Carvedilol
Drug Details
- Generic Name
- Carvedilol
- Brand Names
- Carvedilol, Coreg
- Application Number
- ANDA078786
- Sponsor
- Advagen Pharma Limited
- NDC Codes
- 50
- Dosage Forms
- TABLET, FILM COATED, POWDER
- Routes
- ORAL
- Active Ingredients
- CARVEDILOL
Indications and Usage
1 INDICATIONS AND USAGE Carvedilol tablets are 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 are 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 tablets are 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 tablets are indicated for the management of essential hypertension [see Clinical Studies ( 14.3 , 14.4 )] . They can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics [see Drug Interactions ( 7.2 )] .