Adenosine-Claris

New Zealand - English - Medsafe (Medicines Safety Authority)

Active ingredient:
Adenosine 3 mg/mL;  ;  
Available from:
Baxter Healthcare Ltd
INN (International Name):
Adenosine 3 mg/mL
Dosage:
6 mg/2mL
Pharmaceutical form:
Solution for injection
Composition:
Active: Adenosine 3 mg/mL     Excipient: Sodium chloride Water for injection
Prescription type:
Prescription
Manufactured by:
Xinxiang Tuoxin Biochemical Technology & Science Co Ltd
Therapeutic indications:
Therapeutic Indications Rapid conversion to a normal sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White syndrome). Diagnostic Indications Aid to diagnosis of broad or narrow QRS complex supraventricular tachycardias. Although Adenosine-Claris 6 mg/2 ml is not effective in converting atrial flutter, atrial fibrillation or ventricular tachycardia to sinus rhythm, the slowing of AV conduction helps diagnosis of atrial activity. Sensitisation of intra-cavitary electrophysiological investigations.
Product summary:
Package - Contents - Shelf Life: Vial, glass, sulfur-treated Ph Eur type I clear 2 mL with teflon-coated rubber stopper - 5 dose units - 24 months from date of manufacture stored at or below 25°C. Do not refrigerate - Vial, glass, sulfur-treated Ph Eur type I clear 2 mL with teflon-coated rubber stopper - 10 dose units - 24 months from date of manufacture stored at or below 25°C. Do not refrigerate - Vial, glass, sulfur-treated Ph Eur type I clear 2 mL with teflon-coated rubber stopper - 25 dose units - 24 months from date of manufacture stored at or below 25°C. Do not refrigerate
Authorization number:
TT50-10090a
Authorization date:
2016-12-19

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Page 1 of 9

ADENOSINE‐CLARIS Data Sheet 14 March 2018

Baxter Healthcare Ltd

1. PRODUCT NAME

ADENOSINE‐CLARIS (Adenosine 6 mg/2 mL solution for injection)

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Adenosine 6 mg/2 mL

For the full list of excipients see section 6.1.

3. PHARMACEUTICAL FORM

Solution for injection. A clear, colourless solution free from visible particles.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Rapid conversion to a normal sinus rhythm of paroxysmal supraventricular

tachycardias, including those associated with accessory bypass tracts (Wolff‐

Parkinson‐White syndrome).

Diagnostic Indications

Aid to diagnosis of broad or narrow QRS complex supraventricular tachycardias. Although

ADENOSINE‐CLARIS 6 mg/2 mL is not effective in converting atrial flutter, atrial fibrillation or

ventricular tachycardia to sinus rhythm, the slowing of AV conduction helps diagnosis of atrial

activity. Sensitisation of intracavity electrophysiological investigations.

4.2 Dose and method of administration

ADENOSINE‐CLARIS 6 mg/2 mL should be used only in hospitals, with monitoring and

cardiorespiratory resuscitation equipment available for immediate use if necessary. It should

be administered by rapid IV bolus injection according to the ascending dosage schedule

below. To be certain the solution reaches the systemic circulation, it should be administered

either directly into a vein or into an IV line. If administered via an IV line it should be injected

as proximally as possible, and followed by a rapid saline flush.

ADENOSINE‐CLARIS 6 mg/2 mL should only be used when facilities exist for cardiac

monitoring. Patients who develop high‐level AV block at a particular dose should not be given

further dosage increments.

Therapeutic Dose

Adults

Initial dose: 3 mg given as a rapid intravenous bolus (over 2 seconds).

Second dose: If the first dose does not result in the elimination of supraventricular

tachycardia within 1 or 2 minutes, 6 mg should be given also as a rapid intravenous bolus.

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ADENOSINE‐CLARIS Data Sheet 14 March 2018

Baxter Healthcare Ltd

Third dose: If the second dose does not result in the elimination of supraventricular

tachycardia within 1 or 2 minutes, 12 mg should be given also as a rapid intravenous bolus.

Children

No controlled paediatric studies have been undertaken. The level of evidence does not

allow a recommended posology.

Elderly

See dosage recommendations for adults

Diagnostic Dose

The above ascending dosage schedule should be employed until sufficient diagnostic

information has been obtained.

4.3 Contraindications

ADENOSINE‐CLARIS is contraindicated in patients with:

Known hypersensitivity to adenosine

Sick sinus syndrome, second or third degree AV block (except in patients with a

functioning artificial pacemaker)

Chronic obstructive lung disease (such as asthma)

Long QT syndrome

Severe hypotension, decompensated states of heart failure.

4.4 Special warnings and precautions for use

Adenosine is intended for use by physicians familiar with the product (see ‘DOSAGE AND

ADMINISTRATION’) in a hospital setting with monitoring and cardio‐respiratory resuscitation

equipment available for immediate use if necessary.

The occurrence of angina, severe bradycardia, severe hypotension, respiratory failure

(potentially fatal), or asystole/cardiac arrest (potentially fatal), should lead to immediate

discontinuation of administration.

In patients with history of convulsions/seizures, the administration of adenosine should

be carefully monitored.

As dipyridamole is a known inhibitor of adenosine uptake, it may potentiate the action of

adenosine administration. The use of ADENOSINE‐CLARIS 30 mg/10 mL is contraindicated in

patients receiving dipyridamole (see ADENOSINE‐CLARIS 30 mg/10mL datasheet

“CONTRAINDICATIONS”). If use of adenosine bolus injection (ADENOSINE‐CLARIS 6 mg/2 mL) is

judged to be essential, dipyridamole should be discontinued 24 hours beforehand or the dose

of adenosine should be significantly reduced.

ADENOSINE‐CLARIS 6 mg/2 mL (adenosine) should be given as a rapid intravenous bolus.

Adenosine is ineffective in the management of SVT when given as an infusion, rather than a

bolus. This is most probably due to the different effect on sinus rate and atrioventricular nodal

conduction.

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ADENOSINE‐CLARIS Data Sheet 14 March 2018

Baxter Healthcare Ltd

Hypotension

Because it has the potential to cause significant hypotension, adenosine should be used

with caution in patients with left main coronary stenosis, uncorrected hypovolaemia,

stenotic valvular heart disease, left to right shunt, pericarditis or pericardial effusion,

autonomic dysfunction or stenotic carotid artery disease with cerebrovascular insufficiency.

Atrial Fibrillation

ADENOSINE‐CLARIS 6 mg/2 mL should be used with caution in patients with atrial

fibrillation or flutter and especially those with an accessory by‐pass tract since

particularly the latter may develop increased conduction down the anomalous

pathway.

Bradycardia

Some cases of severe bradycardia have been reported. Some occurred in early post heart

transplant patients; in other cases occult sino‐atrial disease was present. The occurrence of

severe bradycardia should be taken as a warning of underlying disease and could potentially

favour the occurrence of torsades de pointes.

Heart Block and Myocardial Infarction

ADENOSINE‐CLARIS 6 mg/2 mL (adenosine) exerts its effect by decreasing conduction

through the AV node and may produce a short lasting first, second or third‐degree heart

block. In extreme cases, transient asystole may result (one case has been reported in a

patient with atrial flutter who was receiving carbamazepine). Appropriate therapy should be

instituted as needed. Patients who develop high level block on one dose of ADENOSINE‐

CLARIS 6 mg/2 mL should not be given additional doses. Because of the very short half‐life of

adenosine, these effects are generally self‐limiting.

ADENOSINE‐CLARIS 6 mg/2 mL should be used with caution in patients with recent

myocardial infarction, heart failure, or in patients with minor conduction defects (first

degree AV block, bundle branch block) that could be transiently aggravated during infusion.

Arrythmias at Time of Conversion

At the time of conversion to normal sinus rhythm, a variety of new rhythms may appear on

the electrocardiogram. They generally last only a few seconds without intervention and may

take the form of premature ventricular contractions, premature atrial contractions, atrial

fibrillation, sinus bradycardia, sinus tachycardia, skipped beats, sinus pause and varying

degrees of AV nodal block. Such findings were seen in 55% of patients. The induced

bradycardia predisposes the patient to ventricular excitability disorders including ventricular

fibrillation and torsades de pointes.

Because of the possible risk of torsades de pointes, ADENOSINE‐CLARIS 6 mg/2 mL

should be used with caution in patients with a prolonged QT interval.

Post Heart Transplantation

In patients with recent heart transplantation (less than 1 year) an increased sensitivity of the

heart to adenosine has been observed. ADENOSINE‐CLARIS 6 mg/2 mL should be used with

caution in such cases.

Bronchoconstriction

Adenosine administered by inhalation has been reported to cause bronchoconstriction in

asthmatic patients, presumably due to mast cell degranulation

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ADENOSINE‐CLARIS Data Sheet 14 March 2018

Baxter Healthcare Ltd

and histamine release. These effects have not been observed in normal subjects.

Adenosine has been administered to a limited number of patients with asthma and mild to

moderate exacerbation of their symptoms has been reported. ADENOSINE‐CLARIS 6 mg/2

mL should not be used in patients with asthma (see CONTRAINDICATIONS).

Respiratory compromise has occurred during adenosine infusion in patients with obstructive

pulmonary disease. ADENOSINE‐CLARIS 6 mg/2 mL should be used with caution in patients

with obstructive lung disease not associated with bronchoconstriction (e.g. emphysema,

bronchitis, etc) and should be avoided in patients with bronchoconstriction or bronchospasm

(e.g. asthma). ADENOSINE‐CLARIS 6 mg/2 mL should be discontinued in any patient who

develops severe respiratory difficulties.

Adenosine may precipitate or aggravate bronchospasm.

Carcinogenicity/Mutagenicity

Studies in animals have not been performed to evaluate the carcinogenic potential of

ADENOSINE‐CLARIS 6 mg/2 mL. Adenosine tested negative for mutation in the

Salmonella/Mammalian Microsome Assay. Adenosine, like other nucleosides at millimolar

concentrations present for several doubling times of cells in culture, is known to produce a

variety of chromosomal alterations. In rats and mice, adenosine administered

intraperitoneally once a day for 5 days at 50, 100 and 150 mg/kg caused decreased

spermatogenesis and increased numbers of abnormal sperm.

Paediatric Use

No data has been submitted from controlled studies in children.

4.5 Interaction with other medicine and other forms of interaction

Intravenous ADENOSINE‐CLARIS 6 mg/2 mL (adenosine) has been effectively administered in

the presence of other cardioactive drugs, such as digitalis, quinidine, beta‐adrenergic blocking

agents, calcium channel blocking agents, and angiotensin‐ converting enzyme inhibitors,

without any change in the adverse reaction profile.

Adenosine may interact with drugs that tend to impair cardiac conduction. Aminophylline,

theophylline and other xanthines are competitive adenosine antagonists and should be

avoided for 24 hours prior to the administration of adenosine. Food and drinks containing

xanthines (e.g. tea, coffee, chocolate and cola) should be avoided for at least 12 hours prior to

the administration of adenosine.

Nucleoside transport inhibitors such as dipyridamole inhibit adenosine cellular uptake and

metabolism, and potentiate the action of adenosine. In one study dipyridamole was shown to

produce a four‐fold increase in adenosine activity. The use of ADENOSINE‐CLARIS 30 mg/10 mL

infusion is contraindicated in patients receiving dipyridamole (see ADENOSINE‐CLARIS 30

mg/10 mL datasheet “CONTRAINDICATION”). If the use of adenosine bolus injection

(ADENOSINE‐CLARIS 6 mg/2 mL) is judged to be essential, dipyridamole should be

discontinued 24 hours beforehand, or the dose of ADENOSINE‐CLARIS 6 mg/2 mL should be

significantly reduced.

Carbamazepine has been reported to increase the degree of heart block produced by other

agents. As the primary effect of adenosine is to decrease conduction through the AV node,

higher degrees of heart block may be produced in the presence of carbamazepine.

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ADENOSINE‐CLARIS Data Sheet 14 March 2018

Baxter Healthcare Ltd

4.6 Fertility, pregnancy and lactation

Use in Pregnancy

Category B2

Animal reproductive studies have not been conducted with adenosine, nor have studies

been performed on pregnant women. In the absence of evidence that adenosine does not

cause foetal harm, ADENOSINE‐CLARIS 6 mg/2 mL should not be used during pregnancy

unless the physician considers the benefits outweigh the potential risks.

Use in Lactation

Studies have not been performed in lactating animals or women. Therefore, adenosine

should not be used during lactation. If adenosine treatment is considered essential by the

physician, another form of infant feeding should be considered.

4.7 Effects on ability to drive and use machines

None

4.8 Undesirable effects

The following adverse reactions have been reported with adenosine rapid intravenous bolus

injection. These adverse reactions have been classified using standard terminology and are

categorised by body system. They are listed in order of decreasing frequency according to the

following definitions:

very common: ≥ 1/10 (10%)

common: ≥ 1/100 (1%) and < 1/10 (10%)

uncommon: ≥ 1/1000 (0.1%) and < 1/100 (1%) rare: ≥

1/10000 (0.01%) and < 1/1000 (0.1%) very rare: <

1/10000 (0.01%)

Cardiovascular System

Very common: bradycardia; sinus pause, skipped beats; atrial extrasystoles; A‐V block;

ventricular excitability disorders such as ventricular extrasystoles, non‐ sustained

ventricular tachycardia.

Uncommon: sinus tachycardia; palpitations.

Very rare: atrial fibrillation; ventricular excitability including ventricular fibrillation and

torsade de pointes; severe bradycardia not corrected by atropine and possibly requiring

temporary pacing.

Respiratory System

Very common: dyspnoea (or the urge to breathe deeply).

Uncommon: hyperventilation.

Very rare: bronchospasm.

Central Nervous System

Common: headache; dizziness, light‐headedness.

Uncommon: head pressure;

Very rare: transient and spontaneously rapidly reversible worsening of intracranial

hypertension.

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ADENOSINE‐CLARIS Data Sheet 14 March 2018

Baxter Healthcare Ltd

Gastrointestinal System

Common: nausea. Uncommon: metallic taste.

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ADENOSINE‐CLARIS Data Sheet 14 March 2018

Baxter Healthcare Ltd

Other

Very common: flushing; chest pressure/pain, feeling of thoracic

constriction/oppression.

Common: apprehension; burning sensation.

Uncommon: blurred vision; sweating; feeling of general discomfort/weakness/pain.

Very rare: injection site reactions.

Postmarketing Experience

In postmarket clinical experience with ADENOSINE‐CLARIS, hypotension, sometimes severe,

has been reported. There have been reports of cerebrovascular accident/transient ischemic

attack, secondary to the hemodynamic effects of adenosine, including hypotension.

Cases of asystole/cardiac arrest, sometimes fatal especially in patients with underlying

ischaemic heart disease/cardiac disorder have been reported (see ‘PRECAUTIONS’).

Loss of consciousness/syncope, and convulsions especially in predisposed patients have been

reported (see ‘PRECAUTIONS’).

Apnoea/respiratory arrest, and respiratory failure (see ‘PRECAUTIONS’) have been reported.

Cases of fatal outcome of respiratory failure, of bronchospasm, and of apnoea/respiratory

arrest have also been reported.

Cases of vomiting have been reported.

Other reports include tingling in arms, numbness, pressure in groin and transient increase

in blood pressure.

Myocardial infarction and ST segment elevation have been reported, especially in patients

with pre‐existing severe coronary artery disease.

Anaphylactic reactions, including angioedema and skin reactions such as urticaria and rash,

have been reported.

4.9 Overdose

As the half‐life of adenosine is very short (less than 10 seconds), adverse effects are generally

rapidly self‐limiting. Treatment of any prolonged adverse effects should be individualised and be

directed toward the specific symptoms. Methylxanthines, such as caffeine and theophylline, and

aminophylline are competitive antagonists of adenosine. Intravenous aminophylline or

theophylline may be needed.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Mechanism of Action

ADENOSINE‐CLARIS 6 mg/2 mL administered by rapid intravenous injections depresses

conduction through the AV node. This action can interrupt re‐entry circuits involving the AV

node and restore normal sinus rhythm in patients with paroxysmal supraventricular

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ADENOSINE‐CLARIS Data Sheet 14 March 2018

Baxter Healthcare Ltd

tachycardias and paroxysmal supraventricular tachycardias associated with Wolff‐Parkinson‐

White Syndrome. Once the circuit has been interrupted, the tachycardia stops and normal sinus

rhythm is re‐established.

By transiently slowing AV conduction, atrial activity is easier to evaluate from ECG

recordings and therefore ADENOSINE‐CLARIS can aid the diagnosis of broad or narrow

QRS complex tachycardias.

ADENOSINE‐CLARIS may be useful during electrophysiological studies to determine the site of

AV block or to determine, in some cases of pre‐excitation, whether conduction is occurring by

an accessory pathway or via the AV node.

Haemodynamics

The usual intravenous bolus dose of 3 or 6 mg ADENOSINE‐CLARIS usually has no systemic

haemodynamic effects. Rarely significant hypotension and tachycardia

have been observed. When larger doses are given by infusion, adenosine decreases blood

pressure by decreasing peripheral resistance.

5.2 Pharmacokinetic properties

Intravenously administered ADENOSINE‐CLARIS(adenosine) is removed from the circulation

very rapidly. Following an intravenous bolus, adenosine is taken up by erythrocytes and

vascular endothelial cells. The half‐life of intravenous adenosine is estimated to be less than 10

seconds. Adenosine enters the body pool and is primarily metabolised to inosine and

adenosine monophosphate (AMP).

Hepatic and Renal Failure Hepatic and renal failure should have no effect on the activity of a

bolus ADENOSINE‐CLARIS (adenosine) injection. Since ADENOSINE‐CLARIS (adenosine) has a

direct action, hepatic and renal function are not required for the activity or metabolism of a

bolus adenosine injection.

5.3 Preclinical safety data

None

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium chloride

9 mg/mL

Water for injections

q.s to 2 mL

Nitrogen

q.s.

6.2 Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other

medicinal products.

6.3 Shelf life

Unopened: 24 months

The product should be used immediately after opening

Page 9 of 9

ADENOSINE‐CLARIS Data Sheet 14 March 2018

Baxter Healthcare Ltd

6.4 Special precautions for storage

Store below 25

C. Do not refrigerate

6.5 Nature and contents of container

Clear, type I glass vials (2 mL) sealed with chlorobutyl rubber closures. Packs of 5,

10 or 25 vials packed in a tray in a cardboard carton.

6.6 Special precautions for disposal

Any portion of the vial not used at once should be discarded.

7. MEDICINE SCHEDULE

Prescription Medicine

8. SPONSOR

ADENOSINE‐CLARIS is distributed in New Zealand by:

Baxter Healthcare Ltd

33 Vestey Drive

Mt Wellington

Auckland 1060.

Baxter Healthcare Ltd

PO Box 14 062

Panmure

Auckland 1741

Phone (09) 574 2400.

9. DATE OF FIRST APPROVAL

31/08/2017

10. DATE OF REVISION OF THE TEXT

14 March 2018

SUMMARY TABLE OF CHANGES

Section changed

Summary of new information

Sponsor details updated.

Date of revision, and footer date updated.

Please refer to the Medsafe website (www.medsafe.govt.nz) for most recent data sheet.

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