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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 ) ] .

sandoz inc


4 years ago OVAL WHITE SZ 116 carvedilol 12.5 MG Oral Tablet

OVAL WHITE SZ 116

4 years ago OVAL WHITE SZ 116 carvedilol 12.5 MG Oral Tablet

SZ 116 OVAL WHITE

16 HOW SUPPLIED/STORAGE AND HANDLING

CARVEDILOL tablets, USP are available as follows: 3.125 mg, white, oval shaped, film-coated tablets debossed with SZ on one side and 61 on the other side. NDC 0781-5221-60, bottle of 60 tablets NDC 0781-5221-01, bottle of 100 tablets NDC 0781-5221-29, in unit of use pack of 60 tablets (6 cards of 10 tablets each) 6.25 mg, white, oval shaped, film-coated tablets debossed with SZ on one side and 62 on the other side. NDC 0781-5222-60, bottle of 60 tablets NDC 0781-5222-01, bottle of 100 tablets NDC 0781-5222-29, in unit of use pack of 60 tablets (6 cards of 10 tablets each) 12.5 mg, white, oval shaped, film-coated tablets debossed with SZ on one side and 116 on the other side. NDC 0781-5223-60, bottle of 60 tablets NDC 0781-5223-01, bottle of 100 tablets NDC 0781-5223-29, in unit of use pack of 60 tablets (6 cards of 10 tablets each) 25 mg, white, oval shaped, film-coated tablets debossed with SZ on one side and 117 on other side. NDC 0781-5224-60, bottle of 60 tablets NDC 0781-5224-01, bottle of 100 tablets NDC 0781-5224-29, in unit of use pack of 60 tablets (6 cards of 10 tablets each) Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container.


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