Eplerenone: Drug information

For additional information see "Eplerenone: Patient drug information"

For abbreviations, symbols, and age group definitions show table

Brand Names: US

Inspra

Brand Names: Canada

Inspra;
JAMP-Eplerenone;
MINT-Eplerenone

Pharmacologic Category

Antihypertensive;
Diuretic, Potassium Sparing;
Mineralocorticoid (Aldosterone) Receptor Antagonist

Dosing: Adult

Heart failure

Heart failure:

Note: When initiating therapy, verify the following: serum potassium <5 mEq/L and either serum creatinine ≤2.5 mg/dL in males and ≤2 mg/dL in females or eGFR >30 mL/minute/1.73 m². If patient develops hyperkalemia or kidney function worsens, reduce the dose, change to every-other-day dosing, or discontinue therapy; assess for other causes of hyperkalemia before permanent discontinuation. If serum potassium cannot be maintained <5.5 mEq/L, discontinue therapy (Ref).

Heart failure with preserved ejection fraction (off-label use):

Note: Some experts recommend treatment with a sodium-glucose co-transporter 2 (SGLT2) inhibitor (eg, empagliflozin or dapagliflozin) prior to initiating eplerenone; however, eplerenone is still reasonable in patients who cannot take an SGLT2 inhibitor (Ref). Some experts are more conservative regarding serum potassium for patients with HFpEF. They recommend initiating therapy or up-titrating the dose only if serum potassium is ≤4.7 mEq/L and eGFR is ≥30 mL/minute/1.73 m². They recommend dose reduction or discontinuation if serum potassium is >5 mEq/L (Ref).

Oral: Initial: 25 mg once daily; may double the dose after 4 weeks if serum potassium and kidney function are stable, to a maximum target dose of 50 mg once daily (Ref).

Heart failure with reduced ejection fraction (off-label use):

Note: Should be considered for use in patients with symptomatic (New York Heart Association class II to IV) heart failure with reduced ejection fraction (HFrEF) (≤40%) as part of an optimal medical regimen for HFrEF (Ref).

Oral: Initial: 25 mg once daily; may double the dose after 4 weeks if serum potassium and kidney function are stable, to a maximum target dose of 50 mg once daily (Ref).

Post myocardial infarction, complicated by reduced ejection fraction:

Note: Should be considered for use following acute myocardial infarction in patients with left ventricular ejection fraction ≤40% plus symptoms of heart failure or diabetes. Use in addition to other pharmacologic therapies (Ref).

Oral: Initial: 25 mg once daily; may double the dose after 4 weeks if serum potassium and kidney function are stable, up to a maximum target dose of 50 mg once daily.

Hypertension, chronic

Hypertension, chronic (alternative agent):

Note: Not recommended for initial management but may be considered as additional therapy for resistant hypertension in patients who do not respond adequately to combination therapy with preferred agents (Ref).

Oral: Initial: 50 mg once daily; evaluate response after ~2 to 4 weeks and titrate dose, as needed, to a maximum of 50 mg twice daily. Twice daily dosing is usually required for adequate BP lowering. Patients with severe asymptomatic hypertension and no signs of acute end organ damage should be evaluated for medication titration within 1 week (Ref).

Primary aldosteronism

Primary aldosteronism (alternative agent) (off-label use):

Oral: Initial: 25 mg twice daily; gradually titrate to the lowest effective dose, up to 300 mg/day. For patients undergoing surgical intervention, administer the last dose of eplerenone on the day of surgery, then discontinue eplerenone on postoperative day 1 (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

Note: Although eplerenone clearance is not significantly impacted by kidney impairment, the primary concern about use in this population is an increased risk of hyperkalemia (Ref). Eplerenone should be used with increasing caution as eGFR declines (Ref).

Altered kidney function: Oral:

Heart failure :

eGFR ≥50 mL/minute/1.73 m²: No dosage adjustment necessary (Ref).

eGFR 31 to 49 mL/minute/1.73 m²: Initial: 25 mg every other day; may increase to maximum target dose of 25 mg once daily after 4 weeks if serum potassium and kidney function are stable (Ref).

eGFR ≤30 mL/minute/1.73 m²: Use is contraindicated (Ref).

Hypertension:

eGFR ≥50 mL/minute/1.73 m²: No dosage adjustment necessary (Ref).

eGFR 31 to 49 mL/minute/1.73 m²: Although the manufacturer's labeling states use is contraindicated in patients with CrCl <50 mL/minute in the treatment of chronic hypertension, limited data suggest mineralocorticoid receptor antagonists (eg, eplerenone) may be used (sometimes in combination with a potassium-binding polymer) if the potential benefits outweigh the risks (Ref). If use deemed appropriate, initiate therapy with 50% of the usual recommended dose; may gradually titrate with caution and close monitoring of serum potassium and kidney function; use the lowest effective dose, not to exceed the usual indication specific dose (Ref).

eGFR ≤30 mL/minute/1.73 m²: Use is contraindicated (Ref).

Hemodialysis, intermittent (thrice weekly): Poorly dialyzable (10%) (Ref): Use not routinely recommended, but one pilot trial demonstrated tolerability of eplerenone in patients with end-stage kidney disease receiving dialysis (Ref). Only use if potassium is well-controlled, patient can be monitored closely for hyperkalemia, and potential benefits outweigh the risks (Ref). If use deemed appropriate, initiate therapy with 50% of the usual recommended dose (eg, 25 mg every other day for heart failure; 25 mg once daily for hypertension). May gradually titrate with extreme caution and close monitoring of serum potassium. A maximum dose of 25 mg once daily is recommended for the treatment of heart failure, and a maximum of 50 mg once daily is suggested for hypertension (Ref).

Peritoneal dialysis: Unlikely to be dialyzable (Ref): Use not routinely recommended. Only use if potassium is well-controlled, patient can be monitored closely for hyperkalemia, and potential benefits outweigh the risks (Ref). If use deemed appropriate, initiate therapy with 50% of the usual recommended dose (eg, 25 mg every other day for heart failure; 25 mg once daily for hypertension). May gradually titrate to lowest effective dose with extreme caution and close monitoring of serum potassium. A maximum dose of 25 mg once daily is recommended for the treatment of heart failure (Ref). A maximum dose of 50 mg once daily is suggested for hypertension, as one case report has described successful use of 50 mg/day to treat resistant hypertension in a patient with end-stage kidney disease receiving peritoneal dialysis (Ref).

CRRT: Use not routinely recommended. Only use if potential benefits outweigh the risks. If use deemed appropriate, initiate therapy with 50% of the usual dose (eg, 25 mg every other day for heart failure; 25 mg once daily for hypertension). May gradually titrate with caution and close monitoring of serum potassium; use the lowest effective dose, not to exceed the usual indication-specific dose (Ref).

PIRRT (eg, sustained, low-efficiency diafiltration): Use not routinely recommended. Only use if potential benefits outweigh the risks. If use deemed appropriate, initiate therapy with 50% of the usual dose (eg, 25 mg every other day for heart failure; 25 mg once daily for hypertension). May gradually titrate with caution and close monitoring of serum potassium; use the lowest effective dose, not to exceed the usual indication-specific dose (Ref).

Dosing: Liver Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling. Systemic exposure is increased in moderate hepatic impairment (Child-Pugh class B).

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions (Significant): Considerations

Hyperkalemia

Eplerenone can cause reversible hyperkalemia; however, if potassium is monitored periodically and with suspected changes in electrolytes (vomiting, diarrhea), the risk does not appear to translate into a higher risk of hospitalization or death (Ref).

Mechanism: Dose-related; related to the pharmacologic action. Competes with aldosterone for binding to the mineralocorticoid receptor, thereby inhibiting the exchange of sodium for potassium in the distal convoluted renal tubule and preventing potassium excretion (Ref).

Onset: Intermediate; usually occurs within 4 weeks of initiation or dose titration (Ref).

Risk factors:

• Doses >100 mg daily (Ref)

• Older patients (≥75 years of age) (Ref)

• Diabetes (Ref)

• Kidney impairment (Ref)

• Excessive potassium intake (eg, potassium supplements, potassium-containing salt substitutes)

• Concomitant use of certain medications (eg, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, sacubitril/valsartan, nonsteroidal anti-inflammatory drugs, moderate CYP3A inhibitors)

• Baseline serum potassium >4.3 mEq/L (Ref)

• Prior use of antiarrhythmic agents (Ref)

• Proteinuria

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%: Endocrine & metabolic: Hyperkalemia (cardiac failure, post-myocardial infarction: 3%; >5.5 mEq/L: 16%; ≥6 mEq/L: 6%) (table 1)Hyperkalemia

**Eplerenone: Adverse Reaction: Hyperkalemia**
Drug (Eplerenone)	Placebo	Indication	Number of Patients (Eplerenone)	Number of Patients (Placebo)	Comments
16%	11%	Cardiac failure, post-myocardial infarction	3251	3237	>5.5 mEq/L
6%	4%	Cardiac failure, post-myocardial infarction	3251	3237	≥6 mEq/L
3%	2%	Cardiac failure, post-myocardial infarction	3307	3301	N/A

1% to 10%: Renal: Increased serum creatinine (cardiac failure, post-myocardial infarction: 2% to 7%)

Frequency not defined:

Cardiovascular: Acute myocardial infarction, angina pectoris

Endocrine & metabolic: Gynecomastia, increased gamma-glutamyl transferase

Genitourinary: Abnormal vaginal hemorrhage

Nervous system: Dizziness, headache

Renal: Renal insufficiency

Postmarketing:

Dermatologic: Skin rash

Hypersensitivity: Angioedema

Contraindications

Serum potassium >5.5 mEq/L at initiation; CrCl ≤30 mL/minute; concomitant use of strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir).

Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

The following additional contraindications apply to patients with hypertension: Type 2 diabetes mellitus with microalbuminuria; concomitant use with potassium supplements or potassium-sparing diuretics (eg, amiloride, spironolactone, triamterene).

Although the manufacturer’s labeling contraindicates use in males with serum creatinine >2 mg/dL, females with serum creatinine >1.8 mg/dL, or any patient with CrCl <50 mL/minute, limited data suggest mineralocorticoid receptor antagonists (eg, eplerenone) can be cautiously used (sometimes in combination with a potassium-binding polymer) in select patients with an eGFR between 30 and 50 mL/minute/1.73m²(Ref).

Based on the Endocrine Society (ES) clinical practice guidelines on the diagnosis and treatment of primary adrenal insufficiency, use of eplerenone in patients with Addison disease is contraindicated (ES [Bornstein 2016]).

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to eplerenone or any component of the formulation; serum potassium >5 mEq/L at initiation; severe hepatic impairment (Child-Pugh class C); clinically significant hyperkalemia; concomitant use with potassium supplements or potassium-sparing diuretics

The following additional contraindications apply to patients with hypertension: Serum creatinine >1.5 mg/dL [132 micromole/L] in males or >1.3 mg/dL [115 micromole/L] in females

Warnings/Precautions

Disease-related concerns:

• Heart failure: When evaluating a heart failure patient for eplerenone treatment, eGFR should be >30 mL/minute/1.73 m² or creatinine should be ≤2.5 mg/dL (males) or ≤2 mg/dL (females) with no recent worsening and potassium should be <5 mEq/L with no history of severe hyperkalemia. Discontinue therapy if serum potassium cannot be maintained <5.5 mEq/L or if kidney function worsens. Consider the entire medical regimen and other potential causes of hyperkalemia (AHA/ACC/HFSA [Heidenreich 2022]).

• Hepatic impairment: Use with caution in patients with moderate to severe hepatic impairment.

• Kidney impairment: Use in patients with kidney impairment is dependent on the degree of impairment and indication for use; dosage adjustment may be necessary.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Inspra: 25 mg, 50 mg

Generic: 25 mg, 50 mg

Generic Equivalent Available: US

Yes

Pricing: US

Tablets (Eplerenone Oral)

25 mg (per each): $4.17 - $4.34

50 mg (per each): $4.17 - $4.34

Tablets (Inspra Oral)

25 mg (per each): $17.74

50 mg (per each): $17.74

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Inspra: 25 mg, 50 mg [contains polysorbate 80]

Generic: 25 mg, 50 mg

Administration: Adult

Oral: Administer with or without food.

Use: Labeled Indications

Hypertension, chronic: Management of hypertension. Note: Not recommended for the initial treatment of hypertension (ACC/AHA [Whelton 2018]).

Post myocardial infarction, complicated by heart failure with reduced ejection fraction: To improve survival of stable patients with symptomatic heart failure (left ventricular ejection fraction ≤40%) following acute myocardial infarction.

Use: Off-Label: Adult

Heart failure with preserved ejection fraction; Heart failure with reduced ejection fraction; Primary aldosteronism

Medication Safety Issues

Older Adult: High-Risk Medication:

Beers Criteria: Diuretics are identified in the Beers Criteria as potentially inappropriate medications to be used with caution in patients 65 years and older due to the potential to cause or exacerbate syndrome of inappropriate antidiuretic hormone secretion (SIADH) or hyponatremia; monitor sodium concentration closely when initiating or adjusting the dose in older adults (Beers Criteria [AGS 2023]).

Sound-alike/look-alike issues:

Inspra may be confused with Spiriva

Metabolism/Transport Effects

Substrate of CYP3A4 (Major with inhibitors), CYP3A4 (Minor with inducers); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential;

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Alfuzosin: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Aliskiren: Potassium-Sparing Diuretics may increase hyperkalemic effects of Aliskiren. Risk C: Monitor

Amifostine: Blood Pressure Lowering Agents may increase hypotensive effects of Amifostine. Management: When used at chemotherapy doses, hold blood pressure lowering medications for 24 hours before amifostine administration. If blood pressure lowering therapy cannot be held, do not administer amifostine. Use caution with radiotherapy doses of amifostine. Risk D: Consider Therapy Modification

Ammonium Chloride: Potassium-Sparing Diuretics may increase adverse/toxic effects of Ammonium Chloride. Specifically the risk of systemic acidosis. Risk C: Monitor

Amphetamines: May decrease antihypertensive effects of Antihypertensive Agents. Risk C: Monitor

Angiotensin II Receptor Blockers: Potassium-Sparing Diuretics may increase hyperkalemic effects of Angiotensin II Receptor Blockers. Risk C: Monitor

Angiotensin-Converting Enzyme Inhibitors: Potassium-Sparing Diuretics may increase hyperkalemic effects of Angiotensin-Converting Enzyme Inhibitors. Risk C: Monitor

Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may increase hypotensive effects of Antipsychotic Agents (Second Generation [Atypical]). Risk C: Monitor

Arginine: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Barbiturates: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Benperidol: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Brigatinib: May decrease antihypertensive effects of Antihypertensive Agents. Brigatinib may increase bradycardic effects of Antihypertensive Agents. Risk C: Monitor

Brimonidine (Topical): May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Bromperidol: May decrease hypotensive effects of Blood Pressure Lowering Agents. Blood Pressure Lowering Agents may increase hypotensive effects of Bromperidol. Risk X: Avoid

Clofazimine: May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor

CycloSPORINE (Systemic): Potassium-Sparing Diuretics may increase hyperkalemic effects of CycloSPORINE (Systemic). Risk X: Avoid

CYP3A4 Inducers (Strong): May decrease serum concentration of Eplerenone. Risk C: Monitor

CYP3A4 Inhibitors (Moderate): May increase serum concentration of Eplerenone. Management: If coadministered with moderate CYP3A4 inhibitors, the max dose of eplerenone is 25 mg daily if used for heart failure; if used for hypertension initiate eplerenone 25 mg daily, titrate to max 25 mg twice daily. Risk D: Consider Therapy Modification

CYP3A4 Inhibitors (Strong): May increase serum concentration of Eplerenone. Risk X: Avoid

Desmopressin: Hyponatremia-Associated Agents may increase hyponatremic effects of Desmopressin. Risk C: Monitor

Dexmethylphenidate: May decrease therapeutic effects of Antihypertensive Agents. Risk C: Monitor

Diacerein: May increase therapeutic effects of Diuretics. Specifically, the risk for dehydration or hypokalemia may be increased. Risk C: Monitor

Diazoxide: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Digitoxin: Potassium-Sparing Diuretics may increase adverse/toxic effects of Digitoxin. Potassium-Sparing Diuretics may decrease therapeutic effects of Digitoxin. Risk C: Monitor

Drospirenone-Containing Products: May increase hyperkalemic effects of Potassium-Sparing Diuretics. Risk C: Monitor

DULoxetine: Blood Pressure Lowering Agents may increase hypotensive effects of DULoxetine. Risk C: Monitor

Finerenone: Potassium-Sparing Diuretics may increase hyperkalemic effects of Finerenone. Risk C: Monitor

Fludrocortisone: May decrease therapeutic effects of Mineralocorticoid (Aldosterone) Receptor Antagonists. Mineralocorticoid (Aldosterone) Receptor Antagonists may decrease therapeutic effects of Fludrocortisone. Risk C: Monitor

Flunarizine: May increase therapeutic effects of Antihypertensive Agents. Risk C: Monitor

Fusidic Acid (Systemic): May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Consider avoiding this combination if possible. If required, monitor patients closely for increased adverse effects of the CYP3A4 substrate. Risk D: Consider Therapy Modification

Grapefruit Juice: May increase serum concentration of Eplerenone. Risk C: Monitor

Heparin: May increase hyperkalemic effects of Potassium-Sparing Diuretics. Risk C: Monitor

Heparins (Low Molecular Weight): May increase hyperkalemic effects of Potassium-Sparing Diuretics. Risk C: Monitor

Herbal Products with Blood Pressure Increasing Effects: May decrease antihypertensive effects of Antihypertensive Agents. Risk C: Monitor

Herbal Products with Blood Pressure Lowering Effects: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Hypotension-Associated Agents: Blood Pressure Lowering Agents may increase hypotensive effects of Hypotension-Associated Agents. Risk C: Monitor

Iloperidone: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Indoramin: May increase hypotensive effects of Antihypertensive Agents. Risk C: Monitor

Isocarboxazid: May increase hypotensive effects of Diuretics. Risk X: Avoid

Itraconazole: May increase serum concentration of Eplerenone. Risk X: Avoid

Levodopa-Foslevodopa: Blood Pressure Lowering Agents may increase hypotensive effects of Levodopa-Foslevodopa. Risk C: Monitor

Lithium: Potassium-Sparing Diuretics may decrease serum concentration of Lithium. Potassium-Sparing Diuretics may increase serum concentration of Lithium. Risk C: Monitor

Loop Diuretics: May increase hypotensive effects of Antihypertensive Agents. Risk C: Monitor

Lormetazepam: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Metergoline: May decrease antihypertensive effects of Blood Pressure Lowering Agents. Blood Pressure Lowering Agents may increase orthostatic hypotensive effects of Metergoline. Risk C: Monitor

Methylphenidate: May decrease antihypertensive effects of Antihypertensive Agents. Risk C: Monitor

Molsidomine: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Naftopidil: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Nicergoline: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Nicorandil: May increase hyperkalemic effects of Potassium-Sparing Diuretics. Risk C: Monitor

Nicorandil: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Nitroprusside: Blood Pressure Lowering Agents may increase hypotensive effects of Nitroprusside. Risk C: Monitor

Nonsteroidal Anti-Inflammatory Agents: May decrease antihypertensive effects of Eplerenone. Nonsteroidal Anti-Inflammatory Agents may increase hyperkalemic effects of Eplerenone. Risk C: Monitor

Obinutuzumab: May increase hypotensive effects of Blood Pressure Lowering Agents. Management: Consider temporarily withholding blood pressure lowering medications beginning 12 hours prior to obinutuzumab infusion and continuing until 1 hour after the end of the infusion. Risk D: Consider Therapy Modification

Opioid Agonists: May increase adverse/toxic effects of Diuretics. Opioid Agonists may decrease therapeutic effects of Diuretics. Risk C: Monitor

Pentoxifylline: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Perazine: May increase hypotensive effects of Antihypertensive Agents. Risk C: Monitor

Pholcodine: Blood Pressure Lowering Agents may increase hypotensive effects of Pholcodine. Risk C: Monitor

Phosphodiesterase 5 Inhibitors: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Piperacillin: May increase hypokalemic effects of Diuretics. Risk C: Monitor

Polyethylene Glycol-Electrolyte Solution: Diuretics may increase nephrotoxic effects of Polyethylene Glycol-Electrolyte Solution. Risk C: Monitor

Potassium Salts: Eplerenone may increase hyperkalemic effects of Potassium Salts. Management: This combination is contraindicated in patients receiving eplerenone for treatment of hypertension. Potassium supplements may be needed to treat/prevent hypokalemia in select patients with heart failure receiving eplerenone and high dose loop diuretics. Risk D: Consider Therapy Modification

Potassium-Sparing Diuretics: May increase hyperkalemic effects of Potassium-Sparing Diuretics. Risk X: Avoid

Prazosin: Antihypertensive Agents may increase hypotensive effects of Prazosin. Risk C: Monitor

Prostacyclin Analogues: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Quinagolide: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Silodosin: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Sodium Phosphates: Diuretics may increase nephrotoxic effects of Sodium Phosphates. Specifically, the risk of acute phosphate nephropathy may be enhanced. Risk C: Monitor

Tacrolimus (Systemic): Potassium-Sparing Diuretics may increase hyperkalemic effects of Tacrolimus (Systemic). Risk C: Monitor

Terazosin: Antihypertensive Agents may increase hypotensive effects of Terazosin. Risk C: Monitor

Tolvaptan: May increase hyperkalemic effects of Potassium-Sparing Diuretics. Risk C: Monitor

Trimethoprim: May increase hyperkalemic effects of Potassium-Sparing Diuretics. Risk C: Monitor

Urapidil: Antihypertensive Agents may increase hypotensive effects of Urapidil. Risk C: Monitor

Food Interactions

Grapefruit juice increases eplerenone AUC ~25%. Management: Dosage adjustments of eplerenone may be needed.

Reproductive Considerations

Eplerenone may be preferred for the treatment of primary aldosteronism (PA) in patients who are planning to become pregnant and require treatment with a mineralocorticoid receptor antagonist (Forestiero 2022; Riester 2015). Use of eplerenone may be considered for patients experiencing menstrual irregularities or erectile dysfunction with other mineralocorticoid receptor antagonists during treatment for PA or resistant hypertension (ACC/AHA [Whelton 2018]; ES [Funder 2016]; Kallistratos 2018).

Medications considered acceptable for the treatment of chronic hypertension during pregnancy may generally be continued in patients trying to conceive. The use of mineralocorticoid receptor antagonists is not recommended for the treatment of chronic hypertension in pregnant patients (ACOG 2019). Consider transitioning to an agent preferred for use during pregnancy in patients planning to become pregnant (ACC/AHA [Whelton 2018]; ACOG 2019; NICE 2019).

Patients with heart failure who are planning to become pregnant should discontinue mineralocorticoid receptor antagonists prior to conception (AHA/ACC/HFSA [Heidenreich 2022]).

Pregnancy Considerations

Eplerenone crosses the placenta (Saito 2021).

Data related to eplerenone use in pregnancy are limited (Cabassi 2012; Gehlert 2021; Gunganah 2015; Hutter 2006; Morton 2011; Morton 2017).

Chronic maternal hypertension is associated with adverse events in the fetus/infant. Chronic maternal hypertension may increase the risk of birth defects, low birth weight, premature delivery, stillbirth, and neonatal death. Actual fetal/neonatal risks may be related to the duration and severity of maternal hypertension. Untreated chronic hypertension may also increase the risks of adverse maternal outcomes, including gestational diabetes, preeclampsia, delivery complications, stroke, and myocardial infarction (ACOG 2019). Patients with preexisting hypertension may continue their medication during pregnancy unless contraindications exist (ESC [Regitz-Zagrosek 2018]). When treatment of chronic hypertension during pregnancy is indicated, the use of mineralocorticoid receptor antagonists is generally not recommended (ACOG 2019).

Data specific to the treatment of primary aldosteronism (PA) in pregnancy are limited. Patients with PA should stop eplerenone before conception if possible. If treatment is stopped and PA is not controlled, eplerenone can be restarted in the second or third trimester (ES [Funder 2016]; Forestiero 2022; Riester 2015; Sanga 2022).

Heart failure in pregnancy is associated with adverse maternal and fetal outcomes, including premature birth, infants born small for gestational age, and increased risk of maternal and fetal death (Bright 2021). When treatment of heart failure during pregnancy is needed, the use of an agent other than a mineralocorticoid receptor antagonist is recommended (AHA/ACC/HFSA [Heidenreich 2022]; ESC [Regitz-Zagrosek 2018]).

Case reports describe the use of potassium sparing diuretics such as eplerenone for the adjunctive treatment of Gitleman syndrome during pregnancy (Calò 2012; Moustakakis 2012; Shahzad 2019).

Breastfeeding Considerations

Eplerenone is present in breast milk.

Data related to the presence of eplerenone in breast milk are available from a case report. Eplerenone 50 mg once daily was initiated during pregnancy and continued postpartum. Multiple breast milk samples were obtained on postpartum days 7 and 35. The highest breast milk concentration observed was 161.2 ng/mL, obtained 4 hours after the dose on postpartum day 35. Using a milk concentration of 161.2 ng/mL, authors of the study calculated the estimated daily infant dose via breast milk to be 0.024 mg/kg/day, providing a relative infant dose of 3% based on the weight adjusted maternal dose. The infant was partially breastfed (over 50%); no adverse reactions were reported, and normal development was observed at 1 and 3 months (Saito 2021).

Dietary Considerations

Do not use salt substitutes containing potassium.

Monitoring Parameters

BP; serum potassium (prior to therapy, within the first week, 1 month after start of treatment or dose adjustment, then periodically as clinically indicated); serum potassium and serum creatinine within 3 to 7 days after initiating concurrent therapy with a moderate CYP3A inhibitor, angiotensin-converting enzyme (ACE) inhibitor, angiotensin-II receptor blocker (ARB), or nonsteroidal anti-inflammatory drug.

Heart failure: Serum potassium and kidney function should be checked in 3 days after initiation, at 1 week after initiation, at least monthly for the first 3 months of therapy, and every 3 months thereafter. If adding or increasing the dose of concomitant ACE inhibitors or ARBs, a new cycle of monitoring should be done. If serum potassium increases to >5.5 mEq/L or kidney function worsens, hold doses until potassium is <5 mEq/L and consider restarting with a reduced dose after confirming resolution of hyperkalemia/kidney insufficiency for at least 72 hours. If serum potassium cannot be maintained <5.5 mEq/L, discontinue therapy (ACC [Maddox 2021]; AHA/ACC/HFSA [Heidenreich 2022]).

Mechanism of Action

Aldosterone, a mineralocorticoid, increases blood pressure primarily by inducing sodium and water retention. Overexpression of aldosterone is thought to contribute to myocardial fibrosis (especially following myocardial infarction) and vascular fibrosis. Mineralocorticoid receptors are located in the kidney, heart, blood vessels, and brain. Eplerenone selectively blocks mineralocorticoid receptors reducing blood pressure in a dose-dependent manner and appears to prevent myocardial and vascular fibrosis.

Pharmacokinetics (Adult Data Unless Noted)

Distribution: V_d: 42 to 90 L

Protein binding: ~50%; primarily to alpha₁-acid glycoproteins

Metabolism: Primarily hepatic via CYP3A4; metabolites inactive

Bioavailability: 69%

Half-life elimination: ~3 to 6 hours

Time to peak, plasma: ~1.5 to 2 hours; may take up to 4 weeks for full antihypertensive effect

Excretion: Urine (~67%); feces (~32%); <5% as unchanged drug in urine and feces

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Altered kidney function: AUC and C_max increased 38% and 24%, respectively, in severe kidney impairment and decreased by 26% and 3%, respectively, in hemodialysis.

Hepatic function impairment: C_max and AUC increased 3.6% and 42%, respectively, in moderate hepatic impairment.

Older adult: C_max and AUC increased 22% and 45%, respectively.

Race/ethnicity: C_max and AUC decreased 19% and 25%, respectively, in black patients.

Brand Names: International

International Brand Names by Country

For country code abbreviations (show table)

(AE) United Arab Emirates: Eptus | Inspra;
(AR) Argentina: Aldactone EP | Dilacor | Eplena | Etiles;
(AT) Austria: Eplerenon accord | Eplerenon actavis | Eplerenon Generic | Eplerenon hcs | Eplerenon pharmathen | Eplerenon ratiopharm | Eplerenon stada | Eplezot | Inspra;
(AU) Australia: Apo eplerenone | Eplerenone an | Espler | Inpler | Inspra;
(BD) Bangladesh: Aldonist | Epleron | Erutic;
(BE) Belgium: Eplerenone ab | Eplerenone mylan | Inspra;
(BG) Bulgaria: Carditrust | Eplerenone accord | Eplerium | Espiro | Inspra;
(CH) Switzerland: Eplerenon mepha | Eplerenon sandoz | Eplerenon spirig hc | Inspra;
(CL) Chile: Amiocar | Inspra;
(CO) Colombia: Cardionona | Epnone | Inspra;
(CZ) Czech Republic: Apleria | Eplerenon actavis | Eplerenon sandoz | Inspra;
(DE) Germany: Epleraxiro | Epleren.rati | Eplerenhexal | Eplerenon 1a pharma | Eplerenon aaa pharma | Eplerenon accord | Eplerenon al | Eplerenon beta | Eplerenon heumann | Eplerenon mylan | Eplerenon puren | Eplerenon stada | Eplerenon teva | Eplerenon tillomed | Eplerenon vivanta | Eplerenon zentiva | Inspra;
(DO) Dominican Republic: Inspra;
(EE) Estonia: Apleria | Eplerenone accord | Inspra;
(EG) Egypt: Aldospira | Carfalone | Cholaflux | Eplorefix | Tensopleron;
(ES) Spain: Eplerenona Actavis | Eplerenona amneal | Eplerenona Apotex | Eplerenona bluefish | Eplerenona Cinfa | Eplerenona Combix | Eplerenona Kern pharma | Eplerenona krka | Eplerenona lorien | Eplerenona mabo | Eplerenona Mylan | Eplerenona Normon | Eplerenona pensa | Eplerenona Ranbaxy | Eplerenona Ratiopharm | Eplerenona Sandoz | Eplerenona Stada | Eplerenona Tarbis | Eplerenona tecnigen | Eplerenona teva | Eplerenona vir | Eplerenona Zentiva | Inspra;
(ET) Ethiopia: Eplehef;
(FI) Finland: Inspra;
(FR) France: Eplerenone accord | Eplerenone arrow | Eplerenone biogaran | Eplerenone cristers | Eplerenone Dci | Eplerenone eg | Eplerenone krka | Eplerenone mylan | Eplerenone sandoz | Eplerenone teva | Eplerenone zentiva | Eplerenone Zydus | Inspra;
(GB) United Kingdom: Inspra;
(GR) Greece: Eleveon | Eplerenone/teva | Eplerium | Evadil | Inosamin | Inspra | Licepler | Vaner;
(HK) Hong Kong: Epeflo;
(HR) Croatia: Diuron | Inspra;
(HU) Hungary: Eplerenon krka | Eplerenone mylan | Inspra | Licepler;
(IE) Ireland: Eplerenone actavis | Eplerenone bluefish | Eplerenone krka | Eplerenone mylan | Eplerenone rowex | Inspra;
(IL) Israel: Inspra;
(IN) India: Eplebless | Eplecard | Eplehef | Epleran | Eplerite | Eplezen | Eplinice | Eplitar | Epnone | Eptus | Exenta | Exinia | Ezuric | Planep;
(IT) Italy: Eplerenone accord | Eplerenone doc generici | Eplerenone krka | Eplerenone mylan | Eplerenone tecnigen | Inspra;
(JO) Jordan: Elerax | Epnone | Inspra;
(JP) Japan: Eplerenone kyorin | Selara;
(KE) Kenya: Eplone | Epnone | Inspra;
(KR) Korea, Republic of: Eprenone;
(KW) Kuwait: Inspra;
(LB) Lebanon: Eplerenone arrow | Eplerenone biogaran;
(LT) Lithuania: Apleria | Inspra;
(LU) Luxembourg: Inspra;
(LV) Latvia: Eplerenone accord | Inspra | Plecard;
(MA) Morocco: Inspra;
(MX) Mexico: Inspra | Inspra ic | Zinfarel;
(NG) Nigeria: Dosterep;
(NL) Netherlands: Eplerenon accord | Eplerenon aurobindo | Eplerenon cf | Eplerenon krka | Eplerenon mylan | Eplerenon sandoz | Eplerenon teva | Eplerenon vivanta | Inspra;
(NO) Norway: Eplerenon accord | Eplerenon krka | Inspra;
(NZ) New Zealand: Inspra;
(PH) Philippines: Inspra;
(PK) Pakistan: Cardise | Epler | Epliron;
(PL) Poland: Eleveon | Eplenocard | Eplerenon medical valley | Eplerenone medreg | Espiro | Inspra | Malidum | Nonpres;
(PR) Puerto Rico: Inspra;
(PT) Portugal: Eplerenona | Eplerenona bluepharma | Inspra;
(PY) Paraguay: Eplerone | Hidroretic;
(QA) Qatar: Inspra;
(RO) Romania: Inspra;
(RU) Russian Federation: Eplenor | Eplerenon teva | Espiro | Ipleron;
(SE) Sweden: Eplerenon accord | Eplerenon actavis | Eplerenon bluefish | Eplerenon krka | Eplerenon medical valley | Eplerenon stada | Eplerenone sandoz | Eplerenone teva | Inspra;
(SG) Singapore: Inspra;
(SI) Slovenia: Carditrust | Elreptic | Enplerasa | Eplerenon stada | Inspra;
(SK) Slovakia: Aldepla | Apleria | Eleveon | Eplerad | Eplerenon medreg | Eplerenon mylan | Eplerenon sandoz | Eplerenon stada | Eplerenone actavis | Eplerenone teva | Inspra;
(TN) Tunisia: Inspra;
(TR) Turkey: Epleday;
(TW) Taiwan: Epnone | Inspra;
(UA) Ukraine: Dekriz | Efez | Eplepres | Epletor | Espiro | Renial;
(UG) Uganda: Epnone;
(UY) Uruguay: Inspra | Suficard

2023 American Geriatrics Society Beers Criteria Update Expert Panel. American Geriatrics Society 2023 updated AGS Beers Criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2023;71(7):2052-2081. doi:10.1111/jgs.18372 [PubMed 37139824]
Agarwal R, Rossignol P, Romero A, et al. Patiromer versus placebo to enable spironolactone use in patients with resistant hypertension and chronic kidney disease (AMBER): a phase 2, randomised, double-blind, placebo-controlled trial. Lancet. 2019;394(10208):1540-1550. doi:10.1016/S0140-6736(19)32135-X [PubMed 31533906]
American College of Obstetricians and Gynecologists (ACOG). ACOG Practice Bulletin No. 203: Chronic hypertension in pregnancy. Obstet Gynecol. 2019;133(1):e26-e50. [PubMed 30575676]
Amsterdam EA, Wenger NK, Brindis RG, et al; American College of Cardiology; American Heart Association Task Force on Practice Guidelines; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons; American Association for Clinical Chemistry. 2014 AHA/ACC guideline for the management of patients with non-ST-elevation acute coronary syndromes: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines [published correction appears in J Am Coll Cardiol. 2014;64(24):2713-2714]. J Am Coll Cardiol. 2014;64(24):e139-e228. doi: 10.1016/j.jacc.2014.09.017. [PubMed 25260718]
Bazoukis G, Thomopoulos C, Tsioufis C. Effect of mineralocorticoid antagonists on blood pressure lowering: overview and meta-analysis of randomized controlled trials in hypertension. J Hypertens. 2018;36(5):987-994. doi: 10.1097/HJH.0000000000001671. [PubMed 29356711]
Bornstein SR, Allolio B, Arlt W, et al. Diagnosis and treatment of primary adrenal insufficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2016;101(2):364-389. [PubMed 26760044] 10.1210/jc.2015-1710
Borlaug BA, Colucci WS. Treatment and prognosis of heart failure with preserved ejection fraction. Connor RF, ed. UpToDate. Waltham, MA: UpToDate Inc. https://www.uptodate.com. Accessed May 5, 2025.
Bright RA, Lima FV, Avila C, Butler J, Stergiopoulos K. Maternal Heart Failure. J Am Heart Assoc. 2021;10(14):e021019. doi:10.1161/JAHA.121.021019 [PubMed 34259013]
Cabassi A, Rocco R, Berretta R, et al. Eplerenone use in primary aldosteronism during pregnancy. Hypertension. 2012;59(2):e18-e19. [PubMed 22146514]
Calò LA, Caielli P. Gitelman's syndrome and pregnancy: new potential pathophysiological influencing factors, therapeutic approach and materno-fetal outcome. J Matern Fetal Neonatal Med. 2012;25(8):1511-1513. doi:10.3109/14767058.2011.629254 [PubMed 21999963]
Craft J. Eplerenone (Inspra), a new aldosterone antagonist for the treatment of systemic hypertension and heart failure. Proc (Bayl Univ Med Cent). 2004;17(2):217-220. doi:10.1080/08998280.2004.11927973 [PubMed 16200104]
Donderski RŁ, Stróżecki P. Eplerenone add-on treatment in resistant hypertension in peritoneal dialysis patient. A case report. Medical Research Journal. 2023;8(1):81-84.
Eschalier R, McMurray JJ, Swedberg K, et al. Safety and efficacy of eplerenone in patients at high risk for hyperkalemia and/or worsening renal function: analyses of the EMPHASIS-HF study subgroups (Eplerenone in Mild Patients Hospitalization And SurvIval Study in Heart Failure). J Am Coll Cardiol. 2013;62(17):1585-1593. doi:10.1016/j.jacc.2013.04.086 [PubMed 23810881]
Expert opinion. Senior Renal Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.
Ferreira JP, Abreu P, McMurray JJV, et al. Renal function stratified dose comparisons of eplerenone versus placebo in the EMPHASIS-HF trial. Eur J Heart Fail. 2019;21(3):345-351. doi:10.1002/ejhf.1400 [PubMed 30768732]
Forestiero V, Sconfienza E, Mulatero P, Monticone S. Primary aldosteronism in pregnancy. Rev Endocr Metab Disord. Published online May 10, 2022. doi:10.1007/s11154-022-09729-6 [PubMed 35536535]
Funder JW, Carey RM, Mantero F, et al. The management of primary aldosteronism: case detection, diagnosis, and treatment: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2016;101(5):1889-1916. doi: 10.1210/jc.2015-4061. [PubMed 26934393]
Gehlert J, Morton A. Eplerenone as a treatment for resistant hypertension in pregnancy. Obstet Med. 2021;14(1):35-38. doi:10.1177/1753495X19825967 [PubMed 33995571]
Go AS, Bauman M, King SM, et al. An effective approach to high blood pressure control: a science advisory from the American Heart Association, the American College of Cardiology, and the Centers for Disease Control and Prevention [published online November 15, 2013]. Hypertension. [PubMed 24243703]
Gunganah K, Carpenter R, Drake WM. Eplerenone use in primary aldosteronism during pregnancy. Clin Case Rep. 2015;4(1):81-82. doi: 10.1002/ccr3.355. [PubMed 26783442]
Heidenreich PA, Bozkurt B, Aguilar D, et al. 2022 AHA/ACC/HFSA guideline for the management of heart failure: a report of the American College of Cardiology/American Heart Association Joint Committee on clinical practice guidelines. Circulation. 2022;145(18):e895-e1032. doi:10.1161/CIR.0000000000001063 [PubMed 35363499]
Hutter DA, Berkowitz R, Davis SE 3rd, Ashtyani H. Application of continuous positive airway pressure in hypoxemic acute respiratory failure associated with diastolic dysfunction in pregnancy. Congest Heart Fail. 2006;12(3):174-175. [PubMed 16760705]
Inspra (eplerenone) [prescribing information]. Morgantown, WV: Viatris Specialty LLC; July 2023.
Inspra (eplerenone) [prescribing information]. New York, NY: Pfizer Inc; October 2021.
Inspra (eplerenone) [product monograph]. Etobicoke, Ontario, Canada: Upjohn Canada ULC; July 2023.
James PA, Oparil S, Carter BL, et al. 2014 Evidence-Based Guideline for the Management of High Blood Pressure in Adults: Report From the Panel Members Appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014;311(5):507-520. [PubMed 24352797]
Kallistratos MS, Pittaras A, Theodoulidis I, Grassos C, Poulimenos LE, Manolis AJ. Adverse effects of mineralocorticoid receptor antagonist administration. Curr Pharm Des. 2018;24(46):5537-5541. doi:10.2174/1381612825666190222144359 [PubMed 30799782]
Lindenfeld J, Albert NM, Boehmer JP, et al. HFSA 2010 Comprehensive Heart Failure Practice Guideline. J Card Fail. 2010;16(6):e1-e194. [PubMed 20610207]
Maddox TM, Januzzi JL Jr, Allen LA, et al. 2021 update to the 2017 ACC expert consensus decision pathway for optimization of heart failure treatment: answers to 10 pivotal issues about heart failure with reduced ejection fraction: a report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. 2021;77(6):772-810. doi:10.1016/j.jacc.2020.11.022 [PubMed 33446410]
Mann JFE, Flack JM. Hypertension in adults: Initial drug therapy. Connor RF, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed March 7, 2023.
Morton A, Laurie J. Eplerenone in the management of resistant hypertension with obstructive sleep apnoea in pregnancy. Pregnancy Hypertens. 2017;7:54-55. [PubMed 28279449]
Morton A, Panitz B, Bush A. Eplerenone for Gitelman Syndrome in Pregnancy. Nephrology (Carlton). 2011;16(3):349. [PubMed 21342329]
Moustakakis MN, Bockorny M. Gitelman syndrome and pregnancy. Clin Kidney J. 2012;5(6):552-555. doi:10.1093/ckj/sfs126 [PubMed 26064481]
Mulatero P, Rabbia F, Milan A, et al. Drug effects on aldosterone/plasma renin activity ratio in primary aldosteronism. Hypertension. 2002;40(6):897-902. doi: 10.1161/01.hyp.0000038478.59760.41 [PubMed 12468576]
National Institute for Health and Care Excellence (NICE). Hypertension in pregnancy: diagnosis and management. www.nice.org.uk/guidance/ng133. Published June 25, 2019. Accessed December 1, 2022.
Nishimura RA, Otto CM, Bonow RO, et al, 2014 AHA/ACC guideline for the management of patients with valvular heart disease: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014;129(23):2440-92. doi: 10.1161/CIR.0000000000000029. [PubMed 24589852]
O'Gara PT, Kushner FG, Ascheim DD, et al. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines [published correction appears in Circulation. 2013;128(25):e481]. Circulation. 2013;127(4):e362-e425. [PubMed 23247304]
Parthasarathy HK, Ménard J, White WB, et al. A double-blind, randomized study comparing the antihypertensive effect of eplerenone and spironolactone in patients with hypertension and evidence of primary aldosteronism. J Hypertens. 2011;29(5):980-990. doi: 10.1097/HJH.0b013e3283455ca5 [PubMed 21451421]
Pisoni R, Acelajado MC, Cartmill FR, et al. Long-term effects of aldosterone blockade in resistant hypertension associated with chronic kidney disease. J Hum Hypertens. 2012;26(8):502-506. doi:10.1038/jhh.2011.60 [PubMed 21677673]
Pitt B, Bakris G, Ruilope LM, DiCarlo L, Mukherjee R; EPHESUS Investigators. Serum potassium and clinical outcomes in the Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study (EPHESUS). Circulation. 2008 Oct 14;118(16):1643-50. doi:10.1161/CIRCULATIONAHA.108.778811 [PubMed 18824643]
Pitt B, Remme W, Zannad F, et al. Eplerenone, a selective aldosterone blocker, in patients with left ventricular dysfunction after myocardial infarction. N Engl J Med. 2003;348(14):1309-1321. [PubMed 12668699]
Pitt B, Zannad F, Remme WJ, et al. The effect of spironolactone on morbidity and mortality in patients with severe heart failure. Randomized Aldactone Evaluation Study Investigators. N Engl J Med. 1999;341(10):709-717. [PubMed 10471456]
Ravis WR, Reid S, Sica DA, Tolbert DS. Pharmacokinetics of eplerenone after single and multiple dosing in subjects with and without renal impairment. J Clin Pharmacol. 2005;45(7):810-821. doi:10.1177/0091270005275894 [PubMed 15951471]
Refer to manufacturer’s labeling.
Regitz-Zagrosek V, Roos-Hesselink JW, Bauersachs J, et al. 2018 ESC guidelines for the management of cardiovascular diseases during pregnancy. Eur Heart J. 2018;39(34):3165-3241. [PubMed 30165544]
Riester A, Reincke M. Progress in primary aldosteronism: mineralocorticoid receptor antagonists and management of primary aldosteronism in pregnancy. Eur J Endocrinol. 2015;172(1):R23-R30. doi:10.1530/EJE-14-0444 [PubMed 25163723]
Saito J, Mito A, Yakuwa N, et al. Eplerenone levels in maternal serum, cord blood, and breast milk during pregnancy and lactation. Hypertens Res. 2021;44(7):879-881. doi:10.1038/s41440-021-00621-5 [PubMed 33564177]
Sanga V, Rossitto G, Seccia TM, Rossi GP. Management and outcomes of primary aldosteronism in pregnancy: a systematic review. Hypertension. 2022:101161HYPERTENSIONAHA12118858. doi:10.1161/HYPERTENSIONAHA.121.18858 [PubMed 35686552]
Shahzad MA, Mukhtar M, Ahmed A, Ullah W, Saeed R, Hamid M. Gitelman syndrome: a rare cause of seizure disorder and a systematic review. Case Rep Med. 2019;2019:4204907. doi:10.1155/2019/4204907 [PubMed 30867665]
Sica DA, Flack JM. Treatment considerations with aldosterone receptor antagonists. J Clin Hypertens (Greenwich). 2011;13(1):65-69. doi:10.1111/j.1751-7176.2010.00377.x [PubMed 21214724]
Smith SC Jr, Benjamin EJ, Bonow RO, et al. AHA/ACCF Secondary Prevention and Risk Reduction Therapy for Patients With Coronary and Other Atherosclerotic Vascular Disease: 2011 Update: A Guideline From the American Heart Association and American College of Cardiology Foundation. Circulation. 2011;124(22):2458-2473. [PubMed 22052934]
Vemulapalli S, Tyson CC, Svetkey LP. Apparent treatment-resistant hypertension and chronic kidney disease: another cardiovascular-renal syndrome? Adv Chronic Kidney Dis. 2014;21(6):489-499. doi:10.1053/j.ackd.2014.08.006 [PubMed 25443574]
Walsh M, Manns B, Garg AX, et al. The safety of eplerenone in hemodialysis patients: a noninferiority randomized controlled trial. Clin J Am Soc Nephrol. 2015;10(9):1602-1608. doi:10.2215/CJN.12371214 [PubMed 26138259]
Weber MA, Schiffrin EL, White WB, et al. Clinical practice guidelines for the management of hypertension in the community: a statement by the American Society of Hypertension and the International Society of Hypertension. J Clin Hypertens (Greenwich). 2014;16(1):14-26. doi: 10.1111/jch.12237. [PubMed 24341872]
Whelton PK, Carey RM, Aronow WS, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines [published correction appears in Hypertension. 2018;71(6):e140-e144]. Hypertension. 2018;71(6):e13-e115. doi: 10.1161/HYP.0000000000000065 [PubMed 29133356]
Yancy CW, Jessup M, Bozkurt B, et al; American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. 2013;128(16):e240-e327. [PubMed 23741058]
Zannad F, McMurray JJ, Krum H, et al; EMPHASIS-HF Study Group. Eplerenone in patients with systolic heart failure and mild symptoms. N Engl J Med. 2011;364(1):11-21. doi: 10.1056/NEJMoa1009492. [PubMed 21073363]

Topic 8789 Version 457.0

خرید پکیج

Eplerenone: Drug information