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ADRENALINE INJECTION 1MG IN 10ML IN A PREFILLED SYRINGE

Active substance(s): ADRENALINE ACID TARTRATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Adrenaline (Epinephrine) Injection 1:10,000.

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Adrenaline (Epinephrine) as Acid Tartrate
BP
Sodium Chloride BP
Citric Acid Monohydrate BP
Sodium Citrate Dihydrate BP
Sodium Metabisulphite BP
Hydrochloric Acid BP
Water for Injections BP
Nitrogen PF9

3

%w/v
0.01
0.6
0.16
0.04
0.1
qs
To 100%
qs

PHARMACEUTICAL FORM
A sterile aqueous solution for slow intravenous injection.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Cardiopulmonary Resuscitation in adults children and newborn
Acute anaphylaxis

4.2

Posology and method of administration
Cardiopulmonary Resuscitation:

Adults and children over 12 years:
1 in 10,000 (1mg in 10ml) is recommended in a dose of 10ml by intravenous
injection.
The procedure for Cardiopulmonary Resuscitation as given in the algorithm which
reflects the recommendations of the European Resuscitation Council and the
Resuscitation Council (UK) should be employed.

Cardiac arrest:
Recommended dose:
Ventricular Fibrillation / Pulseless ventricular tachycardia:
1mg adrenaline IV/IO, repeated every 3-5 minutes until return of spontaneous
circulation.
Asystole / Pulseless electrical activity (PEA):
1mg adrenaline IV/IO, repeated every 3-5 minutes until return of spontaneous
circulation.
Once a perfusing rhythm is established, if further adrenaline is deemed necessary, the
dose should be titrated against response carefully to achieve an appropriate blood
pressure. Intravenous doses of 50 microgram are usually sufficient for most
hypotensive patients.
Cardiac arrest following cardiac surgery:
Cardiac arrest following major cardiac surgery is relatively common in the immediate
post-operative period. The resuscitation council recommends that during the
management of such patients, according to guidelines, adrenaline is administered
intravenously in doses of up to 100microgram in adults (1ml of 1 in 10000 solution)
very cautiously and titrated to effect.

Children under 12 years:
Management of non shockable asystole and pulseless electrical activity:
10 microgram/kg (0.1ml/kg of 1 in 10000 or 0.01ml/kg of 1 in 1000 solution)
repeated every 3-5 minutes.
Management of shockable VF/ pulseless VT:
Adrenaline 10microgram/kg and amiodarone 5mg/kg given after the third shock, once
CPR has been resumed.
Adrenaline can be repeated every alternative cycle (i.e. every 3-5 minutes during
CPR)
In the management of respiratory and circulatory failure in children:
First and subsequent dose: 10microgram /kg by IV or IO route.
Maximum dose is 1mg.
If needed, further doses of adrenaline should be given every 3-5 minutes

Tracheal administration should be used as a last resort only if there is no alternative.
If required, consider giving adrenaline 100 microgram/kg (1ml /kg of 1 in 10000 or
0.1ml /kg of 1 in 1000 solution) via the tracheal tube. This is the least satisfactory
route.
Newborn:
When adequate ventilation and chest compression have failed to increase the heart
rate above 60 beats per minute, adrenaline may be given in a dose of 1030microgram/kg intravenously as soon as possible (0.1-0.3ml/kg of the 1:10000
solution or 0.01-0.03ml/kg of the 1:1000 solution). This is best given via an umbilical
venous catheter.
The tracheal route is not recommended, but if used, the dose is 50-100 microgram/kg
(0.5ml/kg of the 1:10000 solution or 0.05ml/kg of the 1:1000 solution).

Acute Anaphylaxis:
Constant vigilance is needed to ensure that the correct strength of Adrenaline solution is
used in the treatment of anaphylaxis. Anaphylactic shock kits need to make a very clear
distinction between the 1 in 10,000 strength and the 1 in 1000 strength Adrenaline
solutions.
(The intramuscular route is the first choice route for administration of Adrenaline
(1:1000) in the management of anaphylactic shock. It is also important that, where
intramuscular injection might still succeed, time should not be wasted seeking
intravenous access.)
Intravenous adrenaline should only be administered by those experienced in the use
and titration of vasopressors in their normal clinical practice. In adults, titrate IV
adrenaline 1 in 10000 using 50 microgram boluses according to response.

4.3

Contraindications
These should be regarded as relative and not absolute contraindications in life
threatening emergency situations
Adrenaline is contraindicated in patients with shock (other than anaphylactic
shock), organic heart disease, or cardiac dilatation, as well as most patients
with arrhythmias, organic brain damage, or cerebral arteriosclerosis.
Adrenaline injection is contraindicated in patients with narrow angle
glaucoma. Adrenaline is contraindicated for use during general anaesthesia
with chloroform, trichloroethylene, or cyclopropane, and should be used
cautiously, it at all, with other halogenated hydrocarbon anaesthetics and
adrenaline is contraindicated for use in fingers, toes, ears, nose or genitalia.

Adrenaline should not be used during the second stage of labour (see
pregnancy and lactation).

4.4

Special warnings and precautions for use
IM injection of adrenaline into the buttocks should be avoided because of the
risk of tissue necrosis. Prolonged use of adrenaline can result in severe
metabolic acidosis because of elevated blood concentrations of lactic acid.
Adrenaline Injection 1 in 10000 BP contains sodium metabisulphite that can
cause allergic-type reactions, including anaphylaxis and life-threatening or less
severe asthmatic episodes, in certain susceptible individuals.
The presence of sodium metabisulphite in parenteral adrenaline and the
possibility of allergic-type reactions should not deter use of the drug when
indicated for the treatment of serious allergic reactions or for other emergency
situations.

4.5

Interaction with other medicinal products and other forms of interaction
Sympathomimetic agents: Adrenaline should not be administered
concomitantly with other sympathomimetic agents because of the possibility
of additive effects and increased toxicity.
Alpha and beta blocking agents: The cardiac and bronchodilating effects of
adrenaline are antagonised by β-adrenergic blocking drugs such as
propranolol, and the vasoconstriction and hypertension caused by high doses
of adrenaline are antagonised by alpha-adrenergic blocking agents such as
phentolamine. Because of their alpha-adrenergic blocking properties, ergot
alkaloids can reverse the pressor response to adrenaline.
General anaesthetics
Administration of adrenaline in patients receiving cyclopropane or
halogenated hydrocarbon general anaesthetics that increase cardiac irritability
and seem to sensitise the myocardium to adrenaline may result in arrhythmias
including ventricular premature contractions, tachycardia, or fibrillation.
Prophylactic administration of lignocaine or prophylactic administration of
propranolol 0.05 mg/kg may protect against ventricular irritability if
adrenaline is used during anaesthesia with a halogenated hydrocarbon
anaesthetic.

Dopaminergics: increased risk of toxicity can be seen with the effects of
adrenaline enhanced by entacapone.
Other Drugs: Adrenaline should not be used in patients receiving high dosage
of other drugs (e.g. cardiac glycosides) that can sensitise the heart to
arrhythmias.
Tricyclic antidepressants such as imipramine, some
antihistamines (e.g. diphenhydramine) and thyroid hormones may potentiate
the effects of adrenaline, especially on heart rhythm and rate. Although
monoamine oxidase (MAO) is one of the enzymes responsible for adrenaline
metabolism, MAO inhibitors do not markedly potentiate the effects of
adrenaline.
Adrenaline should not be used to counteract circulatory collapse of
hypotension caused by phenothiazines: a reversal of adrenaline’s pressor
effects resulting in further lowering of blood pressure may occur.
Because adrenaline may cause hyperglycaemia, diabetic patients receiving
adrenaline may require increased dosage of insulin or oral hyperglycaemia
agents.

4.6

Pregnancy and lactation
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. If used during
pregnancy, adrenaline may cause anoxia to the foetus. 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.
Adrenaline is distributed into breast milk. Breast-feeding should be avoided in
mothers receiving adrenaline injection.

4.7

Effects on ability to drive and use machines
Not applicable in normal conditions of use.

4.8

Undesirable effects

Side effects such as anxiety, dyspnoea, hyperglycaemia, restlessness,
palpitations, tachycardia, tremors, weakness, dizziness, headache, and
coldness of the extremities may occur even with small doses of adrenaline.
Other side effects include; cerebral haemorrhage, nausea vomiting, sweating
and pulmonary oedema (on excessive dosage or extreme sensitivity)
In patients with Parkinsonian Syndrome, adrenaline increases rigidity and
tremor.
Adrenaline causes ECG changes including a decrease in T-wave amplitude in
all leads in normal persons.
Disturbances of cardiac rhythm and rate may result in palpitation and
tachycardia. Adrenaline can cause potentially fatal ventricular arrhythmias
including fibrillation, especially in patients with organic heart disease or other
receiving other drugs that sensitise the heart to arrhythmias.
Subarachnoid haemorrhage and hemiplegia have resulted from hypertension,
even following subcutaneous administration of usual doses of adrenaline.
Repeated injections of adrenaline can cause necrosis as a result of vascular
constriction at the injection site. Tissue necrosis may also occur in the
extremities, kidneys and liver.

4.9

Overdose
After overdose or inadvertent IV administration of usual subcutaneous doses
of adrenaline, systolic and diastolic blood pressure rise sharply; venous
pressure also rises. Cerebrovascular or other haemorrhage and hemiplegia
may result, especially in elderly patients. Because adrenaline is rapidly
inactivated in the body, treatment of acute toxicity is mainly supportive. The
pressor effects of adrenaline may be counteracted by an immediate
intravenous injection of a quick-acting alpha-adrenoreceptor blocking agents,
such as 5 - 10mg of phentolamine mesylate, followed by a beta-adrenoreceptor
blocking agent such as 2.5mg to 5mg of propranolol.
Adrenaline overdose causes transient bradycardia followed by tachycardia and
may cause other potentially fatal cardiac arrhythmias. Arrhythmias, if they
occur, may be counteracted by propranolol injection. Kidney failure,
metabolic acidosis and cold, white skin may also occur.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Adrenaline is a direct acting sympathomimetic agent, which exerts effects on
both ∝ and β adrenoceptors. It exhibits little selectivity towards ∝1 and ∝2
receptors but is significantly more selective to β2 than β1 . Major effects
include increased systolic blood pressure, reduced diastolic pressure,
tachycardia, hyperglycaemia and hypoglycaemia.

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 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.
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.
Adrenaline is rapidly metabolised in the liver, neuronal tissues and elsewhere.
Up to 91% of the intravenous dose is excreted in the urine, but only 1% of the
dose can be recovered unchanged.

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.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Sodium Chloride BP
Citric Acid monohydrate BP
Sodium Citrate Dihydrate BP
Sodium Metabisulphite BP

Water for Injections BP
Nitrogen PF9

6.2

Incompatibilities
Oxidising agents rapidly denature adrenaline 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.

6.3

Shelf life
18 Months

6.4

Special precautions for storage
Store below 25°C.
Protect from light

6.5

Nature and contents of container
Sterile aqueous solution in glass (Type 1 Borosilicate) prefilled syringes.

6.6

Instructions for Use, Handling and Disposal
None

7

MARKETING AUTHORISATION HOLDER
Aurum Pharmaceuticals Ltd
Bampton Road,
Harold Hill,

Romford,
Essex RM3 8UG

8

MARKETING AUTHORISATION NUMBER(S)
PL 12064/0006

9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
04 September 1996

10

DATE OF REVISION OF THE TEXT
29/07/2013

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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