Eplon
Generic Name
Eplerenone
Manufacturer
Hypothetical Pharma Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
eplon 5 mg capsule | ৳ 6.00 | ৳ 60.00 |
Description
Overview of the medicine
Eplerenone is a selective aldosterone receptor antagonist used to treat high blood pressure and heart failure post-myocardial infarction. This 5 mg capsule formulation provides a lower strength option for specific dosing requirements.
Uses & Indications
Dosage
Adults
For heart failure, typically start with 25 mg once daily, increasing to 50 mg once daily if tolerated. For hypertension, usually 50 mg once daily. For 5mg capsule, multiple capsules will be required to reach the target dose as directed by the physician.
Elderly
Similar to adults, with careful monitoring of renal function and serum potassium levels.
Renal_impairment
Initial dose of 25 mg every other day may be considered if creatinine clearance is 30-50 mL/min. Contraindicated in severe renal impairment (CrCl <30 mL/min).
How to Take
Administer orally, with or without food. Swallow the capsule whole with water.
Mechanism of Action
It selectively binds to the mineralocorticoid receptor, blocking the action of aldosterone, leading to increased sodium and water excretion and potassium retention.
Pharmacokinetics
Onset
Varies, blood pressure reduction usually within 2 weeks for hypertension; clinical benefits in heart failure seen over time.
Excretion
Primarily through urine (67%) and feces (33%), mainly as metabolites.
Half life
Approximately 4-6 hours.
Absorption
Well absorbed, bioavailability ~69%, not significantly affected by food.
Metabolism
Primarily metabolized by CYP3A4, forming inactive metabolites.
Side Effects
Contraindications
- Hypersensitivity to Eplerenone or any component of the formulation.
- Hyperkalemia (serum potassium >5.5 mEq/L) at initiation.
- Severe renal impairment (creatinine clearance <30 mL/min).
- Moderate to severe hepatic impairment.
- Co-administration with potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, nelfinavir).
- Concomitant use with other potassium-sparing diuretics or potassium supplements.
Drug Interactions
Lithium
Eplerenone may reduce renal clearance of lithium, leading to increased lithium levels and potential toxicity.
Cyclosporine, Tacrolimus
Increased risk of hyperkalemia and renal dysfunction.
NSAIDs (Nonsteroidal Anti-Inflammatory Drugs)
May reduce the natriuretic and diuretic effects of eplerenone and increase the risk of hyperkalemia in susceptible patients.
ACE inhibitors and Angiotensin Receptor Blockers (ARBs)
Increased risk of hyperkalemia, especially in patients with renal impairment. Monitor serum potassium closely.
Potent CYP3A4 inhibitors (e.g., ketoconazole, ritonavir)
Significantly increase eplerenone exposure and risk of 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
Manifestations of overdose are expected to be hyperkalemia, hypotension, or dehydration. Management is symptomatic and supportive; includes gastric lavage, activated charcoal, and monitoring of electrolytes (especially potassium) and vital signs. Hemodialysis is not effective in removing eplerenone.
Pregnancy & Lactation
Limited data on use during pregnancy. Use only if potential benefit justifies potential risk to the fetus, and after consulting a physician. Eplerenone is excreted in rat milk; human data is unknown, so caution is advised during breastfeeding.
Side Effects
Contraindications
- Hypersensitivity to Eplerenone or any component of the formulation.
- Hyperkalemia (serum potassium >5.5 mEq/L) at initiation.
- Severe renal impairment (creatinine clearance <30 mL/min).
- Moderate to severe hepatic impairment.
- Co-administration with potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, nelfinavir).
- Concomitant use with other potassium-sparing diuretics or potassium supplements.
Drug Interactions
Lithium
Eplerenone may reduce renal clearance of lithium, leading to increased lithium levels and potential toxicity.
Cyclosporine, Tacrolimus
Increased risk of hyperkalemia and renal dysfunction.
NSAIDs (Nonsteroidal Anti-Inflammatory Drugs)
May reduce the natriuretic and diuretic effects of eplerenone and increase the risk of hyperkalemia in susceptible patients.
ACE inhibitors and Angiotensin Receptor Blockers (ARBs)
Increased risk of hyperkalemia, especially in patients with renal impairment. Monitor serum potassium closely.
Potent CYP3A4 inhibitors (e.g., ketoconazole, ritonavir)
Significantly increase eplerenone exposure and risk of 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
Manifestations of overdose are expected to be hyperkalemia, hypotension, or dehydration. Management is symptomatic and supportive; includes gastric lavage, activated charcoal, and monitoring of electrolytes (especially potassium) and vital signs. Hemodialysis is not effective in removing eplerenone.
Pregnancy & Lactation
Limited data on use during pregnancy. Use only if potential benefit justifies potential risk to the fetus, and after consulting a physician. Eplerenone is excreted in rat milk; human data is unknown, so caution is advised during breastfeeding.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from the date of manufacture.
Availability
Pharmacies
Approval Status
Approved by regulatory authorities (e.g., FDA, DGDA)
Patent Status
Generic available
Clinical Trials
Eplerenone has been extensively studied in clinical trials, notably the EPHESUS (Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study) trial, which demonstrated significant reductions in morbidity and mortality in patients with heart failure post-myocardial infarction.
Lab Monitoring
- Serum potassium levels (before initiation, within 1 week of initiation/dose adjustment, and regularly thereafter)
- Renal function (serum creatinine, BUN) (before initiation, within 1 week of initiation/dose adjustment, and regularly thereafter)
- Blood pressure
Doctor Notes
- Crucially monitor serum potassium and renal function (CrCl) at baseline, 1 week, 1 month, and then every 3 months or as clinically indicated, especially with dose adjustments or changes in concomitant medications.
- Educate patients on symptoms of hyperkalemia and emphasize avoiding potassium supplements or high-potassium foods unless advised.
- Start with a low dose and titrate slowly, particularly in elderly or renally impaired patients, or those on ACEIs/ARBs, to minimize hyperkalemia risk.
Patient Guidelines
- Take Eplon exactly as prescribed by your doctor, even if you feel well.
- Do not take potassium supplements, potassium-sparing diuretics, or salt substitutes containing potassium without consulting your doctor.
- Report any symptoms of hyperkalemia (e.g., muscle weakness, tiredness, irregular heartbeat) to your doctor immediately.
- Inform your doctor about all other medications, including over-the-counter drugs and herbal supplements.
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 resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Eplerenone may cause dizziness, especially during the initial phase of treatment or dose adjustments. Patients should be cautioned about operating machinery or driving until they know how Eplon affects them.
Lifestyle Advice
- Follow a low-salt diet as advised by your physician or dietitian.
- Limit foods high in potassium (e.g., bananas, oranges, leafy greens) if advised by your doctor.
- Regular physical activity can help manage blood pressure and heart health, but consult your doctor before starting any new exercise regimen.
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