DBL™ Adrenaline Injection BP

Main information

  • Trade name:
  • DBL™ Adrenaline Injection BP 1:1000 Solution for injection
  • Dosage:
  • 1:1000
  • Pharmaceutical form:
  • Solution for injection
  • Units in package:
  • Ampoule, glass, 5 x 1mL, 5 mL
  • Class:
  • Restricted
  • Prescription type:
  • Restricted
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Boehringer Ingelheim Pharma GmbH & Co KG

Documents

Localization

  • Available in:
  • DBL™ Adrenaline Injection BP 1:1000 Solution for injection
    New Zealand
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • For the treatment of acute allergic reactions, life-threatening angioneurotic oedema, and anaphylactic shock resulting from reactions to drugs, animal serums, insect stings and other allergens.

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 4229
  • Authorization date:
  • 08-03-1984
  • Last update:
  • 27-09-2017

Summary of Product characteristics: dosage,interactions,side effects

Data Sheet – New Zealand

DBL™ ADRENALINE INJECTION 1:10,000

Adrenaline Acid Tartrate 1:10,000 (1mg in 10ml)

Presentation

Adrenaline

(R)1-(3,4-dihydroxyphenyl)-2-methylaminoethanol;

white

odourless

crystalline powder, soluble in solutions of mineral acids and alkalis. DBL™ Adrenaline Injection 1:10,000 is a

sterile solution of adrenaline acid tartrate in water containing adrenaline acid tartrate 0.1 mg/mL, 1mg/ml

sodium metabisulphite as an antioxidant, and sodium chloride 8mg/ml. The solution contains no antimicrobial

preservatives.

Uses

Actions

Adrenaline is a direct-acting sympathomimetic agent exerting its effect on alpha and beta adrenoreceptors.

Major effects are increased systolic blood pressure, reduced diastolic pressure, tachycardia, hyperglycaemia

and hypokalaemia. It is a powerful cardiac stimulant. It has vasopressor properties, an antihistaminic action

and is a bronchodilator. Its action is rapid in onset and of short duration.

Adrenaline is rapidly distributed to the heart, spleen, several glandular tissues and adrenergic nerves. It

crosses the placenta and is excreted in breast milk. It is approximately 50% bound to plasma proteins. The

onset of action is rapid and after intravenous infusion the half life is approximately 5-10 minutes.

Adrenaline is rapidly metabolised in the liver and tissues. Up to 90% of the IV dose is excreted as

metabolites in the urine.

Indications

Adjunctive use in the management of cardiac arrest, and anaphylactic shock resulting from reactions to

drugs, animal serums, insect stings and other allergens.

Dosage and Administration

Do not use if the injection is brown or contains a precipitate.

Adrenaline is given by subcutaneous or intramuscular injection. In extreme emergencies, where a more

rapid effect is required, adrenaline may be given as a dilute solution (1 in 10,000 or 1 in 100,000) by slow

intravenous injection or by slow intravenous infusion.

Adults:

In cardiopulmonary resuscitation the initial dose is 1 mg (10mL of 1:10,000) delivered intravenously,

preferably through a central line, and repeated as often as every 2 to 3 minutes during CPR for up to an

hour. Depending on the arrhythmia the dose may in increased after three injections of 1mg to 5mg or

100ug/kg bodyweight.

Data Sheet – New Zealand

Further bolus doses or continuous infusion may be required to maintain an adequate blood pressure after

the patient generated pulse has returned.

Elderly patients:

The adult dose is used but should be given very slowly with caution as these patients may be more sensitive

to adrenaline.

Children:

In cardiopulmonary resuscitation, the dose is 0.1 mL/kg bodyweight (0.01mg/kg) intravenously initially then

100ug/kg bodyweight. Doses may be repeated every five minutes if necessary.

For anaphylactic shock, if intravenous administration is required the dose is 10ug/kg bodyweight at a rate of

1ml (100ug) or less per minute.

Contraindications

The following contraindications should

be considered: hyperthyroidism, hypertension,

ischaemic heart

disease, diabetes mellitus, narrow angle glaucoma and known sensitivity to sympathomimetic amines.

Adrenaline should not be used in the presence of cardiac dilation.

Adrenaline should not be used in most patients with arrhythmias and cerebral arteriosclerosis, where

vasopressor drugs may be contraindicated eg in thyrotoxicosis, in obstetrics when maternal blood pressure

is in excess of 130/80.

Adrenaline is also contraindicated in shock (other than anaphylactic shock), in patients with organic brain

damage, during general anaesthesia with halogenated hydrocarbons and cyclopropane.

Adrenaline should not be injected into fingers, toes, ears, nose or genitalia.

Warnings and Precautions

Use with caution in patients with ventricular fibrillation, prefibrillatory rhythm, tachycardia, myocardial

infarction, phenothiazine induced circulatory collapse and prostatic hypertrophy.

Administer slowly with caution to elderly patients and to patients with hypertension, diabetes mellitus,

hyperthyroidism and psychoneurosis. 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. Use with caution in patients with narrow angle glaucoma.

Adrenaline may delay the second stage of labour by inhibiting contractions of the uterus.

Syncope has occurred following administration to asthmatic children.

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

Intra-arterial administration should be avoided since marked vasoconstriction may result in gangrene.

Intramuscular injection into the buttocks should be avoided as gas gangrene is a possibility.

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

DBL™ Adrenaline Injection 1:10,000 contains a sulfate which may cause allergic type reactions in certain

susceptible individuals.

Data Sheet – New Zealand

Use in Pregnancy (Category A):

Adrenaline has been given 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 foetus

having been observed. Adrenaline may delay the second stage of labour by inhibiting contractions of the

uterus.

Use

in Lactation:

Adrenaline is excreted in breast milk.

Interactions with other drugs:

Adrenaline should not be administered with other sympathomimetic agents because of the danger of additive

effects and increased toxicity.

Rapidly acting vasodilators can counteract the marked pressor effects of adrenaline.

The effects of adrenaline may be potentiated by tricyclic antidepressants, some antihistamines and thyroid

hormones.

Halothane and other anaesthetics such as cyclopropane and trichlorethylene increase the risk of adrenaline-

induced ventricular arrhythmias and acute pulmonary oedema if hypoxia is present.

Severe hypertension and bradycardia may occur with non-selective beta-blocking drugs. Proranolol inhibits

the bronchodilator effect of adrenaline. The risk of cardiac arrhythmias is higher when adrenaline is given to

patients receiving digoxin or quinidine.

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

hypoglycaemic agents.

Patients on monoamine oxidase inhibitors should not receive sympathomimetic treatment.

Adrenaline is physically incompatible with alkalis, metals, oxidising agents, sodium warfarin, hyaluronidase

and many other drugs; it forms polymers with sodium bicarbonate.

Adverse Effects

Common

symptomatic

adverse

effects

include

anxiety,

restlessness,

tachycardia,

tremor,

weakness,

dizziness,

headache,

dyspnoea,

cold

extremities,

pallor,

sweating,

nausea,

vomiting,

sleeplessness,

hallucinations and flushing or redness of face and skin. Psychomotor agitation, disorientation, impaired

memory and psychosis may occur.

The potentially severe adverse effects of adrenaline arise from its effect upon blood pressure and cardiac

rhythm. Ventricular fibrillation may occur and severe hypertension may lead to cerebral haemorrhage and

pulmonary oedema.

Overdosage

Effects

Cardiac arrhythmias leading to ventricular fibrillation and death. Severe hypertension leading to pulmonary

oedema and cerebral haemorrhage.

Overdosage of adrenaline can result in severe metabolic acidosis because of elevated blood concentration

of lactic acid.

Data Sheet – New Zealand

Treatment

Combined alpha and beta adrenergic blocking agents such as labetalol may counteract the effects of

adrenaline, or a beta blocking agent may be used to treat supraventricular arrhythmias and phentolamine to

control the alpha mediated effects on the peripheral circulation. Rapidly acting vasodilators such as nitrates

and sodium nitroprusside may also be helpful

In case of overdose, immediately contact the Poisons Information Centre for advice (in New Zealand call

0800 764 766).

Pharmaceutical Precautions

Store below 25°C. Protect from light. Do not use if the injection is brown or contains a precipitate.

Medicine Classification

Restricted Medicine

Package Quantities

DBL™ Adrenaline Injection 1:10,000 is available in single use ampoules containing 1mg adrenaline acid

tartrate in 10 mL (1:10,000). It is presented in packs of 5 or 50.

Name and Address

Toll Free Number: 0800 736 363

Date of Preparation

23 June 2017

Pfizer New Zealand Limited,

PO Box 3998

Auckland, New Zealand, 1140

3-8-2018

Scientific guideline:  Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

31-7-2018

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam for Injection 3.375 grams per vial, Due to Presence of Particulates Identified as Glass and Silicone Material

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam for Injection 3.375 grams per vial, Due to Presence of Particulates Identified as Glass and Silicone Material

East Windsor, New Jersey, AuroMedics Pharma LLC is voluntarily recalling two lots of Piperacillin and Tazobactam for injection, USP 3.375 g (Piperacillin Sodium equivalent to 3 g of Piperacillin USP and Tazobactam Sodium equivalent to 0.375 g of Tazobactam USP. Each vial contains 7.05 mEq (162 mg) of Sodium) in a Single-Dose vial, to the hospital level. One vial from lot# PP0317012-A was found to contain particulate matter, identified as glass within the vial and another vial from lot# PP0317059-A was fo...

FDA - U.S. Food and Drug Administration

27-4-2018

EpiPen 300 mcg adrenaline auto-injector

EpiPen 300 mcg adrenaline auto-injector

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