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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)

Phase III GXR study shows improvement in core symptoms of ADHD
Source: ADHD News From Medical News Today [2014.12.10]
Results published in European Neuropsychopharmacology demonstrate the efficacy of the Attention-Deficit/Hyperactivity Disorder (ADHD) medication, guanfacine hydrochloride extended release (GXR).

High fitness levels reduce hypertension risk
Source: Cardiovascular / Cardiology News From Medical News Today [2014.12.18]
Researchers have found that individuals with high levels of physical fitness are less likely to develop high blood pressure in a new study.

Poor semen quality linked to hypertension, other health problems
Source: Dermatology News From Medical News Today [2014.12.10]
A study of more than 9,000 men with fertility problems has revealed a correlation between the number of different defects in a man's semen and the likelihood that the man has other health problems.

How obesity causes hypertension
Source: Endocrinology News From Medical News Today [2014.12.09]
The link between obesity and cardiovascular diseases is well acknowledged. Being obese or overweight is a major risk factor for the development of elevated blood pressure, and cardiovascular diseases.

Picture of Hypertension
Source: MedicineNet Pregnancy Induced Hypertension Specialty [2014.12.09]
Title: Picture of Hypertension
Category: Images
Created: 2/3/2011 1:47:00 PM
Last Editorial Review: 12/9/2014 12:00:00 AM

more news >>

Published Studies Related to Intuniv (Guanfacine)

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.

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...

more studies >>

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.

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.

The 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.

Open-Label Pilot Study of Guanfacine-Extended Release for the Treatment of Cannabis Dependence [Recruiting]
The purpose of this study is to determine whether guanfacine represents a tolerable, potentially effective pharmacotherapy option for cannabis dependence. Interested in seeing whether guanfacine treatment reduces marijuana consumption, withdrawal symptoms, and craving as compared to baseline.

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: 2014-12-18

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