英文药名：CRAVIT INTRAVENOUS DRIP INFUSION(Levofloxacin Hydrate)

中文药名：左氧氟沙星水合物

生产厂家：第一三共

クラビット点滴静注バッグ５００ｍｇ／１００ｍＬ／クラビット点滴静注５００ｍｇ／２０ｍＬ

治疗类别名称
新喹诺酮类抗菌注射剂
商標名
CRAVIT INTRAVENOUS DRIP INFUSION
1. 一般名
レボフロキサシン水和物(Levofloxacin Hydrate)
2. 略名
LVFX
3. 化学名
(3S )-9-Fluoro-3-methyl-10-(4-methylpiperazin-1-yl)-7-oxo-2,3-dihydro-7H -pyrido[1,2,3-de ][1,4]benzoxazine-6-carboxylic acid hemihydrate
4. 分子式
C18H20FN3O4・1/2H2O
5. 分子量
370.38
6. 構造式

7. 性状
巴结是一种白色至黄白色结晶或结晶粉末。易溶于乙酸（100），微溶于水或甲醇，乙醇（99.5）微溶。易溶于0.1mol / L的盐酸测试解决方案。
光逐渐变成暗淡黄白色。
8.熔点
约226℃（分解）
9.分配系数
正辛醇-Sorensen缓冲液（pH7.0）;0.553（37℃）
1. 制定袋
(1) 保留的产品的质量，它包围该产品外袋不应该被打开，直到使用。
(2) 当时间和内容液体外袋破损泄漏，请勿使用。
(3) 不能使用残液。
(4) 通风针不是必需
(5) 容器的规模是要用作粗略指导。
2. 小瓶调配
(1) 使用后，你不使用使用一次性的，残留的液体。
(2) 保留了产品的质量，纸箱小瓶应当不能打开直到使用。
(2) 它显示了在24小时内输液没有不相容性的作为稀释剂已被证实。

适应病症
主要用于上述革兰阴性菌所致的呼吸道、咽喉、扁桃体、泌尿道（包括前列腺）、皮肤及软组织、胆囊及胆管、中耳、鼻窦、泪囊、肠道等部位的急、慢性感染等。
用法用量
成人，每天一次，每次500毫克，到静脉滴注历时约60分钟。（注：由于剂型及规格不同，用法用量请仔细阅读药品说明书或遵医嘱）
药效药理
左氧氟沙星，氧氟沙星外消旋光学活性的一个（-） - 一（S）身上。
(1) 抗菌作用
左氧氟沙星，对革兰氏阳性菌组和革兰氏阴性细菌组包括厌氧菌，有广泛的抗菌谱，葡萄球菌，链球菌属，肺炎链球菌，肠球菌属，以及大肠杆菌，克雷伯氏菌属，沙雷氏菌属属，变形杆菌，摩根Morugani，肠杆菌，包括普罗维登斯菌属，葡萄糖非发酵革兰氏阴性细菌群，包括绿脓杆菌，流感嗜血杆菌，军团菌属，消化链球菌，沙眼衣原体（沙眼衣原体） ，肺炎衣原体（肺炎衣原体），显示出抗菌活性，如肺炎支原体（支原体肺炎）。
此外，伤寒杆菌，副伤寒杆菌，炭疽杆菌，鼠疫耶尔森菌，属布鲁，土拉弗朗西斯菌，即使对于Q热立克次氏体（贝氏Buruneti）显示抗菌活性。
在实验小鼠感染防御测试和感染治疗试验，左氧氟沙星，显示治疗效果。
(2) 作用机理
左氧氟沙星作用于细菌的DNA促旋酶和拓扑异构酶IV，抑制DNA的复制。DNA促旋酶和拓扑异构酶IV的抑制活性，对抗菌作用是被在一个浓度观察到杀菌MIC附近氧氟沙星的2倍强度的裂解。
包装规格
静脉滴注袋
500毫克/100毫升（100毫升）10袋

静脉滴注
500毫克/20毫升（20毫升），1瓶

制造厂商
第一三共有限公司
原处方资料附件：http://www.info.pmda.go.jp/go/pack/6241402A1021_1_09/6241402A1021_1_09?view=body
Quinolone injectable antibacterial agent "Club iT (R) intravenous infusion bag 500mg/100mL·intravenous infusion 500mg/20mL" released Announcement
Daiichi Sankyo Co., Ltd. (Headquarters: Chuo-ku, Tokyo, hereinafter referred to as "Company"), in Japan, new quinolone antibacterial injectable formulation "Cravit® Ⓡ intravenous drip bag 500mg / 100mL · intravenous infusion 500mg / 20mL" ( generic name: levofloxacin hydrate, manufacturing and marketing approval acquisition date: October 27, 2010, drug price standards listed Date: December 10, 2010) will be notified that it has launched.
Cravit intravenous drip infusion, intravenous infusion bags, in a single dosage formulation per day in line with the PK-PD theory 1), penicillin-based drugs, cephem drugs, or even atypical bacteria treatment is difficult in the carbapenems has excellent antibacterial activity, apply to "less Pilate Lee quinolone 2)" in particular represents a new quinolone antibacterial agents suitable for the treatment of respiratory infections. Club iT has been approved in 120 countries and regions, has earned a high reputation in the world.
In Japan launched a 100mg oral formulation in December 1993, in July 2009, it launched a 500mg oral formulation, once administration per day of 500mg in conformity with PK-PD theory at present is not in widespread use you. This time, we are confident that we can expand the treatment options with the addition of a drip infusion formulation. Our company in order to develop a drug that can contribute to the improvement of the treatment of infectious diseases long, we are committed to the spread of this drug.
1) PK-PD theory
In scientific basis for designing the optimal method of administration of the antimicrobial agent, PK (Pharmacokinetics) and the "pharmacokinetics (changes in the concentration of the antimicrobial agent in vivo)" PD (Pharmacodynamics) "pharmacodynamics (in vivo by combining the action of antibacterial drugs) ", the concept to evaluate the effectiveness and safety of antimicrobial drugs.
2) less Pilate Lee quinolone
It has a strong antibacterial effect on pathogens and many other bacterial pneumococcal is the leading cause bacterial respiratory infection, in addition to them, the treatment effect of penicillin-based drug-cephem drugs, carbapenems can not be expected new quinolone antibacterial drugs also may indicate efficacy against atypical bacteria (mycoplasma pneumoniae, Chlamydia pneumoniae).
New Product Overview
Drug Name: injection of new quinolone antibacterial
Named Ⓡ levofloxacin intravenous bags 500 mg / 100 ml
Ⓡ intravenous levofloxacin 500 mg / 20 ml
Bags of intravenous levofloxacin 500 mg / 100 ml 1 pack
Intravenous levofloxacin 500 mg / 20 ml 1 bottle
[201012 January 10 the latest statement]
Effect-efficacy
<Adaptation species>
Levofloxacin sensibility of Staphylococcus to, Streptococcus spp., Streptococcus pneumoniae, Moraxella (Branhamella) catarrhalis, anthrax, E. coli, Salmonella typhi, paratyphoid bacteria, Klebsiella, Enterobacter, Serratia, Yersinia pestis, Haemophilus influenzae, green Pseudomonas aeruginosa, Acinetobacter, Legionella, Brucella, tularemia, Q fever rickettsia (Coxiella Buruneti), Chlamydia pneumoniae (Chlamydia pneumoniae), mycoplasma pneumoniae (mycoplasma pneumoniae)
<Indications>
Pneumonia, secondary infection of chronic respiratory disease, typhoid, paratyphoid, anthrax, brucellosis, plague, tularemia, Q fever
Dosage and usually, for adults once a day once 500mg as levofloxacin, to intravenous drip infusion over a period of about 60 minutes.
Manufacturing vendor Daiichi Sankyo Co., Ltd.