BOX WARNING Drug Dependence
Daytrana™ 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.
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DAYTRANA SUMMARY
Daytrana™ (methylphenidate transdermal system) C II
Rx Only
Daytrana™ (day-TRON-ah)
Prescribing Information
Daytrana™ (methylphenidate transdermal system) is an adhesive-based matrix transdermal system (patch) that is applied to intact skin.
Daytrana™ (methylphenidate transdermal system) is indicated for the following:
Attention Deficit Hyperactivity Disorder (ADHD)
Daytrana™ (methylphenidate transdermal system) is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
The efficacy of Daytrana™ was established in two controlled clinical trials in children with ADHD.
A diagnosis of ADHD (DSM-IV-TR®) 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 Type 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-TR® characteristics.
Need for Comprehensive Treatment Program
Daytrana™ 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 Daytrana™ for long-term use, i.e., for more than 7 weeks, has not been systematically evaluated in controlled trials. The physician who elects to use Daytrana™ for extended periods should periodically re-evaluate the long-term usefulness of Daytrana™ for the individual patient (see DOSAGE AND ADMINISTRATION).
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NEWS HIGHLIGHTS
Published Studies Related to Daytrana (Methylphenidate Transdermal)
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 Daytrana (Methylphenidate Transdermal)
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 (CONCERTAŇ 90mg) and a single dose of Long-acting
MPH (RITALIN LAŇ 90mg). Hypotheses are as follows:
Hypothesis 1: OROS-MPH (CONCERTAŇ) will be later than SODOS-MPH (RITALIN LAŇ) in its Tmax
(time to Cmax).
Hypothesis 2: The subjective feelings of detection and likeability would be greater for
SODOS-MPH (RITALIN LAŇ) than for an equivalent total dose of OROS-MPH (CONCERTAŇ).
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.
Reports of Suspected Daytrana (Methylphenidate Transdermal) Side Effects
Product Quality Issue (2393),
NO Adverse Event (1767),
Drug Administration Error (1213),
OFF Label USE (816),
Wrong Technique in Drug Usage Process (690),
Incorrect Drug Administration Duration (586),
Application Site Erythema (506),
Drug Ineffective (450),
Drug Prescribing Error (297),
Drug Administered AT Inappropriate Site (264), more >>
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Page last updated: 2013-02-10
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