部份中文新体卡松处方资料（仅供参考） 新体卡松Neotigason 用于严重银屑病及角质化疾患口服治疗的维甲酸类。 成分 活性成分：acitretin，10mg及25mg胶囊。 赋形剂：抗氧化剂sodium ascorbate。 性能与作用 Neotigason的活性成分acitretin，为一种类似维甲酸的芳香族合成物质。在 acitretin耐受性的临床前期试验中，未发现有相应的诱变或致癌作用，亦未发现对肝脏有直接的毒性损害。但即使低剂量的acitretin，仍可导致动物的畸胎发生。 临床试验证实，acitretin可以使银屑病及角质化疾患表皮细胞的增殖，分化及角化正常化，而副作用一般是可以耐受的。Neotigason可以减轻症状，但其作用机理不明。 药物动力学 吸收 服药后1-4小时acitretin的血浆浓度达到高峰。在与食物同服时，经口摄入的acitretin生物利用度最佳。单一剂量的生物利用度效力约为60%，但可因人而异（36-95%）。 分布 acitretin为高度脂溶性物质，易于渗入机体组织。Acitretin同蛋白质的结合可超越99%。在动物实验中，acitretin大量通过胎盘屏障，足以造成胎儿畸形，根据acitretin的脂溶性质，可以设想相当数量的acitretin能够进入母乳。 代谢 Acitretin通过同分异化作用（转化为13-顺acitretin），葡萄糖醛酸化作用以及侧链分裂而被代谢。 排泄 Acitretin在血浆中的半衰期约为50小时，其主要代谢产物顺acitretin（仍为致畸胎物质）的半衰期约为60小时。Acitretin以代谢产物形式，约以相同等份经由肾脏与胆汁完全排泄。 适应症 严重银屑病患包括 红皮性银屑病 局部性或全身性脓疱银屑病。 哺乳期妇女 正在哺乳的妇女不得服用Neotigason。 副作用 最常见的副作用是维生素A增多症的症状，如口唇干燥，唯可用油性软膏涂抹，以减轻症状。 罕有出现颅内高血压（虚瘤脑），但偶有头痛纪录。 剂量与服法 由于acitretin的吸收和代谢率不同，服药剂量必须因人而定。 Acitretin胶囊以每日一次与膳食或牛奶同服为宜。以下为推荐剂量 成人： 疗程初2-4周每日剂量25mg（即1粒25mg胶囊）或30mg（即3粒10mg胶囊），即可获得满意疗效。 根据临床疗效和耐受性决定维持剂量，一般而言，在随后的6-8周内每日服25-50mg可以达到最佳疗效。 对于某些患者，可能需要增加到最大剂量每日75mg（即3粒25mg胶囊）。 银屑病患者的病灶如已充分消退，可终止治疗。如复发，则按上述剂量继续治疗。 角质化疾患通常需要持续治疗。应服用可能的最低剂量，每日小于20mg，而不应超过50mg。 儿童： 鉴于长期治疗可能导致严重副作用，应慎重权衡利弊。只有在所有可选择的治疗均已证实无效时，方可考虑使用acitretin。 应根据体重决定剂量。每日剂量约为0.5mg/公斤体重。对某些病例可以短期内使用较高剂量（每日最多1mg/公斤体重），但每日最大剂量不得超过35mg。由于长期服药可能产生副作用，维持量应尽可能低。 联合用药： 当Neotigason同其它药物联合应用时，可以根据患者个体反应，减少Neotigason的剂量。常规的局部治疗可以继续进行及不妨碍Neotigason治疗。 禁忌症 Neotigason为高度致畸物质，孕妇禁服。育龄妇女只有在服药前四周内，服药期间以及停药后两年之内采取严格的避孕措施，方可服用。 育龄妇女不可接受正在Neotigason治疗病人的捐血，在服用Neotigason期间及停药后一年内，患者不得捐血。 严重肝肾功能不全者及慢性血脂异常升高者禁用。 由于Neotigason及四环素均可引起颅内压增高，因此不得两药合用。 已有报道，联合应用氨甲喋吟（活性成分为etretinate）可导致罹患肝炎危险的增加，所以禁忌氨甲喋吟和Neotigason合用。 禁忌Neotigason与维生A或其它维甲酸类并用，以避免维生素A过多症的发生。 对acitretin或赋形剂的制剂或其它维甲酸类过敏的病人，忌用Neotigason。 稳定性 药品包装上印有失效日期，过期请勿服用。 TIGASON Capsule 10（チガソンカプセル10） Brand name : TIGASON Capsule 10 　Active ingredient: Etretinate 　Dosage form: pale red-brown/pale red-white capsule (major axis: approx. 14.5mm) 　Print on wrapping: チガソン10mg TIGASON Capsule 25（チガソンカプセル25） Brand name : TIGASON Capsule 25 　Active ingredient: Etretinate 　Dosage form: pale red-brown/pale red-brown capsule (major axis: approx. 17.6mm) 　Print on wrapping: チガソン25mg  Effects of this medicine This medicine makes abnormally stiffened part on the skin and the oral mucosa easy to peel off and re-forms normal surface skin and mucosa. It is usually used to treat serious psoriasis and ichthyosis. 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 hepatic/renal disorder or hypervitaminosis A. If you are predisposed to have hypertriglyceridemia. (For example, you have diabetes, obesity, alcoholism or lipid metabolism abnormality.) •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>> •General dosage regimen: For adults, in order to induce a remission, take 40-50mg of the active ingredient in 2-3 divided doses a day for 2-4 weeks. The maximum daily dosage is 75mg of the active ingredient. After that, in order to maintain remission, take 10-30mg of the active ingredient in 1-3 divided doses a day according to the patient's symptoms. For infants and children, in order to induce a remission, take 1.0mg/kg of the active ingredient in 1-3 divided doses a day for 2-4 weeks. After that, in order to remain remission, take 0.6-0.8 mg/kg of the active ingredient in 1-3 divided doses a day according to the patient's symptoms. It should be adjusted according to your disease, age and symptoms in any case. 1 capsule contains 10mg of the active ingredient. Strictly follow the instructions of your doctor/pharmacist. •Avoid taking this medicine with a great amount of milk or fatty food. •Take the missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. DO NOT take a double dose to make up for the missed dose. •If you took too much of this medicine (more than ordered), check with your doctor/pharmacist. •Do not stop taking this medicine without the instructions of your doctor. Precautions while taking this medicine •This medicine has teratogenic potential (possibility to cause fetal anomaly) and has a higher incidence of side effects. You need to be informed of the side effects until you fully understand them. •In using this medicine, you need to be informed of precautions mentioned below until you fully understand them. If you agree to them, sign the letter of consent. •If you have a possibility of pregnancy, you have to wait a few days after your menstruation begins before taking this medicine. Also, you may have a pregnancy test within 2 weeks before taking this medicine. •If you have a possibility of pregnancy, make sure to avoid pregnancy during use and for at least 2 years after withdrawal of this medicine. •A male patient must avoid pregnancy during use and for at least 6 months after withdrawal of this medicine. •You cannot make a blood donation during use and for at least 2 years after withdrawal of this medicine. •When you have joint/bone pain, contact your doctor immediately. Also, if you are supposed to take this medicine for a long period, you may have to take an X-ray examination, etc. •This medicine may cause liver damage. For the early detection of the side effects, your liver function will be checked before and 1 month after starting this medication, and also every 3 months during use. Do not forget to undergo it on each designated date. •A patient with hypertriglyceridemia tends to have lipid metabolism abnormality. So, blood test will be conducted to the patient. •This medicine may cause hair loss, cheilitis, or desquamation (peeled surface skin). •Avoid breastfeeding. Possible adverse reactions to this medicine Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: cheilitis, desquamation (scurfy thing peeling off), dry mouth, thinning of the skin, pruritus. 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. •joint pain, sore red skin, red spots and breakable blisters all over the body, lassitude [toxic epidermal necrosis (Lyell syndrome)] •rash and blister, joint pain, fever [erythema multiforme] •angialgia, purple bruise, swelling [vasculitis] 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 children. Store at room temperature (1-30℃), away from light and moisture. •Discard the remainder. Do not store them. Ask the pharmacist how to discard.  ------------------------------------------- 产地国家： 日本 原产地英文商品名: TIGASON（チガソンカプセル）10mg/Capsule 100Capsule/box 原产地英文药品名: Etretinate 中文参考商品译名: 新体卡松(チガソンカプセル)10毫克/胶囊 100胶囊/盒 中文参考药品译名: 阿维A酯 生产厂家中文参考译名: 中外制药 生产厂家英文名: Chugai Pharmaceutical Co.Ltd ------------------------------------------- 产地国家： 日本  原产地英文商品名: TIGASON（チガソンカプセル）25mg/Capsule 100Capsule/box 原产地英文药品名: Etretinate 中文参考商品译名: 新体卡松(チガソンカプセル)25毫克/胶囊 100胶囊/盒 中文参考药品译名: 阿维A酯 生产厂家中文参考译名: Chugai Pharmaceutical Co.Ltd 生产厂家英文名: 中外制药