carvedilol 25 MG Oral Tablet
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 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 ) ].
Solco Healthcare US LLC
OVAL WHITE 257
257 OVAL WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING Carvedilol Tablets are available as follows: 3.125 mg- Each white, oval shaped, biconvex, film-coated tablet engraved with 254 on one side and plain on the other side contains 3.125 mg of Carvedilol. Tablets are supplied as follows: NDC 43547-254-10 in bottles of 100 tablets NDC 43547-254-50 in bottles of 500 tablets NDC 43547-254-11 in bottles of 1000 tablets 6.25 mg- Each white, oval shaped, biconvex, film-coated tablet engraved with 255 on one side and plain on the other side contains 6.25 mg of Carvedilol. Tablets are supplied as follows: NDC 43547-255-10 in bottles of 100 tablets NDC 43547-255-50 in bottles of 500 tablets NDC43547-255-11 in bottles of 1000 tablets 12.5 mg- Each white, oval shaped, biconvex, film-coated tablet engraved with 256 on one side and plain on the other side, and contains 12.5 mg of Carvedilol. Tablets are supplied as follows: NDC 43547-256-10 in bottles of 100 tablets NDC 43547-256-50 in bottles of 500 tablets NDC 43547-256-11 in bottles of 1000 tablets 25 mg- Each white, oval shaped, biconvex, film-coated tablet engraved with 257 on one side and plain on the otherside contains 25 mg of Carvedilol. Tablets are supplied as follows: NDC 43547-257-10 in bottles of 100 bottles NDC 43547-257-50 in bottles of 500 tablets NDC 43547-257-11 in bottles of 1000 tablets Store below 30°C (86°F). Protect from moisture. Dispense in a tight, light-resistant container.
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