ERONE® (Eplerenone)

ERONE® (Eplerenone) is a potassium-sparing diuretic and a selective mineralocorticoid (aldosterone) receptor antagonist. It is indicated, alongside standard therapy (including beta-blockers), to reduce the risk of cardiovascular mortality and morbidity in stable patients with left ventricular dysfunction and clinical signs of heart failure following a recent heart attack (myocardial infarction). It is taken orally in 25 mg or 50 mg tablets, once daily.

Disclaimer

The information in this article is intended for educational purposes and is not meant to be health medicines advice. ERONE® is a drug that can only be obtained with a prescription. Discuss any treatment plans, changes or discontinuations with a trusted health care provider.

Formula

• ERONE® 25 mg: Each film-coated tablet contains Eplerenone 25 mg + excipients q.s.
• ERONE® 50 mg: Each film-coated tablet contains Eplerenone 50 mg + excipients q.s.

Therapeutic Indication

ERONE® is indicated for the treatment of heart failure, added to standard therapy including beta-blockers, to:

• Reduce the risk of cardiovascular mortality
• Lower cardiovascular morbidity
• Treat stable patients with left ventricular dysfunction
• Help patients with clinical signs of heart failure after a recent heart attack

Dosage

Adults:

• Start with 25 mg once daily.
• Increase to the optimal dose of 50 mg once daily, preferably within 4 weeks.
• Always take serum potassium levels into account.

Elderly patients, mild to moderate liver impairment, or kidney impairment:

• No dose adjustment is required.
• Frequent and regular monitoring of serum potassium is recommended.

Important notes:

• Can be taken with or without food.
• Treatment should begin between 3 and 14 days after an acute heart attack.

When to Avoid ERONE® (Contraindications)

ERONE® should not be used in patients with:

• Hypersensitivity to eplerenone or any of its components.
• Concurrent use of potassium-sparing diuretics.
• Potassium supplements.
• Strong CYP3A4 inhibitors, including:
  • Ketoconazole, itraconazole, fluconazole.
  • Clarithromycin, erythromycin.
  • Amiodarone.
  • Grapefruit juice.
• Moderate to severe kidney impairment.
• Severe liver impairment.

Common Side Effects

The most frequently reported adverse reactions include:

• Hyperkalemia (high potassium levels)
• Dizziness
• Hypotension (low blood pressure)
• Diarrhea
• Nausea
• Kidney impairment
• Gynecomastia (breast enlargement in men)
• Mastodynia (breast pain or tenderness)

Precautions and Warnings

• Serum potassium monitoring: Recommended at the start of treatment and with any dose change. Periodic monitoring is also advised, especially in patients at higher risk of hyperkalemia (elderly, kidney impairment, diabetes).
• Potassium supplements: Not recommended after starting therapy with eplerenone, due to increased risk of hyperkalemia.
• Mild kidney impairment: Use with caution.
• Mild to moderate liver impairment: Use with caution.
• Pregnancy: No adequate data is available on use in pregnant women.
• Breastfeeding: It is unknown whether eplerenone is excreted in breast milk after oral administration.

Drug Interactions

Avoid or use with caution alongside:

• Lithium salts – avoid concurrent use.
• Cyclosporine and tacrolimus – may cause kidney impairment and increase the risk of hyperkalemia.
• NSAIDs (non-steroidal anti-inflammatory drugs) – may cause acute kidney failure, especially in high-risk patients.
• Trimethoprim – increases the risk of hyperkalemia.
• Digoxin and warfarin – caution required when dosed near the upper limit of the therapeutic range.

Overdose (Signs, Symptoms, and Management)

Symptoms of overdose may include:

• Fainting and dizziness
• Blurred vision
• Stomach discomfort
• Tingling sensation in arms and legs
• Loss of muscle tone
• Weakness or heaviness in the legs
• Confusion and lack of energy
• Cold, grayish skin
• Irregular or slower than normal heart rate

In case of overdose, seek emergency medical help immediately.

Presentation

• ERONE® 25 mg: Box of 30 film-coated tablets / Box of 2 film-coated tablets (Medical sample).
• ERONE® 50 mg: Box of 30 film-coated tablets.

Storage

• Store below 30 °C (86 °F) in a cool, dry place.
• Keep out of reach of children.
• Available by medical prescription only.