API

Eplerenone (50mg)

Drug classification

Aldosterone antagonist; specific subclass: selective mineralocorticoid receptor antagonist (MRA).

Dosage form

Film-coated oral tablet containing 50 mg eplerenone.

API strength per dosage

Dose

Eplerenone 50 mg is typically used in adults for heart failure or hypertension, with dosing individualized and often starting at 25 mg once daily, titrated to 50 mg once daily. Dose adjustments are required in renal or hepatic impairment. Not recommended in severe renal impairment or for paediatric use. Always monitor potassium and renal function.

Mechanism of action

Eplerenone selectively antagonizes mineralocorticoid receptors in the distal nephron, blocking aldosterone’s effects. This reduces sodium and water reabsorption while decreasing potassium excretion, leading to lowered blood pressure and reduced cardiac remodeling in heart failure.

Indications

Treatment of Hypertension (high blood pressure)Treatment of EdemaTreatment of Heart failure

Side effects

Dizziness Diarrhea Nausea Cough Flu like symptoms Fatigue Increased potassium level in blood Increased creatinine level in blood Headache

Pregnancy category

Eplerenone should be used during pregnancy only if clearly needed; limited human data are available, and animal studies have shown adverse effects.

Precautions

Hyperkalemia risk, monitor serum potassium and renal function before and during therapy, caution in renal impairment, avoid with potassium-sparing diuretics or potassium supplements, use cautiously in hepatic impairment, contraindicated in severe renal dysfunction, monitor blood pressure, assess for drug interactions (especially CYP3A4 inhibitors), avoid in pregnancy and breastfeeding.

Contraindications

Hypersensitivity to eplerenone, serum potassium >5.5 mmol/L, severe renal impairment, concomitant use with potassium-sparing diuretics or strong CYP3A4 inhibitors, severe hepatic impairment, type 2 diabetes with microalbuminuria.