Adrenaline

Registered South African indications:

• Anaphylactic shock
• Acute allergy

Contraindications

South African recommendations

Adrenaline 1mg/ml (1:1000) injection

• Hypersensitivity to sympathomimetics, including adrenaline, or to any of the other ingredients
• Adrenaline should not be used in fingers, toes, ears, nose or genitalia owing to the risk of ischaemic tissue necrosis
• Adrenaline is frequently used in emergency situations and any contraindications are therefore relative
• Coadministration with monoamine oxidase inhibitors or within 14 days of its termination

Adrenaline 0.3mg & 0.15mg auto-injector

• Hypersensitivity to any of the ingredients including sensitivity to sulphites

Recommendations in other jurisdictions

Adrenaline 1mg/ml (1:1000) injection

• Hypersensitivity to adrenaline, sodium metabisulfite or to any of the excipients
• Adrenaline 1 in 1000 should not be used in fingers, toes, ears, nose or genitalia owing to the risk of ischaemic tissue necrosis

Adrenaline 0.3mg & 0.15mg auto-injector

• There are no absolute contraindications to the use of adrenaline 0.3mg & 0.15mg auto-injector during an allergic emergency

Cautions

• Pregnancy
• Breastfeeding
• Severe renal impairment
• Elderly
• Hyperthyroidism
• Psychoneurosis
• Phaeochromocytoma
• Narrow angle glaucoma
• Diabetes mellitus
• Hypokalaemia
• Hypercalcaemia
• Prostatic hypertrophy
• Urination difficulty
• Cerebrovascular disease
• Organic brain damage
• Arteriosclerosis
• Autonomic dysreflexia (hyperreflexia)
• Spinal cord injury (e.g. tetraplegics)
• Shock (other than anaphylactic shock)
• Cardiac dilatation
• Organic heart disease
• Angina pectoris
• Obstructive cardiomyopathy
• Hypertension
• Arrhythmias
• Coronary insufficiency
• Long-standing bronchial asthma and emphysema in patients who have developed degenerative heart disease
• Parkinson's Disease
• Second stage of labour
• Accidental intravascular injection
• Prolonged use
• Sodium controlled diet (certain formulations)
• May impair ability to drive and operate machinery

Forms avail. in SA and covered in this monograph: inj

Dosages below include:

• South African registered indications and dosages

South African registered indications and dosages

Bronchodilator

• SC: 0.2-0.5mg (0.2-0.5ml of 1:1000 (one:one thousand)), repeat every 20min to 4hrs if needed; Max: 1mg/dose

Anaphylactic reaction

• IM/SC: 0.2-0.5mg (0.2-0.5ml of 1:1000 (one:one thousand)), repeat every 10-15min if needed; Max: 1mg/dose

Anaphylactic shock (vasopressor)

• IV: 0.1mg to 0.25mg (base), administered slowly; May be repeated every 5-15min as needed

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The intramuscular (IM) route is generally preferred in the initial treatment of anaphylaxis, the IV route is generally more appropriate in the Intensive Care Unit or Emergency Department setting. Epinephrine (adrenaline) 1mg/ml (1:1 000) solution for injection is not suitable for IV use. If the adrenaline 0.1mg/ml (1:10 000) injection is not available, adrenaline 1mg/ml (1:1 000) solution must be diluted to 0.1mg/ml (1:10 000) before IV use. The IV route for injection of adrenaline must be used with extreme caution and is best reserved for specialists familiar with IV use of adrenaline

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Discard contents if discoloured. Continuous patient monitoring is required

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The best site for IM injection is the anterolateral aspect of the middle third of the thigh. The needle used for injection needs to be sufficiently long to ensure that the epinephrine (adrenaline) is injected into muscle. Intramuscular injections of adrenaline 1mg/ml into the buttocks should be avoided because of the risk of tissue necrosis

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As an adjunct in the emergency treatment for severe anaphylactic or life-threatening reactions
- For patients who are highly allergic and in danger of developing a life-threatening reaction

• IM (0.3mg/0.3ml auto-injector): >45kg: 0.3mg (0.23-0.37ml), administered immediately as a single dose

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Adrenaline is intended as emergency treatment and should not substitute any medical care to be implemented at a later stage

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Administration instructions for auto-injector: Grasp unit with the orange tip pointing downward, form a fist around the unit (orange tip down). With your other hand, pull off the blue safety release. Hold the orange tip near outer thigh. DO NOT INJECT INTO BUTTOCK. Push hard against the skin with the orange tip until the mechanism releases the injection needle. Hold the device in position for at least 10 seconds. Remove the unit from thigh (the orange needle cover will extend to cover needle). Massage the injection area for 10 seconds. Advise patient to consult a doctor as soon as possible and to bring the used device along

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Each auto-injector is for single dose administration only and the unused portion must be discarded. Avoid intravascular injection

Paed. forms avail. in SA and covered in this monograph: inj

Paed. dosages below include:

• South African registered indications and dosages

South African registered indications and dosages

Bronchodilator
Anaphylactic reactions

• SC: 0.01mg/kg body weight, every 15min for 2 doses and then every 4hrs as needed; Max: 0.5mg/dose

Anaphylactic shock (vasopressor)

• IV: 0.01mg (base)/kg body weight, every 5-15min as needed, if an inadequate response to IM or SC administration

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The intramuscular (IM) route is generally preferred in the initial treatment of anaphylaxis, the IV route is generally more appropriate in the Intensive Care Unit or Emergency Department setting. Epinephrine (adrenaline) 1mg/ml (1:1 000) solution for injection is not suitable for IV use. If the adrenaline 0.1mg/ml (1:10 000) injection is not available, adrenaline 1mg/ml (1:1 000) solution must be diluted to 0.1mg/ml (1:10 000) before IV use. The IV route for injection of adrenaline must be used with extreme caution and is best reserved for specialists familiar with IV use of adrenaline

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Discard contents if discoloured. Continuous patient monitoring is required

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The best site for IM injection is the anterolateral aspect of the middle third of the thigh. The needle used for injection needs to be sufficiently long to ensure that the epinephrine (adrenaline) is injected into muscle. Intramuscular injections of adrenaline 1mg/ml into the buttocks should be avoided because of the risk of tissue necrosis

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As an adjunct in the emergency treatment for severe anaphylactic or life-threatening reactions
- For patients who are highly allergic and in danger of developing a life-threatening reaction

• IM (0.15mg/0.3ml auto-injector): <45kg: 0.15mg (0.23-0.37ml), administered immediately as a single dose
• IM (auto-injector): >45kg: See adult dosage

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Adrenaline is intended as emergency treatment and should not substitute any medical care to be implemented at a later stage

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Administration instructions for auto-injector: Grasp unit with the orange tip pointing downward, form a fist around the unit (orange tip down). With your other hand, pull off the blue safety release. Hold the orange tip near outer thigh. DO NOT INJECT INTO BUTTOCK. Push hard against the skin with the orange tip until the mechanism releases the injection needle. Hold the device in position for at least 10 seconds. Remove the unit from thigh (the orange needle cover will extend to cover needle). Massage the injection area for 10 seconds. Advise patient to consult a doctor as soon as possible and to bring the used device along

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Each auto-injector is for single dose administration only and the unused portion must be discarded. Avoid intravascular injection

Pregnancy

• Caution; positive evidence of risk
• Adrenaline crosses the placenta. There is some evidence of a slightly increased evidence of congenital abnormalities. Injection of adrenaline may cause anoxia to the foetus, foetal tachycardia, cardiac irregularities, extrasystoles and louder heart sounds
• 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, the drug 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
• Adrenaline should only be used during pregnancy if the potential benefits justify the possible risks to the foetus

Breastfeeding

• Caution; not recommended
• Adrenaline is distributed into breast milk. Breastfeeding should be avoided in mothers receiving adrenaline

Renal Impairment

• Mild to moderate: No dose adjustment recommended
• Severe: Caution; no dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended

Elderly

• Caution; no dose adjustment recommended

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Prohibited - In competition

Central Nervous System Disorders

• Psychotic states
• Anxiety
• Nervousness
• Fear
• Hallucinations
• Confusion
• Irritability
• Insomnia
• Restlessness
• Headache
• Dizziness
• Tremors
• Rigidity
• Subarachnoid haemorrhage
• Hemiplegia
• Syncope

Cardiovascular Disorders

• Palpitation
• Tachycardia
• Cardiac dysrhythmia
  - Sinus tachycardia
  - Cardiac arrest
• Ventricular arrhythmias (including fibrillation)
• Myocardial ischaemia
• Myocardial infarction
• ECG abnormalities
• Stress cardiomyopathy
• Hypertension (with risk of cerebral haemorrhage)
• Acute angina
• Vasoconstriction

Respiratory Disorders

• Dyspnoea
• Pulmonary oedema (excessive doses or sensitivity)

Gastrointestinal Disorders

• Dry mouth
• Reduced appetite
• Nausea and vomiting
• Hypersalivation
• Bowel necrosis

Genitourinary Disorders

• Difficulty in micturition
• Urinary retention

Endocrine and Metabolic Disorders

• Hypokalaemia
• Metabolic acidosis
• Inhibition of insulin secretion
• Hyperglycaemia
• Gluconeogenesis
• Glycolysis
• Lipolysis
• Ketogenesis
• Sweating

Skin and Subcutaneous Tissue Disorders

• Tissue necrosis

Immune, Blood and Lymphatic System Disorders

• Anaphylaxis
  - Severe bronchospasm

Sensory disorders

• Mydriasis

Others

• Weakness
• Pallor
• Coldness of extremities

• Sympathomimetic agents
• Alpha-adrenergic agonists
• Ergot alkaloids
• Oxytocin
• Alpha-adrenergic antagonists
• Phentolamine
• Guanethidine
• Beta-adrenergic antagonists
• Propranolol
• Halogenated hydrocarbon general anaesthetics
• Antihypertensive agents
• Serotoninergic-adrenergic antidepressants
• Tricyclic antidepressants
• Imipramine
• Monoamine oxidase inhibitors
• Linezolid
• Phenothiazines
• Cardiac glycosides (high doses)
• Antihistamines
• Diphenhydramine
• Levodopa
• Entacapone
• Thyroid hormones
• Corticosteroids
• Potassium-depleting diuretics
• Aminophylline
• Theophylline
• Insulin
• Oral hypoglycaemic agents
• Agents that sensitise the myocardium to sympathomimetic agents

• ECG
• Pulse oximetry
• Blood pressure
• Heart rate

Specific cases may require

• Intra-ocular pressure
• Blood glucose

Incompatibilities

• Adrenaline is rapidly denatured by oxidising agents and alkalis including sodium bicarbonate, halogens, nitrates, nitrites and salts of iron, copper and zinc. Adrenaline may be mixed with 0.9% Sodium Chloride injection but is incompatible with 5% sodium chloride injection. The stability of adrenaline in 5% dextrose injection decreases when the pH is greater than 5.5

Adrenaline is a sympathomimetic amine which is a potent stimulant of alpha- and beta- adrenergic receptors.  It has strong vasoconstrictor action through alpha- adrenergic stimulation, which counteracts the vasodilatation and increases vascular permeability leading to loss of intravascular fluid and subsequent hypotension in anaphylactic shock. Adrenaline stimulates bronchial beta-adrenergic receptors, causing bronchial smooth muscle relaxation. Adrenaline also alleviates pruritus, urticaria and angioedema associated with anaphylaxis.

Injection (per 0.3ml) 0.3mg

• Epipen Auto Injector (Mylan) originator

Injection (per 0.3ml) 0.15mg

• Epipen Junior Auto Injector (Mylan) originator

Injection (per ml) 1mg (1:1000)

• Adrenaline-Fresenius  (Fresenius) originator
• Pharma-Q Adrenaline (Pharma-Q)