A02BC03 lansoprazole
ALIMENTARY TRACT AND METABOLISM ›DRUGS FOR ACID RELATED DISORDERS ›DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD) ›Proton pump inhibitors
健保收載品項 TFDA 在效許可證 19 FDA 已核准 健保給付條款 1
台灣藥品與外觀
健保收載品名："""南光"" 益胃安膠囊１５公絲"、"南光" 益胃安膠囊15毫克、"南光" 胃全膠囊３０毫克、"嘉林"潰可舒膠囊 30 毫克、"衛達"樂胃如膠囊 30 毫克、來得適胃膠囊15毫克、來得適胃膠囊30毫克、優豪凍晶注射劑30毫克、永勝佳胃膠囊15毫克、永勝佳胃膠囊30毫克、泰克胃通 口溶錠15毫克、泰克胃通 口溶錠30毫克、泰克胃通 膠囊 30 毫克、泰克胃通膠囊３０公絲、泰克胃通靜脈注射劑30毫克、泰潰定膠囊３０毫克
無外觀照
蘭索拉唑
無外觀照
蘭索拉唑
無外觀照
拉索咪唑
無外觀照
“生泰”蘭索拉唑
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
- 胃潰瘍、十二指腸潰瘍、胃食道逆流性疾病-糜爛性逆流性食道炎之治療、胃食道逆流性疾病之症狀治療、ZOLLINGER-ELLISON症候群、合併抗生素治療與幽門螺旋桿菌(HELICOBACTERPYLORI)相關的消化性潰瘍、治療因NSAID類藥物引起之胃潰瘍。
- 胃潰瘍、十二指腸潰瘍、胃食道逆流性疾病-糜爛性逆流性食道炎之治療、胃食道逆流性疾病之症狀治療、Zollinger-Ellison症候群、合併抗生素治療與幽門螺旋桿菌(Helicobacterpylori)相關的消化性潰瘍、治療因NSAID類藥物引起之胃潰瘍。
- 胃潰瘍、十二指腸潰瘍、胃食道逆流性疾病-糜爛性逆流性食道炎之治療、胃食道逆流性疾病之症狀治療、Zollomger-Ellison症候群、合併抗生素治療與幽門螺旋桿菌(Helicobacterpylori)相關的消化性潰瘍、治療因NSAID類藥物引起之胃潰瘍。
- 胃潰瘍、十二指腸潰瘍、胃食道逆流性疾病-靡爛性逆流性食道炎之治療、胃食道逆流性疾病之症狀治療、Zollinger-Ellison症侯群、合併抗生素治療與幽門螺旋桿菌(Helicobacterpylori)相關的消化性潰瘍、治療因NSAID類藥物引起之胃潰瘍。
- 胃潰瘍、十二指腸潰瘍、胃食道逆流性疾病-糜爛性逆流性食道炎之治療、胃食道逆流性疾病之症狀治療。Zollomger-Ellison症候群、合併抗生素治療與幽門螺旋桿菌(Helicobacterpylori)相關的消化性潰瘍、治療因NSAID類藥物引起之胃潰瘍。
- 胃潰瘍、十二指腸潰瘍、胃食道逆流性疾病-靡爛性逆流性食道炎之治療、胃食道逆流性疾病之症狀治療。ZOLLINGER-ELLISON症候群、合併抗生素治療與幽門螺旋桿菌(HELICOBACTERPYLORI)相關的消化性潰瘍、治療因NSAID類藥物引起之胃潰瘍。
- 胃潰瘍、十二指腸潰瘍、胃食道逆流性疾病-靡爛性逆流性食道炎之治療、胃食道逆流性疾病之症狀治療。Zollinger-Ellison症候群、合併抗生素治療與幽門螺旋桿菌(Helicobacterpylori)相關的消化性潰瘍、治療因NSAID類藥物引起之胃潰瘍。
- 胃潰瘍、十二指腸潰瘍、胃食道逆食性疾病-糜爛性逆流性食道炎之治療、胃食道逆流性疾病之症狀治療。ZOLLINGER-ELLISON症候群、合併抗生素治療與幽門螺旋桿菌(HELICOBACTERPYLORI)相關的消化性潰瘍、治療因NSAID類藥物引起之胃潰瘍。
- 胃潰瘍、十二指腸潰瘍、逆流性食道炎、ZOLLINGER-ELLISON症候群。
- 無法投與口服藥物之胃潰瘍、十二指腸潰瘍與急性壓力性潰瘍病人。
- 消化性潰瘍。
美國 FDA 適應症（英文原文對照）
1 INDICATIONS AND USAGE Lansoprazole delayed-release capsule is a proton pump inhibitor (PPIs) indicated for the: • Treatment of active duodenal ulcer in adults. ( 1.1 ) • Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults. ( 1.2 ) • Maintenance of healed duodenal ulcers in adults. ( 1.3 ) • Treatment of active benign gastric ulcer in adults. ( 1.4 ) • Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. ( 1.5 ) • Risk reduction of NSAID-associated gastric ulcer in adults. ( 1.6 ) • Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older.( 1.7 ) • Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. ( 1.8 ) • Maintenance of healing of EE in adults. ( 1.9 ) • Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. ( 1.10 ) 1.1 Treatment of Active Duodenal Ulcer Lansoprazole delayed-release capsules are indicated in adults for short-term treatment (for four weeks) for healing and symptom relief of active duodenal ulcer [see Clinical Studies ( 14.1 ) ]. 1.2 Eradication of H.pylori to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy: Lansoprazole delayed-release capsules/amoxicillin/clarithromycin Lansoprazole delayed-release capsules in combination with amoxicillin plus clarithromycin as triple therapy is indicated in adults for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies ( 14.2 ) ]. Please refer to the full prescribing information for amoxicillin and clarithromycin. Dual Therapy: Lansoprazole delayed-release capsules /amoxicillin Lansoprazole delayed-release capsules in combination with amoxicillin as dual therapy is indicated in adults for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected (see the clarithromycin prescribing information, Microbiology section). Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies ( 14.2 ) ]. Please refer to the full prescribing information for amoxicillin. 1.3 Maintenance of Healed Duodenal Ulcers Lansoprazole delayed-release capsules are indicated in adults to maintain healing of duodenal ulcers. Controlled studies do not extend beyond 12 months. [see Clinical Studies ( 14.3 ) ]. 1.4 Treatment of Active Benign Gastric Ulcer Lansoprazole delayed-release capsules are indicated in adults for short-term treatment (up to eight weeks) for healing and symptom relief of active benign gastric ulcer [see Clinical Studies ( 14.4 ) ]. 1.5 Healing of NSAID-Associated Gastric Ulcer Lansoprazole delayed-release capsules are indicated in adults for the treatment of NSAID-associated gastric ulcer in patients who continue NSAID use. Controlled studies did not extend beyond eight weeks [see Clinical Studies ( 14.5 ) ]. 1.6 Risk Reduction of NSAID-Associated Gastric Ulcer Lansoprazole delayed-release capsules are indicated in adults for reducing the risk of NSAID-associated gastric ulcers in patients with a history of a documented gastric ulcer who require the use of an NSAID. Controlled studies did not extend beyond 12 weeks [see Clinical Studies ( 14.6 ) ]. 1.7 Treatment of Symptomatic Gastroesophageal Reflux Disease (GERD) Lansoprazole delayed-release capsules are indicated for short-term treatment in adults and pediatric patients 12 to 17 years of age (up to eight weeks) and pediatric patients one to 11 years of age (up to 12 weeks) for the treatment of heartburn and other symptoms associated with GERD [see Clinical Studies ( 14.7 ) ]. 1.8 Treatment of Erosive Esophagitis (EE) Lansoprazole delayed-release capsules are indicated for short-term treatment in adults and pediatric patients 12 to 17 years of age (up to eight weeks) and pediatric patients one to 11 years of age (up to 12 weeks) for healing and symptom relief of all grades of EE. For adults who do not heal with lansoprazole delayed-release capsules for eight weeks (5 to 10%), it may be helpful to give an additional eight weeks of treatment. If there is a recurrence of erosive esophagitis an additional eight week course of lansoprazole delayed-release capsules may be considered [see Clinical Studies ( 14.8 )]. 1.9 Maintenance of Healing of EE Lansoprazole delayed-release capsules are indicated in adults to maintain healing of EE. Controlled studies did not extend beyond 12 months [see Clinical Studies ( 14.9 ) ]. 1.10 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (ZES) Lansoprazole delayed-release capsules are indicated in adults for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome [see Clinical Studies ( 14.10 ) ].
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
上層 ATC 繼承條款
繼承自 ATC A02
§ 7.1 消化性潰瘍用藥
腸胃藥物 › 消化性潰瘍用藥
消化性潰瘍用藥 (Peptic ulcer drugs)
1.藥品種類：
(1)制酸懸浮劑：各廠牌瓶裝、袋裝制酸懸浮劑及袋裝顆粒制酸劑。
(2)乙型組織胺受體阻斷劑：各廠牌乙型組織胺受體阻斷劑之口服製劑與針劑。
(3)氫離子幫浦阻斷劑：各廠牌氫離子幫浦阻斷劑。
(4)細胞保護劑：如gefarnate、cetraxate、carbenoxolone等。
(5)其他消化性潰瘍用藥：dibismuth trioxide, sucralfate, pirenzepine HCl, Gaspin, Caved-S, misoprostol, proglumide及其他未列入之同類藥品，價格與其相當者比照辦理。
2.使用規定：(106/12/1、110/12/1、113/8/1)
(1)使用於治療活動性（active）或癒合中（healing）之消化性潰瘍及逆流性食道炎。(92/10/1)
(2)瘢痕期（scar stage）之消化性潰瘍復發預防，其劑量依照醫理減量使用。
(3)消化性潰瘍及逆流性食道炎符合洛杉磯食道炎分級表（The Los Angeles Classification of Esophagitis※備註）Grade A或Grade B者，欲使用消化性潰瘍用藥，其使用期間以四個月為限，申報費用時需檢附四個月內有效之上消化道內視鏡檢查或上消化道Ｘ光攝影報告，其針劑限使用於消化道出血不能口服之病人急性期替代療法。(92/10/1)
(4)經上消化道內視鏡檢查，診斷為重度逆流性食道炎，且符合洛杉磯食道炎分級表（The Los Angeles Classification of Esophagitis※備註）Grade C或Grade D者，得經消化系專科醫師之確認後可長期使用消化性潰瘍用藥一年。另外，下列病患得比照辦理：(92/10/1)
Ⅰ.胃切除手術縫接處產生之潰瘍。
Ⅱ.經消化系專科醫師重覆多次（三次以上）上消化道內視鏡檢查確認屬難治癒性之潰瘍。經診斷確定為Zollinger-Ellision症候群之病患，得長期使用氫離子幫浦阻斷劑而不受一年之限制。
(5)因腦中風，冠狀動脈疾病或周邊血管疾病，或易出血體質(備註)而需使用雙重抗血小板藥物及抗凝血藥物，如aspirin、warfarin、tirofiban、cilostazol、P2Y12 inhibitor（如clopidogrel、ticagrelor、ticlopidine、prasugrel）或新一代口服抗凝血藥物（如rivaroxaban、apixaban、edoxaban、dabigatran）病人得以使用每日藥費6.5元以下之氫離子幫浦阻斷劑(PPI)，最長以16週為限；若為曾接受過內視鏡檢查，經彩色內視鏡圖譜證實有活動性消化性潰瘍或上消化道出血，最長以一年為限，如使用期間或停藥後，活動性消化性潰瘍再發或上消化道出血，得再治療一年。(110/12/1)
備註：易出血性體質建議如下(110/12/1)：
I.第五期慢性腎臟病(eGFR<15mL/min/1.73M2)或透析治治療中
II.血小板＜80,000 /mm3。
III.肝臟疾病且INR>1.7。
IV.其他凝血功能不全疾病。
(6)需使用NSAIDs而曾經上消化道內視鏡或Ｘ光攝影證實有過潰瘍，得於使用NSAIDs期間內，使用消化性潰瘍用藥。(92/10/1、110/12/1)
(7)對於症狀擬似逆流性食道炎之患者，但其上消化道內視鏡檢查無異常，若欲使用消化性潰瘍用藥，則需檢附其他相關檢查（如24小時pH監測）的結果。(92/10/1)
(8)消化性潰瘍穿孔病人經手術證實者，且所施手術僅為單純縫合，未作胃酸抑制相關手術者，可檢附手術記錄或病理檢驗報告，申請使用消化性潰瘍用藥，但以四個月內為限，如需繼續使用，仍請檢附胃鏡檢查或上腸胃道Ｘ光檢查四個月內有效報告影本。(92/10/1)
(9)嚴重外傷、大手術、腦手術、嚴重燙傷、休克、嚴重胰臟炎及急性腦中風者為預防壓力性潰瘍，得使用消化性潰瘍藥品。此類藥物之針劑限使用於不能口服之前述病患短期替代療法。
(10)經由碳13尿素呼氣檢查、或幽門螺旋桿菌糞便抗原檢查、或上消化道內視鏡切片檢查，確診為幽門螺旋桿菌感染之病人，得進行初次幽門螺旋桿菌消除治療，使用時需檢附檢測報告並註明初次治療。(92/10/1、113/8/1)
(11)幽門螺旋桿菌之消除治療療程以二週為原則，特殊病例需延長治療或再次治療，需檢附相關檢驗報告說明理由。
(12)下列病患若因長期服用NSAIDs而需使用前列腺素劑(如misoprostol)，得免附胃鏡報告：(99/7/1)
Ⅰ.紅斑性狼瘡。
Ⅱ.五十歲以上罹患類風濕性關節炎或僵直性脊椎炎之病患。
(13)經消化系專科醫師上消化道內視鏡檢查，並經病理切片確診為Barrett's esophagus之病患，可使用消化性潰瘍用藥一年，一年內至少須經上消化道內視鏡檢查追蹤一次。(101/1/1)
(14)腦性麻痺、先天性心臟病、消化道畸形及其他有施行胃鏡檢查困難之兒科病患有消化道出血、消化性潰瘍、逆流性食道炎者，可使用消化性潰瘍用藥六個月。上述病人若經上消化道X光攝影或經食道酸鹼度測定為重度逆流者，得經兒科消化醫學次專科醫師確認後長期使用消化性潰瘍用藥一年。(106/12/1)
備註：
1.The Los Angeles Classification of Esophagitis
Grade A: One or more mucosal break,each ≦5mm long,confined to the mucosal folds。
Grade B: One or more mucosal break > 5mm long, confined to the mucosal folds but not continuous between the tops of two mucosal folds。
Grade C: One or more mucosal break continuous between the tops of two or more mucosal folds but which involve less than 75% of the esophageal circumference。
Grade D: Mucosal breaks which involve less than 75% of the esophageal circumference。
2.醫療院所使用單價新台幣四元(含)以下之消化性潰瘍用藥時，得由醫師視病情決定是否需要上消化道內視鏡檢查。(92/10/1) 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。