Eplerenone

Eplerenone
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Gerald Chi

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Overview

Eplerenone is a aldosterone antagonist that is FDA approved for the {{{indicationType}}} of hypertension and congestive heart failure after myocardial infarction. Common adverse reactions include hyperkalemia, diarrhea, dizziness, elevated serum creatinine, cough, and fatigue.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Congestive Heart Failure Post-Myocardial Infarction

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.

• Dosing Information

• Treatment 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 the table below.

This image is provided by the National Library of Medicine.

Hypertension

• Dosing Information

• The recommended starting dose of eplerenone tablets are 50 mg 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.

Dose Modifications for Specific Populations

• 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.

• For 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.

• No adjustment of the starting dose is recommended for the elderly or for patients with mild-to-moderate hepatic impairment.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Heart Failure, Myocardial infarction with Complication

• Developed by: American College of Cardiology (ACC) and American Heart Association (AHA)

• Class of Recommendation: Class IIa

• Strength of Evidence: Category A

• Dosing Information

• 25 mg daily initially, titrated to a maximum of 50 mg/day

Non–Guideline-Supported Use

Albuminuria in Diabetes Mellitus

• Dosing Information

• 50 mg once daily

Low-Renin Essential Hypertension

• Dosing Information

• 100 mg once daily

Systolic Heart Failure (Mild)

• Dosing Information

• 25 mg once daily

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

• Eplerenone tablets has not been studied in hypertensive patients less than 4 years old because the study in older pediatric patients did not demonstrate effectiveness.

• Eplerenone has not been studied in pediatric patients with heart failure.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Eplerenone in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Eplerenone in pediatric patients.

Contraindications

For All Patients

• Serum potassium >5.5 mEq/L at initiation
• Creatinine clearance ≤30 mL/min
• Concomitant administration of strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, and nelfinavir)

For Patients Treated for Hypertension

• Type 2 diabetes with microalbuminuria
• Serum creatinine >2.0 mg/dL in males or >1.8 mg/dL in females
• Creatinine clearance <50 mL/min
• Concomitant administration of potassium supplements or potassium-sparing diuretics (e.g., amiloride, spironolactone, or triamterene)

Warnings

Hyperkalemia

• Minimize the risk of hyperkalemia with proper patient selection and monitoring, and avoidance of certain concomitant medications. Monitor patients for the development of hyperkalemia until the effect of eplerenone tablets are established. Patients who develop hyperkalemia (>5.5 mEq/L) may continue eplerenone tablets therapy with proper dose adjustment. Dose reduction decreases potassium levels.

• The rates of hyperkalemia increase with declining renal function. Patients with hypertension who have serum creatinine levels >2.0 mg/dL (males) or >1.8 mg/dL (females) or creatinine clearance ≤50 mL/min should not be treated with eplerenone tablets. Patients with CHF post-MI who have serum creatinine levels >2.0 mg/dL (males) or >1.8 mg/dL (females) or creatinine clearance ≤50 mL/min should be treated with eplerenone tablets with caution.

• Diabetic patients with CHF post-MI should also be treated with caution, especially those with proteinuria. The subset of patients in the EPHESUS study with both diabetes and proteinuria on the baseline urinalysis had increased rates of hyperkalemia compared to patients with either diabetes or proteinuria.

• The risk of hyperkalemia may increase when eplerenone is used in combination with an angiotensin converting enzyme (ACE) inhibitor and/or an angiotensin receptor blocker (ARB).

Impaired Hepatic Function

• Mild-to-moderate hepatic impairment did not increase the incidence of hyperkalemia. In 16 subjects with mild-to-moderate hepatic impairment who received 400 mg of eplerenone, no elevations of serum potassium above 5.5 mEq/L were observed. The mean increase in serum potassium was 0.12 mEq/L in patients with hepatic impairment and 0.13 mEq/L in normal controls. The use of eplerenone tablets in patients with severe hepatic impairment has not been evaluated.

Impaired Renal Function

• Patients with decreased renal function are at increased risk of hyperkalemia.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Eplerenone in the drug label.

Central Nervous System

Cardiovascular

Respiratory

Gastrointestinal

Hypersensitivity

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Eplerenone in the drug label.

Central Nervous System

Cardiovascular

Respiratory

Gastrointestinal

Hypersensitivity

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Eplerenone in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Eplerenone during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Eplerenone with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Eplerenone with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Eplerenone with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Eplerenone with respect to specific gender populations.

Race

There is no FDA guidance on the use of Eplerenone with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Eplerenone in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Eplerenone in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Eplerenone in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Eplerenone in patients who are immunocompromised.

Administration and Monitoring

Administration

Oral

Intravenous

Monitoring

There is limited information regarding Monitoring of Eplerenone in the drug label.

Condition1

Description

IV Compatibility

There is limited information regarding IV Compatibility of Eplerenone in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

Description

Management

Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Eplerenone in the drug label.

Pharmacology

There is limited information regarding Eplerenone Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Eplerenone Mechanism of Action in the drug label.

Structure

There is limited information regarding Structure of Eplerenone in the drug label.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Eplerenone in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Eplerenone in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Eplerenone in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Eplerenone in the drug label.

Condition1

Description

How Supplied

There is limited information regarding Eplerenone How Supplied in the drug label.

Storage

There is limited information regarding Eplerenone Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Eplerenone in the drug label.

Precautions with Alcohol

Alcohol-Eplerenone interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Inspra®

Look-Alike Drug Names

• Inspra® — Spiriva®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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