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Dexmethylphenidate, Methylphenidate

All Dexmethylphenidate, Methylphenidate Products

  • Chronic abusive use can lead to a marked tolerance and psychological dependence with varying degree of abnormal behavior
  • Frank psychotic episodes can occur, especially with parenteral abuse.
  • CNS stimulants, including Focalin, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy.

Methylphenidate Products: Concerta, Cotempla XR-ODT, Jornay PM, Metadate, Ritalin, Daytrana

Dexmethylphenidate Products: Focalin

  • Should be given cautiously to patients with a history of drug dependence or alcoholism.
  • Careful supervision 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. 

Methylphenidate Products: Methylin Products

  • Should be given cautiously to emotionally unstable patients, such as those with a history of drug dependence or alcoholism, because such patients may increase dosage on their own initiative.
  • Careful supervision required during drug withdrawal, since severe depression as well as the effects of chronic over activity can be unmasked.
  • Long term follow-up may be required because of the patient's basic personality disturbances.

Serdexmethylphenidate/Dexmethylphenidate Capsules

  • CNS stimulants, including AZSTARYS, other methylphenidatecontaining products, and amphetamines, have a high potential for abuse and dependence.
  • Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy.

 


FDA and Industry Communications

Attention-Deficit Hyperactivity Disorder (ADHD) Drug Patient Medication Guides and Package Inserts(February 2007)

FDA News Release Regarding Attention-Deficit Hyperactivity Disorder (ADHD) and Patient Notification of Psychiatric and Cardiac Adverse Events(February 2007)

Dexmethylphenidate FDA Medication Guide

Methylphenidate FDA Medication Guide

Patient Counseling Information

Medication Guides

Patient Medication Guide
Patient Medication Guide - Dexmethylphenidate
Patient Medication Guide - Methylphenidate

Package Inserts

Dexmethylphenidate

Methylphenidate

Serdexmethylphenidate/Dexmethyphenidate

Additional Information

Updated April 2021