Fresenius Kabi USA LLC
07/10/2018 | Press release | Archived content
Fresenius Kabi Introduces Adenosine Injection, USP in 60 mg per 20 mL and 90 mg per 30 mL Presentations
LAKE ZURICH, Ill., July 10, 2018 - Fresenius Kabi announced today the immediate availability in the United States of Adenosine Injection, USP in 60 mg per 20 mL and 90 mg per 30 mL presentations.
Fresenius Kabi has sold 6 mg per 2 mL and 12 mg per 4 mL Adenosine presentations since 2013. With the addition of the two new presentations, the company now offers a complete portfolio of the four Adenosine Injection, USP vial presentations.
Fresenius Kabi is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition.
"With the extension of our Adenosine product line, Fresenius Kabi is pleased to offer another essential product to support cardiac care in hospitals and cardiology centers for their patient care needs," said John Ducker, president and CEO of Fresenius Kabi USA.
About Adenosine Injection, USP 60 mg per 20 mL and 90 mg per 30 mL Presentations
INDICATIONS AND USAGE
Adenosine injection, USP a pharmacologic stress agent, is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately.
IMPORTANT SAFETY INFORMATION
Adenosine Injection, USP is contraindicated in patients with second- or third-degree AV block (except in patients with a functioning artificial pacemaker), sinus node disease, such as sick sinus syndrome or symptomatic bradycardia (except in patients with a functioning artificial pacemaker), known or suspected bronchoconstrictive or bronchospastic lung disease (e.g. asthma), and known hypersensitivity to adenosine.
Cardiac Arrest, Ventricular Arrhythmias, and Myocardial Infarction: Fatal cardiac events have occurred. Avoid use in patients with symptoms or signs of acute myocardial ischemia. Appropriate resuscitative measures should be available.
Sinoatrial (SA) and Atrioventricular (AV) Nodal Block: First-, second-, or third-degree AV block, or sinus bradycardia can occur. Use adenosine with caution in patients with pre-existing first-degree AV block or bundle branch block. Do not use in patients with high-grade AV block or sinus node dysfunction (except in patients with a functioning artificial pacemaker). Discontinue adenosine if patient develops persistent or symptomatic high-grade AV block.
Bronchoconstriction: Can induce dyspnea, bronchoconstriction, and respiratory compromise, especially in patients with obstructive pulmonary disease. Discontinue adenosine if patient develops severe respiratory difficulties.
Hypotension: Significant hypotension can occur. Discontinue adenosine if patient develops persistent or symptomatic hypotension.
Cerebrovascular Accidents: Hemorrhagic and ischemic cerebrovascular accidents have occurred.
Seizures: New onset or recurrence of convulsive seizures have occurred. Use of methylxanthines (e.g., caffeine, aminophylline and theophylline) is not recommended in patients who experience seizures in association with adenosine.
Hypersensitivity: Dyspnea, throat tightness, flushing, erythema, rash, and chest discomfort have occurred. Have personnel and resuscitative equipment immediately available.
Atrial Fibrillation: Reported in patients with or without a history of atrial fibrillation.
Hypertension: Clinically significant increases in systolic and diastolic pressure have been observed.
The most common adverse reactions (incidence ≥10%) are: flushing, chest discomfort, shortness of breath, headache, throat, neck or jaw discomfort, gastrointestinal discomfort, and dizziness.
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
This Important Safety Information does not include all the information needed to use Adenosine Injection, USP safely and effectively. Please click on this link (https://tinyurl.com/ycql34wh) for the full prescribing information for Adenosine Injection, USP at www.fresenius-kabi.com/us.