英文药名：OZEX ophthalmic solution（Tosufloxacin Tosilate Hydrate）

中文药名：甲苯磺酸托氟沙星眼用溶液

生产厂家：大冢制药

オゼックス点眼液０．３％

治疗类别名称
广泛的抗菌眼药水
批准上市日期：2006年5月
欧文商標名
OZEX ophthalmic solution
一般名：
トスフロキサシントシル酸塩水和物
(Tosufloxacin Tosilate Hydrate)
略号：
TFLX (トスフロキサシン)
化学名：
7-[3(RS)-3-Aminopyrrolidin-1-yl]-1-(2,4-difluorophenyl)-6-fluoro-4-oxo-1,4-dihydro-1,8-naphthyridine-3-carboxylic acid mono-4-toluenesulfonate monohydrate
構造式：

分子式：
C19H15F3N4O3・C7H8O3S・H2O
分子量：
594.56
性状：
白色至浅黄色结晶性粉末。N，N  - 易溶于二甲基甲酰胺，难溶在甲醇中，并在水或乙醇（99.5）几乎不溶。
甲醇溶液（1→100）示出了没有旋光性。
熔点：
约254℃（分解）
操作注意事项
●包含主滴眼液的变化
这种药物1mL中和混合药物1mL中放置在玻璃管中，并混合10秒在一个混合器，观察外观的变化
有复利变化
Rinderon溶液，Nifuran眼用溶液，Jikurodo眼用溶液，Buronakku滴眼剂，眼滴剂，鼻为Rinderon的溶液，Ekorishin眼用溶液，RIZABEN眼用溶液，色甘酸钠眼用溶液，谷胱甘肽眼科，Mydrin男，适利达眼用溶液，Timoptol 0.25 ％，Timoptol XE0.5％，Trusopt滴眼液1％，Mikelan滴眼液2％，Rizumon TG滴眼液0.5％，Furabitan滴眼液
配方没有变化
Toburashin眼用溶液，Zajiten眼用溶液，Mukozomu眼用溶液，卡塔琳眼用溶液，Mydrin P，Rescula滴眼剂，Sankoba眼用溶液
其中1小时后静置立即混合或在室温（混浊）更改的外观进行了观察。阴天，螯合平衡托氟沙星和铝离子是这种药物，在眼科溶液中的其它四乙酸二钠，柠檬酸等受影响的磷酸的溶解机理，活性组分被假定为沉淀。
药效药理
1.抗菌作用
托氟沙星的抗菌谱是此药物的活性体是广泛Oyobi，金在体外，链球菌属，肺炎链球菌，肠球菌属，属微球菌，属的棒状杆菌革兰氏阳性菌，等，莫拉氏，克雷伯氏菌属，肠杆菌属，沙雷氏菌属，变形杆菌属，摩根氏Morugani，普罗维登斯菌属，流感嗜血杆菌，流感嗜血杆菌Ejipuchiusu（科赫-周菌），假单胞菌属，绿脓杆菌，洋葱伯克霍尔德菌，嗜（黄单胞菌）麦芽，显示针对眼部感染如痤疮细菌菌致病很强的抗菌活性是革兰氏阴性细菌以及属不动杆菌等的厌氧菌。
2.作用机制
作用于DNA促旋酶和拓扑异构酶IV细菌DNA的高级结构转换，通过抑制DNA复制，作用杀菌。
3.对实验眼部感染的治疗效果
针对在角膜基质眼部感染模型被接种绿脓杆菌或兔子的表皮葡萄球菌的临床分离株中创建，该药物表现出治疗效果。
适应症
<适应物种>
葡萄球菌的托氟沙星敏感性，链球菌属，肺炎链球菌，肠球菌属，微球菌属，莫拉氏菌属，棒状杆菌属，克雷伯氏菌属，肠杆菌属，沙雷氏菌属，变形杆菌属，摩根氏Morugani，普罗维登斯菌属，流感嗜血杆菌，流感嗜血杆菌Ejipuchiusu（科赫-周菌），假单胞菌属，绿脓杆菌，洋葱伯克霍尔德菌，嗜（黄单胞菌属）麦芽，不动杆菌，痤疮菌
<适应症>
睑缘炎，（包括角膜溃疡）泪囊炎，麦粒肿，结膜炎，睑板腺炎症，角膜炎，眼围手术期的消毒治疗
用法与用量
成人和儿童；每天滴三次，每次一滴。此外，在适当增加疾病和症状。
包装规格
滴眼液0.3％：
5毫升×5本，5毫升×10本

制造厂商
大冢制药有限公司[联盟]富山化学工業株式会社
完整资料附件：http://www.info.pmda.go.jp/go/pack/1319751Q1020_1_08/
Otsuka Pharmaceutical releases New Quinolone Antimicrobial Eye Drop Ozec Eye Solution 0.3% on May 11
Otsuka Pharmaceutical Co., Ltd. (Head office: Chiyoda-ku, Tokyo, President: Tatsuo Higuchi, TEL: 03-3292-0021) has added a new quinolone antimicrobial ophthalmic solution "Ozox ophthalmic solution 0.3%" (generic name: tosylate tosylate) We will release it from May 11th.
"Ozox Ophthalmic Solution 0.3%" is a drug developed for ophthalmic use for ophthalmic use, "Ozex tablet" for oral use New quinolone synthetic antibacterial agent which was created by Toyama Chemical Industry Co., Ltd. since 1990. "Ozox Ophthalmic Solution 0.3%" is a drug that has a broad spectrum of antimicrobial spectrum and strong antimicrobial activity in Gram positive bacteria, negative bacteria and anaerobic bacteria, and has acquired indications for various bacterial outer eye infections.
In addition to adults, clinical trials were conducted for children including newborn babies, and for the first time in Japan the dosage regimen and dose for children were recognized.
"Ozox eye drop 0.3%" is manufactured by Toyama Chemical Industry and sold by Otsuka Pharmaceutical.
Otsuka Pharmaceutical will contribute to the health of the people of the world under the corporate philosophy of "Otsuka - people creating new products for better health worldwide".
<Product features>
1) It has antimicrobial activity against infectious bacteria (Staphylococcus, Streptococcus, Streptococcus, Haemophilus influenzae, Pseudomonas aeruginosa, Acne bacterium) of eye infections.
2) A clinical trial was conducted for children (including infants and newborn babies), the effectiveness and safety were confirmed, and the use and dosage of children were clarified for the first time in Japan as an antibacterial ophthalmic solution.
3) It shows long PAE against Staphylococcus aureus, S. epidermidis, Pseudomonas aeruginosa.
4) Short-time bactericidal action against Staphylococcus aureus, S. epidermidis, Pseudomonas aeruginosa.
5) In the sterilization therapy at the ophthalmic surgery period, the preoperative sterilization rate was 73.4%, and the sterilization rate by the detection bacteria was 86.6%.
6) The side effect rate is 2.42%, the main side effects are 0.97% eye irritation and 0.65% corneal disorder such as punctate keratitis. There are reports of shock and anaphylactoid symptoms as serious side effects.
<Product outline>
Product name Ozex Eye Drop 0.3%
Indication type:
Tusfloxacin sensitive to Staphylococcus, Streptococcus, Streptococcus, Enterococci, Micrococcus, Moraxella, Corynebacterium, Klebsiella, Enterobacter, Serratia, Proteus, Morganella morganii, Providencia , Haemophilus · Egyptius (Koch · Weeks strain), Pseudomonas, Pseudomonas, Pseudomonas, Burkholderia · Cepacia, Stenotrophomonas (Zanthomonas) · Maltophilia, Acinetobacter, Acne bacterium
Indications:
Blepharitis, dacryocystitis, stomatitis, conjunctivitis, tineplateitis, keratitis (including corneal ulcer), ophthalmic perioperative sterilization therapy
Dosage/administration Usually one drop per drop for an adult and a child, three times a day. Incidentally, dosage should be increased according to disease and symptoms.
Usage notes See attached document
Active ingredient Tosufloxacin tosylate
Package 5 × 5, 5 mL × 10
Sales Otsuka Pharmaceutical Co., Ltd.
Manufacturing distributor Toyama Chemical Industry Co., Ltd.