英文药名:FOSMICIN-S FOR OTIC 3%(Fosfomycin sodium)
中文药名:磷霉素钠-S 滴耳 3%
生产厂家:明治制果制药 治疗类别名称 磷霉素抗菌配方 欧文商標名 FOSMICIN-S FOR OTIC 3% 一般名 ホスホマイシンナトリウム Fosfomycin Sodium 略 号 FOM 化学名 Disodium(2R,3S)-3-methyloxiran-2-ylphosphonate 分子式 C3H5Na2O4P 分子量 182.02 構造式
性 状 磷霉素钠是一种白色结晶粉末。 这是非常易溶于水,稍少溶于甲醇,和乙醇(99.5)几乎不溶。 分配係数 (log10 1-オクタノール層/水層、20±5℃) (下表参照)
药效药理 1. 体外抗菌作用 磷霉素革兰氏阳性菌,杀菌方式作用对革兰氏阴性细菌,特别是,显示出金黄色葡萄球菌,绿脓杆菌,相对于所述主要的原因菌化脓性中耳炎变形杆菌优异的抗菌活性,和类似物。 2. 实验性中耳炎治疗效果 为创建感染金黄色葡萄球菌或铜绿假单胞菌豚鼠,所述Hosumishin溶液为0.1mL为耳部的中耳该实验性急性中耳炎,与单次剂量的金黄色葡萄球菌感染,1与绿脓杆菌感染天结果被施用一次持续7天,观察到的治疗效果。 3. 作用机制 磷霉素的作用机制是非常独特的。磷霉素取入细胞内有效地通过细胞膜的主动转运系统,以及通过抑制细胞壁肽聚糖的生物合成的早期阶段表现出抗微生物活性。(Β内酰胺抗生素以抑制在最后阶段)。 适应病症 <适应物种> 金黄色葡萄球菌敏感性磷霉素,变形杆菌,绿脓杆菌 <主治> 外耳道炎,中耳炎 用法用量 溶解在所附溶液,和30毫克(效价)溶液作为1mL中每磷霉素钠,通常两次点耳每天10滴(约0.5毫升)。 应当指出的是,虽然以增加或减少的适当次数的症状,难治性或长期严重的情况下,以增加的倍耳的数量最多一天四次。 (执行大约10分钟后耳浴耳)。 包装规格 1瓶 300毫克,含10瓶(附液10毫升×10片)
制造商 明治制果制药社 原处方资料附件:http://www.info.pmda.go.jp/go/pack/1325703Q1036_1_02/ FOSMICIN-S FOR OTIC 3%(ホスミシンS耳科用3%) Brand name : FOSMICIN-S FOR OTIC 3% Active ingredient: Fosfomycin sodium Dosage form: white crystalline powder with a clear and colorless solution for otic preparation Print on wrapping: Effects of this medicine This medicine is a fosfomycin antibiotic, which inhibits bacterial cell wall synthesis at its initial stage to exert an antibacterial effect. It is usually used to treat otitis externa and otitis media. Before using this medicine, be sure to tell your doctor and pharmacist •If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines. •If you are pregnant or breastfeeding. •If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.) Dosing schedule (How to take this medicine) •Your dosing schedule prescribed by your doctor is <<to be written by a healthcare professional>> •In general, dissolve in the accompanying solution and apply 10 drops in the ear at a time, twice a day. The frequency of dosing may be adjusted according to the symptoms, and will be increased up to 4 times a day when the ear condition is refractory or protracted. After applying, keep the instilled medicine for about 10 minutes inside the ear canal. Strictly follow the instructions. •For applying, lie down on your side so that the affected ear faces up. Take off the small green lid, drop the medicine onto the affected site with care not to touch the applicator tip any surface, and keep the ear facing up for about 10 minutes. Gently wipe off the medicine that has leaked out using sterile gauze. •Use this medicine only for ear dropping. Do not apply to the eye. •Dropping cold medicine into the ear canal may cause dizziness. Warm this medicine as close to your body temperature as possible when applied. •If you miss a dose, use the missed dose as soon as possible. If it is almost time for your next dose, skip the missed dose and follow your regular dosing schedule. You should never take two doses at one time. •If you accidentally use more than your prescribed dose, consult with your doctor or pharmacist. •Do not stop taking this medicine unless your doctor instructs you to do so. Precautions while taking this medicine • Possible adverse reactions to this medicine The most commonly reported adverse reactions include dizziness and hypersensitivity symptoms. If any of these symptoms occur, consult with your doctor or pharmacist. The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately. No pertinent entries. The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above. Storage conditions and other information •Keep out of reach of children. Store away from direct sunlight, heat and moisture. •Do not use medicine which has been stored at room temperature for longer than 2 weeks after preparation. •Discard the remainder. Do not store them. Meiji Seika Pharma Co., Ltd.External Published: 5/2009 The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
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