Consumer medicine information

Naloxone Hydrochloride Injection

Naloxone hydrochloride

BRAND INFORMATION

Brand name

Naloxone Hydrochloride Injection

Active ingredient

Naloxone hydrochloride

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Naloxone Hydrochloride Injection.

WHAT IS IN THIS LEAFLET?

This leaflet contains information about Naloxone Hydrochloride Injection MIN-I-JET. Please read it carefully and keep it for future reference. The information in this leaflet is only a summary and is not intended to replace advice from your doctor.

Please consult your doctor or pharmacist if you have any comments or questions.

WHAT IS NALOXONE?

Naloxone is a medicine which, when injected, reverses the effect of opium-like substances such as morphine, heroin and codeine. It acts very quickly and can be a life saving measure in those people who have received an overdose of a narcotic drug.

WHEN IS NALOXONE USED?

Naloxone is used in any situation where it is necessary to reverse the effects of opium and its derivatives, such as morphine, heroin and codeine.

Naloxone is used after surgical operations when powerful pain killers have been given and are no longer required when the operation is over.

Naloxone is the standard treatment for those who have received an overdose of heroin or similar drugs. Naloxone acts very quickly and is often lifesaving in such cases. It is also used in new-born infants whose mothers have received opium-like drugs.

As naloxone is only used in medical emergencies, injection may be given by paramedical personnel such as ambulance or nursing staff.

WHO SHOULD NOT HAVE NALOXONE INJECTIONS?

Those who are known to have had severe reactions to naloxone injections.

BEFORE YOU HAVE A NALOXONE INJECTION

If you are conscious, you should tell your doctor if you:

  • have ever had an allergic reaction to naloxone
  • are a drug addict
  • are using any drugs and what was the time and size of the last dose
  • have received naloxone previously
  • are suffering from any heart disease
  • have any other type of illness
  • are taking any medicines and what they are
  • are pregnant
  • are breast feeding

SIDE EFFECTS OF NALOXONE

As with any medicine, some side effects may occur.

Nausea, vomiting, sweating and palpitations sometimes occur after an injection of naloxone, particularly if it is given after an anaesthetic.

When naloxone is given to someone who has taken an overdose of heroin or similar drug, it can produce overbreathing and tremor. On rare occasions the treated person has had a fit but this may not have been due to the naloxone.

People who have been given naloxone after having received large doses of heroin or similar drugs may suffer the severe problems associated with sudden drug withdrawal.

Patients with heart disease can sometimes be made worse following naloxone. Alterations in blood pressure and abnormal heart rhythms have occurred.

Always tell your doctor if you have any unpleasant effects after receiving a Naloxone Hydrochloride Injection MIN-I-JET.

THE DOSE OF NALOXONE

The dose varies depending on the reason for which it is being used and the age of the patient.

Adults who have had an overdose of heroin or related drugs, the usual starting dose is 0.4 to 2.0 mg given into a vein. This can be repeated until 10 mg has been given. If a vein is not available, the injection can be given into a muscle or under the skin.

Adults recovering from an anaesthetic usually receive 0.2 mg every few minutes until the desired effect is obtained.

Children: the usual dose is 0.01 mg per kg bodyweight which can be increased to 0.1 mg per kg. Newborn babies usually receive 0.01 mg per kg bodyweight.

OVERDOSE

At large doses of Naloxone the following effects have been reported: seizures, changes in blood pressure, slow heart beat, irritability, anxiety, changes in mood, difficulty concentrating, lack of appetite, dizziness, heaviness, sweating, nausea and stomach aches.

Severe withdrawal symptoms can be produced in drug addicts if too much naloxone is used.

Contact the Poisons Information Centre on 131 126 for advice on overdose management.

WHAT DOES Naloxone Hydrochloride Injection MIN-I-JET CONTAIN?

Naloxone Hydrochloride Injection MIN-I-JET contains naloxone at a concentration of 0.4 mg per mL.

There are two different sizes of Naloxone Hydrochloride Injection MIN-I-JET:
0.8 mg naloxone in 2 mL
AUST R 48534
2.0 mg naloxone in 5 mL
AUST R 48535

Each Naloxone Hydrochloride Injection MIN-I-JET also contains: sodium chloride, hydrochloric acid and water.

HOW TO STORE Naloxone Hydrochloride Injection MIN-I-JET

Naloxone Hydrochloride Injection MIN-I-JET should be protected from light and stored below 25 °C (room temperature). They should not be frozen. They should not be used after the expiry date on the package.

WHERE CAN I GET MORE INFORMATION?

You can get more information from your doctor or pharmacist.

Naloxone Hydrochloride Injection MIN-I-JET are manufactured by:
International Medication Systems, Limited
1886 Santa Anita Avenue
South El Monte, CA 91733, USA

Ashton Pharmaceuticals Limited
Vale of Bardsley, Ashton-under-Lyne,
Lancashire, OL7 9RR, UK

and distributed by:
CSL Limited ABN 99 051 588 348
45 Poplar Road
Parkville 3052, Victoria Australia

Date of Information: February 1996
Date of Amendment: June 2006

BRAND INFORMATION

Brand name

Naloxone Hydrochloride Injection

Active ingredient

Naloxone hydrochloride

Schedule

S3