carvedilol phosphate 80 mg
1 INDICATIONS AND USAGE Carvedilol phosphate extended-release capsules 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 phosphate extended-release capsules 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 phosphate extended-release capsules 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 phosphate extended-release capsules 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) ] .
amneal pharmaceuticals of new york llc
CAPSULE WHITE H 34
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16 HOW SUPPLIED/STORAGE AND HANDLING The hard gelatin extended-release capsules are available in the following strengths: 10 mg – capsules with white opaque body imprinted with “H31” in black ink and dark green opaque cap. Bottles of 30: NDC 0115-1248-08 Bottles of 90: NDC 0115-1248-10 Bottles of 100: NDC 0115-1248-01 Bottles of 1000: NDC 0115-1248-03 20 mg – capsules with white opaque body imprinted with “H32” in black ink and bright orange opaque cap. Bottles of 30: NDC 0115-1249-08 Bottles of 90: NDC 0115-1249-10 Bottles of 100: NDC 0115-1249-01 Bottles of 1000: NDC 0115-1249-03 40 mg – capsules with bright orange opaque body imprinted with “H33” in black ink and dark green opaque cap. Bottles of 30: NDC 0115-1250-08 Bottles of 90: NDC 0115-1250-10 Bottles of 100: NDC 0115-1250-01 Bottles of 1000: NDC 0115-1250-03 80 mg – capsules with white opaque body imprinted with “H34” in black ink and white opaque cap. Bottles of 30: NDC 0115-1251-08 Bottles of 90: NDC 0115-1251-10 Bottles of 100: NDC 0115-1251-01 Bottles of 1000: NDC 0115-1251-03 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. DISPENSE IN A TIGHTLY CLOSED, LIGHT-RESIStanT CONTAINER AS DEFINED IN THE USP, WITH A CHILD-RESIStanT CLOSURE, AS REQUIRED. KEEP OUT OF THE REACH OF CHILDREN.
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