部份中文布地奈德处方资料（仅供参考）
商品名：Rectabul Rectal foam 
英文名：Budesonide
中文名：布地奈德灌肠泡沫
生产商：EA Pharma Co.Ltd.
药品简介
2017年12月7日，新药Rectabul 2mg Rectal foam（Budesonide）在日本上市，为第一款用于治疗溃疡性结肠炎的灌肠用泡沫剂型。其作用直接到达直肠和乙状结肠后留在直肠和乙结肠中，避免了给药后的泄漏。
レクタブル2mg注腸フォーム14回
药用分类名称
溃疡性结肠炎治疗剂
批准日期：2017年11月
商標名
RECTABUL 2mg Rectal foam
一般名
ブデソニド(Budesonide)(JAN)
化学名
(+)-[(RS )-16α,17α-Butylidenedioxy-11β,21-dihydroxy-1,4-pregnadiene-3,20-dione]
化学構造式
分子式
C25H34O6
分子量
430.53
性状
布德索尼德是白色至淡黄色白色晶体或结晶粉末。容易溶于甲醇，不易溶于醋酸盐或乙醇（95），几乎不溶于水。
熔点
约240°C（分解）
处理注意事项
向患者解释
在向患者提供此剂时，将患者解释性文档[Lectable（R）2mg灌肠形式14次传递给使用患者，并指导其使用。
存储、使用和处置注意事项
储存时，应保持正态。
本产品使用高压气体，存在危险，请遵守以下注意事项。
不要在火焰或火附近使用。
由于在高温下存在破裂的风险，因此不应放置在阳光直射或靠近火灾的地方。
铝容器不得进入火中。
处置时，应遵循当地政府规定的铝容器处置方法。
如果附着在手指或眼睛上，请立即用水冲洗。
批准条件
制定并适当实施药品风险管理计划。
药效药理
作用机制
布地奈德具有高的糖皮质激素受体亲和性。此外，在in vitro的炎症模型的试验体系中，布地奈德显示出抗炎作用。
对实验性肠炎的抗炎作用
在由醋酸诱发的大鼠大肠炎模型中，通过结肠内给药布地奈德，发现了有统计学意义的抗炎作用。
局部给药对全身的影响
在各种动物炎症模型中，通过局部给药研究了布地奈德的抗炎作用和不希望的全身性作用（胸腺的萎缩作用）。通过局部给予布地奈德，即使是显示出明显的抗炎效果的给药量，对不希望的全身的影响也几乎没有观察到，即使在观察到的情况下，与其他皮质类固醇相比，也显示出较高的治疗系数（局部抗炎作用/不希望的全身性作用之比）。
适应症
溃疡性结肠炎（严重除外）
用法与用量
通常，成人每次推1次（2mg作为布德索尼德），每天两次注射到直肠中。
包装
30.8克/罐x 4瓶


制造商和分销商
EA Pharma Corporation
プロモーション提携
キッセイ薬品工業株式会社
注：以上中文处方资料不够完整，使用者以原处方资料为准。
完整说明资料附件：
https://www.info.pmda.go.jp/go/pack/2399716K1020_1_07/
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Ulcerative Colitis Treatment "RECTABUL 2 mg Rectal Foam 14 Doses" Launches in Japan
RECTABUL, an in-licensed product of EA Pharma from Dr. Falk Pharma (Germany), is the first foam product for rectal enema (rectal foam) in Japan. EA Pharma and Kissei have jointly developed this product for the Japanese market, and EA Pharma obtained the marketing and manufacturing approval. Since the dosage form is a foam, the drug stays in the rectum and the sigmoid colon after reaching them, and leakage after administration is avoided. In addition, this product is a locally active steroid and, thus, is expected to reduce steroid-related systemic side effects.
Outside Japan, this product was developed by Dr. Falk Pharma and approved for marketing in 2006 in the UK "indicated for the treatment of active ulcerative colitis that is limited to the rectum and the sigmoid colon". Later in 2014, this product was approved in the US "indicated for the induction of remission in patients with active, mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge". As of March 2017, this product is approved for marketing in 36 countries worldwide.
During the development of RECTABUL® in Japan, "The IBD Patients Association Requesting the Immediate Approval of Budesonide in Japan", a patients association consisting of 27 IBD patient groups in Japan, made a request for accelerating the development of this product to the "eva luation Committee on Unapproved or Off-Labeled Drugs with High Medical Needs"*1. In the PIII double-blind placebo-controlled clinical study in patients with active ulcerative colitis conducted in Japan with the primary endpoint of mucosal healing rates*2 measured by endoscopy at 6 weeks of rectal administration of this product twice-daily, the superiority of this product to placebo was confirmed.
Ulcerative colitis is a kind of inflammatory bowel disease. In ulcerative colitis, ulcers develop in the colonic mucosa, with the symptoms including abdominal pain, diarrhea and hemorrhagic stool, leading to a marked decline in QOL (quality of life). In Japan, ulcerative colitis is designated an intractable disease by the Ministry of Health, Labour and Welfare, and it is estimated that at least 170,000 people suffer from the disease in this country.
EA Pharma and Kissei will respectively distribute RECTABUL® under the same brand name in Japan. With RECTABUL®, the two companies will strive to make further contributions to increasing the QOL of patients and respond to the need for easy-to-use and safe locally-active treatment of ulcerative colitis.