ADENOSCAN Solution for infusion Ref.[27893] Active ingredients: Adenine Deoxy Nucleoside

Adenosine is intended for use in a hospital setting with monitoring and cardio-respiratory resuscitation equipment available for immediate use if necessary. During administration, continuous ECG monitoring is necessary as life-threatening arrhythmia might occur (section 4.2).

Because it has the potential to cause significant hypotension, Adenoscan should be used with caution in patients with left main coronary stenosis, uncorrected hypovolemia, stenotic valvular heart disease, left to right shunt, pericarditis or pericardial effusion, autonomic dysfunction or stenotic carotid artery disease with cerebrovascular insufficiency. Adenoscan infusion should be discontinued in any patient who develops persistent or symptomatic hypotension. There have been reports of cerebrovascular accident/transient ischemic attack, secondary to the haemodynamic effects of adenosine.

There have been reports of myocardial infarction shortly after use of Adenoscan. Adenoscan should be used with caution in patients with recent myocardial infarction or severe heart failure. Adenoscan should be used with caution in patients with minor conduction defects (first-degree AV block, bundle branch block) that could be transiently aggravated during infusion.

Adenosine may trigger convulsions in patients who are susceptible to convulsions.

Adenoscan should be used with caution in patients with atrial fibrillation or flutter and especially in those with an accessory by-pass tract since particularly the latter may develop increased conduction down the anomalous pathway.

Rare cases of severe bradycardia have been reported. Some occurred in early post-transplant patients; in the other cases occult sino-atrial disease was present. The occurrence of severe bradycardia should be taken as a warning of underlying disease and should lead to treatment discontinuation. Severe bradycardia would favour the occurrence of torsades de pointes, especially in patients with prolonged QT intervals. But to date, no case of torsades de pointes has been reported when adenosine is continuously infused.

The occurrence of respiratory failure (potentially fatal), asystole/cardiac arrest (potentially fatal), angina, severe bradycardia or severe hypotension should also lead to treatment discontinuation.

In patients with recent heart transplantation (less than 1 year) an increased sensitivity of the heart to adenosine has been observed.

Adenosine may precipitate or aggravate bronchospasm (see sections 4.3 and 4.8).

Adenoscan contains 35.4 mg sodium per vial (3.54 mg sodium per ml), equivalent to 1.77% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

Dipyridamole inhibits adenosine cellular uptake and metabolism and potentiates the action of Adenoscan. In one study dipyridamole was shown to produce a 4-fold increase in adenosine actions. It is therefore suggested that Adenoscan should not be administered to patients receiving dipyridamole; if use of Adenoscan is essential, dipyridamole should be stopped 24 hours before hand, or the dose of Adenoscan should be greatly reduced.

Aminophylline, theophylline and other xanthines are competitive adenosine antagonists and should be avoided for 24 hours prior to use of Adenoscan.

Food and drinks containing xanthines (tea, coffee, chocolate and cola) should be avoided for at least 12 hours prior to use of Adenoscan.

Adenosine may interact with drugs tending to impair cardiac conduction.

Pregnancy

There are no or limited amount of data from the use of adenosine in pregnant women. Animal studies are insufficient with respect to reproductive toxicity. Adenosine is not recommended during pregnancy unless the physician considers the benefits to outweigh the potential risks.

Breast-feeding

It is unknown whether adenosine metabolites are excreted in human milk. Adenoscan should not be used during breast-feeding.

Not relevant.

Effects related to the known pharmacology of adenosine are frequent, but usually self-limiting and of short duration. Discontinuation of infusion may be necessary if the effect is intolerable.

Methylxanthines, such as IV aminophylline or theophylline have been used to terminate persistent side effects (50–125 mg by slow intravenous injection).

Adverse events are ranked under the heading of the frequency: Very common (>1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10000 to <1/1000), very rare (<1/10000), not known (cannot be estimated from available data).

Immune system disorders

Not known: anaphylactic reaction (including angioedema and skin reactions such as urticaria and rash).

Cardiac disorders

Common: ST segment depression, sustained or non-sustained ventricular tachycardia, AV block (see section 4.4).

If sustained second- or third-degree AV block develops the infusion should be discontinued. If first-degree AV block occurs, the patient should be observed carefully as a quarter of patients will progress to a higher degree of block.

Uncommon: bradycardia sometimes severe (see section 4.4)

Not known: asystole/cardiac arrest (sometimes fatal, especially in patients with underlying ischemic heart disease/cardiac disorders, see section 4.4), sinus tachycardia, atrial fibrillation, ventricular fibrillation

Nervous system disorders

Very common: headache

Common: dizziness, light-headedness, paraesthesia

Rare: tremor, drowsiness

Not known: loss of consciousness/syncope, convulsions, especially in predisposed patients (see section 4.4)

Eye disorders

Rare: blurred vision

Ear and labyrinth disorders

Rare: tinnitus

Respiratory, thoracic and mediastinal disorders

Very common: dyspnea (or the urge to breathe deeply)

Rare: bronchospasm (see section 4.4), nasal congestion

Very rare: respiratory failure (see section 4.4)

Not known: apnoea/respiratory arrest

Cases with fatal outcome of respiratory failure, of bronchospasm, and of apnoea/respiratory arrest have been reported.

Gastrointestinal disorders

Very common: abdominal discomfort

Common: dry mouth

Uncommon: metallic taste

Not known: nausea, vomiting

Renal and urinary disorders

Rare: urinary urgency

Vascular disorders

Very common: flushing

Common: hypotension, sometimes severe (see section 4.4)

General disorders and administration site conditions

Very common: chest pain or pressure, feeling of thoracic constriction/oppression

Common: throat, neck and jaw discomfort

Uncommon: sweating, discomfort in the leg, arm or back, feeling of general discomfort, weakness/pain

Very rare: injection site reactions

Reproductive system and breast disorders

Rare: nipple discomfort

Psychiatric disorders

Uncommon: nervousness

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the MHRA Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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