carvedilol 12.5 mg
1 INDICATIONS AND USAGE 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 ) 1.1 Heart Failure Carvedilol 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 Drug Interactions ( 7.4 ), Clinical Studies ( 14.1 )] . 1.2 Left Ventricular Dysfunction following Myocardial Infarction Carvedilol 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 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 )] .
Advagen Pharma Ltd
OVAL WHITE A57
A57 OVAL WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING
CARVEDILOL tablets, USP are white to off white, oval shaped film coated tablets are available in the following strengths: 3.125 mg β debossed with βΙ βon one side and β55βon other side 6.25 mg β debossed with βΙ 56βon one side and plain on other side 12.5 mg β debossed with βΙ 57βon one side and plain on other side 25 mg β debossed with βΙ 59β on one side and plain on other side The 3.125-mg, 6.25-mg, 12.5-mg, and 25-mg tablets are film coated tablets. 3.125 mg bottles of 30: NDC 72888-034-30 3.125 mg bottles of 100: NDC 72888-034-01 3.125 mg bottles of 500: NDC 72888-034-05 3.125 mg bottles of 1000: NDC 72888-034-00 6.25 mg bottles of 30: NDC 72888-035-30 6.25 mg bottles of 100: NDC 72888-035-01 6.25 mg bottles of 500: NDC 72888-035-05 6.25 mg bottles of 1000: NDC 72888-035-00 12.5 mg bottles of 30: NDC 72888-036-30 12.5 mg bottles of 100: NDC 72888-036-01 12.5 mg bottles of 500: NDC 72888-036-05 12.5 mg bottles of 1000: NDC 72888-036-00 25 mg bottles of 30: NDC 72888-037-30 25 mg bottles of 100: NDC 72888-037-01 25 mg bottles of 500: NDC 72888-037-05 25 mg bottles of 1000: NDC 72888-037-00 Store below 30Β°C (86Β°F). Protect from moisture. Dispense in a tight, light-resistant container.
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