Country: Singapore
Language: English
Source: HSA (Health Sciences Authority)
EPLERENONE
VIATRIS PRIVATE LIMITED
NIL
25 mg
TABLET, COATED
EPLERENONE 25 mg
ORAL
Prescription Only
Viatris Pharmaceuticals LLC
ACTIVE
2005-02-17
Page 1 of 14 INSPRA EPLERENONE 1. NAME OF THE MEDICINAL PRODUCT INSPRA 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active Ingredient: eplerenone The tablets for oral administration contain either 25 mg or 50 mg of eplerenone. 3. PHARMACEUTICAL FORM Film-coated tablets 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS HYPERTENSION Eplerenone is indicated for the treatment of hypertension. In these patients, eplerenone may be used alone or in combination with other antihypertensive agents. HEART FAILURE - POST MYOCARDIAL INFARCTION Eplerenone is indicated, in addition to standard therapy, to reduce the risk of cardiovascular mortality and cardiovascular hospitalization in stable patients with left ventricular dysfunction (LVEF 40%) and clinical evidence of heart failure after recent myocardial infarction._ _ NYHA CLASS II (CHRONIC) HEART FAILURE Eplerenone is indicated, in addition to standard optimal therapy to reduce the risk of cardiovascular mortality and hospitalization in heart failure adult patients with NYHA class II (chronic) heart failure and left ventricular systolic dysfunction (LVEF ≤30% or LVEF ≤35% in addition to QRS duration of >130msec). (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 50mg daily for heart failure and 100 mg daily for hypertension. FOR PATIENTS WITH HYPERTENSION: The recommended starting dose of eplerenone is 50 mg administered once daily. The full therapeutic effect of eplerenone is apparent within 4 weeks. For patients with an inadequate blood pressure response to 50 mg once daily the dosage of eplerenone should be increased to 50 mg twice daily. Higher do Read the complete document
INSPRA EPLERENONE 1. NAME OF THE MEDICINAL PRODUCT INSPRA 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active Ingredient: eplerenone The tablets for oral administration contain either 25 mg or 50 mg of eplerenone. 3. PHARMACEUTICAL FORM Film-coated tablets 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS HYPERTENSION Eplerenone is indicated for the treatment of hypertension. In these patients, eplerenone may be used alone or in combination with other antihypertensive agents. HEART FAILURE - POST-MYOCARDIAL INFARCTION (MI) Eplerenone is indicated, in addition to standard therapy, to reduce the risk of cardiovascular mortality and cardiovascular hospitalization in stable patients with left ventricular dysfunction (left ventricular ejection fraction [LVEF] 40%) and clinical evidence of heart failure after recent MI. _ _ NEW YORK HEART ASSOCIATION (NYHA) CLASS II (CHRONIC) HEART FAILURE Eplerenone is indicated, in addition to standard optimal therapy to reduce the risk of cardiovascular mortality and hospitalization in heart failure adult patients with NYHA class II (chronic) heart failure and left ventricular systolic dysfunction (LVEF ≤30% or LVEF ≤35% in addition to QRS duration of >130 msec) (see section 5.1 PHARMACODYNAMIC PROPERTIES ). _ _ 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 heart failure and 100 mg daily for hypertension. FOR PATIENTS WITH HYPERTENSION: The recommended starting dose of eplerenone is 50 mg administered once daily. The full therapeutic effect of eplerenone is apparent within 4 weeks. For patients with an inadequate blood pressure response to 50 mg once daily the dosage of eplerenone should be increased to 50 mg twice daily. Higher dosages of eplerenone are not recommended because they have no greater effect on blood pressure than 100 mg and are associated with an increased risk of hyperkalemia. FOR POST-MYOCARDIAL INFARCTION HEART FAILURE PATIENTS: Th Read the complete document