Consumer medicine information

Aspen Adrenaline Injection

Adrenaline (epinephrine)

BRAND INFORMATION

Brand name

Aspen Adrenaline Injection

Active ingredient

Adrenaline (epinephrine)

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Aspen Adrenaline Injection.

What is in this leaflet

This leaflet answers some common questions about ASPEN ADRENALINE Injection. 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 has weighed the risks of you being given ASPEN ADRENALINE Injection 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. You may need to read it again.

What ASPEN ADRENALINE Injection is used for

ASPEN ADRENALINE Injection is usually only given in cases of extreme emergency.

ASPEN ADRENALINE may be used following a heart attack, or to make the heart beat if it has stopped.

ASPEN ADRENALINE is also used in the emergency treatment of severe allergic reactions to insect bites or stings, medicines, foods or other substances. It may also be given during acute asthma attacks for severe breathing difficulties.

In heart conditions it can help to restart the heart and stimulates it to bet more strongly.

ASPEN ADRENALINE opens up the airways making it easier to breathe.

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.

This medicine is not addictive.

It is available only with a doctor’s prescription.

This medicine is not expected to affect your ability to drive a car or operate machinery.

Before you are given it

When you must not be given it

You must not be given ASPEN ADRENALINE Injection if you have an allergy to:

  • any medicine containing adrenaline (epinephrine)
  • 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 use ASPEN ADRENALINE if you are in childbirth labour. It can stop the contractions in the uterus.

You must 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.

Before you are given it

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 or blood vessel disease
  • glaucoma (increased pressure in the eye)
  • brain damage
  • stroke
  • diabetes
  • high blood pressure
  • lung disease
  • angina or chest pain
  • overactive thyroid gland

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 not told your doctor about any of the above, tell him/her before you are given ASPEN ADRENALINE Injection.

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 or health food shop.

Some medicines and ASPEN ADRENALINE Injection may interfere with each other. These include:

  • blood pressure medicines
  • medicines for your heart
  • general anaesthetics
  • diuretics
  • corticosteroids
  • diabetes medicines

These medicines may be affected by adrenaline (epinephrine) or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while being treated with this medicine.

How it is given

How much is given

Your doctor will decide what dose you will receive. This depends on your condition and other factors, such as your weight.

How it is given

ASPEN ADRENALINE Injection is normally given by a doctor or nurse. The injection will usually be given just under the skin, however, it can also be given into the muscle or straight into the vein or heart.

ASPEN ADRENALINE should not be given into the buttocks.

If you receive too much (overdose)

The doctor or nurse giving you ASPEN ADRENALINE Injection will be experience in its use, so it is extremely unlikely that you will be given too much.

However, if you experience any side effects after being given ASPEN ADRENALINE injections, tell your doctor or nurse immediately.

If you have to give ASPEN ADRENALINE Injection, make sure you give it exactly as directed. This will make it unlikely that too much will be given.

Immediately telephone your doctor or the Poisons Information Centre for advice - the telephone number in Australia is 13 11 26 and in New Zealand is 0800 POISON or 0800 764 766 - or go the Accident and Emergency at the nearest hospital, if you think that you or anyone else may have used too much ASPEN ADRENALINE Injection. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Symptoms of overdose may include feeling unwell, flushing or abnormal heart beats, and headaches.

Ask your doctor or pharmacist if you have any concerns.

Side effects

Tell your doctor or nurse as soon as possible if you do not feel well while you are being treated with ASPEN ADRENALINE Injection.

This medicine helps most people with either a heart problem or suffering an allergic reaction, but it may have unwanted side effects in a few people. It is usually only given in life-threatening circumstances.

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

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

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

  • fear or anxiety
  • tension
  • restlessness
  • headache
  • tremor
  • weakness
  • dizziness
  • abnormal heart beat or palpitations.

The above list includes the more common side effects of your medicine. They are usually mild and short-lived.

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

  • difficulty in breathing
  • whiteness, swelling, pain or loss of feeling at the site of injection.

These side effects are serious and may need urgent medical attention.

Tell your doctor, nurse or pharmacist if you notice anything that is making you feel unwell.

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

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

Product description

What it looks like

ASPEN ADRENALINE Injection is a clear colourless solution.

Storage

ASPEN ADRENALINE Injection will be stored in the pharmacy or on the ward. It should be kept in a cool dry place, protected from light where the temperature stays below 25°C.

Ingredients

ASPEN ADRENALINE Injection contains 1 mg/mL or 1 mg/10mL of adrenaline (epinephrine) as the active ingredient.

It also contains:

  • tartaric acid
  • sodium metabisulfite
  • sodium chloride
  • water for injections.

The 1 mg/mL ampoule [adrenaline (epinephrine) 1:1,000] is available in packs of 5.

The 1 mg/10 mL ampoule [adrenaline (epinephrine) 1:10,000] is available in packs of 10.

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

Sponsor

Aspen Pharmacare Australia Pty Ltd
34-36 Chandos St
St Leonards NSW 2065
Australia

Australian Registration Numbers:

1 mg/mL: AUST R 131782

1 mg/10 mL: AUST R 162463

This leaflet was prepared in October 2017.

Published by MIMS December 2017

BRAND INFORMATION

Brand name

Aspen Adrenaline Injection

Active ingredient

Adrenaline (epinephrine)

Schedule

S3

 

1 Name of Medicine

Adrenaline (epinephrine).

2 Qualitative and Quantitative Composition

Aspen Adrenaline Injection contains adrenaline (epinephrine) 1:1000 (1 mg/mL) or 1:10,000 (1 mg/10 mL) as the active ingredient.
The excipients are tartaric acid, sodium metabisulfite, sodium chloride and water for injections. For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Solution for injection.

4 Clinical Particulars

4.1 Therapeutic Indications

Aspen Adrenaline 1:10,000.

An adjunct in the management of cardiac arrest.

Aspen Adrenaline 1:1,000.

The drug of choice in the emergency treatment of acute severe anaphylactic reactions due to insect bites, drugs and other allergens. It may also be used for the symptomatic relief of respiratory distress due to bronchospasm.

4.2 Dose and Method of Administration

Aspen Adrenaline 1:1,000 injection is preferably administered subcutaneously. It may also be administered intramuscularly but not into the buttocks. In emergency situations, adrenaline (epinephrine) may be injected very slowly intravenously but only as the dilute solution 1:10,000.
Aspen Adrenaline Injection is for single use in one patient only. Discard any residue. Adrenaline injection should not be used if it is coloured.

Cardiac arrest.

Adults.

The recommended dose is 1 mg intravenously, using 10 mL of the 1:10,000 solution. This may be repeated every three to five minutes. If given through a peripheral line, each dose should be followed by a flush of 20 mL of intravenous fluid to ensure delivery of the drug to the central compartment.
Intracardiac administration is no longer recommended.

Children.

The recommended dose is 10 microgram (0.1 mL of the 1:10,000 solution)/kg bodyweight administered intravenously. This may be repeated every three to five minutes.

Severe anaphylaxis or asthma.

Adults.

The usual initial dose is 100 to 500 micrograms (0.1 to 0.5 mL of the 1:1,000 solution) subcutaneously or intramuscularly. Subcutaneous doses may be repeated at 20 minute to four hour intervals depending on the response of the patient and the severity of the condition. In severe anaphylactic shock, slow and cautious intravenous administration may be necessary to ensure absorption of the drug. A dose of 100 to 250 micrograms (1 to 2.5 mL of the 1:10,000 solution) may be administered. Alternatively 25 to 50 micrograms (0.25 to 0.5 mL of the 1:10,000 solution) may be given intravenously every five to 15 minutes following an initial dose of 500 micrograms subcutaneously or intramuscularly.

Children.

10 microgram (0.01 mL of 1:1,000 solution)/kg bodyweight subcutaneously, repeated if necessary at intervals of 20 minutes to four hours depending on the response of the patient and the severity of the condition. Single paediatric doses should not exceed 500 micrograms.

4.3 Contraindications

Known hypersensitivity to adrenaline (epinephrine) or sympathomimetic amines.
Shock (other than anaphylactic shock).
Cardiac dilatation and coronary insufficiency.
Hypertension.
Ischaemic heart disease.
Arrhythmias.
Cerebral arteriosclerosis.
Diabetes mellitus.
Hyperthyroidism.
Narrow angle (congestive) glaucoma.
Organic brain damage.
Phaeochromocytoma.
During general anaesthesia with halogenated hydrocarbons or cyclopropane.
With local anaesthesia in fingers, toes, ears, nose or genitalia: there is a danger of vasoconstriction producing sloughing of tissues in these areas.
Labour: adrenaline (epinephrine) may delay the second stage by inhibiting spontaneous or oxytocin induced contractions of the pregnant human uterus.
Conditions in which vasopressor drugs may be contraindicated, e.g. thyrotoxicosis.
In obstetrics when maternal blood pressure is in excess of 130/80 mmHg. See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

4.4 Special Warnings and Precautions for Use

Identified precautions.

Other beta-agonist sympathomimetics.

Allow sufficient time to elapse before or after administering another beta-agonist sympathomimetic agent to avoid additive effects.

Disease states.

Use with extreme caution in the elderly, and in patients with cardiovascular disease, phenothiazine induced circulatory collapse, cerebrovascular insufficiency, diabetes, hypertension, chronic lung disease, angina pectoris, prostatic hypertrophy, psychoneurosis or hyperthyroidism.
Use with extreme caution in patients with long standing bronchial asthma and emphysema who have developed degenerative heart disease. Angina pain may be induced when coronary insufficiency is present. Syncope has occurred following administration to asthmatic children. In patients with parkinsonian syndrome the drug increases rigidity and tremor.

General anaesthesia.

Concurrent use with cyclopropane, halogenated hydrocarbon or similar volatile anaesthetics may produce fatal ventricular arrhythmias.

Diabetic patients.

A greater increase may be produced in heart rate, blood glucose, lactate, glycerol and free fatty acids when adrenaline (epinephrine) is administered to diabetic patients with autonomic neuropathy than in diabetic patients without neuropathy.

Circulatory support.

When adrenaline (epinephrine) is used for circulatory support, correction of hypovolaemia, metabolic acidosis and hypoxia or hypercapnia should be carried out beforehand or concomitantly.

Sodium metabisulfite.

This product contains sodium metabisulfite, which may cause allergic reactions in susceptible individuals. The possibility of an allergic reaction to sodium metabisulfite should be considered in asthmatic patients who show paradoxical worsening of their condition following use of the drug.

Gangrene.

Interarterial administration must be avoided as marked vasoconstriction may result in gangrene.
Local ischaemic necrosis can occur from repeated injections in one site.
Aspen Adrenaline Injection should be used only once and any residue discarded. It should not be used if it is coloured.

Use in hepatic impairment.

No data available.

Use in renal impairment.

No data available.

Use in the elderly.

No data available.

Paediatric use.

No data available.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Other sympathomimetic agents.

Adrenaline (epinephrine) should not be administered concomitantly with other sympathomimetic agents because of the possibility of additive effects and increased toxicity.

Rapidly acting vasodilators.

These can counteract the marked pressor effects of adrenaline (epinephrine).

General anaesthetics.

Administration of adrenaline (epinephrine) in patients receiving cyclopropane, halogenated hydrocarbon or similar volatile general anaesthetics that increase cardiac irritability and seem to sensitise the myocardium to adrenaline (epinephrine), may result in arrhythmias including ventricular premature contractions, tachycardia or fibrillation and acute pulmonary oedema if hypoxia is present.

Cardiovascular drugs.

Adrenaline (epinephrine) should not be used in patients receiving high dosage of other drugs, e.g. quinidine, digoxin and other cardiac glycosides, that can sensitise the heart to arrhythmias.

Antihypertensive therapy.

Special care is advisable in patients receiving antihypertensive therapy as severe hypertension may result.

Alpha-blockers.

The administration of adrenaline (epinephrine) to patients receiving alpha-blockers may result in both hypotension and cardiac accelerating effects.

Beta-blockers.

The administration of adrenaline (epinephrine) to patients receiving nonselective beta-blockers (e.g. propranolol) may result in severe hypotension, followed by a reflex bradycardia, due to stimulation of adrenergic receptors.

Central nervous system and other drugs.

Tricyclic antidepressants, some other antidepressants, some antihistamines and thyroid hormones may potentiate the effects of adrenaline (epinephrine), especially on heart rhythm and rate.
Patients on MAOIs should not receive sympathomimetic treatment.

Drugs causing potassium loss.

The hypokalaemic effect of adrenaline (epinephrine) may be potentiated by other drugs that cause potassium loss, including corticosteroids, potassium depleting diuretics and aminophylline or theophylline; patients receiving high doses of beta2-adrenergic agonists concomitantly should have their plasma potassium concentration monitored.

Hypoglycaemic agents.

Adrenaline (epinephrine) induced hyperglycaemia may lead to loss of blood sugar control in diabetic patients treated with hypoglycaemic agents.

Incompatibilities.

Adrenaline (epinephrine) is incompatible with oxidising agents, alkalis, copper, zinc, iron, silver and other metals.
Adrenaline (epinephrine) has been reported to be incompatible with solutions containing the following: aminophylline, ampicillin sodium, amylobarbitone sodium, ascorbic acid, benzylpenicillin potassium, calcium chloride, calcium gluconate, cephalothin sodium, chloramphenicol sodium succinate, chlortetracycline hydrochloride, corticotrophin, diazepam, digitoxin, ergometrine maleate, erythromycin gluceptate, frusemide, hyaluronidase, hydrocortisone sodium succinate, methicillin sodium, nitrofurantoin, noradrenaline acid tartrate, novobiocin sodium, pentobarbitone sodium, procaine, prochlorperazine edisylate, promazine hydrochloride, sodium bicarbonate, sulfadiazine sodium, suxamethonium chloride, tetracycline hydrochloride, vancomycin hydrochloride, vitamin B complex with ascorbic acid, warfarin sodium.
This list is not intended to be comprehensive. Refer to standard texts for further information.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category A)
Adrenaline (epinephrine) has been administered to a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed. However, the use of adrenaline (epinephrine) during labour is contraindicated because it may delay the second stage by inhibiting spontaneous or oxytocin induced contractions of the pregnant human uterus.
 Adrenaline (epinephrine) is excreted in the breast milk. The use of adrenaline (epinephrine) in breastfeeding women is therefore not recommended.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration 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 at www.tga.gov.au/reporting-problems.
Adrenaline (epinephrine) may cause reactions such as fear, anxiety, tenseness, restlessness, disorientation, impaired memory, confusion, irritability, hallucinations and psychotic states. Headache, weakness, dizziness, anorexia, nausea and vomiting and difficulty in micturition with urinary retention may also occur.
Muscle tremor and hypokalaemia, psychomotor agitation, pallor, respiratory difficulty, hyperglycaemia, sweating, hypersalivation, cold extremities and insomnia have also been reported.
Palpitations, tachycardia (sometimes with anginal pain) and cardiac arrhythmias may also occur along with hypertension which in some instances may induce reflex bradychardia as can vasodilation with flushing and hypotension. Ventricular fibrillation may occur and severe hypertension may lead to cerebral haemorrhage and pulmonary oedema.
Overdosage or inadvertent intravenous injection of usual subcutaneous doses of adrenaline (epinephrine) may cause hypertension.
Cerebrovascular or other haemorrhage and hemiplegia may result, especially in elderly patients. Inadvertent intravenous injection of adrenaline (epinephrine) has also been reported to have caused convulsions, metabolic acidosis and renal failure with anuria.
Repeated injections of adrenaline (epinephrine) can cause necrosis as a result of vascular constriction at the injection site. Prolonged use or overdosage of adrenaline (epinephrine) can result in severe metabolic acidosis.
Pulmonary oedema has been associated with excessive parenteral administration of adrenaline (epinephrine) and following topical aerosol application.
Gas gangrene, which can be fatal, has been reported following intramuscular injection of adrenaline (epinephrine) into the buttock or thigh. This appears to have been due to Clostridium organisms on the skin being deposited into muscle tissue during injection, with the vasoconstrictor properties of adrenaline (epinephrine) enhancing the effects of the infection (see Section 4.2 Dose and Method of Administration).
High doses may result in ventricular arrhythmias.
Rigidity and tremor may be exacerbated in patients with parkinsonism.
Syncopal episodes have been reported in children.
Psychiatric disorders may be exacerbated.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

Symptoms.

Overdosage with adrenaline (epinephrine) produces a rapid rise in blood pressure resulting in cerebrovascular haemorrhage, cardiac arrhythmias leading to ventricular fibrillation and death. Pulmonary oedema may also lead to death because of the peripheral constriction and cardiac stimulation produced.

Treatment.

To counteract the pressor effects of adrenaline (epinephrine), use rapidly acting vasodilators, e.g. nitrates or alpha-blocking agents.
Immediately telephone the Poisons Information Centre in Australia for advice on 13 11 26 and in New Zealand on 0800 POISON or 0800 764 766.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Adrenaline (epinephrine) acts on both alpha and beta-adrenergic receptors of tissues innervated by sympathetic nerves, except the sweat glands and arteries of the face. It is the most potent alpha-receptor activator. Adrenaline (epinephrine) stimulates the heart to increased output; raises the systolic blood pressure; lowers diastolic blood pressure; relaxes bronchial spasm and mobilises liver glycogen, resulting in hyperglycaemia and possibly glycosuria.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Parenterally administered adrenaline (epinephrine) has a rapid onset and short duration of action.

Distribution.

Adrenaline (epinephrine) crosses the placenta but not the blood-brain barrier. It is also distributed into breast milk (see Section 4.4 Special Precautions and Warnings for Use).

Metabolism.

The circulating drug is metabolised by the liver and other tissues. The majority is taken up and metabolised by sympathetic nerve endings.

Excretion.

Adrenaline (epinephrine) is excreted in the urine, mainly in the form of metabolites.

5.3 Preclinical Safety Data

No data available.

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

See Section 2 Qualitative and Quantitative Composition.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

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

Store below 25°C. Protect from light.

6.5 Nature and Contents of Container

It is a clear, colourless or slightly yellow solution with a pH of 2.5 to 3.5.
Ampoules, 1 mg/mL (1:1,000, clear, colourless solution), 1 mL: 5's, 50's*.
Ampoules, 0.1 mg/mL (1:10,000, clear colourless solution), 10 mL: 10's.
(* Packs of 50 not currently marketed in Australia).

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

The chemical formula is C9H13NO3 and the molecular weight is 183.2. Melting point: 205°C to 212°C.
Adrenaline (epinephrine) is a white or creamy-white, odourless, crystalline powder or granule. It darkens in colour on exposure to air and light. The BP solubilities are: practically insoluble in water, in ethanol (96%) and in methylene chloride. It dissolves in hydrochloric acid.

Chemical structure.


CAS number.

51-43-4.

7 Medicine Schedule (Poisons Standard)

S3.

Summary Table of Changes