ADENOSINE

Adenosine infusion is intended for use in hospitals with monitoring and cardio- respiratory resuscitation equipment available for immediate use if necessary. It should be administered following the same procedure as for exercise testing where facilities for cardiac monitoring and cardio-respiratory resuscitation are available.

During administration of adenosine infusion continuous ECG control is necessary as life-threatening arrhythmia might occur. Heart rate and blood pressure should be monitored every minute.

Posology:

Adults: 1. Adenosine Infusion should be administered undiluted as a continuous peripheral intravenous infusion at a dose of 140 μg/kg/min for six minutes using an infusion pump. Separate venous sites for Adenosine Infusion and radionuclide administration are recommended to avoid an adenosine bolus effect.

2. After three minutes of Adenosine Infusion, the radionuclide is injected to ensure sufficient time for peak coronary blood flow to occur. The optimal vasodilator protocol is achieved with six minutes of Adenosine Infusion. 3. To avoid an adenosine bolus effect, blood pressure should be measured in the arm opposite to the adenosine infusion.

84 mg/kg). 7 Paediatric population The safety and efficacy of adenosine in children aged 0 to 18 years have not been established. 1 but no recommendation on a posology can be made.

Elderly:

See dosage recommendations for adults.

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, <1/10), Uncommon (>1/1,000, <1/100), Rare (>1/10,000, <1/1,000), Very rare (<1/10,000), 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). 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.

4): sinus tachycardia, atrial fibrillation, ventricular fibrillation, arteriospasm coronary which may lead to myocardial infarction. 4) • Not known: apnea/respiratory arrest Cases with fatal outcome of respiratory failure, of bronchospasm, and of apnea/respiratory arrest have been reported.

Gastro-intestinal disorders: • Very common: abdominal discomfort • Common: dry mouth • Uncommon: metallic taste • Not known: nausea, vomiting. 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 authorisation of the medicinal product is important.

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.

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

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

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

1. - Second or third degree atrioventricular (AV) block, sick sinus syndrome, except in patients with a functioning artificial pacemaker. - Long QT syndrome. - Severe hypotension. - Unstable angina not successfully stabilised with medical therapy.

- Decompensated states of heart failure. g. asthma bronchiale). 5)