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              當前位置:首頁 > 產品中心 > 制劑

              注射用阿莫西林鈉克拉維酸鉀

              產品說明書
              【藥品名稱】
              通用名稱:注射用阿莫西林鈉克拉維酸鉀
              英文名稱:Amoxicillin Sodium and Clavulanate Potassium for Injection
              漢語拼音:Zhusheyong Amoxilinna Kelaweisuanjia
              【成份】 本品為復方制劑,其組份為阿莫西林鈉和克拉維酸鉀(5:1)。無輔料。
              【性狀】本品為白色或類白色粉末。
              【適應癥】
              適用于產β-內酰胺酶的敏感菌所致的下列感染:

              1、上呼吸道感染:鼻竇炎、扁桃體炎、咽炎。
              2
              、下呼吸道感染:急性支氣管炎、慢性支氣管炎急性發作、肺炎、肺膿腫和支氣管擴張合并感染。
              3
              、泌尿系統感染:膀胱炎、尿道炎、腎盂腎炎、前列腺炎、盆腔炎、淋病奈瑟菌尿路感染。
              4
              、皮膚及軟組織感染:癤、膿腫、蜂窩組織炎、傷口感染、腹內膿毒病等。
              5
              、其他感染:中耳炎、骨髓炎、敗血癥、腹膜炎和手術后感染。
              【規格】 10.3g(阿莫西林0.25g與克拉維酸0.005g

              20.6g(阿莫西林0.5g與克拉維酸0.1g

              31.2g(阿莫西林1.0g與克拉維酸0.2g
              【用法用量】
              取本品一次用量溶于50-100ml氯化鈉注射液中,靜脈滴注30分鐘。

              成人和12歲以上兒童:常用劑量一次1.2g,每8小時一次。嚴重感染者可增加至每6小時一次。

              3個月至12歲以上兒童:常用劑量每公斤體重30mg(相當于阿莫西林25mg,克拉維酸5mg),每8小時一次。感染嚴重時可增加至每6小時一次。

              0-3個月嬰幼兒:早產兒及足月新生兒美12小時給藥一次,每次每公斤體重30mg(相當于阿莫西林25mg,克拉維酸5mg),以后可增加至每8小時一次。

              療程10-14日。
              【不良反應】
              1.
              少數患者可見惡心、嘔吐、腹瀉等胃腸道反應,對癥治療后可繼續給藥。
              2.
              偶見蕁麻疹和皮疹(尤易發生于傳染性單核細胞增多癥者),若發生,應停止使用本品,并對癥治療。
              3.
              可見過敏性休克、血管神經性水腫、藥物熱和哮喘等。
              4.
              偶見血清氨基轉移酶升高、嗜酸性粒細胞增多、白細胞減少及念珠菌和耐藥菌引起的二重感染。
              5.
              少數患者可見暫時性肝功能異常。

              6.文獻報道個別患者注射部位出現靜脈炎。
              【禁忌】
              青霉素皮試陽性反應者、對本品及其他青霉素類藥物過敏者及傳染性單核細胞增多癥患者禁用。
              【注意事項】
              1.
              用本品前進行青霉素皮試。
              2.
              對頭孢菌素類藥物過敏者、嚴重肝功能障礙者、中度或嚴重腎功能障礙者及有哮喘、濕疹、枯草熱、蕁麻疹等過敏性疾病史者慎用。
              3.
              本品與其他青霉素類和頭孢菌素類藥物之間有交叉過敏性。若有過敏反應產生,則應立即停用本品,并采取相應措施。
              4.
              本品和氨芐西林有完全交叉耐藥性,與其他青霉素類和頭孢菌素類有交叉耐藥性。
              5.
              腎功能減退者應根據血漿肌酐清除率調整劑量或給藥期間;血液透析可影響本品中阿莫西林的血藥濃度,因此在血液透析過程中及結束時應加用本品1次。
              6.
              對懷疑為伴梅毒損害之淋病患者,在使用本品前應進行暗視野檢查,并至少在4個月內,每月接受血清試驗一次。
              7.
              長期或大劑量使用本品者,應定期檢查肝、腎、造血系統功能和檢測血清鉀或鈉。
              8.
              長期使用本品可能導致梭狀芽孢桿菌過度生長,引發“抗生素相關性腸炎”,應明確診斷并采取適當措施。

              9.對實驗室檢查指標的干擾:①硫酸銅法尿糖試驗可呈假陽性,但葡萄糖酶試驗法不受影響;②可使血清丙氨酸氨基轉移酶或門冬氨酸氨基轉移酶測定值升高。
              10.
              本品溶解后應立即給藥(25℃以下最長可在3小時以內給藥),剩余藥液應廢棄,不可再用。制備好的本品溶液不能冷凍保存。
              11.
              本品不宜肌內注射。
              12.
              本品在含有葡萄糖、葡聚糖或酸性碳酸鹽的溶液中會降低穩定性,故本品不能與含有上述物質的溶液混合。
              13.
              本品溶液在體外不可與血制品、含蛋白質的液體(如水解蛋白等)混合,也不可與靜脈脂質乳化液混合。
              14.
              本品不能與氨基糖苷類抗生素在體外混合,因為本品可使后者喪失活性。
              【孕婦及哺乳期婦女用藥】
              1.
              本品可通過胎盤,臍帶血中濃度為母體血藥濃度的1/4-1/3,故孕婦禁用。
              2.
              本品可分泌入母乳中,可能使嬰兒致敏并引起腹瀉、皮疹、念球菌屬感染等,故哺乳期婦女慎用或用藥期間暫停哺乳。
              【兒童用藥】 尚不明確。
              【老年用藥】老年患者應根據腎功能情況調整用藥劑量或用藥間期。
              【藥物相互作用】
              1.
              阿司匹林、吲哚美辛、保泰松、磺胺藥可減少本品在腎小管的排泄,因而使本品的血藥濃度升高,血消除半衰期(t1/2β)延長,毒性也可能增加。
              2.
              本品與別嘌醇合用時,皮疹發生率顯著增高,故應避免合用。
              3.
              本品不宜與雙硫侖等乙醛脫氫酶抑制藥合用。
              4.
              本品與氯霉素合用于細菌性腦膜炎時,遠期后遺癥的發生率較兩者單用時高。
              5.
              本品可刺激雌激素代謝或減少其腸肝循環,因此可降低口服避孕藥的效果。
              6.
              氯霉素、紅霉素、四環素類等抗生素和磺胺藥等抑菌藥可干擾本品的殺菌活性,因此不宜與本品合用,尤其在治療腦膜炎或急需殺菌藥的嚴重感染時。
              7.
              本品可加強華法林的作用。
              8.
              氨基糖苷類抗生素在亞抑菌濃度時一般可增強本品對糞腸球菌的體外殺菌作用。
              【藥物過量】 尚不明確。
              【藥理毒理】
              本品為阿莫西林鈉和克拉維酸鉀的復方制劑。阿莫西林為廣譜青霉素類抗生素,克拉維酸鉀本身只有微弱的抗菌活性,但具有強大廣譜β內酰胺酶水解抑制作用,兩者合用,可保護阿莫西林免遭β內酰胺酶水解。 本品的抗菌譜與阿莫西林相同,且有所擴大。對產酶金黃色葡萄球菌,表皮葡萄球菌,凝固酶陰性葡萄球菌及腸球菌均具良好作用,對某些產β內酰胺酶的腸桿菌科細菌、流感嗜血桿菌、卡他莫拉菌、脆弱擬桿菌等也有較好的抗菌活性。本品對耐甲氧西林葡萄球菌及腸桿菌屬等產染色體介導型酶的腸桿菌科細菌和假單胞菌屬無作用。
              【藥代動力學】
              靜脈給予本品1.2g(含阿莫西林1g與克拉維酸鉀0.2g),藥代動力學均符合二室開放模型,阿莫西林的血消除半衰期(t1/2β)為1.03±0.11小時,克拉維酸的血消除半衰期(t1/2β)為(0.838±0.04)小時。二個藥均有較低的血清蛋白結合率,約70%游離狀態的本品存在于血液中,阿莫西林和克拉維酸均以很高的濃度從尿中排出,8小時尿中排泄率阿莫西林約為60%,克拉維酸約為50%。
              【貯藏】 密閉,在涼暗干燥處保存。
              【包裝】 低硼硅玻璃管制注射劑瓶裝, 10/盒。
              【有效期】 24個月
              【執行標準】 《中國藥典》2010年版二部
              【批準文號】 10.3g:國藥準字H20067327 20.6g:國藥準字H20067328

              31.2g:國藥準字H20067326

              ?

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

              金福彩票

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