International Medication Systems (UK) Ltd

Adrenaline (Epinephrine) Injection 1:1,000 Minijet (1ml)

Adrenaline (Epinephrine) 1mg per ml.

For excipients, see section 6.1.

Solution for injection. A clear colourless sterile solution.

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

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 0.25″ integral needle is intended for self-administration by the subcutaneous route and the presentation with the 1.5″ 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 and 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

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. Anginal pain may be induced when coronary insufficiency is present. Use with caution in patients with closed angle glaucoma.

The effects of adrenaline may be potentiated by tricyclic antidepressants. Halothane and other anaesthetics such as cyclopropane and trichloroethylene 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.

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, cold extremities, nausea, vomiting, sweating, local ischaemic necrosis. Biochemical effects include inhibition of insulin secretion and 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. Major effects are increased systolic blood pressure, reduced diastolic pressure, tachycardia, hyperglycaemia and hypokalaemia. It is a powerful cardiac stimulant. It has vasopressor properties and is a bronchodilator.

Adrenaline 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.

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 (Epinephrine) 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.

9 months. The product 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. Two presentations are available; one for patient self-administration with a 0.25″ integral needle and one for paramedic use with a 1.5″ integral needle. Both are 1ml presentations.

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

International Medication Systems (UK) Limited

208 Bath Road

Slough

Berkshire

SL1 3WE

UK

PA 255/2/2

25^th January 1978 / 25^th January 2003

January 2005