Adrenaline Injection BP 1 in 1000

Main information

  • Trade name:
  • Adrenaline Injection BP 1 in 1000 1 mg/mL Solution for injection
  • Dosage:
  • 1 mg/mL
  • Pharmaceutical form:
  • Solution for injection
  • Units in package:
  • Ampoule, glass, 5 x 1ml, 5 dose units
  • Class:
  • Restricted
  • Prescription type:
  • Restricted
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Halewood Chemicals Ltd

Documents

Localization

  • Available in:
  • Adrenaline Injection BP 1 in 1000 1 mg/mL Solution for injection
    New Zealand
  • Language:
  • English

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 5057
  • Authorization date:
  • 09-02-1989
  • Last update:
  • 27-09-2017

Summary of Product characteristics: dosage,interactions,side effects

ADRENALINE ACID TARTRATE INJECTION

1:1 000 (1 mg/mL)

Presentation

Adrenaline injection contains no antimicrobial agent. It should be used only once and any

residue discarded. It is a clear, colourless solution and should not be used if it is coloured.

Adrenaline 1:1000

Adrenaline acid tartrate equivalent to adrenaline 1:1000 (1 mg/1 mL) with sodium metabisulfite

and sodium chloride in Water for Injections BP; Sodium hydroxide or hydrochloric acid is used

for pH adjustment, pH 2.8 to 3.6.

Uses

Actions

Adrenaline acts on both alpha and beta adrenergic receptors of tissues innervated by

sympathetic nerves, except the sweat glands and arteries of the face. It is the most potent

alpha receptor activator. Adrenaline stimulates the heart to increased output; raises the

systolic

blood pressure;

lowers

diastolic

blood

pressure;

relaxes bronchial

spasm and

mobilises liver glycogen, resulting in hyperglycaemia and possibly glycosuria.

Pharmacokinetics

Parentally administered adrenaline has a rapid onset and short duration of action. The

circulating drug is metabolised by the liver and other tissues. The majority is taken up and

metabolised by sympathetic nerve endings. Adrenaline is excreted in the urine, mainly in the

form of metabolites.

Adrenaline crosses the placenta but not the blood-brain barrier. It is also distributed into breast

milk (see USE IN PREGNANCY and USE IN LACTATION).

Indications

Adrenaline 1:10,000 is used as an adjunct in the management of cardiac arrest.

Adrenaline 1:1,000 is the drug of choice in the emergency treatment of acute severe

anaphylactic reactions due to insect bites, drugs and other allergens. It may also be used for

the symptomatic relief of respiratory distress due to bronchospasm.

Dosage and Administration

The 1:1,000 (1 mg/1 mL) injection is preferably administered subcutaneously. It may also be

administered intramuscularly but not in the buttocks.

In emergency situations, adrenaline may be injected very slowly intravenously but only as the

dilute solution 1:10,000.

Adrenaline injection contains no antimicrobial agent. It should be used only once and any

residue discarded. Adrenaline injection should not be used if it is coloured.

Cardiac Arrest

Adults.

The recommended dose is 1 mg intravenously, using 10 mL of the 1:10,000 solution. This

may be repeated every 3-5 minutes. If given through a peripheral line, each dose should be

followed by a flush of 20 mL of IV fluid to ensure delivery of the drug to the central compartment.

Intracardiac administration is no longer recommended.

Children.

The recommended dose is 10 micrograms (0.1 mL of the 1:10,000 solution) per kg bodyweight

administered intravenously. This may be repeated every 3-5 minutes.

Severe Anaphylaxis or Asthma

Adults.

The usual initial dose is 100 to 500 microgram (0.1 to 0.5 mL of the 1:1,000 solution) SC or IM.

SC doses may be repeated at 20 minute to 4 hour intervals depending on the response of the

patient and the severity of the condition.

In severe anaphylactic shock, slow and cautious IV administration may be necessary to ensure

absorption of the drug. A dose of 100 to 250 microgram (1 to 2.5 mL of the 1:10,000 solution)

may be administered. Alternatively 25 to 50 microgram (0.25 to 0.5 mL of the 1:10,000

solution) may be given IV every 5 to 15 minutes following an initial dose of 500 microgram SC

or IM.

Children.

10 microgram (0.01 mL of 1:1,000 solution) per kg body weight SC, repeated if necessary at

intervals of 20 minutes to 4 hours depending on the response of the patient and the severity

of the condition. Single paediatric doses should not exceed 500 microgram.

Contraindictions

Known hypersensitivity to sympathomimetic amines

Shock (other than anaphylactic shock)

Cardiac dilatation and coronary insufficiency

Hypertension

Ischaemic heart disease

Arrhythmias

Cerebral arteriosclerosis

Diabetes mellitus

Hyperthyroidism

Narrow angle (congestive) glaucoma

Organic brain damage

Phaeochromocytoma

During general anaesthesia with halogenated hydrocarbons or cyclopropane

With local anaesthesia in fingers, toes, ears, nose or genitalia - there is a danger of

vasoconstriction producing sloughing of tissues in these areas.

Labour - it may delay the second stage by inhibiting spontaneous or oxytocin-induced

contractions of the pregnant human uterus.

Conditions in which vasopressor drugs may be contraindicated e.g. thyrotoxicosis.

In obstetrics when maternal blood pressure is in excess of 130/80 mmHg.

(See also INTERACTIONS)

Warnings and Precautions

Other beta-agonist sympathomimetics

Allow

sufficient

time

elapse

before

after

administering

another

beta-agonist

sympathomimetic agent to avoid additive effects.

Disease states

Use with extreme caution in the elderly, and in patients with cardiovascular disease,

phenothiazine

induced

circulatory

collapse,

cerebrovascular

insufficiency,

diabetes,

hypertension, chronic lung disease, angina pectoris, prostatic hypertrophy, psychoneurosis or

hyperthyroidism.

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. Syncope has occurred following administration to asthmatic children.

In patients with parkinsonian syndrome the drug increases rigidity and tremor.

General anaesthesia

Concurrent use with cyclopropane, halogenated hydrocarbon or similar volatile anaesthetics

may produce fatal ventricular arrhythmias.

Diabetic patients

A greater increase may be produced in heart rate, blood glucose, lactate, gycerol and free fatty

acids when adrenaline is administered to diabetic patients with autonomic neuropathy than in

diabetics without neuropathy.

Circulatory Support

When adrenaline is used for circulatory support, correction of hypervolaemia, metabolic

acidosis, and hypoxia or hypercapnia should be carried out beforehand or concomitantly.

Sodium metabisulfite

This product contains sodium metabisulfite, which may cause allergic reactions in susceptible

individuals. The possibility of an allergic reaction to sodium metabisulfite should be considered

in asthmatic patients who show paradoxical worsening of their condition following use of the

drug.

GANGRENE

Inter-arterial administration must be avoided as marked vasoconstriction may result in

gangrene.

Local ischaemic necrosis can occur from repeated injections in one site.

Use in Pregnancy

Adrenaline has been administered to a large number of pregnant women and women of

childbearing age without any proven increase in the frequency of malformations or other direct

or indirect harmful effects on the fetus having been observed.

However, the use of adrenaline during labour is contraindicated because it may delay the

second stage by inhibiting spontaneous or oxytocin-induced contractions of the pregnant

human uterus.

Use in Lactation

Adrenaline is excreted in the breast milk. The use of adrenaline in breast-feeding women is

therefore not recommended.

Adverse Effects

Adrenaline may cause reactions such as fear, anxiety, tenseness, restlessness, disorientation,

impaired memory, confusion, irritability, hallucinations and psychotic states. Headache,

weakness, dizziness, anorexia, nausea and vomiting and difficulty in micturition with urinary

retention may also occur.

Muscle

tremor

hypokalaemia,

psychomotor

agitation,

pallor,

respiratory

difficulty,

hyperglycaemia, sweating, hypersalivation, cold extremities and insomnia have also been

reported.

Adrenaline causes E.C.G. changes including a decrease in T-wave amplitude in all leads in

normal persons.

Palpitations, tachycardia (sometimes with anginal pain) and cardiac arrhythmias may also

occur along with hypertension which in some instances may induce reflex bradycardia as can

vasodilation with flushing and hypotension. Ventricular fibrillation may occur and severe

hypertension may lead to cerebral haemorrhage and pulmonary oedema.

Overdosage or inadvertent IV injection of usual subcutaneous doses of adrenaline may cause

hypertension. Cerebrovascular or other haemorrhage and hemiplegia may result, especially

in geriatric patients. Inadvertent IV injection of adrenaline has also been reported to have

caused convulsions, metabolic acidosis, and renal failure with anuria.

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.

Prolonged use or overdosage of adrenaline can result in severe metabolic acidosis.

Pulmonary

oedema

been

associated

with

excessive

parenteral

administration

adrenaline and following topical aerosol application.

Gas gangrene which can be fatal has been reported following intramuscular injection of

adrenaline into the buttock or thigh. This appears to have been due to clostridium organisms

on the skin being deposited into muscle tissue during injection, with the vasoconstrictor

properties

adrenaline

enhancing

effects

infection

(see

DOSAGE

ADMINISTRATION).

High doses may result in ventricular arrhythmias.

Rigidity and tremor may be exacerbated in patients with Parkinsonism.

Syncopal episodes have been reported in children.

Psychiatric disorders may be exacerbated.

Interactions

Other Sympathomimetic Agents

Adrenaline should not be administered concomitantly with other sympathomimetic agents

because of the possibility of additive effects and increased toxicity.

Rapidly Acting Vasodilators

These can counteract the marked pressor effects of adrenaline.

General Anaesthetics

Administration of adrenaline in patients receiving cyclopropane, halogenated hydrocarbon or

similar volatile general anaesthetics that increase cardiac irritability and seem to sensitise the

myocardium

adrenaline,

result

arrhythmias

including

ventricular

premature

contractions, tachycardia or fibrillation and acute pulmonary oedema if hypoxia is present.

Cardiovascular Drugs

Adrenaline should not be used in patients receiving high dosage of other drugs, eg. quinidine,

digoxin and other cardiac glycosides, that can sensitise the heart to arrhythmias.

Antihypertensive Therapy

Special care is advisable in patients receiving antihypertensive therapy as severe hypertension

may result.

Alpha Blockers

The administration of adrenaline to patients receiving alpha blockers may result in both

hypotension and cardiac-accelerating effects.

Beta Blockers

The administration of adrenaline to patients receiving non-selective beta blockers

(eg. propranolol) may result in severe hypotension, followed by a reflex bradycardia, due to

stimulation of adrenergic receptors.

CNS and Other Drugs

Tricyclic antidepressants, some antidepressants, some antihistamines and thyroid hormones

may potentiate the effects of adrenaline, especially on heart rhythm and rate.

Patients on MAOIs should not receive sympathomimetic treatment.

Drugs Causing Potassium Loss

The hypokalaemic effect of adrenaline may be potentiated by other drugs that cause potassium

loss,

including

corticosteroids,

potassium-depleting

diuretics

aminophylline

theophylline; patients receiving high doses of beta2-adrenergic agonists concomitantly should

have their plasma-potassium concentration monitored.

Hypoglycaemic Agents

Adrenaline induced hyperglycaemia may lead to loss of blood sugar control in diabetic patients

treated with hypoglycaemic agents.

Overdosage

Symptoms

Overdosage

with

adrenaline

produces

rapid

rise

blood

pressure

resulting

cerebrovascular haemorrhage, cardiac arrhythmias leading to ventricular fibrillation and death.

Pulmonary oedema may also lead to death because of the peripheral constriction and cardiac

stimulation produced.

Treatment

To counteract the pressor effects of adrenaline, use rapidly acting vasodilators, for instance

nitrates or

-blocking agents.

Pharmaceutical Precautions

Incompatibilities

Adrenaline is incompatible with oxidising agents, alkalis, copper, zinc, iron, silver and other

metals.

Adrenaline has been reported to be incompatible with solutions containing the following:

aminophylline, ampicillin sodium, amylobarbitone sodium, ascorbic acid, benzylpenicillin

potassium, calcium chloride , calcium gluconate, cephalothin sodium, chloramphenicol sodium

succinate, chlortetracycline hydrochloride, corticotrophin, diazepam, digitoxin, ergometrine

maleate,

erythromycin

gluceptate,

frusemide,

hyaluronidase,

hydrocortisone

sodium

succinate, methicillin sodium, nitrofurantoin, noradrenaline acid tartrate, novobiocin sodium,

pentobarbitone sodium, procaine, prochlorperazine edisylate, promazine hydrochloride,

sodium bicarbonate, sulfadiazine sodium, suxamethonium chloride, tetracycline hydrochloride,

vancomycin hydrochloride, vitamin B complex with ascorbic acid, warfarin sodium.

This list is not intended to be comprehensive. Refer to standard texts for further information.

Medicine Classification

Restricted Medicine

Package Quantities

1.0 mg/mL (1:1000) 1 mL glass ampoules in packs of 5 and 50

Shelf Life And Storage Conditions

Store below 25

C and protect from light.

1:1000 syringes have a shelf-life of 18 months.

Further Information

Nil.

Name and Address

Max Health Limited

P O Box 65231

Mairangi Bay

Auckland 0754

Telephone: (09) 815 2664

Date of Preparation

5 May 2016

27-4-2018

EpiPen 300 mcg adrenaline auto-injector

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Medicine shortages

Therapeutic Goods Administration - Australia

17-3-2017

Withdrawal of a batch of EpiPen® 300 micrograms

Withdrawal of a batch of EpiPen® 300 micrograms

MEDA recalls a batch of the adrenaline product EpiPen® 300 micrograms/dose, which is used for sudden allergic reactions. There is a risk that the auto-injector does not work. The withdrawal concerns product number 578818 with batch number: 5FA665B and expiry date 03/2017.

Danish Medicines Agency

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