Application Nr Approved Date Route Status External Links
NDA021648 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Digoxin Is A Cardiac Glycoside Indicated In Adults For The Treatment Of Mild To Moderate Heart Failure And For The Control Of Resting Ventricular Rate In Patients With Chronic Atrial Fibrillation. ( 1.1 , 1.3 ) In Pediatric Patients With Heart Failure, Digoxin Is Indicated To Increase Myocardial Contractility. ( 1.2 ) 1.1 Heart Failure In Adults Digoxin Oral Solution Usp Is Indicated For The Treatment Of Mild To Moderate Heart Failure. Digoxin Increases Left Ventricular Ejection Fraction And Improves Heart Failure Symptoms As Evidenced By Increased Exercise Capacity And Decreased Heart Failure-Related Hospitalizations And Emergency Care, While Having No Effect On Mortality. Where Possible, Digoxin Should Be Used With A Diuretic And An Angiotensin-Converting Enzyme Inhibitor, But An Optimal Order For Starting These Three Drugs Cannot Be Specified. 1.2 Heart Failure In Pediatric Patients Digoxin Is Indicated To Increase Myocardial Contractility In Pediatric Patients With Heart Failure. 1.3 Atrial Fibrillation In Adults Digoxin Oral Solution Usp Is Indicated For The Control Of Resting Ventricular Response Rate In Patients With Chronic Atrial Fibrillation. Digoxin Should Not Be Used For The Treatment Of Multifocal Atrial Tachycardia.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Digoxin

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