Consumer medicine information

Adrenaline-Link

Adrenaline (epinephrine)

BRAND INFORMATION

Brand name

Adrenaline-Link Injection BP

Active ingredient

Adrenaline (epinephrine)

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Adrenaline-Link.

What is in this leaflet

This leaflet answers some of the common questions people ask about Adrenaline-Link. It does not contain all the information that is known about Adrenaline-Link.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor will have weighed the risks of you using Adrenaline-Link against the benefits they expect it will have for you.

If you have any concerns about using this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Adrenaline-Link is used for

Adrenaline-Link is usually only given in cases of extreme emergency.

Adrenaline-Link may be used following a heart attack, or to make the heart beat if it has stopped.

Adrenaline-Link 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 beat more strongly. Adrenaline-Link also 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.

Adrenaline-Link is not addictive.

Before you use Adrenaline-Link

When you must not use it

Adrenaline-Link is an emergency life-saving product.

However, it should be given with care if you have an allergy to:

  • Adrenaline
  • sodium metabisulfite
  • or any other ingredients listed at the end of the 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

Do not use Adrenaline-Link if:

  • you are pregnant unless your doctor says so.
    Your doctor will discuss the possible risks and benefits of using Adrenaline-Link during pregnancy.
  • you are in labour.
    Adrenaline-Link can stop the contractions in the womb during labour.

Do not use Adrenaline-Link after the use-by (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 start using this medicine, talk to your doctor.

Before you start to use 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 problems
  • angina or chest pains
  • high blood pressure
  • irregular heart rate
  • high pressure in the eyes (glaucoma)
  • diabetes
  • brain damage
  • over active thyroid gland
  • lung disease
  • stroke
  • phaeochromocytoma (rare tumour of the adrenal gland)

Tell your doctor if you are breastfeeding. Adrenaline-Link passes into breastmilk and there is a possibility that your baby may be affected. Your doctor can discuss with you the risks and benefits of using it during breastfeeding.

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 Adrenaline-Link may interfere with each other. These include:

  • some medicines used to treat coughs and colds
  • medicines used to treat depression such as monoamine oxidase inhibitors
  • medicines which affect potassium levels such as diuretics, theophylline
  • medicines used for high blood pressure or heart conditions
  • medicines to treat high blood sugar
  • general anaesthetics

These medicines may be affected by Adrenaline-Link or may affect how well it works. You may need different amounts of your medicines, or you may need to use different medicines.

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

If you have not told your doctor about any of these things, tell them before you are given any Adrenaline-Link.

How to give Adrenaline-Link

How to use it

Adrenaline-Link will normally be given to you by your doctor or by a specially trained nurse.

If you have to give Adrenaline-Link, your doctor will have told you what dose to use. Follow all directions given to you by your doctor carefully.

This may differ from the information contained in this leaflet.

The injection will usually be given just under the skin, however it can also be given into the muscle, or straight into the vein. Adrenaline-Link should not be given into the buttocks.

Children will be given a lower dose of Adrenaline-Link depending on their weight.

For patients using the injection for an allergic reaction emergency:

If you get an allergic reaction as described by your doctor, use Adrenaline-Link immediately. Keep the medicine ready to use at all times.

This medicine is for injection only. If you will be giving yourself or anybody else injections, make sure you know how to give them. Ask your doctor if you are unsure. If you have to use Adrenaline-Link in an emergency tell your doctor immediately, or go to Accident and Emergency at your nearest hospital. You may need further medical treatment.

If you use too much (overdose)

The doctor or nurse giving you Adrenaline-Link will be experienced 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 Adrenaline-Link, tell your doctor or nurse immediately.

If you have to give Adrenaline-Link, 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 (telephone 13 11 26) for advice or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have used too much Adrenaline-Link. 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.

While you are using Adrenaline-Link

Things you must not do

Do not use Adrenaline-Link to treat any other complaints unless your doctor tells you to.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are being given Adrenaline-Link.

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.

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

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

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

  • fear, anxiety, confusion
  • tenseness
  • restlessness
  • headache
  • tremor
  • weakness
  • dizziness
  • cold hands and feet
  • nausea and vomiting
  • difficulty passing urine

These side effects are usually mild.

Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following:

  • difficulty in breathing
  • whiteness, swelling, pain or loss of feeling at the site of injection
  • convulsions, fits or seizures
  • abnormal heart beat or palpitations

These are all serious side effects. You may need urgent medical attention

Serious side effects are rare.

Tell your doctor or pharmacist if you notice anything else that is making you feel unwell. Other side effects not listed above may also occur in some people.

After using Adrenaline-Link

Storage

If you are storing Adrenaline-Links at home, they should be stored in the original pack in a cool dark place where the temperature stays below 25°C.

Do not store it or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop using Adrenaline-Link or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

Adrenaline-Link is a clear, colourless solution.

Adrenaline-Link 1:1,000 1mg/1mL contains adrenaline (epinephrine) acid tartrate as the active ingredient, plus

  • Sodium metabisulfite
  • Sodium chloride
  • Sodium hydroxide or hydrochloric acid for pH adjustment
  • Water for Injections.

Adrenaline-Link 1:10,000 1mg/10mL contains adrenaline (epinephrine) acid tartrate as the active ingredient, plus

  • Sodium metabisulfite
  • Sodium chloride
  • Sodium citrate dihydrate
  • Citric acid monohydrate
  • Dilute hydrochloric acid for pH adjustment
  • Water for Injections.

Adrenaline-Link is available in:

Adrenaline-Link 1:1,000 1mg/1mL packs of 5, 10 and 50* clear glass ampoules.

Adrenaline-Link 1:10,000 1mg/10mL in packs of 10 clear glass ampoules.

Adrenaline-Link 1:10,000 1mg/10mL in a single dose pack of clear glass Pre-Filled Syringes.

(*pack size not marketed in Australia)

Sponsor

Link Medical Products Pty Ltd
5 Apollo Street
Warriewood
NSW 2102.

Australian Registration Numbers:

1mg/1mL ampoule: AUST R 12048

1mg/10mL ampoule: AUST R 119194

1mg/10mL Pre-Filled Syringe AUST R 210672

This leaflet was prepared in August 2020.

Published by MIMS October 2020

BRAND INFORMATION

Brand name

Adrenaline-Link Injection BP

Active ingredient

Adrenaline (epinephrine)

Schedule

S3

 

1 Name of Medicine

Adrenaline (epinephrine) acid tartrate.

2 Qualitative and Quantitative Composition

Adrenaline-Link 1:1,000 1 mg/1 mL: Adrenaline (epinephrine) acid tartrate 1 mg in 1 mL ampoules.
Adrenaline-Link 1:10,000 1 mg/10 mL: Adrenaline (epinephrine) acid tartrate 1 mg in 10 mL ampoules.
Adrenaline-Link 1:10,000 1 mg/10 mL: Adrenaline (epinephrine) acid tartrate 1 mg in 10 mL pre-filled syringe.

Excipients with known effect.

Contains sulfites.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Adrenaline (epinephrine) acid tartrate solution for injection is a clear, colourless solution and should not be used if it is coloured.

4 Clinical Particulars

4.1 Therapeutic Indications

Adrenaline-Link 1:10,000 1 mg/10 mL is used as an adjunct in the management of cardiac arrest.
Adrenaline-Link 1:1,000 1 mg/1 mL is 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

The 1:1,000 (1 mg/1 mL) injection is preferably administered subcutaneously. It may also be administered intramuscularly but not in the buttocks.
In emergency situations, adrenaline (epinephrine) acid tartrate may be injected very slowly intravenously but only as the dilute solution 1:10,000.
Adrenaline-Link injection contains no antimicrobial agent. It should be used only once and any residue discarded. Adrenaline (epinephrine) acid tartrate 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 3-5 minutes. If given through a peripheral line, each dose should be followed by a flush of 20 mL of IV fluid to ensure delivery of the drug to the central compartment.
Intracardiac administration is no longer recommended.

Children.

The recommended dose is 10 micrograms (0.1 mL of the 1:10,000 solution) per kg bodyweight administered intravenously. This may be repeated every 3-5 minutes.

Severe anaphylaxis or asthma.

Adults.

The usual initial dose is 100 to 500 microgram (0.1 to 0.5 mL of the 1:1,000 solution) SC or IM. SC doses may be repeated at 20 minute to 4 hour intervals depending on the response of the patient and the severity of the condition.
In severe anaphylactic shock, slow and cautious IV administration may be necessary to ensure absorption of the drug. A dose of 100 to 250 microgram (1 to 2.5 mL of the 1:10,000 solution) may be administered. Alternatively 25 to 50 microgram (0.25 to 0.5 mL of the 1:10,000 solution) may be given IV every 5 to 15 minutes following an initial dose of 500 microgram SC or IM.

Children.

10 microgram (0.01 mL of 1:1,000 solution) per kg bodyweight SC, repeated if necessary at intervals of 20 minutes to 4 hours depending on the response of the patient and the severity of the condition. Single paediatric doses should not exceed 500 microgram.

4.3 Contraindications

Known hypersensitivity to 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: it 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

Other beta-agonist sympathomimetics.

Allow sufficient time to elapse before or after administering another β-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. Anginal 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) acid tartrate is administered to diabetic patients with autonomic neuropathy than in diabetics without neuropathy.

Circulatory support.

When adrenaline (epinephrine) acid tartrate is used for circulatory support, correction of hypervolaemia, 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.

Intra-arterial administration must be avoided as marked vasoconstriction may result in gangrene.
Local ischaemic necrosis can occur from repeated injections in one site.

Use in the elderly.

See Section 4.4 Special Warnings and Precautions for Use, Disease states.

Paediatric use.

See Section 4.4 Special Warnings and Precautions for Use, Disease states.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Other sympathomimetic agents.

Adrenaline (epinephrine) acid tartrate 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) acid tartrate.

General anaesthetics.

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

Cardiovascular drugs.

Adrenaline (epinephrine) acid tartrate 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) acid tartrate to patients receiving α-blockers may result in both hypotension and cardiac accelerating effects.

Beta-blockers.

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

CNS and other drugs.

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

Drugs causing potassium loss.

The hypokalaemic effect of adrenaline (epinephrine) acid tartrate may be potentiated by other drugs that cause potassium loss, including corticosteroids, potassium depleting diuretics and aminophylline or theophylline; patients receiving high doses of β2-adrenergic agonists concomitantly should have their plasma potassium concentration monitored.

Hypoglycaemic agents.

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

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category A)
Adrenaline (epinephrine) acid tartrate 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) acid tartrate 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) acid tartrate is excreted in the breast milk. The use of adrenaline (epinephrine) acid tartrate 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)

Adrenaline (epinephrine) acid tartrate 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 bradycardia 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 IV injection of usual subcutaneous doses of adrenaline (epinephrine) acid tartrate may cause hypertension. Cerebrovascular or other haemorrhage and hemiplegia may result, especially in geriatric patients. Inadvertent IV injection of adrenaline (epinephrine) acid tartrate has also been reported to have caused convulsions, metabolic acidosis and renal failure with anuria.
Repeated injections of adrenaline (epinephrine) acid tartrate can cause necrosis as a result of vascular constriction at the injection site. Prolonged use or overdosage of adrenaline (epinephrine) acid tartrate can result in severe metabolic acidosis.
Pulmonary oedema has been associated with excessive parenteral administration of adrenaline (epinephrine) acid tartrate and following topical aerosol application.
Gas gangrene, which can be fatal, has been reported following intramuscular injection of adrenaline (epinephrine) acid tartrate 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) acid tartrate 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.

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.

4.9 Overdose

Symptoms.

Overdosage with adrenaline (epinephrine) acid tartrate 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) acid tartrate, use rapidly acting vasodilators, for instance nitrates or α-blocking agents.
For information on the management of overdose, contact the Poison Information Centre on 131 126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Adrenaline (epinephrine) acid tartrate acts on both α and β-adrenergic receptors of tissues innervated by sympathetic nerves, except the sweat glands and arteries of the face. It is the most potent α-receptor activator. Adrenaline (epinephrine) acid tartrate 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

Parenterally administered adrenaline (epinephrine) acid tartrate has a rapid onset and short duration of action. The circulating drug is metabolised by the liver and other tissues. The majority is taken up and metabolised by sympathetic nerve endings.
Adrenaline (epinephrine) acid tartrate is excreted in the urine, mainly in the form of metabolites.
Adrenaline (epinephrine) acid tartrate crosses the placenta but not the blood brain barrier. It is also distributed into breast milk (see Section 4.6 Fertility, Pregnancy and Lactation).

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available

6 Pharmaceutical Particulars

6.1 List of Excipients

Adrenaline-Link 1:1000 1 mg/1 mL: sodium metabisulfite, sodium chloride, water for injections and sodium hydroxide or hydrochloric acid is used for pH adjustment, pH 2.8 to 3.6.
Adrenaline-Link 1:10,000 1 mg/10 mL: sodium metabisulfite, sodium chloride, sodium citrate dihydrate and citric acid monohydrate, water for injections and dilute hydrochloric acid is used for pH adjustment, pH 2.5 to 3.5.

6.2 Incompatibilities

Adrenaline (epinephrine) acid tartrate is incompatible with oxidising agents, alkalis, copper, zinc, iron, silver and other metals.
Adrenaline (epinephrine) acid tartrate 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, furosemide (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.

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

Ampoules, glass type I clear: 1 mg in 1 mL (1:1,000) 1 mL ampoules in packs of 5, 10 and 50*.
1 mg in 10 mL (1:10,000) 10 mL ampoules in packs of 10.
Pre-filled syringe, glass type I clear: 1 mg in 10 mL (1:10,000) 10 mL pre-filled syringe in a pack of 1.
(*Pack size not marketed in Australia).

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

Chemical structure.


CAS number.

51-42-3.

7 Medicine Schedule (Poisons Standard)

Schedule 3 - Pharmacist Only Medicine.

Summary Table of Changes