Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
adenosine (UNII: K72T3FS567) (adenosine - UNII:K72T3FS567)
Sagent Pharmaceuticals
adenosine
adenosine 3 mg in 1 mL
PRESCRIPTION DRUG
Abbreviated New Drug Application
ADENOSINE- ADENOSINE INJECTION, SOLUTION SAGENT PHARMACEUTICALS ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ADENOSINE INJECTION, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ADENOSINE INJECTION, USP. ADENOSINE INJECTION, USP FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 1995 RECENT MAJOR CHANGES Warnings and Precautions: Cardiac Arrest, Ventricular Arrhythmias, and Myocardial Infarction (5.1) 10/2013 Warnings and Precautions: Cerebrovascular Accidents (5.5) 08/2014 Warnings and Precautions: Seizures (5.6) 08/2014 Warnings and Precautions: Hypersensitivity, Including Anaphylaxis (5.7) 08/2014 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 (1) DOSAGE AND ADMINISTRATION Recommended dose is 0.14 mg/kg/min infused over six minutes as a continuous peripheral intravenous infusion (total dose of 0.84 mg/kg) (2) DOSAGE FORMS AND STRENGTHS Adenosine Injection, USP: 3 mg per mL in single-dose vials (3) CONTRAINDICATIONS Second- or third-degree AV block (except in patients with a functioning artificial pacemaker) (4) Sinus node disease, such as sick sinus syndrome or symptomatic bradycardia (except in patients with a functioning artificial pacemaker) (4) Known or suspected bronchoconstrictive or bronchospastic lung disease (e.g., asthma) (4) Known hypersensitivity to adenosine (4) WARNINGS AND PRECAUTIONS 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 (5.1) Sinoatrial (SA) and Atrioventricular (AV) Nodal Block. First-, second-or third-degree AV block, or sinus bradycardia can occur. Discontinue adenosine if patient develops persistent or symptomatic high-grade AV block (5.2) Bronchoconstriction. Can induce d Lees het volledige document