The safety and efficacy of eplerenone have been evaluated alone and in combination with other antihypertensive agents in clinical studies of 3,091 hypertensive patients. The studies included 46% women, 14% Blacks, and 22% elderly (age ≥65). The studies excluded patients with elevated baseline serum potassium (greater than 5.0 mEq/L) and elevated baseline serum creatinine (generally greater than 1.5 mg/dL in males and greater than 1.3 mg/dL in females).
Two fixed-dose, placebo-controlled, 8- to 12-week monotherapy studies in patients with baseline diastolic blood pressures of 95 mm Hg to 114 mm Hg were conducted to assess the antihypertensive effect of eplerenone. In these two studies, 611 patients were randomized to eplerenone and 140 patients to placebo. Patients received eplerenone in doses of 25 mg to 400 mg daily as either a single daily dose or divided into two daily doses. The mean placebo-subtracted reductions in trough cuff blood pressure achieved by eplerenone in these studies at doses up to 200 mg are shown in Figures 3 and 4.
Patients treated with eplerenone 50 mg to 200 mg daily experienced significant decreases in sitting systolic and diastolic blood pressure at trough with differences from placebo of 6 mm Hg to 13 mm Hg (systolic) and 3 mm Hg to 7 mm Hg (diastolic). These effects were confirmed by assessments with 24-hour ambulatory blood pressure monitoring (ABPM). In these studies, assessments of 24-hour ABPM data demonstrated that eplerenone, administered once or twice daily, maintained antihypertensive efficacy over the entire dosing interval. However, at a total daily dose of 100 mg, eplerenone administered as 50 mg twice per day produced greater trough cuff (4/3 mm Hg) and ABPM (2/1 mm Hg) blood pressure reductions than 100 mg given once daily.
Blood pressure lowering was apparent within 2 weeks from the start of therapy with eplerenone, with maximal antihypertensive effects achieved within 4 weeks. Stopping eplerenone following treatment for 8 to 24 weeks in six studies did not lead to adverse event rates in the week following withdrawal of eplerenone greater than following placebo or active control withdrawal. Blood pressures in patients not taking other antihypertensives rose 1 week after withdrawal of eplerenone by about 6/3 mm Hg, suggesting that the antihypertensive effect of eplerenone was maintained through 8 to 24 weeks.
Blood pressure reductions with eplerenone in the two fixed-dose monotherapy studies and other studies using titrated doses, as well as concomitant treatments, were not significantly different when analyzed by age, gender, or race with one exception. In a study in patients with low renin hypertension, blood pressure reductions in Blacks were smaller than those in whites during the initial titration period with eplerenone.
Eplerenone has been studied concomitantly with treatment with ACE inhibitors, ARB, calcium channel blockers, beta-blockers, and hydrochlorothiazide. When administered concomitantly with one of these drugs eplerenone usually produced its expected antihypertensive effects.
Eplerenone Tablets, 25 mg, are beige, round, biconvex film-coated tablets debossed with “25” on one side. They are supplied as follows:
|Bottles of 30||NDC 69367-307-30|
|Bottles of 90||NDC 69367-307-09|
Eplerenone Tablets, 50 mg, are beige, round, biconvex film-coated tablets debossed with “50” on one side. They are supplied as follows:
|Bottles of 30||NDC 69367-308-30|
|Bottles of 90||NDC 69367-308-09|
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
Advise patients receiving eplerenone tablets:
- Not to use potassium supplements or salt substitutes containing potassium without consulting the prescribing physician.[see WARNINGS AND PRECAUTIONS (5.1)].
- To call their physician if they experience dizziness, diarrhea, vomiting, rapid or irregular heartbeat, lower extremity edema, or difficulty breathing [see WARNINGS AND PRECAUTIONS (5.1)].
Westminster Pharmaceuticals, LLC
Nashville, TN 37217
Bluepharma Indústria Farmacêutica, S.A. S.
Martinho do Bispo
3045-016 Coimbra, Portugal
PRINCIPAL DISPLAY PANEL — 25 mg Tablet Bottle Label
Tablets 25 mg
Tablets 50 mg
|EPLERENONE eplerenone tablet, coated|
|EPLERENONE eplerenone tablet, coated|
|Labeler — Westminster Pharmaceuticals, LLC (079516651)|
|Bluepharma — IndÚstria FarmacÊutica, S.a.||449909329||MANUFACTURE (69367-307), MANUFACTURE (69367-308)|
Revised: 11/2021 Westminster Pharmaceuticals, LLC
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