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              當前位置:首頁 > 產品中心 > 制劑

              注射用氨曲南

              產品說明書

              請仔細閱讀說明書并在醫師指導下使用

              【藥品名稱】

              通用名稱:注射用氨曲南

              英文名稱:Aztreonam for Injection

              漢語拼音:Zhusheyong Anqunan

              【成份】本品主要成份為氨曲南。輔料為:精氨酸。

              化學名稱:[2S-[2α3β(z)]]-2-[[[1-(2-氨基-4-噻唑基)-2-[2-甲基-4-氧代-1-磺基-3-氮雜環丁烷基)氨基]-2-氧代亞乙基]氨基]]-2-甲基丙酸。

              化學結構式:

              分子式:C13H17N5O8S2

              分子量:435.43

              【性狀】

              本品為白色或類白色粉末。

              【適應癥】

              本品適用于治療敏感需氧革蘭陰性菌所致的各種感染,如:尿路感染、下呼吸道感染、敗血癥、腹腔內感染、婦科感染、術后傷口及燒傷、潰瘍等皮膚軟組織感染等。亦用于治療醫院內感染中的上述類型感染(如免疫缺陷病人的醫院內感染)。

              【規格】(10.5g21.0g(按C13H17N5O8S2計算)

              【用法用量】

              用法:

              1.靜脈滴注:每1g氨曲南至少用注射用水3mL溶解,再用適當輸液(0.9%氯化鈉注射液、5%10%葡萄糖注射液或林格氏注射液)稀釋,氨曲南濃度不得超過2%,滴注時間20-60分鐘。

              2.靜脈推注:每瓶用注射用水6-10mL溶解,于3-5分鐘內緩慢注入靜脈。

              3.肌內注射:每1g氨曲南至少用注射用水或0.9%氯化鈉注射液3mL溶解,深部肌內注射。

              用量:

              感染類型

              劑量(g)

              間隔時間(小時)

              尿路感染

              0.51

              812

              全身中重度感染

              12

              812

              全身嚴重感染或危及生命感染

              2

              68

              病人單次劑量大于1g或患敗血癥、其他全身嚴重感染或危及生命的感染應靜脈給藥,最高劑量每日8g

              病人有短暫或持續腎功能減退時:宜根據腎功能情況,酌情減量。對肌酐清除率小于10-30ml/min/1.73m2的腎功能損害者,首次用量1g2g,以后用量減半;對肌酐清除率小于10ml/min/1.73m2,如依靠血液透析的腎功能嚴重衰竭者,首次用量0.5g1g2g,維持量為首次劑量的1/4,間隔時間為6812小時;對嚴重或危及生命的感染者,每次血液透析后,在原有的維持量上增加首次用量的1/8

              【不良反應】

              不良反應較少見,全身性不良反應發生率約1-1.3%或略低,包括消化道反應,常見為惡心、嘔吐、腹瀉及皮膚過敏反應。白血球計數降低、血小板減少、難辨梭菌腹瀉、胃腸出血、剝脫性皮炎、低血壓、一過性心電圖變化、肝膽系統損害、中樞神經系統反應及肌肉疼痛等較罕見。

              靜脈給藥偶見靜脈炎,肌內注射可產生局部不適或腫脹,發生率分別約為1.9%2.4%

              【禁忌】對氨曲南有過敏史者禁用。

              【注意事項】

              1.本品與青霉素之間無交叉過敏反應,但對青霉素、頭孢菌素過敏及過敏體質者仍需慎用。

              2.本品肝毒性低,但對肝功能已受損的病人應觀察其動態變化。

              3.氨曲南可與氯霉素磷酸酯、硫酸慶大霉素、硫酸妥布霉素、頭孢唑啉鈉、氨芐青霉素鈉聯合使用,但和萘呋西林、頭孢拉定、甲硝唑有配伍禁忌。

              4.幾乎所有抗生素均有不同程度的偽膜性結腸炎報道,包括氨曲南在內,因此,在治療過程中應注意腹瀉癥狀,并明確診斷。

              5.使用本品前,請詳閱本品說明書。

              【孕婦及哺乳期婦女用藥】

              1.本品能透過胎盤進入胎兒循環,雖然動物實驗顯示其對胎兒無影響、無毒性和無致畸作用,但缺乏在妊娠婦女進行充分良好對照的臨床研究,對妊娠婦女或有妊娠可能性的婦女,僅在必要時方可給藥。

              2.本品可經乳汁分泌,濃度不及母體血濃度的1%,哺乳婦女使用本品時應暫停哺乳。

              3.其他藥物相互作用尚不明確。

              【兒童用藥】嬰幼兒的安全性尚未確立,應慎用。

              【老年用藥】老年人用藥劑量應按其腎功能減退情況酌情減量。

              【藥物相互作用】

              1.本品與氨基糖苷類(慶大霉素、妥布霉素、阿米卡星等)聯合、對綠膿桿菌、不動桿菌、沙雷桿菌、克雷伯桿菌、普羅威登菌、腸桿菌屬、大腸埃希菌、摩根桿菌等起協同抗菌作用。

              2.本品與頭孢西丁,在體外與體內起拮抗作用;與萘呋西林、氯唑西林、紅霉素、萬古霉素等在藥效方面不起相互干擾作用。

              【藥物過量】

              尚未見使用本品藥物過量的報道,血液透析和腹膜透析將有助于本品從血清中清除。

              【藥理毒理】

              氨曲南對大多數需氧革蘭陰性菌具有高度的抗菌活性,包括大腸埃希菌、克雷伯氏菌屬的肺炎桿菌和奧可西托菌、產氣桿菌、陰溝桿菌、變形桿菌屬、沙雷菌屬、枸櫞酸菌屬、志賀菌屬等腸桿菌科細菌,以及流感桿菌、淋球菌、腦膜炎雙球菌等。其對銅綠假單胞菌也具有良好的抗菌作用,對某些除銅綠假單胞菌以外的假單胞菌屬和不動桿菌屬的抗菌作用較差,對葡萄球菌屬、鏈球菌屬等需氧革蘭陽性菌以及厭氧菌無抗菌活性。氨曲南通過與敏感需氧革蘭陰性菌細胞膜上青霉素結合蛋白3PBP3)高度親和而抑制細胞壁的合成。與大多數β-內酰胺類抗生素不同的是它不誘導細菌產生β-內酰胺酶,同時對細菌產生的大多數β-內酰胺酶高度穩定。

              【藥代動力學】

              肌注吸收迅速、完全,正常受試者單次肌注1g,血藥峰濃度可達45mg/L,達峰時間1小時左右。單次靜脈滴注(30分鐘)0.5g1g2g后,血清峰濃度分別為54mg/L90mg/L204mg/L8小時后各為1mg/L3mg/L6mg/L。以相同劑量改用3分鐘靜脈推注,血清峰濃度分別為58mg/L125mg/L242mg/L 在體內廣泛分布于各種組織和體液中,其分布容積成人為20L。在腎、肝、肺、心、膽囊、骨、輸卵管、卵巢、子宮內膜和前列腺等組織,以及膽汁、胸腹膜液、心包液、支氣管液、羊水、唾液和腦脊液等體液中均可達有效治療濃度。給藥后約60-70%以原形由尿中排泄,12%經糞便排出,以單次0.5g1g2g(30分鐘)靜脈滴注后2小時,尿中濃度可達1100mg/L3500mg/L6600mg/L8-12小時仍可維持在25-120mg/L,以單次0.5g1g肌注給藥后2小時,尿中濃度分別為500mg/L1200mg/L6-8小時后降至180-470mg/L。本品蛋白結合率為40-65%,血清清除半衰期為1.5-2小時,腎功能不全者血清清除半衰期明顯延長,肝功能不全者則略有延長。本品與丙磺舒或磺胺合用將導致氨曲南血藥濃度明顯升高。

              【貯藏】遮光、密閉,在涼暗處保存。

              【包裝】低硼硅玻璃管制注射劑瓶裝,10/盒。配一次性使用預充注射式溶藥器(帶針)。

              【有效期】24個月。

              【執行標準】國家食品藥品監督管理總局標準YBH01002014

              【批準文號】(10.5g:國藥準字H20055485

              21.0g:國藥準字H20055484

              【生產企業】

              企業名稱:福安藥業集團慶余堂制藥有限公司

              址:重慶市渝北區黃楊路2

              郵政編碼:401121

              電話號碼:023-67030096

              傳真號碼:023-67030063


              ?

              福安藥業(集團)股份有限公司 ? 2007 - 2018

              金福彩票

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