Carvedilol
Drug Details
- Generic Name
- Carvedilol
- Brand Names
- Carvedilol, Coreg
- Application Number
- ANDA076373
- Sponsor
- NCS HealthCare of KY, LLC dba Vangard Labs
- NDC Codes
- 50
- Dosage Forms
- TABLET, FILM COATED, POWDER
- Routes
- ORAL
- Active Ingredients
- CARVEDILOL
Indications and Usage
1 INDICATIONS AND USAGE Carvedilol Tablet 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 Tablets 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 Tablet 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 Tablet 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 )].