近日，美国食品和药物管理局（FDA）批准新药KERYDIN（tavaborole）外用溶液，5%，这是首个被批准用于外用治疗的氧代谢抗真菌药物。趾甲甲真菌病甲真菌病是一种真菌感染的指甲和指甲床，推荐每日一次用于感染的趾甲，疗程共48周，不需要进行趾甲清创术。
批准日期：2014年7月7日；公司：Anacor Pharmaceuticals
KERYDINTM (tavaborole)局部溶液，5%
美国初始批准：2014
作用机制
KERYDIN是一种oxaborole抗真菌药 [见临床药理学]。
适应证和用途
KERYDIN是一种oxaborole抗真菌药适用为由于红色毛癣菌[Trichophyton rubrum]或须癣毛癣菌[Trichophyton mentagrophytes]趾甲甲真菌病的局部治疗。
剂量和给药方法
⑴应用KERYDIN至受影响的趾甲每天1次共48周.
⑵KERYDIN应被应用至正在治疗的整个趾甲表面和每个趾甲的尖下。
⑶只为局部使用。
⑷不为口，眼，或阴道内使用。
剂型和规格
溶液，5%。
禁忌证
无。
不良反应
用KERYDIN治疗受试者中常见不良反应发生在≥1%包括应用部位表皮脱落，趾甲内生，应用部位红斑，和应用部位皮炎。
包装供应/贮存和处置
供应
KERYDIN (tavaborole)局部溶液，5%是一个透明，无色溶液在一个12-mL有螺旋盖的琥珀色玻璃瓶供应。在初始使用时，螺旋盖用滴组装替代。
KERYDIN (tavaborole)局部溶液，5%以下供应：
NDC 55724-111-11：一瓶含10 mL溶液有一个玻璃滴头。
贮存和处置
贮存在20–25°C (68–77°F)；外出允许至15–30°C(59–86°F)[见USP控制室温]。注意：可燃。远离热和火焰保存。插上滴头后3个月遗弃产品。紧闭保存瓶。保存在儿童拿不到的地方。 http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204427s000lbl.pdf https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1ae61072-bca0-43f0-a741-07bda2d50c87。
KERYDIN™ is a topical prescription medicine used to treat fungal infections of the toenails.
Important Safety Information
KERYDIN™ is for use on toenails only. Do not use KERYDIN™ in your mouth, eyes, or vagina.
Tell your doctor about all of your medical conditions, including if you are pregnant or plan to become pregnant or are breastfeeding or plan to breastfeed. It is not known if KERYDIN™ can harm your unborn baby or if KERYDIN™ passes into your breast milk. It is not known if KERYDIN™ is safe and effective in children.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Use KERYDIN™ exactly as your healthcare provider tells you to use it. Avoid getting KERYDIN™ on skin that is not surrounding the treated toenail. KERYDIN™ is flammable. Avoid heat and flame while applying KERYDIN™ to your toenail.
KERYDIN™ may cause irritation at the treated site. The most common side effects include: skin peeling, ingrown toenail, redness, itching, and swelling. Tell your doctor if you have any side effect that bothers you or does not go away.
