G01AF01 metronidazole

GENITO URINARY SYSTEM AND SEX HORMONES GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS Imidazole derivatives

健保收載品項 TFDA 在效許可證 13 FDA 已核准

台灣藥品與外觀

台灣食藥署在效西藥許可證 13 張;以下列出 13 個品項(1 項有外觀照)。

健保收載品名:"信隆" 美婦寧 陰道用凝膠 0.75%、"信隆"美膚達凝膠0.75%、"嘉林"脫利可膣錠、"大豐" 滅菌佳得陰道栓劑500毫克、"大豐"滅菌佳得陰道栓劑250毫克、"應元" 愛美達凝膠 0.75%、"應元" 柔康陰道用凝膠0.75%、"汎生"潔諾凝膠 0.75%、"華興" 膣潔陰道錠500公絲(硝基甲嘧唑乙醇)、"華興"膣潔陰道錠250公絲(硝基甲嘧唑乙醇)、克柔潔凝膠 7.5 毫克/公克、婦美寧陰道用凝膠0.75%、惠朗陰道錠、服樂淨栓劑、素女潔陰道用凝膠、美充寧陰道錠500公絲

無外觀照
服樂淨栓劑
"強生"妳樂淨膣錠 外觀
"強生"妳樂淨膣錠
橢圓形 · 白 · 刻痕:無 · 17.5 mm
無外觀照
"中美" 愛潔栓劑
無外觀照
"優生"弗滴淨錠
無外觀照
“大豐”滅菌佳得陰道栓劑250毫克
無外觀照
"嘉林"脫利可膣錠
無外觀照
"華興"膣潔陰道錠250公絲(硝基甲嘧唑乙醇)
無外觀照
"大豐" 滅菌佳得陰道栓劑500毫克
無外觀照
"華興" 膣潔陰道錠500公絲(硝基甲嘧唑乙醇)
無外觀照
"信隆" 美婦寧 陰道用凝膠 0.75%
無外觀照
素女潔陰道用凝膠
無外觀照
"應元" 柔康陰道用凝膠0.75%
無外觀照
婦美寧陰道用凝膠0.75%

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

  1. 治療細菌陰道炎:如Haemophilusvaginitis、Gardnereallavaginitis、Nonspecificvaginitis、Corynebacteriumvaginitis或Anaerobicvaginosis。
  2. 治療細菌陰道炎如HAEMOPHILUSVAGINITIS、GARDNEREALLAVAGINITIS、NONSPECIFICVAGINITIS、CORYNEBACTERIUMVAGINITIS或ANAEROBICVAGINOSIS。
  3. 治療陰道滴蟲感染所引起之陰道炎、白帶、阿米巴痢疾、阿米巴肝膿腫及對METRONIDAZOLE具有感受性之厭氧菌所引起之嚴重感染。
  4. 陰道滴蟲感染所引起之陰道炎。

美國 FDA 適應症(英文原文對照)

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: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

查無健保特殊給付規定條款;本藥品依一般健保藥品支付規定給付。

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。