- Approval Id
- c832f26e342d24fa
- Drug Approval Emc Name
- Adrenaline (Epinephrine) Injection 1:10,000 (glass prefilled syringe)
- Drug Name
- Adrenaline (Epinephrine) Injection 1:10,000 (glass prefilled syringe)
- Company Name
- Martindale Pharma, an Ethypharm Group Company
- Company Address
- Jupiter House, Mercury Park, Wooburn Green, High Wycombe, Buckinghamshire, HP10 0HH, UK
- Company Website
- http://ethypharm.co.uk/
- Company Telephone
- +44 (0) 1277 266 600
- Company Medical Info Email
- medinfo@ethypharm.com
- Atc Code
- C01CA24
- Legal Category
- Prescription only medicine
- Authorisation Holder
- Aurum Pharmaceuticals Ltd
Bampton Road,
Harold Hill,
Romford,
Essex RM3 8UG
- Authorisation Number
- PL 12064/0006
- Authorisation Date
- 04 September 1996
- Instruction Authorisation Holder
- Aurum Pharmaceuticals Ltd
Bampton Road,
Harold Hill,
Romford,
Essex RM3 8UG
- Instruction Authorisation Number
- PL 12064/0006
- Instruction Authorisation Date
- 04 September 1996
- Instruction Composition
- Each ml of solution for injection contains 0.1 mg of adrenaline (as adrenaline acid tartrate)
Each 10 ml pre-filled syringe contains 1 mg adrenaline (as adrenaline acid tartrate)
Excipient with known effect: sodium
Each ml of solution for injection contains 2.695 mg equivalent to 0.117 mmol of sodium.
Each 10 ml pre-filled syringe contains 26.95 mg equivalent to 1.17 mmol of sodium.
For a full list of excipients, see section 6.1.
- Instruction Dosage Form
- A sterile aqueous clear and colourless solution for slow intravenous injection in pre-filled syringe.
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
Adrenaline (Epinephrine) Injection 1 in 10,000 may be used in the
• Cardiopulmonary Resuscitation in adults and children over 5kg
• Acute anaphylaxis in adults4.2 Posology and method of administration
\*\*This medicinal product is not intended to deliver volumes of less than 2 mL.\*\*
\*\*Intravenous adrenaline should only be administered by those experienced in the use and titration of vasopressors in their normal clinical practice.\*\*
\*\*Cardiopulmonary Resuscitation:\*\*
10 ml of the 1:10,000 solution (1 mg) by the intravenous or intraosseous route, repeated every 3-5 minutes until return of spontaneous circulation.
Endotracheal use should only be considered as a last resort if no other route of administration is accessible, at a dose of 20 to 25 ml of the 1:10,000 solution (2 to 2.5 mg).
In cardiac arrest following cardiac surgery, Adrenaline should be administered intravenously in doses of 0.5 ml or 1ml of 1:10,000 solution (50 or 100 micrograms) very cautiously and titrated to effect.
\*\*Acute Anaphylaxis:\*\*
Titrate using intravenous boluses of 0.5 ml 1:10,000 solution (0.05 mg) according to response.
Adrenaline 1mg/10ml (1:10,000) solution for injection in pre-filled syringe is not recommended for intramuscular use in acute anaphylaxis. For intramuscular administration, a 1mg/ml (1:1000) solution should be used
\*\*Paediatric Population\*\*
This medicinal product is not appropriate to deliver a dose of less than 0.5 ml and should therefore not be used by the intravenous or intraosseous route, in neonates and infants with body weight less than 5 kg.
Cardiac arrest in children:
Intravenous or intraosseous route (above 5 kg only): 0.1 ml/kg of 1:10,000 solution (10 micrograms/kg) to a maximum single dose of 10 ml of 1:10,000 solution (1 mg), repeated every 3-5 minutes until return of spontaneous circulation.
Endotracheal use (any body weight) should only be considered as a last resort if no other route of administration is accessible, at a dose of 1 ml/kg of 1:10,000 solution (100 micrograms/kg) to a maximum of single dose of 25 ml of 1:10,000 solution (2.5 mg).4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, where an alternative presentation of adrenaline or alternative vasopressor is available.4.4 Special warnings and precautions for use
Adrenaline 1 mg/10 ml (1:10,000), solution for injection in pre-filled syringe is indicated for emergency treatment. Medical supervision is necessary after administration.
The prefilled syringes must be used with compatible needle-free connectors (NFCs).
Using an incompatible NFC may lead to blockages, potentially delaying the delivery of emergency medication.
To avoid such issues, ensure compatible NFCs are procured in advance and stored together with the Aurum range of prefilled syringes.
List of compatible NFCs can be found in the link below:
https://ethypharm.co.uk/files/aurum-connector-compatibility-chart.pdf
For intramuscular administration, a 1 mg/ml (1:1000) solution should be used.
In the treatment of anaphylaxis and in other patients with a spontaneous circulation, intravenous adrenaline can cause life-threatening hypertension, tachycardia, arrhythmias and myocardial ischaemia.
Intravenous adrenaline should only be used by those experienced in the use and titration of vasopressors in their normal clinical practice. Patients who are given IV adrenaline require continuous monitoring of ECG, pulse oximetry and frequent blood pressure measurements as a minimum.
The risk of toxicity is increased if the following conditions are pre-existing
• Hyperthyroidism
• Hypertension
• Structural cardiac disease, cardiac arrhythmias, severe obstructive cardiomyopathy,
• Coronary insufficiency
• Phaeochromocytoma,
• Hypokalaemia
• Hypercalcaemia
• Severe renal impairment
• Cerebrovascular disease, organic brain damage or arteriosclerosis
• Patients taking Monoamine oxidase (MAO) inhibitors (see section 4.5)
• Patients taking concomitant medication which results in additive effects, or sensitizes the myocardium to the actions of sympathomimetic agents (see section 4.5)
Prolonged use of adrenaline can result in severe metabolic acidosis because of elevated blood concentrations of lactic acid.
Adrenaline may increase intra-ocular pressure in patients with narrow angle glaucoma.
Adrenaline should be used with caution in patients with prostatic hyperplasia with urinary retention.
Adrenaline may cause or exacerbate hyperglycaemia, blood glucose should be monitored, particularly in diabetic patients.
Adrenaline should be used with caution in elderly patients.
Adrenaline should not be used during the second stage of labour (See Section 4.6).
This medicinal product contains 2.70 mg of sodium per ml of solution for injection: to be taken into consideration by patients on a strict sodium diet.4.5 Interaction with other medicinal products and other forms of interaction
\*\*Volatile halogen anaesthetics:\*\* severe ventricular arrhythmia (increase in cardiac excitability).
\*\*Imipramine antidepressants:\*\* paroxysmal hypertension with the possibility of arrhythmia (inhibition of the entry of sympathomimetics into sympathetic fibres).
\*\*Serotoninergic-adrenergic antidepressants:\*\* paroxysmal hypertension with the possibility of arrhythmia (inhibition of the entry of sympathomimetics into sympathetic fibres).
\*\*Sympathomimetic agents:\*\* concomitant administration of other sympathomimetic agents may increase toxicity due to possible additive effects.
\*\*Non-selective MAO inhibitors\*\*: increased pressor action of adrenaline, usually moderate.
\*\*Selective MAO-A inhibitors, Linezolid (by extrapolation from non-selective MAO inhibitors):\*\* Risk of aggravation of pressor action.
\*\*Alpha-adrenergic blocking agents:\*\* Alpha-blockers antagonise the vasoconstriction and hypertension effects of adrenaline, increasing the risk of hypotension and tachycardia.
\*\*Beta-adrenergic blocking agents:\*\* Severe hypertension and reflex bradycardia may occur with non-cardioselective beta-blocking agents. Beta-blockers, especially non-cardioselective agents, also antagonise the cardiac and bronchodilator effects of adrenaline.
\*\*Insulin or oral hypoglycaemic agents\*\*: Adrenaline-induced hyperglycaemia may lead to loss of blood-sugar control in diabetic patients treated with insulin or oral hypoglycaemic agents.4.6 Fertility, pregnancy and lactation
Pregnancy
Teratogenic effect has been demonstrated in animal experiments.
Adrenaline should only be used during pregnancy if the potential benefits outweigh the possible risks to the foetus. If used during pregnancy, adrenaline may cause anoxia to the foetus.
Adrenaline usually inhibits spontaneous or oxytocin induced contractions of the pregnant human uterus and may delay the second stage of labour. In dosage sufficient to reduce uterine contractions, adrenaline may cause a prolonged period of uterine atony with haemorrhage. For this reason, parenteral adrenaline should not be used during the second stage of labour.
Breast-feeding
Adrenaline is distributed into breast milk. Breast-feeding should be avoided in mothers receiving Adrenaline injection.
Fertility
No information available concerning impact of adrenaline on fertility.4.7 Effects on ability to drive and use machines
Not applicable in normal conditions of use.4.8 Undesirable effects
The adverse events of adrenaline mainly relate to the stimulation of both alpha- and beta-adrenergic receptors. The occurrence of undesirable effects depends on the sensitivity of the individual patient and the dose involved.
Frequencies are defined using the following convention: very common (>1/10), common (>1/100 to <1/10), uncommon (>1/1000 to<1/100), rare (>1/10000 to<1/1000), very rare (<1/10000), not known (cannot be estimated from the available data).
| | | |
| --- | --- | --- |
| \*\*System organ class\*\* | \*\*Frequency\*\* | \*\*Undesirable effects\*\* |
| Metabolism and nutrition disorders | Not known | Hyperglycaemia, Hypokalaemia, Metabolic acidosis. |
| Psychiatric disorders | Not known | Anxiety, Nervousness, Fear, Hallucinations. |
| Nervous system disorders | Not known | Headache, Tremors, Dizziness, Syncope. |
| Eye disorder | Not known | Mydriasis |
| Cardiac disorders | Not known | Palpitations, Tachycardia. In high dosage or for patients sensitive to adrenaline: cardiac dysrhythmia (sinus tachycardia, ventricular fibrillation/cardiac arrest), acute angina attacks, and risk of acute myocardial infarction. |
| Vascular Disorder | Not known | Pallor, Coldness of the extremities. In high dosage or for patient's sensitive to adrenaline: hypertension (with risk of cerebral haemorrhage), vasoconstriction1 |
| Respiratory, thoracic and mediastinal disorders | Not known | Dyspnoea |
| Gastrointestinal disorders: | Not known | Nausea, Vomiting |
| General disorders and administration site conditions | Not known | Sweating, Weakness Repeated local injections may produce necrosis at sites of injection as a result of vascular constriction. |
1 For example cutaneous, in the extremities or kidneys.
\*\*Reporting of suspected adverse reactions\*\*
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme.Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow card in the Google Play or Apple App Store.4.9 Overdose
Over dosage or inadvertent intravenous administration of adrenaline may produce severe hypertension. Cerebral, cardiac or vascular accidents which could be potentially fatal may occur as a result (cerebral haemorrhage, dysrhythmias such as transient bradycardia followed by tachycardia that may result in arrhythmia, myocardial necrosis, acute pulmonary oedema, renal insufficiency).
The effects of adrenaline may be counteracted, depending on the condition of the patient, by administration of quick-acting vasodilators, of quick-acting alpha-adrenoreceptor blocking agents (e.g. phentolamine), or beta-adrenoreceptor blocking agents (e.g. propanolol).
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
\*Pharmacotherapeutic group\*: adrenergic and dopaminergic agents, adrenaline.
ATC code: C01 CA 24
Adrenaline is a direct acting sympathomimetic agent, which exerts effects on both α and β adrenoceptors. It has more pronounced effects on β than on α adrenoceptors, although α effects prevail at high doses.
The effects of adrenaline include increased rate and force of cardiac contraction, cutaneous vasoconstriction and broncho-dilatation. With higher doses, stimulation of peripheral α receptors results in an increase in peripheral resistance and in blood pressure.5.2 Pharmacokinetic properties
Pharmacologically active concentrations of adrenaline are not achieved following oral administration as it is rapidly oxidised and conjugated in the gastrointestinal mucosa and the liver.
\*\*Absorption\*\*
Absorption from subcutaneous tissue is slow due to local vasoconstriction; effects are produced within 5 minutes. Absorption is more rapid after intramuscular injection than after subcutaneous injection.
\*\*Distribution\*\*
Adrenaline is rapidly distributed into the heart, spleen, several glandular tissues and adrenergic nerves. It readily crosses the placenta and is approximately 50% bound to plasma proteins.
\*\*Biotransformation\*\*
Adrenaline is rapidly inactivated in the body, mostly in the liver by the enzymes catechol-O-methyltransferase (COMT) and monoamine oxidase (MAO). Most of a dose of adrenaline is excreted as metabolites in urine.
\*\*Elimination\*\*
After intravenous administration, the plasma half-life is about 2-3 minutes.5.3 Preclinical safety data
There are no pre-clinical data of relevance to the prescriber, which are additional to that already included in other sections of the SPC.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Sodium Chloride Citric Acid monohydrate
Sodium Citrate Dihydrate
Sodium Metabisulphite
Water for Injections
Hydrochloric acid (for pH adjustment)6.2 Incompatibilities
In the absence of compatibility studies, this product must not be mixed with other medicinal products.6.3 Shelf life
18 Months6.4 Special precautions for storage
Store below 25°C.
Protect from light6.5 Nature and contents of container
10 ml sterile aqueous solution in glass (Type 1 Borosilicate) prefilled syringes.6.6 Special precautions for disposal and other handling
The syringe should only be opened immediately prior to administration.
Any unused product or waste material should be disposed of in accordance with local requirements.
- Instruction Content
- ## Composition
Each ml of solution for injection contains 0.1 mg of adrenaline (as adrenaline acid tartrate)
Each 10 ml pre-filled syringe contains 1 mg adrenaline (as adrenaline acid tartrate)
Excipient with known effect: sodium
Each ml of solution for injection contains 2.695 mg equivalent to 0.117 mmol of sodium.
Each 10 ml pre-filled syringe contains 26.95 mg equivalent to 1.17 mmol of sodium.
For a full list of excipients, see section 6.1.
## Pharmaceutical Form
A sterile aqueous clear and colourless solution for slow intravenous injection in pre-filled syringe.
## Clinical Particulars
4.1 Therapeutic indications
Adrenaline (Epinephrine) Injection 1 in 10,000 may be used in the
• Cardiopulmonary Resuscitation in adults and children over 5kg
• Acute anaphylaxis in adults4.2 Posology and method of administration
\*\*This medicinal product is not intended to deliver volumes of less than 2 mL.\*\*
\*\*Intravenous adrenaline should only be administered by those experienced in the use and titration of vasopressors in their normal clinical practice.\*\*
\*\*Cardiopulmonary Resuscitation:\*\*
10 ml of the 1:10,000 solution (1 mg) by the intravenous or intraosseous route, repeated every 3-5 minutes until return of spontaneous circulation.
Endotracheal use should only be considered as a last resort if no other route of administration is accessible, at a dose of 20 to 25 ml of the 1:10,000 solution (2 to 2.5 mg).
In cardiac arrest following cardiac surgery, Adrenaline should be administered intravenously in doses of 0.5 ml or 1ml of 1:10,000 solution (50 or 100 micrograms) very cautiously and titrated to effect.
\*\*Acute Anaphylaxis:\*\*
Titrate using intravenous boluses of 0.5 ml 1:10,000 solution (0.05 mg) according to response.
Adrenaline 1mg/10ml (1:10,000) solution for injection in pre-filled syringe is not recommended for intramuscular use in acute anaphylaxis. For intramuscular administration, a 1mg/ml (1:1000) solution should be used
\*\*Paediatric Population\*\*
This medicinal product is not appropriate to deliver a dose of less than 0.5 ml and should therefore not be used by the intravenous or intraosseous route, in neonates and infants with body weight less than 5 kg.
Cardiac arrest in children:
Intravenous or intraosseous route (above 5 kg only): 0.1 ml/kg of 1:10,000 solution (10 micrograms/kg) to a maximum single dose of 10 ml of 1:10,000 solution (1 mg), repeated every 3-5 minutes until return of spontaneous circulation.
Endotracheal use (any body weight) should only be considered as a last resort if no other route of administration is accessible, at a dose of 1 ml/kg of 1:10,000 solution (100 micrograms/kg) to a maximum of single dose of 25 ml of 1:10,000 solution (2.5 mg).4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, where an alternative presentation of adrenaline or alternative vasopressor is available.4.4 Special warnings and precautions for use
Adrenaline 1 mg/10 ml (1:10,000), solution for injection in pre-filled syringe is indicated for emergency treatment. Medical supervision is necessary after administration.
The prefilled syringes must be used with compatible needle-free connectors (NFCs).
Using an incompatible NFC may lead to blockages, potentially delaying the delivery of emergency medication.
To avoid such issues, ensure compatible NFCs are procured in advance and stored together with the Aurum range of prefilled syringes.
List of compatible NFCs can be found in the link below:
https://ethypharm.co.uk/files/aurum-connector-compatibility-chart.pdf
For intramuscular administration, a 1 mg/ml (1:1000) solution should be used.
In the treatment of anaphylaxis and in other patients with a spontaneous circulation, intravenous adrenaline can cause life-threatening hypertension, tachycardia, arrhythmias and myocardial ischaemia.
Intravenous adrenaline should only be used by those experienced in the use and titration of vasopressors in their normal clinical practice. Patients who are given IV adrenaline require continuous monitoring of ECG, pulse oximetry and frequent blood pressure measurements as a minimum.
The risk of toxicity is increased if the following conditions are pre-existing
• Hyperthyroidism
• Hypertension
• Structural cardiac disease, cardiac arrhythmias, severe obstructive cardiomyopathy,
• Coronary insufficiency
• Phaeochromocytoma,
• Hypokalaemia
• Hypercalcaemia
• Severe renal impairment
• Cerebrovascular disease, organic brain damage or arteriosclerosis
• Patients taking Monoamine oxidase (MAO) inhibitors (see section 4.5)
• Patients taking concomitant medication which results in additive effects, or sensitizes the myocardium to the actions of sympathomimetic agents (see section 4.5)
Prolonged use of adrenaline can result in severe metabolic acidosis because of elevated blood concentrations of lactic acid.
Adrenaline may increase intra-ocular pressure in patients with narrow angle glaucoma.
Adrenaline should be used with caution in patients with prostatic hyperplasia with urinary retention.
Adrenaline may cause or exacerbate hyperglycaemia, blood glucose should be monitored, particularly in diabetic patients.
Adrenaline should be used with caution in elderly patients.
Adrenaline should not be used during the second stage of labour (See Section 4.6).
This medicinal product contains 2.70 mg of sodium per ml of solution for injection: to be taken into consideration by patients on a strict sodium diet.4.5 Interaction with other medicinal products and other forms of interaction
\*\*Volatile halogen anaesthetics:\*\* severe ventricular arrhythmia (increase in cardiac excitability).
\*\*Imipramine antidepressants:\*\* paroxysmal hypertension with the possibility of arrhythmia (inhibition of the entry of sympathomimetics into sympathetic fibres).
\*\*Serotoninergic-adrenergic antidepressants:\*\* paroxysmal hypertension with the possibility of arrhythmia (inhibition of the entry of sympathomimetics into sympathetic fibres).
\*\*Sympathomimetic agents:\*\* concomitant administration of other sympathomimetic agents may increase toxicity due to possible additive effects.
\*\*Non-selective MAO inhibitors\*\*: increased pressor action of adrenaline, usually moderate.
\*\*Selective MAO-A inhibitors, Linezolid (by extrapolation from non-selective MAO inhibitors):\*\* Risk of aggravation of pressor action.
\*\*Alpha-adrenergic blocking agents:\*\* Alpha-blockers antagonise the vasoconstriction and hypertension effects of adrenaline, increasing the risk of hypotension and tachycardia.
\*\*Beta-adrenergic blocking agents:\*\* Severe hypertension and reflex bradycardia may occur with non-cardioselective beta-blocking agents. Beta-blockers, especially non-cardioselective agents, also antagonise the cardiac and bronchodilator effects of adrenaline.
\*\*Insulin or oral hypoglycaemic agents\*\*: Adrenaline-induced hyperglycaemia may lead to loss of blood-sugar control in diabetic patients treated with insulin or oral hypoglycaemic agents.4.6 Fertility, pregnancy and lactation
Pregnancy
Teratogenic effect has been demonstrated in animal experiments.
Adrenaline should only be used during pregnancy if the potential benefits outweigh the possible risks to the foetus. If used during pregnancy, adrenaline may cause anoxia to the foetus.
Adrenaline usually inhibits spontaneous or oxytocin induced contractions of the pregnant human uterus and may delay the second stage of labour. In dosage sufficient to reduce uterine contractions, adrenaline may cause a prolonged period of uterine atony with haemorrhage. For this reason, parenteral adrenaline should not be used during the second stage of labour.
Breast-feeding
Adrenaline is distributed into breast milk. Breast-feeding should be avoided in mothers receiving Adrenaline injection.
Fertility
No information available concerning impact of adrenaline on fertility.4.7 Effects on ability to drive and use machines
Not applicable in normal conditions of use.4.8 Undesirable effects
The adverse events of adrenaline mainly relate to the stimulation of both alpha- and beta-adrenergic receptors. The occurrence of undesirable effects depends on the sensitivity of the individual patient and the dose involved.
Frequencies are defined using the following convention: very common (>1/10), common (>1/100 to <1/10), uncommon (>1/1000 to<1/100), rare (>1/10000 to<1/1000), very rare (<1/10000), not known (cannot be estimated from the available data).
| | | |
| --- | --- | --- |
| \*\*System organ class\*\* | \*\*Frequency\*\* | \*\*Undesirable effects\*\* |
| Metabolism and nutrition disorders | Not known | Hyperglycaemia, Hypokalaemia, Metabolic acidosis. |
| Psychiatric disorders | Not known | Anxiety, Nervousness, Fear, Hallucinations. |
| Nervous system disorders | Not known | Headache, Tremors, Dizziness, Syncope. |
| Eye disorder | Not known | Mydriasis |
| Cardiac disorders | Not known | Palpitations, Tachycardia. In high dosage or for patients sensitive to adrenaline: cardiac dysrhythmia (sinus tachycardia, ventricular fibrillation/cardiac arrest), acute angina attacks, and risk of acute myocardial infarction. |
| Vascular Disorder | Not known | Pallor, Coldness of the extremities. In high dosage or for patient's sensitive to adrenaline: hypertension (with risk of cerebral haemorrhage), vasoconstriction1 |
| Respiratory, thoracic and mediastinal disorders | Not known | Dyspnoea |
| Gastrointestinal disorders: | Not known | Nausea, Vomiting |
| General disorders and administration site conditions | Not known | Sweating, Weakness Repeated local injections may produce necrosis at sites of injection as a result of vascular constriction. |
1 For example cutaneous, in the extremities or kidneys.
\*\*Reporting of suspected adverse reactions\*\*
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme.Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow card in the Google Play or Apple App Store.4.9 Overdose
Over dosage or inadvertent intravenous administration of adrenaline may produce severe hypertension. Cerebral, cardiac or vascular accidents which could be potentially fatal may occur as a result (cerebral haemorrhage, dysrhythmias such as transient bradycardia followed by tachycardia that may result in arrhythmia, myocardial necrosis, acute pulmonary oedema, renal insufficiency).
The effects of adrenaline may be counteracted, depending on the condition of the patient, by administration of quick-acting vasodilators, of quick-acting alpha-adrenoreceptor blocking agents (e.g. phentolamine), or beta-adrenoreceptor blocking agents (e.g. propanolol).
## Pharmacological Properties
5.1 Pharmacodynamic properties
\*Pharmacotherapeutic group\*: adrenergic and dopaminergic agents, adrenaline.
ATC code: C01 CA 24
Adrenaline is a direct acting sympathomimetic agent, which exerts effects on both α and β adrenoceptors. It has more pronounced effects on β than on α adrenoceptors, although α effects prevail at high doses.
The effects of adrenaline include increased rate and force of cardiac contraction, cutaneous vasoconstriction and broncho-dilatation. With higher doses, stimulation of peripheral α receptors results in an increase in peripheral resistance and in blood pressure.5.2 Pharmacokinetic properties
Pharmacologically active concentrations of adrenaline are not achieved following oral administration as it is rapidly oxidised and conjugated in the gastrointestinal mucosa and the liver.
\*\*Absorption\*\*
Absorption from subcutaneous tissue is slow due to local vasoconstriction; effects are produced within 5 minutes. Absorption is more rapid after intramuscular injection than after subcutaneous injection.
\*\*Distribution\*\*
Adrenaline is rapidly distributed into the heart, spleen, several glandular tissues and adrenergic nerves. It readily crosses the placenta and is approximately 50% bound to plasma proteins.
\*\*Biotransformation\*\*
Adrenaline is rapidly inactivated in the body, mostly in the liver by the enzymes catechol-O-methyltransferase (COMT) and monoamine oxidase (MAO). Most of a dose of adrenaline is excreted as metabolites in urine.
\*\*Elimination\*\*
After intravenous administration, the plasma half-life is about 2-3 minutes.5.3 Preclinical safety data
There are no pre-clinical data of relevance to the prescriber, which are additional to that already included in other sections of the SPC.
## Pharmaceutical Particulars
6.1 List of excipients
Sodium Chloride Citric Acid monohydrate
Sodium Citrate Dihydrate
Sodium Metabisulphite
Water for Injections
Hydrochloric acid (for pH adjustment)6.2 Incompatibilities
In the absence of compatibility studies, this product must not be mixed with other medicinal products.6.3 Shelf life
18 Months6.4 Special precautions for storage
Store below 25°C.
Protect from light6.5 Nature and contents of container
10 ml sterile aqueous solution in glass (Type 1 Borosilicate) prefilled syringes.6.6 Special precautions for disposal and other handling
The syringe should only be opened immediately prior to administration.
Any unused product or waste material should be disposed of in accordance with local requirements.
