Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Narcan® Injection. It does not contain all the available information. It does not take the place of talking to your doctor.

All medicines have risks and benefits. Your doctor has weighed the risks of you being given Narcan® Injection against the benefits they expect it will have for you.

If you have any concerns about being given Narcan® Injection, ask your doctor.

Keep this leaflet in a safe place.

You may need to read it again.

What Narcan® Injection is used for

Narcan® Injection belongs to a group of medicines called opioid antagonists.

Narcan® Injection works by reversing the effects of opium-like substances such as morphine, heroin and codeine.

Ask your doctor if you have any questions about why Narcan® Injection has been prescribed for you.

Your doctor may have prescribed it for another reason.

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

Before you are given Narcan® Injection

When you must not be given Narcan® Injection

You should not be given Narcan® Injection if you have an allergy to:

• any medicine containing naloxone hydrochloride
• 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 Narcan® Injection if the solution is discoloured, cloudy, turbid or a precipitate is present.

The injection is normally a clear and colourless solution.

The doctor or your healthcare professional will check to ensure the medicine is not past its expiry date and has not been tampered with.

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

Before you are given Narcan® Injection

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.

Your doctor can discuss with you the risks and benefits involved.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Your doctor can discuss with you the risks and benefits involved.

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

Taking other medicines

Tell your doctor or healthcare professional 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.

These medicines may be affected by Narcan® Injection or may affect how well Narcan® Injection works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor has more information on medicines to be careful with or avoid while being given this medicine.

How Narcan® Injection is given

Narcan® Injection must only be given by a doctor or a healthcare professional.

How it is given

Narcan® Injection 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 Narcan® Injection 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 Narcan® Injection is required.

If you are given too much (overdose)

As Narcan® Injection is always given to you in a hospital under the supervision of a doctor, it is unlikely that you will receive an overdose.

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 Side effects below.

If you notice any symptoms of an overdose immediately contact your doctor or go to the Emergency Department at the nearest hospital.

Contact the Poisons Information Centre on 13 11 26 for further advice on overdose management.

While you are being given Narcan® Injection

Things you must do

If you are about to be started on any new medicine, remind your doctor and healthcare professional that you have been given Narcan® Injection.

Tell any other doctors or dentists, who treat you that you have been given Narcan® Injection.

If you are going to have surgery, tell the surgeon or anaesthetist that you have been given Narcan® Injection.

It may affect other medicines used during surgery.

If you become pregnant while being given this medicine, tell your doctor immediately.

If you are about to have any blood tests, tell your doctor that you are being given this medicine.

It may interfere with the results of some tests.

If you are on a salt restricted diet, tell your doctor that you are taking this medicine.

Your diet may need to be changed.

Things to be careful of

Do not drive or operate machinery after you have been given Narcan® Injection for at least 24 hours (1 day).

Do not drink alcohol while you are being given this medicine.

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.

Side effects

Tell your doctor or nurse as soon as possible if you do not feel well while you are being given Narcan® Injection.

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. 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 to answer any questions you may have.

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

• dizziness
• headache
• nausea
• vomiting
• pain at the site of injection.

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 or healthcare professional immediately:

• 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.

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

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 Narcan® Injection

Storage

Narcan® Injection will be stored in the hospital. The injection is kept in a cool dry place, protected from light where the temperature stays below 25°C.

Narcan® Injection will only be opened when it is time for you to have the injection.

Product description

What it looks like

Narcan® Injection is a clear, colourless solution in ampoules of 2 mL capacity.

Ingredients

Narcan® Injection contains 400 micrograms of naloxone hydrochloride in 1 mL Water for injections.

It also contains:

• sodium chloride.

This medicine does not contain lactose, sucrose, gluten, tartrazine, alcohol, dyes or preservatives.

Supplier

Narcan® Injection is supplied in Australia by:
Phebra Pty Ltd
19 Orion Road,
Lane Cove West, NSW 2066,
Australia

Narcan® (naloxone hydrochloride 400 micrograms in 1 mL) injection ampoule
AUST R 57306

Phebra product code INJ174

This leaflet was prepared in February 2013

Phebra, Narcan and the phi symbol are trademarks of Phebra Pty Ltd.

Name of the medicine

Naloxone hydrochloride.

Excipients.

Description

Chemical name: 4,5 α-epoxy- 3,14-dihydroxy- 17-(prop-2-enyl) morphinan-6-one hydrochloride. Molecular formula: C₁₉H₂₁NO₄.HCl. MW: 363.84. CAS: 357-08-4. Narcan (naloxone hydrochloride), an opioid antagonist, is a synthetic congener of oxymorphone. In structure it differs from oxymorphone in that the methyl group on the nitrogen atom is replaced by an allyl group. Naloxone hydrochloride 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.

Pharmacology

Narcan prevents or reverses the effects of opioids including respiratory depression, sedation and hypotension. Also, it can reverse the psychotomimetic and dysphoric effects of agonist-antagonists such as pentazocine.
Narcan (naloxone hydrochloride) is an essentially pure opioid antagonist, i.e. it does not possess the agonistic or morphine-like properties characteristic of other opioid antagonists. Narcan does not produce respiratory depression, psychotomimetic effects of pupillary constriction. In the absence of opioid or agonistic effects of other opioid antagonists it exhibits essentially no pharmacologic activity.
Narcan has not been shown to produce tolerance or to cause physical or psychological dependence.
In the presence of physical dependence on opioids, Narcan will produce withdrawal symptoms.
While the mechanism of action of Narcan is not fully understood, the preponderance of evidence suggests that Narcan antagonises the opioid effects by competing for the same receptor sites.
When Narcan is administered intravenously the onset of action is generally apparent within two minutes; the onset of action is only slightly less rapid when it is administered subcutaneously or intramuscularly. The duration of action is dependent upon the dose and route of administration of Narcan. Intramuscular administration produces a more prolonged effect than intravenous administration. The requirement for repeat doses of Narcan, however, will also be dependent upon the amount, type and route of administration of the opioid being antagonised.
Following parenteral administration, Narcan is rapidly distributed in the body. It is metabolised in the liver, primarily by glucuronide conjugation, and excreted in the urine. In one study the serum half-life in adults ranged from 30 to 81 minutes (mean 64 ± 12 minutes). In a neonatal study the mean plasma half-life was observed to be 3.1 ± 0.5 hours.

Indications

Narcan 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. Narcan is also indicated for the diagnosis of suspected acute opioid overdosage.

Contraindications

Narcan is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any other ingredients in Narcan.

Precautions

Narcan 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 Narcan should be kept under continued surveillance and repeated doses of Narcan should be administered, as necessary, since the duration of action of some opioids may exceed that of Narcan. Large doses of naloxone hydrochloride 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.
Narcan 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 bemechanically assisted.
In addition to Narcan, 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 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, Narcan 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 Narcan 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 should also be used with caution in patients with pre-existing pulmonary disease, since sudden exacerbation of underlying pulmonary disease may occur.
Each 1 mL ampoule contains 3.54 mg of sodium which corresponds to 17.7 mg of sodium per 2 mg dose (5 mL) of naloxone hydrochloride and to 3.8 mmol (88.5 mg) of sodium per maximum daily dose of 10 mg naloxone hydrochloride. This should be taken into consideration by patients on a controlled sodium diet.

Carcinogenesis, mutagenesis, impairment of fertility.

Use in pregnancy.

Teratogenic effects.

Nonteratogenic effects.

Use in labour and delivery.

Use in lactation.

Renal insufficiency/ failure.

Liver disease.

Effects on ability to drive and use machines.

Interactions

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

Adverse 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.

Drug abuse and dependence.

Dosage and Administration

Narcan 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 Narcan the patient should be kept under continued surveillance, and repeated doses of Narcan should be administered, as necessary.
Use in one patient on one occasion only and discard. Contains no antimicrobial preservative.

Intravenous infusion.

Usage in adults.

Opioid overdose: known or suspected.

Postoperative opioid depression.

Usage in children.

Opioid overdose: known or suspected.

Postoperative opioid depression.

Usage in neonates.

Opioid induced depression.

Overdosage

There is limited clinical experience with Narcan overdosage in humans.
In a study, 36 patients with acute stroke received a loading dose of 4 mg/kg (10 mg/m²/min) of Narcan followed immediately by 2 mg/kg/hour 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 have been reported.

Patient management.

Presentation

Solution for intravenous, intramuscular and subcutaneous injection (sterile), 400 microgram/mL, 1 mL (AUST R 57306): 10's (clear glass ampoule with a red colourbreak point).

Storage

Protect from light. Store below 25°C.

Poison Schedule

S4.