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METADATE ER is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep METADATE ER in a safe place to prevent misuse and abuse. Selling or giving away METADATE ER may harm others, and is against the law.
Tell your doctor if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs.
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METADATE ER SUMMARY
MEDICATION GUIDE
METADATE ER Tablets (methylphenidate hydrochloride extended-release tablets, USP) are a mild central nervous system (CNS) stimulant. METADATE ER is available as extended-release tablets of 10 and 20 mg for oral administration.
Attention Deficit Disorders, Narcolepsy: Attention Deficit Disorders
(previously known as Minimal Brain Dysfunction in Children). Other terms being used to describe the behavioral syndrome below include: Hyperkinetic Child Syndrome, Minimal Brain Damage, Minimal Cerebral Dysfunction, Minor Cerebral Dysfunction.
METADATE ER is indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.
Special Diagnostic Considerations: Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources.
Characteristics commonly reported include: chronic history of short attention span, distractibility, emotional lability, impulsivity, and moderate-to-severe hyperactivity; minor neurological signs and abnormal EEG. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of one or more of these characteristics.
Drug treatment is not indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is generally necessary. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms.
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NEWS HIGHLIGHTSMedia Articles Related to Metadate ER (Methylphenidate)
In Children With ADHD Methylphenidate 'Normalizes' Activation In Key Brain Areas
Source: ADHD News From Medical News Today [2013.05.14]
The stimulant drug methylphenidate "normalizes" activation of several brain areas in young patients with attention-deficit/hyperactivity disorder (ADHD), according to a review published in the May Harvard Review of Psychiatry. The journal is published by Lippincott Williams & Wilkins, a part of Wolters Kluwer Health...
Published Studies Related to Metadate ER (Methylphenidate)
Ameliorating attention problems in children with sickle cell disease: a pilot
study of methylphenidate. [2012]
disease (SCD) with cerebrovascular complications who evidence attention problems... CONCLUSIONS: Stimulant medication positively impacted select measures of memory
Methylphenidate treatment of adult male prison inmates with attention-deficit
hyperactivity disorder: randomised double-blind placebo-controlled trial with
open-label extension. [2012]
CONCLUSIONS: Osmotic-release oral system methylphenidate is an effective
Is response to OROS-methylphenidate treatment moderated by treatment with
antidepressants or psychiatric comorbidity? A secondary analysis from a large
randomized double blind study of adults with ADHD. [2012]
disorders... CONCLUSIONS: We found few moderating effects in this large
Efficacy of lisdexamfetamine dimesylate in children with attention-deficit/hyperactivity disorder previously treated with methylphenidate: a post hoc analysis. [2011.11.04]
ABSTRACT: BACKGROUND: Attention-deficit/hyperactivity disorder (ADHD) is a common neurobehavioral psychiatric disorder that afflicts children, with a reported prevalence of 2.4% to 19.8% worldwide. Stimulants (methylphenidate [MPH] and amphetamine) are considered first-line ADHD pharmacotherapy. MPH is a catecholamine reuptake inhibitor, whereas amphetamines have additional presynaptic activity. Although MPH and amphetamine can effectively manage ADHD symptoms in most pediatric patients, many still fail to respond optimally to either. After administration, the prodrug stimulant lisdexamfetamine dimesylate (LDX) is converted to l-lysine and therapeutically active d-amphetamine in the blood. The objective of this study was to evaluate the clinical efficacy of LDX in children with ADHD who remained symptomatic (ie, nonremitters; ADHD Rating Scale IV [ADHD-RS-IV] total score > 18) on MPH therapy prior to enrollment in a 4-week placebo-controlled LDX trial, compared with the overall population... CONCLUSION: In this analysis, children with significant clinical ADHD symptoms despite MPH treatment improved during treatment with LDX and experienced similar improvements in their symptoms as the overall study population. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00556296.
Comparison of the Efficacy of Two Different Modified Release Methylphenidate Preparations for Children and Adolescents with Attention-Deficit/Hyperactivity Disorder in a Natural Setting: Comparison of the Efficacy of Medikinet((R)) Retard and Concerta((R))-a Randomized, Controlled, Double-Blind Multicenter Clinical Crossover Trial. [2011.10]
Abstract Objective: The comparison of the efficacy of Medikinet((R)) retard and Concerta((R)) trial was a multisite, randomized, double-blind, crossover trial that aimed at comparing the effects of two different modified release methylphenidate preparations (Medikinet retard: 50% immediate release (IR); Concerta: 22% IR) in a natural setting across the day in 113 randomized children and adolescents with attention-deficit/hyperactivity disorder (age range 6-16 years)...
Clinical Trials Related to Metadate ER (Methylphenidate)
A Double-Blind Randomized, Placebo-Controlled, Crossover Study of Single Doses of OROS Methylphenidate Hydrochloride (CONCERTA) and Long-Acting Methylphenidate Hydrochloride (RITALIN LA) in Healthy Adults [Completed]
This is a double-blind, placebo-controlled study, three-period crossover study to examine the
likeability of a single dose of OROS MPH (CONCERTẢ 90mg) and a single dose of Long-acting
MPH (RITALIN LẢ 90mg). Hypotheses are as follows:
Hypothesis 1: OROS-MPH (CONCERTẢ) will be later than SODOS-MPH (RITALIN LẢ) in its Tmax
(time to Cmax).
Hypothesis 2: The subjective feelings of detection and likeability would be greater for
SODOS-MPH (RITALIN LẢ) than for an equivalent total dose of OROS-MPH (CONCERTẢ).
An Effectiveness and Safety Study Evaluating OROS® Methylphenidate HCl, Ritalin® (Methylphenidate HCl) and Placebo in Children With Attention Deficit Hyperactivity Disorder [Completed]
The purpose of this study is to provide data on the effectiveness of the OROS®
Methylphenidate HCl formulation compared to placebo and standard immediate-release Ritalin®
with respect to improving attention and behavior, and decreasing hyperactivity in children
with Attention Deficit Hyperactivity Disorder (ADHD). Both OROS® Methylphenidate HCl and
Ritalin® contain the central nervous system stimulant, methylphenidate HCl. The safety
associated with the two methylphenidate formulations will also be compared with placebo.
A Comparative Effectiveness Study Evaluating OROS® Methylphenidate HCl, Ritalin® (Methylphenidate HCl), and Placebo for the Treatment of Attention Deficit Hyperactivity Disorder in Children [Completed]
A Multicenter Study Comparing the Efficacy and Safety of OROS® Methylphenidate HCl, Ritalin® (Methylphenidate HCl) and Placebo in Children With Attention Deficit Hyperactivity Disorder [Completed]
The purpose of this study is to evaluate the efficacy and safety of OROS® Methylphenidate HCl
as compared with placebo and standard immediate-release Ritalin® (taken three time per day)
for the treatment of Attention Deficit Hyperactivity Disorder in children. Both OROS®
Methylphenidate HCl and Ritalin® contain the central nervous system stimulant,
methylphenidate HCl.
Naturalistic Substitution of Concerta in Adult Subject With ADHD Receiving Immediate Release Methylphenidate [Completed]
This is a single-blind study looking at the efficacy and satisfaction of Concerta
substitution in adult subjects with ADHD receiving immediate release methylphenidate.
Subjects will be administered a maximum dose of 1. 3mg/kg/day of either methylphenidate or
Concerta. The specific hypotheses of this study are:
Hypothesis 1: ADHD symptomatology in adults with DSM-IV, ADHD will continue to be controlled
in patients switched from MPH IR TID to Concerta.
Hypothesis 2: Patient satisfaction will not decrease in patients switched from MPH IR TID to
Concerta (ie., all patients will be equally or more satisfied on Concerta as compared with
MPH IR TID.
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Page last updated: 2013-05-14
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