ADENOSINE injection, solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

Adenosine (UNII: K72T3FS567) (Adenosine - UNII:K72T3FS567)

Tilgjengelig fra:

Akorn

Administreringsrute:

INTRAVENOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 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 in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions from adenosine in nursing infants, the decision to interrupt nursing after administration of adenosine or not to administer adenosine, should take into account the importance of the drug to the mother. The safety and effectiveness of adenosine 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.

Produkt oppsummering:

Adenosine Injection, USP is supplied as 20 mL and 30 mL vials of sterile, nonpyrogenic, preservative-free, solution in normal saline: NDC 17478-544-20         60 mg/20 mL (3 mg/mL) in a 20 mL single-dose, flip-top glass vial, packaged individually NDC 17478-544-30         90 mg/30 mL (3 mg/mL) in a 30 mL single-dose, flip-top glass vial, packaged individually Storage: Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. DO NOT REFRIGERATE as crystallization may occur. If crystallization has occurred, dissolve crystals by warming to room temperature. The solution must be clear at the time of use. Discard unused portion.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

ADENOSINE- ADENOSINE INJECTION, SOLUTION
AKORN
----------
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, 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 if patient
develops persistent or symptomatic
hypotension (5.4