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-myocardial infarction 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 myocardial infarction.

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. 0 mmol/L. Paediatric population The safety and efficacy of eplerenone in children and adolescents have not been established. 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.

4). Renal impairment No initial dose adjustment is required in patients with mild renal impairment. 4) and doses adjusted according to Table 1. 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).

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.

3). Eplerenone is not dialysable. Hepatic impairment No initial dose adjustment is necessary for patients with mild-to-moderate hepatic impairment. 4). g. amiodarone, diltiazem and verapamil, the dose of 25 mg OD may be initiated. 5). Method of administration For oral use.

2).

In two studies (Eplerenone Post-acute Myocardial Infarction Heart Failure Efficacy and Survival Study (EPHESUS) and Eplerenone in Mild Patients Hospitalization and Survival Study in Heart Failure [EMPHASIS-HF]), the overall incidence of adverse events reported with eplerenone was similar to placebo.

Adverse events reported below are those with suspected relationship to treatment and in excess of placebo or are serious and significantly in excess of placebo, or have been observed during post marketing surveillance. Adverse events are listed by body system and absolute frequency.

Frequencies are defined as:

Common (≥1/100 to < 1/10); Uncommon (≥1/1,000 to < 1/100); not known (cannot be estimated from the available data). 5) Reproductive system and breast disorders Uncommon: gynaecomastia General disorders and administration site conditions Common: asthenia Uncommon: malaise Investigations Common: blood urea increased, blood creatinine increase Uncommon: epidermal growth factor receptor decreased, blood glucose increased In EPHESUS, there were numerically more cases of stroke in the very elderly group (≥ 75 years old).

There was however no statistical significant difference between the occurrence of stroke in the eplerenone (30) vs placebo (22) groups. In EMPHASIS- HF, the number of cases of stroke in the very elderly (≥ 75 years old) was 9 in the eplerenone group and 8 in the placebo group.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard

Hyperkalaemia Consistent with its mechanism of action, hyperkalaemia may occur with eplerenone. Serum potassium levels should be monitored in all patients at initiation of treatment and with a change in dosage. 2) and patients with diabetes.

The use of potassium supplements after initiation of eplerenone therapy is not recommended, due to an increased risk of hyperkalaemia. Dose reduction of eplerenone has been shown to decrease serum potassium levels. In one study, the addition of hydrochlorothiazide to eplerenone therapy has been shown to offset increases in serum potassium.

The risk of hyperkalaemia may increase when eplerenone is used in combination with an angiotensin converting enzyme (ACE) inhibitor and/or an angiotensin receptor blocker (ARB). 5). Impaired renal function Potassium levels should be monitored regularly in patients with impaired renal function, including diabetic microalbuminuria.

The risk of hyperkalaemia increases with decreasing renal function. While the data from Eplerenone Post-acute Myocardial Infarction Heart failure Efficacy and Survival Study (EPHESUS) in patients with type 2 diabetes and microalbuminuria is limited, an increased occurrence of hyperkalaemia was observed in this small number of patients.

Therefore, these patients should be treated with caution. Eplerenone is not removed by haemodialysis. 5 mmol/L were observed in patients with mild to moderate hepatic impairment (Child Pugh class A and B). Electrolyte levels should be monitored in patients with mild to moderate hepatic impairment.

3). 5). 5). Excipients with known effect The tablets contains lactose. Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicine. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

1. 5) - The combination of an angiotensin converting enzyme (ACE) inhibitor and an angiotensin receptor blocker (ARB) with eplerenone