美国FDA于4月30日批准Amitiza（Lubiprostone中文译名：鲁比前列酮）用于治疗18周岁以上（含）成年女性患者伴有便秘症状的肠易激综合征（IBS–C），在此之前一直没有治疗该疾病的处方药物，所以Amitiza（Lubiprostone）成为FDA唯一批准在美国本土治疗IBS-C的药物。
肠易激综合征的主要特征为腹部痉挛，腹痛，胃气胀，便秘以及腹泻，会给病人带来巨大的痛苦，女性比男性更容易发病（2倍）。一些IBS的患者可能会完全残疾，丧失活动能力，因此Amitiza（Lubiprostone）的出现对于缓解患者的症状非常重要。
包含1154名IBS-C患者的两项研究建立了Amitiza（Lubiprostone）的安全性和有效性，这些对象绝大多数是女性（只有近8％是男性）。研究入选的患者至少表现为轻度的腹部不适或疼痛，并且至少伴随以下两种额外的症状：1）每周少于3次自主的排便（排除使用缓泻剂的情况）；2）大便硬；3）排便有中重度下坠感。所有患者分为给药组和安慰剂组，与安慰剂组比较，给药组在用药12周后大部分的患者IBS症状都得到适度或明显缓解。在其中一项所有患者接受Amitiza治疗持续时间为9~13个月的研究中，对该药长期治疗的安全性进行了评估。
遗憾的是，对于男性患者的用药效果还没有最后确定。与其他药物一样，Amitiza（Lubiprostone）也有不良反应，恶心、腹泻、腹痛是常见的副作用。其他一些比较罕见的不良反应有：尿路感染，口干，昏厥，肢端水肿，呼吸困难以及心悸。
Amitiza（Lubiprostone）的剂量为8微克，一天两次，可以同食物和水一起服用。Amitiza（Lubiprostone）也可用于慢性先天性便秘（CIC），24微克每日两次。Amitiza（Lubiprostone）不得用于男性以及儿童，也不能用于正患有严重腹泻或已知或怀疑有肠梗阻的患者。对于肝肾功能不全的患者，妊娠及哺乳期妇女的用药安全性和有效性尚未建立。

 
包装规格：24微克×60粒胶囊

生产厂家：
Takeda Pharmaceuticals America / Sucampo 武田制药（美国）公司生产 / 美国Sucampo制药公司
原产地国家批准上市年份：2006/01/31
英文适应病症：Chronic Idiopathic Constipation；Constipation
 
美国FDA批准用于成年人慢性“原发性”便秘治疗的新处方药Amitiza（通用名：lubiprostone），用于治疗原因不明的成年人慢性便秘。该产品的胶囊剂型将可供成年人用于治疗不是由其他疾病或用药而导致的原发性（idiopathic）便秘。

慢性原发性便秘通常被定义为很少排便且排便困难，是美国人最常遭受的疾病之一。该病的女性患病率高于男性，并且65岁以上的老年人患病率更高。慢性原发性便秘的症状为腹部疼痛与不适、气胀、压挤和便干。
Amitiza通过增加肠液（intestinal fluid）而起作用，肠液能帮助排便和帮助减轻与慢性原发性便秘有关的症状。FDA批准Amitiza的决定是基于两个临床试验的结果，该临床实验研究对象为在参加研究前每周排便少于3次且便秘症状至少达6个月的患者。这两个临床实验证明了用Amitiza治疗的受试者在第一周的排便次数高于安慰剂组。在两个临床试验中，第2、第3和第4周的治疗结果跟第1周类似。此外，3个长期研究表明Amitiza使用6至12个月减少了便秘的严重程度、腹部气胀和不适。

Amitiza
Generic name: Lubiprostone

Why is Amitiza prescribed?

Amitiza is used to relieve chronic constipation when the cause is unknown. It is intended to treat constipation that has lasted for 3 months or more and that is not due to an underlying illness or medication side effect.

Most important fact about Amitiza

Amitiza has not been studied in pregnant women and should only be used during pregnancy if the potential benefits justify the potential risk to the fetus. Women should have a negative pregnancy test before beginning treatment with Amitiza and need to use contraception to prevent pregnancy while being treated with the drug. If you are pregnant or become pregnant while taking Amitiza, talk with your doctor to evaluate the risks.

How should you take Amitiza?

Unless instructed otherwise by your doctor, take Amitiza twice a day, with food or a meal. Most people have a bowel movement within 24 hours of taking their first dose.

If you miss a dose...
Take it as soon as you remember. If it is almost time for the next dose, skip the one you missed and go back to your regular schedule. Do not take 2 doses at once.
Storage instructions...
Store at room temperature.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Amitiza.

Side effects may include:
Diarrhea, headache, nausea

Why should Amitiza not be prescribed?

Do not take Amitiza if you:

Have a history of bowel obstruction.
Are pregnant, unless, after discussion with your doctor, the potential
benefit justifies the potential risk to the fetus.
Have severe diarrhea.
Are allergic to Amitiza or any of its ingredients.

Special warnings about Amitiza

Tell your doctor about your complete medical history, especially if you have ever been told you have a bowel obstruction or you have kidney or liver problems.

Let the doctor know if you cannot swallow capsules; you may not be able to take this medication.

Before beginning treatment with Amitiza, be sure to tell the doctor about all prescription, over-the-counter, and herbal medications you are taking.

Tell your doctor if you experience nausea while taking this drug; the doctor may be able to suggest ways to manage this side effect.

If you get diarrhea during treatment or your diarrhea worsens, stop taking Amitiza and contact your doctor immediately.

Amitiza has not been studied in children under 18 years old.
Possible food and drug interactions when taking Amitiza

Although studies have suggested a low risk of interactions with other drugs and products, only your doctor can decide whether Amitiza is right for you. It is important to check with your doctor before combining Amitiza with any other medication or dietary supplement.

Special information if you are pregnant or breastfeeding

The effects of Amitiza during pregnancy are unknown (see "Most important fact about this drug"). It is also not known whether Amitiza appears in breast milk. If you would like to breastfeed, discuss your options with your doctor
Recommended dosage for Amitiza

ADULTS

The recommended dosage is 24 micrograms taken twice a day with food.

Overdosage

There is little information on the potential results of Amitiza overdose. However, any medication taken in excess can have serious consequences. If you suspect an overdose, seek medical attention immediately.

Symptoms of Amitiza overdose may include:
Abdominal pain, breathing problems, diarrhea, dizziness, feeling faint or lightheaded, headache, loose or watery stools, pale skin, severe nausea, skin flushing, vomiting

慢性特发性便秘治疗药Amitiza在瑞士上市

日前，瑞士治疗学产品署批准了Sucampo制药有限公司开发的鲁比前列酮24mcg凝胶胶囊剂（lubiprostone／Amitiza），用于长期治疗成人慢性特发性便秘。这是鲁比前列酮在欧洲首次获得批准。鲁比前列酮也是迄今在瑞士获准长期治疗慢性特发性便秘的第一个处方药物。

Amitiza 24微克x60粒胶囊|

Indication

AMITIZA (24 mcg) twice daily is approved to treat Chronic Idiopathic Constipation in adults. “Idiopathic” means the cause of the constipation is unknown and not due to an underlying illness or medication. AMITIZA (8 mcg) twice daily is approved to treat Irritable Bowel Syndrome with Constipation (IBS-C) in women 18 years of age and older.

Important Safety Information

AMITIZA 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 should evaluate your condition before starting AMITIZA. You should not take AMITIZA if you have severe diarrhea.

AMITIZA has not been studied in pregnant women and should only be used during a pregnancy if the potential benefits justify the potential risk to the fetus. Women should have a negative pregnancy test before beginning treatment with AMITIZA and need to practice effective birth control measures. If you are pregnant or become pregnant while being treated with AMITIZA, talk to your healthcare provider to evaluate the risks to the fetus.

Some patients taking AMITIZA may experience nausea or diarrhea. If nausea occurs, take AMITIZA with food. If your nausea or diarrhea becomes severe, tell your healthcare provider.

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 healthcare provider if you experience these symptoms.

The most common side effects of taking AMITIZA (24 mcg) twice daily, orange capsules for Chronic Idiopathic Constipation are nausea, diarrhea, and headache. The most common side effects of taking AMITIZA (8 mcg) twice daily, pink capsules for IBS-C are nausea, diarrhea, and abdominal pain. These are not all the side effects associated with AMITIZA.