Adenoscan

Name: Adenoscan

Uses of Adenoscan

  • It is used to treat certain types of abnormal heartbeats.
  • It is used during a stress test of the heart.
  • It may be given to you for other reasons. Talk with the doctor.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

For Healthcare Professionals

Applies to adenosine: compounding powder, intravenous solution, sublingual spray

General

The most common adverse reactions are flushing, chest discomfort, dyspnea, facial flushing, headache, throat/neck/jaw discomfort, gastrointestinal discomfort, and lightheadedness/dizziness.[Ref]

Cardiovascular

Very common (10% or more): Flushing (44%), facial flushing (18%)
Common (1% to 10%): First degree atrioventricular block, second degree atrioventricular block, hypotension, arrhythmias, ventricular tachycardia
Uncommon (0.1% to 1%): Bradycardia, sinus tachycardia, palpitations
Very rare (less than 0.01%): Atrial fibrillation, ventricular fibrillation, Torsade de pointes, severe bradycardia
Frequency not reported: Myocardial infarction, ventricular arrhythmia, third degree atrioventricular block, sinus exit block, sinus pause, hypertension, skipped beats, atrial extrasystoles, ventricular extrasystoles
Postmarketing reports: Cardiac arrest/asystole, cardiac failure, tachycardia, prolonged asystole, transient increase in blood pressure[Ref]

Other

Very common (10% or more): Chest discomfort (40%)
Common (1% to 10%): ST segment depression, chest pressure
Uncommon (0.1% to 1%): Feeling of general discomfort/weakness/pain
Rare (less than 0.1%): Tinnitus, nipple discomfort
Frequency not reported: Chest pain, feeling of thoracic constriction/oppression, weakness, T wave changes, ear discomfort, tongue discomfort, heaviness in arms, pressure in groin
Postmarketing reports: ST segment elevation[Ref]

Respiratory

Very common (10% or more): Dyspnea (up to 28%)
Uncommon (0.1% to 1%): Hyperventilation
Rare (0.01% to 0.1%): Bronchospasm, nasal congestion
Very rare (less than 0.01%): Respiratory failure
Frequency not reported: Cough, throat tightness
Postmarketing reports: Respiratory arrest/apnea[Ref]

Nervous system

Very common (10% or more): Headache (up to 18%), lightheadedness/dizziness (12%)
Common (1% to 10%): Paresthesia, tingling in arms, numbness, burning sensation
Uncommon (0.1% to 1%): Metallic taste, head pressure
Rare (0.01% to 0.1%): Tremor, drowsiness
Very rare (less than 0.01%): Intracranial hypertension worsening
Frequency not reported: Scotomas, convulsions
Postmarketing reports: Cerebrovascular accident, intracranial hemorrhage, seizure, tonic clonic seizures, loss of consciousness/syncope[Ref]

Musculoskeletal

Very common (10% or more): Throat/neck/jaw discomfort (15%)
Common (1% to 10%): Upper extremity discomfort
Frequency not reported: Back discomfort, lower extremity discomfort, neck and back pain[Ref]

Gastrointestinal

Very common (10% or more): Gastrointestinal discomfort (13%)
Common (1% to 10%): Dry mouth, nausea
Frequency not reported: Abdominal discomfort
Postmarketing reports: Vomiting[Ref]

Psychiatric

Common (1% to 10%): Nervousness, apprehension
Frequency not reported: Emotional instability[Ref]

Dermatologic

Uncommon (0.1% to 1%): Sweating
Postmarketing reports: Angioedema, urticaria, rash[Ref]

Ocular

Uncommon (0.1% to 1%): Blurred vision[Ref]

Genitourinary

Rare (less than 0.1%): Urinary urgency
Frequency not reported: Vaginal pressure[Ref]

Local

Very rare (less than 0.01%): Injection site reaction
Postmarketing reports: Infusion site pain[Ref]

Hypersensitivity

Postmarketing reports: Hypersensitivity, anaphylaxis[Ref]

Some side effects of Adenoscan may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Adverse Reactions

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.

Flushing 44%
Chest discomfort 40%
Dyspnea or urge to breathe deeply 28%
Headache 18%
Throat, neck or jaw discomfort 15%
Gastrointestinal discomfort 13%
Lightheadedness/dizziness 12%
Upper extremity discomfort 4%
ST segment depression 3%
First-degree AV block 3%
Second-degree AV block 3%
Paresthesia 2%
Hypotension 2%
Nervousness 2%
Arrhythmias 1%

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.

How Supplied

Adenoscan (adenosine injection) is supplied as 20 mL and 30 mL vials of sterile nonpyrogenic solution in normal saline.

Product
Code
NDC
No.
87120 0469-0871-20 60 mg/20 mL (3 mg/mL) in a 20 mL single-dose, flip-top glass vial, packaged individually and in packages of ten.
87130 0469-0871-30 90 mg/30 mL (3mg/mL) in a 30 mL single-dose, flip-top glass vial, packaged individually and in packages of ten.

Store at controlled room temperature 15°-30°C (59°-86°F).

Do not refrigerate as crystallization may occur. If crystallization has occurred, dissolve crystals by warming to room temperature. The solution must be clear at the time of use.

Contains no preservative. Discard unused portion.

Rx only

Manufactured for:

Fujisawa Healthcare, Inc.

Deerfield, IL 60015

Revised: April 2004

PRODUCT PHOTO(S):

NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size.

The product samples shown here have been supplied by the manufacturer. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary. In cases of poisoning or suspected overdosage, the drug's identity should be verified by chemical analysis.

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