注射用头孢美唑钠说明书

注射用头孢美唑钠说明书 美之全 注射用头孢美唑钠说明书 请仔细阅读说明书并在医师指导下使用 【药品名称】 通用名称:注射用头孢美唑钠 商品名称:美之全 英文名称:Cefmetazole Sodium for Injection 汉语拼音:Zhusheyong Toubaomeizuona 【成份】本品主要成分为头孢美唑钠，化学名称:(6R,7R)-7-[2-[(氰甲基)硫]乙酰氨基]-7-甲氧基-3-[(1-甲基-1H-四唑-5-基)硫烷基甲基]-8-氧代-5-硫杂-1-氮杂双环[4.2.0]辛-2-烯-2-羧酸钠盐。 其结构式为: 分子式:C15H16N7NaO5S3: 分子量:493.52 【性状】本品为白色至微黄色粉末。 【适应症】 本品适用于治疗由对头孢美唑钠敏感的金黄色葡萄球菌、大肠埃希菌、肺炎杆菌、变形杆菌属、摩氏摩根菌、普罗威登斯菌属、消化链球菌属、拟杆菌属、普雷沃菌属(双路普雷沃菌除外)所引起的下述感染: ? 败血症 ? 急性支气管炎、肺炎、肺脓肿、脓胸、慢性呼吸道疾病继发感染 ? 膀胱炎、肾盂肾炎 ? 腹膜炎 ? 胆囊炎、胆管炎 ? 前庭大腺炎、子宫内感染、子宫附件炎、子宫旁组织炎 ? 颌骨周围蜂窝织炎、颌炎 【规格】0.5g(按头孢美唑计算) 【用法与用量】 成人，每日1,2克(效价)，分2次静脉注射或静脉滴注。 小儿，每日25,100毫克(效价)/公斤体重，分2,4次静脉注射或静脉滴注。 另外，难治性或严重感染，可随症状将每日量成人增至4克(效价)、小儿增至150毫克(效价)/公斤体重，分2,4次给药。 静脉注射时，本品1克(效价)溶于注射用蒸馏水、生理盐水或葡萄糖注射液10毫升中，缓慢注入。另外，本品还可加入补液中静脉滴注，此时不得用注射用蒸馏水溶解，因溶液渗透压不等张。 <用法、用量的使用注意事项> (1) 严重肾功能损害患者，应适当调节给药剂量及给药间隔等，慎重用药(参照【慎重用药】及【药代动力学】项)。 (2) 使用本品时，原则上应做药敏试验，且用药应限于治疗疾病必要的最短时间[防止出现耐药菌等]。 <用药须知> (1) 配制方法:配制静脉滴注剂时，应参照前述用法用量栏记载的注意事项。 (2) 给药:静脉内大量给药时，可能会引起血管刺激性痛，故应充分注意注射液的配制、注射部位及注射方法等并尽量缓慢注入。 for computer software engineering GB/T50314-2000 of electrical installations code for construction and acceptance of GBJ232- 92 intelligent building weak design construction figure set GJBT-471 2. system description this times engineering weak design including: hours a Kok information facilities system integrated wiring system (containing room network, communications part) wired TV system information guide and the released system hours II Kok public security system fire automatically alarm system (containing public broadcast part) security technology prevention system security monitoring system out entrance control system car library management system hours three Kok building equipment monitoring system hours four Kok information application system queued station ICU visitation system operation the system monitoring and training system call intercom system hours, five hours Kok Kok intelligent integrated system of information system (1) cabling systems (including computer room network, communication component) computer network systems and voice communications systems Center of information on medical floor computer room located in the engine room. Voice communication system using a local telecommunications operator providing voice service, configuration-independent integrated services digital program-controlled switchboards. Operators providing communications ... If any compatibility requirements, by way of increased access to the Communications Board within the chassis to meet 【不良反应】(本项包括不能计算发生率的不良反应) 总计27，356个病例中,不良反应报告例为841例(3.07%),主要有AST(GOT)升高(0.94%)、ALT(GPT)升高(0.90%)皮疹(0.82%)、恶心及呕吐(0.20%)等。 1. 重大不良反应 (1)罕见引起休克(0.01%以下)、过敏反应症状(不适感、口腔异常感、喘鸣、眩晕、便意、耳鸣、发汗等)(发生率不详)。故应注意观察，若出现异常，应立即停药并作适当处理。 (2)有可能出现皮肤粘膜眼综合征(Stevens-Johnson综合症)(发生率不详)、中毒性表皮坏死症(Lyell综合征)(发生率不详)。一旦发现类似症状，应立即停药并作适当处理。 (3)有可能出现急性肾功能衰竭(发生率不详)等严重肾功能损害，故应仔细观察，定期检查肾功能，若出现BUN及血肌酐升高等，应立即停药并作适当处理。 (4)肝炎(发生率不详)、肝功能障碍(发生率不详)、黄疸(发生率不详):因为有AST(GOT)、ALT(GPT)显著升高等肝炎、肝功能障碍表现，故应注意观察，若出现异常，应立即停药并作适当处理。 (5)有可能出现粒细胞缺乏症(发生率不详)、溶血性贫血(发生率不详)、血小板减少(发生率不详)。故应注意观察，若出现异常，应立即停药并作适当处理。 (6)罕见出现伴有便血的伪膜性肠炎(低于0.01%)(初期症状:腹痛、腹泻频繁)。故应注意观察，若出现异常，应立即停药并作适当处理。 (7)有可能出现伴有发热、咳嗽、呼吸困难、胸部X射线检查异常、嗜酸细胞增多等症状的间质性肺炎(发生率不详)、伴有嗜酸细胞增多肺浸润(PIE)综合症(发生率不明)。一旦出现类似症状，应立即停药并作适当处理，如使用肾上腺皮质激素。 2. 其它不良反应 不良反应发生率 发生率不详 0.1~<,, <0.1% 过敏反应注) 皮疹、瘙痒 荨麻疹、红斑、发热 粒细胞减少、 红细胞减少、 血液 嗜酸粒细胞增多 血小板减少 AST(GOT)升高、 肝脏 ALT(GPT)升高、 ALP升高 肝功能异常 消化系统 恶心及呕吐、腹泻 食欲不振 菌群失调 口腔炎、念珠菌病 维生素B群缺乏(舌炎、维生素 维生素K缺乏(低凝血酶原血 口腔炎、食欲不振、神缺乏症 症、 出血倾向等) 经炎等) 其他 头痛 (注)出现症状时应立即停药并作适当处理。 for computer software engineering GB/T50314-2000 of electrical installations code for construction and acceptance of GBJ232- 92 intelligent building weak design construction figure set GJBT-471 2. system description this times engineering weak design including: hours a Kok information facilities system integrated wiring system (containing room network, communications part) wired TV system information guide and the released system hours II Kok public security system fire automatically alarm system (containing public broadcast part) security technology prevention system security monitoring system out entrance control system car library management system hours three Kok building equipment monitoring system hours four Kok information application system queued station ICU visitation system operation the system monitoring and training system call intercom system hours, five hours Kok Kok intelligent integrated system of information system (1) cabling systems (including computer room network, communication component) computer network systems and voice communications systems Center of information on medical floor computer room located in the engine room. Voice communication system using a local telecommunications operator providing voice service, configuration-independent integrated services digital program-controlled switchboards. Operators providing communications ... If any compatibility requirements, by way of increased access to the Communications Board within the chassis to meet 【禁忌】 对本剂成分有休克既往史患者不得用药。 对本剂成分或头孢烯类抗生素有过敏症既往史患者原则上不得不用药时慎用. 【注意事项】 1、慎重用药(下述患者应慎重用药) (1)对青霉素类抗生素有过敏症即往史者。 (2)本人或双亲、弟兄有易引起支气管哮喘、皮疹、寻麻疹等过敏症状体质患者。 (3)严重肾损害患者[有可能出现血药浓度升高、半衰期延长](参照 [用法用量]的使用注意及[药代动力学]项)。 (4)经口摄食不足患者或非经口维持营养者、全身状态不良患者(通过摄食不能补充维生素K的患者，会出现维生素K缺乏)。 (5)高龄者(参照 [老年用药]项)。 2、重要注意事项 (1)因为没有确切的方法预知本品引起的休克、过敏样反应，应采取如下措施; 1)使用前应充分询问病史，尤其必须确认对抗生素的过敏史。 2)使用时，必须准备好休克的急救措施。 3)从给药开始到结束，患者保持安静状态，充分观察。特别是给药刚开始时要充分注意观察。 (2)给药期间及给药后至少1周避免饮酒(参照[药物相互作用]项) 3、对临床检验结果所及影响 linitest进行的尿(1)除了用检尿糖用试纸反应以外，用本尼迪特氏试药、费林氏试药及C糖检查，有时呈阳性，故应注意。 (2)用雅费氏反应进行肌酐检查时，表观肌酐值有可能示高值，故应注意。 (3)直接库姆斯氏试验，有时呈阳性。 【孕妇及哺乳期妇女用药】 孕妇或可能妊娠的妇女，仅在治疗的有益性超过危险性时方可给药[尚未确立妊娠期用药的安全性]。 【儿童用药】 详见【用法用量】项。 【老年用药】 对老年患者，应在注意以下因素的同时，考虑用量和给近间隔等因素，慎重给药。 (1)老年患者因生理机能降低，易发生不良反应。 (2)老年患者因维生素K缺乏可能引起出血倾向。 【药物相互作用】 合并用药时应注意: 药物名称 临床症状及处理方法 机理及危险因子 饮酒会出现双硫仑样作用(颜面潮红、虽不明确，但3位侧链的N-甲硫四唑酒精 心悸、眩晕、头痛、欲吐等)[给药期基可能有双硫仑样作用。 间及给药后至少1周避免饮酒]。 虽不明机理，但据报道，动物实验(大利尿剂 有可能增强肾损害。 鼠)合用呋塞米，见到轻度至中度的(呋塞米等) 近端肾小管上皮细胞核萎缩及浓缩。 for computer software engineering GB/T50314-2000 of electrical installations code for construction and acceptance of GBJ232- 92 intelligent building weak design construction figure set GJBT-471 2. system description this times engineering weak design including: hours a Kok information facilities system integrated wiring system (containing room network, communications part) wired TV system information guide and the released system hours II Kok public security system fire automatically alarm system (containing public broadcast part) security technology prevention system security monitoring system out entrance control system car library management system hours three Kok building equipment monitoring system hours four Kok information application system queued station ICU visitation system operation the system monitoring and training system call intercom system hours, five hours Kok Kok intelligent integrated system of information system (1) cabling systems (including computer room network, communication component) computer network systems and voice communications systems Center of information on medical floor computer room located in the engine room. Voice communication system using a local telecommunications operator providing voice service, configuration-independent integrated services digital program-controlled switchboards. Operators providing communications ... If any compatibility requirements, by way of increased access to the Communications Board within the chassis to meet 【药物过量】尚不明确。 【药理毒理】 [药理作用] 1.抗菌作用: (l)头孢美唑钠对β-内酰胺酶高度稳定，对产β-内酰胺酶以及不产β-内酰胺酶的敏感菌具有相同的强的抗菌活性。 (2)对金黄色葡萄球菌、大肠埃希菌、肺炎杆菌、奇异变形杆菌有良好的抗菌作用，而且对耐头孢菌素类及耐青霉素类抗生素的普通变形杆菌、摩氏摩根菌、普罗威登斯菌属也有很强的抗菌活性。另外，对消化链球菌及拟杆菌属、普雷沃菌属(双路普雷沃菌除外)等厌氧菌也显示出很强的抗菌作用。 2.作用机理 通过抑制增殖期细菌的细胞壁合成，而发挥杀菌作用。 [毒理研究] 1.幼年大鼠皮下给药实验，有睾丸萎缩、抑制精子形成作用的报告。 2.用小鼠、家兔、豚鼠探讨了头孢美唑钠的抗原性，其结果与其它头孢菌素类抗生素相同，所有动物的抗原性均较弱，与头孢唑林、头孢噻吩的被动皮肤过敏反应的交叉性也较弱。另外，库姆斯氏阳性反应较头孢噻吩明显减弱。 【药代动力学】 1. 血药浓度: (l)静脉注射:健康成人静脉注射头孢美唑钠1克(效价)时，给药10分钟后的平均血药浓度为188微克,毫升，6小时后为1.9微克,毫升，血药浓度半衰期为1小时左右，血药浓度和给药剂量呈相关性。 (2)静脉滴注:健康成人静脉滴注头孢美唑钠1克(效价)1小时，血药浓度在滴注结束时达峰值，平均值为76.2微克,毫升，6小时后为2.7微克/毫升，血药浓度半衰期为1.2小时左右，血药浓度和给药剂量呈相关性。 2. 血清蛋白结合率: 头孢美唑钠100微克,毫升:84.8, 头孢美唑钠25微克,毫升:83.6, (体外，离心超滤法) 3. 分布 高浓度分布于痰液、腹水、腹腔渗出液、胆囊壁、胆汁、子宫/卵巢/输卵管、盆腔积液、颌骨、上颌窦粘膜、牙龈等。另外，也分布于羊水、脐带血、肾(皮质及髓质)，但几乎不分布于母乳中。 4. 代谢及排泄 头孢美唑钠在体内不代谢，大部分以具有抗菌活性的原型状态从尿中排泄。6小时内尿中回收率为85,92,，代谢率高。 5. 肾功能损害时的血中浓度及尿中排泄 肾功能降低时，尿中排泄减少，出现血药浓度上升及半衰期延长。 6. 肾功能损害患者用药 肾功能损害患者静脉滴注头孢美唑钠1克(效价)，用一室开放模型解析药代动力学，结果显示肾功能与头孢美唑钠的血清清除率及肾清除率之间有显著相关性。 for computer software engineering GB/T50314-2000 of electrical installations code for construction and acceptance of GBJ232- 92 intelligent building weak design construction figure set GJBT-471 2. system description this times engineering weak design including: hours a Kok information facilities system integrated wiring system (containing room network, communications part) wired TV system information guide and the released system hours II Kok public security system fire automatically alarm system (containing public broadcast part) security technology prevention system security monitoring system out entrance control system car library management system hours three Kok building equipment monitoring system hours four Kok information application system queued station ICU visitation system operation the system monitoring and training system call intercom system hours, five hours Kok Kok intelligent integrated system of information system (1) cabling systems (including computer room network, communication component) computer network systems and voice communications systems Center of information on medical floor computer room located in the engine room. Voice communication system using a local telecommunications operator providing voice service, configuration-independent integrated services digital program-controlled switchboards. Operators providing communications ... If any compatibility requirements, by way of increased access to the Communications Board within the chassis to meet Ccr范围 Ccr Sc1 Rc1 (毫升/分钟) (毫升/分钟) (毫升/分钟) (毫升/分钟) 健康成人组 >90 115.8?7.4 160.8?2.9 110.6?14.9 60~90 76.1?2.8 69.4?7.0 41.9?3.8 肾功能损害 30~60 43.8?4.9 40.9?8.6 29.9?5.1 患者组 10~30 17.1?2.3 26.9?7.0 12.1?3.7 <10 4.4?1.9 11.2?3.9 3.9?2.8 头孢美唑钠的临床结果表明，1次给药1克、1日2次，每12小时给药一次的方法为最多，且有效率高。以该方法给药时，肾功能损害患者的给药剂量与给药间隔之间的关系请见下表。 Ccr 调节给药间隔 调节用量 (毫升/分钟) 用量(毫克) 给药间隔(小时) 用量(毫克) 给药间隔(小时) >60 1,000 12 1,000 12 60~30 1,000 24 500 12 30~10 1,000 48 250 12 <10 1,000 120 100 12 【贮藏】密闭，在凉暗干燥处(避光并不超过20?)保存。 for computer software engineering GB/T50314-2000 of electrical installations code for construction and acceptance of GBJ232- 92 intelligent building weak design construction figure set GJBT-471 2. system description this times engineering weak design including: hours a Kok information facilities system integrated wiring system (containing room network, communications part) wired TV system information guide and the released system hours II Kok public security system fire automatically alarm system (containing public broadcast part) security technology prevention system security monitoring system out entrance control system car library management system hours three Kok building equipment monitoring system hours four Kok information application system queued station ICU visitation system operation the system monitoring and training system call intercom system hours, five hours Kok Kok intelligent integrated system of information system (1) cabling systems (including computer room network, communication component) computer network systems and voice communications systems Center of information on medical floor computer room located in the engine room. Voice communication system using a local telecommunications operator providing voice service, configuration-independent integrated services digital program-controlled switchboards. Operators providing communications ... If any compatibility requirements, by way of increased access to the Communications Board within the chassis to meet