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  药店国别: 意大利药房
产地国家: 意大利
所属类别: 抗微生物药物->抗感染
处方药:处方药
包装规格: 400毫克 14胶囊
计价单位:
   
生产厂家英文名:
Sandoz SpA
原产地英文商品名:
Norfloxacina SAND 400mg 14 Capsules
原产地英文药品名:
NORFLOXACINE
中文参考商品译名:
Norfloxacina SAND 400毫克 14胶囊
中文参考药品译名:
诺氟沙星
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Genitourinary infections
英文适应病症2:
respiratory infections
英文适应病症3:
intestinal infections
临床试验期:
完成
中文适应病症参考翻译1:
泌尿生殖系感染
中文适应病症参考翻译2:
呼吸道感染
中文适应病症参考翻译3:
肠道感染
药品信息:
药理药动 药效学 诺氟沙星为喹诺酮类,其作用机制尚未完全阐明,一般认为本类药物作用于 DNA旋转酶的 A亚单位,影响DNA的合成和复制而引起细菌死亡。本品低浓度时为抑菌,较高浓度时则具杀菌作用。 药动学 空腹时口服吸收迅速但不完全( 30~40%);广泛分布于各组织、体液,如肝、肾、肺、前列腺、睾丸、子宫及胆汁、痰液、水疱液、血、尿液等中,但未见于中枢神经系统。血清蛋白结合率为10~15%,T1/2为3~4小时,肾功能减退时可延长为6~8小时。单次口服 400mg和 800mg,l~2小时血药浓度达峰值,血药峰浓度分别为 1.4~1.6和2.5μg/ml。肾脏(肾小球滤过和肾小管分泌)和肝胆系统为主要排泄途径,26~40%以原形和< 10%以代谢物形式自尿中排出,自胆汁和(或)粪便排出占 28~30%。 [药理作用]本品对大肠杆菌、肺炎杆菌、产气杆菌、阴沟杆菌、变形杆菌属、沙门菌属、志贺菌属、枸椽酸杆菌和沙雷菌属等肠杆菌科细菌具有强大抗菌活性,抑制上述细菌 90%菌株的最低抑菌浓度( MIC90)为0.02~1mg/L;嗜血流感杆菌属和淋球菌对本品高度敏感;本品对绿脓杆菌等假单胞菌亦具抗菌作用,但较肠杆菌科细菌者为差;对革兰阳性球菌作用较差,除对葡萄球菌属具有一定作用外,肺炎球菌、溶血性链球菌大多对本品耐药;诺氟沙星对厌氧菌的作用差。本品及其他喹诺酮类药物的作用机制主要是拮抗细菌的 DNA旋转酶,从而阻断 DNA复制而产生快速杀菌作用。 近年来本品等氟喹诺酮类在临床上被广泛应用,细菌耐药菌株明显增多,大肠杆菌、葡萄球菌属(尤其是耐甲氧西林葡萄球菌)、绿脓杆菌等假单胞菌的耐药现象尤为严重,细菌对该类药物耐药的主要机制为 DNA旋转酶 A亚单位突变或细菌对药物渗透性改变引起。 药动学 本品口服吸收不完全,约可吸收给药量的 35%~45%,成人单剂口服 200mg和 400mg后,高峰血药浓度分别为 0.75mg/L和 1.58mg/L。药物吸收后在体内广泛分布,在水泡液、生殖道、精液、脐带、羊水和前列腺等组织和体液中均可达有效药物浓度;本品的消除半减期为 3~4h,主要经肾排泄,自尿中以药物原形排出给药量的 30%左右,部分药物经肝脏代谢,自粪中约可排出给药量的 8.3%~53.3%,胆汁药物浓度明显高于血药浓度。 本品等氟喹诺酮类血浆蛋白结合率均低,约 20%~40%。 适 应 症 适用于敏感菌所致的成人感染。1.尿路感染诺氟沙星可用于枸橼酸菌属、阴沟肠杆菌、大肠杆菌、肺炎杆菌、变形杆菌属、摩根杆菌、雷极杆菌、绿脓杆菌、葡萄球菌属等所致的单纯或复杂尿路感染,作为选用药物之一。2.肠道感染本品对致病性和产毒素性大肠杆菌、沙门菌属(包括伤寒杆菌等)、志贺菌属、副溶血弧菌、亲水气单胞菌等所致的胃肠炎、菌痢、伤寒等有良好疗效,为首选药物或选用药物。3.淋病或淋球菌性尿道炎本品也有一定疗效,但非首选药物.因菌种或菌株间存在敏感性差异,选用本品前宜作药敏测定。 诺氟沙星已广泛用于临床,治疗下列感染:①泌尿生殖系感染,包括单纯性和复杂性尿路感染、细菌性前列腺炎、淋球菌性尿道及生殖系感染(包括产酶株所致者)。②胃肠道感染,如细菌性痢疾等。③耐氯霉素菌株所致伤寒和其他沙门菌感染。④呼吸道感染,由革兰阴性杆菌所致的支气管感染等。⑤皮肤软组织感染,由革兰阴性杆菌所致者。⑥革兰阴性杆菌所致的骨关节感染。由于诺氟沙星口服吸收不完全,对肺炎球菌等呼吸道常见病原菌作用差,目前该药主要用于泌尿生殖系感染及肠道感染。 用法用量 1,尿路感染每8小时口服 0.2g,轻症感染服用 3日,重症感染者 10—21日。 2.细菌性胃肠炎每 8小时口服 0.2g,疗程 5日。 3.伤寒每 8小时口服 0.4g,疗程 10一 14日。 4.淋病每 6小时口服 0.6g,共 2次。 16岁以下小儿不宜服用。 [制剂与规格]诺氟沙星胶囊0.1g 口服,一日0.4-0.8g,分2-4次用.伤寒或沙门氏菌感染,剂量加倍,空腹服.一疗程3-8日,少数病例可达3周.慢性泌尿道感染,可用一般量两周后减量到0.2g/日,睡前服,可连用数月. [用法及用量]成人口服量每日 600~800mg,分 2~3次服用;治疗较重感染(如伤寒),可增大至每日 800~1200mg,疗程视病种病情而定。治疗急性淋病可予单剂0.8g;或 1.2g,分 2次服用。 避免大剂量应用,以免发生结晶尿。避免与制酸剂同用,以免影响其口服吸收。 [剂型与规格]片剂:0.1g/片,0.2g/片,0.4g/片。胶囊剂:0.1g/粒,0.2g/粒。 不良反应 不良反应的发生率(包括实验室检测异常)为 7— 8%,但大多轻微;主要为:①胃肠道反应,如恶心、呕吐、腹痛、胃纳减退、口干、便秘或腹泻等;②中枢神经系症状,如头昏、头痛、倦睡或失眠等;③过敏性反应,如皮疹、瘙痒等;④实验室检测异常,如血中转氨酶、碱性磷酸酶、肌酐或尿素氮等升高。少见的副作用有肌肉震颤、抽搐、结晶尿、光敏感、视力障碍、关节肿胀等,前三者可能与用量较大有关。 可引起轻度胃肠道刺激或不适,食欲不振.一般不用停药可自行消退.少数人转氨酶升高,停药后可恢复.部分病人出现周围神经刺激症状,四肢皮肤有针扎感或轻度妁热感. 本品的不良反应主要有:①恶心、呕吐、上腹不适、腹泻、纳减等消化道反应。②头晕、头痛、情绪不安、失眠等神经系统反应,此类反应的发生率低于消化道反应。③皮疹、皮肤瘙痒、血管神经性水肿、光感皮炎等过敏反应,偶可发生过敏性休克。④少数患者可发生肌肉疼痛、无力、关节肿痛、心悸等。⑤实验室检查可发生一过性白细胞减少,血清转氨酶、血尿素氮和肌酐等的轻度增高,亦为可逆性。上述不良反应多轻微,大多患者可耐受。然而诺氟沙星等氟喹诺酮类偶可致严重不良反应,包括:①神志改变、袖搐、癫痫样发作。②短暂性幻觉、幻视、复视等。③结晶尿,发生于大剂量用药时。 禁忌症 (1)对某一喹诺酮类不能耐受者对本品也可能不耐受。 (2)固有交叉过敏反应,对喹诺酮类过敏者不宜应用本品。 (3)肾功能减退(肌酐清除率<30ml/min)者宜权衡利弊或减量给药。 (4)本品不宜用于儿童、孕妇和哺乳期妇女。 (5)有癫痫或癫痫病史者应在医护人员观察和随访下用喹诺酮类。 诺氟沙星等氟喹诺酮类药物的作用机制为抑制 DNA的合成,在幼鼠中发现该类药物对软骨的损害,故此类药物不宜用于小儿、孕妇,乳妇应用时需暂停哺乳,因药物可分泌至乳汁中。 原有癫痫等中枢神经疾患者,应避免应用本品等氟喹诺酮类,因易发生严重中枢神经系统反应。 严重肾功能减退者亦宜避免应用,因可发生抽搐等不良反应。有胃溃疡史的病人,应慎用。 药物相互作用 (1)抗酸剂可减少诺氟沙星的口服吸收,最好不同用,或于后者应用后2小时进服。 (2)丙磺舒可减少本品的肾小管分泌,导致本品的血浓度增高,因此不宜同用。 诺氟沙星等喹诺酮类可抑制茶碱类、咖啡因和口服抗凝剂(华法林)在肝脏的代谢,使上述药物因代谢减少而血药浓度升高,致不良反应易于发生,应避免同用。必须合用时,应监测茶碱类血药浓度或凝血酶元时间,并据以调整剂量。制酸剂可减少本品等喹诺酮类口服制剂的肠道吸收,不宜同用。 Pharmacology, Pharmacokinetics  Pharmacodynamic Norfloxacin as quinolones, its mechanism of action is not fully understood , the role of this class of drugs is generally believed in the DNA gyrase A subunit of DNA synthesis and replication impact caused by bacterial death. This product is bacteriostatic at low concentrations , the bactericidal effects at higher concentrations . Pharmacokinetics Fasting rapid oral absorption , but not completely ( 30 to 40% ) ; widely distributed in various tissues, body fluids , such as liver, kidney, lung , prostate , testis, uterus and bile , sputum, blister fluid , blood , urine , etc. , but not found in the central nervous system. Serum protein binding rate of 10 ~ 15%, T1 / 2 of 3 to 4 hours , extended from 6 to 8 hours renal dysfunction . Single oral dose of 400mg and 800mg, l ~ 2 hour plasma concentration peak, peak plasma concentrations were 1.4 to 1.6 and 2.5μg/ml. Kidney ( glomerular filtration and tubular secretion ) and the hepatobiliary system as the main route of excretion , 26 to 40 % of the prototype and <10% in the form of metabolites from the urine , bile and ( or ) feces accounted for 28 ~ 30% . [ Pharmacological action ] The product of Enterobacteriaceae Escherichia coli , Klebsiella pneumoniae, aerogenes , Enterobacter cloacae , Proteus , Salmonella , Shigella , and Serratia spp citrate has strong antibacterial activity etc. , 90% inhibition of bacterial strains above the minimum inhibitory concentration (MIC90) of 0.02 ~ 1mg / L; Haemophilus influenzae and Neisseria gonorrhoeae is highly sensitive to the chemicals ; this product is also against Pseudomonas aeruginosa and other tools antibacterial effect, but more Enterobacteriaceae were worse ; effect on Gram-positive cocci poor, in addition to having a role outside of Staphylococcus , Streptococcus pneumoniae , Streptococcus mostly resistant to the chemicals ; norfloxacin the role of anaerobes difference . Mechanism of action of the product and other quinolones mainly antagonistic bacterial DNA gyrase , thereby blocking DNA replication and produce rapid bactericidal effect. In recent years , such as fluoroquinolones This product is widely used in clinical practice , drug-resistant strains of bacteria increased significantly , Escherichia coli, Staphylococcus spp ( especially methicillin-resistant Staphylococcus aureus ) , Pseudomonas aeruginosa and other Pseudomonas resistance phenomenon is particularly severe , drug -resistant bacteria in the main mechanism of DNA gyrase a subunit mutations or drug permeability changes caused by bacteria . Pharmacokinetics The incomplete oral absorption , can absorb about 35% to 45% of the administered dose for adults after a single oral dose of 200mg and 400mg, the peak plasma concentrations were 0.75mg / L and 1.58mg / L. After absorption of the drug is widely distributed in the body, in blister fluid, genital tract , semen , umbilical cord, amniotic fluid and prostate tissue and body fluids can reach effective drug concentration ; elimination half -life of this product is 3 ~ 4h, primarily by renal excretion since the drug is excreted unchanged in the urine of 30% of the administered dose , some of the drugs metabolized by the liver , can be discharged from the feces of about 8.3% ~ 53.3% of the administered dose , the drug concentration was significantly higher than that of bile plasma concentration . This product and other fluoroquinolones low plasma protein binding rate of about 20% to 40%. Indications  Applicable to adult infections caused by susceptible strains . Simple one . Citrate can be used for urinary tract infections norfloxacin genus , Enterobacter cloacae , Escherichia coli , Klebsiella pneumoniae, Proteus, Morgan bacillus , Ray pole , Pseudomonas aeruginosa , Staphylococcus spp caused or complicated urinary tract infections, as one of the choice of drugs . 2 . The product of pathogenic intestinal infection and toxigenic E. coli , Salmonella ( including Salmonella typhi , etc. ) , Shigella , Vibrio parahaemolyticus , hydrophilic Aeromonas gastroenteritis caused by bacteria , dysentery , typhoid and other good effect, as the drug of choice or use drugs . 3 . Gonorrhea or gonococcal urethritis This product can also have some effect , but non-preferred drugs. Due to the existence of inter- species or strain differences in susceptibility , the FDA before the election should be determined susceptibility . Norfloxacin has been widely used in clinical treatment of the following infections : ① genitourinary infections, including simple and complicated urinary tract infections, bacterial prostatitis, gonococcal infection of the urethra and reproductive system (including producing strains caused persons ) . ② gastrointestinal infections , such as bacterial dysentery and so on. ③ chloramphenicol -resistant strains of typhoid fever caused by Salmonella and other infections . ④ respiratory tract infections, caused by gram -negative bacilli bronchial infections. ⑤ skin and soft tissue infections caused by gram -negative bacilli were . ⑥ caused by Gram-negative bacilli bone and joint infections. Due to incomplete absorption of oral norfloxacin , pneumococcus and other common respiratory pathogens effects on poor, currently the drug is mainly used for urinary and reproductive tract infections and intestinal infections. Dosage  1 , urinary tract infection orally every 8 hours 0.2g, taking the 3rd mild infection , severe infections 10-21 days. 2 . Bacterial gastroenteritis orally every 8 hours 0.2g, course of 5 days. 3 . Every eight hours of oral typhoid 0.4g, 10 an 14 course . 4 . Every six hours of oral gonorrhea 0.6g, 2 times. Children under the age of 16 should not be taken . [ Formulations and specifications ] norfloxacin capsules 0.1g Orally, 0.4-0.8g, 2-4 times with typhoid or salmonella infection, double dose empty stomach . A course of 3-8 days , a few cases up to three weeks . Chronic urinary tract infections, the amount of two generally available weeks after the reduction to 0.2g / day , before bedtime , you can once every few months. [ Usage and dosage ] adult daily oral dose of 600 ~ 800mg, 2 to 3 times daily ; treatment of severe infections ( such as typhoid ) , can be increased to a daily 800 ~ 1200mg, depending on the disease course of the disease. Treatment of acute gonorrhea may be a single dose 0.8g; or 1.2g, divided into 2 doses . Avoid large doses in order to avoid crystallization of urine . Avoid using antacids with , to avoid affecting their oral absorption . [ Formulations and specifications ] tablet : 0.1g / tablets , 0.2g / piece , 0.4g / piece . Capsules : 0.1g / tablets , 0.2g / tablets. Adverse reactions  The incidence of adverse events (including laboratory test abnormalities ) of 7 - 8%, but mostly mild ; mainly : ① gastrointestinal reactions , such as nausea , vomiting , abdominal pain, decreased appetite , dry mouth , constipation or diarrhea ; ② central nervous system symptoms such as dizziness , headache, drowsiness or insomnia ; ③ allergic reactions , such as rash , itching , etc. ; ④ laboratory test abnormalities, such as serum transaminases , alkaline phosphatase, and creatinine or blood urea nitrogen increased. Rare side effects are muscle tremors , convulsions, crystallized urine, light- sensitive , visual disturbances , joint swelling , the first three may be related to a larger amount . Can cause mild gastrointestinal irritation or discomfort , loss of appetite . Generally subside on their own without discontinuation . Few elevated transaminase resume after the withdrawal . Some patients peripheral nerve irritation , limb skin sensation or light needlestick degree Shuo thermal. The main adverse effects of this product are: ① nausea , vomiting, abdominal discomfort , diarrhea, and other gastrointestinal reactions less satisfied . ② dizziness , headache, restlessness , insomnia , etc. The incidence of nervous system reactions, such reactions is lower than the gastrointestinal reactions. ③ rash , pruritus, angioedema , dermatitis and other allergic reactions light perception , can occur even anaphylactic shock. ④ few patients can occur muscle pain, weakness, joint pain, heart palpitations and so on. ⑤ laboratory tests can occur a transient leukopenia, serum transaminases , blood urea nitrogen and creatinine of slightly elevated , is also reversible . These adverse reactions mild , most patients can tolerate . However, norfloxacin and other fluoroquinolones even can cause serious adverse reactions , including: ① altered consciousness , sleeves twitch , epileptic seizures. ② transient hallucinations, visual hallucinations, diplopia . ③ crystallization of urine , occurs when large doses of medication. Contraindications  ( 1 ) for those who can not tolerate certain quinolones of the goods may not be tolerated . ( 2 ) the inherent cross- allergic reactions to quinolones allergies should not be using . ( 3 ) renal dysfunction ( creatinine clearance <30ml/min) are advised to weigh or decrement administration. ( 4 ) This product is not suitable for children, pregnant and lactating women. ( 5 ) there is a history of seizures or epilepsy should be under observation and follow-up with quinolones in health care workers. Mechanism of action of fluoroquinolones such as norfloxacin for inhibition of DNA synthesis , these drugs damage to the cartilage found in young rats , so these drugs should not be used in children , pregnant women , breastfeeding women milk need to suspend the application , because drugs can be excreted in human milk . Original epilepsy and other central nervous disease patients should avoid the FDA and other fluoroquinolones, because prone to serious central nervous system reactions. Severe renal dysfunction should be matched to avoid the application of adverse reactions due to convulsions may occur . Patients with a history of ulcer should be used with caution. Drug Interactions  ( 1 ) antacids can reduce the absorption of oral norfloxacin , preferably with a different , or two hours after the application of the latter into the service . ( 2 ) probenecid can reduce the tubular secretion of the product , resulting in increased blood concentration of this product , it would be inappropriate with the use. Norfloxacin and other quinolones inhibit theophylline , caffeine and oral anticoagulants ( warfarin ) in the metabolism of the liver , so that the metabolism of these drugs due to a decrease in plasma concentration, prone to cause adverse reactions , should avoided with the use. When necessary combination should be monitored theophylline serum concentration or prothrombin time , and to adjust the dose . Antacids may decrease the oral formulations of products such as quinolones intestinal absorption , not with the use.
更新日期: 2014-01-21
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