Adrenaline Sintetica 1 mg/ml

/ CTS

This medicinal product can be administered by intramuscular (I.M.), subcutaneous (S.C.) and intravenous (I.V.) injection, and in extremely serious cases and if the intravenous route is not practicable, via the intracardiac route.
The intravenous and intracardiac routes must be used in the hospital setting, after dilution of the solution in 0.9% sodium chloride solution and under cardiac monitoring. This medicinal product will be administered by healthcare personnel. It must be diluted in 0.9% sodium chloride solution to 1:10,000 before I.V. or intracardiac administration. To prevent degradation by light or oxidation, it is recommended that the product be used immediately after dilution. The dosage and route of administration depend on the diagnosis and the clinical condition of patients. In an emergency situation, a rapid route of absorption should be used.
Acute asthma attacks, allergic reactions and anaphylactic shock:
The usual dose for the treatment of acute asthma attacks and allergic reactions in adults is 0.3-0.5 mg (0.3-0.5 ml) by I.M. or subcutaneous injection, with the I.M. route being the quickest and most effective. In the case of anaphylactic shock, the I.M. route or, in very serious cases and in the hospital setting, the I.V. route must be used. If necessary, the administration can be repeated after 15-20 minutes and then at intervals of 4 hours. In serious conditions, the dose can be increased up to 1 mg (1 ml).
In elderly patients, the recommended doses are the same as for adults, but special caution is needed.
The usual dose for children is 0.01 mg (0.01 ml) per kg of body weight either by intramuscular or subcutaneous injection up to a maximum dose of 0.5 mg (0.5 ml). If necessary, the administration can be repeated after 15-20 minutes and then at intervals of 4 hours.
Cardiac arrest and cardiopulmonary resuscitation:
For the treatment of cardiac arrest and cardiopulmonary resuscitation, the recommended dose of epinephrine (adrenaline) is 1 mg by intravenous injection which must be administered after dilution in 0.9% sodium chloride solution to 1:10,000 and can be repeated every 3-5 minutes as many times as necessary.
In children, the standard dose is 0.01 mg/kg by intravenous injection, which can be repeated every 5 minutes if necessary.
When the intravenous route is not practicable, the intracardiac route can be used (using the same diluted solution). However, it should be borne in mind that this route presents serious risks and should only be used if the intravenous route is persistently inaccessible.
The lowest dose that produces relief should be used. For acute asthma attacks, low doses administered at the outset are more effective than higher doses administered later. Patients who frequently receive adrenaline (and other sympathomimetics), such as asthmatic patients, may develop tolerance and therefore require increased doses to achieve the same therapeutic effect. In advanced cases, this may lead to resistance or refractoriness to the clinical effects of this medicinal product.

This medicinal product is indicated in the following situations:
• Spasm of the airways in acute asthma attacks.
• Rapid relief of allergic reactions to drugs or other substances.
• Emergency treatment of anaphylactic shock.
• Cardiac arrest and cardiopulmonary resuscitation (physical measures should be used first).

* Hypersensitivity to epinephrine, sympathomimetics or to any of the excipients
* Should not be used during labour or with local anaesthesia of peripheral structures including digits, ear lobe.
* Should not be used in the presence of ventricular fibrillation.
* Should not be used in the presence of cardiac dilatation, coronary insufficiency, organic brain disease or arteriosclerosis, except in emergencies where the potential benefit clearly outweighs the risk.
See prescribing information for full details

* Epinephrine should be administered with special caution in: elderly patients, patients with hyperthyroidism, diabetes mellitus, phaeochromocytoma, narrow angle glaucoma, hypokalaemia, hypercalcaemia, severe renal impairment and prostatic adenoma leading to residual urine, cerebrovascular disease, organic brain damage, in patients with shock (other than anaphylactic shock) and in organic heart disease or cardiac dilatation (severe angina pectoris, obstructive cardiomyopathy, hypertension) as well as most patients with arrhythmias. Anginal pain maybe induced when coronary insufficiency is present.
* Repeated local administration may produce necrosis at the sites of injection.
* Intramuscular injections of Epinephrine into the buttocks should be avoided because of the risk of tissue necrosis.
* IV route for injection of epinephrine must be used with extreme caution.
* Prolonged administration may induce metabolic acidosis, renal necrosis and epinephrine-fastness or tachyphylaxis.
* Epinephrine should be avoided or used with extreme caution in patients undergoing anaesthesia with halothane or other halogenated anaesthetics, in view of the risk of inducing ventricular fibrillation. Do not mix with other agents unless compatibility is known.
* Should not be used during the second stage of labour. Accidental intravascular injection may result in cerebral haemorrhage due to the sudden rise in blood pressure.
* Monitor as soon as possible (pulse, blood pressure, ECG, pulse oximetry) in order to assess the response to epinephrine.
See prescribing information for full details.

Common:  Fear, anxiety, throbbing headache, dyspnoea, sweating and nausea, vomiting, trembling, dizziness, tachycardia, palpitations, pallor, a (modest) increase in blood pressure.
See prescribing information for full details.

Alpha-adrenergic blocking agents:
Alpha-blockers such as phentolamine antagonise the vasoconstriction and hypertension effects of epinephrine. This effect may be beneficial in epinephrine overdose.
Beta-adrenergic blocking agents:
Severe hypertension and reflex bradycardia may occur with non-cardioselective beta-blocking agents such as propranolol, due to alpha-mediated vasoconstriction. Beta-blockers, especially non-cardioselective agents, also antagonise the cardiac and bronchodilator effects of epinephrine. Patients with severe anaphylaxis who are taking non-cardioselective beta-blockers may not respond to epinephrine treatment.
General Anaesthetics:
Administration of epinephrine in patients receiving halogenated hydrocarbon general anaesthetics that increase cardiac irritability and seem to sensitise the myocardium to epinephrine may result in arrhythmias including ventricular premature contractions, tachycardia or fibrillation
Antihypertensive agents:
Epinephrine reverses the antihypertensive effects of adrenergic neurone blockers such as guanethidine, with the risk of severe hypertension. Epinephrine increases blood pressure and may antagonise the effects of antihypertensive drugs.
Antidepressant agents:
Tricyclic antidepressants such as imipramine inhibit reuptake of directly acting sympathomimetic agents, and may potentiate the effect of epinephrine, increasing the risk of development of hypertension and cardiac arrhythmias. Although monoamine oxidase (MAO) is one of the enzymes responsible for Epinephrine metabolism, MAO inhibitors do not markedly potentiate the effects of epinephrine.
Phenothiazines:
Phenothiazines block alpha-adrenergic receptors. Epinephrine should not be used to counteract circulatory collapse or hypotension caused by phenothiazines since a reversal of the pressor effects of Epinephrine may result in further lowering of blood pressure.
Other drugs:
Epinephrine should not be used in patients receiving high dosage of other drugs (e.g. cardiac glycosides) that can sensitise the heart to arrhythmias. Some antihistamines (e.g. diphenhydramine) and thyroid hormones may potentiate the effects of Epinephrine, especially on heart rhythm and rate.
Hypokalaemia:
The hypokalaemic effect of epinephrine may be potentiated by other drugs that cause potassium loss, including corticosteroids, potassium-depleting diuretics, aminophylline and theophylline.
Hyperglycaemia:
Epinephrine-induced hyperglycaemia may lead to loss of blood sugar control in diabetics treated with insulin or oral hypoglycaemic agents.
See prescribing information for full details.

Pregnancy:
No adequate and well-controlled studies have been conducted in humans. However, animal studies have demonstrated that adrenaline produces teratogenic effects when administered at doses several times higher than the human doses. The use of this medicinal product during pregnancy is only accepted if the potential benefits justify the possible risks to the foetus.
If used during pregnancy, adrenaline may cause anoxia to the foetus. It is not recommended for use during labour, as its relaxing effect on the muscles of the uterus may delay the second stage by inhibiting spontaneous or oxytocin-induced contractions, and may even cause a prolonged period of uterine atony with haemorrhage if doses are high.
Lactation:
Adrenaline is excreted in breast milk. Due to the potential risk of serious adverse effects in the infant, it is recommended that breast-feeding be discontinued or administration be avoided.

Symptoms:
Restlessness, confusion, pallor, tachycardia, bradycardia, cardiac arrhythmias and cardiac arrest.
Emergency treatment and antidotes:
Treatment is primarily symptomatic and supportive. Prompt injection of a rapidly-acting alpha-adrenoceptor blocking agent such as phentolamine, followed by a beta-blocker such as propranolol, has been tried to counteract the pressor and arrhythmogenic effects of epinephrine. A rapidly-acting vasodilator such as glycetyl trinitrate has also been used.

Store in the original package below 25ºC. Protect from light. In case of prolonged administration (e.g. infusion), it must be performed protected from light.