2009年2月5日 FDA批准KAPIDEX治疗胃食管反流病 最近美国食品和药物管理局（FDA）批准KAPIDEX ™ （dexlansoprazole）缓释胶囊，按每日一次口服的方式用于与烧心相关的病症，如非糜烂性反流病（NERD） ，胃食管反流病（ GERD ） ，糜烂食管炎（ EE ）的治疗和愈合维持。 KAPIDEX （分30毫克和60毫克两种剂量）是第一个质子泵抑制剂（PPI）的双缓释™ （DDR）构造，目的是提供两个单独的释放药物。该项批准是基于在全球20个国家约6000名糜烂患者和非糜烂性胃食管反流病患者研究评价基础上的。这些研究结果表明：两个双盲的为期8周的对照试验比较，分别是服用KAPIDEX与兰索拉唑治疗患者的糜烂性食管炎。 KAPIDEX （ 60毫克）在第8周都表现出较高的愈合率，与兰索拉唑30毫克相比较分别是第一次研究87 ％比85 ％ ，第二次研究85 ％比79 ％。从6个月的研究维持愈后糜烂性食管炎的数据中表明，患者服用KAPIDEX 30毫克相比较安慰剂都具有较低的复发率，同时烧心等症状也较少发生。在一项为期4周用于烧心是患者胃食管反流病的主要症状，还是患者直接患有糜烂性食管炎的测试中， KAPIDEX相对于安慰剂也表现出较大的一天内无烧心症状的天数百分比。

Kapidex is used to treat heartburn caused by gastroesophageal reflux disease (GERD), and to heal erosive esophagitis (damage to the esophagus from stomach acid).Kapidex may also be used for other purposes not listed in this medication guide.

Important information about Kapidex
Before taking Kapidex, tell your doctor if you are allergic to any drugs, or if you have liver disease. You may need a dose adjustment or special tests to safely take Kapidex. Take this medicine for the entire length of time prescribed by your doctor. Your symptoms may get better before your treatment is completed.

When treating heartburn, Kapidex is usually given for 4 weeks. To best heal erosive esophagitis, you may need to take this medicine for several months. Follow your doctor's instructions.

Heartburn can be confused with early symptoms of heart attack. Seek emergency medical attention if you have chest pain or heavy feeling, dizziness, pain spreading to the arm or shoulder, sweating, nausea or vomiting, and a general ill feeling.

Take each dose with a full glass (8 ounces) of water.Kapidex may be taken with or without food.

Do not crush, break, or open a delayed-release capsule. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time.

If you are unable to swallow a delayed-release capsule whole: Open the capsule and sprinkle the medicine into a spoonful of applesauce. Swallow this mixture right away without chewing. Do not save the mixture for later use. Discard the empty capsule.

It is important to use Kapidex regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

When treating heartburn, Kapidex is usually given for 4 weeks. To best heal erosive esophagitis, you may need to take Kapidex for several months. Follow your doctor's instructions.

Store this medication at room temperature away from moisture and heat.

What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of Kapidex is not expected to produce life-threatening symptoms.

What should I avoid while taking Kapidex?
Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using Kapidex.

命名相近促使GERD药Kapidex更换商标，以减少发药错误

2010年3月4日，美国食品药品管理局(FDA)和日本武田制药公司宣布，为了患者的安全，Kapidex(右旋兰索拉唑)——一种用于治疗胃食管反流性疾病(GERD)及相关疾病的质子泵抑制剂，将进行名称变更。其新商品名将为Dexilant。

自2009年1月Kapidex获准以来，已出现多份有关发药错误的报告。这些错误产生的原因为，Kapidex与商品名为Casodex (比卡鲁胺) 和 Kadian (硫酸吗啡)的药品之间存在混淆。Casodex用于治疗晚期前列腺癌，而Kadian是一种用于治疗疼痛的阿片类止痛药。

Dexilant的分子式、适应证及获准剂量将与Kapidex保持一致。胶囊上的标识仍保持不变，其外观将与Kapidex商品名下标注的完全相同。

武田公司预计，新命名的药品Dexilant将在2010年近4月底上市。

ST LOUIS (MD Consult) - On March 4, 2010, the US Food and Drug Administration (FDA) and Takeda Pharmaceuticals announced that Kapidex (dexlansoprazole), a proton pump inhibitor used for the treatment of gastroesophageal reflux disease (GERD) and related conditions, will undergo a name change in the interest of patient safety. The new trade name of the product will be Dexilant.

Several reports of dispensing errors have been generated since the approval of Kapidex in January 2009. These errors have occurred because confusion existed between Kapidex and the drugs known by the brand names Casodex (bicalutamide) and Kadian (morphine sulfate). Casodex is used for the treatment of advanced prostate cancer, whereas Kadian is an opioid analgesic used for the treatment of pain.

The formulation, indication, and approved dosages of Dexilant will remain the same as those for Kapidex. The markings on the capsules remain unchanged and their appearance will be identical to those marked under the Kapidex trade name.

Takeda anticipates that the newly named product Dexilant will be available near the end of April 2010. Persons responsible for ordering, stocking, and billing for the product should be aware that Dexilant will have a new National Drug Code number assigned to it.

中文参考商品译名:
KAPIDEX 60毫克×30粒
中文参考药品译名:
dexlansoprazole 60毫克×30粒
生产厂家中文参考译名:
武田北美制药
生产厂家英文名:
Takeda Pharmaceuticals North America, Inc