The following reactions were reported with intravenous Adenocard (adenosine) used in controlled U.S. clinical trials. The placebo group had a less than 1% rate of all of these reactions.

Cardiovascular: Facial flushing (18%), headache (2%), sweating, palpitations, chest pain, hypotension (less than 1%).

Respiratory: Shortness of breath / dyspnea (12%), chest pressure (7%), hyperventilation, head pressure (less than 1%).

Central Nervous System: Lightheadedness (2%), dizziness, tingling in arms, numbness (1%), apprehension, blurred vision, burning sensation, heaviness in arms, neck and back pain (less than 1%).

Gastrointestinal: Nausea (3%), metallic taste, tightness in throat, pressure in groin (less than 1%).

In post-market clinical experience with Adenocard, cases of prolonged asystole, ventricular tachycardia, ventricular fibrillation, transient increase in blood pressure, bradycardia, hypotension, atrial fibrillation, and bronchospasm, in association with Adenocard use, have been reported.

Postmarketing Experience (see WARNINGS)

The following adverse events have been reported from marketing experience with Adenocard. Because these events are reported voluntarily from a population of uncertain size, are associated with concomitant diseases and multiple drug therapies and surgical procedures, it is not always possible to reliably estimate their frequency or establish a causal relatioship to drug exposure. Decisions to include these events in labeling are typically based on one or more of the following factors: (1) seriousness of the event, (2) frequency of the reporting, (3) strength of causal connection to the drug, or a combination of these factors.

Cardiovascular

Prolonged asystole, ventricular tachycardia, ventricular fibrillation, transient increase in blood pressure, bradycardia, atrial fibrillation, and Torsade de Pointes

Respiratory

Bronchospasm

Central Nervous System

Seizure activity, including tonic clonic (grand mal) seizures, and loss of conciousness.

Intravenous Adenocard (adenosine) has been effectively administered in the presence of other cardioactive drugs, such as quinidine, beta-adrenergic blocking agents, calcium channel blocking agents, and angiotensin converting enzyme inhibitors, without any change in the adverse reaction profile. Digoxin and verapamil use may be rarely associated with ventricular fibrillation when combined with Adenocard (see WARNINGS). Because of the potential for additive or synergistic depressant effects on the SA and AV nodes, however, Adenocard should be used with caution in the presence of these agents. The use of Adenocard in patients receiving digitalis may be rarely associated with ventricular fibrillation (see WARNINGS).

The effects of adenosine are antagonized by methylxanthines such as caffeine and theophylline. In the presence of these methylxanthines, larger doses of adenosine may be required or adenosine may not be effective. Adenosine effects are potentiated by dipyridamole. Thus, smaller doses of adenosine may be effective in the presence of dipyridamole. 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 A-V node, higher degrees of heart block may be produced in the presence of carbamazepine.

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