1. Name Of The Medicinal Product
Adrenaline (Epinephrine) 1:10,000 Sterile Solution Minijet®.
2. Qualitative And Quantitative Composition
Adrenaline (Epinephrine) USP 0.1mg per ml.
3. Pharmaceutical Form
Sterile aqueous solution for parenteral administration.
4. Clinical Particulars
4.1 Therapeutic Indications
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.
4.2 Posology And Method Of Administration
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).
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 or quinidine. 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 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.
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. 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.
5.2 Pharmacokinetic Properties
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.
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
Sodium Citrate Dihydrate
Sodium Chloride
Sodium Bisulphite
Hydrochloric Acid 10%w/v
Water for Injection
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
3ml - 18 months.
10ml - 24 months.
6.4 Special Precautions For Storage
Do not store above 25°C. Keep container in outer carton.
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. The product is available either as 3ml or 10ml.
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) Ltd
208 Bath Road
Slough
Berkshire
SL1 3WE
UK
8. Marketing Authorisation Number(S)
PL 03265/0011R
9. Date Of First Authorisation/Renewal Of The Authorisation
21 March 1991 / 30 August 2001
10. Date Of Revision Of The Text
14 October 2005
POM
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