Carvedilol

FDA Drug Profile — Carvedilol, Coreg

Carvedilol is listed in the FDA National Drug Code directory with 50 NDC codes, marketed under brand names including Carvedilol, Coreg. Available dosage forms: tablet, film coated, powder.

Drug Details

Generic Name
Carvedilol
Brand Names
Carvedilol, Coreg
Application Number
ANDA078251
Sponsor
Major Pharmaceuticals
NDC Codes
50
Dosage Forms
TABLET, FILM COATED, POWDER
Routes
ORAL
Active Ingredients
CARVEDILOL

Indications and Usage

1 INDICATIONS AND USAGE Carvedilol is an alpha-/beta-adrenergic blocking agent indicated for the treatment of: mild to severe chronic heart failure ( 1.1 ) left ventricular dysfunction following myocardial infarction in clinically stable patients ( 1.2 ) hypertension ( 1.3 ) 1.1 Heart Failure Carvedilol is indicated for the treatment of mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin, usually in addition to diuretics, ACE inhibitors, and digitalis, to increase survival and, also, to reduce the risk of hospitalization [see Drug Interactions ( 7.4 ), Clinical Studies ( 14.1 )] . 1.2 Left Ventricular Dysfunction following Myocardial Infarction Carvedilol is indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of less than or equal to 40% (with or without symptomatic heart failure) [see Clinical Studies ( 14.2 )] . 1.3 Hypertension Carvedilol is indicated for the management of essential hypertension [see Clinical Studies ( 14.3 , 14.4 )] . It can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics [see Drug Interactions ( 7.2 )] .