adenosine Injection, USP Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use ADENOSINE INJECTION, USP safely and effectively. See full prescribing information for ADENOSINE INJECTION, USP.
ADENOSINE INJECTION, USP for intravenous use
Initial U.S. Approval: 1995

INDICATIONS AND USAGE

Adenosine Injection, a pharmacologic stress agent, is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately (1)

DOSAGE AND ADMINISTRATION

Recommended dose is 0.14 mg/kg/min infused over six minutes as a continuous peripheral intravenous infusion (total dose of 0.84 mg/kg) (2)

DOSAGE FORMS AND STRENGTHS

For Injection: 3 mg/mL in single-dose vials (3)

CONTRAINDICATIONS

•
Second- or third-degree AV block (except in patients with a functioning artificial pacemaker) (4)
•
Sinus node disease, such as sick sinus syndrome or symptomatic bradycardia (except in patients with a functioning artificial pacemaker) (4)
•
Known or suspected bronchoconstrictive or bronchospastic lung disease (e.g., asthma) (4)
•
Known hypersensitivity to adenosine injection (4)

WARNINGS AND PRECAUTIONS

•
Cardiac Arrest, Ventricular Arrhythmias, and Myocardial Infarction. Fatal cardiac events have occurred. Avoid use in patients with symptoms or signs of acute myocardial ischemia. Appropriate resuscitative measures should be available (5.1)
•
Sinoatrial (SA) and Atrioventricular (AV) Nodal Block. First,second- or third-degree AV block, or sinus bradycardia can occur. Discontinue adenosine injection if patient develops persistent or symptomatic high-grade AV block (5.2)
•
Bronchoconstriction. Can induce dyspnea, bronchoconstriction, and respiratory compromise, especially in patients with obstructive pulmonary disease. Discontinue adenosine injection if patient develops severe respiratory difficulties (5.3)
•
Hypotension. Significant hypotension can occur. Discontinue adenosine injection if patient develops persistent or symptomatic hypotension (5.4)
•
Cerebrovascular Accidents. Hemorrhagic and ischemic cerebrovascular accidents have occurred (5.5)
•
Seizures. New onset or recurrence of convulsive seizures have occurred. Use of methylxanthines (e.g., caffeine, aminophylline and theophylline) is not recommended in patients who experience a seizures in association with adenosine injection (5.6)
•
Hypersensitivity. Dyspnea, throat tightness, flushing, erythema, rash, and chest discomfort have occurred. Have personnel and resuscitative equipment immediately available (5.7)
•
Atrial Fibrillation. Reported in patients with or without a history of atrial fibrillation (5.8)
•
Hypertension. Clinically significant increases in systolic and diastolic pressure have been observed (5.9)

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥10%) are: flushing; chest discomfort; shortness of breath; headache; throat, neck or jaw discomfort; gastrointestinal discomfort; and dizziness (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

•
Methylxanthines interfere with the activity of adenosine injection (7.1, 10)
•
Nucleoside transport inhibitors such as dipyridamole can increase the activity of adenosine injection (7.1)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 2/2020

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use ADENOSINE INJECTION, USP safely and effectively. See full prescribing information for ADENOSINE INJECTION, USP.
ADENOSINE INJECTION, USP for intravenous use
Initial U.S. Approval: 1995

INDICATIONS AND USAGE

Adenosine Injection, a pharmacologic stress agent, is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately (1)

DOSAGE AND ADMINISTRATION

Recommended dose is 0.14 mg/kg/min infused over six minutes as a continuous peripheral intravenous infusion (total dose of 0.84 mg/kg) (2)

DOSAGE FORMS AND STRENGTHS

For Injection: 3 mg/mL in single-dose vials (3)

CONTRAINDICATIONS

•
Second- or third-degree AV block (except in patients with a functioning artificial pacemaker) (4)
•
Sinus node disease, such as sick sinus syndrome or symptomatic bradycardia (except in patients with a functioning artificial pacemaker) (4)
•
Known or suspected bronchoconstrictive or bronchospastic lung disease (e.g., asthma) (4)
•
Known hypersensitivity to adenosine injection (4)

WARNINGS AND PRECAUTIONS

•
Cardiac Arrest, Ventricular Arrhythmias, and Myocardial Infarction. Fatal cardiac events have occurred. Avoid use in patients with symptoms or signs of acute myocardial ischemia. Appropriate resuscitative measures should be available (5.1)
•
Sinoatrial (SA) and Atrioventricular (AV) Nodal Block. First,second- or third-degree AV block, or sinus bradycardia can occur. Discontinue adenosine injection if patient develops persistent or symptomatic high-grade AV block (5.2)
•
Bronchoconstriction. Can induce dyspnea, bronchoconstriction, and respiratory compromise, especially in patients with obstructive pulmonary disease. Discontinue adenosine injection if patient develops severe respiratory difficulties (5.3)
•
Hypotension. Significant hypotension can occur. Discontinue adenosine injection if patient develops persistent or symptomatic hypotension (5.4)
•
Cerebrovascular Accidents. Hemorrhagic and ischemic cerebrovascular accidents have occurred (5.5)
•
Seizures. New onset or recurrence of convulsive seizures have occurred. Use of methylxanthines (e.g., caffeine, aminophylline and theophylline) is not recommended in patients who experience a seizures in association with adenosine injection (5.6)
•
Hypersensitivity. Dyspnea, throat tightness, flushing, erythema, rash, and chest discomfort have occurred. Have personnel and resuscitative equipment immediately available (5.7)
•
Atrial Fibrillation. Reported in patients with or without a history of atrial fibrillation (5.8)
•
Hypertension. Clinically significant increases in systolic and diastolic pressure have been observed (5.9)

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥10%) are: flushing; chest discomfort; shortness of breath; headache; throat, neck or jaw discomfort; gastrointestinal discomfort; and dizziness (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

•
Methylxanthines interfere with the activity of adenosine injection (7.1, 10)
•
Nucleoside transport inhibitors such as dipyridamole can increase the activity of adenosine injection (7.1)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 2/2020
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