carvedilol 12.5 MG Oral Tablet
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 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) ] .
Aurobindo Pharma Limited
OVAL WHITE E 03
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16 HOW SUPPLIED/STORAGE AND HANDLING
CARVEDILOL Tablets USP, 3.125 mg are white to off-white, oval shaped, film-coated tablets debossed with ‘E’ on one side and ‘01’ on the other side. Bottles of 100 NDC 65862-142-01 Bottles of 500 NDC 65862-142-05 Bottles of 1,000 NDC 65862-142-99
CARVEDILOL Tablets USP, 6.25 mg are white to off-white, oval shaped, film-coated tablets debossed with ‘E’ on one side and ‘02’ on the other side. Bottles of 100 NDC 65862-143-01 Bottles of 500 NDC 65862-143-05 Bottles of 1,000 NDC 65862-143-99
CARVEDILOL Tablets USP, 12.5 mg are white to off-white, oval shaped, film-coated tablets debossed with ‘E’ on one side and ‘03’ on the other side. Bottles of 100 NDC 65862-144-01 Bottles of 500 NDC 65862-144-05 Bottles of 1,000 NDC 65862-144-99
CARVEDILOL Tablets USP, 25 mg are white to off-white, oval shaped, film-coated tablets debossed with ‘E’ on one side and ‘04’ on the other side. Bottles of 100 NDC 65862-145-01 Bottles of 500 NDC 65862-145-05 Bottles of 1,000 NDC 65862-145-99 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.
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