecular weight anions, or any solution having an alkaline pH.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Protect from light, store below 25°C.

6.5 Nature and Contents of Container

Naloxone Juno: naloxone hydrochloride (as dihydrate) 400 micrograms / 1 mL in clear glass ampoules.
Naloxone Juno Neonatal: naloxone hydrochloride (as dihydrate) 40 micrograms / 2 mL in clear glass ampoules.

Pack size.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Naloxone hydrochloride dihydrate occurs as a white to slightly off-white powder, and is soluble in water, in dilute acids, and in strong alkalis, slightly soluble in alcohol, practically insoluble in ether and in chloroform.

Chemical structure.

Chemical name.

Molecular formula.

Molecular weight.

CAS number.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription only Medicine.

Summary Table of Changes