ADENOCOR

Adenocor is intended for hospital use only with monitoring and cardiorespiratory resuscitation equipment available for immediate use. Adenocor 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.

Posology Rapid conversion to a normal sinus rhythm of paroxysmal supraventricular tachycardias Adult: Initial dose: 3 mg given as a rapid intravenous bolus (over 2 seconds).

Second dose:

If the first dose does not result in elimination of the supraventricular tachycardia within 1 – 2 minutes, 6 mg should be given also as a rapid intravenous bolus.

Third dose:

If the second dose does not result in elimination of the supraventricular tachycardia within 1 – 2 minutes. 12 mg should be given also as a rapid intravenous bolus. Additional or higher doses are not recommended. Paediatric population During administration of adenosine cardio-respiratory resuscitation equipment must be available for immediate use if necessary.

Adenosine is intended for use with continuous monitoring and ECG recording during administration. 1 mg/kg body weight as needed to achieve termination of supraventricular tachycardia (maximum dose of 12 mg). Elderly See dosage recommendations for adults.

Method of administration Adenosine should be administered by rapid intravenous (IV) bolus injection into a vein or into an IV line. If given into an IV line it should be injected through as proximally as possible, and followed by a rapid saline flush.

If administered through a peripheral vein, a large bore cannula should be used. Diagnostic dose The above ascending dosage schedule should be employed until sufficient diagnostic information has been obtained. Method of administration Rapid intravenous (IV) injection only.

These side effects are generally mild, of short duration (usually less than 1 minute) and well tolerated by the patient. However severe reactions can occur. 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). 4). Arteriospasm coronary which may lead to myocardial infarction. 4), apnoea/respiratory arrest Cases of respiratory failure, bronchospasm, apnoea, and respiratory arrest with fatal outcome have been reported.

Gastrointestinal disorders:

Common: nausea Uncommon: metallic taste Not known: vomiting Psychiatric disorders: Common: nervousness General disorders and administration site conditions: Very common: chest pain or pressure, feeling of thoracic constriction/oppression Uncommon: sweating, discomfort in the leg, arm or back, feeling of general discomfort, weakness/pain Very rare: injection site reactions Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Special warnings Due to the possibility of transient cardiac arrhythmias arising during conversion of the supraventricular tachycardia to normal sinus rhythm, administration should be carried out in a hospital setting with monitoring and cardio- respiratory resuscitation equipment available for immediate use if necessary.

2). Because it has the potential to cause significant hypotension, adenosine 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.

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 Adenocor. Adenosine should be used with caution in patients with recent myocardial infarction, severe heart failure, or in patients with minor conduction defects (first degree A-V block, bundle branch block) that could be transiently aggravated during infusion.

Adenosine 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 heart 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 could potentially favour the occurrence of torsades de pointes, especially in patients with prolonged QT intervals.

In patients with recent heart transplantation (less than 1 year) an increased sensitivity of the heart to adenosine has been observed. Since neither the kidney nor the liver are involved in the degradation of exogenous adenosine, Adenocor’s efficacy should be unaffected by hepatic or renal insufficiency.

1. • Sick sinus syndrome, second or third degree Atrio-Ventricular (AV) block (except in patients with a functioning artificial pacemaker). g. asthma bronchiale) • Long QT syndrome • Severe hypotension • Decompensated states of heart failure