C03DA04 eplerenone
CARDIOVASCULAR SYSTEM ›DIURETICS ›ALDOSTERONE ANTAGONISTS AND OTHER POTASSIUM-SPARING AGENTS ›Aldosterone antagonists
健保收載品項 FDA 已核准 TFDA 在效許可證 5 健保給付條款 3
健保收載品名:立心復膜衣錠25毫克、立心復膜衣錠50毫克、迎甦心 膜衣錠 50毫克
FDA 適應症
1 INDICATIONS AND USAGE Eplerenone is an aldosterone antagonist indicated for: Improving survival of stable adult patients with symptomatic heart failure with reduced ejection fraction (HFrEF) after an acute myocardial infarction. (1.1) The treatment of hypertension in adults, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.2 ) 1.1 Heart Failure Post-Myocardial Infarction Eplerenone is indicated to improve survival of stable adult patients with symptomatic heart failure with reduced ejection fraction (≤40%) (HFrEF) after an acute myocardial infarction (MI). 1.2 Hypertension Eplerenone tablets are indicated for the treatment of hypertension in adults, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and MI. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes. Control of high blood pressure should be part of comprehensive CV risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).Control of high blood pressure should be part of comprehensive CV risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce CV morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent CV outcome benefit has been a reduction in the risk of stroke, but reductions in MI and CV mortality also have been seen regularly.Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce CV morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent CV outcome benefit has been a reduction in the risk of stroke, but reductions in MI and CV mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased CV risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.Elevated systolic or diastolic pressure causes increased CV risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Eplerenone may be used alone or in combination with other antihypertensive agents.
資料來源:openFDA(美國 FDA Structured Product Labeling)。為英文原文,僅供對照。
TFDA 適應症
適應症(去重後 3 項):
- 1、心肌梗塞後之心衰竭2、NYHA第II級(慢性)心衰竭3、高血壓。
- 心肌梗塞後之心衰竭、NYHA第II級(慢性)心衰竭、高血壓。
- 心肌梗塞後之心衰竭。NYHA第II級(慢性)心衰竭。
許可證品項:藥品外觀與仿單(5 項)
| 品名 | 外觀 | 仿單/外盒 |
|---|---|---|
| 迎甦心 膜衣錠 25毫克 | — | 仿單 · 外盒 |
| 迎甦心 膜衣錠 50毫克 | 四邊形 · 黃 · 刻痕:無 · 標記:NSR 50 / VLE · 9 外觀圖 | 仿單 · 外盒 |
| 立心復膜衣錠50毫克 | — | 仿單 · 外盒 |
| 立心復膜衣錠25毫克 | — | 仿單 · 外盒 |
| 醫保隆膜衣錠50毫克 | — | 仿單 · 外盒 |
資料來源:食藥署「西藥許可證」+「藥品 ATC 碼」+「藥品仿單或外盒」+「藥品外觀」開放資料。
NHI 給付規定
直接適用條款
§ 2.9.1 Eplerenone (如Inspra):(100/1/1、104/12/1)
心臟血管及腎臟藥物 › 利尿劑
Eplerenone (如Inspra):(100/1/1、104/12/1) 限使用於對spironolactone無法耐受之下述個案: 1.心肌梗塞後之心衰竭病人。 2.紐約心臟學會(NYHA) 心臟功能分類第II級(含)以上之慢性心衰竭及左心室收縮功能不全(LVEF≦30%)的成人患者。(104/12/1)
歷史演變(2 次異動)
| 生效日 | 異動說明 |
|---|---|
| 100/1/1 | legacy_boan_parsed:ch02.txt |
| 104/12/1 | legacy_boan_parsed:ch02.txt |
上層 ATC 繼承條款
繼承自 ATC C03DA
§ 14.8 Ketorolac tromethamine(如Acular Ophthalmic Solution):(89/11/1)
眼科製劑 › Ketorolac tromethamine(如Acular
Ketorolac tromethamine(如Acular Ophthalmic Solution):(89/11/1) 限白內障手術後之眼部發炎使用。
歷史演變(1 次異動)
| 生效日 | 異動說明 |
|---|---|
| 89/11/1 | legacy_boan_parsed:ch14.txt |
繼承自 ATC C03
§ 2.9 利尿劑
心臟血管及腎臟藥物 › 利尿劑
利尿劑 (Diuretics)
實證補充
本藥品尚無實證補充整理(未來新增 Review/指引知識時補列)。
FDA 段:openFDA US SPL · TFDA 段:食藥署西藥許可證+ATC 分類開放資料 · NHI 段:健保署「全民健康保險藥品給付規定」(更新日 2026-05-31)· 實證補充段:人工彙整。 本頁為資訊整理,實際給付與適應症以主管機關公告為準。