Consumer medicine information

WHAT IS IN THIS LEAFLET?

This leaflet contains information about Adrenaline 1:10,000 Injection MINIJET. 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 ADRENALINE?

Adrenaline is a chemical which is produced naturally by our bodies. It helps to regulate most of the important functions such as heart rate, blood pressure and breathing. When we have a fright or have to fight or run, extra adrenaline is released into our blood. As this adrenaline circulates round the body it makes our heart beat faster, helps us to get more air into our lungs and increases the blood supply to the muscles. This helps us to cope with emergencies and is why we often get palpitations when we are frightened. Adrenaline injections are used to treat some emergency situations which can occur in the heart and lungs. It can only be given by injection and it acts very quickly.

WHEN IS ADRENALINE USED?

Adrenaline injections are only used in medical emergencies. They are not used as regular treatment.

Adrenaline 1:10,000 is used in people whose hearts have suddenly stopped (cardiac arrest). The adrenaline can help to restart the heart and stimulates it to beat strongly.

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

WHO SHOULD NOT HAVE ADRENALINE INJECTIONS?

As adrenaline is an emergency life-saving product it should not be withheld from anyone who needs it.

However it should be given cautiously to elderly people, to those with high blood pressure, thyroid problems and some people with high pressure in the eye.

Care must also be taken when giving adrenaline to diabetics, those with heart disease, people allergic to adrenaline, persons with brain damage and persons who are having an anaesthetic.

BEFORE YOU HAVE AN ADRENALINE INJECTION

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

• have high blood pressure
• have high pressure in the eye (glaucoma)
• have diabetes
• have asthma
• have heart problems
• have thyroid problems
• have difficulty urinating or have prostate problems
• have a spinal cord injury or other condition affecting the spinal cord
• are taking any medicines and what they are
• are pregnant
• have ever had an allergic reaction to sodium metabisulfite.

SIDE EFFECTS OF ADRENALINE

As with any medicine, some side effects may occur. Mild side effects are common with adrenaline. Common side effects include: palpitations, tremor, restlessness, anxiety, weakness, dizziness, headache, shortness of breath, cold hands and feet.

More severe side effects can occur occasionally and are due to the effect of adrenaline stimulating the heart and increasing the blood pressure. These side effects can, rarely, cause a stroke, lung upsets, severe heart abnormalities or severe heartbeat irregularities (see OVERDOSE).

Adrenaline may cut off the blood supply if given a number of times in the same area or into fingers and toes.

Adrenaline may also cause reduced blood flow and reduce the amount of oxygen to the moist linings of the body such as in the airways. This can lead to the body’s counter-effect causing more swelling of the moist linings.

The reduced blood flow can also affect the bowels and lead to death of the tissue, especially if there is already reduced blood flow to this area.

Paleness and changes to the blood are also possible side effects of Adrenaline.

Always tell your doctor if you have any unpleasant effects after receiving Adrenaline 1:10,000 Injection MINIJET.

THE DOSE OF ADRENALINE

The dose varies depending on the severity of the condition being treated but the usual doses are as follows:

Adrenaline 1:10,000

Adults: 10 mL (1 mg) injected slowly into a vein and repeated every 5 minutes if necessary.

Children: 0.1 mL per kg of bodyweight.

OVERDOSE

Too much adrenaline will give the severe reactions mentioned above in SIDE EFFECTS OF ADRENALINE. Overstimulation of the heart can cause it to stop and an abnormal increase in blood pressure can cause a stroke or breathing difficulties.

There are medicines available which will reverse the effects of adrenaline.

WHAT DOES Adrenaline 1:10,000 Injection MINIJET CONTAIN?

Adrenaline 1:10,000 Injection MINIJET contains adrenaline at a concentration of 1 mg in each 10 mL (1:10,000) of injection solution.

Each Adrenaline 1:10,000 Injection MINIJET also contains: citric acid, sodium citrate, sodium chloride, sodium bisulfite, hydrochloric acid, water.

HOW TO STORE Adrenaline 1:10,000 Injection MINIJET

Adrenaline 1:10,000 Injection MINIJET should be protected from light and stored below 25°C. They should not be used after the expiry date on the package or if the solution is brown or contains sediment.

WHERE CAN I GET MORE INFORMATION?

You can get more information from your doctor or pharmacist.

Sponsor

UCB Pharma
A division of UCB Australia Pty Ltd
Level 1, 1155 Malvern Road
Malvern Vic 3144, Australia

Adrenaline 1:10,000 Injection MINIJET - AUST R 213983

Date of Preparation

January 2014

MINIJET® is a registered trademark of International Medications Systems, Limited.

Published by MIMS September 2018

Name of the medicine

Adrenaline hydrochloride.

Excipients.

Description

Chemical name: (R)-1-(3,4-dihydroxyphenyl) -2-methylaminoethanol. Molecular formula: C₉H₁₃NO₃. CAS: 51-43-4. Adrenaline is a white odourless crystalline powder, soluble in solutions of mineral acids and alkalis.

Pharmacology

Adrenaline is a direct acting sympathomimetic agent exerting its effect on α and β-adrenoreceptors. Major effects are increased systolic blood pressure, reduced diastolic pressure, tachycardia, hyperglycaemia and hypokalaemia. It is a powerful cardiac stimulant. It has vasopressor properties, an antihistaminic action and is a bronchodilator. Its action is rapid in onset and of short duration.
Adrenaline is rapidly distributed to the heart, spleen, several glandular tissues and adrenergic nerves. It crosses the placenta and is excreted in breast milk. It is approximately 50% bound to plasma proteins. The onset of action is rapid and after intravenous infusion the half-life is approximately 5-10 minutes.
Adrenaline is rapidly metabolised in the liver and tissues. Up to 90% of the IV dose is excreted as metabolites in the urine.

Indications

Adjunctive use in the management of cardiac arrest.

Contraindications

Contraindications are relative as this product is intended for use in life threatening emergencies.
The following contraindications should be considered: hyperthyroidism, hypertension, ischaemic heart disease, diabetes mellitus, narrow angle glaucoma and known sensitivity to sympathomimetic amines.
Adrenaline should not be used in the presence of cardiac dilation.
Adrenaline should not be used in most patients with arrhythmias and cerebral arteriosclerosis, where vasopressor drugs may be contraindicated, e.g. in thyrotoxicosis, in obstetrics when maternal blood pressure is in excess of 130/80.
Adrenaline is also contraindicated in shock (other than anaphylactic shock), in patients with organic brain damage, during general anaesthesia with halogenated hydrocarbons or cyclopropane.
Adrenaline should not be injected into fingers, toes, ears, nose or genitalia.

Precautions

Use with caution in patients with ventricular fibrillation, prefibrillatory rhythm, tachycardia, myocardial infarction, phenothiazine induced circulatory collapse, urination difficulty and prostatic hypertrophy.
Adrenaline injection Minijet should be used with caution in patients suffering from autonomic dysreflexia (hyperreflexia), particularly in spinal cord injury (e.g. tetraplegics).
Administer slowly with caution to elderly patients and to patients with hypertension, diabetes mellitus, hyperthyroidism and psychoneurosis. Use with extreme caution in patients with long standing bronchial asthma and emphysema who have developed degenerative heart disease. Anginal pain may be induced when coronary insufficiency is present. Use with caution in patients with narrow angle glaucoma.
Adrenaline may delay the second stage of labour by inhibiting contractions of the uterus.
Syncope has occurred following administration to asthmatic children.
In patients with parkinsonian syndrome the drug increases rigidity and tremor.
Intra-arterial administration should be avoided since marked vasoconstriction may result in gangrene.
Intramuscular injection into the buttocks should be avoided as gas gangrene is a possibility.
Local ischaemic necrosis can occur from repeated injections in one site.
Adrenaline Injection Minijet contains a sulfite which may cause allergic type reactions in certain susceptible individuals.
Endotracheal administration of adrenaline can contaminate the colorimeter carbon dioxide detector and lead to its false-positive colour change (fixed yellow discolouration).
The adrenaline is in a single use Minijet prefilled syringe. Once the unit is assembled and used, any remaining portion of the solution must be discarded with the entire unit.

Use in pregnancy.

Use in lactation.

Interactions

Adrenaline should not be administered with other sympathomimetic agents because of the danger of additive effects and increased toxicity such as an increased risk of serious cardiac arrhythmias.
Rapidly acting vasodilators can counteract the marked pressor effects of adrenaline.
The effects of adrenaline may be potentiated by tricyclic antidepressants, some antihistamines and thyroid hormones.
Halothane and other anaesthetics such as cyclopropane and trichlorethylene increase the risk of adrenaline induced ventricular arrhythmias and acute pulmonary oedema if hypoxia is present.
Severe hypertension and bradycardia may occur with nonselective β-blocking drugs. Propranolol inhibits the bronchodilator effect of adrenaline. The risk of cardiac arrhythmias is higher when adrenaline is given to patients receiving digoxin or quinidine.
There is an increased the risk of hypotension and tachycardia with α-blockers.
Drugs which cause potassium loss (corticosteroids, potassium depleting diuretics, aminophylline, theophylline) may increase the risk of hypokalaemia.
Adrenaline induced hyperglycaemia may lead to loss of blood sugar control in diabetic patients treated with hypoglycaemic agents.
Patients on monoamine oxidase inhibitors should not receive sympathomimetic treatment. There is an increased risk of adverse events with concurrent use, or use within 2 weeks, of monoamine oxidase inhibitors and sympathomimetic treatment.
Entacapone may potentiate the chronotropic and arrhythmogenic effects of adrenaline. Use of adrenaline and levodopa may increase the risk of cardiac adverse effects of levodopa.
Adrenaline is physically incompatible with alkalis, metals, oxidising agents, sodium warfarin, hyaluronidase and many other drugs; it forms polymers with sodium bicarbonate.

Adverse Effects

Common symptomatic adverse events include anxiety, restlessness, tachycardia, tremor, weakness, dizziness, headache, dyspnoea, cold extremities, pallor, sweating, nausea, vomiting, sleeplessness, hallucinations and flushing or redness of face and skin. Psychomotor agitation, disorientation, impaired memory and psychosis may occur.
The following adverse events are also possible: stress cardiomyopathy; bowel necrosis (in patients whose intestinal blood flow is already compromised); local vasoconstriction and hypoxia of mucosa, which may lead to compensatory rebound congestion of the mucosa (in case of endotracheal administration); pallor and thrombocytosis.
The potentially severe adverse effects of adrenaline arise from its effect upon blood pressure and cardiac rhythm. Ventricular fibrillation may occur and severe hypertension may lead to cerebral haemorrhage and pulmonary oedema.

Dosage and Administration

Do not use if the injection is brown or contains a precipitate.

Adults.

Elderly patients.

Children.

Overdosage

Effects.

Treatment.

Presentation

Solution for injection, 1 mg/10 mL (sterile, single use prefilled Minijet syringe).
Do not use if the injection is brown or contains a precipitate.

Storage

Store below 25°C. Protect from light.

Poison Schedule

S3.