N07BB03 acamprosate

NERVOUS SYSTEM ›OTHER NERVOUS SYSTEM DRUGS ›DRUGS USED IN ADDICTIVE DISORDERS ›Drugs used in alcohol dependence

非健保收載 TFDA 在效許可證 1 FDA 已核准

台灣藥品與外觀

台灣食藥署在效西藥許可證 1 張；以下列出 1 個品項（1 項有外觀照）。

戒酒妥333毫克腸溶錠

圓形 · 白 · 刻痕：無 · 標記：435 · 10 mm

仿單外盒

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

適用於酒精成癮之輔助治療、協助已達戒酒狀態之酒精依賴病人於治療初期維持戒酒、應與社會心理治療併用。

美國 FDA 適應症（英文原文對照）

美國 FDA 核准成分 acamprosate calcium （商品名 acamprosate calcium） · 仿單更新 2023-11-06

1 INDICATIONS AND USAGE Acamprosate calcium delayed-release tablets are indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation ( 1 , 14 ). Treatment with acamprosate calcium delayed-release tablets should be part of a comprehensive management program that includes psychosocial support ( 1 ). Acamprosate calcium delayed-release tablets are indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation. Treatment with acamprosate calcium delayed-release tablets should be part of a comprehensive management program that includes psychosocial support. The efficacy of acamprosate calcium delayed-release tablets in promoting abstinence has not been demonstrated in subjects who have not undergone detoxification and not achieved alcohol abstinence prior to beginning acamprosate calcium delayed-release tablets treatment. The efficacy of acamprosate calcium delayed-release tablets in promoting abstinence from alcohol in polysubstance abusers has not been adequately assessed.

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。