ADRENALINE-LINK

MIMS Revision Date: 01 January 2026

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.
Do not use if solution is discoloured.
(See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

4.4 Special Warnings and Precautions for Use

The patient/carer should be informed about the possibility of biphasic anaphylaxis which is characterised by initial resolution followed by recurrence of symptoms sometime later.
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. 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.
In patients with high intraocular pressure in angle-closure glaucoma, adrenaline dilates the pupil (mydriasis) and produces an acute episode of angle-closure. Adrenaline reduces intraocular pressure in open-angle glaucoma, decreasing aqueous formation and increasing outflow facility.
The risk of toxicity is increased if the following conditions are pre-existing: structural cardiac disease, severe obstructive cardiomyopathy, hypokalaemia, hypercalcaemia, severe renal impairment, patients taking monoamine oxidase (MAO) inhibitors (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions), patients taking concomitant medication which results in additive effects, or sensitises the myocardium to the actions of sympathomimetic agents (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Prolonged use of adrenaline can result in severe metabolic acidosis because of elevated blood concentrations of lactic acid.
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 vasoconstrictive and hypertensive effects of adrenaline are antagonised by alpha-adrenergic blocking agents such as ergot alkaloids and phentolamine. The administration of adrenaline (epinephrine) acid tartrate to patients receiving alpha-blockers may result in both hypotension and cardiac accelerating effects.
Beta-blockers. The administration of adrenaline (epinephrine) acid tartrate to patients receiving nonselective beta-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, monoamine oxidase inhibitors (MAO inhibitors), catechol-O-methyl transferase inhibitors (COMT inhibitors), theophylline, oxytocin, parasympatholytics, some antihistamines, thyroid hormones, levodopa and alcohol 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 beta₂-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. It may be necessary for diabetic patients receiving adrenaline to increase their dosage of insulin or oral hypoglycaemic drugs.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility. No data available.
Use in pregnancy. (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.
Use in lactation. 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 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action. Adrenaline (epinephrine) acid tartrate 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) 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.

Date of First Approval

24 June 2005

Date of Revision

10 November 2025

Summary Table of Changes