氧氟沙星片说明书
盐酸左氧氟沙星片说明书-推荐下载
盐酸左氧氟沙星片说明书【药品名称】通用名称：盐酸左氧氟沙星片英文名称：Levofloxacin Hydrochloride Tablets汉语拼音：Yansuan Zuoyangfushaxing Pian【成份】本品主要成份为盐酸左氧氟沙星，其化学名称为：（S）-(-)-9-氟-2,3-二氢-3-甲基-10-（4-甲基-1-哌嗪）-7-氧-7H-吡啶骈[1,2,3-de]-[1,4]苯骈噁嗪-6-羧酸盐酸盐的水合物。
分子式：C18H20FN3O4·HCl·H2O分子量：415.85【性状】本品为类白色或淡黄色片。
【药理毒理】药理作用本品为氧氟沙星的左旋体，其抗菌活性约为氧氟沙星的两倍，它的主要作用机理是通过抑制细菌DNA旋转酶（细菌拓扑异构酶Ⅱ）的活性，阻碍细菌DNA的复制而达到抗菌作用。
本品具有抗菌谱广，抗菌作用强的特点，对大多数肠杆菌科细菌，如大肠埃希菌、克雷伯菌属、沙雷氏菌属、变形杆菌属、志贺菌属、沙门氏菌属、枸橼酸杆菌、不动杆菌属以及铜绿假单胞菌、流感嗜血杆菌、淋病菌等革兰阴性菌有较强的抗菌活性。
对部分甲氧西林敏感葡萄球菌、肺炎链球菌、化脓性链球菌、溶血性链球菌等革兰阳性菌和军团菌、支原体、衣原体等也有良好的抗菌作用。
但对厌氧菌和肠球菌的作用较差。
毒理研究重复给药毒性：大鼠连续4周经口给予本品剂量分别为50、200、800mg/kg,仅见800mg/kg 用药组动物出现中性白细胞的减少和骨髓M/E的上升；病理组织学可见肢关节表面出现轻度变性。
猕猴经口给药4周，100mg/kg以上剂量时，出现流涎、腹泻、体重减轻和尿中pH升高。
大鼠经口给药26周，80和320mg/kg剂量组动物也出现流涎、尿中pH升高。
320mg/kg组动物的排粪量增加，盲肠粘膜的杯状细胞出现肿大。
猕猴经口给药26周时，在10、25、62.5mg/kg剂量下均未出现明显毒性反应。
对关节软骨的影响：幼年和3～4周龄大鼠、4月龄猎兔犬经口给药7天，大鼠在300mg/kg以上、猎兔犬在10mg/kg以上剂量时，出现关节软骨病变，并在幼、年轻猎兔犬中易发现关节毒性。
可乐必妥左氧氟沙星片说明书
【药代动力学】口服后吸收完全，相对生物利用度接近100%。单剂量空腹口服0.1g和0.2g后，血药峰浓度(Cmax)分别达1.36mg/L和3.06mg/L，达峰时间(Tmax)约为1小时。血消除半衰期(t1/2β)约为5.1～7.1小时。蛋白结合率约为30%～40%。本品吸收后广泛分布至各组织、体液，在扁桃体、前列腺组织、痰液、泪液、妇女生殖道组织、皮肤和唾液等组织和体液中的浓度与血药浓度之比约在1.1～2.1之间。本品主要以原形自肾排泄，在体内代谢甚少。口服48小时内尿中排出量约为给药量的80%～90%。本品以原形自粪便中排出少量，给药后72小时内累积排出量少于给药量的4%。
【儿童用药】本品在婴幼儿及18岁以下青少年的安全性尚未确定。但本品用于数种幼龄动物时，可致关节病变。因此不宜用于18岁以下的小儿及青少年。
【老年患者用药】老年患者常有肾功能减退，因本品部分经肾排出，需减量应用。
【孕妇及哺乳期妇女用药】动物实验未证实喹诺酮类药物有致畸作用，但对孕妇用药进行的研究尚无明确结论。鉴于本药可引起未成年动物关节病变，故孕妇禁用，哺乳期妇女应用本品时应暂停哺乳。
【药物相互作用】1．尿碱化剂可减低本品在尿中的溶解度，导致结晶尿和肾毒性。 2．喹诺酮类抗菌药与茶碱类合用时可能由于与细胞色素P450结合部位的竞争性抑制，导致茶碱类的肝消除明显减少，血消除半衰期(t1/2β)延长，血药浓度升高，出现茶碱中毒症状，如恶心、呕吐、震颤、不安、激动、抽搐、心悸等。本品对茶碱的代谢虽影响较小，但合用时仍应测定茶碱类血药浓度和调整剂量。 3.本品与环孢素合用，可使环孢素的血药浓度升高，必须监测环孢素血浓度，并调整剂量。 4.本品与抗凝药华法林合用时虽对后者的抗凝作用增强较小，但合用时也应严密监测患者的凝血酶原时间。 5.丙磺舒可减少本品自肾小管分泌约50%，合用时可因本品血浓度增高而产生毒性。 6.本品可干扰咖啡因的代谢，从而导致咖啡因消除减少，血消除半衰期(t1/2β)延长，并可能产生中枢神经系统毒性。 7.含铝、镁的制酸药、铁剂均可减少本品的口服吸收，不宜合用。 8.本品与非甾体类抗炎药芬布芬合用时，偶有抽搐发生，因此不宜与芬布芬合用。 9.本品与口服降血糖药合用可能会引起血糖失调，因此用药过程中应注意监测血糖浓度，一旦发生低血糖时应立即停用本品，并给予适当处理。
左氧氟沙星使用说明书
LEVAQUIN®（左氧氟沙星）片剂LEVAQUIN®（左氧氟沙星）口服液LEVAQUIN®（左氧氟沙星）注射剂LEVAQUIN®（含5%葡萄糖的左氧氟沙星）注射剂处方信息为减少耐药菌株的发生并维持LEV AQUIN®（左氧氟沙星）与其他抗菌药物的疗效，LEVAQUIN®（左氧氟沙星）只能用于治疗或预防已证实由细菌引起或高度疑似由细菌引起的感染。
描述LEVAQUIN®（左氧氟沙星）是人工合成的口服或静脉滴注用广谱抗菌药。
左氧氟沙星是消旋氧氟沙星的纯-(S)-异构体，化学上来讲它是一种手性氟羧基喹诺酮。
化学名是(S)-(-)-9-氟-2，3-二氢-3-甲基-10-(4-甲基-1-哌嗪基)-7-氧代-7H-吡啶并[1,2,3-de]-[1,4]苯并噁嗪-6-羧酸半水合物。
化学结构是：分子式是C18H20FN3O4·1/2H2O，分子量370.38。
左氧氟沙星是一种白色至淡黄色的晶体或晶状粉末。
在小肠pH条件下呈两性离子。
数据显示在pH0.6-5.8范围内，左氧氟沙星的溶解度恒定（大约为100mg/ml）。
USP命名原则指出在这个pH范围内，左氧氟沙星溶解度是“可溶至易溶”。
超过pH5.8，溶解度迅速增加并在pH6.7时的达最大值（272mg/ml），此范围内是“易溶”。
超过pH6.7，溶解度下降并在pH约为6.9时达到最小值（约50mg/ml）。
左氧氟沙星能与许多金属离子生成稳定的配位化合物。
在体外，金属离子与其螯合的能力顺序为：Al+3>Cu+2>Zn+2>Mg+2>Ca+2。
LEVAQUIN片剂是薄膜衣片剂，含有下列非活性成分：250mg（以无水形式）：羟丙甲纤维素，交联聚维酮，维晶纤维素，硬脂酸镁，聚乙二醇，钛白粉，聚山梨酯80和合成氧化铁红500mg（以无水形式）：羟丙甲纤维素，交联聚维酮，维晶纤维素，硬脂酸镁，聚乙二醇，钛白粉，聚山梨酯80和合成氧化铁红750mg（以无水形式）：羟丙甲纤维素，交联聚维酮，维晶纤维素，硬脂酸镁，聚乙二醇，钛白粉，聚山梨酯80LEVAQUIN口服液（25mg/ml）是多用途，自我防腐的左氧氟沙星溶液，pH范围在5.0至6.0 LEVAQUIN口服液外观澄清，呈黄色至绿黄色。
国食药监注[2012]373号 附件2-左氧氟沙星口服和注射剂说明书
![国食药监注[2012]373号 附件2-左氧氟沙星口服和注射剂说明书](https://img.taocdn.com/s3/m/2a4a842a192e45361066f573.png)
附件2左氧氟沙星口服和注射剂说明书请仔细阅读说明书并在医师指导下使用【药品名称】根据原审批文件确定通用名称：商品名称：英文名称：汉语拼音：【成份】本品主要成份为左氧氟沙星，其化学名称为：(-)-(S)-3-甲基-9-氟-2,3-二氢-10-(4-甲基-1-哌嗪基)-7氧代-7H-吡啶并[1,2,3-de]-1,4 苯并口恶嗪-6-羧酸半水合物。
其化学结构式：分子式：C18H20FN3O4 ²12H2O分子量：370.38本品其他成份为：根据原审批文件确定。
【性状】根据具体品种确定【适应症】为减少耐药菌的产生，保证左氧氟沙星及其他抗菌药物的有效性，左氧氟沙星只用于治疗或预防已证明或高度怀疑由敏感细菌引起的感染。
在选择或修改抗菌药物治疗方案时，应考虑细菌培养和药敏试验的结果。
如果没有这些试验的数据做参考，则应根据当地流行病学和病原菌敏感性进行经验性治疗。
在治疗前应进行细菌培养和药敏试验以分离并鉴定感染病原菌，确定其对左氧氟沙星的敏感性。
在获得以上检验结果之前可以先使用左氧氟沙星进行治疗，得到检验结果之后再选择适当的治疗方法。
与此类中的其他药物相同，使用左氧氟沙星进行治疗时，铜绿假单胞菌的某些菌株可以很快产生耐药性。
在治疗期间应定期进行细菌培养和药敏试验以掌握病原菌是否对抗菌药物持续敏感，并在细菌出现耐药性后能够及时发现。
左氧氟沙星口服制剂和注射剂可用于治疗成年人（≥ 18岁）由下列细菌的敏感菌株所引起的下列轻、中、重度感染。
如静脉滴注对患者更为有利时（如患者不能耐受口服给药等）可使用左氧氟沙星注射液。
1.医院获得性肺炎治疗由对甲氧西林敏感的金黄色葡萄球菌、铜绿假单胞菌、粘质沙雷氏菌、大肠埃希菌、肺炎克雷白杆菌、流感嗜血杆菌或肺炎链球菌引起的医院获得性肺炎。
同时应根据临床需要采取其他辅助治疗措施。
如果已证明或怀疑是铜绿假单胞菌感染，建议联合应用抗假单胞菌β-内酰胺类药物进行治疗。
2.社区获得性肺炎7～14天治疗方案：治疗由对甲氧西林敏感的金黄色葡萄球菌、肺炎链球菌[包括多重耐药性菌株（MDRSP*）]、流感嗜血杆菌、副流感嗜血杆菌、肺炎克雷白杆菌、卡他莫拉菌、肺炎衣原体、肺炎军团菌或肺炎支原体引起的社区获得性肺炎。
左氧氟沙星使用说明书
左氧氟沙星使⽤说明书LEV AQUIN?（左氧氟沙星）⽚剂LEV AQUIN?（左氧氟沙星）⼝服液LEV AQUIN?（左氧氟沙星）注射剂LEV AQUIN?（含5%葡萄糖的左氧氟沙星）注射剂处⽅信息为减少耐药菌株的发⽣并维持LEV AQUIN?（左氧氟沙星）与其他抗菌药物的疗效，LEV AQUIN?（左氧氟沙星）只能⽤于治疗或预防已证实由细菌引起或⾼度疑似由细菌引起的感染。
描述LEV AQUIN?（左氧氟沙星）是⼈⼯合成的⼝服或静脉滴注⽤⼴谱抗菌药。
左氧氟沙星是消旋氧氟沙星的纯-(S)-异构体，化学上来讲它是⼀种⼿性氟羧基喹诺酮。
化学名是(S)-(-)-9-氟-2，3-⼆氢-3-甲基-10-(4-甲基-1-哌嗪基)-7-氧代-7H-吡啶并[1,2,3-de]-[1,4]苯并噁嗪-6-羧酸半⽔合物。
化学结构是：分⼦式是C18H20FN3O4·1/2H2O，分⼦量370.38。
左氧氟沙星是⼀种⽩⾊⾄淡黄⾊的晶体或晶状粉末。
在⼩肠pH条件下呈两性离⼦。
数据显⽰在pH0.6-5.8范围内，左氧氟沙星的溶解度恒定（⼤约为100mg/ml）。
USP命名原则指出在这个pH范围内，左氧氟沙星溶解度是“可溶⾄易溶”。
超过pH5.8，溶解度迅速增加并在pH6.7时的达最⼤值（272mg/ml），此范围内是“易溶”。
超过pH6.7，溶解度下降并在pH约为6.9时达到最⼩值（约50mg/ml）。
左氧氟沙星能与许多⾦属离⼦⽣成稳定的配位化合物。
在体外，⾦属离⼦与其螯合的能⼒顺序为：Al+3>Cu+2>Zn+2>Mg+2>Ca+2。
LEV AQUIN⽚剂是薄膜⾐⽚剂，含有下列⾮活性成分：250mg（以⽆⽔形式）：羟丙甲纤维素，交联聚维酮，维晶纤维素，硬脂酸镁，聚⼄⼆醇，钛⽩粉，聚⼭梨酯80和合成氧化铁红500mg（以⽆⽔形式）：羟丙甲纤维素，交联聚维酮，维晶纤维素，硬脂酸镁，聚⼄⼆醇，钛⽩粉，聚⼭梨酯80和合成氧化铁红750mg（以⽆⽔形式）：羟丙甲纤维素，交联聚维酮，维晶纤维素，硬脂酸镁，聚⼄⼆醇，钛⽩粉，聚⼭梨酯80LEV AQUIN⼝服液（25mg/ml）是多⽤途，⾃我防腐的左氧氟沙星溶液，pH范围在5.0⾄6.0 LEV AQUIN⼝服液外观澄清，呈黄⾊⾄绿黄⾊。
盐酸左氧氟沙星片(特格尔)的说明书
盐酸左氧氟沙星片(特格尔)的说明书日常生活中难免会遇到各种疾病的困扰，温毒和瘟疫常常会存在人体当中，对身体造成危害，体内产生毒素和热毒在所难免。
因此，只要您及时服用正规药物进行治疗，达到清热解毒的效果并不是什么难事。
今天我们为您推荐一种名为盐酸左氧氟沙星片(特格尔)的药物，它对于解毒去热很有帮助，下面来看看介绍吧。
【药品名称】通用名称：盐酸左氧氟沙星片商品名称：盐酸左氧氟沙星片(特格尔)【规格型号】0.1g*12s【用法用量】口服，成人每次0.1～0.2g，每日两次。
病情偏重者可增为每日三次。
【不良反应】用药期间可能出现恶心、呕吐、腹部不适、腹泻、食欲不振、腹痛、腹胀等症状，失眠、头晕、头痛等神经系统症状和皮疹、搔痒等症状。
亦可出现一过性肝功能异常，如血清转氨酶增高、血清总胆红素升高等。
上述不良反应发生率在0.1～5％之间。
偶见血中尿素氮上升、倦怠、发热、心悸、味觉异常等，一般均能耐受，疗程结束后迅速消失。
【禁忌】对喹诺酮类药物过敏者、妊娠及哺乳期妇女、18岁以下患者禁用。
【注意事项】1．肾功能不全者应减量或者延长给药间期，重度肾功能不全者慎用。
2．有中枢神经系统疾病及癫痫史患者应慎用。
3．喹诺酮类药物尚可引起少见的光毒性反应（发生率＜0.1％）。
在接受本品治疗时应避免过度阳光曝晒和人工紫外线。
如出现光敏反应或皮肤损伤应停用本品。
4．若发生过敏，应立即停药，并根据临床具体情况而采取以下药物或方法治疗；肾上腺素及其它抢救措施，包括吸氧、静脉输液、抗组织胺药、皮质类固醇等。
5．此外偶有用药后发生跟踺炎或跟踺断裂的报告，故如有上述症状发生时须立即停药并休息，严禁运动，直到症状消失。
6．若过量服用，应清除患者胃内容物，维持适当补液，并进行临床观察。
7．左氧氟沙星无法通过血液透析或腹膜透析被有效地排除。
8．药物相互作用：本品与含镁或铝之抗酸剂、硫糖铝、金属阳离子（如铁）、含锌的多种维生素制剂等药物同时使用时将干扰胃肠道对本品的吸收，使该药在各系统内的浓度明显降低。
左氧氟沙星使用说明书
LEVAQUIN®（左氧氟沙星）片剂LEVAQUIN®（左氧氟沙星）口服液LEVAQUIN®（左氧氟沙星）注射剂LEVAQUIN®（含5%葡萄糖的左氧氟沙星）注射剂处方信息为减少耐药菌株的发生并维持LEV AQUIN®（左氧氟沙星）与其他抗菌药物的疗效，LEVAQUIN®（左氧氟沙星）只能用于治疗或预防已证实由细菌引起或高度疑似由细菌引起的感染。
描述LEVAQUIN®（左氧氟沙星）是人工合成的口服或静脉滴注用广谱抗菌药。
左氧氟沙星是消旋氧氟沙星的纯-(S)-异构体，化学上来讲它是一种手性氟羧基喹诺酮。
化学名是(S)-(-)-9-氟-2，3-二氢-3-甲基-10-(4-甲基-1-哌嗪基)-7-氧代-7H-吡啶并[1,2,3-de]-[1,4]苯并噁嗪-6-羧酸半水合物。
化学结构是：分子式是C18H20FN3O4·1/2H2O，分子量370.38。
左氧氟沙星是一种白色至淡黄色的晶体或晶状粉末。
在小肠pH条件下呈两性离子。
数据显示在pH0.6-5.8范围内，左氧氟沙星的溶解度恒定（大约为100mg/ml）。
USP命名原则指出在这个pH范围内，左氧氟沙星溶解度是“可溶至易溶”。
超过pH5.8，溶解度迅速增加并在pH6.7时的达最大值（272mg/ml），此范围内是“易溶”。
超过pH6.7，溶解度下降并在pH约为6.9时达到最小值（约50mg/ml）。
左氧氟沙星能与许多金属离子生成稳定的配位化合物。
在体外，金属离子与其螯合的能力顺序为：Al+3>Cu+2>Zn+2>Mg+2>Ca+2。
LEVAQUIN片剂是薄膜衣片剂，含有下列非活性成分：250mg（以无水形式）：羟丙甲纤维素，交联聚维酮，维晶纤维素，硬脂酸镁，聚乙二醇，钛白粉，聚山梨酯80和合成氧化铁红500mg（以无水形式）：羟丙甲纤维素，交联聚维酮，维晶纤维素，硬脂酸镁，聚乙二醇，钛白粉，聚山梨酯80和合成氧化铁红750mg（以无水形式）：羟丙甲纤维素，交联聚维酮，维晶纤维素，硬脂酸镁，聚乙二醇，钛白粉，聚山梨酯80LEVAQUIN口服液（25mg/ml）是多用途，自我防腐的左氧氟沙星溶液，pH范围在5.0至6.0 LEVAQUIN口服液外观澄清，呈黄色至绿黄色。
左氧氟沙星FDA说明书
HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use LEVAQUIN® safely and effectively. See full prescribing informationfor LEVAQUIN ® .LEVAQUIN® (levofloxacin) Tablet, Film Coated for Oral use LEVAQUIN® (levofloxacin) Solution for Oral useLEVAQUIN® (levofloxacin) Injection, Solution, Concentrate for Intravenous useLEVAQUIN® (levofloxacin) Injection, Solution for Intravenous useInitial U.S. Approval: 1996WARNING:See full prescribing information for complete boxed warning. Fluoroquinolones, including LEVAQUIN®, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants [See Warnings and Precautions (5.1)]. Fluoroquinolones, including LEVAQUIN®, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid LEVAQUIN® in patients with a known history of myasthenia gravis [See Warnings and Precautions (5.2)].effectiveness of LEVAQUIN® and other antibacterial drugs, LEVAQUIN® should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.—————————RECENT MAJOR CHANGES——————— Warnings and Precautions• Peripheral Neuropathy (5.8) 07/2013 —————————INDICATIONS AND USAGE———————— LEVAQUIN® is a fluoroquinolone antibacterial indicated in ad ults (≥18 years of age) with infections caused by designated, susceptible bacteria (1, 12.4).• Pneumonia: nosocomial (1.1) and community acquired (1.2, 1.3)• Acute bacterial sinusitis (1.4)• Acute bacterial exacerbation of chronic bronchitis (1.5)• Skin and skin structure infections: complicated (1.6) and uncomplicated (1.7)• Chronic bacterial prostatitis (1.8)• Urinary tract infections: complicated (1.9, 1.10) and uncomplicated(1.12)• Acute pyelonephritis (1.11)• Inhalational anthrax, post-exposure (1.13)• Plague (1.14)———————DOSAGE AND ADMINISTRATION——————— • Dosage in patients with normal renal function (2.1)Type of Infection Dose Every 24hours Duration (days)Nosocomial Pneumonia (1.1) 750 mg 7–14 Community Acquired Pneumonia (1.2) 500 mg 7–14 Community Acquired Pneumonia (1.3) 750 mg 5 Acute Bacterial Sinusitis (1.4) 750 mg 5500 mg 10–14 Acute Bacterial Exacerbation of ChronicBronchitis (1.5)500 mg 7 Complicated Skin and Skin Structure Infections(SSSI) (1.6)750 mg 7–14 Uncomplicated SSSI (1.7) 500 mg 7–10 Chronic Bacterial Prostatitis (1.8) 500 mg 28 Complicated Urinary Tract Infection (1.9) orAcute Pyelonephritis (1.11)750 mg 5 Complicated Urinary Tract Infection (1.10) orAcute Pyelonephritis (1.11)250 mg 10 Uncomplicated Urinary Tract Infection (1.12) 250 mg 3Type of Infection Dose Every 24hoursDuration(days) Inhalational Anthrax (Post-Exposure) (1.13)Adults and Pediatric Patients > 50 kgPediatric Patients < 50 kg and ≥ 6 months ofage500 mg8 mg/kg BID(not to exceed250 mg/dose)6060 Plague (1.14)Adults and Pediatric Patients > 50 kgPediatric Patients < 50 kg and ≥ 6 months ofage500 mg8 mg/kg BID(not to exceed250 mg/dose)10 to 1410 to 14• Adjust dose for creatinine clearance < 50 mL/min (2.3, 8.6, 12.3)• IV Injection, Single-Use or Premix: Slow IV infusion only, over60 or 90 minutes depending on dose. Avoid rapid or bolus IV (2.5) • Dilute single-use vials to 5 mg/mL prior to IV infusion (2.6)• Do not mix with other medications in vial or IV line (2.6) ———————DOSAGE FORMS AND STRENGTHS——————Formulation (3) StrengthTablets 250 mg, 500 mg, and 750 mg Oral Solution 25 mg/mLInjection: single-use vials for dilution 500 mg in 20 mL750 mg in 30 mL Injection: premix single-use flexiblecontainers250 mg in 50 mL500 mg in 100 mL750 mg in 150 mL ——————————CONTRAINDICATIONS————————— Known hypersensitivity to LEVAQUIN® or other quinolones (4, 5.3) ———————WARNINGS AND PRECAUTIONS——————— • Risk of tendinitis and tendon rupture is increased. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroids, and in patients with kidney, heart or lung transplants. Discontinue if pain or inflammation in a tendon occurs(5.1, 8.5)• May exacerbate muscle weakness in persons with myasthenia gravis.Avoid use in patients with a known history of myasthenia gravis (5.2) • Anaphylactic reactions and allergic skin reactions, serious, occasionally fatal, may occur after first dose (4, 5.3)• Hematologic (including agranulocytosis, thrombocytopenia), and renal toxicities may occur after multiple doses (5.4)• Hepatotoxicity: Severe, and sometimes fatal, hepatoxicity has been reported. Discontinue immediately if signs and symptoms of hepatitis occur (5.5)• Central nervous system effects, including convulsions, anxiety, confusion, depression, and insomnia may occur after the first dose. Use with caution in patients with known or suspected disorders that may predispose them to seizures or lower the seizure threshold. Increased intracranial pressure (pseudotumor cerebri) has been reported (5.6)• Clostridium difficile-associated colitis: evaluate if diarrhea occurs (5.7) • Peripheral neuropathy: discontinue immediately if symptoms occur in order to prevent irreversibility (5.8)• Prolongation of the QT interval and isolated cases of torsade de pointes have been reported. Avoid use in patients with known prolongation, those with hypokalemia, and with other drugs that prolong the QT interval (5.9, 8.5)——————————ADVERSE REACTIONS————————— The most common reactions (≥3%) were nausea, headache, diarrhea, insomnia, constipation and dizziness (6.2).To report SUSPECTED ADVERSE REACTIONS, contact Janssen Pharmaceuticals, Inc. at 1-800-526-7736 or FDA at 1-800-FDA-1088 or /medwatch.——————————DRUG INTERACTIONS—————————Interacting Drug InteractionMultivalent cation-containing products including antacids, metal cations or didanosine Absorption of levofloxacin is decreased when the tablet or oral solution formulation is taken within 2 hours of these products. Do not co-administer the intravenous formulation in the same IV line with a multivalent cation, e.g., magnesium (2.4, 7.1)Warfarin Effect may be enhanced. Monitor prothrombintime, INR, watch for bleeding (7.2)Antidiabetic agents Carefully monitor blood glucose (5.11, 7.3) ———————USE IN SPECIFIC POPULATIONS——————— • Geriatrics: Severe hepatotoxicity has been reported. The majority of reports describe patients 65 years of age or older (5.5, 8.5, 17). Mayhave increased risk of tendinopathy (including rupture), especiallywith concomitant corticosteroid use (5.1, 8.5, 17). May be moresusceptible to prolongation of the QT interval. (5.9, 8.5, 17).FULL PRESCRIBING INFORMATION: CONTENTS*WARNING:1 INDICATIONS AND USAGE1.1 Nosocomial Pneumonia1.2 Community-Acquired Pneumonia: 7–14 dayTreatment Regimen1.3 Community-Acquired Pneumonia: 5-dayTreatment Regimen1.4 Acute Bacterial Sinusitis: 5-day and 10–14 dayTreatment Regimens1.5 Acute Bacterial Exacerbation of ChronicBronchitis1.6 Complicated Skin and Skin Structure Infections1.7 Uncomplicated Skin and Skin StructureInfections1.8 Chronic Bacterial Prostatitis1.9 Complicated Urinary Tract Infections: 5-dayTreatment Regimen1.10 Complicated Urinary Tract Infections: 10-dayTreatment Regimen1.11 Acute Pyelonephritis: 5 or 10-day TreatmentRegimen1.12 Uncomplicated Urinary Tract Infections1.13 Inhalational Anthrax (Post-Exposure)1.14 Plague2 DOSAGE AND ADMINISTRATION2.1 Dosage in Adult Patients with Normal RenalFunction2.2 Dosage in Pediatric Patients2.3 Dosage Adjustment in Adults with RenalImpairment2.4 Drug Interaction With Chelation Agents:Antacids, Sucralfate, Metal Cations,Multivitamins2.5 Administration Instructions2.6 Preparation of Intravenous Product3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS5 WARNINGS AND PRECAUTIONS5.1 Tendinopathy and Tendon Rupture5.2 Exacerbation of Myasthenia Gravis5.3 Hypersensitivity Reactions5.4 Other Serious and Sometimes Fatal Reactions5.5 Hepatotoxicity5.6 Central Nervous System Effects5.7 Clostridium difficile-Associated Diarrhea5.8 Peripheral Neuropathy5.9 Prolongation of the QT Interval5.10 Musculoskeletal Disorders in Pediatric Patientsand Arthropathic Effects in Animals5.11 Blood Glucose Disturbances5.12 Photosensitivity/Phototoxicity5.13 Development of Drug Resistant Bacteria6 ADVERSE REACTIONS6.1 Serious and Otherwise Important AdverseReactions • Pediatrics: Musculoskeletal disorders (arthralgia, arthritis, tendinopathy, and gait abnormality) seen in more LEVAQUIN®treated patients than in comparator. Shown to cause arthropathy andosteochondrosis in juvenile animals (5.10, 8.4, 13.2). Safety in pediatric patients treated for more than 14 days has not been studied.Risk-benefit appropriate only for the treatment of inhalational anthrax(post-exposure) (1.13, 2.2, 8.4, 14.9) and plague (1.14, .2.2, 8.4,14.10)See 17 for PATIENT COUNSELING INFORMATION and the FDA-approved Medication GuideRevised: 05/20146.3 Postmarketing Experience7 DRUG INTERACTIONS7.1 Chelation Agents: Antacids, Sucralfate, MetalCations, Multivitamins7.2 Warfarin7.3 Antidiabetic Agents7.4 Non-Steroidal Anti-Inflammatory Drugs7.5 Theophylline7.6 Cyclosporine7.7 Digoxin7.8 Probenecid and Cimetidine7.9 Interactions with Laboratory or DiagnosticTesting8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.3 Nursing Mothers8.4 Pediatric Use8.5 Geriatric Use8.6 Renal Impairment8.7 Hepatic Impairment10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action12.3 Pharmacokinetics12.4 Microbiology13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment ofFertility13.2 Animal Toxicology and/or Pharmacology14 CLINICAL STUDIES14.1 Nosocomial Pneumonia14.2 Community-Acquired Pneumonia: 7–14 dayTreatment Regimen14.3 Community-Acquired Pneumonia: 5-dayTreatment Regimen14.4 Acute Bacterial Sinusitis: 5-day and 10–14 dayTreatment Regimens14.5 Complicated Skin and Skin Structure Infections14.6 Chronic Bacterial Prostatitis14.7 Complicated Urinary Tract Infections and AcutePyelonephritis: 5-day Treatment Regimen14.8 Complicated Urinary Tract Infections and AcutePyelonephritis: 10-day Treatment Regimen14.9 Inhalational Anthrax (Post-Exposure)14.10 Plague15 REFERENCES16 HOW SUPPLIED/STORAGE AND HANDLING16.1 LEVAQUIN® Tablets16.2 LEVAQUIN® Oral Solution16.3 LEVAQUIN® Injection, Single-Use Vials16.4 LEVAQUIN® Injection Pre-Mixed Solution,Single-Use in Flexible Container17 PATIENT COUNSELING INFORMATION17.1 Antibacterial Resistance17.2 Administration with Food, Fluids, andConcomitant Medications17.3 17.4Serious and Potentially Serious AdverseReactionsDrug Interactions with Insulin, OralHypoglycemic Agents, and Warfarin17.517.6Plague and Anthrax StudiesFDA-Approved Medication Guide*Sections or subsections omitted from the full prescribing information arenot listedFULL PRESCRIBING INFORMATIONWARNING:Fluoroquinolones, including LEVAQUIN® , are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants [See Warnings and Precautions (5.1)].Fluoroquinolones, including LEVAQUIN®, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid LEVAQUIN® in patients with a known history of myasthenia gravis [See Warnings and Precautions (5.2)].1 INDICATIONS AND USAGETo reduce the development of drug-resistant bacteria and maintain the effectiveness of LEVAQUIN® and other antibacterial drugs, LEVAQUIN® 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 epidemiologyand susceptibility patterns may contribute to the empiric selection of therapy.LEVAQUIN® Tablets/Injection and Oral Solution are indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates ofthe designated microorganisms in the conditions listed in this section. LEVAQUIN® Injectionis indicated when intravenous administration offers a route of administration advantageous tothe patient (e.g., patient cannot tolerate an oral dosage form).Culture and susceptibility testingAppropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin [see Microbiology (12.4)]. Therapy with LEVAQUIN® may be initiated before results of these tests are known; once results become available, appropriate therapy should be selected.As with other drugs in this class, some isolates of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with LEVAQUIN®. Culture and susceptibility testing performed periodically during therapy will provide information about the continued susceptibility of the pathogens to the antimicrobial agent and also the possible emergence of bacterial resistance.1.1 Nosocomial PneumoniaLEVAQUIN® is indicated for the treatment of nosocomial pneumonia due to methicillinsusceptible Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, or Streptococcus pneumoniae. Adjunctive therapy should be used as clinically indicated. Where Pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an antipseudomonal β-lactam is recommended [see Clinical Studies (14.1)].1.2 Community-Acquired Pneumonia: 7–14 day Treatment RegimenLEVAQUIN® is indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multidrug-resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Dosage and Administration (2.1) and Clinical Studies (14.2)].MDRSP isolates are isolates resistant to two or more of the following antibacterials: penicillin (MIC ≥2 mcg/mL), 2nd generation cephalosporins, e.g., cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole.1.3 Community-Acquired Pneumonia: 5-day Treatment RegimenLEVAQUIN® is indicated for the treatment of community-acquired pneumonia due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Dosage and Administration (2.1) and Clinical Studies (14.3)].1.4 Acute Bacterial Sinusitis: 5-day and 10–14 day Treatment Regimens LEVAQUIN® is indicated for the treatment of acute bacterial sinusitis due to Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis [see Clinical Studies (14.4)].1.5 Acute Bacterial Exacerbation of Chronic BronchitisLEVAQUIN® is indicated for the treatment of acute bacterial exacerbation of chronic bronchitis due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis.1.6 Complicated Skin and Skin Structure InfectionsLEVAQUIN® is indicated for the treatment of complicated skin and skin structure infections due to methicillin-susceptible Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, or Proteus mirabilis [see Clinical Studies (14.5)].1.7 Uncomplicated Skin and Skin Structure InfectionsLEVAQUIN® is indicated for the treatment of uncomplicated skin and skin structure infections (mild to moderate) including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to methicillin-susceptible Staphylococcus aureus, or Streptococcus pyogenes.1.8 Chronic Bacterial ProstatitisLEVAQUIN® is indicated for the treatment of chronic bacterial prostatitis due to Escherichia coli, Enterococcus faecalis, or methicillin-susceptible Staphylococcus epidermidis [see Clinical Studies (14.6)].1.9 Complicated Urinary Tract Infections: 5-day Treatment RegimenLEVAQUIN® is indicated for the treatment of complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis [see Clinical Studies (14.7)].1.10 Complicated Urinary Tract Infections: 10-day Treatment Regimen LEVAQUIN® is indicated for the treatment of complicated urinary tract infections (mild to moderate) due to Enterococcus faecalis, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa [see Clinical Studies (14.8)].1.11 Acute Pyelonephritis: 5 or 10-day Treatment RegimenLEVAQUIN® is indicated for the treatment of acute pyelonephritis caused by Escherichia coli, including cases with concurrent bacteremia [see Clinical Studies (14.7, 14.8)].1.12 Uncomplicated Urinary Tract InfectionsLEVAQUIN® is indicated for the treatment of uncomplicated urinary tract infections (mild to moderate) due to Escherichia coli, Klebsiella pneumoniae, or Staphylococcus saprophyticus.1.13 Inhalational Anthrax (Post-Exposure)LEVAQUIN® is indicated for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. The effectiveness of LEVAQUIN® is based on plasma concentrations achieved in humans, a surrogate endpoint reasonably likely to predict clinical benefit. LEVAQUIN® has not been tested in humans for the post-exposure prevention of inhalation anthrax. The safety of LEVAQUIN® in adults for durations of therapy beyond 28 days or in pediatric patients for durations of therapy beyond 14 days has not been studied. Prolonged LEVAQUIN® therapy should only be used when the benefit outweighs the risk [see Dosage and Administration (2.1, 2.2) and Clinical Studies (14.9)].1.14 PlagueLEVAQUIN® is indicated for treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis (Y. pestis) and prophylaxis for plague in adults and pediatric patients, 6 months of age and older. Efficacy studies of LEVAQUIN® could not be conducted in humans with plague for ethical and feasibility reasons. Therefore, approval of this indication was based on an efficacy study conducted in animals [see Dosage and Administration (2.1, 2.2) and Clinical Studies (14.10)].2 DOSAGE AND ADMINISTRATION2.1 Dosage in Adult Patients with Normal Renal FunctionThe usual dose of LEVAQUIN® Tablets or Oral Solution is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1. The usual dose of LEVAQUIN® Injection is 250 mg or 500 mg administered by slow infusion over 60 minutes every 24 hours or 750 mg administered by slow infusion over 90 minutes every 24 hours, as indicated by infection and described in Table 1.These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].Table 1: Dosag e in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min) Type of Infection* Dosed Every 24 hours Duration(days)† Nosocomial Pneumonia 750 mg 7–14 Community Acquired Pneumonia‡ 500 mg 7–14 Community Acquired Pneumonia§ 750 mg 5 Acute Bacterial Sinusitis 750 mg 5500 mg 10–14Table 1: Dosag e in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min) Type of Infection* Dosed Every 24 hours Duration(days)† Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 Complicated Skin and Skin Structure Infections (SSSI) 750 mg 7–14 Uncomplicated SSSI 500 mg 7–10 Chronic Bacterial Prostatitis 500 mg 28 Complicated Urinary Tract Infection (cUTI) orAcute Pyelonephritis (AP)¶750 mg 5Complicated Urinary Tract Infection (cUTI) orAcute Pyelonephritis (AP)#250 mg 10 Uncomplicated Urinary Tract Infection 250 mg 3Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kg Þ,ßPediatric patients < 50 kg and ≥ 6 months of age Þ,ß500 mgsee Table 2 below (2.2)60ß60ßPlague, adult and pediatric patients > 50 kg à Pediatric patients < 50 kg and ≥ 6 months of age500 mgsee Table 2 below (2.2)10 to 1410 to 14Due to the designated pathogens [see Indications and Usage (1)].† Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)].§ Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)].¶ This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.# This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli.Þ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].ß The safety of LEVAQUIN® in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged LEVAQUIN® therapy should only be used when the benefit outweighs the risk.à Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of LEVAQUIN® typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.2.2 Dosage in Pediatric PatientsThe dosage in pediatric patients ≥ 6 months of age is described below in Table 2.Table 2: Dosage in Pediatric Patients ≥ 6 months of ageType of Infection* Dose Freq. Once every Duration† Inhalational Anthrax (post-exposure)‡,§Pediatric patients > 50 kg 500 mg 24 hr 60 days§Pediatric patients < 50 kg and ≥ 6 months of age8 mg/kg(not to exceed 250 mgper dose)12 hr 60 days§Table 2: Dosage in Pediatric Patients ≥ 6 months of agePlague¶Pediatric patients > 50 kg 500 mg 24 hr 10 to 14 daysPediatric patients < 50 kg and ≥ 6 months of age8 mg/kg(not to exceed 250 mgper dose)12 hr 10 to 14 daysDue to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].† Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.‡ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)]§ The safety of LEVAQUIN® in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged LEVAQUIN® therapy should only be used when the benefit outweighs the risk.¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.2.3 Dosage Adjustment in Adults with Renal ImpairmentAdminister LEVAQUIN® with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].Table 3 shows how to adjust dose based on creatinine clearance.Table 3: Dosage Adjustment in Adult Patients with Renal Impairment (creatinine clearance <50 mL/min)Dosage in Normal Renal Function Every 24 hours Creatinine Clearance20 to 49 mL/minCreatinine Clearance10 to 19 mL/minHemodialysis or ChronicAmbulatory PeritonealDialysis (CAPD)750 mg 750 mg every 48 hours 750 mg initial dose, then500 mg every 48 hours 750 mg initial dose, then 500 mg every 48 hours500 mg 500 mg initial dose, then250 mg every 24 hours 500 mg initial dose, then250 mg every 48 hours500 mg initial dose, then250 mg every 48 hours250 mg No dosage adjustmentrequired 250 mg every 48 hours.If treating uncomplicated UTI,then no dosage adjustment isrequiredNo information on dosingadjustment is available2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, MetalCations, MultivitaminsLEVAQUIN® Tablets and Oral SolutionLEVAQUIN® Tablets and Oral Solution should be administered at least two hours before or two hours after antacids containing magnesium, aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc or didanosine chewable/buffered tablets or the pediatric powder for oral solution [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].LEVAQUIN® InjectionLEVAQUIN® Injection should not be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line [see Dosage and Administration (2.6)].2.5 Administration InstructionsFood and LEVAQUIN® Tablets and Oral SolutionLEVAQUIN® Tablets can be administered without regard to food. It is recommended that LEVAQUIN® Oral Solution be taken 1 hour before or 2 hours after eating.LEVAQUIN® InjectionCaution: Rapid or bolus intravenous infusion of LEVAQUIN® has been associated with hypotension and must be avoided. LEVAQUIN® Injection should be infused intravenously slowly over a period of not less than 60 or 90 minutes, depending on the dosage. LEVAQUIN® Injection should be administered only by intravenous infusion. It is not for intramuscular, intrathecal, intraperitoneal, or subcutaneous administration.Hydration for Patients Receiving LEVAQUIN® Tablets, Oral Solution, and InjectionAdequate hydration of patients receiving oral or intravenous LEVAQUIN® should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].2.6 Preparation of Intravenous ProductParenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.Because only limited data are available on the compatibility of LEVAQUIN® Injection with other intravenous substances, additives or other medications should not be added to。
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氧氟沙星片 说明书
【药品名称】
通用名：氧氟沙星片
商品名：
英文名：Ofloxacin Tablets
汉语拼音：Yangfushaxing Pian
本品主要成分为氧氟沙星。其化学名为(±)-9-氟-2，3-二氢-3-甲基-10-（4-甲基-1-哌嗪基）-7-
氧代-7H –吡啶并[1，2，3-de]-[1，4]苯并嗪-6-羧酸。
其化学结构式为:
分子式：C18H20FN3O4
分子量：361.38
【性 状】 本品为白色薄膜衣片，除去薄膜衣后显类白色或微黄色。
【药理毒理】
本品具广谱抗菌作用，尤其对需氧革兰阴性杆菌抗菌活性高，对下列细菌在体外具良好抗菌作用：
肠杆菌科的大部分细菌，包括枸椽酸杆菌属、阴沟、产气肠杆菌等肠杆菌属、大肠埃希菌、克雷伯菌属、
变形杆菌属、沙门菌属、志贺菌属、弧菌属、耶尔森菌等。常对多重耐药菌也具有抗菌活性。对青霉素
耐药的淋病奈瑟菌、产酶流感嗜血杆菌和莫拉菌属均具有高度抗菌活性。对铜绿假单胞菌等假单胞菌属
的大多数菌株具抗菌作用 。本品对甲氧西林敏感葡萄球菌具抗菌活性，对肺炎链球菌、溶血性链球菌
和粪肠球菌仅具中等抗菌活性。对沙眼衣原体、支原体、军团菌具良好抗微生物作用，对结核杆菌和非
典型分枝杆菌也有抗菌活性。对厌氧菌的抗菌活性差。氧氟沙星为杀菌剂，通过作用于细菌DNA螺旋酶
的A亚单位，抑制DNA的合成和复制而导致细菌死亡。
【药代动力学】
口服后吸收完全，相对生物利用度达95%～100%。血药达峰时间（Tmax）约为1小时。食物对本品
的吸收影响很少。多次给药后稳态血药浓度（Css）约给药后第3天达到。血消除半衰期（t1/2β）约
为4.7～7.0小时，蛋白结合率为20%～25%。本品吸收后广泛分布至各组织、体液，组织中的浓度常超
过血药浓度而达有效水平。本品尚可通过胎盘屏障。本品主要以原形自肾排泄，少量（3%）在肝内代谢。
口服24小时内尿中排出给药量的75%～90%，尿中代谢物很少。本品以原形自粪便中排出少量，给药后
24小时和48小时内累积排出量分别为给药量的1.6%和3.9%。本品也可通过乳汁分泌。
【适应症】
适用于敏感菌引起的：
1．泌尿生殖系统感染，包括单纯性、复杂性尿路感染、细菌性前列腺炎、淋病奈瑟菌尿道炎或宫
颈炎（包括产酶株所致者）。
2．呼吸道感染，包括敏感革兰阴性杆菌所致支气管感染急性发作及肺部感染。
3．胃肠道感染，由志贺菌属、沙门菌属、产肠毒素大肠杆菌、亲水气单胞菌、副溶血弧菌等所致。
4．伤寒。
5．骨和关节感染。
6．皮肤软组织感染。
7．败血症等全身感染。
【用法用量】
口服。
成人常用量：
1．支气管感染、肺部感染：一次0.3g，一日2次，疗程7～14日。
2. 急性单纯性下尿路感染：一次0.2g，一日2次，疗程5～7日；复杂性尿路感染：一次0.2g，
一日2次，疗程10～14日。
3. 前列腺炎：一次0.3g，一日2次，疗程6周；衣原体宫颈炎或尿道炎，一次0.3g，一日2次，
疗程7～14日。
4. 单纯性淋病：一次0.4g，单剂量。
5. 伤寒：一次0.3g，一日2次，疗程10～14日。
铜绿假单胞菌感染或较重感染剂量可增至一次0.4g，一日2次。
【不良反应】
1．胃肠道反应：腹部不适或疼痛、腹泻、恶心或呕吐。
2．中枢神经系统反应可有头昏、头痛、嗜睡或失眠。
3．过敏反应： 皮疹、皮肤瘙痒，偶可发生渗出性多形性红斑及血管神经性水肿。光敏反应较少见。
4．偶可发生：
(1)癫痫发作、精神异常、烦躁不安、意识混乱、幻觉、震颤。
(2)血尿、发热、皮疹等间质性肾炎表现。
(3)静脉炎。
(4)结晶尿，多见于高剂量应用时。
(5)关节疼痛。
5．少数患者可发生血清氨基转移酶升高、血尿素氮增高及周围血象白细胞降低，多属轻度，并呈
一过性。
【禁忌症】 对本品及氟喹诺酮类药过敏的患者禁用。
【注意事项】
1. 由于目前大肠埃希菌对氟喹诺酮类药物耐药者多见，应在给药前留取尿培养标本，参考细菌药
敏结果调整用药。
2. 本品大剂量应用或尿pH值在7以上时可发生结晶尿。为避免结晶尿的发生，宜多饮水，保持24
小时排尿量在1200ml以上。
3．肾功能减退者，需根据肾功能调整给药剂量。
4．应用本品时应避免过度暴露于阳光，如发生光敏反应需停药。
5．肝功能减退时，如属重度（肝硬化腹水）可减少药物清除，血药浓度增高，肝、肾功能均减退
者尤为明显，均需权衡利弊后应用，并调整剂量。
6．原有中枢神经系统疾患者，例如癫痫及癫痫病史者均应避免应用，有指征时需仔细权衡利弊后
应用。
【孕妇及哺乳期妇女用药】
动物实验未证实喹诺酮类药物有致畸作用，但对孕妇用药进行的研究尚无明确结论。鉴于本药可引
起未成年动物关节病变，故孕妇禁用，哺乳期妇女应用本品时应暂停哺乳。
【儿童用药】
本品在婴幼儿及18岁以下青少年的安全性尚未确定。但本品用于数种幼龄动物时，可致关节病变。
因此不宜用于18岁以下的小儿及青少年。
【老年患者用药】 老年患者常有肾功能减退，因本品部分经肾排出，需减量应用。
【药物相互作用】
1．尿碱化剂可减低本品在尿中的溶解度，导致结晶尿和肾毒性。
2．喹诺酮类抗菌药与茶碱类合用时可能由于与细胞色素P450结合部位的竞争性抑制，导致茶碱类
的肝消除明显减少，血消除半衰期(t1/2β)延长，血药浓度升高，出现茶碱中毒症状，如恶心、呕吐、
震颤、不安、激动、抽搐、心悸等。本品对茶碱的代谢影响虽较小，但合用时仍应测定茶碱类血药浓度
和调整剂量。
3．本品与环孢素合用，可使环孢素的血药浓度升高，必须监测环孢素血浓度，并调整剂量。
4．本品与抗凝药华法林合用时虽对后者的抗凝作用增强较小，但合用时也应严密监测患者的凝血
酶原时间。
5．丙磺舒可减少本品自肾小管分泌约50%，合用时可因本品血浓度增高而产生毒性。
6．本品可干扰咖啡因的代谢，从而导致咖啡因消除减少，血消除半衰期（t1/2β）延长，并可能
产生中枢神经系统毒性。
7．含铝、镁的制酸药可减少本品口服吸收，不宜合用。
【药物过量】
【规 格】
【贮 藏】 遮光，密封保存。
【包 装】
【有效期】
【批准文号】
【生产单位】
企业名称：
地 址：
邮政编码：
电话号码： 传真号码： 网 址：