Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
EPLERENONE
Synthon BV
50 Milligram
Film Coated Tablet
2011-11-25
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Eplefa 50 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg of eplerenone. Excipient: Each 50 mg tablet contains 71.4 mg of lactose monohydrate (see Section 4.4). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. light yellow, round, biconvex film-coated tablet, debossed with ‘E9RN’ on one side and ‘50’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Eplerenone is indicated, in addition to standard therapy including beta-blockers, 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For the individual adjustment of dose, the strengths of 25 mg and 50 mg are available. 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. 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 SERUM Read the complete document