ADENOSINE injection solution

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

adenosine (UNII: K72T3FS567) (adenosine - UNII:K72T3FS567)

Saatavilla:

Sagent Pharmaceuticals

INN (Kansainvälinen yleisnimi):

adenosine

Koostumus:

adenosine 3 mg in 1 mL

Prescription tyyppi:

PRESCRIPTION DRUG

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

ADENOSINE- ADENOSINE INJECTION, SOLUTION
SAGENT PHARMACEUTICALS
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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
RECENT MAJOR CHANGES
Warnings and Precautions: Cardiac Arrest, Ventricular
Arrhythmias, and Myocardial Infarction (5.1)
10/2013
Warnings and Precautions: Cerebrovascular Accidents (5.5)
08/2014
Warnings and Precautions: Seizures (5.6)
08/2014
Warnings and Precautions: Hypersensitivity, Including
Anaphylaxis (5.7)
08/2014
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
Adenosine Injection, USP: 3 mg per 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 d