Pylera®包含三种（枸橼酸铋钾/甲硝唑/盐酸四环素）四种基于铋的四联疗法成分，用于在单个胶囊中根除幽门螺杆菌（幽门螺旋杆菌）。 10天的方案包括相对方便的Pylera®每日四次给药+每日两次给予质子泵抑制剂奥美拉唑。 该方案为基于铋的四联疗法提供了有效的，良好耐受的和相对方便的选择，其推荐用于根除幽门螺杆菌的一线和二线治疗。
批准日期：2013年9月3日 公司：Aptalis Pharma
PYLERA®（枸橼酸铋钾/甲硝唑/盐酸四环素）胶囊，用于口服
美国最初批准：2006年
警告：可能存在致癌性
查看完整的盒装警告的完整处方信息
甲硝唑已被证明在小鼠和大鼠中具有致癌性。目前还不知道甲硝唑是否与人类的致癌性有关。
最近的重大变化
警告和注意事项：01/2018
作用机制
PYLERA是抗菌剂（甲硝唑和盐酸四环素）和次氯酸铋钾的组合[见微生物学]。
适应症和用法
PYLERA是甲硝唑，一种硝基咪唑抗菌剂，四环素，四环素类抗菌药和次氯酸铋钾的组合，用于与奥美拉唑联合用于治疗幽门螺杆菌感染和十二指肠溃疡病（活动或过去的病史） 5年）根除H. pylori。
为了减少抗药性细菌的发展并保持PYLERA和其他抗菌药物的有效性，PYLERA应仅用于治疗或预防已证实或强烈怀疑由细菌引起的感染。
剂量和给药
•每天4次（饭后和卧床时间）给予3个PYLERA胶囊10天。
•每日两次（晚餐和晚餐后）给予PYLERA奥美拉唑20 mg。
剂量形式和强度
PYLERA的每个胶囊包含：
•140毫克次氯酸铋钾
•125毫克甲硝唑
•125毫克四环素盐酸盐
禁忌症
•同时使用甲氧氟烷。
•过去两周内使用双硫仑。
•在治疗期间或治疗后至少三天饮用酒精饮料。
•严重肾功能损害。
•怀孕的妇女。
•已知对产品组件过敏。
警告和注意事项
•胎儿毒性：建议怀孕妇女在整个妊娠期间发生风险，以延缓动物研究中发现的骨骼发育，并在妊娠期或妊娠晚期使用四环素对牙齿进行永久性变色。
•母体毒性：静脉注射四环素大剂量孕妇的肝毒性风险也会导致死产或早产。
•牙釉质变色和发育不全：在牙齿发育期间（怀孕的后半部分，婴儿期和儿童期至8岁）可能会发生永久性变色。
•中枢和周围神经系统影响：脑病，惊厥性癫痫，无菌性脑膜炎和周围神经病变与甲硝唑，颅内高血压伴四环素和含铋产品的神经毒性。严密监测患有CNS病症的患者，如果神经系统异常，应立即停药
迹象发展。
•光敏性：避免暴露在阳光和太阳灯下。
•血液性痉挛：对有血腥病史的患者慎用。
•肝功能损害：不建议严重肝功能不全患者使用。
•皮肤反应：Stevens-Johnson，中毒性表皮坏死松解症，DRESS综合征。在第一次皮肤反应证据时停止治疗。
不良反应
最常见的不良反应（≥5％）;粪便异常，腹泻，恶心和头痛。
要报告疑似不良反应，请致电1-800-678-1605联系Allergan或1-800-FDA-1088或www.fda.gov/medwatch联系FDA
药物相互作用
•甲氧氟烷：致命的肾毒性风险;不要共同管理。
•双硫仑：可能发生精神病反应;在双硫仑的最后2周内不要同时服用。
•酒精：出现腹部绞痛，恶心，呕吐，头痛和潮红;治疗期间至少3天不消耗。
•口服避孕药：可能导致怀孕的疗效降低;使用不同或额外的避孕方法。
•抗凝血剂：增强抗凝血作用;应密切监测凝血酶原时间，国际标准化比率（INR）或其他合适的凝血试验。
•锂：锂血清浓度增加;在治疗期间测量血清血清肌酐浓度。
•抗酸剂，多种维生素或乳制品：降低对PET的吸收;不要同时服用。
•白消安：白消安血清浓度增加;避免同时使用，监测白消安毒性。
•CYP诱导剂和CYP抑制剂：甲硝唑或伴随药物的半衰期延长或加速;谨慎使用。
用于特定人群
•哺乳期：女性应该泵送并丢弃人乳，用于治疗PYLERA疗法，治疗结束后2天。
•儿科用药：四环素可能导致牙齿永久性变色。还报道了牙釉质发育不全。不要在8岁以下的儿童中使用。
包装提供/存储和处理
PYLERA是一种白色不透明胶囊，含有140毫克次氯酸铋钾，125毫克甲硝唑和125毫克四环素盐酸盐，主体上印有APTALISTM标志，盖上印有“BMT”字样。 PYLERA胶囊作为120粒胶囊提供，10天治疗包含10个泡罩卡，每张卡含12个PYLERAcapsules，总共120粒胶囊。
NDC：58914-601-21，瓶装120。
NDC：58914-601-20，吸塑包装120。
存储
储存在受控的室温[68°至77°F或20°至25°C]。
完整说明书附件：
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a762e164-b390-4e8c-bd46-bf6c31eeb486 。



PYLERA capsules are a combination antimicrobial product containing bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride for oral administration.
Name：PYLERA®
Description：PYLERA® (bismuth subcitrate potassium, metronidazole, tetracycline HCl) is an effective 3-in-1 capsule for the first line option in the eradication treatment of H. pylori, a bacteria that is now believed to cause up to 90% of duodenal ulcers.
Active substance：Bismuth subcitrate potassium 140 mg, metronidazole 125 mg, tetracycline hydrochloride 125 mg given as 3 capsules q.i.d. plus omeprazole for 10 days.
Indication：PYLERA® capsules, in combination with omeprazole (20 mg b.i.d), are indicated for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori.
Regulatory Status：Approved by US FDA in September 2006, (NDA) 050786.
MEA region approved countries: Bahrain, Kuwait, Lebanon, Morocco, Qatar Under registration in Tunisia 




NewBridge Announces Licensing of Pylera for Middle East, Africa, Turkey, and Caspian Regions
Dubai-UAE: 22. July, 2009 – NewBridge Pharmaceuticals, a specialty pharmaceutical, biologics, and medical device company serving the Middle East, Africa, Turkey & Caspian regions, today announced that is has entered into an exclusive license and supply agreement with Axcan Pharma for Pylera®, an innovative 3-in-1 capsule therapy for the eradication of Helicobacter pylori, a bacterium now recognized as being the main cause of gastric and duodenal ulcers. Pursuant to the agreement, NewBridge is entitled to obtain exclusive rights in certain markets where it obtains required regulatory approvals and launches the product. The product should be launched in Q4 2010.
Pylera®, which was developed by Axcan over the last ten years, is a patented 3-in-1 capsule therapy. Each Pylera® capsule contains bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride. Pylera® is clinically proven to be as effective as the most widely prescribed therapeutic regimen for the eradication of Helicobacter pylori (omeprazole,amoxicillin and clarithromycin) and has the potential to be used in a wide range of patients as a first-line therapy for the eradication of Helicobacter pylori based on its convenient 10-day treatment dosing regimen. Pylera® provides additional clinical benefit by improving patient compliance. Pylera® received FDA approval in September 2006 and was successfully launched in the United States in May 2007.
"In partnering with Axcan for the Pylera 3-in-1 capsule therapy for Helicobacter pylorieradication, NewBridge Pharmaceuticals advances further to become one of the key providers of innovative pharmaceutical care to the Middle East, Turkey, CIS and Africa" said Dr. Garrett Vygantas, CEO of NewBridge Pharmaceuticals. “NewBridge’s strategy of providing world-class sales and marketing, pharmacovigilance and supply chain support for our innovative products allows patients and physicians across the region access to best-in-class therapeutics, educationand support."
"We are happy to be partnering with NewBridge Pharmaceuticals,” said Nicholas Franco, Axcan’s Senior Vice President, International Commercial Operations, "which will enable Axcan’s Pylera to be launched in rapidly growing markets in which NewBridge has expertise."
About Helicobacter pylori
The discovery in 1983 of the Helicobacter pylori organism was one of the major advances in gastroenterology in recent decades, as it has revolutionized the approach to many upper gastrointestinal disorders. Helicobacter pylori is believed to cause a spectrum of diseases in humans, including gastritis, ulcer disease (gastric and duodenal), gastric cancer and gastric lymphoma. In North-America, 10% of the population will have an ulcer in their lifetime; and many treatments end up with a high rate of recurrences. In fact, 40% to 80% of patients experience a recurrence within only a year after undergoing short-term treatment of gastric acid suppression therapy. Studies have shown that the gastroduodenal reoccurrence rate is only 2% for patients in whom the organism has been eradicated.
About NewBridge Pharmaceuticals
NewBridge Pharmaceuticals (www.nbpharma.com) is a specialty pharmaceutical, biologics, and medical device company serving the Middle East, Africa, Turkey, and Caspian regions to address the unmet needs of diseases with high regional preva lence such as cancer, diabetes, obesity, cardiovascular diseases and other metabolic disorders. NewBridge in-licenses and commercializes FDA and EMEA approved therapeutics, medical devices and diagnostics. Headquartered in UAE with Business Development in the US, NewBridge was founded in 2007 by Burrill & Company, a San Francisco based Life Science Venture Capital, Private Equity, Merchant Banking and Media firm. NewBridge Pharmaceuticals is uniquely positioned as the partner of choice for pharmaceutical, biotechnology and device companies seeking to capture value from their products in these high growth emerging markets.
About Axcan Pharma
Axcan Pharma is a privately-held, leading specialty pharmaceutical company that develops and markets a wide range of products to treat gastrointestinal diseases and disorders, such as inflammatory bowel disease, cholestatic liver diseases, irritable bowel syndrome, and complications related to pancreatic insufficiency. Axcan's products are marketed by its own dedicated and specialized sales forces both in North America and the European Union. The company also markets its products in more than 40 countries through a global network of local partners. 
---------------------------------------------------------------
附件:
201141720383123.pdf