部份中文甲磺酸加雷沙星处方资料（仅供参考）
英文名：Garenoxacin Mesilate Hydrate
商品名：Geninax Tablets
中文名：甲磺酸加雷沙星片
生产商：安斯泰来制药
药品简介
Geninax（Garenoxacin Mesilate Hydrate，甲磺酸加雷沙星）是一种新型喹诺酮类抗生素。抗菌谱较广，包括革兰氏阴性菌和革兰氏阳性菌。
革兰氏阴性菌包括常见的肺炎克雷伯菌、流感嗜血杆菌等，革兰氏阳性菌也是平常最容易引起肺炎的肺炎链球菌，还有金黄色葡萄球菌作用。
ジェニナック錠200mg 
药物分类名称
喹诺酮口服抗菌剂
批准日期：2007年10月 
商品名
Geninax Tablets 200mg 
一般名：メシル酸ガレノキサシン水和物
（Garenoxacin Mesilate Hydrate）
略号：GRNX
化学名：1-Cyclopropyl-8-（difluoromethoxy）-7-［（1R）-1-methyl-2,3-dihydro-1H-isoindol-5-yl］-4-oxo-1,4-dihydroquinoline-3-carboxylic acid monomethanesulfonate monohydrate
構造式
分子式：C23H20F2N2O4・CH4O3S・H2O
分子量540.53性状
药效药理
抗菌作用
革兰氏阳性菌，革兰氏阴性菌和非典型菌均有广谱的抗菌谱，包括葡萄球菌属（包括MRSA），链球菌属，肺炎球菌属，莫拉菌属（blanhamera），粘膜炎莫拉氏菌属（包括产β-内酰胺酶的细菌 ），对大肠杆菌，克雷白杆菌，肠杆菌，流感嗜血杆菌（包括BLNAR），嗜肺军团菌，肺炎衣原体（肺炎衣原体），肺炎支原体（肺炎支原体）具有很强的抗菌活性。 特别是对作为呼吸道感染的病原菌的肺炎球菌（Pneumococcus）显示出强的抗菌活性，包括肺炎球菌在内的肺炎球菌（包括多重耐药肺炎链球菌）。
作用机序
这种药物抑制细菌DNA促旋酶和拓扑异构酶IV并且杀菌。 另一方面，对真核细胞衍生的拓扑异构酶II的抑制作用弱，并且选择性抑制II型拓扑异构酶。
适应症
<适应性真菌种类>
金黄色葡萄球菌加雷沙星敏感性，链球菌属（包括耐青霉素肺炎链球菌）肺炎链球菌，莫拉菌属（布兰汉）卡他莫拉菌，大肠杆菌，克雷伯氏菌属，肠杆菌属，流感嗜血杆菌，嗜肺军团菌，肺炎衣原体（ 肺炎衣原体），肺炎支原体（肺炎支原体）
<适应症>
咽炎，喉炎，扁桃体炎（扁桃体炎，包括扁桃体周围脓肿），急性支气管炎，肺炎，慢性呼吸系统疾病的继发性感染，中耳炎，是鼻窦炎，肺炎球菌多药耐药性的肺炎球菌包括。
·有关耐药细菌等适应性细菌的详情，请参阅“临床结果”和“药理药理学”。
用法与用量
成年，每天一次，每次服400mg。
临床结果
1.针对患者的疾病有效率呼吸道感染和耳鼻喉感染，每天一次，II期和III期临床试验，深受国内外400毫克管理（双盲临床试验下表中每种疾病的有效率如下表所示。 （见临床结果表1）
2.第二阶段和第三阶段收集的细菌类型根除率的临床试验国外（目标呼吸道感染和耳鼻喉感染），在下面的表中的每个细菌物种的清除率这是如下。 66.7％葡萄球菌MRSA包含在日本药物的自适应物种（2/3），在国外（14/16）87.5％，在日本为100％耐青霉素的肺炎链球菌（27/27 ），在国外（12/14）85.7％，在日本100％为多药耐药性肺炎链球菌（81分之81），在国外（32/35）β-内酰胺酶的生产，莫拉氏菌属（布兰汉）卡他莫拉菌91.4％在全国细菌（29/29）100％，是在外国（一百三十四分之一百二十五）93.3％，在国内对流感嗜血杆菌的BLNAR（49/49），100％。 （见临床结果表2）
包装规格
100片（10片×10），500片（10片×50片）
制造商
安斯泰来制药
提示，以上中文资料不够完整，使用者以原处方资料为准。。
完整说明书附件：
http://www.info.pmda.go.jp/go/pack/6241017F1022_1_17/
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Quinolone oral synthetic antibacterial agent "Geninac(R)tablet 200mg" announced on domestic new release on October 5
Taisho Toyama Pharmaceutical Co.,Ltd.(Head office: Tokyo, President: Masaki Nogi Mori, hereinafter "Astellas Pharma") and Taisho Toyama Pharmaceuticals Co., Ltd. (Head office: Tokyo, President: Akira Ohira, hereinafter "Taisho Toyama Pharmaceuticals") and Toyama Chemical Industry Co., (Generic name: galenoxacin mesylate hydrate, development number: T (head name: Masashi Sugata, President: Masashi Sugata, hereinafter "Toyama Chemistry") is a quinolone oral synthetic antibacterial agent " -3811) will be released in Japan on October 5th.
This drug is a new type of quinolone synthetic antibacterial agent created by Toyama Chemistry and has excellent antibacterial activity against the respiratory and otorhinolaryngology infectious disease infectious diseases including resistant bacteria such as multidrug resistant pneumococci It is a medicine that can expect excellent clinical effect once a day administration by good oral absorbability and tissue migration. In addition, since this drug was the first synthetic antimicrobial agent to express penicillin-resistant pneumococci on the type of indication, the addition of usefulness was recognized compared to the drug price of existing drugs. In Japan, Toyama Chemical and Taisho Pharmaceutical Co., Ltd. (Headquarters: Tokyo, President: Akira Uehara) jointly developed respiratory infections and otorhinolary infections as target indications.
In March 2006, Toyama Chemical and Astellas Pharma have signed basic license agreement on sales and co-development in Japan, Toyama Chemical manufactures the same, Astellas Pharma distributes and sells it We will conduct sales promotion activities (co · promotion) in collaboration with Taisho Toyama Medicine.
The outline of "Geninac(R) tablet 200 mg" is as follows.
Manufacturing marketing approval acquisition date July 31, 2007
Product name Geninac (R)tablet 200 mg (English name: Geninax (R))
Generic name galenoxacin mesylate hydrate (English name: Garenoxacin Mesilate Hydrate)
Classification synthetic antibacterial agent
Indication/effect <Adaptive fungal species>
Escherichia coli, Klebsiella, Enterobacter, Haemophilus influenzae, Legionella pneumophila, Chlamydia pneumoniae (Staphylococcus aureus), which are sensitive to galenoxacin, Streptococcus, Streptococcus pneumoniae (including penicillin-resistant pneumococci), Moraxella (Blanhamera) Chlamydia pneumoniae), pneumonia mycoplasma (Mycoplasma pneumoniae)
<Indication>
Sore throat · laryngitis, tonsillitis (including amygdalis, amygdala abscess), acute bronchitis, pneumonia, secondary infection of chronic respiratory lesions, otitis media, sinusitis
Dosage /dose Usually, oral administration of 400 mg once a day as galenoxacin in adults。
Characteristic
1. It has an antibacterial spectrum and excellent antimicrobial activity suitable for the main phytopathogenic bacteria of respiratory / otolaryngology area infection (in vitro).
2. It also shows excellent antimicrobial activity against multidrug-resistant S. pneumoniae (in vitro).
3. Even when administered once a day, a large AUC (area under the blood concentration curve) is obtained and shows good migration to body fluids and tissues.
Four. It shows an excellent clinical effect with once-daily administration to respiratory / otorhinolaryngology area infections.
Five. In S. pneumoniae and Staphylococcus aureus, resistant mutants are difficult to appear (in vitro).
6. Side effects were observed in 132 (18.80%) out of 702 subjects subject to safety assessment in clinical trials carried out in Japan by the time of approval, and abnormal laboratory test values ​​were found in 211 cases (30.06%).
Approval acquirer Toyama Chemical Industry Co., Ltd.
Packaging tablets 200 mg: 100 tablets (PTP), 500 tablets (PTP, roses)
Drug price listing date September 21, 2007
Release date October 5, 2007