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.
- 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
Patient Counseling Information
Patient Medication Guide
Patient Medication Guide - Dexmethylphenidate
Patient Medication Guide - Methylphenidate