部份中文他克莫司处方资料（仅供参考）
普特彼（Protopic）又名他克莫司软膏。
他克莫司（Tacrolimus，商品名Protopic，普特彼），是从日本发现的链霉菌streptomyces tsukubaens 培养液中提取的大环内酯类抗生素，外用制剂为0.03%和0.1%软膏。
作用机制　　
其治疗作用和毒副作用都是通过抑制细胞增殖的信号传导通道而产生的。他克莫司与特异性胞浆内免疫亲和蛋白（FKBP－12）结合后，抑制T细胞内钙依赖性信号传导途径，从而阻止IL－2、IL－3、IL－4、IL－5以及其他细胞因子如GM－CSF、TNF－α、IFN－γ的转录与合成。体外研究显示，他克莫司可以降低从正常人体皮肤分离出的朗格罕斯细胞对T细胞的刺激活性，同时还可以抑制皮肤肥大细胞、嗜碱性粒细胞和嗜酸性粒细胞释放炎性介质[1-3]。临床资料显示外用他克莫司后其血药浓度很低，其持续时间非常短暂。尚无证据表明长期（1年）外用治疗的成人与儿童患者会出现他克莫司的蓄积。他克莫司主要在肝脏经CYP 3A4代谢。成人和儿童反复外用他克莫司软膏的平均半衰期分别为75 h和65 h。
适应症
*特应性皮炎（AD）
特应性皮炎（异位性皮炎）是一种顽固性、炎症性的慢性皮肤病，好发于婴幼儿及青少年，发病部位遍及脸、颈、手肘、四肢背侧等，由于患处反复发作且瘙痒难耐，对个人甚至家庭的生活质量可能产生严重影响。在美国的3项临床研究（2项为成年人，1项为儿童）中，使用0.03%或0.1%他克莫司软膏的治疗组中，临床总体评估改善率≥90%的患者比例较安慰剂组高出4～5倍。在美国和欧洲的两项长疗程（1年）、开放的临床试验中，对0.1% 他克莫司软膏进行评价，结果均在用药1周内显现疗效，并且在随后的1年时间里病情持续获得改善，未出现长期用药而疗效随之降低的征象。　　
*银屑病
试验证明局部应用免疫调节剂对临床前T细胞介导的皮肤病模型有很好疗效。由于T细胞活化是银屑病的关键病因之一，所以使用他克莫司治疗银屑病有效。系统应用他克莫司治疗各种严重的、复发性银屑病已取得良效。一项16例的慢性斑块状银屑病白人患者自身对照临床试验中，选择分散性的小斑块皮损外用他克莫司，每2～3天封包1次，疗程2周。结果使用他克莫司的皮损处的红斑、浸润、表层血流和皮肤厚度均有显著改善；而使用倍他米松、卡泊三醇或安慰剂都未出现皮肤的上述变化。
*皮炎、湿疹
局部免疫调节剂他克莫司皮肤局部应用对皮炎、湿疹可以有很好的疗效，而无外用糖皮质激素的不良反应。在对出汗不良性掌部湿疹的随机单盲、自身对照临床试验中，0.1%他克莫司软膏与0.1%糠酸莫米松软膏进行比较，结果2周后两组出汗不良症状的面积和严重指数均减少50%以上。
*扁平苔藓
扁平苔藓是一种亚急性或慢性炎症性皮肤病，表现为紫红色的多角形丘疹，病因不明，以往的治疗方法疗效不佳。扁平苔藓可能是由T细胞介导的炎症性皮肤病，提示可用局部免疫调节剂治疗。在一项19例患者，疗程8周的开放性临床试验中，外用0.1%他克莫司软膏治疗顽固性糜烂型口腔扁平苔藓。结果用药1周后患者的临床症状即有明显改善，8周后溃疡面积平均缩小73.3%，但停药后2～5周内有68.4%患者复发。因此，延长治疗时间可能是重要的。
*坏疽性脓皮病
坏疽性脓皮病病因不明，以疼痛、迅速扩大的溃疡为主要特征。Reich等对2例坏疽性脓皮病患者使用0.1%他克莫司软膏治疗。其中1例于开始时单用他克莫司（2次/d）以治疗早期溃疡，3周后治愈。对以后新发皮损外用他克莫司软膏，结合口服环孢素治疗，也取得了良好效果，并减少了环孢素的用量。另1例在开始就以外用他克莫司软膏（1次/d）结合口服环孢素治疗，3周后停用他克莫司，5周后溃疡面缩小一半，再随访5个月未见复发。可见对于坏疽性脓皮病，早期的溃疡可单用他克莫司软膏治疗，晚期可联合用系统免疫抑制剂，在停用系统免疫抑制剂后，可外用他克莫司软膏，以预防复发。
*其他
目前已有报道外用他克莫司软膏治疗的皮肤疾病中，可能有效的包括由皮质激素引起的酒渣鼻，斑秃，白癜风，鱼鳞病，结节病，移植物抗宿主病，良性淋巴细胞浸润症等。
用法用量　　
该种钙调神经磷酸酶抑制剂可用于全身体表的任何部位，包括头面部、颈部、屈侧部和擦破的部位，但不能用于粘膜。将药物在受累皮肤局部涂一薄层，轻柔地充分涂擦，2次/d，直到症状和体征消失。停药后若症状和体征再次出现，应立即重新开始使用，以预防病情加重。通常在开始治疗1周内即出现病情改善。
不良反应　　
长期使用他克莫司软膏既无外用糖皮质激素产生的副作用，也没有全身性免疫抑制的副作用。最常见的是用药部位出现皮肤刺激症状，如烧灼感、瘙痒和红斑，这些反应通常发生于治疗早期，一般为轻度或中度，且持续时间短，治疗开始1周内趋于消退。其他常见的皮肤刺激症状包括皮肤敏感性增加、皮肤刺痛感。酒精不耐受（饮用含酒精饮料后出现面部潮红或皮肤刺激）也较常见。
注意事项
（1）不能用于黏膜部位。避免与眼睛及其他黏膜接触。若不小心接触到这些部位时，应将其彻底擦除和/或用水冲洗。
（2）不能用于急性皮肤病毒感染（单纯疱疹、水痘等）部位。
（3）不推荐使用封包治疗。治疗期间，应尽量减少暴露在日光下，并避免使用紫外线灯、UVB或光化学（PUVA）治疗。建议患者采取适当的日光防护措施，并穿适当衣服遮盖皮肤。
（4）特应性皮炎患者易患浅表皮肤感染，包括疱疹性湿疹。外用他克莫司或吡美莫司治疗也可能使皮肤单纯疱疹病毒感染或疱疹性湿疹（表现为水疱和糜烂）快速播散发生的危险性增加。当出现皮肤单纯疱疹病毒感染时，应暂时中止在感染部位用药，待病毒感染清除后方可重新使用。
（5）如果用于非手部治疗，患者用药后应洗手。
（6）妊娠期不宜使用。哺乳期不推荐使用。
包装规格
他克莫司软膏0.1％
5克*10管/盒

克莫司软膏0.03％儿童用
5克*10管/盒

生产厂家：Maruho Co
Protopic Ointment 0.03% for pediatric use（プロトピック軟膏0.03%小児用） 
Brand name : Protopic Ointment 0.03% for pediatric use
　Active ingredient: Tacrolimus hydrate
　Dosage form: white to pale yellow ointment
　Print on wrapping: プロトピック軟膏0.03%小児用, 5g
Effects of this medicine
This medicine suppresses cytokine synthesis and allergic reactions, thus decreasing inflammation.
It is usually used to treat atopic dermatitis in children (aged 2 years or older) .
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 have: ulcerated or erosive (sores) skin, kidney impairment, hyperkalaemia or ichthyosiform erythroderma (a condition by which the skin peels off the body as with fish-scaling).
If you are younger than 2 years old or undergoing ultraviolet treatment.
If you have skin infections.
•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, for children, apply an appropriate amount of the ointment on the affected area, once or twice daily. The applied dose should not exceed 5 g (1.5 mg of tacrolimus) at a time. The dose may be adjusted depending on the child's age. Strictly follow the instructions.
•Wash your hands before using the medicine. Wash the fingers you used well after using the medicine.
•Do not apply the medicine on areas where the skin is oozing or sore, on boils or pimples, on other surfaces than skin such as the mucosa of the mouth, nose, etc. or on the vulva.
•Pay close attention when you apply the medicine around your eyes to avoid it from getting into your eyes. If the medicine gets into your eyes by accident, wash it away with water. If you feel any abnormal sensation, consult with an ophthalmologist.
•If you miss a dose, use one dose as soon as possible, but the next dose should be at least 12 hours apart. You should never use two doses at one time.
•If you accidentally use more than your prescribed dose, wipe it off immediately. If you use more than 1 tube of the medicine at one time, consult with your doctor or pharmacist.
•Do not stop using this medicine unless your doctor instructs you to do so. If improvement was not observed after two weeks of continuous use, consult with your doctor or pharmacist.
Precautions while taking this medicine
•Wear appropriate clothing to prevent the skin area where the ointment was applied from being exposed to sunlight for a long time. Avoid using tanning or ultraviolet lamps.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include feeling hot (burning sensation, feeling of hot flushes), pain (tingling feeling, smarting feeling), folliculitis, itching, impetigo contagious, acne, acneiform eruption, papules, dry skin, contact dermatitis, erythema, rosacea-like dermatitis and application site oedema. 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 the reach of infants and children. Store away from direct sunlight, heat and humidity.
•Discard the remainder. Do not store it. Consult with your dispensing pharmacy or medical institution when you discard the medicine.
Maruho Co.,Ltd.External
Revised: 4/2014
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.