P01AB01 metronidazole

ANTIPARASITIC PRODUCTS, INSECTICIDES AND REPELLENTS ANTIPROTOZOALS AGENTS AGAINST AMOEBIASIS AND OTHER PROTOZOAL DISEASES Nitroimidazole derivatives

健保收載品項 FDA 已核准 TFDA 在效許可證 40 健保給付條款 3

健保收載品名:" 大豐"滅菌佳得膠囊250公絲(硝基甲嘧唑乙醇)、"井田" 服膣淨糖衣錠、"人生"可邁淨糖衣錠250毫克、"信隆"咪唑尼達膠囊250公絲、"健康"科理淨膠囊、"優生"弗滴淨錠、"元宙"特力克益舒錠250毫克(硝基甲嘧唑乙醇)、"台灣?野義"服立治兒錠250毫克(硝基甲嘧唑乙醇)、"國嘉"德利治癒膠囊250毫克(硝基甲嘧唑乙醇)、"強生" 妳樂淨內服膜衣錠、"強生"妳樂淨膣錠、"成大" 婦女望錠250毫克(硝基甲嘧唑乙醇)、"易陽" 美托尼達若糖衣錠(咪唑尼達)、"正和"婦女寶膠囊(咪唑尼達)、"福元" 得利根糖衣錠、"紐約"美得康糖衣錠250公絲(硝基甲嘧唑乙醇)

FDA 適應症

美國 FDA 核准成分 metronidazole (商品名 Acnil / METRONIDAZOLE / Metronidazole / metronidazole / metronidazole vaginal) · 仿單更新 2026-04-13

INDICATIONS AND USAGE Symptomatic Trichomoniasis. Metronidazole tablets USP is indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis. Metronidazole tablets USP is indicated in the treatment of asymptomatic T. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatment of Asymptomatic Sexual Partners. T. vaginalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become reinfected if her sexual partner is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the sexual partner should be treated with metronidazole tablets USP in cases of reinfection. Amebiasis. Metronidazole tablets USP is indicated in the treatment of acute intestinal amebiasis (amebic dysentery) and amebic liver abscess. In amebic liver abscess, metronidazole tablets USP therapy does not obviate the need for aspiration or drainage of pus. Anaerobic Bacterial Infections. Metronidazole tablets USP is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with metronidazole tablets USP therapy. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to metronidazole tablets USP. INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroides species including the B. fragilis group ( B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus ), Clostridium species, Eubacterium species, Peptococcus species, and Peptostreptococcus species. SKIN AND SKIN STRUCTURE INFECTIONS caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. GYNECOLOGIC INFECTIONS, including endometritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus species, Peptostreptococcus species, and Fusobacterium species. BACTERIAL SEPTICEMIA caused by Bacteroides species including the B. fragilis group and Clostridium species. BONE AND JOINT INFECTIONS, (as adjunctive therapy), caused by Bacteroides species including the B. fragilis group. CENTRAL NERVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by Bacteroides species including the B. fragilis group. LOWER RESPIRATORY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B. fragilis group. ENDOCARDITIS caused by Bacteroides species including the B. fragilis group. To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole tablets USP and other antibacterial drugs, metronidazole tablets USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

資料來源:openFDA(美國 FDA Structured Product Labeling)。為英文原文,僅供對照。

TFDA 適應症

台灣食藥署在效西藥許可證 40 張。

適應症(去重後 12 項):

  1. 治療陰道滴蟲感染所引起之陰道炎、白帶、阿米巴痢疾、阿米巴肝膿腫、及對METRONIDAZOLE具有感受性之厭氣菌所引起之嚴重感染。
  2. 治療陰道滴蟲感染所引起之陰道炎、白帶、阿米巴痢疾、阿米巴膿腫、及對METRONIDAZOLE具有感受性之厭氣菌所引起之嚴重感染。
  3. 治療陰道滴蟲感染所引起之陰道炎、白帶、阿米巴痢疾、阿米巴肝腫脹及對METRONEDAZOLE具有感受性之厭氣菌所引起之嚴重感染。
  4. 治療陰道滴蟲感染所引起之陰道炎、白帶、阿米巴痢疾、阿米巴肝腫脹及對METRONIDAZOLE具有感受性之厭氣菌所引起之嚴重感染。
  5. 治療陰道滴蟲感染所引起之陰道炎、白帶、阿米巴痢疾、阿米巴肝腫脹及對METRONIDAZOLE具有感受性之厭氧菌所引起之嚴重感染。
  6. 治療陰道滴蟲感染所引起之陰道炎、白帶、阿米巴痢疾、阿米巴肝膿腫及對METROMIDAZOLE具有感受性之厭氣菌所引起之嚴重感染。
  7. 治療陰道滴蟲感染所引起之陰道炎、白帶、阿米巴痢疾、阿米巴肝膿腫及對METRONIDAZOLE具有感受性之厭氣菌所引起之嚴重感染。
  8. 治療陰道滴蟲感染所引起之陰道炎、白帶、阿米巴痢疾、阿米巴肝膿腫及對METRONIDAZOLE具有感受性之厭氧菌所引起之嚴重感染。
  9. 治療陰道滴蟲感所引起之陰道炎、白帶、阿米巴痢疾、阿米巴肝膿腫及對Metronidazole具有感受性之厭氣菌所引起之嚴重感染。
  10. 治療陰道滴蟲感染所引起之陰道炎、白帶、阿米巴痢疾、阿米巴肝腫脹及對METRONIDAZOLE具感受性之厭氧菌所引起之嚴重感染。
  11. 治療陰道滴蟲感染所引起之陰道炎、白帶、阿米巴痢疾、阿米巴肝膿腫及對METROIDAZOLE具有感受性之厭氣菌所引起之嚴重感染。
  12. 治療陰道滴蟲感染所引起之陰道炎、白帶、阿米巴痢疾、阿米巴肝膿腫及對METRONIDAZOLE具有感受性之厭氣菌所引之嚴重感染。
許可證品項:藥品外觀與仿單(24 項)
品名外觀仿單/外盒
硝基甲嘧唑乙醇 仿單
必耐糖衣錠 仿單 · 外盒
滅滴膠囊 仿單
可敵帶膠囊 仿單
脫利可片 仿單 · 外盒
"強生"妳樂淨膣錠 橢圓形 · 白 · 刻痕:無 · 17.5 外觀圖 仿單 · 外盒
"強生" 妳樂淨內服膜衣錠 圓形 · 白 · 刻痕:無 · 11 外觀圖 仿單 · 外盒
"黃氏"妥理帶膠囊 仿單 · 外盒
婦力清錠 圓形 · 白 · 刻痕:直線 · 10 外觀圖 仿單 · 外盒
"美的" 婦樂安膠囊 仿單
帶寧錠 圓形 · 黃 · 刻痕:無 · 標記:SWISS · 11 外觀圖 仿單 · 外盒
妥你寧膠囊(硝基甲嘧唑乙醇) 仿單 · 外盒
"福元" 得利根糖衣錠 圓形 · 白 · 刻痕:無 · 12 外觀圖 仿單 · 外盒
除得淨糖衣錠 圓形 · 粉 · 刻痕:無 · 10 外觀圖 仿單 · 外盒
"中美" 愛潔栓劑 仿單 · 外盒
"成大" 婦女望錠250毫克(硝基甲嘧唑乙醇) 仿單 · 外盒
"光南"舒利蒙膠囊 膠囊 · 黑;;;紅 · 刻痕:無 · 標記:Kuangnan · 21 外觀圖
可靜糖衣錠 仿單
"井田" 服膣淨糖衣錠 圓形 · 橘 · 刻痕:無 · 9 外觀圖 仿單 · 外盒
"優生"弗滴淨錠 仿單 · 外盒
服樂淨腸溶糖衣錠 圓形 · 粉 · 刻痕:無 · 10.7 外觀圖 仿單 · 外盒
"健康"科理淨膠囊 仿單 · 外盒
"人生"可邁淨糖衣錠250毫克 仿單
怡嫝錠 圓形 · 白 · 刻痕:直線 · 標記:MEIDER M · 9.5 外觀圖 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

§ 10.3.7 ceftolozane+tazobactam (如Zerbaxa):(110/3/1)
抗微生物劑 › 頭孢子菌素
ceftolozane+tazobactam (如Zerbaxa):(110/3/1)
1.治療18歲以上成人,患有對ceftolozane/tazobactam有感受性的致病菌引起的以下感染症:
  (1)複雜性腹內感染,需與metronidazole併用。
  (2)複雜性泌尿道感染,包括腎盂腎炎。
  (3)院內感染性肺炎,包括呼吸器相關肺炎。
2.需經會診感染科醫師同意後使用。申報費用時,需檢附感染科醫師會診報告。
歷史演變(1 次異動)
生效日異動說明
110/3/1legacy_boan_parsed:ch10.txt
§ 10.8.1.1 Teicoplanin及vancomycin注射劑:(88/3/1、110/7/1)
抗微生物劑 › 其他
Teicoplanin及vancomycin注射劑:(88/3/1、110/7/1)
1.對其他抗生素有抗藥性之革蘭氏陽性菌感染。
2.病患對其他抗生素有嚴重過敏反應之革蘭氏陽性菌感染。
3.治療抗生素引起之腸炎(antibiotics-associated colitis),經使用metronidazole無效者始可使用口服vancomycin。
4.vancomycin 10 gm(溶液用粉劑)限骨髓移植病例使用。
5.其他經感染症專科醫師認定需使用者。
歷史演變(2 次異動)
生效日異動說明
88/3/1legacy_boan_parsed:ch10.txt
110/7/1legacy_boan_parsed:ch10.txt
§ 10.8.8 Fidaxomicin(如Dificid):(103/9/1)
抗微生物劑 › 其他
Fidaxomicin(如Dificid):(103/9/1)
1.限用於經第一線藥物metronidazole及vancomycin治療無效或復發,且細菌培養或毒素分析(toxin assay)報告證實為困難梭狀桿菌相關腹瀉(C. difficile-associated diarrhoea, CDAD),並經感染症專科醫師會診,確認有感染症需使用者。
2.申報費用時需檢附會診紀錄及相關之病歷資料。
歷史演變(1 次異動)
生效日異動說明
103/9/1legacy_boan_parsed:ch10.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。