M02AA12 naproxen
MUSCULO-SKELETAL SYSTEM ›TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN ›TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN ›Antiinflammatory preparations, non-steroids for topical use
非健保收載 TFDA 在效許可證 7 FDA 已核准 健保給付條款 1
台灣藥品與外觀
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
- 急慢性風濕關節炎、關節局部腫脹、強直性脊椎關節炎、脊椎炎、椎關節炎、關節周圍炎、上腕肩甲骨炎及骨骼肌不適之粘液囊炎、腱鞘炎等之消炎、鎮痛、解熱。
- 消炎、鎮痛、(風濕性關節炎、骨關節炎、僵直性脊椎炎、外科手術後疼痛、急慢性肌肉骨骼疾患、急性痛風)。
- 風濕性關節炎、關節痛之消炎、解熱、鎮痛。
- 抗炎、解熱鎮痛劑。
- 消炎、鎮痛劑。
- 消炎、鎮痛藥。
- 鎮痛、抗炎劑。
美國 FDA 適應症（英文原文對照）
1 INDICATIONS AND USAGE Naproxen and esomeprazole magnesium delayed-release tablets, a combination of naproxen and esomeprazole magnesium, is indicated in adult and adolescent patients 12 years of age and older weighing at least 38 kg, requiring naproxen for symptomatic relief of arthritis and esomeprazole magnesium to decrease the risk for developing naproxen-associated gastric ulcers. The naproxen component of naproxen and esomeprazole magnesium delayed-release tablets are indicated for relief of signs and symptoms of: osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in adults. juvenile idiopathic arthritis (JIA) in adolescent patients. The esomeprazole magnesium component of naproxen and esomeprazole magnesium delayed-release tablets are indicated to decrease the risk of developing naproxen-associated gastric ulcers. Limitations of Use: Do not substitute naproxen and esomeprazole magnesium delayed-release tablets with the single-ingredient products of naproxen and esomeprazole magnesium. Naproxen and esomeprazole magnesium delayed-release tablets are not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen-containing products. Controlled studies do not extend beyond 6 months [see Use in Specific Populations (8.4) , Clinical Studies (14) ] . Naproxen and esomeprazole magnesium delayed-release tablets are a combination of naproxen, a non-steroidal anti-inflammatory drug (NSAID), and esomeprazole magnesium, a proton pump inhibitor (PPI) indicated in adult and adolescent patients 12 years of age and older weighing at least 38 kg, requiring naproxen for symptomatic relief of arthritis and esomeprazole magnesium to decrease the risk of developing naproxen-associated gastric ulcers. The naproxen component of naproxen and esomeprazole magnesium delayed-release tablets is indicated for relief of signs and symptoms of: osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in adults. juvenile idiopathic arthritis (JIA) in adolescent patients. The esomeprazole magnesium component of naproxen and esomeprazole magnesium delayed-release tablets is indicated to decrease the risk of developing naproxen-associated gastric ulcers. ( 1 ) Limitations of Use: Do not substitute naproxen and esomeprazole magnesium delayed-release tablets with the single-ingredient products of naproxen and esomeprazole magnesium. ( 1 ) Naproxen and esomeprazole magnesium delayed-release tablets are not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen-containing products. ( 1 ) Controlled studies do not extend beyond 6 months. ( 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
上層 ATC 繼承條款
繼承自 ATC M02AA
§ 1.1.1 非類固醇抗發炎劑外用製劑：(88/9/1、92/2/1、94/9/1、109/2/1)
神經系統藥物 › 疼痛解除劑
非類固醇抗發炎劑外用製劑：(88/9/1、92/2/1、94/9/1、109/2/1) 1.外用非類固醇抗發炎軟膏，不得同時併用口服或其他外用非類固醇發炎製劑，每4週至多以處方40gm為限(94/9/1、109/2/1)。 2.Flurbiprofen 40mg patch (如Flur Di Fen Patch)：限同時符合下列條件之病患使用：(92/2/1、109/2/1) (1)單一關節（部位）或軟組織風濕症。 (2)不適合口服非類固醇抗發炎製劑者。 (3)不得同時併用口服或其他外用非類固醇發炎製劑，亦不得開立慢性連續處方箋(109/2/1)。 (4)每4週限處方16片以內(109/2/1)。
歷史演變（4 次異動）
| 生效日 | 異動說明 |
|---|---|
| 88/9/1 | legacy_boan_parsed:ch01.txt |
| 92/2/1 | legacy_boan_parsed:ch01.txt |
| 94/9/1 | legacy_boan_parsed:ch01.txt |
| 109/2/1 | 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 2026-07-01）· 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。