Regadenoson is an adenosine receptor agonist sold in the U.S. under 2 brand and generic names. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Lexiscan (application NDA022161). Other regadenoson products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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. • Administer LEXISCAN as an intravenous injection within 10 seconds into a peripheral vein using a 22 gauge or larger catheter or needle. • Administer a 5 mL saline flush immediately after the injection of LEXISCAN. • Administer the radionuclide myocardial perfusion imaging agent 10–20 seconds after the saline flush. The radionuclide may be injected directly into the same catheter as LEXISCAN.
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 under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. During clinical development, 1,651 patients were exposed to LEXISCAN, with most receiving 0.4 mg as a rapid (≤ 10 seconds) intravenous injection. Most of these patients received LEXISCAN in two clinical studies that enrolled patients who had no history of bronchospastic lung disease as well as no history of a cardiac conduction block of greater than first-degree AV block, except for patients…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | Injectable | — | — | View → | |
| 2 | Not yet rated | Prescription | Injectable | — | — | View → |
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
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)].
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 )]. • In clinical studies, LEXISCAN was administered to patients taking other cardioactive drugs (i.e., β-blockers, calcium channel blockers, ACE inhibitors, nitrates, cardiac glycosides, and angiotensin receptor blockers) without reported adverse reactions or apparent effects on efficacy. • Dipyridamole may change the effects of LEXISCAN. When possible, withhold dipyridamole for at least two days prior to LEXISCAN administration. 7.2 Effect of LEXISCAN on Other Drugs Regadenoson does not inhibit the metabolism of substrates for CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, or CYP3A4 in human liver microsomes, indicating that it is unlikely to alter the pharmacokinetics of drugs metabolized by these cytochrome…