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格隆溴铵口服液|Cuvposa(glycopyrrolate)

2011-04-25 09:43:12  作者:新特药房  来源:中国新特药网天津分站  浏览次数:397  文字大小:【】【】【
简介:制造商: 盐野义制药公司 药理分类: 抗胆碱。 活性成分(补): 长宁1mg/5mL;溶液;樱桃味的。 指示(补): 为了减少慢性重症患者流口水3中,与有问题的流口水(例如,脑性麻痹)相关的神经功能状况的年龄 ...

制造商:
盐野义制药公司

药理分类:
抗胆碱。

活性成分(补):
长宁1mg/5mL;溶液;樱桃味的。
指示(补):
为了减少慢性重症患者流口水3中,与有问题的流口水(例如,脑性麻痹)相关的神经功能状况的年龄16yrs。

药理作用:
长宁乙酰胆碱受体是一种竞争性抑制剂,是对某些周边组织,包括唾液腺位置。长宁行为间接地减少防止这些受体刺激的唾液分泌率。

临床试验:
在一个多中心,随机,双盲,安慰剂对照,八周的研究,Cuvposa进行了评价的病理3岁至23岁儿童流口水的控制。这项研究涉及38个科目谁了脑瘫,精神发育迟缓或其他神经系统状况,流口水的问题,在治疗流口水的情况下,使服装变得潮湿的大部分时间定义有关。受试者被随机分派接受Cuvposa(超过4周期间的最佳响应滴定)或安慰剂。

受试者评估在9修饰教师的流口水量表(mTDS)为1 =干定义的点:永远不要流口水,2 =轻度:只有嘴唇是湿的,有时3 =轻度:只有嘴唇是湿的,经常4 =中度:上嘴唇和下巴,偶尔湿; 5 =中度:上嘴唇和下巴,经常湿; 6 =严重:流口水的程度变得潮湿的衣服,偶尔,7 =严重:流口水的范围内,成为服装潮湿,经常; 8 =丰富:服装,手,托盘和对象变得湿润,偶尔; 9 =丰富:服装,手,托盘和对象变得湿润,频繁。录得的mTDS评价由家长/照顾者,每日3次约两个小时后在治疗前基线和周2,4,第6和第8治疗剂量。者定义为研究对象,至少有一个从基线平均每天mTDS分数来第8周3点减少。有反应的比例为8周时显着的Cuvposa组(75%)相比,安慰剂组(11%)为高。

法律分类:
接收

成人:
不适用。

儿童:
<3岁:不推荐。使用精确的测量装置。空腹服用。 3 - 16yrs:最初0.02mg/kg,每日3次,可滴定在0.02mg/kg每5-7反应和不良反应的天递增。最大0.1mg/kg,每日3次,以不超过1.5根据重量计算,每剂量3毫克。见文献。

禁忌(补):
抗胆碱治疗条件,排除(例如,青光眼,麻痹性肠梗阻,不稳定的心血管状态的急性出血,严重的溃疡性结肠炎,中毒性巨结肠症,重症肌无力)。伴随氯化钾固体口服制剂(地通过胃肠道可被逮捕或延迟)。

警告/注意事项:
尤监控便秘。在最初的4-5天或后服用剂量的增加。如果不完全停止机械性肠梗阻发展(腹泻可能是早期症状)。自主神经病变。肾功能损害。溃疡性结肠炎(尤其是大剂量)。甲状腺功能亢进症。心血管疾病。瑞士法郎。心律失常。心动过速。高血压。裂孔疝与返流性食管炎。避免高温环境。妊娠(Cat.C)。哺乳的母亲。

互动(补):
见禁忌。缓慢溶解,会增强地高辛口服标签,监测,并考虑使用其他形式(如灵丹妙药,帽)。添加剂antichlolinergic与金刚烷胺影响;考虑减少长宁剂量。会增强阿替洛尔,二甲双胍,考虑减少剂量。可拮抗氟哌啶醇(密切监察或避免),左旋多巴(考虑增加剂量)。

不良反应(补):
口干,呕吐,便秘,潮红,鼻塞,嗜睡,视力模糊,假性肠梗阻,机械性肠梗阻。

如何提供:
溶液- 16盎司

最后更新:
2011年4月21日

CUVPOSA

Manufacturer:

Shionogi Pharma Inc.

Pharmacological Class:

Anticholinergic.

Active Ingredient(s):

Glycopyrrolate 1mg/5mL; soln; cherry-flavored.

Indication(s):

To reduce chronic severe drooling in patients 3–16yrs of age with neurologic conditions associated with problem drooling (eg, cerebral palsy).

Pharmacology:

Glycopyrrolate is a competitive inhibitor of acetycholine receptors that are located on certain peripheral tissues, including salivary glands. Glycopyrrolate acts indirectly to reduce the rate of salivation by preventing the stimulation of these receptors.

Clinical Trials:

In a multicenter, randomized, double-blind, placebo-controlled, eight-week study, Cuvposa was evaluated for the control of pathologic drooling in children aged 3 to 23 years of age. The study involved 38 subjects who had cerebral palsy, mental retardation, or another neurologic condition associated with problem drooling defined as drooling in the absence of treatment so that clothing became damp on most days. Subjects were randomized to receive Cuvposa (titrated over a 4-week period to optimal response) or placebo.

Subjects were evaluated on the 9-point modified Teacher’s Drooling Scale (mTDS) defined as 1 = dry: never drools; 2 = mild: only the lips are wet, occasionally; 3 = mild: only the lips are wet, frequently; 4 = moderate: wet on the lips and chin, occasionally; 5 = moderate: wet on the lips and chin, frequently; 6 = severe: drools to the extent that clothing becomes damp, occasionally; 7 = severe: drools to the extent that clothing becomes damp, frequently; 8 = profuse: clothing, hands, tray and objects become wet, occasionally; 9 = profuse: clothing, hands, tray and objects become wet, frequently. The mTDS evaluations were recorded by parents/caregivers 3 times daily approximately two hours post-dose during pre-treatment baseline and at Weeks 2, 4, 6 and 8 of therapy. Responders were defined as subjects with at least a 3-point reduction in mean daily mTDS scores from baseline to Week 8. The percentage of responders at Week 8 was significantly higher for the Cuvposa group (75%) as compared with the placebo group (11%).

Legal Classification:

Rx

Adults:

Not applicable.

Children:

<3yrs: not recommended. Use accurate measuring device. Take on empty stomach. 3–16yrs: initially 0.02mg/kg 3 times daily; may titrate in increments of 0.02mg/kg every 5–7 days based on response and adverse reactions. Max 0.1mg/kg 3 times daily, not to exceed 1.5–3mg per dose based upon weight. See literature.

Contraindication(s):

Conditions that preclude anticholinergic therapy (eg, glaucoma, paralytic ileus, unstable cardiovascular status in acute hemorrhage, severe ulcerative colitis, toxic megacolon, myasthenia gravis). Concomitant potassium chloride solid oral dosage forms (passage through GI may be arrested or delayed).

Warnings/Precautions:

Monitor for constipation esp. within 4–5 days of initial dosing or after dose increase. Discontinue if incomplete mechanical intestinal obstruction develops (diarrhea may be early symptom). Autonomic neuropathy. Renal impairment. Ulcerative colitis (esp. large doses). Hyperthyroidism. Cardiovascular disease. CHF. Arrhythmias. Tachycardia. Hypertension. Hiatal hernia associated with reflux esophagitis. Avoid high environmental temperature. Pregnancy (Cat.C). Nursing mothers.

Interaction(s):

See Contraindications. May potentiate digoxin slow dissolution oral tabs; monitor and consider using other forms (eg, elixir, caps). Additive antichlolinergic effects with amantadine; consider reducing glycopyrrolate dose. May potentiate atenolol, metformin; consider dose reduction. May antagonize haloperidol (closely monitor or avoid), levodopa (consider increasing dose).

Adverse Reaction(s):

Dry mouth, vomiting, constipation, flushing, nasal congestion; drowsiness, blurred vision, intestinal pseudo-obstruction, mechanical intestinal obstruction.

How Supplied:

Soln—16oz

责任编辑:admin


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