N01AH01 fentanyl
NERVOUS SYSTEM ›ANESTHETICS ›ANESTHETICS, GENERAL ›Opioid anesthetics
健保收載品項 TFDA 在效許可證 9 FDA 已核准 健保給付條款 1
台灣藥品與外觀
健保收載品名："仁山" 吩坦尼注射液０．０５公絲/公撮、"岱比博" 吩坦尼注射液０．０５公絲/公撮、"管制藥品廠" 吩坦尼注射液0.05毫克/毫升、"菲尼斯" 吩坦尼注射液0.05毫克/毫升、吩坦尼注射液0.05 毫克/ 毫升
無外觀照
"肯恩"檸檬酸吩坦尼
無外觀照
"阿威"檸檬酸吩坦尼
無外觀照
檸檬酸吩坦尼
無外觀照
吩坦尼
資料來源：食藥署「西藥許可證」＋「藥品 ATC 碼」＋「藥品外觀」＋「藥品仿單或外盒」開放資料。外觀照與仿單連結指向食藥署原始檔。
適應症
台灣 TFDA 核准適應症
- 麻醉和麻醉前給藥、急性劇烈疼痛之緊急治療。
- 麻醉和麻醉前給藥、急性疼痛之緊急治療。
- 麻醉性鎮痛劑。
- 麻醉性鎮痛藥。
美國 FDA 適應症（英文原文對照）
1 INDICATIONS AND USAGE Fentanyl Citrate Injection is indicated for: • analgesic action of short duration during the anesthetic periods, premedication, induction and maintenance, and in the immediate postoperative period (recovery room) as the need arises. • use as a narcotic analgesic supplement in general or regional anesthesia. • administration with a neuroleptic as an anesthetic premedication, for the induction of anesthesia and as an adjunct in the maintenance of general and regional anesthesia. • use as an anesthetic agent with oxygen in selected high-risk patients, such as those undergoing open heart surgery or certain complicated neurological or orthopedic procedures. Fentanyl Citrate Injection is indicated for: • analgesic action of short duration during the anesthetic periods, premedication, induction and maintenance, and in the immediate postoperative period (recovery room) as the need arises. • use as an opioid analgesic supplement in general or regional anesthesia. • administration with a neuroleptic as an anesthetic premedication, for the induction of anesthesia and as an adjunct in the maintenance of general and regional anesthesia. • use as an anesthetic agent with oxygen in selected high-risk patients, such as those undergoing open heart surgery or certain complicated neurological or orthopedic procedures.
資料來源：食藥署西藥許可證適應症（中文）、openFDA US SPL（英文，僅供對照）。
健保給付規定
直接適用條款
§ 1.1.9 Fentanyl citrate 口頰溶片或口頰錠(108/10/1、111/2/1)
神經系統藥物 › 疼痛解除劑
Fentanyl citrate口頰溶片或口頰錠(108/10/1、111/2/1) 1.限用於突發性疼痛(breakthrough pain)，並已接受過口服morphine至少60mg/day、oxycodone至少30mg/day、hydromorphone至少8mg/day、或fentanyl貼片劑至少25/mcg/hr或其他等止痛劑量之類鴉片藥物達一星期(含)以上之18歲以上癌症患者(111/2/1)。 2.不得用於急性或術後疼痛之處置。
歷史演變（2 次異動）
| 生效日 | 異動說明 |
|---|---|
| 108/10/1 | legacy_boan_parsed:ch01.txt |
| 111/2/1 | legacy_boan_parsed:ch01.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）。
台灣藥品與適應症：食藥署西藥許可證＋ATC＋外觀＋仿單開放資料 · FDA：openFDA US SPL · 健保給付：健保署「全民健康保險藥品給付規定」（更新日 2026-06-09）· 實證補充：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。