C08DA01 verapamil

CARDIOVASCULAR SYSTEM CALCIUM CHANNEL BLOCKERS SELECTIVE CALCIUM CHANNEL BLOCKERS WITH DIRECT CARDIAC EFFECTS Phenylalkylamine derivatives

AHFS/DI 分類: 24289200 其他鈣離子通道阻斷劑

健保收載品項 FDA 已核准 TFDA 在效許可證 13 健保給付條款 1

健保收載品名:"""南光"" 脈定緩釋膠囊120公絲"、"中國化學"必得命糖衣錠40毫克、"井田"心鬆膜衣錠40毫克(唯律脈必利)、"亞培" 伊抒婷膜衣錠40毫克、"信隆"易舒平40毫克錠(唯律脈必利)、"優生"依索蜜糖衣錠40公絲(唯律脈必利)、"優良"優賜定注射液2.5公絲/公撮(唯律脈必利)、"國嘉"心健膜衣錠40毫克(唯律脈必利)、"易陽" 益心糖衣錠40毫克、"永信"心舒糖衣錠40毫克(唯律脈必利)、"皇佳"心樂舒膜衣錠40毫克(唯律脈必利)、依心樂徐放膜衣錠240公絲(唯律脈必利)、依心樂膜衣錠80 毫克(唯律脈必利)、卡衛克糖衣錠80公絲、唯律脈必利膜衣錠120公絲、唯律脈必利錠40毫克

FDA 適應症

美國 FDA 核准成分 verapamil hydrochloride (商品名 VERAPAMIL HYDROCHLORIDE / Verapamil Hydrochloride / Verapamil hydrochloride) · 仿單更新 2025-09-22

INDICATIONS AND USAGE Verapamil Hydrochloride Tablets are indicated for the treatment of the following: Angina 1. Angina at rest including: – Vasospastic (Prinzmetal’s variant) angina – Unstable (crescendo, pre-infarction) angina 2. Chronic stable angina (classic effort-associated angina) Arrhythmias 1. In association with digitalis for the control of ventricular rate at rest and during stress in patients with chronic atrial flutter and/or atrial fibrillation (see WARNINGS; Accessory bypass tract ) 2. Prophylaxis of repetitive paroxysmal supraventricular tachycardia Essential hypertension: Verapamil is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. Control of high blood pressure should be part of comprehensive cardiovascular 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 cardiovascular 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 cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular 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.

資料來源:openFDA(美國 FDA Structured Product Labeling)。為英文原文,僅供對照。

TFDA 適應症

台灣食藥署在效西藥許可證 13 張。

適應症(去重後 3 項):

  1. 陣發性上室性心搏過速、對於心房撲動、心房纖維顫動情形時、快速心室心搏之暫時性控制。
  2. 狹心症。
  3. 高血壓。
許可證品項:藥品外觀與仿單(12 項)
品名外觀仿單/外盒
心舒平持續性膜衣錠240毫克 橢圓形 · 綠 · 刻痕:直線 · 20 外觀圖 仿單 · 外盒
"亞培" 伊抒婷膜衣錠40毫克 圓形 · 白 · 刻痕:無 · 標記:40 · 8 外觀圖 仿單 · 外盒
"優良"優賜定注射液2.5公絲/公撮(唯律脈必利) 仿單
"皇佳"心樂舒膜衣錠40毫克(唯律脈必利) 圓形 · 黃 · 刻痕:無 · 標記:RP · 7 外觀圖 仿單 · 外盒
"中國化學"必得命糖衣錠40毫克 仿單 · 外盒
"永信"心舒糖衣錠40毫克(唯律脈必利) 圓形 · 黃 · 刻痕:無 · 6.7 外觀圖 仿單
"優生"依索蜜糖衣錠40公絲(唯律脈必利) 仿單 · 外盒
"國嘉"心健膜衣錠40毫克(唯律脈必利) 仿單 · 外盒
"信隆"易舒平40毫克錠(唯律脈必利) 仿單 · 外盒
依心樂徐放膜衣錠240公絲(唯律脈必利) 橢圓形 · 白 · 刻痕:直線 · 標記:SR 240 · 18.8 外觀圖 仿單 · 外盒
"井田"心鬆膜衣錠40毫克(唯律脈必利) 仿單 · 外盒
依心樂膜衣錠80 毫克(唯律脈必利) 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

§ 2.19 Mavacamten(如Camzyos):(115/4/1)
心臟血管及腎臟藥物 › Mavacamten(如Camzyos):(115/4/1)
Mavacamten(如Camzyos):(115/4/1)

1.限用於治療症狀性紐約心臟學會(NYHA)分級第二級及第三級阻塞型肥厚性心肌病變(HCM)之18歲以上成人病人,用以改善功能容量與症狀。病人須符合以下條件:
  (1)左心室壁厚度(left ventricular wall thickness)≥15mm(具有HCM家族史者則≥13mm)。
  (2)經心臟超音波檢測之靜止時、伐式操作(Valsalva maneuver)或運動後之LVOT壓力差≥50mmHg且LVEF≥55%。
  (3)曾接受過乙型阻斷劑或鈣離子阻斷劑(verapamil或diltiazem)治療並已達最大LVOT壓力差下降效果的劑量後,在治療期間仍無法控制LVOT壓力差;但具禁忌症或無法耐受者不在此限。
2.須經事前審查核准後使用,第一次申請以6個月為限,期滿需經再次申請核准後使用,每次續用申請以12個月為限。
3.續用條件:使用藥物治療達6個月以上,LVEF≥55%,並且靜止時、伐式操作(Valsalva maneuver)或運動後之LVOT壓力差<50mmHg或治療前後LVOT壓力差下降幅度達20mmHg。
4.停藥條件:
  (1)當LVEF<50%時應中斷治療,每4週再次確認心臟超音波參數,直到LVEF≥50%為止,並依仿單用法重啟治療。
  (2)當每日劑量2.5mg時,發生2次LVEF<50%或1次LVEF≤30%時,須永久停藥。
5.限心臟專科醫師處方。
6.Camzyos 2.5mg每日至多給付2粒,Camzyos 10mg或15mg每日至多給付1粒,且2.5mg不得與10mg或15mg併用。
歷史演變(1 次異動)
生效日異動說明
115/4/1legacy_boan_parsed:ch02.txt

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。