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Methylphenidate (Methylphenidate Hydrochloride) - Summary

 
 



Methylphenidate HCl Extended-Release Tablets is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Methylphenidate HCl Extended-Release Tablets in a safe place to prevent misuse and abuse. Selling or giving away Methylphenidate HCl Extended-Release Tablets may harm others, and is against the law.

Tell your doctor if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs.

 

SUMMARY

Methylphenidate HCl Extended-Release Tablets is a central nervous system (CNS) stimulant.

Methylphenidate HCl Extended-Release Tablets is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65 [see Clinical Studies].

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 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 of medical and 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 patient and not solely on the presence of the required number of DSM-IV characteristics.

Need for Comprehensive Treatment Program

Methylphenidate HCl Extended-Release Tablets is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social). Drug treatment may not be indicated for all patients with ADHD. Stimulants are not intended for use in patients who exhibit 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 patient's symptoms.


See all Methylphenidate indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Methylphenidate

Scientists show cognitive enhancing drugs can improve chess play
Source: Pharma Industry / Biotech Industry News From Medical News Today [2017.03.08]
The first study to both show and measure the effects of cognitive-enhancing drugs such as modafinil, methylphenidate (best known under the trade name Ritalin), and caffeine, on chess play is being...

more news >>

Published Studies Related to 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 Methylphenidate

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.

Patient Controlled Administration of Methylphenidate for Cancer Related Fatigue - PRN Methylphenidate [Recruiting]
The goal of this clinical research study is to evaluate the effectiveness of ritalin (methylphenidate) taken on an as needed basis for the management of cancer related fatigue. The effects of methylphenidate on pain, mood, and sedation will be evaluated. Researchers will also evaluate the level of fatigue throughout the day and any possible causes of fatigue.

Efficacy and Effectiveness of Methylphenidate in Swedish Male Prison Inmates With Attention-deficit Hyperactivity Disorder (ADHD) [Completed]
The purpose of this study is to evaluate the efficacy and effectiveness of methylphenidate in treatment of ADHD in Swedish adult male prison inmates diagnosed with ADHD.

Effect of Methylphenidate on Connectivity [Withdrawn]
The goal of the study is to use graph theory to examine how the organization of the functional brain network may be altered by the administration of methylphenidate. This effect is to be compared between methylphenidate intake and placebo intake, as well as between healthy adult males and adult males with a diagnosis of Attention Deficit Hyperactivity Disorder.

more trials >>

Reports of Suspected Methylphenidate Side Effects

Completed Suicide (26)Toxicity TO Various Agents (17)Drug Ineffective (15)Death (12)Product Substitution Issue (11)Agitation (10)Anxiety (10)Tachycardia (9)Drug Abuse (8)Decreased Appetite (7)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based 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.

See all Methylphenidate reviews / ratings >>

Page last updated: 2017-03-08

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