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  药店国别: 美国药房
产地国家: 美国
所属类别: 神经系统药物->神经肌肉功能障碍
处方药:处方药
包装规格: 1毫克/5毫升 473毫升/瓶
计价单位:
  点击放大  
生产厂家中文参考译名:
麦氏
生产厂家英文名:
MERZ PHARMS
该药品相关信息网址1:
http://www.cuvposa.com/
该药品相关信息网址2:
www.drugs.com/cuvposa.html
该药品相关信息网址3:
www.rxlist.com/cuvposa-drug.htm
原产地英文商品名:
CUVPOSA SOLUTION 1MG/5ML 473ML/BOTTLE
原产地英文药品名:
GLYCOPYRROLATE
中文参考商品译名:
CUVPOSA溶液剂 1毫克/5毫升 473毫升/瓶
中文参考药品译名:
格隆溴铵
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Salivation
英文适应病症2:
Neuromuscular dysfunction caused by salivation
临床试验期:
完成
中文适应病症参考翻译1:
流涎
中文适应病症参考翻译2:
因神经肌肉功能障碍而引起的流涎
药品信息:

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 详细处方信息以本药内容附件PDF文件(201933113371332.pdf)的“原文Priscribing Information”为准
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 部分中文Cuvposa处方资料(仅供参考)

FDA批准Cuvposa用于儿童因神经疾病引起的过度流涎
    流涎在婴儿中是一种常见现象。但有很多正处于发育阶段的残疾儿童会发生主要因神经肌肉功能障碍而引起的流涎,这种疾病会使患者无法吞咽。美FDA批准Cuvposa(通用名glycopyrrolate,甘罗溴铵)口服液用于治疗3~16岁儿童因神经疾病而引起的长期过度流涎。临床研究证实Cuvposa可通过降低唾液的分泌量来减少流涎。
    Cuvposa为伴有神经疾病的患者提供了一种有效地用于控制唾液分泌的治疗方案。Cuvposa是一种有味道的口服液。FDA的这次批准,不仅保证了该药在安全性、有效性、质量和标签方面是符合最新标准的,更重要的是,此次批准的剂型为Cuvposa的口服液,更适合于患者的使用。

Cuvposa甘罗溴铵口服液的临床试验
    78%服用该药的儿童在治疗流涎方面达到了临床改善的结果,而在被给予非活性物质(安慰剂)的儿童中则仅有19%达到类似结果。

Cuvposa 甘罗溴铵相关的常见不良反应
    口干、便秘、潮红和尿潴留。

Cuvposa治疗儿童流涎
    在此次批准之前,根据一种说明书以外的适应症原则,甘罗溴铵已被用于治疗处于发育阶段的残疾儿童的流涎现象,但之前所用的剂型与这次批准的并不相同。当医生开具某药的用途在FDA已批准的该药说明书中未提及时,则该药就被认为用于说明书以外的适应症。在之前被作为说明书以外的适应症用药时,甘罗溴铵口服片剂必须被碾碎后才能用于治疗患有神经疾病的儿童的流涎症状。

*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%).

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 详细处方信息以本药内容附件PDF文件(201933113371332.pdf)的“原文Priscribing Information”为准
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更新日期: 2019-03-31
附件:
201933113371332.pdf    

 
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