The following reactions with an incidence of at least 1% were reported with intravenous Adenoscan among 1421 patients enrolled in controlled and uncontrolled U.S. clinical trials. Despite the short half-life of adenosine, 10.6% of the side effects occurred not with the infusion of Adenoscan but several hours after the infusion terminated. Also, 8.4% of the side effects that began coincident with the infusion persisted for up to 24 hours after the infusion was complete. In many cases, it is not possible to know whether these late adverse events are the result of Adenoscan infusion.

Adverse experiences of any severity reported in less than 1% of patients include:

Body as a whole: back discomfort; lower extremity discomfort; weakness.

Cardiovascular System: nonfatal myocardial infarction; life-threatening ventricular arrhythmia; third-degree AV block; bradycardia; palpitation; sinus exit block; sinus pause; sweating; T-wave changes; hypertension (systolic blood pressure > 200 mm Hg).

Central Nervous System: drowsiness; emotional instability; tremors.

Genital/Urinary System: vaginal pressure; urgency.

Respiratory System: cough.

Special Senses: blurred vision; dry mouth; ear discomfort; metallic taste; nasal congestion; scotomas; tongue discomfort.

Post Marketing Experience (see WARNINGS)

The following adverse events have been reported from marketing experience with Adenoscan. 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 relationship 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.

Body as a Whole

Injection site reaction

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

Nausea and vomiting

Respiratory arrest

Intravenous Adenoscan (adenosine injection) has been given with other cardioactive drugs (such as beta adrenergic blocking agents, cardiac glycosides, and calcium channel blockers) without apparent adverse interactions, but its effectiveness with these agents has not been systematically evaluated. Because of the potential for additive or synergistic depressant effects on the SA and AV nodes, however, Adenoscan should be used with caution in the presence of these agents.

The vasoactive effects of Adenoscan are inhibited by adenosine receptor antagonists, such as methylxanthines (e.g., caffeine and theophylline). The safety and efficacy of Adenoscan in the presence of these agents has not been systematically evaluated.

The vasoactive effects of Adenoscan are potentiated by nucleoside transport inhibitors, such as dipyridamole. The safety and efficacy of Adenoscan in the presence of dipyridamole has not been systematically evaluated.

Whenever possible, drugs that might inhibit or augment the effects of adenosine should be withheld for at least five half-lives prior to the use of Adenoscan.

Brand Name: Adenoscan
Generic Name: Adenosine Inj

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