Inspra^®

Abbreviated Prescribing Information¹

Indication: Heart failure – Post-myocardial infarction (MI): Eplerenone is indicated, in addition to standard therapy, to reduce the risk of cardiovascular (CV) mortality and morbidity in stable patients with left ventricular dysfunction (left ventricular ejection fraction [LVEF] <40%) and clinical evidence of heart failure after recent MI. Presentation: Inspra^® (Eplerenone) tablet is available in 25 mg and 50 mg in 30’s. Dosage: 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 OD and titrated to the target dose of 50 mg OD, preferably within 4 weeks, taking into account the serum potassium level (please refer to full prescribing information for details on dose adjustments specific to serum potassium levels). Therapy should usually be started within 3–14 days after an acute MI. Contraindications: Hypersensitivity to eplerenone or any component of this medication, clinically significant hyperkalaemia or with conditions associated with hyperkalaemia, serum potassium level >5.0 mmol/L (mEq/L) at initiation, moderate-to-severe renal impairment (creatinine clearance <50 mL/min) in post-MI heart failure (Eplerenone Post-acute Myocardial Infarction Heart failure Efficacy and Survival Study [EPHESUS]), severe hepatic impairment (Child-Pugh Class C), concomitant use with potassium-sparing diuretics, or potent inhibitors of CYP450 3A4 such as ketoconazole, itraconazole and ritonavir. Adverse reactions: The most frequent adverse event reported was hyperkalaemia. Other common adverse events reported include infection, dehydration, dizziness, syncope, MI, hypotension, cough, diarrhoea, nausea, constipation, pruritus, muscle spasms, musculoskeletal pain, renal impairment and increased blood urea. Special precautions: Hyperkalaemia; impaired hepatic function; impaired renal function; elderly; CYP3A4 inducers; and patients receiving eplerenone should be informed not to use potassium supplements; salt substitutes containing potassium or contraindicated medications without consulting the prescribing healthcare professional.

API-INSPRA-0224

Reference: 1. Malaysia Inspra^® Package Insert dated 2 February 2024.