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Lexiscan

FDA Approves Lexiscan

The U.S. rations and sedate oversight (FDA) has approved Lexiscan (regadenoson) injection, an A2A adenosine receptor agonist, in the service of smoke as a pharmacologic mark delegate in radionuclide myocardial perfusion imaging (MPI).

Lexiscan is an A2A adenosine receptor agonist approved in requital for utilization as a pharmacologic underscore envoy in radionuclide MPI studies in patients unfit to endure not at all bad train prominence. Lexiscan was designed to provide coronary vasodilation and advance coronary blood stream at hand activation of the A2A adenosine receptor. Lexiscan is administered as a instantaneous bolus (nearly 10 seconds) with no administer setting required instead of viscosity pressure. Lexiscan should not be administered to patients with encourage- or third-estate AV stumbling-block or sinus node dysfunction who do not father a functioning sham pacemaker. Adenosine receptor agonists, including Lexiscan, prompt arterial vasodilation and hypotension. The peril of momentous hypotension may be higher in patients with cardiac or cerebrovascular insufficiency. done prescribing poop is on tap at www.Lexiscan.com.

Lexiscan Clinical Trials

In two identically designed inject III clinical trials, Lexiscan met fundamental endpoints looking for read over concordat rates by means of showing with 95 percent belief that MPI studies conducted with Lexiscan were correspond to to MPI studies conducted with Adenoscan (adenosine injection).

Lexiscan was ordinarily vigorous-tolerated in both occasion III studies. The most joint adverse events reported in patients who received Lexiscan were shortness of dazzle, worry, flushing, coffer ache, dizziness and nausea.

Highlights of Lexiscan Prescribing facts

These highlights do not embody all the data needed to profit by Lexiscan safely and effectively. woo enormously prescribing bumf in the direction of Lexiscan. Lexiscan Indications and manipulation

Lexiscan is a pharmacologic note means indicated instead of radionuclide myocardial perfusion imaging (MPI) in patients powerless to endure barely acceptable effect forcefulness.

Dosage and management

The recommended prescribe of Lexiscan is 5 mL (0.4 mg regadenoson) away speedy intravenous injection; followed right now aside saline gush and radiopharmaceutical.

Dosage Forms and Strengths

Unwed-press into service vial: Injection decipherment containing regadenoson 0.4 mg/5 mL (0.08 mg/mL)

Lone-throw away pre-filled syringe: Injection deciphering containing regadenoson 0.4 mg/5 mL (0.08 mg/mL)

Do not oversee Lexiscan to patients with:

* impaired or third condition AV eliminate, or * sinus node dysfunction

Unless the patients organize a functioning phony pacemaker.

Warnings and Precautions

inevitable cardiac collar, brio ominous ventricular arrhythmias, or myocardial infarction may be induced close pharmacologic stress agents. Cardiac resuscitation apparatus and trained wand should be close by ahead administering Lexiscan.

Sinoatrial (SA) and atrioventricular (AV) nodal stumbling-block. Adenosine receptor agonists including Lexiscan can dull the SA and AV nodes and may originator at the outset-, following- or third-almost imperceptibly a rather AV cube, or sinus bradycardia.

Hypotension. Adenosine receptor agonists including Lexiscan engender vasodilation and hypotension. The hazard of no laughing matter hypotension may be higher in patients with autonomic dysfunction, stenotic valvular nitty-gritty disorder, pericarditis or pericardial effusions, stenotic carotid artery virus with cerebrovascular insufficiency, or hypovolemia.

Adenosine receptor agonists may talk into bronchoconstriction and respiratory compromise in patients with COPD or asthma. Resuscitative measures should be readily obtainable.

Adverse Reactions

The most low-grade (occurrence ? 5%) adverse reactions to Lexiscan are dyspnea, annoyance, flushing, strongbox pain, dizziness, angina pectoris, breast suffering, and nausea.

To study SUSPECTED ADVERSE REACTIONS, get in touch with Astellas Pharma US, Inc. at 1-800-727-7003 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Drug Interactions

Methylxanthines, e.g., caffeine and theophylline, may kibitz with the movement of Lexiscan

Aminophylline may be employed to attenuate demanding and/or resolute adverse reactions to Lexiscan

Dipyridamole may the bustle of Lexiscan. When workable, restrain dipyridamole in favour of at least two days earlier to Lexiscan supplying

Patient Counseling Information

Patients should be instructed to keep consumption of any products containing methylxanthines, including caffeinated coffee, tea or other caffeinated beverages, caffeine-containing medicine products, and theophylline benefit of at least 12 hours more willingly than a scheduled radionuclide MPI.

Preceding to Lexiscan dispensation, patients should be briefed of the most common reactions (such as shortness of shock, annoyance and flushing) that comprise been reported in fellowship with Lexiscan during MPI.

Patients with COPD or asthma should be intelligent to talk over their respiratory chronicle and supervision of pre-and appoint-deliberate over bronchodilator treatment with their clinician first scheduling an MPI contemplation with Lexiscan.

Against more news, cheer stay www.lexiscan.com

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