托拉塞米片使用说明书

托拉塞米片使用说明书 托拉塞米片说明书 【药品名称】 通 用 名,托拉塞米片 商 品 名,特苏敏 英 文 名,Torasemide Tables 汉语拼音,Tuolasaimi Pian 本品主要成分为托拉塞米,化学名为,1,异丙基,3,[,4–间甲苯氨基,3,吡啶基,磺酰基]脲 化学结构如下, CH3 HN SONHCONHCH(CH)232 N 分子式,CHNOS 162043 分子量,348.43 【性 状】本品为白色或类白色片。 【药理毒理】 作用机理 本品为磺酰脲吡啶类利尿药,其作用于亨利氏髓袢升支粗段,抑制++-++-Na /K/2Cl 载体系统,使尿中Na 、K、Cl 和水的排泄增加,但对肾小球滤过率、肾血浆流量或体内酸碱平衡无显著影响。 药效学 本品对大鼠和狗都有强的利尿作用,在这两种动物中,尿量、尿电解质排泄与剂量的对数呈线性关系。大鼠口服本的最小有效剂量为0.2mg/kg,狗为小于0.1mg/kg,最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 大作用剂量为10mg/kg。以药理重量计,本品对大鼠的利尿作用为速尿的9,40倍,对狗为10倍,利尿作用大鼠持续约2小时,而狗持续8小时以上,大鼠每日口服本品10mg/kg共15天其利尿作用并不减弱。 狗静脉注射托拉塞米1、3、10mg/kg,收缩压、舒张压、平均压、心率、呼吸频率、呼吸压、心电图均无明显影响。 致癌性 大鼠和小鼠终生致癌试验,给予本品分别为9mg/kg/日和32mg/kg/日未见肿瘤发生率增加。基于体重，该剂量为人服剂量20mg的27-96倍;基于体面积为5-8倍。 致突变性 托拉塞米及其主要代谢物经细菌Ames实验，染色体畸变和人淋巴姊妹染色单体互换实验，仓鼠和鼠的骨髓细胞核异常实验，小鼠和大鼠非常规DNA合成实验等，体内外试验结果均无致突变性。 殖毒性 雌、雄大鼠剂量为25mg/kg/日时对生殖性能没有不良影响。大鼠剂量为生 5mg/kg/日或兔剂量为1.6mg/kg/日时无胎毒或致畸作用。大鼠和兔剂量分别大于5倍和4倍时，胎儿和母体平均体重有所下降，胎儿吸收和骨化延迟有所增加。 长期毒性 大鼠口服托拉塞米0.2、1、5和25mg/kg，连续12个月。5mg/kg以上剂 -量组体重增长受到抑制，总蛋白和Cl降低,BUN增高,病理检查肾脏表面呈颗粒状,肾小 +管扩张并有细胞浸润和纤维化,25mg/kg组K有所降低。 狗口服托拉塞米0.01、0.08和0.4mg/kg/天，连续12个月，0.4mg/kg 剂量组,雄狗全部有鼻腔干燥。病理检查雄狗0.4mg/kg组和雌狗0.08mg/kg以上组，可见肾小管变性，扩张，细胞浸润，钙沉着和纤维化等。听觉，眼科，生理，肾功能等检查均未见与本品有关的变化。 【药代动力学】 托拉塞米的生物利用度约80%，受试者间的变异不大，95%CI为75%-89%。药物吸收后首过效应不明显，口服后1小时血药浓度达到峰值，在2.5mg-200mg剂量范围内，Cmax和AUC与服用剂量呈比例关系。服药同时进食可以使达峰时间延后30min，但是AUC及利尿效果不受影响。特别的，肾及肝功能不全不会影响托拉塞米的吸收。 Voice communication system using a local telecommunications operator providing voice service, configurationoom. network systems and voice communications systems Center of information on medical floor computer room located in the engine r tegrated system of information system (1) cabling systems (including computer room network, communication component) computerent invisitation system operation the system monitoring and training system call intercom system hours, five hours Kok Kok intelligsystem hours three Kok building equipment monitoring system hours four Kok information application system queued station ICU ement roadcast part) security technology prevention system security monitoring system out entrance control system car library managmation guide and the released system hours II Kok public security system fire automatically alarm system (containing public bwiring system (containing room network, communications part) wired TV system infor471 2. system description this times engineering weak design including: hours a Kok information facilities system integrated -uilding weak design construction figure set GJBT92 intelligent b -2000 of electrical installations code for construction and acceptance of GBJ232-for computer software engineering GB/T503142y way of increased access to the Communications Board within the chassis to meetcontrolled switchboards. Operators providing communications ... If any compatibility requirements, b-independent integrated services digital program- 在正常成人及轻、中度肾脏及心功能不全的患者中，托拉塞米的血浆分布容积为12L-15L。在肝功能不全的患者，血浆分布容积加倍。 在正常人，托拉塞米的血浆清除半衰期为3.5小时。托拉塞米主要通过肝脏代谢(约占总清除的80%)和分泌到尿液(在肾功能正常的情况下，约占20%)清除。托拉塞米的主要代谢产物为无生物活性的羧酸派生物。另外两种代谢物有一定的利尿活性，但是从临床的角度看，药物的代谢意味着药物作用的终止。 托拉塞米的血浆蛋白结合率很高(,99%)，很少量的药物可以通过肾小球滤过到原尿中。托拉塞米主要是通过近曲小管主动分泌到尿液而从肾脏清除。 在失代偿的充血性心力衰竭患者，托拉塞米的肝脏和肾脏清除都减少，可能是因为肝脏充血和肾脏血流的减少。在这些患者中，托拉塞米的总清除仅为正常人的50,，同时药物的血浆半衰期及AUC相应增加，由于肾脏清除减少，分泌到作用部位的药物及尿钠排泄相应减少。 在肾功能衰竭患者，托拉塞米的肾脏清除明显降低，但总的血浆清除变化不大。分泌到作用部位的药物及尿钠排泄相应减少。如果给予较高剂量仍能达到利尿效果。由于肝脏的代谢清除不受影响，托拉塞米总体的血浆清除和血浆半衰期不变。 在肝硬化患者，托拉塞米的血浆分布容积、半衰期及肾脏清除都增加，但总的清除不变。 托拉塞米在老年人的药代动力学特征与年轻人相似，除非出现肾功能减退造成肾脏清除减少，但总的血浆清除和清除半衰期不变。 【适应症】 用于充血性心力衰竭、肝硬化腹水、肾脏疾病所致的水肿患者,也可用于原发性高血 压患者。 【用法用量】 充血性心力衰竭、肾功能衰竭及肾脏疾病所致的水肿,一般初始剂量为10mg,每日早晨一次,口服。以后根据病情调整剂量,一般每日最高不超过200mg。 肝硬化腹水,一般初始剂量为10mg,每日早晨一次口服,与醛固酮拮抗剂或保钾利尿剂同时服用。 原发性高血压,一般初始剂量为5mg,每日一次,口服。如果在4周之内没有达到足够的降压效果,可以加量到10mg,每日一次,口服。如果降压效应仍不充分,应加用其他 independent integrated services digital program-tem using a local telecommunications operator providing voice service, configurationon sysice communications systems Center of information on medical floor computer room located in the engine room. Voice communicatirmation system (1) cabling systems (including computer room network, communication component) computer network systems and vof infotion the system monitoring and training system call intercom system hours, five hours Kok Kok intelligent integrated system obuilding equipment monitoring system hours four Kok information application system queued station ICU visitation system operaKok technology prevention system security monitoring system out entrance control system car library management system hours three leased system hours II Kok public security system fire automatically alarm system (containing public broadcast part) securitywiring system (containing room network, communications part) wired TV system information guide and the re471 2. system description this times engineering weak design including: hours a Kok information facilities system integrated -struction figure set GJBT92 intelligent building weak design con -2000 of electrical installations code for construction and acceptance of GBJ232-for computer software engineering GB/T503143ss to the Communications Board within the chassis to meetcontrolled switchboards. Operators providing communications ... If any compatibility requirements, by way of increased acce- 降压药物。 【不良反应】 常见不良反应有头痛、眩晕、疲乏、食欲减退、肌肉痉挛、恶心呕吐、高血糖、高尿酸血症、便秘和腹泻,长期大量使用可能发生水和电解质平衡失调。治疗初期和年龄较大的患者常发生多尿,个别患者由于血液浓缩而引起低血压、精神紊乱、血栓性并发症及心或脑缺血引起心律紊乱、心绞痛、急性心肌梗塞或昏厥等,低血钾可发生在低钾饮食、呕吐、腹泻、过多使用泻药和肝功能异常的患者。个别患者可出现皮肤过敏,偶见瘙痒、皮疹、光敏反应,罕见口干、肢体感觉异常、视觉障碍。 【禁 忌】 肾功能衰竭无尿患者，肝昏迷前期或肝昏迷患者，对本品及磺酰脲类过敏患者,低血压、低血容量、低钾或低钠血症患者,严重排尿困难,如前列腺肥大,患者禁用本品。 【注意事项】 1、使用本品者应定期检查血电解质,特别是血钾,、血糖、尿酸、肌酐、血脂等。 2、本品开始治疗前排尿障碍必须纠正，特别对老年病人或治疗刚开始时要仔细监察电解质和血容量的不足和血液浓缩的有关症状。 3、肝硬化腹水患者应用本品进行利尿时,应住院进行治疗。这些病人如利尿过快,可造成严重的电解质紊乱和肝昏迷。 4、本品与醛固酮拮抗剂或与保钾药物一起使用可防止低钾血症和代谢性碱中毒。 5、前列腺肥大的患者排尿困难,使用本品尿量增多可导致尿潴留和膀胱扩张。 6、在刚开始用本品治疗或由其它药物转为使用本品治疗或开始一种新的辅助药物治疗 时,个别人警觉状态受到影响,如在驾驶车辆或操作机器时,。 【孕妇及哺乳期妇女用药】 不推荐怀孕期和哺乳期的妇女使用本品。 oom. network systems and voice communications systems Center of information on medical floor computer room located in the engine r tegrated system of information system (1) cabling systems (including computer room network, communication component) computerent invisitation system operation the system monitoring and training system call intercom system hours, five hours Kok Kok intelligsystem hours three Kok building equipment monitoring system hours four Kok information application system queued station ICU ement roadcast part) security technology prevention system security monitoring system out entrance control system car library managmation guide and the released system hours II Kok public security system fire automatically alarm system (containing public bwiring system (containing room network, communications part) wired TV system infor471 2. system description this times engineering weak design including: hours a Kok information facilities system integrated -uilding weak design construction figure set GJBT92 intelligent b -2000 of electrical installations code for construction and acceptance of GBJ232-for computer software engineering GB/T503144y way of increased access to the Communications Board within the chassis to meetcontrolled switchboards. Operators providing communications ... If any compatibility requirements, b-independent integrated services digital program-Voice communication system using a local telecommunications operator providing voice service, configuration 【儿童用药】 对儿童患者是否安全有效尚不明确。 【老年患者用药】 老年患者使用本品的疗效和安全性与成人无区别,但老年患者使用本品初期尤其需注 意监测血压、电解质及有无排尿困难。 【药物相互作用】 1、本品引起的低钾可加重强心甙类的不良反应。 2、本品可加强盐和糖皮质类固醇和轻泻剂的钾消耗作用。 3、非甾体类抗炎药,如消炎痛,和丙磺舒可降低本品的利尿和降压作用。 4、本品可加强抗高血压药物的作用。 5、本品连续用药或开始与一种血管紧张素转换酶抑制剂合并用药可能会使血压过度降低。 6、本品可降低抗糖尿病药物的作用。 7、本品在高剂量使用时可能会加重氨基糖甙类抗生素,如卡那霉素、庆大霉素、妥布霉素,、顺铂类制剂、头孢类的耳毒性与肾毒性。 8、本品可加强箭毒样肌松药和茶碱类药物的作用。 9、本品可降低去甲肾上腺素和肾上腺素的作用。 10、当病人使用大剂量水杨酸盐类时本品可增加水杨酸盐类的毒性。 【药物过量】 药物过量时,体液和电解质的丢失可能导致嗜睡、电解质紊乱和胃肠道症状。 处理,对症及支持疗法,及时补充体液及电解质,并对电解质进行动态监测。 【规 格】 on sysice communications systems Center of information on medical floor computer room located in the engine room. Voice communicatirmation system (1) cabling systems (including computer room network, communication component) computer network systems and vof infotion the system monitoring and training system call intercom system hours, five hours Kok Kok intelligent integrated system obuilding equipment monitoring system hours four Kok information application system queued station ICU visitation system operaKok technology prevention system security monitoring system out entrance control system car library management system hours three leased system hours II Kok public security system fire automatically alarm system (containing public broadcast part) securitywiring system (containing room network, communications part) wired TV system information guide and the re471 2. system description this times engineering weak design including: hours a Kok information facilities system integrated -struction figure set GJBT92 intelligent building weak design con -2000 of electrical installations code for construction and acceptance of GBJ232-for computer software engineering GB/T503145ss to the Communications Board within the chassis to meetcontrolled switchboards. Operators providing communications ... If any compatibility requirements, by way of increased acce-independent integrated services digital program-tem using a local telecommunications operator providing voice service, configuration 5mg，10mg，20mg 【贮 藏】 遮光,密封保存。 【包 装】 铝塑包装 ,1,5mg:7片/板，2板/盒;7片/板,4板/盒 (2)10mg:6片/板，1板/盒;6片/板，2板/盒 (3)20mg:6片/板，1板/盒;6片/板，2板/盒 【有效期】 24个月 【批准文号】 【生产企业】 企业名称,南京新港联合制药有限公司 地 址,南京经济技术开发区新港大道惠美路3号 邮政编码,210038 电话号码,025,85803351 传真号码,025,85804043 网 址,www.xingangmed.com tegrated system of information system (1) cabling systems (including computer room network, communication component) computerent invisitation system operation the system monitoring and training system call intercom system hours, five hours Kok Kok intelligsystem hours three Kok building equipment monitoring system hours four Kok information application system queued station ICU ement roadcast part) security technology prevention system security monitoring system out entrance control system car library managmation guide and the released system hours II Kok public security system fire automatically alarm system (containing public bwiring system (containing room network, communications part) wired TV system infor471 2. system description this times engineering weak design including: hours a Kok information facilities system integrated -uilding weak design construction figure set GJBT92 intelligent b -2000 of electrical installations code for construction and acceptance of GBJ232-for computer software engineering GB/T503146y way of increased access to the Communications Board within the chassis to meetcontrolled switchboards. Operators providing communications ... If any compatibility requirements, b-independent integrated services digital program-Voice communication system using a local telecommunications operator providing voice service, configurationoom. network systems and voice communications systems Center of information on medical floor computer room located in the engine r