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 )]. It can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics [see Drug Interactions ( 7.2 )].
Glenmark Pharmaceuticals Inc., USA
OVAL WHITE G 164
G 164 OVAL WHITE
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carvedilol tablet film coated
glenmark pharmaceuticals inc., usa
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16 HOW SUPPLIED/STORAGE AND HANDLING
CARVEDILOL Tablets, USP are available in the following strengths: 3.125 mg – white, film-coated circular shaped tablets with ‘G’ engraved on one side and plain on the other side, 6.25 mg – white, film-coated circular shaped tablets with ‘G’ engraved on one side and ‘41’ engraved on the other side, 12.5 mg – white, film-coated capsule shaped tablets with ‘G’ engraved on one side and ‘164’ engraved on the other side, 25 mg – white, film-coated circular shaped tablets with ‘G41’ engraved on one side and ‘25’ engraved on the other side. • 3.125 mg 60’s: NDC 68462-162-60 100’s: NDC 68462-162-01 180’s: NDC 68462-162-18 500’s: NDC 68462-162-05 1000’s: NDC 68462-162-10 • 6.25 mg 60’s: NDC 68462-163-60 100’s: NDC 68462-163-01 180’s: NDC 68462-163-18 500’s: NDC 68462-163-05 1000’s: NDC 68462-163-10 • 12.5 mg 60’s: NDC 68462-164-60 100’s: NDC 68462-164-01 180’s: NDC 68462-164-18 500’s: NDC 68462-164-05 1000’s: NDC 68462-164-10 • 25 mg 60’s: NDC 68462-165-60 100’s: NDC 68462-165-01 180’s: NDC 68462-165-18 500’s: NDC 68462-165-05 1000’s: NDC 68462-165-10 Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container.
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