BOX WARNING Drug Dependence
Methylphenidate 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 drug 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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SUMMARY
Methylphenidate Hydrochloride Tablets, USP
Methylphenidate Hydrochloride
Extended-Release Tablets, USP
Methylphenidate hydrochloride is a mild central nervous system (CNS) stimulant. Methylphenidate hydrochloride is available as 5, 10 and 20 mg tablets for oral administration. A 20 mg extended-release tablet for oral administration is also available.
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.
Methylphenidate hydrochloride 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.
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NEWS HIGHLIGHTSMedia Articles Related to 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.
Published Studies Related to 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.
Clinical Trials Related to 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.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 1 ratings/reviews, Methylphenidate has an overall score of 10. The effectiveness score is 10 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
| | Methylphenidate review by 45 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | Adult ADD |
| Dosage & duration: | | 20 mg qid taken qid for the period of 5 years- still |
| Other conditions: | | anxiety, depression |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | Changed my life- for the better |
| Side effects: | | Skin picking (at hands) when peak dosage declines |
| Comments: | | To treat adult ADD. Alleviated many elements of anger/depresion that had been present since childhood. Completely eradicated a 10 year cocaine habit (cocaine used to get through the day, get tasks accomplished). Never used cocaine again. Ended 20 years of heavy social drinking. |
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Page last updated: 2009-10-31
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