International Medication Systems (UK) Ltd

Adrenaline (Epinephrine) 1:10,000 Sterile Solution Minijet^®.

Adrenaline (Epinephrine) 0.1mg per ml, in total volume presentations of 0.3mg / 3ml and 1mg / 10ml.

For excipients, see 6.1

Solution for injection.

Clear glass vials, sealed and containing a clear, colourless solution.

Adjunctive use in the management of cardiac arrest.

In cardiopulmonary resuscitation. Intracardiac puncture and intramyocardial injection of adrenaline may be effective when external cardiac compression and attempts to restore the circulation by electrical defibrillation or use of a pacemaker fail.

Ventricular fibrillation (pulseless ventricular tachycardia)

Adults:

Intravenous injection: 10ml (1mg) by intravenous injection repeated every 2-3 minutes as necessary.

Endotracheal: 20-30ml (2-3mg) via an endotracheal tube, repeated as necessary.

Intracardiac injection: 1 to 10ml (0.1 to 1mg), direct into the atrium of the heart.

Intracardiac injection should only be considered if there is no other access available. It should be undertaken by personnel trained in the technique.

Children:

Intravenous injection: Initially 0.1ml/kg body weight (10mcg/kg); e.g. 2kg infant would receive 0.2ml of Adrenaline 1:10,000. Subsequent doses should be 1ml/kg (100mcg/kg).

Intraosseous: 0.1ml/kg body weight (10mcg/kg).

Endotracheal: A dose has not been established; 10 times the intravenous dose may be appropriate.

Asystole

Adults:

Intravenous: 10ml (1mg) by intravenous injection repeated every 2-3 minutes as necessary. If there is no response after three cycles, consider injections of adrenaline 5mg.

Endotracheal: 20-30 ml (2-3mg) via an endotracheal tube, repeated as necessary.

Children:

Intravenous: 0.1ml/kg initially (10mcg/kg). If no response give 1ml/kg (100mcg/kg). After 3 cycles consider alkalising or antiarrhytmic agents.

Intraosseus: 0.1 ml/kg initially (10mcg/kg). If no response give 1ml/kg (100mcg/kg). After 3 cycles consider alkalising or antiarrhythmic agents.

Electromechanical Dissociation (EMD)

Adults:

Intravenous: 10ml (1mg) by intravenous injection repeated every 2-3 minutes as necessary. If normal rhythm does not return after standard measures, consider adrenaline 5mg intravenous.

Children:

Intravenous: 0.1ml/kg initially (10mcg/kg) every 3 minutes, until underlying cause identified. Subsequent doses should be 1ml/kg (100mcg/kg).

Contraindications are relative as this product is intended for use in life-threatening emergencies.

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

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.

The effects of adrenaline may be potentiated by tricyclic antidepressants. Halothane can 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 or quinidine. Adrenaline –induced hyperglycaemia may lead to loss of blood-sugar control in diabetic patients treated with hypoglycaemic agents.

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

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

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

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. Symptomatic adverse effects are anxiety, dyspnoea, restlessness, palpitations, tachycardia, tremor, weakness, dizziness, headache and cold extremities. Biochemical effects include inhibition of insulin secretion, stimulation of growth hormone secretion, hyperglycaemia (even with low doses), gluconeogenesis, glycolysis, lipolysis and ketogenesis.

Symptoms: cardiac arrhythmias leading to ventricular fibrillation and death; severe hypertension leading to pulmonary oedema and cerebral haemorrhage.

Treatment: combined alpha- and beta-adrenergic blocking agents such as labetalol may counteract the effects of adrenaline, or a beta-blocking agent may be used to treat any supraventricular arrhythmias and phentolamine to control the alpha-mediated effects on the peripheral circulation. Rapidly acting vasodilators such as nitrates and sodium nitroprusside may also be helpful.

Immediate resuscitation support must be available.

Adrenaline is a direct-acting sympathomimetic agent exerting its effect on alpha- and beta-adrenoceptors. The overall effect of adrenaline depends on the dose used, and may be complicated by the homeostatic reflex responses. In resuscitation procedures it is used to increase the efficacy of basic life support. It is a positive cardiac inotrope. Major effects are increased systolic blood pressure, reduced diastolic pressure (increased at higher doses), tachycardia, hyperglycaemia and hypokalaemia.

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

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

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

Citric Acid Monohydrate

Sodium Citrate Dihydrate

Sodium Chloride

Sodium Bisulphite

Dilute Hydrochloric Acid

Water for Injection

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

3ml - 18 months unopened.

10ml - 24 months unopened.

The solution should be used immediately after opening. Discard any unused portion.

Do not store above 25°C. Keep container in outer carton.

The solution is contained in a USP type I glass vial with an elastomeric closure which meets all the relevant USP specifications. The product is available either as 3ml or 10ml.

The container is specially designed for use with the IMS Minijet injector. Do not use if discoloured.

International Medication Systems (UK) Ltd

208 Bath Road

Slough

Berkshire

SL1 3WE

UK

PA 255/2/3

25 January 1978 / 25 January 2003

August 2005.

POM