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US FDA Approves 30-Minute Onset of Action for Focalin(R) XR, Bringing Potential Benefits to ADHD Patients During Early Morning Period
Date:11/12/2008

rs and older. Focalin XR is indicated as an integral part of a total treatment program for ADHD that may include other measures (e.g., psychological, educational and social).

Important Safety Information

The most common adverse events seen with Focalin XR were dyspepsia, decreased appetite, headache and anxiety in pediatric studies; and dry mouth, dyspepsia, feeling jittery, dizziness, headache and anxiety in adult studies.

Focalin XR is contraindicated in patients with marked anxiety, tension and agitation since the drug may aggravate these symptoms; in patients known to be hypersensitive to methylphenidate or other components of the product; in patients with glaucoma; in patients with motor tics or with a family history or diagnosis of Tourette's syndrome; and during or following treatment with monoamine oxidase inhibitors.

Stimulants should generally not be used in children, adolescents or adults with known serious structural cardiac abnormalities, cardiomyopathy, serious heart-rhythm abnormalities or other serious cardiac problems. Use with caution in treating patients with underlying medical conditions that might be compromised by increases in blood pressure or heart rate, such as those with pre-existing hypertension, heart failure, recent myocardial infarction or ventricular arrhythmia. Before initiating treatment, patients should have careful history and physical exam to assess for presence of cardiac disease.

Use with caution in psychosis or bipolar disorder. Discontinuation of treatment may be appropriate in the presence of treatment-emergent psychotic or manic symptoms. While aggressive behavior is often observed in children or adolescents with ADHD, patients beginning treatment should be monitored for the appearance of or worsening of aggressive behavior or hostility.

Suppression of growth has been reported with long-term use of stimulants. Stimulants should be used with caution in patients with a prior history of
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SOURCE Novartis Pharmaceuticals Corporation
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