新剂型Dexilant SoluTab缓释口腔崩解片获美国FDA批准用于成年治疗胃灼热伴有症状的非糜烂性胃食管反流病（GERD）和维护治愈糜烂性食管炎（EE）和胃灼热的质子泵抑制剂（PPI）。Dexilant SoluTab 是双延迟的释放 （DDR）技术的PPI药物，在治疗过程中提供两个独立的释放系统。 批准日期：2016年1月27日  公司：武田制药北美公司 DEXILANT（右兰索拉唑[dexlansoprazole]）的缓释胶囊剂，供​​口服使用 DEXILANT SoluTab（右兰索拉唑[dexlansoprazole]）的缓释口服崩解片剂，口服使用 最初美国批准：1995年（兰索拉唑） 目前的主要变化 适应证和用途 01/2016 用法与用量，推荐剂量 01/2016 在肝功能受损的EE的治疗成人的剂量调整 01/2016 用法与用量，重要管理信息 01/2016 禁忌证 01/2016 警告和注意事项，以诊断为调查神经内分泌肿瘤的相互作用。 01/2016 作用机理 右兰索拉唑属于一类抗分泌化合物中，取代的苯并咪唑，其抑制由（H+，K +）的特异性抑制胃酸分泌 -  ATP酶在胃壁细胞的分泌表面。因为这种酶被认为是壁细胞内酸（-proton）泵，右兰索拉唑已酸生产的最后步骤，其特征为胃质子泵抑制剂的，因为它的块 适应症和用法 DEXILANT为质子泵抑制剂（PPI）。 DEXILANT缓释胶囊（DEXILANT胶囊）指示成人为： •糜烂性食管炎（EE）的所有等级的治疗。 •维护EE的治疗和缓解胃灼热。 •有症状的非糜烂性胃食管反流病（GERD）相关的治疗胃灼热。 DEXILANT SoluTab缓释口腔崩解片（DEXILANT SoluTab）指示成人为： •维护EE的治疗和缓解胃灼热。 •治疗与GERD相关的胃灼热。 用法用量 推荐成人用量： 30毫克DEXILANT SoluTab不是一个60毫克胶囊DEXILANT互换。 DEXILANT胶囊 •EE愈合：60毫克，每天一次长达8周。 •愈合EE保养：30毫克，每天一次长达6个月。 •对症非糜烂GERD：30毫克，每天一次，连续4周。 DEXILANT SoluTab •愈合EE保养：30毫克，每天一次长达6个月。 •对症非糜烂GERD：30毫克，每天一次，连续4周。 调整剂量与肝损害的EE的治疗成人： •中度肝功能不全（Child-Pugh分级B级）：30毫克，每日一次，长达8周DEXILANT胶囊或DEXILANT SoluTab的。 •严重肝功能受损（Child-Pugh类别C）：不建议使用。 行政指令： DEXILANT胶囊 •就拿不考虑食物。 •整片吞服;不嚼。 •请参阅替代管理选项的完整处方信息。 DEXILANT SoluTab •饭前至少30分钟。 •不要打破或切断。 •将在舌头上的平板电脑，让瓦解并没有水咽下去。不要嚼微粒。 •也可与水整个吞下。 •服用DEXILANT SoluTab时，避免使用酒精 •请参阅替代管理选项的完整处方信息。 剂型和规格 •延迟释放胶囊剂：30毫克和60毫克。 •延迟释放口服崩解片剂：30毫克。 禁忌症 •例已知过敏制剂的任何部分。 •患者接受含rilpivirine产品。 警告和注意事项 •胃恶性：与DEXILANT症状反应并不排除胃恶性的存在。 •急性间质性肾炎：观察服用质子泵抑制剂的患者。 •氰钴胺素（维生素B-12）缺乏症：每日长期使用（例如，超过3年）可能导致吸收不良或氰钴胺素的缺乏。 •艰难梭菌相关性腹泻：PPI治疗可能会增加一些风险有关。 •骨折：长期和多次的每日剂量PPI治疗可能与髋部，腕部或脊柱的骨质疏松相关的骨折风险增加有关。 •低镁血症：与质子泵抑制剂长期治疗鲜有报道。 •用诊断为调查神经内分泌肿瘤的相互作用：在胃内pH值升高，可能会导致高胃泌素血症和肠嗜铬细胞样细胞增生和增加可能与神经内分泌肿瘤的诊断调查干扰嗜水平。 •甲氨喋呤相互作用：用质子泵抑制剂伴随使用可提高和/或延长甲氨蝶呤和/或其代谢物的血清浓度，很可能导致毒性。随着大剂量甲氨蝶呤管理，考虑DEXILANT的暂时撤离。 不良反应 最常见的不良反应（≥2％）：腹泻，腹痛，恶心，上呼吸道感染，呕吐，胀气。 要报告疑似不良反应，请联系武田制药美国公司在1-877-武田-7（1-877-825-3327）或FDA电话1-800-FDA-1088或www.fda.gov/medwatch。 药物相互作用 查看全部处方信息为临床上重要的药物相互作用的列表。 包装规格 缓释口腔崩解片:30毫克*100片/盒 FDA Approves Takeda's Dexilant SoluTab (dexlansoprazole) U.S. Food and Drug Administration (FDA) approved Dexilant SoluTab delayed-release orally disintegrating tablets, a new formulation of dexlansoprazole that can be taken by allowing the tablet to melt in the patient's mouth. Dexilant SoluTab is a proton pump inhibitor (PPI) indicated for the treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) and the maintenance of healed erosive esophagitis (EE) and relief of heartburn in adults 18 years and older. Dexilant SoluTab is a PPI with dual delayed release (DDR) technology that is designed to provide two separate releases of medication. "Our more than 20 years of leadership in gastroenterology has allowed us to provide another option that offers relief from heartburn associated with GERD in an orally disintegrating tablet," explained Thomas Gibbs, Senior Vice President, General Medicines, Takeda. "This new formulation expands the Dexilant Family and offers appropriate patients with GERD, who may struggle with swallowing capsules, a melt in your mouth alternative."  In addition to Dexilant SoluTab, Dexilant is also available as a capsule. The capsule is indicated for heartburn associated with symptomatic non-erosive gastroesophageal reflux disease, the healing of erosive esophagitis (EE) and the maintenance of healed EE in adults. Since being approved by the FDA, Dexilant capsules have been available for nearly 7 years with over 25 million prescriptions filled. About GERD GERD is a chronic condition commonly known as acid reflux disease. GERD can occur when the valve at the lower end of the esophagus, called the lower esophageal sphincter (LES), does not work properly. This valve opens to allow food and liquids to enter the stomach and closes to keep acid and food in the stomach. When the LES does not close as tightly as it should, or relaxes too often, it can cause stomach contents to get into the esophagus. GERD affects about 20 percent of the U.S. population and is often characterized by frequent and persistent heartburn two or more days a week despite treatment and diet changes. Adults who have trouble swallowing pills may consider discussing an alternate formulation option, such as an orally disintegrating tablet, with their doctor. DEXILANT (dexlansoprazole) 30 mg and 60 mg delayed-release capsules are indicated for: •Healing all grades of erosive esophagitis (EE) for up to 8 weeks •Maintaining healing of EE and relief of heartburn for up to 6 months •Treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for 4 weeks DEXILANT SoluTab (dexlansoprazole) 30 mg delayed-release orally disintegrating tablets are indicated for: •Maintaining healing of EE and relief of heartburn for up to 6 months •Treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for 4 weeks Two 30 mg Dexilant SoluTab are not interchangeable with one 60 mg Dexilant Capsule. Dexilant SoluTab should be taken at least 30 minutes before a meal. Do not break or cut. Dexilant SoluTab should be placed on the tongue, and allowed to disintegrate (melt). The microgranules should be swallowed without water and should not be chewed. Dexilant SoluTab may also be swallowed whole with water. Avoid use of alcohol when taking Dexilant SoluTab. See full prescribing information for additional administration options. IMPORTANT SAFETY INFORMATION •DEXILANT is contraindicated in patients with known hypersensitivity to any component of the formulation. Hypersensitivity reactions, including anaphylaxis have been reported. Acute interstitial nephritis has been reported with other proton pump inhibitors (PPIs), including lansoprazole. PPIs, including DEXILANT, are contraindicated with rilpivirine-containing products. •Symptomatic response with DEXILANT does not preclude the presence of gastric malignancy. •Acute interstitial nephritis has been observed in patients taking PPIs, including lansoprazole. Discontinue DEXILANT if acute interstitial nephritis develops. •Daily treatment with any acid-suppressing medications over a long period of time (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin (vitamin B12). •PPI therapy may be associated with increased risk of Clostridium difficile associated diarrhea. •Long-term (a year or longer) and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the conditions being treated. •Hypomagnesemia has been reported rarely with prolonged treatment with PPIs. •Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity which may cause false positive results in diagnostic investigations for neuroendocrine tumors. Temporarily stop DEXILANT treatment at least 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high. •Concomitant use of PPIs with methotrexate may elevate and prolong serum concentrations of methotrexate and/or its metabolite, possibly leading to toxicity. With high dose methotrexate administration, consider a temporary withdrawal of DEXILANT. •Most commonly reported adverse reactions were diarrhea (4.8%), abdominal pain (4.0%), nausea (2.9%), upper respiratory tract infection (1.9%), vomiting (1.6%), and flatulence (1.6%). •Decreased exposure of some antiretroviral drugs (e.g., rilpivirine, atazanavir, and nelfinavir) when used concomitantly with DEXILANT may reduce antiviral effect. Avoid concomitant use of nelfinavir with DEXILANT. Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with DEXILANT may increase toxicity of the antiretroviral drugs.  •Patients taking concomitant warfarin may require monitoring for increases in international normalized ratio (INR) and prothrombin time. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. •DEXILANT may interfere with absorption of drugs for which gastric pH is important for bioavailability (e.g., drugs with pH-dependent absorption such as digoxin, iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil [MMF], ketoconazole/itraconazole). Use DEXILANT with caution in transplant patients receiving MMF. •Concomitant tacrolimus use may increase tacrolimus whole blood concentrations. •A hyper-response in gastrin secretion in response to the secretin stimulation test may falsely suggest gastrinoma. Temporarily stop DEXILANT treatment at least 30 days before assessing to allow gastrin levels to return to baseline. •There have been reports of false positive urine screening tests for tetrahydrocannabinol (THC) in patients receiving PPIs.  •Avoid concomitant use of DEXILANT with St. John's Wort or rifampin due to decreased exposure of DEXILANT.  Please see accompanying full Prescribing Information, including Medication Guide for DEXILANT. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9819f033-3bbe-442e-8e92-45fec77b237d