carvedilol 12.5 MG Oral Tablet
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 )] .
Teva Pharmaceuticals USA, Inc.
OVAL WHITE TV 7295
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16 HOW SUPPLIED/STORAGE AND HANDLING
CARVEDILOL tablets USP, 3.125 mg, are available as white, film-coated, elliptical-shaped tablets, debossed with "TV" on one side and "51" on the other. They are available in bottles of 100 (NDC 0093-0051-01) and 500 (NDC 0093-0051-05).
CARVEDILOL tablets USP, 6.25 mg, are available as white, film-coated, elliptical-shaped tablets, debossed with "TV" on one side and "135" on the other. They are available in bottles of 100 (NDC 0093-0135-01) and 500 (NDC 0093-0135-05).
CARVEDILOL tablets USP, 12.5 mg, are available as white, film-coated, elliptical-shaped tablets, debossed with "TV" on one side and "7295" on the other. They are available in bottles of 100 (NDC 0093-7295-01) and 500 (NDC 0093-7295-05).
CARVEDILOL tablets USP, 25 mg, are available as white, film-coated, elliptical-shaped tablets, debossed with "TV" on one side and "7296" on the other. They are available in bottles of 100 (NDC 0093-7296-01) and 500 (NDC 0093-7296-05). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
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