Eplerenone is contraindicated in all patients with serum potassium greater than 5.5 mEq/L at initiation, creatinine clearance less than or equal to 30 mL/min, or concomitant administration of strong CYP3A4 inhibitors. Eplerenone is also contraindicated for the treatment of hypertension in patients with type 2 diabetes with microalbuminuria, serum creatinine greater than 2.0 mg/dL in males or greater than 1.8 mg/dL in females, creatinine clearance less than 50 mL/min, or concomitant administration of potassium supplements or potassium sparing diuretics.
Serum potassium should be measured before initiating eplerenone therapy, within the first week, and at one month after the start of treatment or dose adjustment. Serum potassium should be assessed periodically thereafter, especially in patients at risk for the development of hyperkalemia such as elderly patients with renal insufficiency and patients with type 2 diabetes and microalbuminuria.
Most common adverse reactions (greater than 2% and more frequent than with placebo) in patients with CHF Post-MI: hyperkalemia and increased creatinine. Most common adverse reactions (greater than or equal to 2% and more frequent than with placebo) in hypertensive patients: dizziness, diarrhea, coughing, fatigue and flu-like symptoms.
In the European Union, eplerenone is indicated, in addition to standard optimal therapy, to reduce the risk of cardiovascular mortality and morbidity in adult patients with NYHA class II (chronic) heart failure and left ventricular systolic dysfunction (LVEF ≤30%). Eplerenone is also indicated to reduce the risk of cardiovascular mortality and morbidity in stable patients with left ventricular dysfunction (LVEF ≤40%) and clinical evidence of heart failure after recent myocardial infarction.
In Japan, eplerenone is approved for the treatment of hypertension.
For additional product information in the US, visit:
UK prescribing information is available at:
Other countries should refer to local prescribing information.
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