Indications & Usage Section

Highlight: 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 INDICATIONS AND USAGE

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)]. It can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics [see Drug Interactions (7.2)].

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