Inspra Dosage/Direction for Use

Posology: For the individual adjustment of dose, the strengths of 25 mg and 50 mg are available. The maximum dose regimen is 50 mg daily.
For post-MI heart failure patients: The recommended maintenance dose of eplerenone is 50 mg once daily (OD). Treatment should be initiated at 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).
Eplerenone therapy should usually be started within 3-14 days after an acute MI.
Patients with a serum potassium of >5.0 mmol/L should not be started on eplerenone (see Contraindications).
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 as needed periodically thereafter.
After initiation, the dose should be adjusted based on the serum potassium level as shown in Table 1. (See Table 1.)

Click on icon to see table/diagram/image

Following withholding eplerenone due to serum potassium ≥6.0 mmol/L (or ≥6.0 mEq/L), eplerenone can be re-started at a dose of 25 mg every other day when potassium levels have fallen below 5.0 mmol/L (or 5.0 mEq/L).
General Considerations: Potassium: 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.
Food: Eplerenone may be administered with or without food.
Concomitant CYP3A4 Medications: Patients receiving mild to moderate CYP3A4 inhibitors, such as erythromycin, saquinavir, verapamil, and fluconazole should receive the dose of 25 mg once daily (see Interactions).
Special Populations and Special Considerations for Dosing: Use in children: Safety and efficacy of eplerenone has not been studied in pediatric patients with heart failure.
Elderly: No initial dose adjustment is required in the elderly. Due to an age-related decline in renal function, the risk of hyperkalemia is increased in elderly patients. This risk may be further increased when co-morbidity associated with increased systemic exposure is also present, in particular mild-to-moderate hepatic impairment. Periodic monitoring of serum potassium is recommended (see Precautions).
Use in renal impairment: No initial dose adjustment is required in patients with mild renal impairment. Periodic monitoring of serum potassium with dose adjustment according to Table 1 is recommended (see Precautions).
Patients with moderate renal impairment (CrCl 30-60 mL/min) should be started at 25 mg every other day, and dose should be adjusted based on the potassium level (see Table 1).
Periodic monitoring of serum potassium is recommended (see Precautions).
In patients with post-MI heart failure, there is no experience in patients with CrCl <50 mL/min.
Use in patients with severe renal impairment (CrCl <30 mL/min) is contraindicated (see Contraindications). Eplerenone is not dialysable.
Use in hepatic impairment: Mild-to-Moderate Hepatic Impairment: No initial dose adjustment is necessary (see Contraindications and Precautions).