Eplon
Generic Name
Eplerenone
Manufacturer
Beximco Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| eplon 10 mg capsule | ৳ 10.00 | ৳ 100.00 |
Description
Overview of the medicine
Eplerenone is a selective aldosterone antagonist used in the treatment of hypertension and heart failure (post-myocardial infarction with left ventricular systolic dysfunction, or heart failure with reduced ejection fraction). It helps to reduce blood pressure and improve cardiovascular outcomes.
Uses & Indications
Dosage
Adults
Hypertension: Initial dose of 10 mg once daily may be used for titration. Typical starting dose is 50 mg once daily, adjusted up to a maximum of 100 mg daily. Heart failure: Initial dose of 10 mg once daily may be used for titration. Typical starting dose is 25 mg once daily, titrated to 50 mg once daily within 4 weeks.
Elderly
No specific dose adjustment is generally required, but close monitoring of renal function and serum potassium is recommended due to potential age-related decline in renal function.
Renal_impairment
Contraindicated in severe renal impairment (CrCl <30 mL/min). Use with caution in moderate impairment (CrCl 30-50 mL/min) with frequent monitoring of serum potassium. Not recommended for initiation if serum potassium is >5.0 mEq/L.
How to Take
Eplon 10 mg capsule can be taken orally, with or without food. It should be taken once daily.
Mechanism of Action
Eplerenone selectively binds to the mineralocorticoid receptor, blocking the action of aldosterone. This prevents aldosterone-induced sodium and water reabsorption and potassium excretion, leading to diuresis, natriuresis, and a reduction in blood pressure and cardiac remodeling.
Pharmacokinetics
Onset
Blood pressure reduction typically starts within 2 weeks, with full effect seen in about 4 weeks. Cardioprotective effects in heart failure are longer term.
Excretion
Approximately 67% excreted in urine (primarily as metabolites) and 33% in feces (as metabolites and unchanged drug).
Half life
Approximately 4-6 hours.
Absorption
Well absorbed from the gastrointestinal tract, with absolute bioavailability of approximately 69%. Peak plasma concentrations are reached within 1.5-2 hours.
Metabolism
Primarily metabolized by CYP3A4 in the liver. No active metabolites.
Side Effects
Contraindications
- Hypersensitivity to eplerenone or any excipients
- Serum potassium >5.0 mEq/L at initiation
- Severe renal impairment (CrCl <30 mL/min)
- Severe hepatic impairment
- Concomitant use with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin)
- Concomitant use with other potassium-sparing diuretics or potassium supplements.
Drug Interactions
Lithium
Eplerenone may reduce renal clearance of lithium, increasing lithium toxicity. Monitor lithium levels.
NSAIDs (Nonsteroidal Anti-inflammatory Drugs)
May reduce the natriuretic and antihypertensive effects of eplerenone and increase the risk of hyperkalemia and renal dysfunction in susceptible patients.
ACE inhibitors and Angiotensin II Receptor Blockers (ARBs)
Increased risk of hyperkalemia. Monitor serum potassium closely.
Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin)
Significant increase in eplerenone exposure, leading to increased risk of hyperkalemia. Concomitant use is contraindicated.
Potassium-sparing diuretics (e.g., spironolactone, amiloride, triamterene) or Potassium supplements
Increased risk of severe hyperkalemia. Concomitant use is contraindicated.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
The most likely manifestation of overdose is hyperkalemia, which may present as nausea, vomiting, diarrhea, dehydration, and hypotension. Treatment involves inducing emesis or gastric lavage, followed by supportive care. If hyperkalemia occurs, discontinue Eplon and initiate potassium-lowering measures (e.g., intravenous calcium, insulin with glucose, sodium polystyrene sulfonate).
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have not shown a risk, but there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed and the potential benefit justifies the potential risk to the fetus. It is unknown whether eplerenone is excreted in human milk; caution should be exercised when administered to a nursing woman.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from manufacturing date
Availability
Pharmacies, hospitals
Approval Status
Approved
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Key clinical trials include the EPHESUS (Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study) trial, which demonstrated improved survival in patients with heart failure following acute myocardial infarction. Other trials have supported its efficacy in hypertension and heart failure with reduced ejection fraction.
Lab Monitoring
- Serum potassium levels (before initiation, within 1 week of initiation or dose change, and periodically thereafter)
- Renal function (serum creatinine, BUN) (before initiation, within 1 week of initiation or dose change, and periodically thereafter)
- Blood pressure
Doctor Notes
- Emphasize the importance of strict adherence to prescribed dosage and avoiding self-medication with potassium supplements.
- Educate patients on symptoms of hyperkalemia and when to seek immediate medical attention.
- Periodically assess renal function and serum potassium, especially when initiating or titrating dose, and in patients with co-morbidities like diabetes or renal insufficiency.
Patient Guidelines
- Take Eplon exactly as prescribed by your doctor.
- Do not stop taking this medicine abruptly without consulting your doctor.
- Report any symptoms of high potassium (e.g., muscle weakness, fatigue, irregular heartbeat) to your doctor immediately.
- Avoid potassium supplements or potassium-rich salt substitutes unless advised by your doctor.
Missed Dose Advice
If a dose is missed, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Eplon may cause dizziness, especially during the initial phase of treatment or when the dose is increased. Patients should be cautioned about driving or operating machinery until they know how Eplon affects them.
Lifestyle Advice
- Maintain a healthy and balanced diet, avoiding excessive potassium intake.
- Engage in regular physical activity as advised by your healthcare provider.
- Limit sodium intake to help manage blood pressure.
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