制造商：
美国Shire公司
药理分类：
中央α2A受体激动剂
活性成分（补）：
胍法辛（如盐酸）1毫克，2毫克，3毫克，4毫克;分机- REL的标签。
指示（补）：
注意缺陷多动障碍（ADHD）患者年龄6-17岁。
药理作用：
本产品是一种缓释，在选择性α2A-肾上腺素受体激动剂矩阵片剂，胍法辛，这也是在一种治疗（从牙周膜生物制药Tenex）高血压立即释放形式提供。通过刺激α2A-肾上腺素受体，胍法辛减少从大脑血管运动中心同情输出到心脏和血管。其在治疗多动症的作用机理目前尚不清楚。立即释放胍法辛和Intuniv有不同的药代动力学特征。在吸收程度和最大血Intuniv达到较低水平相比，立即释放胍法辛产品的参数。
临床试验：
对疗效进行了研究Intuniv两次审判6-17岁的患者患有ADHD的历史。研究一，涉及345例，是一个为期8周，双盲，安慰剂对照，平行组研究，评估在固定每日一次的剂量2毫克，3毫克，和4mg Intuniv。研究二，与324例9周的审判，是相似，但它包括在一个1毫克剂量以及其他剂量Intuniv。在这两项研究中，患者被随机分配到固定剂量滴定后，患者体重<25公斤被排除在外。多动症的症状和体征进行了评价，每周一次使用ADHD评分标准，四，临床医生管理的评分，其中包括两个过动/冲动，注意力不集中分量。对于这两项研究，主要结果测量的变化，从基线到平均多动症- RS的分数端点。
在终点，在ADHD - RS的分数的平均值均显着减少更大的Intuniv相比，这两项研究安慰剂。剂量反应效果是明显的，尤其是当数据被上一重调整的基础研究。临床改善被认为开始于由每日0.05-0.08mg/kg不等剂量，以每天高达0.12mg/kg剂量看到额外的好处。
法律分类：
接收
成人：
≥十八年：不成立的。
儿童：
燕子与水，牛奶或其他液体的整体。不要给高脂肪食物。 <六年：不推荐。 6十七年：最初每天一次1毫克;由1mg/day滴定在1周的时间间隔;一般最多4毫克，每日一次。在0.05-0.08mg/kg改善见过每天一次的剂量。至0.12mg/kg剂量每日一次可提供额外的好处。定期重新评估。逐步撤出（由1毫克每3-7天）。
禁忌（补）：
伴随使用胍法辛的其他形式。
警告/注意事项：
不要代替其他形式胍法辛一毫克毫克的基础。伴随抗高血压药，低血压，晕厥，心动过缓，心血管疾病等风险。监测心率，血压。脱水。温度升高。肾或肝功能不全。妊娠（Cat.B）。哺乳的母亲。
互动（补）：
可能会增强被CYP3A4 / 5抑制剂（如酮康唑）。可拮抗CYP3A4的诱导剂（如利福平）。会增强丙戊酸。与其他抗高血压药，中枢神经系统抑制剂（如苯，抗精神病药物，巴比妥酸盐）加性效应。
不良反应（补）：
嗜睡，镇静，腹痛，头晕，低血压，口干，便秘，心动过缓。
如何提供：
制表- 100
最后更新：
11/12/2009
Manufacturer:
Shire US, Inc.
Pharmacological Class:
Central α2A-agonist
Active Ingredient(s):
Guanfacine (as HCl) 1mg, 2mg, 3mg, 4mg; ext-rel tabs.
Indication(s):
Attention deficit hyperactivity disorder (ADHD) in patients 6–17 years of age.
Pharmacology:
This product is an extended-release, matrix tablet formulation of the selective α2A-adrenergic receptor agonist, guanfacine, which is also available in an immediate-release form for treating hypertension (Tenex, from PDL Bio-Pharma). By stimulating α2A-adrenergic receptors, guanfacine reduces sympathetic output from the vasomotor centers of the brain to the heart and vasculature. Its mechanism of action in treating ADHD is not known. Immediate-release guanfacine and Intuniv have different pharmacokinetic characteristics. The extent of absorption and the maximum blood levels reached with Intuniv are lower compared to those parameters for immediate-release guanfacine products.
Clinical Trials:
The efficacy of Intuniv was studied in two trials in patients 6–17 years old with ADHD. Study 1, which involved 345 patients, was an 8-week, double-blind, placebo-controlled, parallel-group study that evaluated Intuniv at fixed once-daily doses of 2mg, 3mg, and 4mg. Study 2, a 9-week trial with 324 patients, was similar but it included Intuniv at a dose of 1mg as well the other doses. In both studies, patients were randomized to a fixed dose after titration; patients weighing <25kg were excluded. The signs and symptoms of ADHD were evaluated once weekly using the ADHD Rating Scale-IV, a clinician-administered score that included both hyperactive/impulsive and inattentive subscales. For both studies, the primary outcome measure was the change from baseline to endpoint in mean ADHD-RS scores.
At endpoint, the mean reductions in ADHD-RS scores were significantly greater for Intuniv compared to placebo in both studies. A dose-response efficacy was evident, especially when the data were examined on a weight-adjusted basis. Clinical improvements were seen beginning at doses ranging from 0.05–0.08mg/kg per day, with additional benefit seen at doses up to 0.12mg/kg per day.
Legal Classification:
Rx
Adults:
≥18years: not established.
Children:
Swallow whole with water, milk, or other liquid. Do not give with high-fat meals. <6years: not recommended. 6–17years: Initially 1mg once daily; titrate by 1mg/day at 1-week intervals; usual max 4mg once daily. Improvements seen at doses of 0.05–0.08mg/kg once daily. Doses up to 0.12mg/kg once daily may provide additional benefit. Reevaluate periodically. Withdraw gradually (by 1mg every 3–7 days).
Contraindication(s):
Concomitant use with other forms of guanfacine.
Warnings/Precautions:
Do not substitute with other forms of guanfacine on a mg-mg basis. Concomitant antihypertensives, other risks for hypotension, syncope, bradycardia, cardiovascular disease. Monitor heart rate, BP. Dehydration. Elevated temperature. Renal or hepatic impairment. Pregnancy (Cat.B). Nursing mothers.
Interaction(s):
May be potentiated by CYP3A4/5 inhibitors (eg, ketoconazole). May be antagonized by CYP3A4 inducers (eg, rifampin). May potentiate valproic acid. Additive effects with other antihypertensives, CNS depressants (eg, benzodiazepines, antipsychotics, barbiturates).
Adverse Reaction(s):
Somnolence, sedation, abdominal pain, dizziness, hypotension, dry mouth, constipation, bradycardia.
How Supplied:
Tabs—100