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 3091 hypertensive patients. The studies included 46% women, 14% Blacks, and 22% elderly (age ≥65). The studies excluded patients with elevated baseline serum potassium (>5.0 mEq/L) and elevated baseline serum creatinine (generally >1.5 mg/dL in males and >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 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
(click image for full-size original)
Figure 4
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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 6–13 mm Hg (systolic) and 3–7 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 are yellow, diamond biconvex, and film-coated. They are debossed with “G” on one side. They are supplied as follows:

Dose Deboss Side 2 NDC 59762-xxxx-x
Bottle/30 Bottle/90 Unit dose
Abbreviation: NA=not applicable
25 mg 25 1710-2 1710-3 1710-1
50 mg 50 1720-1 1720-2 NA

Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [See USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Advise patients receiving eplerenone:

  • 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)].

This product’s labeling may have been updated. For the most recent prescribing information, please visit www.greenstonellc.com.

Greenstone signature

LAB-0376-10.0

PRINCIPAL DISPLAY PANEL — 25 mg Tablet Bottle Label

NDC 59762-1710-2
30 Tablets

GREENSTONE® BRAND

eplerenone
tablets

25 mg

Rx only

GTIN: 00359762171023LOT:/EXP:

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

PRINCIPAL DISPLAY PANEL — 25 mg Tablet Blister Pack

13884600
eplerenone
tablet

25 mg

Greenstone LLCPeapack, NJ 07977

PRINCIPAL DISPLAY PANEL -- 25 mg Tablet Blister Pack
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 25 mg Tablet Blister Pack Carton

UNIT DOSE

NDC 59762-1710-1
100 Tablets

GREENSTONE® BRAND

eplerenone
tablets

25 mg For in-institution use only

Rx only

PRINCIPAL DISPLAY PANEL -- 25 mg Tablet Blister Pack Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 50 mg Tablet Bottle Label

NDC 59762-1720-1
30 Tablets

GREENSTONE® BRAND

eplerenone
tablets

50 mg

Rx only

GTIN: 00359762172013LOT:/EXP:

PRINCIPAL DISPLAY PANEL -- 50 mg Tablet Bottle Label
(click image for full-size original)
EPLERENONE eplerenone tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59762-1710
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, UNSPECIFIED FORM
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
HYPROMELLOSE, UNSPECIFIED
SODIUM LAURYL SULFATE
TALC
MAGNESIUM STEARATE
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
Product Characteristics
Color YELLOW Score no score
Shape DIAMOND (biconvex) Size 7mm
Flavor Imprint Code G;25mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59762-1710-2 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:59762-1710-3 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:59762-1710-1 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (59762-1710-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA021437 09/27/2002
EPLERENONE eplerenone tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59762-1720
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, UNSPECIFIED FORM
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
HYPROMELLOSE, UNSPECIFIED
SODIUM LAURYL SULFATE
TALC
MAGNESIUM STEARATE
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
Product Characteristics
Color YELLOW Score no score
Shape DIAMOND (biconvex) Size 9mm
Flavor Imprint Code G;50mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59762-1720-1 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:59762-1720-2 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA021437 09/27/2002
Labeler — Greenstone LLC (825560733)
Establishment
Name Address ID/FEI Operations
Pharmacia and Upjohn Company LLC 618054084 API MANUFACTURE (59762-1710), API MANUFACTURE (59762-1720)
Establishment
Name Address ID/FEI Operations
Excella GmbH & Co. KG 329809800 API MANUFACTURE (59762-1710), API MANUFACTURE (59762-1720)
Establishment
Name Address ID/FEI Operations
Pfizer Pharmaceuticals LLC 829084552 ANALYSIS (59762-1710), ANALYSIS (59762-1720), LABEL (59762-1710), LABEL (59762-1720), MANUFACTURE (59762-1710), MANUFACTURE (59762-1720), PACK (59762-1710), PACK (59762-1720)

Revised: 08/2020 Greenstone LLC

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