Eplerenone
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Uses
Serum potassium levels should be measured before initiating eplerenone tablet therapy and eplerenone tablets should not be prescribed if serum potassium is >5.5 mEq/L [see CONTRAINDICATIONS (4)].
Eplerenone tablets are indicated to improve survival of stable patients with left ventricular (LV) systolic dysfunction (ejection fraction ≤40%) and clinical evidence of congestive heart failure (CHF) after an acute myocardial infarction (MI).
Eplerenone tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
Eplerenone tablets may be used alone or in combination with other antihypertensive agents.
History
There is currently no drug history available for this drug.
Other Information
Eplerenone tablets contain eplerenone, a blocker of aldosterone binding at the mineralocorticoid receptor.
Eplerenone is chemically described as Pregn-4-ene-7,21-dicarboxylic acid, 9,11-epoxy-17-hydroxy-3-oxo-, γ-lactone, methyl ester, (7α,11α,17α)-. Its empirical formula is C24H30O6 and it has a molecular weight of 414.50.
The structural formula of eplerenone is represented below:
Eplerenone is an odorless, white to off-white crystalline powder. It is very slightly soluble in water, with its solubility essentially pH-independent. The octanol/water partition coefficient of eplerenone is approximately 7.1 at pH 7.0.
Eplerenone tablets for oral administration contain 25 mg or 50 mg of eplerenone and the following inactive ingredients: lactose monohydrate, silicified microcrystalline cellulose, croscarmellose sodium, hypromellose, talc, magnesium stearate, titanium dioxide, polyethylene glycol. In addition, the 25 mg tablets also contain polysorbate and the 50 mg tablets also contain FD&C yellow No. 5 (tartrazine) and FD&C yellow No. 6, polydextrose and triacetin.
Sources
Eplerenone Manufacturers
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American Health Packaging
![Eplerenone Tablet [American Health Packaging]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Eplerenone | American Health Packaging
2.1 Congestive Heart Failure Post-Myocardial InfarctionTreatment should be initiated at 25 mg once daily and titrated to the recommended dose of 50 mg once daily, preferably within 4 weeks as tolerated by the patient. Eplerenone tablets may be administered with or without food.
Once treatment with eplerenone tablets has begun, adjust the dose based on the serum potassium level as shown in Table 1.
Table 1: Dose Adjustment in Congestive Heart Failure Post-MISerum
Potassium
(mEq/L)
Action
Dose Adjustment
<5
Increase
25 mg every other day to 25 mg once daily
25 mg once daily to 50 mg once daily
5 to 5.4
Maintain
No adjustment
5.5 to 5.9
Decrease
50 mg once daily to 25 mg once daily
25 mg once daily to 25 mg every other day
25 mg every other day to withhold
≥ 6
Withhold
Restart at 25 mg every other day when potassium levels fall to <5.5 mEq/L
2.2 HypertensionThe recommended starting dose of eplerenone tablets is 50 mg administered once daily. The full therapeutic effect of eplerenone tablets is apparent within 4 weeks. For patients with an inadequate blood pressure response to 50 mg once daily the dosage of eplerenone tablets should be increased to 50 mg twice daily. Higher dosages of eplerenone tablets are not recommended because they have no greater effect on blood pressure than 100 mg and are associated with an increased risk of hyperkalemia [see CLINICAL STUDIES (14.2)].
2.3 Recommended MonitoringSerum potassium should be measured before initiating eplerenone tablet therapy, within the first week, and at one month after the start of treatment or dose adjustment. Serum potassium should be assessed periodically thereafter. Patient characteristics and serum potassium levels may indicate that additional monitoring is appropriate [see WARNINGS AND PRECAUTIONS (5.1), ADVERSE REACTIONS (6.2)]. In the EPHESUS study [see CLINICAL STUDIES (14.1)], the majority of hyperkalemia was observed within the first three months after randomization.
In all patients taking eplerenone tablets who start taking a moderate CYP3A4 inhibitor, check serum potassium and serum creatinine in 3 to 7 days.
2.4 Dose Modifications for Specific PopulationsFor hypertensive patients receiving moderate CYP3A4 inhibitors (e.g., erythromycin, saquinavir, verapamil and fluconazole), the starting dose of eplerenone tablets should be reduced to 25 mg once daily [see DRUG INTERACTIONS (7.1)].
No adjustment of the starting dose is recommended for the elderly or for patients with mild-to-moderate hepatic impairment [see CLINICAL PHARMACOLOGY (12.3)].
-
Rebel Distributors Corp.
Eplerenone | Rebel Distributors Corp.
2.1 Congestive Heart Failure Post-Myocardial InfarctionTreatment should be initiated at 25 mg once daily and titrated to the recommended dose of 50 mg once daily, preferably within 4 weeks as tolerated by the patient. Eplerenone may be administered with or without food.
Once treatment with eplerenone has begun, adjust the dose based on the serum potassium level as shown in Table 1.
Table 1: Dose Adjustment in Congestive Heart Failure Post-MISerum
Potassium
(mEq/L) Action Dose Adjustment <5.0 Increase25 mg every other day to 25 mg once daily
25 mg once daily to 50 mg once daily 5.0–5.4 Maintain No adjustment 5.5–5.9 Decrease50 mg once daily to 25 mg once daily
25 mg once daily to 25 mg every other day
25 mg every other day to withhold≥ 6.0
WithholdRestart at 25 mg every other day when potassium levels fall to <5.5 mEq/L
2.2 HypertensionThe recommended starting dose of eplerenone is 50 mg administered once daily. The full therapeutic effect of eplerenone is apparent within 4 weeks. For patients with an inadequate blood pressure response to 50 mg once daily the dosage of eplerenone should be increased to 50 mg twice daily. Higher dosages of eplerenone are not recommended because they have no greater effect on blood pressure than 100 mg and are associated with an increased risk of hyperkalemia. [See CLINICAL STUDIES, 14.2 Hypertension .]
2.3 Recommended MonitoringSerum potassium should be measured before initiating eplerenone therapy, within the first week and at one month after the start of treatment or dose adjustment. Serum potassium should be assessed periodically thereafter. Patient characteristics and serum potassium levels may indicate that additional monitoring is appropriate. [See WARNINGS AND PRECAUTIONS, 5.1 Hyperkalemia , ADVERSE REACTIONS, 6.2 Clinical Laboratory Test Findings .] In the EPHESUS study [See CLINICAL STUDIES, 14.1 Congestive Heart Failure Post-Myocardial Infarction ], the majority of hyperkalemia was observed within the first three months after randomization.
In all patients taking eplerenone who start taking a moderate CYP3A4 inhibitor, check serum potassium and serum creatinine in 3 to 7 days.
2.4 Dose Modifications for Specific PopulationsFor hypertensive patients receiving moderate CYP3A4 inhibitors (e.g., erythromycin, saquinavir, verapamil and fluconazole), the starting dose of eplerenone should be reduced to 25 mg once daily. [See DRUG INTERACTIONS, 7.1 CYP3A4 Inhibitors.]
No adjustment of the starting dose is recommended for the elderly or for patients with mild-to-moderate hepatic impairment. [See CLINICAL PHARMACOLOGY, 12.3 Pharmacokinetics.]
-
Physicians Total Care, Inc.
Eplerenone | Physicians Total Care, Inc.
2.1 Congestive Heart Failure Post-Myocardial InfarctionTreatment should be initiated at 25 mg once daily and titrated to the recommended dose of 50 mg once daily, preferably within 4 weeks as tolerated by the patient. Eplerenone may be administered with or without food.
Once treatment with eplerenone has begun, adjust the dose based on the serum potassium level as shown in Table 1.
Table 1: Dose Adjustment in Congestive Heart Failure Post-MISerum
Potassium
(mEq/L) Action Dose Adjustment <5.0 Increase25 mg every other day to 25 mg once daily
25 mg once daily to 50 mg once daily 5.0–5.4 Maintain No adjustment 5.5–5.9 Decrease50 mg once daily to 25 mg once daily
25 mg once daily to 25 mg every other day
25 mg every other day to withhold≥ 6.0
WithholdRestart at 25 mg every other day when potassium levels fall to <5.5 mEq/L
2.2 HypertensionThe recommended starting dose of eplerenone is 50 mg administered once daily. The full therapeutic effect of eplerenone is apparent within 4 weeks. For patients with an inadequate blood pressure response to 50 mg once daily the dosage of eplerenone should be increased to 50 mg twice daily. Higher dosages of eplerenone are not recommended because they have no greater effect on blood pressure than 100 mg and are associated with an increased risk of hyperkalemia. [See CLINICAL STUDIES, 14.2 Hypertension .]
2.3 Recommended MonitoringSerum potassium should be measured before initiating eplerenone therapy, within the first week and at one month after the start of treatment or dose adjustment. Serum potassium should be assessed periodically thereafter. Patient characteristics and serum potassium levels may indicate that additional monitoring is appropriate. [See WARNINGS AND PRECAUTIONS, 5.1 Hyperkalemia , ADVERSE REACTIONS, 6.2 Clinical Laboratory Test Findings .] In the EPHESUS study [See CLINICAL STUDIES, 14.1 Congestive Heart Failure Post-Myocardial Infarction ], the majority of hyperkalemia was observed within the first three months after randomization.
In all patients taking eplerenone who start taking a moderate CYP3A4 inhibitor, check serum potassium and serum creatinine in 3 to 7 days.
2.4 Dose Modifications for Specific PopulationsFor hypertensive patients receiving moderate CYP3A4 inhibitors (e.g., erythromycin, saquinavir, verapamil and fluconazole), the starting dose of eplerenone should be reduced to 25 mg once daily. [See DRUG INTERACTIONS, 7.1 CYP3A4 Inhibitors.]
No adjustment of the starting dose is recommended for the elderly or for patients with mild-to-moderate hepatic impairment. [See CLINICAL PHARMACOLOGY, 12.3 Pharmacokinetics.]
-
Apotex Corp
Eplerenone | Apotex Corp
2.1 Congestive Heart Failure Post-Myocardial InfarctionTreatment should be initiated at 25 mg once daily and titrated to the recommended dose of 50 mg once daily, preferably within 4 weeks as tolerated by the patient. Eplerenone tablets may be administered with or without food.
Once treatment with eplerenone tablets have begun, adjust the dose based on the serum potassium level as shown in Table 1.
Table 1. Dose Adjustment in Congestive Heart Failure Post-MI
Serum Potassium (mEq/L) Action Dose Adjustment < 5.0 Increase 25 mg every other day to 25 mg once daily 25 mg once daily to 50 mg once daily 5.0 to 5.4 Maintain No adjustment 5.5 to 5.9 Decrease 50 mg once daily to 25 mg once daily25 mg once daily to 25 mg every other day25 mg every other day to withhold ≥ 6.0 Withhold Restart at 25 mg every other day when potassium levels fall to <5.5 mEq/L 2.2 HypertensionThe recommended starting dose of eplerenone tablets are 50 mg administered once daily. The full therapeutic effect of eplerenone tablets is apparent within 4 weeks. For patients with an inadequate blood pressure response to 50 mg once daily the dosage of eplerenone tablets should be increased to 50 mg twice daily. Higher dosages of eplerenone tablets are not recommended because they have no greater effect on blood pressure than 100 mg and are associated with an increased risk of hyperkalemia. [See CLINICAL STUDIES (14.2).]
2.3 Recommended MonitoringSerum potassium should be measured before initiating eplerenone tablet therapy, within the first week, and at one month after the start of treatment or dose adjustment. Serum potassium should be assessed periodically thereafter. Patient characteristics and serum potassium levels may indicate that additional monitoring is appropriate. [See WARNINGS AND PRECAUTIONS (5.1), ADVERSE REACTIONS (6.2).] In the EPHESUS study [See CLINICAL STUDIES (14.1)], the majority of hyperkalemia was observed within the first three months after randomization.
In all patients taking eplerenone tablets who start taking a moderate CYP3A4 inhibitor, check serum potassium and serum creatinine in 3 to 7 days.
2.4 Dose Modifications for Specific PopulationsFor hypertensive patients receiving moderate CYP3A4 inhibitors (e.g., erythromycin, saquinavir, verapamil, and fluconazole), the starting dose of eplerenone tablets should be reduced to 25 mg once daily. [See DRUG INTERACTIONS (7.1).]
No adjustment of the starting dose is recommended for the elderly or for patients with mild-to-moderate hepatic impairment. [See CLINICAL PHARMACOLOGY (12.3).]
-
Eon Labs, Inc.
Eplerenone | Eon Labs, Inc.
2.1 Congestive Heart Failure Post-Myocardial InfarctionTreatment should be initiated at 25 mg once daily and titrated to the recommended dose of 50 mg once daily, preferably within 4 weeks as tolerated by the patient. Eplerenone tablets may be administered with or without food.
Once treatment with eplerenone tablets has begun, adjust the dose based on the serum potassium level as shown in Table 1.
Table 1: Dose Adjustment in Congestive Heart Failure Post-MISerum
Potassium
(mEq/L)
Action
Dose Adjustment
<5
Increase
25 mg every other day to 25 mg once daily
25 mg once daily to 50 mg once daily
5 to 5.4
Maintain
No adjustment
5.5 to 5.9
Decrease
50 mg once daily to 25 mg once daily
25 mg once daily to 25 mg every other day
25 mg every other day to withhold
≥ 6
Withhold
Restart at 25 mg every other day
when potassium levels fall to <5.5 mEq/L
2.2 HypertensionThe recommended starting dose of eplerenone tablets is 50 mg administered once daily. The full therapeutic effect of eplerenone tablets is apparent within 4 weeks. For patients with an inadequate blood pressure response to 50 mg once daily the dosage of eplerenone tablets should be increased to 50 mg twice daily. Higher dosages of eplerenone tablets are not recommended because they have no greater effect on blood pressure than 100 mg and are associated with an increased risk of hyperkalemia [see CLINICAL STUDIES, (14.2)].
2.3 Recommended MonitoringSerum potassium should be measured before initiating eplerenone tablet therapy, within the first week, and at one month after the start of treatment or dose adjustment. Serum potassium should be assessed periodically thereafter. Patient characteristics and serum potassium levels may indicate that additional monitoring is appropriate [see WARNINGS AND PRECAUTIONS (5.1), ADVERSE REACTIONS (6.2)]. In the EPHESUS study [see CLINICAL STUDIES (14.1)], the majority of hyperkalemia was observed within the first three months after randomization.
In all patients taking eplerenone tablets who start taking a moderate CYP3A4 inhibitor, check serum potassium and serum creatinine in 3 to 7 days.
2.4 Dose Modifications for Specific PopulationsFor hypertensive patients receiving moderate CYP3A4 inhibitors (e.g., erythromycin, saquinavir, verapamil, and fluconazole), the starting dose of eplerenone tablets should be reduced to 25 mg once daily [see DRUG INTERACTIONS (7.1)].
No adjustment of the starting dose is recommended for the elderly or for patients with mild-to-moderate hepatic impairment [see CLINICAL PHARMACOLOGY (12.3)].
-
Greenstone Llc
Eplerenone | Greenstone Llc
2.1 Congestive Heart Failure Post-Myocardial InfarctionTreatment should be initiated at 25 mg once daily and titrated to the recommended dose of 50 mg once daily, preferably within 4 weeks as tolerated by the patient. Eplerenone may be administered with or without food.
Once treatment with eplerenone has begun, adjust the dose based on the serum potassium level as shown in Table 1.
Table 1. Dose Adjustment in Congestive Heart Failure Post-MI Serum Potassium
(mEq/L) Action Dose Adjustment < 5.0 Increase 25 mg every other day to 25 mg once daily
25 mg once daily to 50 mg once daily 5.0–5.4 Maintain No adjustment 5.5–5.9 Decrease 50 mg once daily to 25 mg once daily
25 mg once daily to 25 mg every other day
25 mg every other day to withhold ≥ 6.0 Withhold Restart at 25 mg every other day when potassium levels fall to <5.5 mEq/L 2.2 HypertensionThe recommended starting dose of eplerenone is 50 mg administered once daily. The full therapeutic effect of eplerenone is apparent within 4 weeks. For patients with an inadequate blood pressure response to 50 mg once daily the dosage of eplerenone should be increased to 50 mg twice daily. Higher dosages of eplerenone are not recommended because they have no greater effect on blood pressure than 100 mg and are associated with an increased risk of hyperkalemia. [See CLINICAL STUDIES (14.2).]
2.3 Recommended MonitoringSerum potassium should be measured before initiating eplerenone therapy, within the first week, and at one month after the start of treatment or dose adjustment. Serum potassium should be assessed periodically thereafter. Patient characteristics and serum potassium levels may indicate that additional monitoring is appropriate. [See WARNINGS AND PRECAUTIONS (5.1), ADVERSE REACTIONS (6.2).] In the EPHESUS study [See CLINICAL STUDIES (14.1)], the majority of hyperkalemia was observed within the first three months after randomization.
In all patients taking eplerenone who start taking a moderate CYP3A4 inhibitor, check serum potassium and serum creatinine in 3–7 days.
2.4 Dose Modifications for Specific PopulationsFor hypertensive patients receiving moderate CYP3A4 inhibitors (e.g., erythromycin, saquinavir, verapamil, and fluconazole), the starting dose of eplerenone should be reduced to 25 mg once daily. [See DRUG INTERACTIONS (7.1).]
No adjustment of the starting dose is recommended for the elderly or for patients with mild-to-moderate hepatic impairment. [See CLINICAL PHARMACOLOGY (12.3).]
-
American Health Packaging
Eplerenone | American Health Packaging
2.1 Congestive Heart Failure Post-Myocardial InfarctionTreatment should be initiated at 25 mg once daily and titrated to the recommended dose of 50 mg once daily, preferably within 4 weeks as tolerated by the patient. Eplerenone tablets may be administered with or without food.
Once treatment with eplerenone tablets has begun, adjust the dose based on the serum potassium level as shown in Table 1.
Table 1: Dose Adjustment in Congestive Heart Failure Post-MISerum
Potassium
(mEq/L)
Action
Dose Adjustment
<5
Increase
25 mg every other day to 25 mg once daily
25 mg once daily to 50 mg once daily
5 to 5.4
Maintain
No adjustment
5.5 to 5.9
Decrease
50 mg once daily to 25 mg once daily
25 mg once daily to 25 mg every other day
25 mg every other day to withhold
≥ 6
Withhold
Restart at 25 mg every other day when potassium levels fall to <5.5 mEq/L
2.2 HypertensionThe recommended starting dose of eplerenone tablets is 50 mg administered once daily. The full therapeutic effect of eplerenone tablets is apparent within 4 weeks. For patients with an inadequate blood pressure response to 50 mg once daily the dosage of eplerenone tablets should be increased to 50 mg twice daily. Higher dosages of eplerenone tablets are not recommended because they have no greater effect on blood pressure than 100 mg and are associated with an increased risk of hyperkalemia [see CLINICAL STUDIES (14.2)].
2.3 Recommended MonitoringSerum potassium should be measured before initiating eplerenone tablet therapy, within the first week, and at one month after the start of treatment or dose adjustment. Serum potassium should be assessed periodically thereafter. Patient characteristics and serum potassium levels may indicate that additional monitoring is appropriate [see WARNINGS AND PRECAUTIONS (5.1), ADVERSE REACTIONS (6.2)]. In the EPHESUS study [see CLINICAL STUDIES (14.1)], the majority of hyperkalemia was observed within the first three months after randomization.
In all patients taking eplerenone tablets who start taking a moderate CYP3A4 inhibitor, check serum potassium and serum creatinine in 3 to 7 days.
2.4 Dose Modifications for Specific PopulationsFor hypertensive patients receiving moderate CYP3A4 inhibitors (e.g., erythromycin, saquinavir, verapamil and fluconazole), the starting dose of eplerenone tablets should be reduced to 25 mg once daily [see DRUG INTERACTIONS (7.1)].
No adjustment of the starting dose is recommended for the elderly or for patients with mild-to-moderate hepatic impairment [see CLINICAL PHARMACOLOGY (12.3)].
![Eplerenone Tablet [Rebel Distributors Corp.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=4743a48b-d4b5-4054-85e1-9d64cc40de25&name=4743a48b-d4b5-4054-85e1-9d64cc40de25-07.jpg)
![Eplerenone Tablet [Physicians Total Care, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e8323922-191d-4bfc-8871-fbe15a8a7b58&name=6065.jpg)
![Eplerenone (Eplerenone ) Tablet [Apotex Corp]](http://recallguide.cwdevelopsp.com/wp-content/themes/recallguide/assets/img/drug-image-placeholder.jpg)
![Eplerenone Tablet [Eon Labs, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=cd6cbf0b-34b8-43aa-8037-360480a19cf8&name=42048fe3-6c0a-45eb-839a-d03ebc1a7b86-06.jpg)
![Eplerenone Tablet, Film Coated [Greenstone Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6d988699-95c2-46b9-8266-23fe7016f33b&name=eplerenone-10.jpg)
![Eplerenone Tablet [American Health Packaging]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=4ab6168f-3bc2-45e2-ae27-5f8271602abb&name=0294825_0715OS_EplerenoneTablets_25mg_V1-FINAL-print.jpg)
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