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Metadate CD (Methylphenidate Hydrochloride) - Summary

 
 



BOX WARNING

Drug Dependence

METADATE CD should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during withdrawal from abusive use since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.

 

METADATE CD SUMMARY

METADATE CD is a central nervous system (CNS) stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by the ER component.

Attention Deficit Hyperactivity Disorder (ADHD): METADATE® CD (methylphenidate HCl, USP) Extended-Release Capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

The efficacy of METADATE CD in the treatment of ADHD was established in one controlled trial of children aged 6 to 15 who met DSM-IV criteria for ADHD (see CLINICAL PHARMACOLOGY).

A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 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 Types requires both inattentive and hyperactive-impulsive criteria to be met.

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. 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 the required number of DSM-IV characteristics.

Need for Comprehensive Treatment Program: METADATE CD is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be 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 other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. 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.

Long-Term Use: The effectiveness of METADATE CD for long-term use, i.e., for more than 3 weeks, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use METADATE CD for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE and ADMINISTRATION).


See all Metadate CD indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Metadate CD (Methylphenidate)

The Effect of Methylphenidate on Fatigue in Advanced Cancer: An Aggregated N-of-1 Trial. [2015]
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 memory. [2014]
CONCLUSIONS: The study shows both shared and drug-specific effects. ATX

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. [2014]
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

Effect of extended-release dexmethylphenidate and mixed amphetamine salts on sleep: a double-blind, randomized, crossover study in youth with attention-deficit hyperactivity disorder. [2014]
measures of sleep... CONCLUSIONS: Higher stimulant doses were associated with reduced sleep duration

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 Japan. [2014]
attention-deficit/hyperactivity disorder (ADHD)... CONCLUSIONS: OROS MPH in a dose range of 18-72 mg once daily was effective and

more studies >>

Clinical Trials Related to Metadate CD (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.

more trials >>

Reports of Suspected Metadate CD (Methylphenidate) Side Effects

Contusion (3)Head Injury (3)Delusion (3)Suicidal Ideation (3)Mania (3)Malaise (3)TIC (3)Dystonia (3)Euphoric Mood (3)Insomnia (3)more >>


Page last updated: 2015-08-10

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