盐酸左氧氟沙星片说明书

盐酸左氧氟沙星片书 【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?)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。13月龄犬，经口给药7天，在40mg/kg剂量时出现轻度的关节毒性。但18月龄application; infection and antibacterial drug of clinical application; transfusion refers to levy; nutrition support of adapted card and clinical application; common life support technology (as cycle breathing support, and nutrition support,) and emergency technology of application; common guardianship instrument using. Look: shock, cardiac respiratory arrest and acute organ failure, systemic inflammatory response syndrome and severe infection and multiple organ dysfunction syndrome (MODS), severe disturbance of body fluid environment such as critical theory and progress of the illness. 2. basic requirements (1) species and cases of study requirements: severe pneumonia in disease-disease myocardial infarction ... 3. high requirements (1) learning disease species: disease species disease species image radiation: rheumatic heart congenital heart intestinal Crohn's (Crohn) disease intestinal tuberculosis bile duct cancer chronic pancreatic inflammatory urinary system stone urinary system tumor adrenal disease thyroid disease cranial within infection nervous system tumor nuclear medical: Digest road bleeding explicit like brain blood flow perfusion explicit like testicular blood pool explicit like salivary glands explicit like (2) clinical knowledge, and skills requirements: understand various image check 犬静脉注射14天，30mg/kg剂量时未出现关节毒性。 生殖毒性:大鼠妊娠前、妊娠初期经口给药剂量360mg/kg时，对雌、雄动物的生殖能力和胎儿均未见影响。大鼠在器官形成期给药，剂量达90mg/kg时，对胎儿和新生儿均无明显影响。家兔经口给药50mg/kg时，未出现胚胎、胎儿致死以及胎儿生长迟缓作用，也未出现致畸作用。大鼠围产期、授乳期经口给药达360mg/kg时，对动物的分娩、授乳以及出生儿均未见明显影响。 光毒性:采用长波长紫外线(320-400nm)照射，以小鼠耳廓厚度变化为指标进行了光毒性研究，结果经口给药剂量达200mg/kg，未见明显异常变化。 【药代动力学】 据国外资料报道:健康成人单次口服左氧氟沙星0.2g(以C18H20FN3O4计)后0.67?0.15小时可达血药峰浓度。Cmax为2.92?0.54μg/ml，消除半衰期为6小时。国外资料单次静注左氧氟沙星0.3g和相同剂量口服给药的药代动力学参数相似(见表)。 左氧氟沙星0.3g静注(n=8)和口服(n=12)后 药代动力学参数的平均值 给药 Cmax AUC(0,24) T(1/2) 肾清除率 途径 (μg/ml) (μg h/ml) (h) (ml/min) 静注 6.27 20.73 6.28 145.55 口服 4.04 22.62 6.48 162.80 [AUC(0-48)] application; infection and antibacterial drug of clinical application; transfusion refers to levy; nutrition support of adapted card and clinical application; common life support technology (as cycle breathing support, and nutrition support,) and emergency technology of application; common guardianship instrument using. Look: shock, cardiac respiratory arrest and acute organ failure, systemic inflammatory response syndrome and severe infection and multiple organ dysfunction syndrome (MODS), severe disturbance of body fluid environment such as critical theory and progress of the illness. 2. basic requirements (1) species and cases of study requirements: severe pneumonia in disease-disease myocardial infarction ... 3. high requirements (1) learning disease species: disease species disease species image radiation: rheumatic heart congenital heart intestinal Crohn's (Crohn) disease intestinal tuberculosis bile duct cancer chronic pancreatic inflammatory urinary system stone urinary system tumor adrenal disease thyroid disease cranial within infection nervous system tumor nuclear medical: Digest road bleeding explicit like brain blood flow perfusion explicit like testicular blood pool explicit like salivary glands explicit like (2) clinical knowledge, and skills requirements: understand various image check 左氧氟沙星在体内组织中分布广泛。主要以原形由尿中排出，口服给药后48小时内，尿中原形排出量占给药量的87%;72小时内粪便中的排出量少于给药量的4%;约5%的药物以无活性代谢物的形式由尿中排出。 肾功能减退的患者左氧氟沙星清除率下降，消除半衰期延长，为避免药物蓄积，应进行剂量调整。血液透析和连续腹膜透析(CAPD)不影响左氧氟沙星从体内排除。 【适应症】 本品适用于敏感细菌引起的下列轻、中度感染: 呼吸系统感染:急性支气管炎、慢性支气管炎急性发作、弥漫性细支气管炎、支气管扩张合并感染、肺炎、扁桃体炎(扁桃体周围脓肿); 泌尿系统感染:肾盂肾炎、复杂性尿路感染等; 生殖系统感染:急性前列腺炎、急性附睾炎、宫腔感染、子宫附件炎、盆腔炎(疑有厌氧菌感染时可合用甲硝唑); 皮肤软组织感染:传染性脓疱病、蜂窝组织炎、淋巴管(结)炎、皮下脓肿、肛周脓肿等; 肠道感染:细菌性痢疾、感染性肠炎、沙门菌属肠炎、伤寒及副伤寒; 败血症、粒细胞减少及免疫功能低下患者和各种感染; 其他感染:乳腺炎、外伤、烧伤及手术后伤口感染、腹腔感染(必要时合用甲硝唑)、胆囊炎、胆管炎、骨与关节感染以及五官科感染等。 【用法用量】 口服。 成人每次1,2片(0.1,0.2g),每日两次。病情偏重者可增为每日三次。另外，可根据感染的种类及症状适当增减。 【不良反应】 盐酸左氧氟沙星用药期间可能出现不良反应: 消化系统:有时会出现恶心、呕吐、腹部不适、腹泻、食欲不振、腹痛、消化不良等; 过敏症:偶有浮肿、荨麻疹、发热感、光过敏症以及有时会出现皮疹、瘙痒、红斑等症状; 神经系统:偶有震颤、麻木感、视觉异常、耳鸣、幻觉、嗜睡，有时会出现失眠、头晕、头痛等症状; 肾脏:偶见血中尿素氮上升; 肝脏:可出现一过性肝功能异常，如血清转氨酶增高、血清总胆红素增加等; application; infection and antibacterial drug of clinical application; transfusion refers to levy; nutrition support of adapted card and clinical application; common life support technology (as cycle breathing support, and nutrition support,) and emergency technology of application; common guardianship instrument using. Look: shock, cardiac respiratory arrest and acute organ failure, systemic inflammatory response syndrome and severe infection and multiple organ dysfunction syndrome (MODS), severe disturbance of body fluid environment such as critical theory and progress of the illness. 2. basic requirements (1) species and cases of study requirements: severe pneumonia in disease-disease myocardial infarction ... 3. high requirements (1) learning disease species: disease species disease species image radiation: rheumatic heart congenital heart intestinal Crohn's (Crohn) disease intestinal tuberculosis bile duct cancer chronic pancreatic inflammatory urinary system stone urinary system tumor adrenal disease thyroid disease cranial within infection nervous system tumor nuclear medical: Digest road bleeding explicit like brain blood flow perfusion explicit like testicular blood pool explicit like salivary glands explicit like (2) clinical knowledge, and skills requirements: understand various image check 血液:有时会出现贫血、白细胞减少、血小板减少和嗜酸性粒细胞增加等; 上述不良反应发生率在0.1,5%之间，一般均能耐受，疗程结束后迅速消失。如发现异常时应注意观察，必要时可停止用药并进行适当处置。 【禁忌】 对喹诺酮类药过敏者、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时应停用本品。 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。 【孕妇及哺乳期妇女用药】 孕妇、哺乳期妇女患者禁用。 【儿童用药】 18岁以下患者禁用。 【老年用药】 本品主要以原形由尿液排出，老年患者常有肾功能减退，需酌情减量应用。高龄患者推荐剂量为一次1片，每12小时一次。 【药物相互作用】 1(本品不能与多价金属离子如镁、钙等溶液在同一输液管中使用。 2(避免与茶碱同时使用，如需同时使用，应监测茶碱的血药浓度，据以调整剂量。 3(与华法令或其衍生物同时应用时，应监测凝血酶原时间或其他凝血试验。 4(与非甾体类抗炎药物同时应用，有引发抽搐的可能。 5(与口服降血糖药同时使用可能引起低血糖，因此用药过程中应注意监测血药浓度，一旦发生低血糖时应立即停用本品，并给予适当处理。 【药物过量】 喹诺酮类药物过量时，可出现以下症状:恶心、呕吐、胃痛、胃灼热、腹泻、口渴、口腔炎、蹒跚、头晕、头痛、全身倦怠、麻木感、发冷、发热、锥体外系症状、兴奋、application; infection and antibacterial drug of clinical application; transfusion refers to levy; nutrition support of adapted card and clinical application; common life support technology (as cycle breathing support, and nutrition support,) and emergency technology of application; common guardianship instrument using. Look: shock, cardiac respiratory arrest and acute organ failure, systemic inflammatory response syndrome and severe infection and multiple organ dysfunction syndrome (MODS), severe disturbance of body fluid environment such as critical theory and progress of the illness. 2. basic requirements (1) species and cases of study requirements: severe pneumonia in disease-disease myocardial infarction ... 3. high requirements (1) learning disease species: disease species disease species image radiation: rheumatic heart congenital heart intestinal Crohn's (Crohn) disease intestinal tuberculosis bile duct cancer chronic pancreatic inflammatory urinary system stone urinary system tumor adrenal disease thyroid disease cranial within infection nervous system tumor nuclear medical: Digest road bleeding explicit like brain blood flow perfusion explicit like testicular blood pool explicit like salivary glands explicit like (2) clinical knowledge, and skills requirements: understand various image check 幻觉、抽搐、谵妄、小脑共济失调、颅内压升高(头痛、呕吐、视神经乳头水肿)、代谢性酸中毒、血糖增高、GOT/GPT/AL-P增高、白细胞减少、嗜酸性粒细胞增加、血小板减少、溶血性贫血、血尿、软骨/关节障碍、白内障、视力障碍、色觉异常及复视。 急救措施及解毒药(1)洗胃;(2)吸附药:活性炭(40g,60g加水200ml口服);(3)泻药:硫酸镁(30g加水200ml)，或其他缓泻药;(4)输液(加保肝药物);代谢性酸中毒给以碳酸氢钠注射液，尿碱化给以碳酸氢钠注射液，以增加本品由肾脏的排泄;(5)强制利尿:给予呋喃苯氨酸注射液;(6)对症疗法:抽搐时应反复投以安定静脉注射液;(7)重症:可考虑进行血液透析。 【规格】 0.1g(以左氧氟沙星计) 【贮藏】 遮光，密封保存。 【包装】 聚氯乙烯固体药用硬片/药品包装用PTP铝箔，12片/板，1板/盒。 【有效期】 24个月。 application; infection and antibacterial drug of clinical application; transfusion refers to levy; nutrition support of adapted card and clinical application; common life support technology (as cycle breathing support, and nutrition support,) and emergency technology of application; common guardianship instrument using. Look: shock, cardiac respiratory arrest and acute organ failure, systemic inflammatory response syndrome and severe infection and multiple organ dysfunction syndrome (MODS), severe disturbance of body fluid environment such as critical theory and progress of the illness. 2. basic requirements (1) species and cases of study requirements: severe pneumonia in disease-disease myocardial infarction ... 3. high requirements (1) learning disease species: disease species disease species image radiation: rheumatic heart congenital heart intestinal Crohn's (Crohn) disease intestinal tuberculosis bile duct cancer chronic pancreatic inflammatory urinary system stone urinary system tumor adrenal disease thyroid disease cranial within infection nervous system tumor nuclear medical: Digest road bleeding explicit like brain blood flow perfusion explicit like testicular blood pool explicit like salivary glands explicit like (2) clinical knowledge, and skills requirements: understand various image check