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EPNONE 50MG TABS 30S

Product code: 1130456

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EPNONE contains eplerenone, a selective aldosterone receptor antagonist used to manage hypertension and heart failure following a heart attack. It helps reduce fluid retention and cardiovascular strain with a lower risk of hormonal side effects than older aldosterone blockers.

Ksh 187

3. What Is EPNONE and What Is It Used For?

Epnone 50mg contains Eplerenone, a selective aldosterone receptor antagonist (also called a selective mineralocorticoid receptor antagonist, MRA). By blocking aldosterone receptors in the kidney and heart, Eplerenone reduces sodium and water retention, decreases blood pressure, and prevents aldosterone-mediated cardiac fibrosis and remodelling.

Unlike Spironolactone (a non-selective MRA), Eplerenone is selective for mineralocorticoid receptors, significantly reducing the hormonal side effects (gynaecomastia, sexual dysfunction) seen with Spironolactone.

In Kenya, Epnone 50mg is prescribed for patients with heart failure following acute myocardial infarction (heart attack), hypertension resistant to standard therapy, and heart failure with reduced ejection fraction (HFrEF) as part of guideline-directed medical therapy. It is evidence-based, having demonstrated mortality reduction in the EPHESUS and EMPHASIS-HF landmark trials.

 

4. How to Take This Medicine

Starting Dose

25mg once daily. May be titrated up to 50mg once daily after 4 weeks if tolerated and potassium levels are acceptable.

With or Without Food

May be taken with or without food. Take at the same time each day.

Potassium Monitoring

Serum potassium must be checked before starting, at 1 week, at 1 month, and then every 3 months. Dose adjustment or discontinuation based on potassium levels.

Missed Dose

Take as soon as remembered. If nearly time for the next dose, skip it. Never double dose.

Renal Monitoring

eGFR must be assessed before and during therapy; contraindicated if eGFR < 30 ml/min.

 

5. Side Effects

Common Side Effects

·       Hyperkalaemia (elevated potassium, most important side effect; monitor closely)

·       Dizziness

·       Mild nausea or diarrhoea

·       Headache

Uncommon Side Effects

·       Hypotension (especially when added to ACE inhibitors or ARBs)

·       Elevated creatinine (renal)

·       Hyponatraemia (low sodium)

·       Cough (uncommon, unlike ACE inhibitors)

Serious Side Effects, Seek Immediate Medical Attention

·       Severe hyperkalaemia (life-threatening cardiac arrhythmia, requires urgent treatment)

·       Acute kidney injury in dehydrated patients or those with renal impairment

 

6. Contraindications

 

The following patients should NOT use this medication:

• Serum potassium > 5.0 mmol/L at initiation

• Severe renal impairment (eGFR < 30 ml/min)

• Severe hepatic impairment

• Concurrent use of potassium-sparing diuretics (amiloride, triamterene) or potassium supplements

• Concurrent use of strong CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir), contraindicated

• Hypersensitivity to eplerenone

• Type 2 Diabetes with microalbuminuria (for hypertension indication, per SmPC)

 

 

 

7. Safety Warnings and Special Precautions

·       HYPERKALAEMIA: The most critical risk. Potassium must be monitored rigorously, weekly for the first month, then monthly for 3 months, then quarterly.

·       AVOID POTASSIUM SUPPLEMENTS: Do not take potassium supplements or use potassium-containing salt substitutes while on Epnone without medical guidance.

·       RENAL FUNCTION: Regularly monitor eGFR. Eplerenone reduces efficacy, and potassium risk increases with declining kidney function.

·       ACE INHIBITOR / ARB COMBINATION: Combination with RAAS blockers increases hyperkalaemia risk; monitor closely.

·       NSAID INTERACTION: NSAIDs reduce efficacy and increase renal and potassium risk; avoid concurrent use.

·       DIABETES: Patients with diabetes are at higher risk of hyperkalaemia, monitor more frequently.

 

8. Drug Interactions

Strong CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir, nelfinavir): CONTRAINDICATED, markedly increase eplerenone levels.

Moderate CYP3A4 inhibitors (erythromycin, fluconazole, verapamil, diltiazem): Increase eplerenone exposure; use with caution; maximum 25mg daily.

ACE inhibitors / ARBs: Additive hyperkalemia risk, monitor potassium closely.

Potassium supplements / Potassium-sparing diuretics: Contraindicated, severe hyperkalemia.

NSAIDs: Reduced antihypertensive efficacy and increased renal risk.

Lithium: Eplerenone may increase lithium levels; monitor.

Digoxin: Eplerenone may modestly increase digoxin levels.

 

9. Storage Instructions

·       Store below 25°C in a cool, dry place.

·       Protect from moisture and light.

·       Keep in original blister packaging.

·       Keep out of reach of children.

 

10. Prescription Status in Kenya

Epnone is a prescription-only medicine (POM) in Kenya, prescribed by cardiologists, internists, or physicians managing heart failure and hypertension. Available at Pharmily with a valid prescription.

 

11. Patient Guidance

 

💊 Key Points for Patients:

Take Epnone at the same time every day, with or without food.

Do not take potassium supplements or use salt substitutes containing potassium without asking your doctor.

Attend all blood test appointments; your potassium and kidney function must be checked regularly.

Report muscle weakness, irregular heartbeat, or significant dizziness to your doctor immediately; these may be signs of high potassium.

Do not take ibuprofen or other anti-inflammatory pain killers while on Epnone without medical advice.

Do not stop taking Epnone without consulting your cardiologist or doctor; it is protecting your heart.

 

 

 

12. Pharmacist / Prescriber Notes

Epnone (Eplerenone) is a selective MRA with a cleaner side-effect profile than spironolactone, particularly regarding sex hormone-related adverse effects (no gynaecomastia at therapeutic doses). It is guideline-recommended in HFrEF (LVEF ≤ 35%) and post-MI heart failure; confirm the clinical indication and prescriber credentials before dispensing.

Hyperkalaemia is the dominant pharmacovigilance concern; establish baseline potassium and eGFR; set up a monitoring schedule at dispensing (Week 1, Month 1, then quarterly).

The strong CYP3A4 inhibitor contraindication is absolute; check for azole antifungals, ritonavir, or other strong inhibitors in the medication history. Moderate CYP3A4 inhibitors (fluconazole, erythromycin, verapamil) require dose capping at 25mg daily.

The 25mg starting dose is typically titrated to 50mg at 4 weeks; anticipate and counsel the patient on this planned titration.

 

13. Frequently Asked Questions (FAQs)

What is Epnone used for?

A: Epnone (Eplerenone) is used to reduce the risk of death and hospitalisation in patients with heart failure, especially following a heart attack. It is also used for resistant hypertension.

How is Eplerenone different from Spironolactone?

A: Both block aldosterone receptors, but Eplerenone is more selective. This means it does not cause the hormonal side effects of spironolactone such as gynaecomastia (breast enlargement in men) or sexual dysfunction.

Why do I need regular blood tests on Epnone?

A: Eplerenone raises potassium levels, which can become dangerously high without regular monitoring. Blood tests check your potassium and kidney function to ensure the dose is safe.

What are the signs of high potassium (hyperkalaemia)?

A: Muscle weakness, fatigue, irregular or slow heartbeat, numbness or tingling. Severe hyperkalaemia can cause cardiac arrest, seek emergency care immediately if these occur.


 

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