ADENOSINE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567)

Available from:

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

INN (International Name):

ADENOSINE

Composition:

ADENOSINE 3 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Adenosine injection, USP is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately. Adenosine injection is contraindicated in patients with: - Second- or third-degree AV block (except in patients with a functioning artificial pacemaker) [see Warnings and Precautions (5.2)] - Sinus node disease, such as sick sinus syndrome or symptomatic bradycardia (except in patients with a functioning artificial pacemaker) [see Warnings and Precautions (5.2)] - Known or suspected bronchoconstrictive or bronchospastic lung disease (e.g., asthma) [see Warnings and Precautions (5.3)] - Known hypersensitivity to adenosine [see Warnings and Precautions (5.7)] Pregnancy Category C. Animal reproduction studies have not been conducted with adenosine; nor have studies been performed in pregnant women. Because it is not known whether adenosine injection can cause fetal harm when administered to pregnant women, adenosine injection should be used during pregnancy only if cle

Product summary:

Adenosine injection, USP is supplied as 20 mL and 30 mL vials of sterile, nonpyrogenic, preservative-free, solution in normal saline: 60 mg/20 mL (3 mg/mL) in a 20 mL single-dose, glass vial, packaged individually in a carton (NDC 23155-258-31) and in packages of ten (NDC 23155-258-41). 90 mg/30 mL (3 mg/mL) in a 30 mL single-dose, glass vial, packaged individually in a carton (NDC 23155-258-32) and in packages of ten (NDC 23155-258-42).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ADENOSINE- ADENOSINE INJECTION, SOLUTION
HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.
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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, 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 pat