ADENOSINE- adenosine injection, solution

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Heritage Pharmaceuticals Inc.

INN (Jina la Kimataifa):

ADENOSINE

Tungo:

ADENOSINE 3 mg in 1 mL

Njia ya uendeshaji:

INTRAVENOUS

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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) [seeWarnings 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 [seeWarnings 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 clea

Bidhaa muhtasari:

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 23155-259-31). 90 mg/30 mL (3 mg/mL) in a 30 mL single-dose, glass vial, packaged individually in a carton (NDC 23155-259-32).

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

ADENOSINE- ADENOSINE INJECTION, SOLUTION
HERITAGE PHARMACEUTICALS INC.
----------
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) 8/2014
Warnings and Precautions: Seizures (5.6) 8/2014
Warnings and Precautions: Hypersensitivity (5.7) 8/2014
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) (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, bronchoconstric