Eplerenone (Page 5 of 5)

14.2 Hypertension

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.

Figure 3. Eplerenone Dose Response – Trough Cuff SBP Placebo-Subtracted Adjusted Mean Change from Baseline in Hypertension Studies
Figure 3
(click image for full-size original)
Figure 4. Eplerenone Dose Response – Trough Cuff DBP Placebo-Subtracted Adjusted Mean Change from Baseline in Hypertension Studies
Figure 4
(click image for full-size original)

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.

16 HOW SUPPLIED/STORAGE AND HANDLING

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].

17 PATIENT COUNSELING INFORMATION

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)].

Distributed by:
Westminster Pharmaceuticals, LLC
Nashville, TN 37217

Manufactured by:
Bluepharma Indústria Farmacêutica, S.A. S.
Martinho do Bispo
3045-016 Coimbra, Portugal
Rev. 10/2021

804531300

PRINCIPAL DISPLAY PANEL — 25 mg Tablet Bottle Label

NDC 69367-307-09
Rx Only

Eplerenone
Tablets 25 mg

90 Tablets

Westminster Pharmaceuticals

PRINCIPAL DISPLAY PANEL -- 25 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 50 mg Tablet Bottle Label

NDC 69367-308-09
Rx Only

Eplerenone
Tablets 50 mg

90 Tablets

Westminster Pharmaceuticals

PRINCIPAL DISPLAY PANEL -- 50 mg Tablet Bottle Label
(click image for full-size original)
EPLERENONE eplerenone tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69367-307
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EPLERENONE (EPLERENONE) EPLERENONE 25 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
HYPROMELLOSE, UNSPECIFIED
SODIUM LAURYL SULFATE
CROSCARMELLOSE SODIUM
TALC
MAGNESIUM STEARATE
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL, UNSPECIFIED
FERRIC OXIDE YELLOW
FD&C BLUE NO. 2–ALUMINUM LAKE
Product Characteristics
Color BROWN (Beige) Score no score
Shape ROUND Size 6mm
Flavor Imprint Code 25
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69367-307-30 30 TABLET, COATED in 1 BOTTLE, PLASTIC None
2 NDC:69367-307-09 90 TABLET, COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207842 11/08/2021
EPLERENONE eplerenone tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69367-308
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EPLERENONE (EPLERENONE) EPLERENONE 50 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
HYPROMELLOSE, UNSPECIFIED
SODIUM LAURYL SULFATE
CROSCARMELLOSE SODIUM
TALC
MAGNESIUM STEARATE
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL, UNSPECIFIED
FERRIC OXIDE YELLOW
FD&C BLUE NO. 2–ALUMINUM LAKE
Product Characteristics
Color BROWN (Beige) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code 50
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69367-308-30 30 TABLET, COATED in 1 BOTTLE, PLASTIC None
2 NDC:69367-308-09 90 TABLET, COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207842 11/08/2021
Labeler — Westminster Pharmaceuticals, LLC (079516651)
Establishment
Name Address ID/FEI Operations
Bluepharma — IndÚstria FarmacÊutica, S.a. 449909329 MANUFACTURE (69367-307), MANUFACTURE (69367-308)

Revised: 11/2021 Westminster Pharmaceuticals, LLC

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