N02AE01 buprenorphine

NERVOUS SYSTEM ANALGESICS OPIOIDS Oripavine derivatives

健保收載品項 TFDA 在效許可證 3 FDA 已核准

台灣藥品與外觀

台灣食藥署在效西藥許可證 3 張;以下列出 3 個品項。

健保收載品名:丁基原啡因注射液0.3毫克/毫升、丁基原啡因舌下錠0.2毫克、全克痛穿皮貼片劑35微克/小時、全克痛穿皮貼片劑52.5微克/小時、比普利注射劑 0.3 毫克/毫升

無外觀照
鹽酸丁基原啡因
無外觀照
丁基原啡因鹽酸鹽
無外觀照
比普利注射劑 0.3 毫克/毫升

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

  1. 中、重度疼痛。
  2. 麻醉性鎮痛藥。

美國 FDA 適應症(英文原文對照)

美國 FDA 核准成分 buprenorphine (商品名 Buprenorphine / Buprenorphine HCl and Naloxone HCl / Buprenorphine and Naloxone / buprenorphine hydrochloride) · 仿單更新 2026-04-28

1 INDICATIONS AND USAGE Buprenorphine transdermal system is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate release opioids. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions ( 5.1 )] , reserve opioid analgesics, including buprenorphine transdermal system, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Buprenorphine transdermal system is not indicated as an as-needed (prn) analgesic Buprenorphine transdermal system is a partial opioid agonist indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. ( 1 ) Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including buprenorphine transdermal system, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. ( 1 , 5.1 ) Buprenorphine transdermal system is not indicated as an as-needed (prn) analgesic. ( 1 )

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

查無健保特殊給付規定條款;本藥品依一般健保藥品支付規定給付。

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。