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EPLERENONA PENTAFARMA TABLETS should not be administered to heart failure patients with initial serum potassium >5.0 mmol/L, serum creatinine >221 μmol/L and/or eGFR <30 mL/min/1.73 m2.
Serum potassium should be measured before initiating EPLERENONA PENTAFARMA TABLETS (eplerenone) therapy, within the first week and at one month after the start of treatment or after a dose adjustment. Serum potassium should be measured periodically thereafter, as clinically warranted.
Hyperkalemia can be expected at any time during treatment with EPLERENONA PENTAFARMA TABLETS.
Efforts should be made to decrease the dietary potassium intake. Patients should be asked about their use of potassium containing salt substitutes and dietary supplements. Factors, such as patient characteristics, serum potassium levels and concomitant medications, may indicate that additional monitoring of serum potassium is appropriate (see Hyperkalemia under Precautions, Adverse Reactions, and Interactions).
Recommended Dose and Dosage Adjustment: Heart failure: Renal Impairment: Patients with eGFR of ≥50 mL/min/1.73 m2: For chronic heart failure NYHA Class II and post-myocardial infarction heart failure patients with serum potassium ≤5 mmol/L, treatment should be initiated at a dose of 25 mg once daily and titrated to the target dose of 50 mg once daily preferably within 4 weeks, taking into account the serum potassium level (see Table 1). Following myocardial infarction EPLERENONA PENTAFARMA TABLETS should be initiated 3-14 days after MI.
The maximum daily dose in patients with eGFR of ≥50 mL/min/1.73 m2 is 50 mg daily. In patients using a mild to moderate CYP3A4 inhibitor, the maximum daily dose of EPLERENONA PENTAFARMA TABLETS is 25 mg.
Patients with eGFR of 30-49 mL/min/1.73 m2: For chronic heart failure NYHA Class II and post-myocardial infarction heart failure patients with serum potassium ≤5 mmol/L, treatment should be initiated at a dose of 25 mg once every other day and titrated to the target dose of 25 mg once daily preferably within 4 weeks, taking into account the serum potassium level (see Table 1). Following myocardial infarction EPLERENONA PENTAFARMA TABLETS should be initiated 3-14 days after MI.
The maximum dose in patients with an eGFR 30-49 mL/min/1.73 m2 is 25 mg once daily. EPLERENONA PENTAFARMA TABLETS should not be given to patients on a mild to moderate CYP3A4 inhibitor because a lower dose than 25 mg once daily has not been studied.
Patients with eGFR of <30 mL/min/1.73 m2: EPLERENONA PENTAFARMA TABLETS is contraindicated in patients with severe renal impairment.
Hepatic Impairment: Mild-to-Moderate Hepatic Impairment: No initial dosage adjustment is necessary.
Severe Hepatic Impairment: See Contraindications and Precautions.
Dose adjustment based on serum potassium levels for heart failure patients: Patients who develop hyperkalemia (>5.5 mmol/L) may still benefit from EPLERENONA PENTAFARMA TABLETS with proper dose adjustment. The dose should be adjusted based on the serum potassium level and the dose adjustment table shown in Table 1. (See Table 1.)
Click on icon to see table/diagram/imageFollowing withholding EPLERENONA PENTAFARMA TABLETS due to serum potassium ≥6.0 mmol/L and the return of potassium levels within acceptable limits, EPLERENONA PENTAFARMA TABLETS can be restarted at a test dose of 25 mg every other day. There are no data to demonstrate that 25 mg every other day is effective and such dosing should be considered to be only a temporary situation. After a test period of one week on 25 mg every other day, serum potassium levels should be measured. If potassium levels return within acceptable limits, the dose can be increased to 25 mg every day and serum potassium should be measured after one week. It could then be determined if EPLERENONA PENTAFARMA TABLETS therapy should be continued or stopped.
