Lexiscan(r) (regadenoson)

Generic Name: lexiscan(r) (regadenoson)

Adenosine Receptor Agonist [EPC]Over-the-Counter (OTC)

Brand Names:

11 DESCRIPTION Regadenoson is an A2A adenosine receptor agonist that is a coronary vasodilator [see Clinical Pharmacology ( 12- 12.1)]. Regadenoson is chemically described as adenosine, 2-[4-[(methylamino)carbonyl]-1H-pyrazol-1-yl]-, monohydrate. Its structural formula is: The molecular formula for regadenoson is C15H18N8O5 • H2O and its molecular weight is 408.37. LEXISCAN is a sterile, nonpyrogenic solution for intravenous injection. The solution is clear and colorless.

Overview

Uses

1 INDICATIONS & USAGE LEXISCAN® (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 LEXISCAN 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- 7.1) and Clinical Pharmacology ( 12- 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 LEXISCAN 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- 5.1)] • Sinoatrial and Atrioventricular Nodal Block [see Warnings and Precautions ( 5- 5.2)] • Atrial Fibrillation/Atrial Flutter [see Warnings and Precautions ( 5- 5.3)] • Hypersensitivity, Including Anaphylaxis [see Warnings and Precautions ( 5- 5.4)] • Hypotension [see Warnings and Precautions ( 5- 5.5)] • Hypertension [see Warnings and Precautions ( 5- 5.6)] • Bronchoconstriction [see Warnings and Precautions ( 5- 5.7)] • Seizure [see Warnings and Precautions ( 5- 5.8)] • Cerebrovascular Accident (Stroke) [see Warnings and Precautions ( 5- 5.9)] 6.1 Clinical Trials Experience Because clinical trials are conducted un...

Interactions

7 DRUG INTERACTIONS No formal pharmacokinetic drug interaction studies have been conducted with LEXISCAN. 7.1 Effects of Other Drugs on LEXISCAN • Methylxanthines (e.g., caffeine, aminophylline and theophylline) are non-specific adenosine receptor antagonists that interfere with the vasodilation activity of LEXISCAN [see Clinical Pharmacology ( 12- 12.2) and Patient Counseling Information ( 17 )]. Patients should avoid consumption of any products containing methylxanthines as well as any drugs containing theophylline or aminophylline for at least 12 hours before LEXISCAN administration. Aminophylline may be used to attenuate severe or persistent adverse reactions to LEXISCAN [see Overdosage ( 10 )].

Warnings

5 WARNINGS AND PRECAUTIONS 5.1 Myocardial Ischemia Fatal and nonfatal myocardial infarction (MI), ventricular arrhythmias, and cardiac arrest have occurred following LEXISCAN injection. Avoid use in patients with symptoms or signs of acute myocardial ischemia, for example unstable angina or cardiovascular instability; these patients may be at greater risk of serious cardiovascular reactions to LEXISCAN. Cardiac resuscitation equipment and trained staff should be available before administering LEXISCAN. Adhere to the recommended duration of injection [see Dosage and Administration ( 2 )]. As noted in an animal study, longer injection times may increase the duration and magnitude of increase in coronary blood flow [see Clinical Pharmacology ( 12- 12.2)]. 4 CONTRAINDICATIONS Do not administer LEXISCAN 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- 5.2)].

Storage

16 HOW SUPPLIED/STORAGE AND HANDLING LEXISCAN(R) (REGADENOSON) INJECTION is supplied in the following dosage forms. NDC 51662-1448-1 LEXISCAN(R) (REGADENOSON) INJECTION 0.4mg/5mL (0.08 mg/mL) 5mL SYR HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms LEXISCAN is supplied as a sterile, preservative-free solution containing 0.08...

Frequently Asked Questions

What is Lexiscan(r) (regadenoson) used for?▼

What are the side effects of Lexiscan(r) (regadenoson)?▼

What are the important warnings for Lexiscan(r) (regadenoson)?▼

Related Medications

Lansoprazole

lansoprazole

Proton Pump Inhibitor [EPC]

Purpose Acid Reducer

Chromium Picolinate

chromium picolinate

Dosage form: POWDER. Active ingredients: CHROMIUM PICOLINATE (1 kg/kg). Category: BULK INGREDIENT.

Asclepias Vincetoxicum, Echinacea (angustifolia), Hypothalamus (suis), Hepar Suis, Kidney (suis), Methylcobalamin, Gambogia, Graphites, Nux Vomica, Phytolacca Decandra, 7-oxo-dehydroepiandrosterone 3b-acetate, Adenosinum Triphosphoricum Dinatrum, Insulinum (human), Pancreas Suis, Sarcolacticum Acidum, Proteus (vulgaris)

asclepias vincetoxicum, echinacea (angustifolia), hypothalamus (suis), hepar suis, kidney (suis), methylcobalamin, gambogia, graphites, nux vomica, phytolacca decandra, 7-oxo-dehydroepiandrosterone 3b-acetate, adenosinum triphosphoricum dinatrum, insulinum (human), pancreas suis, sarcolacticum acidum, proteus (vulgaris)

Insulin [EPC]

INDICATIONS: For temporary relief of symptoms related to increased appetite, regulation of fat metabolism, and detoxification of stress.** **These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.

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.