Adenocor

/ Sanofi

Adenocor is intended for hospital use only with monitoring and cardiorespiratory resuscitation equipment available for immediate use. 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 administer either directly into a vein or into an IV line. If given into an IV line it should be injected as proximally as possible, and followed by a rapid saline flush. 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.
Therapeutic dose
Adult: Initial dose: 3mg 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 to 2 minutes, 6mg should be given also as a rapid intravenous bolus, followed by a rapid saline flush.
Third dose: If the second dose does not result in elimination of the supraventricular tachycardia within 1 to 2 minutes. 12mg should be given also as a rapid intravenous bolus. Additional or higher doses are not recommended.
Children: No controlled pediatric study has been undertaken. The level of evidence does not allow a recommended posology.
Elderly: see dosage recommendations for adults.
Hepatic / Renal impairment: As adenosine requires no hepatic or renal function for its activation or inactivation, hepatic and/or renal failure would not be expected to alter efficacy or tolerance.

Paroxy. supraventricular tachycardia, including Wolf Parkinson-White syndrome.

Adenocor is contraindicated for patients presenting:
− Known hypersensitivity to adenosine.
− Sick sinus syndrome, second or third degree Atrio-Ventricular 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.

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 hospital with electrocardiographic monitoring. 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. Because of the possible risk of torsades de pointes, Adenocor should be used with caution in patients with a prolonged QT interval, whether this is drug induced or of metabolic origin. Adenocor is contraindicated in patients with Long QT syndrome. See prescribing information for full details.
NOTE: 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. Adenosine should be used with caution in patients with recent myocardial infarction, 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 anaccessory by-pass tract since particularly the latter may develop increased conduction down the anomalous pathway. Some 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. In patients with recent heart transplantation (less than 1 year) an increased sensitivity of the heart to adenosine has been observed. As dipyridamole is a known inhibitor of adenosine uptake, it may potentiate the action of Adenocor. It is therefore suggested that Adenocor should not be administered to patients receiving dipyridamoleIt is therefore suggested that Adenocor should not be administered to patients receiving dipyridamole; . If use of Adenocor is essential, dipyridamole should be discontinued 24 hours beforehand, or the dose of adenosine should be reduced.

Nervous System disorders: Common: Headache, Dizziness / light-headedness.
Psychiatric disorders: Common: Apprehension.
Gastrointestinal disorders: Common: Nausea.
Cardiac Disorders: Very common: Bradycardia, Sinus pause, Atrio-ventricular block, Atrial extrasystoles, Skipped beats.
Respiratory, thoracic and mediastinal disorders: Very common: Dyspnoea (or the urge to take a deep breath).
Vascular disorders: Very common: Flushing.
General disorders and Administration Site conditions: Very Common: Chest pressure/pain, feeling of thoracic constriction/oppression. Common: Burning sensation.
For full details see prescribing information.

As dipyridamole is a known inhibitor of adenosine uptake, it may potentiate the action of Adenocor; in one study dipyridamole was shown to produce a 4 fold increase in adenosine actions. Asystole has been reported following
concomitant administration. It is therefore suggested that Adenocor should not be administered to patients receiving dipyridamole . If use of Adenocor is essential, dipyridamole should be discontinued 24 hours beforehand, or the dose of adenosine should be reduced.
Aminophylline, theophylline and other xanthines are competitive adenosine antagonists and should be avoided for 24 hours prior to use of Adenosine.
Food and drinks containing xanthines (tea, coffee, chocolate and cola) should be avoided for at least 12 hours prior to use of Adenosine.
Adenocor may interact with drugs tending to impair cardiac conduction.

Pregnancy: In the absence of evidence that adenosine does not cause foetal harm, Adenocor should only be used during pregnancy where absolutely necessary.
Lactation: In the absence of clinical experience use of Adenocor during lactation should be considered only if essential.

As the half-life of adenosine is very short (less than 10 seconds), adverse effects are generally rapidly self limiting.
Management: Treatment of any prolonged adverse effects should be individualized and directed toward the specific symptom. Methylxanthines, such as caffeine and theophylline, and aminophylline are competitive antagonists of adenosine. Intravenous aminophylline or theophylline may be needed.