Methylin® methylphenidate HCl tablets USP
(5 mg, 10 mg, and 20 mg)
Methylin® ER methylphenidate HCl extended-release tablets USP
(10 mg and 20 mg)
Methylphenidate hydrochloride is a mild central nervous system (CNS) stimulant, available as tablets of 5 mg, 10 mg, and 20 mg and as extended-release tablets of 10 mg and 20 mg.
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.
Methylin® 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 Methylin (Methylphenidate)
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 methylphenidate and folic Acid on ADHD symptoms and quality of life and
aggression: a randomized double blind placebo controlled clinical trial. 
CONCLUSION: considering the marked limitations of this trial, this primarily
Effects of methylphenidate on acute math performance in children with
attention-deficit hyperactivity disorder. 
CONCLUSIONS: MPH improves acute math performance in children with ADHD. Younger
Extended-release dexmethylphenidate 30 mg/d versus 20 mg/d: duration of
attention, behavior, and performance benefits in children with
attention-deficit/hyperactivity disorder. 
performance in children with attention-deficit/hyperactivity disorder... CONCLUSIONS: D-MPH-ER 30 mg was superior to D-MPH-ER 20 mg at later time points
A post hoc comparison of the effects of lisdexamfetamine dimesylate and
osmotic-release oral system methylphenidate on symptoms of attention-deficit
hyperactivity disorder in children and adolescents. 
methylphenidate (OROS-MPH) on symptoms of ADHD in children and adolescents... CONCLUSIONS: This post hoc analysis showed that, at the doses tested, patients
Clinical Trials Related to Methylin (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,
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 Methylin (Methylphenidate) Side Effects
Cerebrovascular Accident (54),
Myocardial Infarction (47),
Drug Abuse (8),
Incorrect Route of Drug Administration (7),
Toxicity TO Various Agents (7),
Drug Ineffective (5),
Somnolence (2), more >>
Page last updated: 2014-11-30