carvedilol phosphate capsule extended release
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 )] . They can be used alone or in combination with other antihypertensive agents, especially thiazide‑type diuretics [see Drug Interactions ( 7.2 )] .
apotex corp.
CAPSULE GREEN GSETX 40mg
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carvedilol phosphate capsule extended release
apotex corp.
carvedilol phosphate capsule extended release
apotex corp.
carvedilol phosphate capsule extended release
apotex corp.
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16 HOW SUPPLIED/STORAGE AND HANDLING The hard gelatin capsules are available in the following strengths: • 10 mg – white and green capsule shell printed with “GSLGK” and “10 mg” • 20 mg – white and yellow capsule shell printed with “GSMHV” and “20 mg” • 40 mg – yellow and green capsule shell printed with “GSETX” and “40 mg” • 80 mg – white capsule shell printed with “GSF1L” and “80 mg” • 10 mg bottles of 30: NDC 60505-4713-3 • 20 mg bottles of 30: NDC 60505-4714-3 • 40 mg bottles of 30: NDC 60505-4715-3 • 80 mg bottles of 30: NDC 60505-4716-3 Store at 25°C (77°F); excursions 15° to 30°C (59° to 86°F). Dispense in a tight, light‑resistant container.
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