Applies to the following strength(s): 25 mg ; 50 mg
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Congestive Heart Failure
Congestive heart failure post-myocardial infarction:
Initial dosage: 25 mg orally once daily. Dosage should titrated to the target dose of 50 mg once daily preferably within 4 weeks.
Usual Adult Dose for Hypertension
50 mg orally once daily. Patients with an inadequate blood pressure response should be increased to 50 mg twice a day.
Renal Dose Adjustments
Eplerenone is contraindicated in patients with a creatinine clearance less than or equal to 30 mL/min. Eplerenone is also contraindicated in the treatment of hypertension in patients who have a serum creatinine greater than 2.0 mg/dL (males) or greater than 1.8 mg/dL (females), and in those with a creatinine clearance less than 50 mL/min.
Liver Dose Adjustments
No dosage adjustment is necessary for patients with mild-to-moderate hepatic impairment. The use of eplerenone has not been evaluated in patients with severe hepatic impairment.
Hypertension: For patient receiving weak CYP450 3A4 inhibiting drugs, such as erythromycin, saquinavir, verapamil, and fluconazole, the starting dose should be reduced to 25 mg once daily.
Congestive heart failure post-myocardial infarction--Dose adjustments based on serum potassium level:
Less than 5 mEq/L: Increase dosage from 25 mg every other day to 25 mg daily or from 25 mg daily to 50 mg daily
5 to 5.4 mEq/L: No adjustment recommended
5.5 to 5.9 mEq/L: Decrease dosage from 50 mg daily to 25 mg daily or from 25 mg daily to 25 mg every other day or from 25 mg every other day to withhold
6 mEq/L or higher: Withhold
The principle risk of eplerenone is hyperkalemia, which can result on serious, sometimes fatal arrhythmias.
Eplerenone is contraindicated in patients with the following conditions: serum potassium greater than 5.5 mEq/L, creatinine clearance less than or equal to 30 mL/min or concomitant use with the following potent CYP450 3A4 inhibitors: ketoconazole, itraconazole nefazodone, troleandomycin, clarithromycin, ritonavir, and nelfinavir.
Eplerenone is also contraindicated for the treatment of hypertension in patients with the following: type 2 diabetes with microalbuminuria, serum creatinine greater than 2.0 mg/dL in males or greater than 1.8 mg/dL in females, concomitant use of potassium supplements or potassium-sparing diuretics (amiloride, spironolactone, or triamterene).
In a 10-week trial of 304 hypertensive pediatric patients age 4 to 17 years treated with eplerenone up to 100 mg per day, doses that produced exposure similar to that in adults, eplerenone did not lower blood pressure effectively. In this trial and in a 1-year pediatric safety study in 149 patients, the incidence of reported adverse events was similar to that of adults. Eplerenone therapy has not been studied in hypertensive patients less than 4 years old because the study in older pediatric patients did not demonstrate effectiveness. Eplerenone therapy has not been studied in pediatric patients with heart failure.
Eplerenone is not removed by hemodialysis.
In patients with congestive heart failure as a result of acute MI, evidence suggests that initiating eplerenone within 3 to 7 days post-MI is associated with a greater reduction in mortality and hospitalizations than late (i.e., 8 to 14 days post-MI) administration.
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- Drug class: aldosterone receptor antagonists
Other brands: Inspra