商品名称：RAYOS 通用名称：PREDNISONE(强的松) 生产商：HORIZON PHARMA 剂型：缓释片 Rayos系由Horizon制药公司（一家专注在风湿领域的生物制药公司）研发，用于治疗中重度类风湿关节炎，对缓解患者的炎症和疼痛有比较好的疗效。在治疗患者的“晨僵”症状方面优于其他药物。 Horizon制药公司 7月26日宣布，美国FDA批准其强的松（prednisone）Rayos缓释片（1毫克，2毫克和5毫克），用以广泛治疗一系列疾病，包括类风湿关节炎（RA）、风湿性多肌痛（PMR），银屑病关节炎（PSA），强直性脊柱炎（AS），哮喘和慢性阻塞性肺疾病（COPD）。 FDA颁发此批准令是根据Rayos的药代动力学与速释泼尼松相衔接的数据以及2项在类风湿性关节炎患者中开展的临床试验（CAPRA-1和2）的数据。CAPRA-2试验表明，在ACR20反应上，使用Rayos治疗的中度至重度类风湿性关节炎患者与安慰剂组相比有统计学上的显著改善。CAPRA-1试验支持了Rayos的全部安全性。 总的来说，这2项临床试验未在速释强的松的原有安全性问题之外新发现其他问题。与使用Rayos有关的最常见不良反应包括液体潴留、高血糖症、高血压、行为异常及情绪改变、食欲增加以及体重增加。 美国首次批准：[1955] 适应症及用法 RAYOS是一种类固醇药膏， 作为抗炎剂或免疫抑制剂某些过敏，皮肤病，胃肠道，血液，眼科，神经系统，肾脏，呼吸，风湿病，具体传染病或条件和器官移植。 治疗某些内分泌条件。 为姑息治疗某些肿瘤的条件。 【用法用量】根据疾病的严重程度和病人的反应个体化给药。给药时间应采取考虑到缓释的药代动力学和所治疗的疾病或病症： 给予初始剂量：RAYOS 5毫克，每天一次。患者当前立即释放泼尼松，泼尼松龙，或甲泼尼龙应该切换到RAYOS的基于相对效力的等效剂量。 维持剂量：使用最低剂量，将保持足够的临床反应。 中止：如果停止长期或高剂量治疗，逐步撤出。 RAYOS应采取每日食物。 应整颗吞服，不易破碎RAYOS，分割，或咀嚼。 剂型和优势 缓释片剂：1毫克，2毫克，5毫克强的松 禁忌 已知的过敏的强的松或任何辅料的配方 警告和注意事项 下丘脑 - 垂体 - 肾上腺（HPA）轴的抑制，皮质醇增多症，和高血糖：监测患者的这些条件与长期使用。圆锥剂量长期使用后逐步撤出。 感染易感性增加新的感染和急性发作的风险增加，传播，或重新激活的隐性感染者。感染症状和体征可能被掩盖。 血压升高，盐和水的潴留，低钾血症：监测血压和钠，钾血清。 在某些胃肠道疾病的患者的胃肠道穿孔的风险增加。体征和症状可能被掩盖。 行为与情绪障碍：可能包括，兴奋，失眠，情绪不稳，性格改变，严重的抑郁症，精神病。现有的条件可能会加重。 骨质密度减少：显示器在长期接受糖皮质激素治疗的患者的骨质密度。 眼效果：包括白内障，感染，青光眼。监测眼压，如果糖皮质激素治疗持续6周以上。 居住或减毒活疫苗：不要给予患者接受免疫抑制剂剂量的皮质类固醇。 对经济增长和发展的负面影响监控儿科患者长期皮质类固醇激素治疗。 在怀孕期间胎儿的伤害可以发生在第一孕期使用。爱普瑞斯女性的潜在危害胎儿。 不良反应 皮质类固醇常见的不良反应包括液体潴留，糖耐量的改变，血压升高，行为和情绪的变化，食欲增加，体重增加。 报告疑似不良反应，请联系我们Horizo​​n制药美国公司在1-866-479-6742或FDA在1-800-FDA-1088或www.fda.gov / medwatch。 药物相互作用 抗凝血剂：抗凝血作用增强或减弱。 降糖药：可能会增加血液中的葡萄糖浓度。降糖药的剂量调整可能是必需的。 CYP 3A4诱导剂和抑制剂：五月，分别增加或减少通关，需要调整剂量的皮质类固醇。 环孢素：活动的增加，环孢素和皮质类固醇同时给药时。抽搐，已报告有同时使用。 非甾体抗炎药，包括阿司匹林和水杨酸的胃肠道副作用的风险增加。 处方更新日期：08/2012 Horizon Pharma announced that the FDA has approved Rayos (prednisone) delayed-release tablets for the treatment of rheumatoid arthritis (RA), polymyalgia rheumatica (PMR), psoriatic arthritis (PsA), ankylosing spondylitis (AS), asthma and chronic obstructive pulmonary disease (COPD). The FDA approval was supported by data bridging the pharmacokinetics of Rayos to immediate-release prednisone and data from the Circadian Administration of Prednisone in RA (CAPRA-1 and 2) trials.  The CAPRA-2 trial demonstrated that people with moderate to severe RA treated with Rayos experienced a statistically significant improvement in ACR20 response criteria compared to placebo.  The CAPRA-1 trial supported the overall safety of Rayos. Rayos is a proprietary formulation of the glucocorticoid prednisone, available in 1mg, 2mg, and 5mg strengths. What is prednisone? Prednisone is in a class of drugs called corticosteroids. Prednisone prevents the release of substances in the body that cause inflammation. Prednisone is used to treat many different conditions such as allergic disorders, skin conditions, ulcerative colitis, arthritis, lupus, psoriasis, or breathing disorders. Prednisone may also be used for purposes not listed in this medication guide. Important information about prednisone You should not use this medication if you are allergic to prednisone, or if you have a fungal infection anywhere in your body. Before taking prednisone, tell your doctor about all of your medical conditions, and about all other medicines you are using. There are many other diseases that can be affected by steroid use, and many other medicines that can interact with steroids. Your dosage needs may change if you have any unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you during treatment. Prednisone can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had. Tell your doctor about any illness or infection you have had within the past several weeks. Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using a steroid. Do not receive a "live" vaccine while using prednisone. The vaccine may not work as well during this time, and may not fully protect you from disease. Wear a medical alert tag or carry an ID card stating that you take prednisone. Any medical care provider who treats you should know that you are using prednisone. Before taking prednisone You should not use this medication if you are allergic to prednisone, or if you have a fungal infection anywhere in your body. Prednisone can weaken your immune system, making it easier for you to get an infection. Steroids can also worsen an infection you already have, or reactivate an infection you recently had. Before taking prednisone, tell your doctor about any illness or infection you have had within the past several weeks. To make sure you can safely take prednisone, tell your doctor if you have any of these other conditions: •liver disease (such as cirrhosis); •kidney disease; •a thyroid disorder; •diabetes; •a history of malaria; •tuberculosis; •osteoporosis; •a muscle disorder such as myasthenia gravis; •glaucoma or cataracts; •herpes infection of the eyes; •stomach ulcers, ulcerative colitis, or diverticulitis; •depression or mental illness; •congestive heart failure; or •high blood pressure FDA pregnancy category C. It is not known whether prednisone will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Prednisone can pass into breast milk but this is not expected to harm a nursing baby however, do not use prednisone without telling your doctor if you are breast-feeding a baby. See also: Prednisone pregnancy and breastfeeding warnings (in more detail) Prednisone can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication. 如何供应/贮存和装卸 RAYOS缓释片（1毫克强的松）呈淡黄白色，圆形，的无裂痕片压花与“NP”，另一面，并提供： NDC号码大小 75987-020-01瓶，30粒 75987-020-02瓶100片 RAYOS缓释片（2毫克强的松）是黄白色，圆形，一侧与“NP”的的无裂痕片压花，并提供： NDC号码大小 75987-021-01瓶，30粒 75987-021-02瓶100片 RAYOS缓释片（5毫克强的松）是浅黄色，圆形，无裂痕片“NP”，另一面浮雕，并作为： NDC号码大小 75987-022-01瓶，30粒 75987-022-02瓶100片 储存在25°C（77°F）;游览获准于15-30°C（59-86°F）。 [见USP控制室温]。