|
美批准Intuniv(guanfacine)用于注意力缺陷综合症,
Shire公司表示美国FDA已批准Intuniv(guanfacine)的上市申请，用于治疗6-17岁儿童与青少年注意力缺陷
【药物名称】胍法新
【英文名】Guanfacine
【别名】氯苯乙胍,胍法新;氯山胍
【外文名】Guanfacine
【适应症】用于治疗中度至重度高血压，可单用或与利尿药合用。
【用量用法】口服：初用剂量１次0.5～1mg，1日1次，睡前服。以后可逐增至1日3mg。
【注意事项】常见的不良反应与可乐定相似，但撤药症状出现较晚、较轻。
【规格】片剂：每片1mg。
胍法新为中枢性α2受体激动剂。其作用与可乐定相似，但其作用较可乐定为弱，因而在降压有效剂量时，中枢性不良反应也小。降压时心率减慢，但心输出量一般并不减少。对肾小球滤过率无明显影响。口服吸收迅速、完全。在血浆中与蛋白结合率亦低。大部分药物被肝灭活。t1/2为21小时。口服后2h开始起效，最大作用约在6h,持续时间较可乐定长，可达36h。
Shire Pharm(SHPGY)发表INTUNIV实验分析结果
公司发表INTUNIV实验分析结果，此种化合物每日服用一次，用来治疗注意力不足过动障碍症(Attention Deficit Hyperactivity Disorder，简称为过动症，或ADHD)。第三阶段数据显示，在服用INTUNIV药剂24小时後ADHD症状大幅减轻.
Intuniv approved for ADHD
The FDA has approved once-daily Intuniv (guanfacine extended-release tablets, from Shire), a selective alpha-2A adrenergic receptor agonist, for the treatment of attention-deficit hyperactivity disorder (ADHD) in children and adolescents 6–17 years of age.
This approval was based on results from two similarly designed, placebo-controlled clinical trials in patients 6–17 years of age who met Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) criteria for ADHD. Both trials demonstrated
statistically significant improvements in ADHD-Rating Scale (RS)-IV scoresinpatients taking Intuniv beginning 1–2 weeks after patients began receiving once-daily doses of Intuniv. In the first trial, the mean reduction in ADHD-RS-IV total scores from baseline to the endpoint were -16.7 for Intuniv compared to -8.9 for placebo (p<.0001).
The mean reduction in ADHD-RS-IV total scores in the second trial were -19.6 for Intuniv and -12.2 for placebo (p=0.004).Significantimprovementswerealsoobserved in secondary efficacy outcome measures, which included the Conners' Parent Rating Scale-Revised: Short Form (CPRS-R) and the Conner's TeacherRating Scale-Revised: Short Form (CTRS-R) that use parent/teacher observer and self-reported ratings to help assess ADHD.
Intuniv is not a controlled substance and has no known potential for drug abuse or dependence. Intuniv is expected to be made available in November 2009 in1mg, 2mg, 3mg, and 4mg dosage strengths.
Intuniv
Intuniv Basics
Intuniv is a new non-stimulant medication for the treatment of children and teens with ADHD. Intuniv is an extended-release form of guanfacine (Tenex).
What Intuniv Is Used For
Intuniv is used to treat children and teens with ADHD. However, Intuniv has not yet been approved by the FDA.
The manufacturer has received an "approvable letter" from the FDA, which is often a big step in getting a medicine approved and many experts believe it will be approved soon.
Intuniv Facts•Intuniv was formally known as GXR and SPD503 •It is a selective alpha-2A-receptoragonist•Like Strattera, another non-stimulant for ADHD, Intuniv is not a controlled substance, whichcanmakinggettingrefillseasier for parents Intuniv BenefitsUntil more is known about Intuniv, the first benefit is that there will simply be another option for treating children with ADHD. This is especially important as Intuniv offers another non-stimulant treatment option for children who don't tolerate medicines such as Ritalin, Concerta, Adderall XR, Focalin XR, or Vyvanse.
Forms Of Intuniv
Intuniv will be available as a pill in four dosage strengths, including 1mg, 2mg, 3mg, and 4mg.
Intuniv Side Effects
Side effects of Intuniv include somnolence (drowsiness), fatigue, abdominal pain, and headache.
What You Need To Know•Intuniv is being marketed by Shire, the same company that makes Adderall XR, Vyvanse, and Daytrana.
•Although Tenex is used to treat high blood pressure, it is already a second-line treatment for ADHD.
|
