Adenocard

This section provides information on the proper use of a number of products that contain adenosine. It may not be specific to Adenocard. Please read with care.

A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed into one of your veins.

Use Adenocard as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into a vein.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Flushing.
• Headache.
• Belly pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.

Intravenous Adenocard (adenosine injection) is contraindicated in:

1. Second- or third-degree A-V block (except in patients with a functioning artificial pacemaker).
2. Sinus node disease, such as sick sinus syndrome or symptomatic bradycardia (except in patients with a functioning artificial pacemaker).
3. Known hypersensitivity to adenosine.

Drug Interactions

Intravenous Adenocard (adenosine injection) 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.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies in animals have not been performed to evaluate the carcinogenic potential of Adenocard (adenosine injection). Adenosine was negative for genotoxic potential in the Salmonella (Ames Test) and Mammalian Microsome Assay.

Adenosine, however, like other nucleosides at millimolar concentrations present for several doubling times of cells in culture, is known to produce a variety of chromosomal alterations. Fertility studies in animals have not been conducted with adenosine.

Pregnancy Category C

Animal reproduction studies have not been conducted with adenosine; nor have studies been performed in pregnant women. As adenosine is a naturally occurring material, widely dispersed throughout the body, no fetal effects would be anticipated. However, since it is not known whether Adenocard can cause fetal harm when administered to pregnant women, Adenocard should be used during pregnancy only if clearly needed.

Pediatric Use

No controlled studies have been conducted in pediatric patients to establish the safety and efficacy of Adenocard for the conversion of paroxysmal supraventricular tachycardia (PSVT). However, intravenous adenosine has been used for the treatment of PSVT in neonates, infants, children and adolescents (see Dosage and Administration).

Geriatric Use

Clinical studies of Adenocard did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, Adenocard in geriatric patients should be used with caution since this population may have a diminished cardiac function, nodal dysfunction, concomitant diseases or drug therapy that may alter hemodynamic function and produce severe bradycardia or AV block.

1. Paul T, Pfammatter. J-P. Adenosine: an effective and safe antiarrhythmic drug in pediatrics. Pediatric Cardiology 1997; 18:118-126.

Ansyr®  is a registered trademark of Hospira, Inc.

Product of Germany

 Marketed by:

Astellas Pharma US, Inc.

Northbrook, IL 60062 USA

Manufactured by:

Hospira, Inc.

Lake Forest, IL 60045 USA

Revised: May 2012

12D026-ADC-SPL

2 mL Syringe Carton

Adenocard is part of the drug class:

• Miscellaneous Cardiac Preparations

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