1. Name Of The Medicinal Product
Adrenaline (Epinephrine) Injection 1:1,000 Minijet.
2. Qualitative And Quantitative Composition
Adrenaline (Epinephrine) 1mg per ml.
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 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: 0.5 ml (0.5 mg), 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 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.
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.
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.
4.6 Pregnancy And Lactation
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.
4.7 Effects On Ability To Drive And Use Machines
Not applicable; this preparation is intended for use only in emergencies.
4.8 Undesirable Effects
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, anginal pain, 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.
4.9 Overdose
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.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
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.
5.2 Pharmacokinetic Properties
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.
5.3 Preclinical Safety Data
Not applicable since Adrenaline (Epinephrine) Injection has been used in clinical practice for many years and its effects in man are well known.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Citric Acid Monohydrate USP
Sodium Citrate Dihydrate USP
Sodium Chloride USP
Sodium Bisulphite USP
Hydrochloric Acid 10% w/v USP
Water for Injection USP
6.2 Incompatibilities
Adrenaline should not be mixed with sodium bicarbonate; the solution is oxidised to adrenochrome and then forms polymers.
6.3 Shelf Life
9 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 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.
6.6 Special Precautions For Disposal And Other Handling
The container is specially designed for use with the IMS Minijet injector.
7. Marketing Authorisation Holder
International Medication Systems (UK) Limited
208 Bath Road
Slough
Berkshire
SL1 3WE
UK
8. Marketing Authorisation Number(S)
PL 03265/0030
9. Date Of First Authorisation/Renewal Of The Authorisation
Date first granted: 8 February 1978
Date renewed: 31 August 2000
10. Date Of Revision Of The Text
14 October 2005
POM
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