INSPRA Film-coated tablet Ref.[6764] Active ingredients: Eplerenone

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.

For patients with NYHA class II (chronic) heart failure

For chronic heart failure NYHA class II patients, 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 and section 4.4).

Patients with a serum potassium of >5.0 mmol/L should not be started on eplerenone (see section 4.3).

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.

Table 1. Dose adjustment table after initiation:

* EOD: Every Other Day

Following withholding eplerenone due to serum potassium ≥6.0 mmol/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.

Paediatric population

The safety and efficacy of eplerenone in children and adolescents have not been established. Currently available data are described in section 5.1 and 5.2.

Elderly

No initial dose adjustment is required in the elderly. Due to an age-related decline in renal function, the risk of hyperkalaemia 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 section 4.4).

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.

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 section 4.4).

There is no experience in patients with CrCl <50 mL/min with post MI heart failure. The use of eplerenone in these patients should be done cautiously. Doses above 25 mg daily have not been studied in patients with CrCl <50 mL/min.

Use in patients with severe renal impairment (CrCl <30 mL/min) is contraindicated (see section 4.3).

Eplerenone is not dialysable.

Hepatic impairment

No initial dose adjustment is necessary for patients with mild-to-moderate hepatic impairment. Due to an increased systemic exposure to eplerenone in patients with mild-to-moderate hepatic impairment, frequent and regular monitoring of serum potassium is recommended in these patients, especially when elderly (see section 4.4).

Concomitant treatment

In case of concomitant treatment with mild to moderate CYP3A4 inhibitors, e.g. amiodarone, diltiazem and verapamil, the dose of 25 mg OD may be initiated. Dosing should not exceed 25 mg OD (see section 4.5).

Eplerenone may be administered with or without food (see section 5.2).

No cases of adverse events associated with overdose of eplerenone in humans have been reported. The most likely manifestation of human overdose would be anticipated to be hypotension or hyperkalaemia. Eplerenone cannot be removed by haemodialysis. Eplerenone has been shown to bind extensively to charcoal. If symptomatic hypotension should occur, supportive treatment should be initiated. If hyperkalaemia develops, standard treatment should be initiated.

Shelf life: 3 years.

No special precautions for storage.

Opaque PVC/Al blisters containing 10, 20, 28, 30, 50, 90, 100 or 200 tablets.

Opaque PVC/Al perforated unit dose blisters containing 10 × 1, 20 × 1, 30 × 1, 50 × 1, 90 × 1, 100 × 1 or 200 × 1 (10 packs of 20 × 1) tablets.

Not all pack sizes may be marketed.

No special requirements.