Metadate CD (Methylphenidate Hydrochloride) - Summary

METADATE CD SUMMARY

Metadate CD™
(methylphenidate HCl, USP)
Extended-Release Capsules
CII

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 indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Metadate CD (Methylphenidate)

Shire Reports Tolerability And Clinical Effects Results Of Daytrana(R) (methylphenidate Transdermal System) From Study In Adolescents With ADHD
Source: ADHD News From Medical News Today [2009.10.31]
Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, announced findings at a major medical meeting from a Phase IIIb study of the tolerability and effectiveness of Daytrana® (methylphenidate transdermal system) in adolescents aged 13 to 17 years diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD). In addition, data regarding the pharmacokinetic profile of Daytrana in children and adolescents was also presented.

Study Findings On ADHD Treatments Presented At Psychiatric Meeting
Source: ADHD News From Medical News Today [2009.10.30]
Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, has announced that it will present key scientific data on its Attention-Deficit/Hyperactivity Disorder (ADHD) treatments, INTUNIV™ (guanfacine) Extended Release Tablets, Vyvanse® (lisdexamfetamine dimesylate) Capsules CII, and Daytrana® (methylphenidate transdermal system) CII, at a national meeting of psychiatrists being held October 27 - November 1 in Honolulu.

more news >>

Published Studies Related to Metadate CD (Methylphenidate)

Stimulant treatment reduces lapses in attention among children with ADHD: the effects of methylphenidate on intra-individual response time distributions. [2009.08]
Recent research has suggested that intra-individual variability in reaction time (RT) distributions of children with ADHD is characterized by a particularly large rightward skew that may reflect lapses in attention. The purpose of the study was to provide the first randomized, placebo-controlled test of the effects of the stimulant methylphenidate (MPH) on this tail and other RT distribution characteristics...

Side effects of methylphenidate in childhood cancer survivors: a randomized placebo-controlled trial. [2009.07]
OBJECTIVES: To investigate the frequency and severity of side effects of methylphenidate among childhood survivors of acute lymphoblastic leukemia and brain tumors and identify predictors of higher adverse effect levels... CONCLUSIONS: Methylphenidate is generally well tolerated by childhood cancer survivors. There is a subgroup at increased risk for side effects that may need to be closely monitored or prescribed a lower medication dose. The seemingly paradoxical findings of increased "side effects" at baseline must be considered when monitoring side effects and designing clinical trials.

Behavioral response to methylphenidate challenge: influence of early life parental care. [2009.07]
Rat studies have shown that pups subjected to suboptimal rearing conditions exhibited permanently dysregulated dopamine activity and altered behavioral responses to dopamine stimulation. In humans, heightened stress-induced mesoaccumbens dopamine release in adults reporting low maternal care experience has been shown...

Safety of methylphenidate following traumatic brain injury: impact on vital signs and side-effects during inpatient rehabilitation. [2009.06]
OBJECTIVE: The aim of the present study was to evaluate the safety of methylphenidate administered during inpatient rehabilitation following traumatic brain injury... CONCLUSION: Methylphenidate given at 0.3 mg/kg body weight appears to be safe in the inpatient rehabilitation phase. This trial is registered with the Australian New Zealand Clinical Trials Registry (12607000503426).

Effects of application to two different skin sites on the pharmacokinetics of transdermal methylphenidate in pediatric patients with attention-deficit/hyperactivity disorder. [2009.06]
OBJECTIVE: This study was conducted to quantify the rate and extent of methylphenidate (MPH) absorption from a transdermal system when applied to two different skin sites in pediatric subjects with attention-deficit/hyperactivity disorder (ADHD)... CONCLUSION: MTS applied to both hip and scapular areas resulted in quantifiable plasma levels of d,l-MPH. Bioavailability of MPH from the same transdermal delivery system appears to differ substantially when applied to two different skin surfaces in young children but with similar overall skin effects assessments.

more studies >>

Clinical Trials Related to Metadate CD (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 (CONCERTAÃ’ 90mg) and a single dose of Long-acting MPH (RITALIN LAÃ’ 90mg). Hypotheses are as follows:

Hypothesis 1: OROS-MPH (CONCERTAÃ’) will be later than SODOS-MPH (RITALIN LAÃ’) in its Tmax (time to Cmax).

Hypothesis 2: The subjective feelings of detection and likeability would be greater for SODOS-MPH (RITALIN LAÃ’) than for an equivalent total dose of OROS-MPH (CONCERTAÃ’).

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.

more trials >>