eplerenone中文版说明书

Chinese version manual

【Indications】

1. Congestive heart failure after acute myocardial infarction: eplerenone can improve the quality of life of patients with left ventricular dysfunction (ejection fraction ≤ 40%). Clinical trials have proven that eplerenone can also be used for congestive heart failure after acute myocardial infarction.

2. Anti-hypertension: eplerenone can be used alone or in combination with other anti-hypertensive drugs for the treatment of hypertension.

【Usage and Dosage】

1. Congestive heart failure after acute myocardial infarction: The recommended dose is 50 mg/time, once/day. The initial dose should be 25 mg/time, once/day, and within 4 weeks, the dose should be gradually increased to 50 mg/time, once/day if the patient tolerates it.

2. Anti-hypertensive: eplerenone can be used alone or in combination with other anti-hypertensive drugs. The recommended initial dose for use alone is 50mg/time, once/day. Obvious antihypertensive effects appear within four weeks of taking the drug. If the antihypertensive effect is not obvious, it can be increased to 50mg/time, 2 times/day. Higher dosages are not recommended, otherwise there is an increased risk of adverse reactions such as hyperkalemia.

【Mechanism of action】

eplerenone binds to mineralocorticoid receptors, thereby blocking the binding of aldosterone, a component of the renin-angiotensin-aldosterone system (RAAS). Aldosterone synthesis occurs primarily in the adrenal gland and is regulated by multiple factors, including angiotensin II and non-RAAS mediators such as adrenocorticotropic hormone (ACTH) and potassium. Aldosterone binds to mineralocorticoid receptors in epithelial tissues (such as the kidneys) and non-epithelial tissues (such as the heart, blood vessels, and brain) and increases blood pressure by inducing sodium reabsorption and possibly other mechanisms.

【Adverse reactions】

The main adverse reactions include: cough, diarrhea, abdominal pain, angina, myocardial infarction, proteinuria, headache, dizziness, fatigue, flu-like symptoms, etc. Other adverse reactions include: gynecomastia, abnormal vaginal bleeding; increases (serum potassium, triglycerides, cholesterol, alanine aminotransferase, γ-glutamyl transferase, creatinine, uric acid levels), and decreases in serum sodium levels.

【Notes】

(1) eplerenone cannot be combined with potassium supplements, potassium-containing salts or contraindicated drugs (potassium-sparing diuretics, strong inhibitors of CYP450 liver enzymes). (2) Non-steroidal anti-inflammatory drugs and lithium can affect the plasma concentration of eplerenone and affect the efficacy. (3) Patients with high serum potassium, type 2 diabetes patients with microalbuminuria, patients with high serum creatinine levels, and patients with muscle intoxication clearance <50 mL/min should not take it. (4) Pregnant women, children, and those with hepatic and renal insufficiency should use with caution.