英文药名：LUCONAC Solution 5%（Luliconazole） 中文药名：卢立康唑用外液 生产厂家：佐藤制药 ルコナック爪外用液5％ 治疗类别名称 灰指甲的治疗剂 商標名 LUCONAC Solution 5% 一般名 ルリコナゾール（JAN）Luliconazole（JAN, INN） 化学名 (-)-(E)-[(4R)-4-(2,4-dichlorophenyl)-1,3-dithiolan-2-ylidene](1H-imidazol-1-yl)acetonitrile 構造式 分子式 C14H9Cl2N3S2 分子量 354.28 性状 此产品是细黄色的晶体或结晶粉末，以淡黄色，N，N-二甲基甲酰胺或易溶于丙酮，乙腈或甲醇中微溶，微溶于乙醇（99.5），几乎到水不融化。 光逐渐着色。 熔点 150〜153℃ 操作注意事项 1.打开能够节省拧紧瓶盖后。 2.存放在儿童接触不到的地方。 3.注意，因为它们可能在黄色着色并附着到衣物。 4.软化合成树脂，应注意，因为它们可能或溶解油漆给出。 5.由于这剂是易燃的，以避免火灾是在使用和储存的时间。（禁火第一石油风险II级） 条件批准 在建立药品风险管理计划的顶部，要正确实施。 适应症 用于指甲癣、皮肤癣菌（毛癣菌） 用法用量 部外用，取本品涂于患处，一日1次。 包装规格 3.5克（4毫升）×5, 3.5g（4毫升）×10（塑料容器） 制造厂商 佐藤制药有限公司 产品特点； 真菌性皮肤病是皮肤组织部位真菌感染的结果 。真菌感染部位可分布于全身皮肤，发病最高的为角质层，其典型代表病症为癣病、念珠菌感染及白癜风。调查显示，皮肤真菌感染患者占皮肤科门诊患者的13%左右，其中包括88.0%的癣病患者、8.5%的念珠菌感染患者和3.4%的白癜风患者，癣病中又有64.0%为足癣。念珠菌感染是由念珠菌属，尤其是白色念珠菌引起的一种真菌病。 该病原菌既可侵犯皮肤和粘膜，又能累及内脏。最常见的皮肤念珠菌感染包括指间糜烂和擦烂。指间糜烂多见于长期浸泡于水中的作业人员，以3-4指间最为常见，指间皮肤浸渍发白，去除浸渍的皮肤，呈界限清楚的湿润面，基底潮红，可有少量渗液。擦烂是发生在皱折部位的皮肤急性炎症，表现为皮肤红斑、肿胀、潮湿、多汗、表皮浸渍，易有糜烂及浆液渗出，继发感染可形成微小脓疱及溃疡，白癜风是后天因皮肤色素脱失而发生的局限性白色斑片，是一种常见病、多发病，为皮肤病中三大顽症之一。世界上各色人种、各种民族均可得病。全世界发病率约在1—2%左右。我国大约在2%左右。白癜风虽无自觉症状，但给患者精神上造成极大痛苦，严重影响美容和社会交往。 卢立康唑是日本农药株式会社开发的咪唑类抗真菌药物，较早即开始非临床试验及乳膏的Ⅰ期临床试验、Ⅱ期临床试验第一阶段，其后由于战略原因停止了开发进程。90年代日本农药株式会社与Pola化工株式会社签署协议共同开发，Pola化工株式会社于2001开始乳膏的Ⅱ期临床试验第二阶段及Ⅲ期临床试验，并进行了洗剂的Ⅰ期临床试验及与乳膏的对比试验。 最终本药于2005年6月获得批准，2005年7月20日起以商品名ルリコン（Lulicon）上市，2013年11月获得FDA批准上市，本品特点： 1．是一种全新的化合物，不会有耐药性等问题。 2．皮肤贮留性好（减少涂抹次数，缩短一半以上治疗期）。 3．抗菌谱广（对发癣菌、念珠菌及白癜风致病菌等均有很强的抗菌活性）。 4．抗菌活性强（对引起癣病的发癣菌的抗菌活性优于现在普遍应用的盐酸特比萘芬；对念珠菌及引起白癜风的酵母菌的抗菌活性高于已知具有最高抗菌活性的拉诺康唑。动物试验及临床试验中，卢立康唑也显示了优于现有抗真菌外用药的治疗效果）。 Product Name: Rukonakku Tsumegaiyo solution 5% Active ingredient: luliconazole (Luliconazole) Dosage form: pale yellow clear liquid for external use Sheet described: the nails only, Rukonakku Tsumegaiyo solution 5%, 3.5g (4mL), LUCONAC Solution 5% Effects of this medicine It shows the anti-fungal effect on the fungi by inhibition of the synthesis of components ergosterol of the cell membrane of the fungi. It is usually used in the treatment of onychomycosis. Please be sure to tell your doctor and pharmacist before people such as the following to use. • Use the previously medicine, itch, there is a thing that came out allergy symptoms such as rash. • If you are pregnant or breastfeeding. • are using, such as other drugs (or strengthen an effect on each other, so there is also likely to weaken, please note, including OTC drugs and food products in use Dosage regimen (proper use of this medicine) • Your dosage regimen is (your doctor) • usually, also including applying the boundary between the skin on the entire nail to be treated once a day. Please follow the instructions of how to use. • Please use only the nails that have been instructed by the doctor. • infected with the fungus, once the appearance changes (eg discoloration) nails does not improve until alternative growing in new nails. Please continue to patiently treated in accordance with the instructions of the doctor. • Please wipe off the medicine that has adhered to the surrounding skin. • Please use caution when in the area around the site of application (the affected area) there is a wound. • Please refer to the care of the nails to paint the medicine, such as file and nail clippers before using the medicine if necessary. • Please do not use in the vicinity of the fire. • Please do not use in the eye. In the case of contact with eyes accidentally, please immediately rinse with water or lukewarm water. • If you forget painted, please apply once worth as soon as possible when I noticed. However, not paint If paint then it is almost time forgot minute, please apply once worth the time to paint the next time. A double dose should not be painted at a time. • If you used a lot by mistake, please consult your doctor or pharmacist. • without the doctor's instructions, please do not stop using their own judgment. Notes on life • Please do not use cosmetics, such as nail polish on the nails to be treated. • Please note that if you adhere to the clothes may be colored yellow. • or soften the synthetic resin, please be aware that there is a thing to or dissolving the paint. That where I am wearing this medicine (side effects) The main side effect, dry skin, contact dermatitis, paronychia, eczema, dermatitis, skin irritation, such as xerosis have been reported. If you notice these symptoms, please consult your doctor or pharmacist. Rarely appeared symptoms such as the following, may be the initial symptoms of the adverse effects indicated in brackets []. In such a case, stop using, please seek medical attention immediately. Appropriate Matters There is no. Other side effects not listed here may occur all. If you notice any symptoms of concern other than the above, please consult your doctor or pharmacist. Storage and other information • infants, out of the reach of children, light, high temperature, humidity, please keep away from fire. • Please keep tighten the tightly cap after opening. • If the drug is remaining, please discard it. Ltd. Paula Pharma External preparation Creating April 2016 The drug can have side effects not only the effect (benefit) (risk). As much as possible to suppress the side effects, it is important to maximize the effect. To that end, we must have the understanding and cooperation of patients that are using this medicine. http://www.info.pmda.go.jp/go/pack/6290703Q1023_1_02/