carvedilol tablet film coated
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) ] .
mylan pharmaceuticals inc.
ROUND BLUE M C31
M C31 ROUND BLUE
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carvedilol tablet film coated
mylan pharmaceuticals inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING Carvedilol Tablets, USP are available containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of carvedilol, USP. The 3.125 mg tablets are blue, film-coated, round, unscored tablets debossed with M on one side of the tablet and C31 on the other side. They are available as follows: NDC 0378-3631-01 bottles of 100 tablets NDC 0378-3631-05 bottles of 500 tablets The 6.25 mg tablets are white, film-coated, round, unscored tablets debossed with M on one side of the tablet and C32 on the other side. They are available as follows: NDC 0378-3632-01 bottles of 100 tablets NDC 0378-3632-05 bottles of 500 tablets The 12.5 mg tablets are white, film-coated, round, unscored tablets debossed with M on one side of the tablet and C33 on the other side. They are available as follows: NDC 0378-3633-01 bottles of 100 tablets NDC 0378-3633-05 bottles of 500 tablets The 25 mg tablets are white, film-coated, round, unscored tablets debossed with M on one side of the tablet and C34 on the other side. They are available as follows: NDC 0378-3634-01 bottles of 100 tablets NDC 0378-3634-05 bottles of 500 tablets 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 using a child-resistant closure. PHARMACIST: Dispense a Patient Information Leaflet with each prescription.
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