Eplerenona Pentafarma

Eplerenone

Adjunct to standard therapy to reduce risk of CV mortality & hospitalization for heart failure in patients w/ NYHA class II systolic chronic heart failure & left ventricular systolic dysfunction. Adjunct to standard therapy to reduce risk of mortality & hospitalization for heart failure following MI in clinically stable adults who have evidence of heart failure & left ventricular systolic dysfunction (ejection fraction ≤40%).

Chronic heart failure NYHA class II & post-MI heart failure w/ serum K ≤5 mmol/L Patient w/ eGFR ≥50 mL/min/1.73 m² Initially 25 mg once daily. Titrate to target dose 50 mg once daily w/in 4 wk, taking into account the serum K level. Following MI, initiate treatment 3-14 days after MI. Max: 50 mg daily (25 mg if using mild to moderate CYP3A4 inhibitor). Patient w/ eGFR 30-49 mL/min/1.73 m² Initially 25 mg once every other day. Titrate to target dose 25 mg once daily w/in 4 wk, taking into account the serum K level. Following MI, initiate treatment 3-14 days after MI. Max: 25 mg once daily.

Hypersensitivity. Patients w/ clinically significant hyperkalemia; severe hepatic impairment (Child-Pugh Class C); serum K >5 mmol/L at initiation; severe renal impairment (eGFR <30 mL/min/1.73 m²). Concomitant use w/ K-sparing diuretics, K supplements or strong CYP3A4 inhibitors eg, ketoconazole, itraconazole, nefazodone, telithromycin, clarithromycin, ritonavir, nelfinavir.

Risk of hyperkalemia. Measure serum K level before treatment initiation, w/in 1 wk & at 1 mth after the 1st dose or after dose adjustment, & measure periodically thereafter, as clinically warranted. Estimate GFR before treatment initiation. Not recommended w/ mild to moderate CYP3A4 inhibitors in patients w/ moderate renal impairment (eGFR 30-49 mL/min/1.73 m²). Pregnancy & lactation. Not recommended in ped population.

NYHA class II chronic heart failure: Anemia; MI; constipation; nasopharyngitis, URTI; hyperkalemia, DM; pain in extremity; dizziness, headache, syncope; renal impairment; cough; pruritus; hypotension. Post-MI heart failure: Hypotension, syncope; asthenia, non-cardiac chest pain, fatigue, fever; dizziness, headache; constipation, diarrhea, dyspepsia, nausea, vomiting; ventricular tachycardia; hyperkalemia; angina pectoris, CAD; anemia; increased creatinine, hematuria, abnormal renal function; cerebrovascular disorder.

Increased exposure w/ strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir, nelfinavir, clarithromycin, telithromycin, nefazodone); mild to moderate CYP3A4 inhibitors (eg, erythromycin, saquinavir, amiodarone, diltiazem, verapamil, fluconazole). Decreased exposure w/ strong CYP3A4 inducers (eg, phenobarb, phenytoin, rifampicin, carbamazepine, St. John's Wort). Potential additive effect on serum K w/ ACE inhibitors/ARBs. Lithium concomitantly used w/ diuretics & ACE inhibitors & concomitant administration of Eplerenona Pentafarma may worsen lithium toxicity. Administration of K-sparing antihypertensive drugs w/ NSAIDs has been shown to reduce the antihypertensive effect in some patients & result in severe hyperkalemia in patients w/ impaired renal function. Risk of hypotension/HTN or hyperkalemia in patients taking herbal prep that affect BP or contain high levels of K (eg, dandelion, K iodine, laminaria, morinda, oleander, phosphate salts & K prep, cat's claw, cod liver oil, licorice).

Diuretics

C03DA04 - eplerenone ; Belongs to the class of aldosterone antagonists. Used as potassium-sparing diuretics.

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