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Intuniv (Guanfacine Hydrochloride) - Summary

 
 



INTUNIV SUMMARY

INTUNIV is a once-daily, extended-release formulation of guanfacine hydrochloride (HCl) in a matrix tablet formulation for oral administration only. The chemical designation is N-amidino-2-(2,6-dichlorophenyl) acetamide monohydrochloride.

INTUNIV is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications. The efficacy of INTUNIV was studied for the treatment of ADHD in three controlled monotherapy clinical trials (up to 8 weeks in duration) and one controlled adjunctive trial with psychostimulants (8 weeks in duration) in children and adolescents ages 6-17 who met DSM-IV criteria for ADHD [ ]. The effectiveness of INTUNIV for longer-term use (more than 8 weeks) has not been systematically evaluated in controlled trials. ® ® ® see Clinical Studies ®


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NEWS HIGHLIGHTS

Media Articles Related to Intuniv (Guanfacine)

ESC: Coffee, Naps, and Depression in Hypertension (CME/CE)
Source: MedPageToday.com - medical news plus CME for physicians [2015.08.29]
(MedPage Today) -- Observations support naps but suggest risk with espresso and depression

Medical News Today: Could hypertension during pregnancy signal elevated risk for siblings?
Source: Featured Health News from Medical News Today [2015.08.28]
The male siblings of women who have high blood pressure during pregnancy are at an increased risk of developing cardiovascular disease in later life, a new study finds.

Could hypertension during pregnancy signal elevated risk for siblings?
Source: Biology / Biochemistry News From Medical News Today [2015.08.28]
The male siblings of women who have high blood pressure during pregnancy are at an increased risk of developing cardiovascular disease in later life, a new study finds.

Common 'heart attack' blood test may predict future hypertension
Source: Hypertension News From Medical News Today [2015.08.27]
Small rises in troponin levels may have value as markers for subclinical heart damage and high blood pressureAnalysis of blood samples from more than 5,000 people suggests that a more sensitive...

ICD-10: Coding for Hypertension and Heart Disease
Source: Medscape Business of Medicine Headlines [2015.08.25]
There are some important elements to be aware of when coding for hypertension, heart disease, and kidney disease in ICD-10.
Medscape Business of Medicine

more news >>

Published Studies Related to Intuniv (Guanfacine)

Efficacy of guanfacine extended release assessed during the morning, afternoon, and evening using a modified Conners' Parent Rating Scale-revised: Short Form. [2014]
attention-deficit/hyperactivity disorder (ADHD)... CONCLUSIONS: These results provide further support for the demonstrated efficacy

Randomized, double-blind trial of guanfacine extended release in children with attention-deficit/hyperactivity disorder: morning or evening administration. [2013]
CONCLUSIONS: GXR administered either in the morning or evening was associated

Naltrexone with or without guanfacine for preventing relapse to opiate addiction in St.-Petersburg, Russia. [2013]
induced craving and have reduced opiate relapse in small clinical trials... CONCLUSIONS: Adding guanfacine to naltrexone did not improve treatment retention

Guanfacine extended-release: in attention deficit hyperactivity disorder. [2010.09.10]
Guanfacine, an alpha(2A)-adrenoceptor agonist, is available in the US as an extended-release (ER) tablet for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents (aged 6-17 years). In two large, randomized, double-blind, placebo-controlled trials of 8 and 9 weeks' duration, guanfacine ER (1-4 mg once daily) was effective in reducing the symptoms of ADHD (hyperactivity, impulsivity and inattention) in children and adolescents...

Effects of guanfacine extended release on oppositional symptoms in children aged 6-12 years with attention-deficit hyperactivity disorder and oppositional symptoms: a randomized, double-blind, placebo-controlled trial. [2010.09.01]
CONCLUSIONS: In this population of children aged 6-12 years with ADHD and the presence of oppositional symptoms, significant reductions in CPRS-R:L oppositional subscale and ADHD-RS-IV total scores were observed with guanfacine XR treatment compared with placebo. Treatment with guanfacine XR at optimized doses was associated with mostly mild or moderate TEAEs. The findings of this study support the efficacy of guanfacine XR in the treatment of children with ADHD and the presence of oppositional symptoms. Clinical Trial Registration Number: NCT00367835.

more studies >>

Clinical Trials Related to Intuniv (Guanfacine)

Efficacy of Intuniv Extended Release as Adjunctive Therapy With Psycho-stimulant on Executive Function in Children With ADHD [Recruiting]
This study looks to examine whether or not INTUNIV extended release can help children aged 6-12 years diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD) in improving Executive Function when added to their usual care stimulant therapy. Executive functions are a set of mental processes that include emotional control, planning, organization, working memory, inhibition of behaviors, and managing time and space. As children with ADHD usually have difficulties with Executive Function, and Executive function difficulties lead to more difficulties in school and behaviour, it is anticipated that adding INTUNIV extended release to usual stimulant therapy will improve Executive Function scores as rated by parents and teachers. Improvements in quality of life will also be measured.

PK/PD Comparison of Guanfacine ER and IR [Active, not recruiting]
Evaluate whether a 4mg/day or 6/mg day dose of extended-release guanfacine produces pharmacokinetic/dynamic (PK/PD) properties similar to 3mg/day immediate release guanfacine.

Intuniv vs Placebo in the Treatment of Childhood Intermittent Explosive Disorder [Recruiting]
Children with explosive aggression are often rejected by their peers, placed in special classroom, and contribute to family discord. When psychotherapy and family therapy is unsuccessful, medications are often used. Current medications are stimulants (e. g. methylphenidate, dextroamphetamine), anticonvulsants (e. g. Divalproex) and antipsychotics (olanzapine, risperidone). At this time, the available medications are of limited usefulness, either because they do not always work or because they have side effects such as weight gain or insomnia. There is a clear need for new medications to treat explosive aggression when psychotherapy is unsuccessful. The hypothesis of this study is the medication Intuniv when combined with psychotherapy will be more helpful to children with explosive aggression than placebo combined with psychotherapy. Intuniv is a long acting form of guanfacine, a medication approved by the FDA for treatment of Attention Deficit Hyperactivity Disorder. Intuniv is not a stimulant, nor is it an anticonvulsant, nor is it an antipsychotic. The children in this study will be between the ages of 6 and 12 and meet Diagnostic and Statistical Manual of Psychiatry Fourth Edition, Text Revision (DSM-IV-TR) criteria for Intermittent Explosive Disorder.

Efficacy and Safety Eval of Guanfacine Hydrochloride in Combination With Psychostimulants in Adults (18-65). [Completed]
This is considered an investigator-initiated clinical research trial, which means that your study doctor is researching a particular medication (in this case a medication that is currently FDA- approved) for the treatment of AD/HD in individuals ages 6-17. The medication is guanfacine hydrochloride. The hypothesis is that this medication could be used in adults with Attention Deficit/Hyperactivity Disorder who have not received satisfactory results with their current stimulant ADHD medication. The study drug is investigational for use in adults. Investigational means it has not been approved by the U. S. Food and Drug Administration (FDA) for use in adults.

Guanfacine for the Treatment of Hyperactivity in Pervasive Developmental Disorder [Completed]
The purpose of this study is to determine whether guanfacine (trade name Intuniv) by itself or in combination with methylphenidate (also known as Ritalin) is helpful for treating hyperactivity in children and adolescents with a Pervasive Developmental Disorders (PDDs).

more trials >>

Reports of Suspected Intuniv (Guanfacine) Side Effects

Syncope (29)Dizziness (9)Hallucination (9)Hypotension (8)OFF Label USE (7)Somnolence (6)Loss of Consciousness (6)Fatigue (6)Inappropriate Schedule of Drug Administration (6)Convulsion (6)more >>


Page last updated: 2015-08-29

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