ADENOSINE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Eugia US LLC

INN (International Name):

ADENOSINE

Composition:

ADENOSINE 60 mg in 20 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 injection [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 clearly needed. It is not known whether adenosine injection is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions from adenosine injection in nursing infants, the decision to interrupt nursing after administration of adenosine injection or not to administer adenosine injection, should take into account the importance of the drug to the mother. The safety and effectiveness of adenosine injection in patients less than 18 years of age have not been established. Clinical studies with adenosine injection did not include sufficient numbers of subjects aged younger than 65 years to determine whether they respond differently. Other reported experience has not revealed clinically relevant differences of the response of elderly in comparison to younger patients.

Product summary:

Adenosine injection, USP is supplied as 20 mL and 30 mL vials of sterile, nonpyrogenic, preservative-free, clear colorless solution in normal saline: 60 mg per 20 mL (3 mg/mL): 20 mL Single-Dose Vials in a Carton of 1                                               NDC 55150-192-01 20 mL Single-Dose Vials in a Carton of 10                                             NDC 55150-192-20 90 mg per 30 mL (3 mg/mL): 30 mL Single-Dose Vials in a Carton of 1                                               NDC 55150-193-01 30 mL Single-Dose Vials in a Carton of 10                                             NDC 55150-193-30 The vial stopper is not made with natural rubber latex.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ADENOSINE - ADENOSINE INJECTION, SOLUTION
EUGIA US LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ADENOSINE INJECTION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ADENOSINE
INJECTION.
ADENOSINE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1995
INDICATIONS AND USAGE
Adenosine injection USP, 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 hypotensi