2010年7月28日罗克维尔，马里兰州报道July 28,—美国食品和药品管理局7月28日批准Cuvposa (吡咯糖[glycopyrrolate])口服溶液治疗年龄3岁至16岁儿童神经疾患引起的慢性严重垂涎。
婴儿中垂涎是正常的。但是有显著比例发育残疾人群经受垂涎其原因主要主要是神经肌肉功能失调使他难以吞咽、Cuvposa通过减低唾液生成的容积而减轻垂涎。
在几十年前批准吡咯糖治疗消化性溃疡和减轻麻醉下患者垂涎。直至今日，吡咯糖曾在说明书外基础上被用于发育残疾人群中的垂涎，但是与批准产品不同剂型。某药说明书外使用是指医生开处方使用是在美国GDA批准药物说明书以外的不同方式。
在2001年，FDA咨询委员会举行了一次会议，讨论如何最好地开发为垂涎新产品，在有神经学疾患儿童中进行伦理和科学上均坚实的临床试验。利用提供的建议，FDA已能面向需求的这个人群。
FDA的药物评价和研究中心新药办公室主任John Jenkins, 医学博士说“Cuvposa为有神经疾患患者中控制唾液分泌提供一种重要的治疗”“FDA 批准不仅保证该产品符合关于安全性、有效性，质量和说明书的现代标准，而且还导致为这个患者群更多适宜剂型”。
FDA药物批准过程提供产品-特异性资料的综述，保证已完成药物产品的安全性和有效性至关重要。例如，申请者必须证实制造过程可以可靠地生产预期同一性、规格、质量和纯度的药物产品‘FDA审评了申请单位的使用说明书确保卫生保健专业人员和患者有需要了解药物产品风险和其安全性和有效使用。
在说明书外使用时，吡咯糖口服片不得不压碎治疗有神经疾患儿童的垂涎。Cuvposa是一种有香味的口服溶液，容易给药和为每位患者提供最佳剂量。
Cuvposa[吡咯糖]口服液临床试验中用药的78%儿童到达临床垂涎改善，与之比较给予无活性物质(安慰剂)儿童为19%。
用吡咯糖报道常见不良反应是口干、便秘、脸红和尿潴留。
Cuvposa (吡咯糖)口服液由日本Shionogi Pharma Inc. of Osaka公司上市。

CUVPOSA（长宁）口服液
美国初始认证：1961年 

 
适应症
CUVPOSA是一种抗胆碱表示要减少老年流口水的问题（例如，脑性麻痹）相关的神经系统慢性重型肝炎患者的条件3-16流口水。 

 
剂量和用法
启动剂量为0.02毫克/公斤，每日三次，并在0.02毫克滴定递增/ kg，每5-7天，根据治疗反应和不良反应。
最大推荐剂量为0.1毫克/公斤，每日三次，每次不超过1.5-3毫克的剂量后，体重。
管理至少一个小时或饭后两小时。 

 
剂型和优势
1毫克/ 5毫升，在16盎司瓶口服液。 

 
禁忌
医疗条件，排除抗胆碱治疗。 
同时使用固体氯化钾口服剂型。 

 
注意事项：
便秘或假性肠梗阻：可以表现为腹胀，疼痛，恶心，呕吐。评估病人便秘，特别是在最初的4-5天或用药剂量增加之后。
不完整的机械性肠梗阻：可能会引起腹泻。如果怀疑是阻塞，停止CUVPOSA和评估。
高环境温度：为了降低中暑的风险，避免高温。 

 
不良反应
最常见的不良反应（发生率≥30％）是口干，呕吐，便秘，法拉盛和鼻塞。 

 
药物相互作用
地高辛片：使用可以增加胃长宁血清地高辛。监测病人的地高辛，并考虑使用其他剂型。
金刚烷胺：对长宁影响可能会随着金刚烷胺伴随管理。同时使用过程中考虑减少对glycoypyrrolate剂量。
阿替洛尔或二甲双胍：长宁可能会增加血清阿替洛尔或二甲双胍。考虑降低剂量使用时，长宁。
氟哌啶醇或左旋多巴：长宁可能减少左旋多巴氟哌啶醇或血清。考虑增加剂量时，长宁使用。 

 
利用在种群
儿童用药：的安全性和有效性长宁尚未确定患者的3岁。
肾损害：使用CUVPOSA与肾功能不全患者慎用。 

 
修订：03/2011

Indication

Cuvposa is indicated to reduce chronic severe drooling in patients aged 3 to 16 years with neurologic conditions associated with problem drooling (e.g. cerebral palsy).

Important Safety Information

• Contraindicated in conditions that preclude anticholinergic therapy (e.g., glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon complicating ulcerative colitis, myasthenia gravis)
  
• Contraindicated in patients taking solid oral dosage forms of potassium chloride. The passage of potassium chloride tablets through the GI tract may be arrested or delayed with coadministration of Cuvposa
  
• Constipation or intestinal pseudo-obstruction: Constipation is a common dose-limiting adverse reaction and may lead to discontinuation of Cuvposa. May present as abdominal distention, pain, nausea, or vomiting. Assess patients for constipation, particularly within 4-5 days of initial dosing or after a dose increase.
  
• Incomplete mechanical intestinal obstruction: Diarrhea may be an early symptom, especially in patients with ileostomy or colostomy. If obstruction is suspected, discontinue Cuvposa.
  
• Avoid high ambient temperatures. Heat prostration (fever and heat stroke due to decreased sweating) can occur with use of anticholinergic drugs such as Cuvposa.
  
• Cuvposa may cause drowsiness or blurred vision, do not engage in age-appropriate activities requiring mental alertness such as operating a motor vehicle or other machinery or performing hazardous work while taking Cuvposa.
  
• Use Cuvposa with caution in patients with conditions that are exacerbated by anticholinergic drug effects including:
• Autonomic neuropathy, renal disease, ulcerative colitis—large doses may suppress intestinal motility to the point of producing a paralytic ileus and for this reason may precipitate or aggravate “toxic megacolon,” a serious complication of the disease; hyperthyroidism, coronary heart disease, congestive heart failure, cardiac tachyarrhythmias, tachycardia, and hypertension; hiatal hernia associated with reflux esophagitis
  
• Glycopyrrolate reduces GI transit time which may result in altered release of certain drugs when formulated in delayed or controlled-release forms. Cuvposa can increase serum levels of atenolol, metformin and digoxin (slow dissolution tablets; consider other dosage forms of digoxin). Dose reductions of atenolol or metformin may be needed.
  
• Cuvposa may decrease serum levels of haloperidol or levodopa. Consider dose increase of levodopa and monitor haloperidol patients for worsening of schizophrenic symptoms and development of tardive dyskinesia
  
• The anticholinergic effects of Cuvposa may be increased with concomitant administration of amantadine; Cuvposa dose reduction should be considered.
  
• Use with caution in patients with renal impairment.
  
• The most common adverse reactions (incidence ≥30%) are dry mouth (40%), vomiting (40%), constipation (35%), flushing (30%), and nasal congestion (30%).

Cuvposa is indicated to reduce chronic severe drooling in patients aged 3 to 16 years with neurologic conditions associated with problem
  drooling (e.g. cerebral palsy)

Cuvposa™ (glycopyrrolate oral solution) has been classified by the FDA as an "Orphan Drug" that was developed to treat a rare condition (chronic severe drooling). Clinical studies of orphan drugs do not typically contain high numbers of study subjects.