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Intuniv ER Tablets 1mg(guanfacine 盐酸胍法辛24小时缓释片)
药店国别  
产地国家 美国 
处 方 药: 是 
所属类别 1毫克/片 100片/瓶 
包装规格 1毫克/片 100片/瓶 
计价单位: 瓶 
生产厂家中文参考译名:
SHIRE US INC
生产厂家英文名:
SHIRE US INC
该药品相关信息网址1:
http://www.intuniv.com/
该药品相关信息网址2:
http://www.drugs.com/intuniv.html
该药品相关信息网址3:
原产地英文商品名:
Intuniv ER 1mg/Tablets 100Tablets/bottle
原产地英文药品名:
guanfacine Extended-Release
中文参考商品译名:
Intuniv缓释片 1毫克/片 100片/瓶
中文参考药品译名:
盐酸胍法辛
曾用名:
简介:

 

日前,美国FDA批准了Shire公司开发的盐酸胍法辛(guanfacine hydrochloride)缓释片Intuniv,用于治疗6-17岁儿童和青少年注意力缺乏和多动症。Intuniv是迄今在全球范围内获准治疗这一适应证的第一个选择性α2a-肾上腺能受体激动剂。Intuniv为一日1次口服制剂。
修改批准日本:2016年7月13日  公司:Shire US Inc
INTANIV(胍法辛guanfacine)延缓释放片剂,用于口服使用
美国初始批准:
®最近的主要变化
剂量和给药,剂量选择,02/2013
作用机制
胍法辛是中枢性α-肾上腺素能受体激动剂。 胍法康不是中枢神经系统(CNS)兴奋剂。 胍法辛在ADHD中的作用机制尚不清楚。
适用范围及用途
INTUNIV是一种中枢性α肾上腺素能受体激动剂,用于治疗注意力缺陷多动障碍(ADHD)作为单一疗法和作为兴奋剂药物的辅助治疗。
剂量和管理
推荐剂量:每天早上或晚上1至4毫克。
以1mg的剂量每天开始,并以不超过1mg/周的增量进行调整。
吞食前不要粉碎,咀嚼或断裂片剂。
不要用高脂肪的饭食,因为暴露增加。
由于不同的药物动力学特征,不能以毫克/毫克mg替代立即释放的胍法西泮片剂。
如果切换立即释放胍苯酰,请停止治疗,并按照IntunIV进行滴定。
考虑以mg/kg为单位的剂量。从0.05-0.08mg/kg的剂量开始观察到的改善,每天一次。每天一次可达0.12mg/kg的剂量可能会提供额外的好处。
停药时,每3-7天减量不超过1mg。
剂量形式和强度
缓释片:1mg,2mg,3mg和4mg
禁忌症
对INTUNIV,其非活性成分或含有胍法辛的其他产品超敏反应的历史。
警告和注意事项
低血压,心动过缓和晕厥:在患有低血压,心动过缓,心脏阻塞或晕厥(例如服用抗高血压药物的患者)的患者中谨慎使用INTUNIV。在治疗开始之前测量心率和血压,剂量增加后,并在治疗时定期测量。建议患者避免脱水或过热。
镇静和嗜睡:通常与INTUNIV发生。考虑与CNS抑制药物相加的镇静作用的潜力。警告患者不要操作重型设备或驾驶,直到知道他们如何回应INTUNIV。
不良反应
单药治疗试验中最常见的不良反应(≥5%和至少两次安慰剂率):嗜睡,疲劳,恶心,嗜睡和低血压。辅助性试验中最常见的不良反应(≥5%和至少两次安慰剂率):嗜睡,疲劳,失眠,眩晕和腹痛。
药物相互作用
强的CYP3A4抑制剂(例如酮康唑):共同给药增加胍法西林的暴露。胍法辛剂量应限制在不超过2毫克/天。停用CYP3A4抑制剂时,根据患者耐受性,胍法卡因剂量应加倍。最大剂量不应超过4毫克/天(和)。
强的CYP3A4诱导剂(如利福平):共同给药降低胍法西林的暴露。胍法辛剂量可以滴定至8毫克/天。当停用CYP3A4诱导剂时,基于患者耐受性,胍法康剂量应在1-2周内减少一半。最大剂量不应超过4毫克/天(和)。
在特定人口中使用
肝或肾损伤:肝功能或肾功能障碍临床显着的患者可能需要减少剂量。
包装规格/存储和处理
NDC:64725-0515-1在30 TABLET的CONTAINER,扩展版
完整说明书附件:
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=B972AF81-3A37-40BE-9FE1-3DDF59852528
Intuniv(guanfacine extended-release)
General Information
Intuniv is a once-daily, extended-release formulation of guanfacine hydrochloride in a tablet formulation. Guanfacine is a selective alpha2A-adrenergic receptor agonist. Guanfacine is not a central nervous system (CNS) stimulant. The mechanism of action of guanfacine in ADHD is not known.
Intuniv is specifically indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents ages 6 to 17 years.
Intuniv is supplied as an extended release tablet designed for oral administration. The recommended initial dose is a single tablet once daily. If switching from immediate-release guanfacine, discontinue that treatment, and titrate with Intuniv according to the following recommended schedule: Begin at a dose of 1 mg/day, and adjust in increments of no more than 1 mg/week. Maintain the dose within the range of 1-4 mg once daily, depending on clinical response and tolerability.
Maintenance Treatment The effectiveness of Intuniv for longer-term use (more than 9 weeks) has not been systematically eva luated in controlled trials.
Discontinuation The Intuniv dose should generally be tapered in decrements of no more than 1 mg every 3 to 7 days.
Clinical Results
FDA Approval
The FDA approval of Intuniv for ADHD in children and adolescents was based on two placebo controlled clinical trials.
Study One was an 8-week, double-blind, placebo controlled, parallel-group, fixed dose design in 345 children and adolescents ages 6-17. The subjects received 2 mg, 3 mg and 4 mg of Intuniv dosed once daily. Study Two was a 9-week, double-blind, placebo-controlled, parallel-group, fixed-dose design in 324 children and adolescents ages 6-17. The subjects received 1 mg, 2 mg, 3 mg and 4 mg of Intuniv dosed once daily. The lowest dose of 1 mg used in Study 2 was assigned only to patients less than 50 kg (110 lbs).
In both studies, the primary outcome was the change from baseline to endpoint in mean ADHD-RS scores. The mean reductions in ADHD-RS scores at endpoint were statistically significantly greater for all doses of Intuniv compared to placebo in both studies. Dose-responsive efficacy was evident, particularly when data were examined on a weight adjusted (mg/kg) basis. When eva luated over the dose range of 0.01-0.17 mg/kg/day, clinically relevant improvements were observed beginning at doses in the range 0.05-0.08 mg/kg/day. Analyses of the primary outcome did not suggest any differential responsiveness on the basis of gender. Analyses by age subgroup revealed a statistically significant treatment effect only in the 6-12 age subgroup. Due to the relatively small proportion of adolescent patients (ages 13-17) enrolled into these studies (approximately 25%), these data may not be sufficient to demonstrate efficacy in the adolescent subgroup.
Side Effects
Adverse events associated with the use of Intuniv may include, but are not limited to, the following:
somnolence
sedation
abdominal pain
dizziness
hypotension/decreased blood pressure
dry mouth
constipation
Mechanism of Action
Intuniv is a once-daily, extended-release formulation of guanfacine hydrochloride in a tablet formulation. Guanfacine is a selective alpha2A-adrenergic receptor agonist. Guanfacine is not a central nervous system (CNS) stimulant. The mechanism of action of guanfacine in ADHD is not known. 
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附件:
201232918250427.PDF   
201232918250030.pdf  

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