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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.

INTUNIVis indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). The efficacy of INTUNIVwas studied for the treatment of ADHD in two controlled clinical trials (8 and 9 weeks in duration) in children and adolescents ages 6-17 who met DSM-IV® criteria for ADHD [see Clinical Studies ]. The effectiveness of INTUNIV for long-term use (more than 9 weeks) has not been systematically evaluated in controlled trials.

A diagnosis of ADHD implies the presence of hyperactive-impulsive and/or inattentive symptoms that cause impairment and were present before the age of 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; "on the go"; excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.
See all Intuniv indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Intuniv (Guanfacine)

Research suggests team-based care is most effective way to control hypertension
Source: Hypertension News From Medical News Today [2014.10.24]
Patients diagnosed with high blood pressure are given better control of their condition from a physician-pharmacist collaborative intervention than physician management alone, according to new...

Exalenz Bioscience launches pivotal study of world's first breath-based test to diagnose clinically significant portal hypertension
Source: Clinical Trials / Drug Trials News From Medical News Today [2014.10.23]
Exalenz Bioscience, a leader in developing and marketing non-invasive medical devices for diagnosing and monitoring a range of gastrointestinal and liver diseases, announced the start of a pivotal...

Binge drinking in young men linked with increased risk of hypertension
Source: Alcohol / Addiction / Illegal Drugs News From Medical News Today [2014.10.21]
Binge drinking in early adulthood is associated with an increased likelihood of high blood pressure in males, while low to moderate alcohol use in early adulthood is associated with a decreased...

Uncontrolled hypertension highest among patients with moderate-to-severe psoriasis
Source: Hypertension News From Medical News Today [2014.10.20]
Patients with moderate and severe psoriasis have the greatest likelihood of uncontrolled hypertension compared to patients without psoriasis.

UF researchers use plants to study new ways of delivering drugs for pulmonary hypertension
Source: Endocrinology News From Medical News Today [2014.10.17]
UF researchers are using the leaves of plants to study new ways to deliver drugs that treat pulmonary hypertension, a disease with few treatment options, according to a study published online in...

more news >>

Published Studies Related to Intuniv (Guanfacine)

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.

Guanfacine extended-release: in attention deficit hyperactivity disorder. [2010]
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 extended-release guanfacine on ADHD symptoms and sedation-related adverse events in children with ADHD. [2010]
CONCLUSION: These results suggest that acclimation to GXR may minimize the risk

Guanfacine extended release in children and adolescents with attention-deficit/hyperactivity disorder: a placebo-controlled trial. [2009.02]
CONCLUSIONS:: Guanfacine extended-release was effective in reducing symptoms of ADHD. Adverse events were mild to moderate, did not interfere with improvements in attention, and rarely led to discontinuation.

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Clinical Trials Related to Intuniv (Guanfacine)

Guanfacine in Children With Tic Disorders [Recruiting]
The goal of this pilot study is to obtain preliminary information on the tolerability and efficacy of extended release guanfacine (trade name Intuniv) in children with Tourette Disorder (TD, also called Tourette syndrome).

Effect of Guanfacine Extended-Release on Attention Deficit Hyperactivity Disorder (ADHD)-Associated Insomnia [Recruiting]
This study seeks to determine, using special sleep tests (polysomnography and actigraphy) if

guanfacine extended release is able to improve nighttime sleep in children with ADHD -

associated insomnia while improving daytime ADHD symptoms. Male and female children with diagnosed or suspected ADHD with sleep problems (difficulty falling asleep, difficulty staying asleep, or less than expected hours of sleep) will be recruited. After obtaining informed consent and assent (when appropriate) and after discontinuation of excluded medications, children will have evaluations of his or her sleep and evaluations confirming the ADHD diagnosis. Children who successfully pass screening will be enrolled into the double-blind, placebo-controlled, randomized investigation with 50% of participants receiving guanfacine extended release and 50% of participants receiving matching placebo. Using a flexible-dose optimization design based on ADHD symptom improvement and medication tolerability, the dose will be adjusted between 1 to 4 mg over the course of four weeks. At the end of medication adjustment (week 4 or 5), ADHD questionnaires, sleep questionnaires, and sleep tests will be repeated and analyzed. The medication will be weaned over the course of the following 3-10 days.

Guanfacine for the Treatment of Hyperactivity in Pervasive Developmental Disorder [Recruiting]
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).

Electrophysiological Effects of Guanfacine Extended Release in Attention Deficit Hyperactivity Disorder (ADHD) [Recruiting]
All subjects with the study will be children (age 6-12) with Attention Deficit Hyperactivity Disorder (ADHD). After baseline assessment confirms the presence of ADHD, children will have an Event related potential (ERP) (a type of electroencephalogram [EEG]) study. After the baseline EEG, children will be randomized to either placebo or GXR for a 4-week, parallel groups trial. During this trial, dosing will be flexibly adjusted according to patient response or presence of side effects. The dosage will range from 1-4 mg. At the end of the four week trial, a follow up ERP study will be obtained.

Neurobiological Basis of Response to Guanfacine Extended Release in Children and Adolescents With ADHD [Recruiting]
This study proposes to evaluate the effects of guanfacine extended release on brain activation during fMRI in children and adolescents with ADHD between the ages 8-15 and ADHD subjects randomized to placebo treatment.

This study also proposes to collect DNA on study participants, to examine the genetic underpinning of the observed fMRI activation profiles at baseline and in response to treatment. The purpose is to examine polymorphisms of the adrenergic 2A gene (and other related targets) for genetic biomarkers in association with the fMRI findings of this study.

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: 2014-10-24

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