A07EA06 budesonide

ALIMENTARY TRACT AND METABOLISM ›ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS ›INTESTINAL ANTIINFLAMMATORY AGENTS ›Corticosteroids acting locally

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：可帝敏持續性釋放錠9毫克

FDA 適應症

美國 FDA 核准成分 budesonide and formoterol fumarate dihydrate （商品名 Budesonide / Budesonide and Formoterol Fumarate Dihydrate / PULMICORT FLEXHALER / Tarpeyo） · 仿單更新 2026-02-27

1 INDICATIONS AND USAGE BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL is a combination product containing a corticosteroid and a long-acting beta 2 -adrenergic agonist indicated for: • Treatment of asthma in patients 6 years of age and older. ( 1.1 ) • Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. ( 1.2 ) Important limitations: • Not indicated for the relief of acute bronchospasm. ( 1.1 , 1.2 ) 1.1 Treatment of Asthma BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL is indicated for the treatment of asthma in patients 6 years of age and older. BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL should be used for patients not adequately controlled on a long-term asthma-control medication such as an inhaled corticosteroid (ICS) or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long-acting beta2-adrenergic agonist (LABA). Important Limitations of Use: • BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL is NOT indicated for the relief of acute bronchospasm. 1.2 Maintenance Treatment of Chronic Obstructive Pulmonary Disease BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 160/4.5 is indicated for the maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema. BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 160/4.5 is also indicated to reduce exacerbations of COPD. BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL 160/4.5 is the only strength indicated for the treatment of COPD. Important Limitations of Use: • BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL is NOT indicated for the relief of acute bronchospasm.

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. 用於誘發緩解成人輕度至中度活動性潰瘍性結腸炎。
許可證品項：藥品外觀與仿單（1 項）
品名外觀仿單／外盒
可帝敏持續性釋放錠9毫克 圓形 · 白 · 刻痕：無 · 標記：MX9 · 9.8 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

§ 7.3.5 Budesonide(如Cortiment MMX)(108/7/1):
腸胃藥物 › 其他 
Budesonide(如Cortiment MMX)(108/7/1)：

1.限符合下列各項條件之病患使用：
  (1)對已接受aminosalicylate類藥物治療效果不佳或不能耐受之成人患者。
  (2)領有潰瘍性結腸炎重大傷病卡。
2.每療程限使用8週，每日限使用1粒。
歷史演變（1 次異動）
生效日異動說明
108/7/1legacy_boan_parsed:ch07.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。