PATANASE 药理分类: 活性成分(补): 药理作用: 临床试验: 法律分类: 成人: 儿童: 警告/注意事项: 互动(补): 不良反应(补): 如何提供: FDA批准PATANASE®鼻喷雾剂用于治疗鼻变态反应症 Alcon公司副总裁兼全球市场和首席营销官Kevin Buehler说,我们期待着医生提供PATANASE®鼻喷雾剂给变态反应患者,迅速缓解患者症状。我们很高兴我们的药物能进入鼻腔市场,同时我们也很有信心把这个新药发展下去以确保我们在局部领域的专营权。 医疗研究中心的医学博士Eli Meltzer说,患有季节性变应反应的患者在患病期间使得他们的生活极其不幸,而PATANASE®是既能快速缓解其变态反应症状,又容易携带的非甾体鼻腔喷雾剂。它起效较快,非常适合我们快节奏社会患者较迅速地改善和缓解他们的变态反应症状。 PATANASE®用于只用于鼻腔给药治疗12岁以上以及老年人的季节性过敏性鼻炎。最常见的不良反应主要有苦涩、头痛、鼻出血、咽喉疼痛、后鼻滴涕、咳嗽和尿路感染。 季节性变应性鼻炎也称为“花粉热”,是由于机体对致敏花粉过敏而引起的一系列变态反应症状,包括眼结膜充血、打喷嚏、鼻子发痒、鼻漏、流泪和眼痒。根据the American College of Allergy, Asthma & Immunology (ACAAI)统计,美国大约有4000万~5000万的人遭受着变态反应疾病,变态反应疾病不仅麻烦,而且已经关联到各种常见的严重的慢性呼吸系统疾病,如鼻窦炎和哮喘。此外,还可能会干扰人们的日常活动或降低人们的生活质量。 PATANASE Manufacturer:Alcon Laboratories, Inc. Pharmacological Class:Antihistamine (H1-blocker) Active Ingredient(s):Olopatadine (as HCl) 0.6% (665mcg/spray); aqueous nasal spray; contains benzalkonium chloride. Indication(s):Seasonal allergic rhinitis. Pharmacology:Seasonal allergic rhinitis describes an array of symptoms such as congestion, sneezing, itchy nose, and rhinorrhea caused by a sensitivity to seasonal pollens.Olopatadine is an antihistamine that relieves these symptoms by interfering with the inflammatory response to the allergens.This nasal spray formulation of the drug enables the patient to directly target the area of the inflammatory symptoms. Clinical Trials:Three randomized, double-blind, placebo-controlled, parallel-group, multicenter, 2-week studies were conducted to establish the safety and efficacy of olopatadine nasal spray in the treatment of seasonal allergic rhinitis. In these studies, 1,598 adult and adolescent patients were treated with either olopatadine 0.4%, olopatadine 0.6%, or placebo (vehicle nasal spray). Efficacy was assessed by patient recordings of four separate nasal symptom scores (nasal congestion, rhinorrhea, itchy nose, and sneezing). Symptoms were recorded as reflective (symptom severity over the past 12 hours) or instantaneous (symptom severity at the time of recording) on a scale of 0 to 3 (absent, mild, moderate, or severe). The primary efficacy endpoint was the difference from placebo in the percentage change from baseline in the sum of AM and PM reflective total nasal symptoms scores, averaged over the 2-week period. In each trial, patients treated with the study drug (two sprays in each nostril twice daily) had statistically significantly greater decreases in the reflective total nasal symptom score, compared to vehicle. For olopatadine 0.6%, the changes from baseline in the two studies were –3.63 and –2.90, respectively, compared to –2.67 and –1.92 for placebo. Legal Classification:Rx Adults:2 sprays in each nostril twice daily. Children:Not recommended. Warnings/Precautions:Other nasal diseases: not recommended. Avoid eyes. Monitor for nasal mucosal changes. Pregnancy (Cat.C). Nursing mothers. Interaction(s):Potentiates CNS depression with alcohol, other CNS depressants. Adverse Reaction(s):Bitter taste, headache, epistaxis, throat pain, post-nasal drip, cough, nasal ulceration, somnolence. How Supplied:Nasal spray pump—30.5g (240 sprays) Additional Patient Information:Prime pump before first use (5 sprays) and if not used for 7 days (2 sprays). Discard after 240 sprays have been dispensed. Last Updated:1/14/2009 |
PATANASE(盐酸奥罗他定鼻喷雾剂)简介:
PATANASE 制造商: 爱尔康实验室公司
药理分类: 抗组胺(H1的-阻断剂)
活性成分(补): 奥洛他定(如盐酸)0.6%(665mcg/spray);水喷鼻剂;含有苯扎氯。 指示(补): 季节性过敏性鼻炎。
药 ... 关键字:PATANASE
盐酸奥罗他定鼻喷雾剂
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