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adenosine Injection, USP

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adenosine Injection, USP Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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1 INDICATIONS AND USAGE

Adenosine Injection is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately.

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2 DOSAGE AND ADMINISTRATION

The recommended adenosine injection dose is 0.14 mg/kg/min infused over six minutes (total dose of 0.84 mg/kg) (Table 1).

Administer adenosine...
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3 DOSAGE FORMS AND STRENGTHS

Adenosine Injection is supplied as 20 mL and 30 mL single-dose vials containing a sterile, nonpyrogenic, clear solution of adenosine 3mg/mL.

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4 CONTRAINDICATIONS

Adenosine injection is contraindicated in patients with:

Second- or third-degree AV block (except in patients with a functioning artificial pacemaker) [see...
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5 WARNINGS AND PRECAUTIONS

5.1 Cardiac Arrest, Ventricular Arrhythmias, and Myocardial Infarction

Fatal and nonfatal cardiac arrest, sustained ventricular...

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6 ADVERSE REACTIONS

The following adverse reactions are discussed in more detail in other sections of the prescribing information:

Fatal Cardiac Arrest, Ventricular Arrhythmias, and Myocardial...
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7 DRUG INTERACTIONS

7.1 Effects of Other Drugs on Adenosine injection

The vasoactive effects of adenosine are inhibited by adenosine receptor antagonists, (such as...
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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Animal reproduction studies have not been conducted with adenosine; nor have studies been performed in pregnant women....

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10 OVERDOSAGE

The half-life of adenosine is less than 10 seconds and adverse reactions of adenosine injection usually resolve quickly when the infusion is discontinued, although delayed or persistent reactions have been...

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11 DESCRIPTION

Adenosine is an endogenous nucleoside and is chemically described as 6-amino-9-beta-D-ribofuranosyl-9-H-purine. Adenosine has the following structural formula:

...
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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Adenosine causes cardiac vasodilation which increases cardiac blood flow. Adenosine is thought to exert its...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies in animals have not been performed to evaluate adenosine's carcinogenic...

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14 CLINICAL STUDIES

In two crossover comparative studies involving 319 subjects who could exercise (including 106 healthy volunteers and 213 patients with known or suspected coronary disease), adenosine injection and...

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16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

Adenosine Injection, USP is supplied as 20 mL and 30 mL vials of sterile, nonpyrogenic, preservative-free, solution in normal saline:

...
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17 PATIENT COUNSELING INFORMATION

Advise patients that they may be at increased risk of fatal and nonfatal heart attacks, abnormal heart rhythms, cardiac arrest, heart block, significant increase or decrease in blood...
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