ADENOSINE injection, solution

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Northstar RxLLC

Vartojimo būdas:

INTRAVENOUS

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Adenosine injection is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately. Adenosine 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)] Animal reproduction studies have not been conducted with adenosine; nor have studies been performed in pregnant women. Because it is not known whether adenosine can cause fetal harm when administered to pregnant women, adenosine should be used during pregnancy only if clearly needed. It is not known whether adenosine is excreted

Produkto santrauka:

Adenosine injection, USP is supplied as 60 mg/20 mL (3 mg/mL) and 90 mg/30 mL (3 mg/mL) in single-dose vials of sterile, nonpyrogenic, preservative-free, clear, colorless solution in normal saline. NDC Number Adenosine Injection, USP 16714-180-01 60 mg/20 mL (3 mg/mL) single-dose vial packaged individually 16714-972-01 90 mg/30 mL (3 mg/mL) single-dose vial packaged individually

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

ADENOSINE- ADENOSINE INJECTION, SOLUTION
NORTHSTAR RXLLC
----------
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, 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
Injection: 60 mg/20 mL (3 mg/mL) and 90 mg/30 mL (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 (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 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
if patient develops severe
respiratory difficulties (5.3)
Hypotension. Significant hypotension can occur. Discontinue adenosine
if patient develops persistent or
symptomatic hypotension (5.