新型口服喹诺酮类抗生素Geninax(Garenoxacin Mesilate Hydrate)获日本批准上市 日本的Astellas药业公司与Taisho Toyama药业公司近日宣布新型口服喹诺酮类抗生素Geninax（garenoxacin mesilate hydrate，甲磺酸加雷沙星水合物）于2007年10月5日正式在日本投放市场，主要用于治疗呼吸道及耳鼻喉科感染。 加雷沙星为Toyama公司发现的一种喹诺酮类药物，对引起呼吸道感染病原体与引起耳鼻咽喉麻风感染病原体有很强的抗毒活性，包括对多药耐受性的肺炎链球菌。该药表现出良好的口服吸收性与组织分分布性，因此一天只需服用一次。 加雷沙星为首个适用于对青霉素类抗生素有耐药性肺炎链球菌的合成抗生素。Geninax于2007年7月31日在日本获得批准，为200mg每片的片剂，对葡萄球菌、链球菌、肺炎链球菌、大肠杆菌、克雷白(氏)杆菌、流感(嗜血)杆菌、肺炎衣原体、肠道细菌等都有抗菌活性。 获得批准的适应症为：咽炎、喉炎、扁桃体炎、扁桃体炎、肺炎、慢性呼吸道感染损害的二次感染、中耳炎，通常成人剂量为每天一次，每次400mg。 --------------------------------------------------------------- 製造販売承認取得日 2007年7月31日 製品名 ジェニナック(R)錠200mg（英名：Geninax(R)） 一般名 メシル酸ガレノキサシン水和物（英名：Garenoxacin Mesilate Hydrate） 分類 合成抗菌剤 効能・効果 ＜適応菌種＞ ガレノキサシンに感性のブドウ球菌属、レンサ球菌属、肺炎球菌（ペニシリン耐性肺炎球菌を含む）、モラクセラ（ブランハメラ）・カタラーリス、大腸菌、クレブシエラ属、エンテロバクター属、インフルエンザ菌、レジオネラ・ニューモフィラ、肺炎クラミジア（クラミジア・ニューモニエ）、肺炎マイコプラズマ（マイコプラズマ・ニューモニエ） ＜適応症＞ 咽頭・喉頭炎、扁桃炎（扁桃周囲炎、扁桃周囲膿瘍を含む）、急性気管支炎、肺炎、慢性呼吸器病変の二次感染、中耳炎、副鼻腔炎  用法・用量 通常、成人においてガレノキサシンとして、1回400mgを1日1回経口投与する 特徴 1． 呼吸器・耳鼻咽喉科領域感染症の主要起炎菌に適した抗菌スペクトルと優れた抗菌活性を有する（in vitro）。 2． 多剤耐性肺炎球菌にも優れた抗菌活性を示す（in vitro）。 3． 1日1回投与でも大きなAUC（血中濃度曲線下面積）が得られ、体液・組織へも良好な移行性を示す。 4． 呼吸器・耳鼻咽喉科領域感染症に1日1回投与で優れた臨床効果を示す。 5． 肺炎球菌および黄色ブドウ球菌において、耐性変異株の出現を来たし難い（in vitro）。 6． 承認時までに国内で実施された臨床試験で、安全性評価対象症例702例中132例（18.80%）に副作用が認められ、211例（30.06%）に臨床検査値異常が認められた。 包装 錠200mg：100錠（PTP）、500錠（PTP、バラ） ------------------------------------------------ 注：以下产品不同厂家和不同价格，购买以咨询为准 ------------------------------------------------ 产地国家: 日本 原产地英文商品名: GENINAX(ジェニナック) 200mg/tab 100tabs/box 原产地英文药品名: GARENOXACIN MESILATE HYDRATE 原产地英文化合物名称: 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 中文参考商品译名: GENINAX(ジェニナック) 200毫克/片 100片/盒 中文参考药品译名: 甲磺酸加雷沙星水合物 生产厂家中文参考译名: 安斯泰来制药 生产厂家英文名: Astellas ------------------------------------------------ 产地国家: 日本 原产地英文商品名: GENINAX(ジェニナック) 200mg/tab 500tabs/box 原产地英文药品名: GARENOXACIN MESILATE HYDRATE 原产地英文化合物名称: 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 中文参考商品译名: GENINAX(ジェニナック) 200毫克/片 500片/盒 中文参考药品译名: 甲磺酸加雷沙星水合物 生产厂家中文参考译名: 安斯泰来制药 生产厂家英文名: Astellas --------------------------------------------------------------- 产地国家: 日本 原产地英文商品名: GENINAX(クラリス錠) 200mg/tab 100tabs/box 原产地英文药品名: GARENOXACIN MESILATE HYDRATE 原产地英文化合物名称: 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 中文参考商品译名: GENINAX(クラリス錠) 200毫克/片 100片/盒 中文参考药品译名: 甲磺酸加雷沙星水合物 生产厂家中文参考译名: 大正富山医薬 生产厂家英文名: Taisho Toyama --------------------------------------------------------------- 产地国家: 日本 原产地英文商品名: GENINAX(クラリス錠) 200mg/tab 500tabs/box 原产地英文药品名: GARENOXACIN MESILATE HYDRATE 原产地英文化合物名称: 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 中文参考商品译名: GENINAX(クラリス錠) 200毫克/片 500片/盒 中文参考药品译名: 甲磺酸加雷沙星水合物 生产厂家中文参考译名: 大正富山医薬 生产厂家英文名: Taisho Toyama http://www.info.pmda.go.jp/go/pack/6149003F2038_1_28/ Manufacturer's name : Taisho Toyama Pharmaceutical Co., Ltd. Information is based on approvals granted in Japan. In some cases, the approved details may vary in countries other than Japan. In deciding to use a medicine, the risk (side effects) of taking the medicine must be weighed against the benefit (effects) it will do. The patient's cooperation is indispensable here.  Brand name : Geninax Tablets 200mg  Active ingredient: Garenoxacin mesilate hydrate Dosage form: pale orange tablet (major axis 11.8 mm, minor axis 7.1 mm, thickness 4.7 mm)  Printings on wrapping: face ジェニナック, 200mg, back ジェニナック200mg, 263  Effects of this medicine This is quinolone antibacterials to inhibit enzymes that bacteria need to grow, and shows antibacterial action. It is usually used in the treatment of respiratory infection andotorhinolaryngological infections. Before using this medicine, be sure to tell your doctor and pharmacist If you ever experienced any allergic reaction (itch, rash etc.) to any medicine. If you are a patient with convulsive diseases such as epilepsy, or have a history of convulsive diseases. If you are a patient with hypotension, arrhythmia or diabetes. If you are a patient with myasthenia gravis. If you are pregnant or breastfeeding. If you are using any other prescription or nonprescription (OTC) medicine. (It is important to reduce the risk of drug interactions.) Dosing schedule (How to take this medicine) General dosage regimen: For adults, take 2 tablets (400 mg of Garenoxacin) at a time, once daily. Strictly follow the instructions of your doctor/pharmacist. Missed dose: Take a dose as soon as possible when you remember that you missed a dose. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. DO NOT take double doses to make up for the missed dose. Overdose: If you took too much of the medicine (more than ordered), check with your doctor/pharmacist. Others: Do not stop taking the medicine without the instructions of your doctor. Precautions while taking this medicine Reversible stained in reddish purple or purple in the skin or mucosa (inside the mouth or mucosa) has been reported in animal studies. Consult with your doctor/pharmacist when you noticed these symptoms. Possible adverse effects of this medicine Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: headache, diarrhea, abdominal pain, loose stool, etc. In rare cases, symptoms described below may be the sign of side effects indicated in brackets [ ]. If they occur, stop taking your medicine and check with your doctor immediately. breathing difficulty, decrease in blood pressure, edema, redness[shock, anaphylactoid symptoms] fever, ocular mucosal congestion, cutaneous symptoms (erythema, blister, erosion) [Stevens-Johnson syndrome] nausea, dizziness, faint [bradycardia, sinus arrest, atrioventricular block] palpitation, pulse skips a beat, feel faint [QT prolonged] general malaise, loss of appetite, nausea, vomiting [fulminant hepatitis, hepatic dysfunction] sweating, hunger sensation, trembling limbs [hypoglycemia] abdominal pain, diarrhea, bloody stool [pseudomembranous colitis] muscular pain, weakness, reddish brown urine [rhabdomyolysis] Other side effects not listed here may occur. Check with your doctor/pharmacist if you have any worrisome symptom.  Storage conditions and other information Keep the medicine out of the reach of children. Store it away from direct sunlight, heat and moisture. Discard the remainder. Do not store them.