G04CA52 tamsulosin and dutasteride
GENITO URINARY SYSTEM AND SEX HORMONES ›UROLOGICALS ›DRUGS USED IN BENIGN PROSTATIC HYPERTROPHY ›Alpha-adrenoreceptor antagonists
健保收載品項 FDA 已核准 TFDA 在效許可證 3 健保給付條款 1
健保收載品名：坦舒淨膠囊0.5mg/0.4mg、多適達膠囊0.5mg/0.4mg
FDA 適應症
1 INDICATIONS AND USAGE Dutasteride and tamsulosin hydrochloride capsules are a combination of dutasteride, a 5-alpha-reductase inhibitor, and tamsulosin, an alpha-adrenergic antagonist, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate. ( 1.1 ) Limitations of Use: Dutasteride-containing products, including dutasteride and tamsulosin hydrochloride capsules, are not approved for the prevention of prostate cancer. ( 1.2 ) 1.1 Benign Prostatic Hyperplasia (BPH) Treatment Dutasteride and tamsulosin hydrochloride capsules are indicated for the treatment of symptomatic BPH in men with an enlarged prostate. 1.2 Limitations of Use Dutasteride-containing products, including dutasteride and tamsulosin hydrochloride capsules, are not approved for the prevention of prostate cancer.
資料來源：openFDA（美國 FDA Structured Product Labeling）。為英文原文，僅供對照。
TFDA 適應症
NHI 給付規定
直接適用條款
§ 5.2.2.2 Dutasteride + tamsulosin (如Duodart) (101/3/1、102/12/1、106/10/1、
激素及影響內分泌機轉藥物 › 雄性激素類製劑與同化作用類固醇及其拮抗劑
Dutasteride + tamsulosin (如Duodart) (101/3/1、102/12/1、106/10/1、108/12/1)： 限前列腺增生且有阻塞症狀，經直腸超音波前列腺掃描 (TRUS of prostate) 或使用腹部超音波測量(僅限無法實施直腸超音波前列腺掃描者)為原則，前列腺大於30mL或最大尿流速 (Qmax) 小於15 mL/sec之病人。 (102/12/1、108/12/1)
歷史演變（4 次異動）
| 生效日 | 異動說明 |
|---|---|
| 101/3/1 | legacy_boan_parsed:ch05.txt |
| 102/12/1 | legacy_boan_parsed:ch05.txt |
| 106/10/1 | legacy_boan_parsed:ch05.txt |
| 108/12/1 | legacy_boan_parsed:ch05.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。