Regadenoson
Generic Name: regadenoson
Brand Names:
Regadenoson
11 DESCRIPTION Regadenoson is an A 2A adenosine receptor agonist that is a coronary vasodilator [ see Clinical Pharmacology ( 12.1 ) ]. Regadenoson is chemically described as adenosine, 2-{4-[(methylamino) carbonyl] - 1h-pyrazol-1-yl} adenosine propane-1,2-diol. Its structural formula is: The molecular formula for regadenoson is C 15 H 18 N 8 O 5 • C 3 H 8 O 2 and its molecular weight is 466.45. Regadenoson injection is a sterile, nonpyrogenic solution for intravenous injection.
Overview
11 DESCRIPTION Regadenoson is an A 2A adenosine receptor agonist that is a coronary vasodilator [ see Clinical Pharmacology ( 12.1 ) ]. Regadenoson is chemically described as adenosine, 2-{4-[(methylamino) carbonyl] - 1h-pyrazol-1-yl} adenosine propane-1,2-diol. Its structural formula is: The molecular formula for regadenoson is C 15 H 18 N 8 O 5 • C 3 H 8 O 2 and its molecular weight is 466.45. Regadenoson injection is a sterile, nonpyrogenic solution for intravenous injection.
Uses
1 INDICATIONS AND USAGE Regadenoson Injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress. Regadenoson Injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress.
Dosage
2 DOSAGE AND ADMINISTRATION The recommended dose of regadenoson injection is 5 mL (0.4 mg regadenoson) administered as an intravenous injection within 10 seconds. Patients should be instructed to avoid consumption of any products containing methylxanthines, including caffeinated coffee, tea or other caffeinated beverages, caffeine-containing drug products, aminophylline and theophylline for at least 12 hours before a scheduled radionuclide MPI [ see Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.2 ) ]. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer regadenoson injection if it contains particulate matter or is discolored.
Side Effects
6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling. Myocardial Ischemia [ see Warnings and Precautions ( 5.1 ) ] Sinoatrial and Atrioventricular Nodal Block [ see Warnings and Precautions ( 5.2 ) ] Atrial Fibrillation/Atrial Flutter [ see Warnings and Precautions ( 5.3 ) ] Hypersensitivity, Including Anaphylaxis [ see Warnings and Precautions ( 5.4 ) ] Hypotension [ see Warnings and Precautions ( 5.5 ) ] Hypertension [ see Warnings and Precautions ( 5.6 ) ] Bronchoconstriction [ see Warnings and Precautions ( 5.7 ) ] Seizure [ see Warnings and Precautions ( 5.8 ) ] Cerebrovascular Accident (Stroke) [ see Warnings and Precautions ( 5.9 ) ] The most common (incidence ≥ 5%) adverse reactions to regadenoson are dyspnea, headache,...
Interactions
7 DRUG INTERACTIONS No formal pharmacokinetic drug interaction studies have been conducted with regadenoson. Methylxanthines, e.g., caffeine, aminophylline and theophylline, interfere with the activity of regadenoson ( 7.1 , 12.2 ). Aminophylline may be used to attenuate severe and/or persistent adverse reactions to regadenoson ( 7.1 , 10 ). Dipyridamole may increase the activity of regadenoson. When possible, withhold dipyridamole for at least two days prior to regadenoson administration ( 7.1 ).
Warnings
5 WARNINGS AND PRECAUTIONS Myocardial Ischemia. Fatal cardiac events have occurred. Avoid use in patients with symptoms or signs of acute myocardial ischemia, for example unstable angina or cardiovascular instability, who may be at greater risk. Cardiac resuscitation equipment and trained staff should be available before administration ( 5.1 ). Sinoatrial (SA) and Atrioventricular (AV) Nodal Block. Adenosine receptor agonists, including regadenoson, can depress the SA and AV nodes and may cause first-, second- or third-degree AV block, or sinus bradycardia ( 5.2 ). Atrial Fibrillation/Atrial Flutter. New-onset or recurrent atrial fibrillation with rapid ventricular response and atrial flutter have been reported ( 5.3 ). 4 CONTRAINDICATIONS Do not administer regadenoson to patients with: Second- or third-degree AV block, or sinus node dysfunction unless these patients have a functioning artificial pacemaker [ see Warnings and Precautions ( 5.2 ) ]. Do not administer regadenoson to patients with: Second- or third-degree AV block, or sinus node dysfunction unless the patients have a functioning artificial pacemaker
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Regadenoson injection is supplied as a sterile, preservative-free, clear and colorless solution containing 0.08 mg/mL regadenoson in the following package: Single-dose 5 mL pre-filled glass syringe (NDC 83032-001-02). Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
Frequently Asked Questions
What is Regadenoson used for?▼
1 INDICATIONS AND USAGE Regadenoson Injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress. Regadenoson Injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress.
What are the side effects of Regadenoson?▼
6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling. Myocardial Ischemia [ see Warnings and Precautions ( 5.1 ) ] Sinoatrial and Atrioventricular Nodal Block [ see Warnings and Precautions ( 5.2 ) ] Atrial Fibrillation/Atrial Flutter [ see Warnings and Precautions ( 5.3 ) ] Hypersensitivity, Including Anaphylaxis [ see Warnings and Precautions ( 5.4 ) ] Hypotension [ see Warnings and Precautions ( 5.5 ) ] Hypertension [ see Warnings and Precautions ( 5.6 ) ] Bronchoconstriction [ see Warnings and Precautions ( 5.7 ) ] Seizure [ see Warnings and Precautions ( 5.8 ) ] Cerebrovascular Accident (Stroke) [ see Warnings and Precautions ( 5.9 ) ] The most common (incidence ≥ 5%) adverse reactions to regadenoson are dyspnea, headache,...
What are the important warnings for Regadenoson?▼
5 WARNINGS AND PRECAUTIONS Myocardial Ischemia. Fatal cardiac events have occurred. Avoid use in patients with symptoms or signs of acute myocardial ischemia, for example unstable angina or cardiovascular instability, who may be at greater risk. Cardiac resuscitation equipment and trained staff should be available before administration ( 5.1 ). Sinoatrial (SA) and Atrioventricular (AV) Nodal Block. Adenosine receptor agonists, including regadenoson, can depress the SA and AV nodes and may cause first-, second- or third-degree AV block, or sinus bradycardia ( 5.2 ). Atrial Fibrillation/Atrial Flutter. New-onset or recurrent atrial fibrillation with rapid ventricular response and atrial flutter have been reported ( 5.3 ). 4 CONTRAINDICATIONS Do not administer regadenoson to patients with: Second- or third-degree AV block, or sinus node dysfunction unless these patients have a functioning artificial pacemaker [ see Warnings and Precautions ( 5.2 ) ]. Do not administer regadenoson to patients with: Second- or third-degree AV block, or sinus node dysfunction unless the patients have a functioning artificial pacemaker
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.