B05XA02 sodium bicarbonate
BLOOD AND BLOOD FORMING ORGANS ›BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS ›I.V. SOLUTION ADDITIVES ›Electrolyte solutions
健保收載品項 FDA 已核准 TFDA 在效許可證 4 健保給付條款 1
健保收載品名:"信東" 樂麗康注射液(碳酸氫鈉)、"壽元"重曹注射液70公絲/公撮(碳酸氫鈉)、"安星"碳酸氫鈉注射液70毫克/毫升、碳酸氫鈉注射液70公絲/公撮、碳酸氫鈉靜脈注射液8.4%W/V、美朗注射液、重曹注射液
FDA 適應症
1 INDICATIONS AND USAGE Omeprazole and Sodium Bicarbonate for oral suspension and Omeprazole and Sodium Bicarbonate capsules are indicated in adults for the : short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. short-term treatment (4 to 8 weeks) of active benign gastric ulcer. treatment of heartburn and other symptoms associated with GERD for up to 4 weeks. short-term treatment (4 to 8 weeks) of EE due to acid-mediated GERD which has been diagnosed by endoscopy in adults. The efficacy of Omeprazole and Sodium Bicarbonate used for longer than 8 weeks in patients with EE has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8-week courses of Omeprazole and Sodium Bicarbonate may be considered. maintenance of healing of EE due to acid-mediated GERD. Controlled studies do not extend beyond 12 months. Omeprazole and Sodium Bicarbonate for oral suspension is indicated in adults for the : reduction of risk of upper GI bleeding in critically ill adult patients. Omeprazole and Sodium Bicarbonate is a proton pump inhibitor (PPI). Omeprazole and Sodium Bicarbonate for oral suspension and Omeprazole and Sodium Bicarbonate capsules are indicated in adults for: Treatment of active duodenal ulcer ( 1 ) Treatment of active benign gastric ulcer ( 1 ) Treatment of erosive esophagitis (EE) due to acid-mediated gastroesophageal reflux disease (GERD) ( 1 ) Maintenance of healing of EE ( 1 ) Omeprazole and Sodium Bicarbonate for oral suspension is indicated in adults for: Reduction of risk of upper gastrointestinal (GI) bleeding in critically ill patients ( 1 )
資料來源:openFDA(美國 FDA Structured Product Labeling)。為英文原文,僅供對照。
TFDA 適應症
適應症(去重後 3 項):
- 酸性中毒疾患、濕疹、蕁麻疹等皮膚疾患、胰島素休克之緩和、孕吐暈車、大腸菌性尿路疾患、結核性膀胱炎、防止由葡萄糖注射液等引起之體液酸化。
- 酸中毒、濕疹、大腸菌性尿道疾患、結核性膀胱炎、葡萄糖注射後體液酸化之防止。
- 制酸劑、一般酸中毒性疾患。
許可證品項:藥品外觀與仿單(4 項)
| 品名 | 外觀 | 仿單/外盒 |
|---|---|---|
| 重曹注射液 | — | 仿單 · 外盒 |
| 碳酸氫鈉注射液70公絲/公撮 | — | 仿單 · 外盒 |
| "信東" 樂麗康注射液(碳酸氫鈉) | — | 仿單 · 外盒 |
| “安星”碳酸氫鈉注射液70毫克/毫升 | — | 仿單 · 外盒 |
資料來源:食藥署「西藥許可證」+「藥品 ATC 碼」+「藥品仿單或外盒」+「藥品外觀」開放資料。
NHI 給付規定
直接適用條款
§ 3.3.7 Sodium bicarbonate 成分之口服製劑給付規定:(95/8/1、96/12/1)
代謝及營養劑 › 其他
Sodium bicarbonate成分之口服製劑給付規定:(95/8/1、96/12/1) 限用於代謝性酸中毒。
歷史演變(2 次異動)
| 生效日 | 異動說明 |
|---|---|
| 95/8/1 | legacy_boan_parsed:ch03.txt |
| 96/12/1 | legacy_boan_parsed:ch03.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。