EPINEPHRINE (ADRENALINE) INJECTION 1:1000 MINIJET - summary of medicine characteristics

Summary of medicine characteristics - EPINEPHRINE (ADRENALINE) INJECTION 1:1000 MINIJET

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Epinephrine (Adrenaline) Injection 1:1,000 MinijetTM

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Adrenaline (Epinephrine) 1mg per ml.

Excipient: sodium metabisulfite (E223) 2.5mg in 1ml and total sodium 3mg in 1ml.

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Sterile aqueous solution for intramuscular or subcutaneous administration.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Emergency treatment of anaphylaxis or acute angioneurotic oedema with airways obstruction, or acute allergic reactions.

4.2 Posology and method of administration

For the relief of life-threatening angioneurotic oedema and anaphylactic shock, adrenaline should be administered by intramuscular injection.

For acute allergic reactions due to insect stings etc: Intramuscular or subcutaneous injection.

The presentation with the 1" integral needle is for paramedic use by subcutaneous or intramuscular injection.

Adults and children over 12 years: 0.5ml (0.5mg), administered slowly. The dose may be repeated every 5 to 15 minutes as needed.

This presentation may not be suitable for small or prepubertal patients over 12 years of age who require a smaller dose.

Elderly: as for adults, use with caution.

Children (up to age of 12): not recommended

4.3 Contraindications

Contraindications are relative as this product is intended for use in lifethreatening emergencies.

Other than in the emergency situation, the following contraindications should be considered: hyperthyroidism, hypertension, ischaemic heart disease, diabetes mellitus, closed angle glaucoma and hypersensitivity to sympathomimetic amines.

4.4 Special warnings and precautions for use

These special warnings and precautions are relative as this product is intended for use in life-threatening situations.

Administer slowly with caution to elderly patients and to patients with ischaemic heart disease, hypertension, diabetes mellitus, hyperthyroidism or 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 pre-existing cardiac arrhythmias. Tissue necrosis at injection site may arise if this product is administered to an inappropriate injection site such as digits or buttocks.

Administer with caution: In patients suffering from autonomic dysreflexia (hyperreflexia), particularly in spinal cord injury (e.g., tetraplegics). Patients with hypersensitivity to sulfites and patients with prostatic hypertrophy or urination difficulty.

Endotracheal administration of adrenaline can contaminate the colorimeter carbon dioxide detector and lead to its false positive colour change (fixed yellow discoloration).

This medicinal product contains less than 1 mmol sodium per ml (3mg/ml), i.e. essentially ‚sodium-free‘

This medicinal product contains sodium metabisulfite which may rarely cause severe hypersensitivity reactions and bronchospasm.

4.5 Interaction with other medicinal products and other forms of interaction

The effects of adrenaline may be potentiated by tricyclic antidepressants. Volatile liquid anaesthetics such as halothane increase the risk of adrenaline-induced ventricular arrhythmias and acute pulmonary oedema if hypoxia is present. Severe hypertension and bradycardia may occur with non-selective beta-blocking drugs such as propranolol. Propranolol also inhibits the bronchodilator effect of adrenaline. The risk of cardiac arrhythmias is higher when adrenaline is given to patients receiving digoxin, quinidine, fluorohydrocarbons or cocaine. Adrenaline -induced hyperglycaemia may lead to loss of blood-sugar control in diabetic patients treated with hypoglycaemic agents.

The vasoconstrictor and pressor effects of adrenaline, mediated by its alpha-adrenergic action, may be enhanced by concomitant administration of drugs with similar effects, such as ergot alkaloids or oxytocin. Adrenaline specifically reverses the antihypertensive effects of adrenergic neurone blockers such as guanethidine with the risk of severe hypertension.

Concurrent use or use within 2 weeks of monoamine oxidase inhibitor increases risk of adverse events. Sympathomimetic drugs (e.g. isoproterenol) increase the risk of serious cardiac arrhythmias. Alpha blockers increase the risk of hypotension and tachycardia. Drugs which cause potassium loss (corticosteroids, potassium-depleting diuretic, aminophylline, theophylline) increases the risk of hypokalemia. Adrenaline increases the risk of cardiac adverse effects of levodopa.

Use of Entacapone may potentiate the chronotropic and arrhythmogenic effects of adrenaline.

4.6 Fertility, pregnancy and lactation

Epinephrine crosses the placenta. There is some evidence of a slightly increased incidence of congenital abnormalities. Injection of adrenaline may cause foetal tachycardia, cardiac irregularities, extra systoles and louder heart sounds. In labour, adrenaline may delay the second stage. Epinephrine should only be used in pregnancy if the potential benefits outweigh the risks to the foetus.

Epinephrine is excreted in breast milk, but as pharmacologically active plasma concentrations are not achieved by the oral route, the use of adrenaline in breastfeeding mothers is presumed to be safe.

4.7 Effects on ability to drive and use machines

Not applicable; this preparation is intended for use only in emergencies.

4.4 Undesirable effects

Psychiatric disorders

Anxiety

Restlessness

Nervous system disorders

Cerebral haemorrhage due to hypertension

Headache

Dizziness

Tremor

Cardiac disorders

The potentially severe adverse effects of adrenaline arise from its effect upon blood pressure and cardiac rhythm.

Ventricular fibrillation

Myocardial ischaemia

Myocardial infarction

Stress cardiomyopathy

Pulmonary oedema due to hypertension

Dyspnoea

Palpitations

Tachycardia

Anginal pain

Vascular disorders

Bowel necrosis

Cold extremities

Renal and urinary disorders

Difficulty in micturition and urinary retention.

General disorders and administration site conditions

Pallor

Weakness

Nausea

Vomiting

Sweating

Local ischaemic necrosis

Biochemical effects include inhibition of insulin secretion, stimulation of growth hormone secretion, hyperglycaemia (even with low doses), involvement in the processes of gluconeogenesis, glycolysis, lipolysis and ketogenesis.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation 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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Epinephrine is a direct-acting sympathomimetic agent exerting its effect on alpha-and beta-adrenoceptors. Major effects are increased systolic blood pressure, reduced diastolic pressure (increased at higher doses), tachycardia, hyperglycaemia and hypokalaemia. It is a powerful cardiac stimulant. It has vasopressor properties and is a bronchodilator.

5.2 Pharmacokinetic properties

Epinephrine is rapid in onset and of short duration and 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 i.v. infusion the half-life is approximately 5–10 minutes.

Epinephrine is rapidly metabolised in the liver and tissues by oxidative deamination and O-methylation followed by reduction or by conjugation with glucuronic acid or sulfate. Up to 90% of the i.v. dose is excreted in the urine as metabolites.

5.3 Preclinical safety data

Not applicable since Epinephrine (Adrenaline) Injection has been used in clinical practice for many years and its effects in man are well known.

6.1 List of excipients

Citric Acid Monohydrate

Sodium Citrate (E331)

Sodium Chloride

Sodium Metabisulfite (E223)

Dilute Hydrochloric Acid (for pH adjustment)

Water for Injection

6.2 Incompatibilities

Epinephrine should not be mixed with sodium bicarbonate; the solution is oxidised to adrenochrome and then forms polymers.

6.3 Shelf life

18 months.

6.4 Special precautions for storage

Store below 25°C. Protect from light.

6.5 Nature and contents of container

The solution is contained in a 1ml Type I glass syringe with a 1” integral needle, polystyrene plunger rod and latex-free bromobutyl rubber plunger stopper.