国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
EPLERENONE
Teva Pharma B.V.
EPLERENONE
25 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Withdrawn
2014-04-24
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Eplerenone Teva 25 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 25 mg of eplerenone. _Excipient with known effect_ Each 25 mg film-coated tablet contains 38 mg of lactose monohydrate (equivalent to 36 mg of lactose anhydrous) (see section 4.4). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Yellow, diamond-shaped, biconvex film-coated tablet, approximately 6.4 mm wide and 7.4 mm long, engraved with “E25” on one side and plain on the other. 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. In addition to standard optimal therapy, to reduce the risk of cardiovascular mortality and morbidity in adult patients with NYHA class II (chronic) heart failure and left ventricular systolic dysfunction (LVEF 30%) (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 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. _For patients with NYHA class II 阅读完整的文件