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制造商：
Sepracor公司，公司
药理分类：
皮质类固醇
活性成分（补）：
环索奈德50micrograms/spray;水喷鼻剂。
指示（补）：
治疗季节性过敏性鼻炎患者≥6yrs老与常年性过敏性鼻炎患者≥12岁。
药理作用：
Omnaris是一种无酒精，对皮质类固醇，环索奈德，这是作为一个鼻腔喷雾，是香水免费提供了一个低喷雾量管理的低渗悬浮剂。继内鼻的应用，环索奈德是其活性代谢物水解，desciclesonide，在鼻腔黏膜酯酶。
临床试验：
环索奈德的安全性和疗效评价鼻腔喷雾剂在四个随机，双盲，安慰剂控制的过敏性鼻炎的成人和青少年的审判。三项研究，这是持续时间2-6周，包括1524年与季节性或常年性过敏性鼻炎患者12-86岁。与环索奈德200mcg治疗，每日一次导致在统计上显着降低总鼻症状评分比安慰剂治疗（流鼻涕，鼻痒/充血，打喷嚏）。
法律分类：
接收
成人：
每个鼻孔2，每天一次（200mcg/day）喷雾剂。
儿童：
季节性过敏性鼻炎：<6yrs：不建议≥6yrs：2。每日一次，在每个鼻孔（200mcg/day）喷雾剂。
警告/注意事项：
呼吸道tuberculosis.Infections（如单纯疱疹眼）。不愈鼻wounds.If肾上腺抑制存在以下全身性类固醇治疗外用类固醇，可能会加剧更换麻疹或水痘接触到肾上腺insufficiency.If症状，应考虑免疫球蛋白预防therapy.Reevaluate 2周后，如果没有改善（季节性过敏性鼻炎）和5周（常年过敏性鼻炎）。增长为hypercorticism和抑制HPA轴的抑制children.Monitor（如果发生中断逐渐）监测，以及念珠菌感染和视力变化或其它鼻腔黏膜changes.Monitor如果历史青光眼或白内障。避开眼睛。妊娠（Cat.C）。哺乳的母亲。
互动（补）：
可能会增强了酮康唑。
不良反应（补）：
头痛，流鼻血，鼻咽炎，耳部疼痛。
如何提供：
喷鼻剂（泵）-12.5克（120喷）
美国FDA批准过敏症新药-Omnaris(ciclesonide)鼻喷
美国FDA今天宣布批准Omnaris(ciclesonide)鼻喷，这是一种治疗成人和12岁及以上儿童的季节性和长期性过敏性鼻炎的相关症状的新药，这种鼻炎就是通常认为的花粉热。
过敏性鼻炎是医学术语，指鼻子出现红肿、流鼻涕等过敏的主要症状。季节性过敏性鼻炎是最常见的过敏症。大约3500万美国人患该病。该病的典型症状是流鼻涕，不断打喷嚏和发痒，这种发痒不仅影响鼻子，还能影响口腔顶、喉咙以及连接中耳和喉咙后部的耳咽管。
在4项持续时间为2周到1年的随机安慰剂对照临床试验中，对Omnaris鼻喷的安全性和有效性进行了研究。这些研究评估了Omnaris治疗花粉热患者的症状(流鼻涕、鼻子发痒、打喷嚏和鼻子充血)的效果。这些试验的结果显示，接受Omnaris鼻喷治疗的患者与接受安慰剂的患者相比，鼻部症状的减少多8-10%。Omnaris鼻喷和安慰剂之间的区别是显著的。
临床研究最常见的副作用是头痛、流鼻血以及鼻子和喉咙内壁的炎症。
英文药名: Omnaris (Ciclesonide Aerosol)
中文药名: 环索奈德气雾剂
生产企业：德国Altana公司
OManufa
OMNARIScturer:
Sepracor, Inc.
Pharmacological Class:
Corticosteroid
Active Ingredient(s):
Ciclesonide 50micrograms/spray; aqueous nasal spray.
Indication(s):
Treatment of seasonal allergic rhinitis in patients ≥6yrs old and perennial allergic rhinitis in patients ≥12yrs old.
Pharmacology:
Omnaris is an alcohol-free, hypotonic suspension formulation of the corticosteroid, ciclesonide, which is administered as a nasal spray that is scent-free and delivers a low spray volume. Following intra-nasal application, ciclesonide is hydrolyzed to its active metabolite, desciclesonide, by esterases in the nasal mucosa.
Clinical Trials:
The safety and efficacy of ciclesonide nasal spray was evaluated in four randomized, double-blind, placebo-controlled trials in adults and adolescents with allergic rhinitis. Three studies, which were 2–6 weeks in duration, included 1524 patients 12–86 years of age with seasonal or perennial allergic rhinitis. Treatment with ciclesonide 200mcg once daily resulted in statistically significantly greater decreases in total nasal symptom scores (runny nose, nasal itching/congestion, sneezing) than treatment with placebo.
Legal Classification:
Rx
Adults:
2 sprays in each nostril once daily (200mcg/day).
Children:
Seasonal allergic rhinitis: <6yrs: not recommended.≥6yrs:2 sprays in each nostril once daily (200mcg/day).
Warnings/Precautions:
Respiratory tract tuberculosis.Infections (eg, ocular herpes simplex). Unhealed nasal wounds.If adrenal suppression exists following systemic corticosteroid therapy, replacement with topical steroids may exacerbate symptoms of adrenal insufficiency.If exposed to measles or chickenpox, consider immunoglobulin prophylactic therapy.Reevaluate if no improvement after 2 weeks (for seasonal allergic rhinitis) and 5 weeks (for perennial allergic rhinitis).Monitor for growth suppression in children.Monitor for hypercorticism and HPA axis suppression (if occur discontinue gradually), and for candida infection and other nasal mucosal changes.Monitor for vision changes or if history of glaucoma or cataracts. Avoid eyes. Pregnancy (Cat.C). Nursing mothers.
Interaction(s):
May be potentiated by ketoconazole.
Adverse Reaction(s):
Headache, epistaxis, nasopharyngitis, ear pain.
How Supplied:
Nasal spray (pump)—12.5g (120 sprays)
Last Updated:
1/14/2009
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