英文药名：REMITCH(Nalfurafine Hydrochloride CAPSULES) 中文药名：盐酸纳呋拉啡胶囊 生产厂家：鸟居药业 レミッチカプセル2.5μg REMITCH胶囊2.5μg（盐酸纳呋拉啡）。REMITCH是一种为进行血液透析的患者提供的口服抗搔痒症药物 药物分类名称 口服瘙痒改善剂 批准日期：2009年3月 商標名 REMITCH CAPSULES 2.5μg 一般名 ナルフラフィン塩酸塩　Nalfurafine Hydrochloride 化学名 （2E）-N-［（5R,6R）-17-（Cyclopropylmethyl）-4,5-epoxy-3,14-dihydroxymorphinan-6-yl］-3-（furan-3-yl）-N-methylprop-2-enamide monohydrochloride 分子式 C28H32N2O5・HCl 分子量 513.03 構造式 性状 是一个非常薄的白色至黄色的粉末。是高度吸湿的，它是稍微不稳定的要轻。它是易溶水，对甲醇，微溶于乙醇（95），溶解性，几乎在乙醚和乙酸乙酯不溶。 分配系数 在0.95[1辛醇/pH6.8缓冲区分配系数（LogD） 药效药理 1.对瘙痒症采取作用 抗组胺药，现有的止痒剂，抑制有效的组胺皮内给药诱导的小鼠搔抓行为和P物质皮内给药诱导的物质搔抓行为，其中抗组胺药效果较差。 抗组胺药还能抑制小鼠脑池内诱导的小鼠搔抓行为，这是一种无效的中枢瘙痒模型。 2. 作用机序 从体外受体结合试验和使用人类阿片受体表达细胞的受体激动试验的结果来看，已经显示它是一种选择性阿片样物质κ受体激动剂。 见表13“人类阿片受体结合试验和可操作性试验结果”。 此外，体外试验不结合除含有组胺受体的阿片受体以外的各种受体，转运蛋白和离子通道，也显示对来自肥大细胞的脱粒反应没有抑制作用。 另外，P物质皮内给药诱导的P物质抑制作用，通过侧脑室给药阿片κ受体拮抗剂norbinaltorphine（nor-BNI）完全拮抗。 3. 依存性 由于在大鼠戒断症状观察中在吗啡中观察到不存在戒断症状的情况下贝伐珠单抗的物理依赖性较弱，所以在猴自我接受测试中没有观察到强化作用，因此精神依赖性 它被认为不是。 药理药理学表 表13人类阿片受体结合试验和功效试验结果 試験項目  κ  μ  δ  κ:μ:δ比  結合試験 Ki値（nmol/L）  0.244±0.0256  2.21±0.214  484±59.6  1：9：1980  作動性試験 EC50（nmol/L）  0.00816±0.00138  1.66±0.09  21.3±1.0  1：203：2610  （平均值±标准误差） 适应症 改善血液透析患者瘙痒 剂量与用法 成人口服，每次2.5μg/丸，每日早晚各一次。请注意，它可以根据症状增加。 包装规格 胶囊为2.5μg 14胶囊（14粒×1）PTP 140胶囊（14粒×10）PTP 制造商名称： 鸟居药业有限公司 提示：以上中文资料不够完整，使用者请以原处方为准。 完整说明书附件：http://www.info.pmda.go.jp/go/pack/1190015M1029_1_13/ REMITCH CAPSULES 2.5 μg Brand name: REMITCH CAPSULES 2.5 μg 　Active ingredient: Nalfurafine hydrochloride 　Dosage form: slightly pale yellow to pale yellow capsule (major axis: 9.7 mm, minor axis: 6.6 mm) 　Printings on wrapping: レミッチカプセル2.5μg, TR11, REMITCH Effects of this medicine This medicine is selective κ opioid receptor agonists to suppress itch. It controls itch when other existing antihistamine or antiallergic drugs are ineffectual. It is usually used for improvement of itch in hemodialysis when other existing treatment is insufficient. Before using this medicine, tell your doctor/pharmacist If you ever experienced any allergic reaction (itch, rash etc.) to any medicine. If you are pregnant or breastfeeding. If you are using any other prescription or nonprescription (OTC) medicine. (It is important to reduce the risk of drug interactions.) Dosage regimen (proper use of this medicine) Your dosage regimen is:(order of your doctor) General dosage regimen: For adults, take 1 capsule (2.5 μg of the active ingredient) at a time, once daily, after supper or before going to bed. The dosage may be increased according to the symptoms, however, the dosage is limited to 2 capsules (5 μg) once daily. Strictly follow the instructions of your doctor/pharmacist. Missed dose: If you are instructed to take the medicine after supper and remember that you missed a dose before going to bed on the same day, take a dose as soon as possible. In other cases, skip the missed dose and continue your regular dosing schedule. DO NOT take double doses to make up for the missed dose. Overdose: If you took too much of the medicine (more than ordered), check with your doctor/pharmacist. Others: Do not stop taking the medicine without the instructions of your doctor. Precautions while using this medicine The medicine may cause drowsiness or dizziness. Avoid driving a car or operating dangerous machinery after taking the medicine. Grapefruit juice may raise the plasma concentration and enhance the effect of the medicine. Never take the medicine with a glass of grapefruit juice. Side effects of this medicine Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: sleeplessness, constipation, drowsiness, etc.In rare cases, symptoms described below may be the sign of side effects indicated in brackets [ ]. If they occur, stop taking your medicine and check with your doctor immediately. generalized fatigability, loss of appetite, yellowness of the skin or conjunctiva[liver dysfunction, jaundice] Other side effects not listed here may occur. Check with your doctor/pharmacist if you have any worrisome symptom.  Storage and other information Keep the medicine out of the reach of children. Store it where the light is blocked, away from heat and moisture. Do not store the remainder and ask your pharmacist how to discard it. Manufacturer's name : Torii Pharmaceutical Co.,Ltd