digoxin

FDA Drug Profile — LANOXIN

Drug Details

Generic Name
digoxin
Brand Names
LANOXIN
Application Number
NDA009330
Sponsor
Covis Pharma US, Inc
NDC Codes
8
Dosage Forms
INJECTION, SOLUTION, TABLET
Routes
INTRAMUSCULAR, INTRAVENOUS, ORAL
Active Ingredients
DIGOXIN

Indications and Usage

1 INDICATIONS & USAGE Digoxin is a cardiac glycoside indicated for: Treatment of mild to moderate heart failure in adults. ( 1.1 ) Increasing myocardial contractility in pediatric patients with heart failure. ( 1.2 ) Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. ( 1.3 ) 1.1 Heart Failure in Adults Digoxin is indicated for the treatment of mild to moderate heart failure in adults. Digoxin increases left ventricular ejection fraction and improves heart failure symptoms as evidenced by improved exercise capacity and decreased heart failure-related hospitalizations and emergency care, while having no effect on mortality. Where possible, digoxin should be used in combination with a diuretic and an angiotensin-converting enzyme (ACE) inhibitor. 1.2 Heart Failure in Pediatric Patients Digoxin increases myocardial contractility in pediatric patients with heart failure. 1.3 Atrial Fibrillation in Adults Digoxin is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation.