Epleron 25 mg (Tablet)
Medicine Details
| Category | Details |
|---|---|
| Generic | Eplerenone |
| Company | Incepta pharmaceuticals ltd |
| Also available as |
Indications
- Congestive heart failure after an acute myocardial infarction
- Hypertension
Pharmacology
Eplerenone selectively binds to the mineralocorticoid receptor and blocks the binding of aldosterone, a key component in the renin-angiotensin-aldosterone-system, which is involved in the regulation of blood pressure and pathophysiology of cardiovascular disease.
Dosage & Administration
- Congestive Heart Failure after an acute Myocardial Infarction: The recommended dose of Eplerenone is 50 mg once daily. Treatment should be initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily preferably within 4 weeks as tolerated by the patient.
- Hypertension: Eplerenone may be used alone or in combination with other antihypertensive agents. The recommended starting dose of Eplerenone is 50 mg administered once daily. For patients with an inadequate blood pressure response to 50 mg once daily, the dosage of Eplerenone should be increased to 50 mg twice daily.
Interaction
May increase risk of hyperkalaemia with ACE inhibitors and/or angiotensin receptor blocker, ciclosporin, tacrolimus, trimethoprim. May reduce antihypertensive effect with NSAIDs, glucocorticoids, tetracosactide.
Contraindications
- Hyperkalaemia
- Severe renal impairment (creatinine clearance less than 30 ml/min)
- Severe hepatic impairment
- Concomitant use with potent CYP3A4 inhibitors like Ketoconazole, Itraconazole, Nefazodone, Troleandomycin, Clarithromycin, Ritonavir, and Nelfinavir or other
- Potassium-sparing diuretics are also contraindicated
Side Effects
- Headache
- Dizziness
- Diarrhea
- Stomach pain
- Nausea
- Cough or flu-like symptoms
Pregnancy & Lactation
- Pregnancy: There are no adequate and well-controlled studies in pregnant women. Eplerenone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
- Lactation: The concentration of Eplerenone in human breast milk after oral administration is unknown. A decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Precautions & Warnings
Epleron should be used with caution in hyperkalemia, severe kidney disease, diabetic patients with congestive heart failure after an acute myocardial infarction including those with proteinuria.
Use in Special Populations
- Pediatric use: The safety and effectiveness of Epleron has not been established in pediatric patients.
- Geriatric use: No differences in overall incidence of effectivity or safety was observed in elderly patients.
Overdose Effects
- Symptoms: Hyperkalaemia, hypotension
- Management: Symptomatic and supportive treatment. Admin activated charcoal. Initiate standard therapy for hyperkalaemia.
Therapeutic Class
- Potassium-sparing diuretics
- Aldosterone antagonists
Storage Conditions
Store below 30°C in a cool and dry place, protected from light and moisture. Keep out of children’s reach.