Eplerenone

Eplerenone is indicated:
in addition to standard therapy including beta blockers, to reduce the risk of cardiovascular mortality and morbidity in stable patients with left ventricular dysfunction (LVEF ≤ 40 %) and clinical evidence of heart failure after recent myocardial infarction.

1).

46 INSPRA (eplerenone) – Product Monograph Page 3 of 49 PrINSPRA® (eplerenone tablets) PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Administration Dosage Form / Strength All Nonmedicinal Ingredients Oral Tablets 25 mg, 50 mg Croscarmellose sodium, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium lauryl sulfate, talc, titanium dioxide, iron oxide yellow, and iron oxide red.

INDICATIONS AND CLINICAL USE INSPRA (eplerenone) is indicated as an adjunct to standard therapy to reduce the risk of cardiovascular mortality and hospitalization for heart failure in patients with NYHA class II systolic chronic heart failure and left ventricular systolic dysfunction.

In patients 75 years and older a reduction in cardiovascular mortality was not observed with INSPRA (see WARNINGS AND PRECAUTIONS - Special Populations - Geriatrics, and CLINICAL TRIALS – EMHASIS-HF Study). INSPRA (eplerenone) is indicated as an adjunct to standard therapy to reduce the risk of mortality and hospitalization for heart failure following myocardial infarction in clinically stable adult patients who have evidence of heart failure and left ventricular systolic dysfunction (ejection fraction ≤40%).