英文药名：Amitiza（Lubiprostone capsules） 中文药名：鲁比前列酮胶囊 生产厂家：日本雅培制药 アミティーザカプセル24μg 治疗类别名称 氯离子通道激活 欧文商標名 Amitiza 一般名 ルビプロストン（Lubiprostone）［JAN］ 化学名称 7 -  [（2R，4AR，5R，7AR）-2-（1,1- Difluoropentan-1-基）-2-羟基-6- oxooctahydrocyclopenta并[b]吡喃-5-基]庚酸 分子式 C20H32F2O5 分子量 390.46 構造式 性状 鲁比前列酮是一种白色结晶粉末。乙醚，和非常易溶于乙醇，并在水或己烷几乎不溶。 药理作用 本品为一局限性氯离子通道激活剂，可选择性活化位于胃肠道上皮尖端管腔细胞膜上的2型氯离子通道(CIC-2)，增加肠液的分泌和肠道的运动性，从而增加排便，减轻慢性特发性便秘的症状，且不改变血浆中钠和钾的浓度。 适应证 成人慢性特发性便秘，便秘型肠易激综合症(只用于18岁以上女性患者)； 用法用量： 口服，推荐剂量为24μg，bid，餐中服。此外，根椐病情适当的症状。 注意事项 鲁比前列酮-Amitiza用于治疗便秘型肠易激综合症时只能用于18岁以上的成人女性，儿童及成年男性禁用。 禁忌证 对本品过敏和机械性肠梗阻病史者禁用。孕妇及哺乳期妇女慎用。 包装规格 胶囊：24μgPTP： 100胶囊（10粒×10）500胶囊（10粒×50） 生产商 雅培日本株式会社 完整处方资料附件：http://www.info.pmda.go.jp/go/pack/2359006M1025_1_06/ 鲁比前列酮产品特点 本品为一局限性氯离子通道激活剂,可选择性活化位于胃肠道上皮尖端管腔细胞膜上的2型氯离子通道(CIC-2),增加肠液的分泌和肠道的运动性,从而增加排便,减轻慢性特发性便秘的症状,且不改变血浆中钠和钾的浓度。 鲁比前列酮属于选择性氯通道激活剂，具有新颖的作用机制，能经提高肠液分泌和增强对有利于通便的肠能动性而缓解便秘症状。但鲁比前列酮禁忌用于具机械性胃肠梗阻史的那些个体。 鲁比前列酮是依据两项合计包括479例每周自发性排便次数少于3次且 种症状至少存在6个月以上患者的安慰剂对照、随机Ⅲ期临床试验结果而获FDA批准的。两项试验均显现，鲁比前列酮治疗可使大多数患者在用药24小时内即产生自发性排便。研究结果还显示，鲁比前列酮治疗患者的便秘严重程度、腹部肿胀和不适改善能够持续6~12个月，且这些作用与患者性别、人种和年龄（65岁以下或以上）无关。 Important Safety Information AMITIZA (lubiprostone) is not for everyone. If you know or suspect you have a bowel blockage, do not take AMITIZA. If you are unsure, your healthcare provider (HCP) should evaluate your condition before starting AMITIZA. You should not take AMITIZA if you have severe diarrhea. Some patients taking AMITIZA may experience nausea or diarrhea. If nausea occurs, take AMITIZA with food and water, if it becomes severe, tell your HCP. If your diarrhea becomes severe, stop taking AMITIZA and tell your HCP. Within an hour of taking AMITIZA, a sensation of chest tightness and shortness of breath may occur. These symptoms usually go away within three hours, but may recur with repeated use. Tell your HCP if you experience these symptoms. The most common side effects of taking AMITIZA (24 mcg) twice daily are nausea, diarrhea, headache, abdominal pain, abdominal distension, and gas for patients treated for CIC; nausea and diarrhea for patients treated for Opioid-Induced Constipation. The most common side effects of taking AMITIZA (8 mcg) twice daily for IBS-C are nausea, diarrhea, and abdominal pain. These are not all the side effects associated with AMITIZA. Tell your HCP if you are taking a diphenylheptane opioid (e.g., methadone). AMITIZA has not been studied in pregnant women. Based on animal studies, AMITIZA may cause fetal harm. AMITIZA should only be used during pregnancy if the potential benefits justify the potential risk to the fetus. If you are pregnant or become pregnant while being treated with AMITIZA, talk to your HCP to evaluate the risks to the fetus. Tell your HCP if you are nursing and monitor infants for diarrhea. Tell your HCP if you have liver problems. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Indication AMITIZA (lubiprostone) 24 mcg capsules twice daily is approved to treat Chronic Idiopathic Constipation (CIC) in adults. "Idiopathic" means the cause of the constipation is unknown and not due to an underlying illness or medication. AMITIZA 24 mcg twice daily is also approved to treat constipation caused by opioids, a type of prescription pain medicine, in adults with chronic, non-cancer pain. The effectiveness of AMITIZA has not been established if you are taking a diphenylheptane opioid (e.g., methadone). AMITIZA 8 mcg capsules twice daily is approved to treat Irritable Bowel Syndrome with Constipation (IBS-C) in women 18 years of age and older. 慢性便秘的处方药AMITIZA获日本批准 Sucampo制药（SPI）与雅培（Abbott）今天宣布，在日本推出AMITIZA（lubiprostone，鲁比前列酮），该药是一种处方药，于今年6月获日本卫生劳动福利部（MHLW）批准，用于非器质性疾病导致的慢性便秘。 AMITIZA有望显著改善慢性便秘的治疗，该药是世界首个获批用于治疗用途的氯离子通道激活剂，也是日本获批的首个慢性便秘处方药。AMITIZA具有一种独特的作用模式，能够诱导患者自然的排便频率更符合于正常的排便习惯。 Sucampo董事兼CEO Ryuji Ueno博士称：“在日本，有数以百万计的患者受慢性便秘困扰，当前无有效的、耐受性良好的长期治疗方案。AMITIZA在美国市场有长达6年的经验及超过600万的处方，我们很高兴能携手雅培将该药推向日本市场，使日本的慢性便秘患者受益。” 慢性便秘是一种最常见的消化系统疾病，困扰着日本数百万患者。相比目前获批的非处方药，医疗服务提供者现在有了一个处方药的选择，来帮助更有效、更长期地管理慢性便秘。 根据2009年达成的授权、商业化、供应协议，雅培将与Sucampo制药共同推进AMITIZA在日本的推广.