Dexmethylphenidate

What are the side effects of Focalin (Dexmethylphenidate)?

• dyspepsia
• decreased appetite
• headache
• anxiety for pediatric patients
• dry mouth
• dyspepsia
• headache
• anxiety for adult patients.

• Focalin XR should not be used in patients being treated (currently or within the preceding two weeks) with MAO Inhibitors

• Focalin XR should be used cautiously with pressor agents

• Antacids or acid suppressants could alter the release of Focalin XR

• Racemic methylphenidate may inhibit the metabolism of coumarin anticoagulants, anticonvulsants, and tricyclic drugs

Serious Cardiovascular Events: Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. Sudden death, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses for ADHD. Stimulant products generally should not be used in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious heart problems.

• Increased Blood Pressure and Heart Rate: have been reported. Monitor patients for changes in blood pressure and heart rate. Caution should be exercised in treating patients whose underlying medical conditions might be compromised by increases in blood pressure or heart rate.

• Assess Cardiovascular Status: prior to stimulant treatment, assess for cardiac disease with history and exam and, if suggested by findings, conduct further cardiac evaluation. Patients with emerging symptoms suggestive of cardiac disease should undergo a prompt cardiac evaluation.

•Psychotic Symptoms: may be exacerbated in patients with psychotic disorders.

• Bipolar Disorder: Use with particular care in ADHD patients with comorbid Bipolar Disorder. Before initiating stimulant therapy, obtain a detailed psychiatric history for patients with comorbid depressive symptoms, in order to determine risk for Bipolar Disorder.

• Emergence of New Psychotic or Manic Symptoms: Treatment-emergent psychotic or manic symptoms without a prior history can be caused by stimulants at usual doses. Discontinuation of stimulant therapy may be indicated.

• Aggression: Monitor for appearance of or worsening of aggressive behavior or hostility.

• Long-Term Suppression of Growth: monitor height and weight in pediatric patients at appropriate intervals. Patients who are not growing or gaining weight as expected may need to have their treatment interrupted.

• Seizures: The threshold for seizures may be lowered. In the presence of seizure, discontinue treatment.

• Priapism: Cases of painful and prolonged penile erections and priapism have been reported with methylphenidate products. Immediate medical attention should be sought if signs or symptoms of prolonged penile erections or priapism are observed.

• Peripheral Vasculopathy, including Raynaud’s phenomenon: Stimulants used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Careful observation for digital changes is necessary during treatment with ADHD stimulants.

• Visual Disturbance: difficulties with accommodation and blurring of vision have been reported with stimulant treatment.

• Hematologic Monitoring: periodic monitoring of CBC with differential is advised during prolonged therapy.