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.
METADATE ER SUMMARY
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.
Published Studies Related to Metadate ER (Methylphenidate)
The Effect of Methylphenidate on Fatigue in Advanced Cancer: An Aggregated N-of-1
advanced cancer... CONCLUSION: MPH does not improve fatigue in the population of patients with
Drug-specific laterality effects on frontal lobe activation of atomoxetine and
methylphenidate in attention deficit hyperactivity disorder boys during working
CONCLUSIONS: The study shows both shared and drug-specific effects. ATX
Effect of extended-release dexmethylphenidate and mixed amphetamine salts on
sleep: a double-blind, randomized, crossover study in youth with
attention-deficit hyperactivity disorder. 
measures of sleep... CONCLUSIONS: Higher stimulant doses were associated with reduced sleep duration
Long-term (1 year) safety and efficacy of methylphenidate modified-release
long-acting formulation (MPH-LA) in adults with attention-deficit hyperactivity
disorder: a 26-week, flexible-dose, open-label extension to a 40-week,
double-blind, randomised, placebo-controlled core study. 
26-week, open-label extension phase of the same study (NCT01338818)... CONCLUSIONS: In adult patients with ADHD, use of MPH-LA up to 1 year continued to
A randomized, double-blind, placebo-controlled, parallel-group study to evaluate
the efficacy and safety of osmotic-controlled release oral delivery system
methylphenidate HCl in adults with attention-deficit/hyperactivity disorder in
attention-deficit/hyperactivity disorder (ADHD)... CONCLUSIONS: OROS MPH in a dose range of 18-72 mg once daily was effective and
Clinical Trials Related to Metadate ER (Methylphenidate)
Study of the Effect of Individualizing Daytrana Wear-times on Sleep in Children With ADHD [Completed]
Methylphenidate may improve sleep in children with ADHD. By leaving Daytrana
(methylphenidate) patch for a longer time then 9 hours, many children report short sleep
latencies and better quality of sleep.
Methylphenidate Study in Breast or Gastrointestinal Cancer Patients [Terminated]
The goal of this clinical research study is to see if the drug OROS Methylphenidate HCl
(Concerta) can help to control fatigue in patients with breast, gastrointestinal, lymphoma,
myeloma or lung cancer who are going through chemotherapy or hormonal treatment or have
completed chemotherapy or hormonal treatment in the last 12 months. The safety of this drug
will also be studied. Another goal of the study is to see how certain cytokines change
while patients undergo chemotherapy or hormonal treatment.
The Effect of Methylphenidate on Non-motor Symptoms and Postural Control in Parkinson's Disease. [Terminated]
This project aims to determine if methylphenidate can improve deficits in attention and
symptoms of orthostatic hypotension, two common non-motor symptoms, in patients with
Parkinson's Disease. This project also seeks to evaluate the effect of methylphenidate on
postural control in these patients, a debilitating motor symptom that places patients at an
increased risk of falling. This study will build on existing data to support a new
indication for the use of methylphenidate in Parkinson's Disease. Using standard and
objective evaluations, this study will quantify the effect of methylphenidate at two doses
on attention levels, orthostatic hypotension, and measures of postural control. Phase I of
the study will compare methylphenidate 10mg three times daily to placebo and Phase II of the
study, for those tolerating the lower dose in Phase I, will compare methylphenidate 20mg
three times daily to placebo. By incorporating two different doses, the study also seeks to
determine if any improvements are dose-related. Secondary endpoints will include safety
assessments (adverse event monitoring and vital signs) performed every 30 minutes following
supervised drug administration. Visual analog scales will be presented to each participant
before treatment and following the final dose of each treatment to assess changes in
fatigue. A secondary task will be added to postural tests to assess the influence of
cognitive processes. It is hypothesized that methylphenidate will demonstrate a significant
beneficial effect on all outcomes. It is projected that objective improvements will be
observed following treatment with methylphenidate at both doses (10 and 20mg three time
daily) when compared to placebo. It is further hypothesized that the effects will be
dose-related and therefore more profound with higher doses.
Dose Response Effects of Quillivant XR in Children With ADHD and Autism: A Pilot Study [Recruiting]
The purpose of this study is to determine whether Quillivant XR is effective in the
treatment of ADHD in children with Autism Spectrum Disorder (ASD).
Safety and Efficacy of MTS Versus Concerta in Pediatric Patients (Aged 6-12 Years) With ADHD [Completed]
Study designed to evaluate the safety and efficacy of MTS compared to placebo with reference
to CONCERTA® in pediatric subjects diagnosed with ADHD.
Page last updated: 2015-08-10