英文药名：SEEBRI NEOHALER(glycopyrrolate inhalation powder) 中文药名：格隆溴铵（胶囊）粉吸入剂 生产厂家：诺华公司 药品介绍 美国食品药品管理局批准了15.6微克的Seebri™ Neohaler®（格隆溴铵）吸入粉雾剂——这是Utibron Neohaler的成分之一——将其用于相同慢阻肺适应症的单方疗法。 Seebri Neohaler，此前名为NVA237，是一种每天使用两次的长效毒蕈碱拮抗剂（LAMA），用于对慢性阻塞性肺病（COPD）——包括慢性支气管炎和/或肺气肿——患者气道阻塞的长期维持治疗。 批准日期：2016年5月  公司：诺华公司 SEEBRI NEOHALER（格隆溴铵 glycopyrrolate）粉吸入剂，口服使用吸入 美国初始批准：1961 作用机理 格隆溴铵是一种长效毒蕈碱性拮抗剂哪一个通常被称为抗胆碱能药。它有毒蕈碱受体M1至M5亚型相似的亲和力。在气道，格隆表现出通过M3受体抑制的平滑肌，导致支气管扩张药理作用。对立的竞争性和可逆性结果表明随着人类和动物来源受体和离体器官的准备工作。在体外临床前以及在体内研究，预防甲胆碱诱导的支气管收缩的是剂量依赖性的效果，历时超过24小时。这些发现的临床意义是未知的。以下格隆吸入支气管扩张主要是位点特异性的效果。 适应症和用法 SEEBRI Neohaler的适应症为长期抗胆碱能，维持治疗慢性阻塞性肺疾病（COPD）气流阻塞. 用法用量 对于口腔吸入只。不要吞咽胶囊SEEBRI。仅使用SEEBRI胶囊的Neohaler设备。 维持治疗慢性阻塞性肺病的：一个胶囊SEEBRI（15.6微克）每日两次的粉末内容物的吸入 剂型和规格 粉吸入剂：SEEBRI 15.6微克胶囊含有格隆溴铵粉吸入剂用于与Neohaler设备使用 禁忌症 已知的过敏史者格隆或任何​​成分。 警告和注意事项 不要发起急性恶化的慢性阻塞性肺病或治疗急性症状。 如果矛盾性支气管痉挛时，Neohaler立即停止SEEBRI并制定替代疗法。 窄角型青光眼的恶化可能会出现。在与窄角型青光眼患者慎用和指导患者向医生咨询，如果症状立即发生。 尿潴留的恶化可能会出现。在患者前列腺增生或膀胱颈梗阻谨慎使用，并指导患者咨询医生，如果症状立即发生。 不良反应 最常见的不良反应（发生率比安慰剂大于或等于2％和更高）是上呼吸道感染和鼻咽炎。 药物相互作用 抗胆碱能药物：可加性相互作用有了同时使用抗胆碱能药物。避免SEEBRI Neohaler的管理与其他抗胆碱含的药物。 特殊人群中使用 使用严重肾功能不全患者，如果大于风险的治疗的潜在益处应予以考虑。 包装规格/储存与处理 如何附送 SEEBRI Neohaler包含SEEBRI（格隆（15.6微克）粉吸入剂）装在铝泡罩卡透明橙色胶囊，一是Neohaler设备，以及FDA批准的患者标签。 单位剂量（泡罩包装），60盒（10卡每6橙色透明吸塑胶囊）NDC0078-0662-19 该Neohaler装置由一个白色保护帽和口罩，胶囊室和2个橙色的按键底座插槽。 储存和处理 贮存于干燥的地方在77°F（25°C）;允许59°F至86°F（15°C至30°C）游览[见USP控制室温。 SEEBRI™ NEOHALER®(glycopyrrolate) inhalation powder About Seebri®/NVA237 Once-daily Seebri® (NVA237) (glycopyrronium bromide; Seebri® Breezhaler® (EU), Seebri® Inhalation Capsules 50mcg (Japan)) is an inhaled long-acting muscarinic antagonist (LAMA) that has already been approved in the EU and Japan as a maintenance bronchodilator treatment for COPD. In the US, NVA237 was approved in October 2015 as a twice daily inhaled monotherapy for the long-term maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema under the brand name Seebri™ Neohaler® (glycopyrrolate 15.6 mcg). SEEBRI NEOHALER Rx Pharmacological Class: Long-acting anticholinergic. Active Ingredient(s): Glycopyrrolate 15.6mcg; per capsule; dry powder for oral inhalation for use with Neohaler device; contains lactose. Company Novartis Pharmaceuticals Corp Indication(s): Long-term maintenance treatment of airflow obstruction due to chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Pharmacology: Glycopyrrolate is a long-acting muscarinic antagonist (anticholinergic) with similar affinity to muscarinic receptor subtypes M1-M5. In the airways, glycopyrrolate exhibits pharmacological effects through inhibition of M3 receptor at the smooth muscle leading to bronchodilation. Following inhalation of glycopyrrolate, the bronchodilation is predominantly a site-specific effect. Clinical Trials: The safety and efficacy of Seebri Neohaler were evaluated in two dose-ranging trials, four 12-week efficacy and safety trials, and a 52-week long-term safety trial. The dose-ranging trial was a 28-day, randomized, double-blind, placebo-controlled, 2-period, crossover study that supported the dose selection of glycopyrrolate in chronic obstructive pulmonary disease (COPD). Seven doses of glycopyrrolate (15.6mcg, 31.2mcg, 62.4mcg, 124.8mcg once-daily and 15.6mcg, 31.2mcg, 62.4mcg twice-daily) were evaluated compared to placebo in 388 subjects with COPD. The differences in trough FEV1 from baseline after 28 days for ­glycopyrrolate 15.6mcg, 31.2mcg, 62.4mcg, 124.8mcg once-daily and 15.6mcg, 31.2mcg, 62.4mcg twice-daily vs. placebo were 0.083L (95% CI: 0.030, 0.136), 0.098L (0.048, 0.148), 0.090L (0.038, 0.142), 0.176L (0.132, 0.220), 0.139L (0.089, 0.189), 0.167L (0.115, 0.219), and 0.177L (0.132, 0.222), respectively. These results supported the evaluation of the glycopyrrolate 15.6mcg twice daily dose in the confirmatory COPD trials. The confirmatory trials included two (Trials 1 and 2) similar 12-week, randomized, double-blind, placebo-controlled, parallel-group studies that evaluated glycopyrrolate 15.6mcg twice daily and placebo twice daily in 867 subjects with COPD. The primary endpoint was the change from baseline in FEV1 AUC0–12h after the morning dose at Day 85 compared with placebo. In both trials, Seebri Neohaler demonstrated a larger increase in mean change from baseline in FEV1 AUC0–12h vs. placebo, with a treatment difference of 0.139L (95% CI: 0.095, 0.184) in Trial 1 and 0.123L (95% CI: 0.081, 0.165) in Trial 2. Both trials also showed that patients treated with Seebri Neohaler used less daily rescue albuterol during the trial compared to placebo patients. For more clinical trial data, see full labeling. Legal Classification: Rx Adults: For oral inhalation use only with Neohaler device; do not swallow caps. Administer at the same time of the day (AM + PM). Inhale contents of one capsule (15.6mcg) twice daily. Children: Not established. Warnings/Precautions: Do not initiate in patients during acutely deteriorating or potentially life-threatening COPD episodes. Not for treating acute symptoms. Do not exceed recommended dose. Discontinue immediately and treat if paradoxical bronchospasm or immediate hypersensitivity reactions occur; use alternative therapy. Severe milk protein hypersensitivity. Narrow-angle glaucoma. Urinary retention. Prostatic hyperplasia. Bladder-neck obstruction. Severe renal impairment, including ESRD requiring dialysis. Pregnancy (Category C). Nursing mothers: not recommended. Interaction(s) Additive effects with concomitant other anticholinergic-containing drugs; avoid. Adverse Reaction(s) Upper respiratory tract infection, nasopharyngitis, urinary tract infection, sinusitis, oropharyngeal pain; paradoxical bronchospasm, hypersensitivity reactions. How Supplied: Blister pack—60 (w. one Neohaler device) LAST UPDATED: 3/23/2016 https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8839674f-26d6-4302-9da0-258decfba9aa