A07AA12 fidaxomicin

ALIMENTARY TRACT AND METABOLISM ›ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS ›INTESTINAL ANTIINFECTIVES ›Antibiotics

健保收載品項 FDA 已核准 TFDA 在效許可證 1 健保給付條款 1

健保收載品名：鼎腹欣膜衣錠 200 毫克

FDA 適應症

美國 FDA 核准成分 fidaxomicin （商品名 Dificid / Fidaxomicin） · 仿單更新 2026-02-13

1 INDICATIONS AND USAGE Fidaxomicin tablets are a macrolide antibacterial indicated in adult patients for the treatment of C. difficile -associated diarrhea. ( 1.1 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of fidaxomicin tablets and other antibacterial drugs, fidaxomicin tablets should be used only to treat infections that are proven or strongly suspected to be caused by C. difficile. ( 1.2 ) 1.1 Clostridioides difficile -Associated Diarrhea Fidaxomicin tablets are indicated in adult patients for the treatment of C. difficile-associated diarrhea (CDAD). 1.2 Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of fidaxomicin tablets and other antibacterial drugs, fidaxomicin tablets should be used only to treat infections that are proven or strongly suspected to be caused by C. difficile. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Pediatric use information is approved for Cubist Pharmaceuticals LLC's DIFICID ® (fidaxomicin) tablets. However, due to Cubist Pharmaceuticals LLC's marketing exclusivity rights, this drug product is not labeled with that information.

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 1 張。

適應症（去重後 1 項）：

  1. 困難梭狀桿菌相關腹瀉(C.difficile-associateddiarrhoea、CDAD)。
許可證品項：藥品外觀與仿單（1 項）
品名外觀仿單／外盒
鼎腹欣膜衣錠 200 毫克 橢圓形 · 白 · 刻痕：無 · 標記：FDX / 200 · 14 外觀圖 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

§ 10.8.8 Fidaxomicin(如Dificid)：(103/9/1)
抗微生物劑 › 其他 
Fidaxomicin(如Dificid)：(103/9/1)
1.限用於經第一線藥物metronidazole及vancomycin治療無效或復發，且細菌培養或毒素分析(toxin assay)報告證實為困難梭狀桿菌相關腹瀉(C. difficile-associated diarrhoea, CDAD)，並經感染症專科醫師會診，確認有感染症需使用者。
2.申報費用時需檢附會診紀錄及相關之病歷資料。
歷史演變（1 次異動）
生效日異動說明
103/9/1legacy_boan_parsed:ch10.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。