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12-Month Study Demonstrated Tolerability and Efficacy of DAYTRANA,(methylphenidate transdermal system)

vention Center 12-Month Efficacy and Tolerability of MTS in Children with ADHD marion.glick@porternovelli.com jennifer.anello@porternovelli.com

Frank A. Lopez, MD; Oscar G. Bukstein, MD; Robert L. Findling, MD; John M. Turnbow, MD; Liza Squires, MD

Children's Developmental Center, Maitland, FL; Western Psychiatric Institute and Clinic, Pittsburgh, PA; University Hospitals of Cleveland, Cleveland, OH; Westex Clinical Investigations, Lubbock, TX; Shire US Inc., Wayne, PA

About DAYTRANA

DAYTRANA should not be used in patients with allergy to methylphenidate or patch components; marked anxiety, tension and agitation; glaucoma; tics, diagnosis or a family history of Tourette's syndrome; seizures; or during or within 14 days after treatment with monoamine oxidase inhibitors (MAOIs).

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 deaths, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses in ADHD. Physicians should take a careful patient history, including family history, and physical exam, to assess the presence of cardiac disease. Patients who report symptoms of cardiac disease such as exertional chest pain and unexplained syncope should be promptly evaluated. Use with caution in patients whose underlying medical condition might be affected by increases in blood pressure or heart rate.

New psychosis, mania, aggression, growth suppression, and visual disturbances have been associated with the use of stimulants. Use with caution in patients with a history of: psychosis; EEG abnormalities; bipolar disorder; depression. Growth and hematologic monitoring is advised during prolonged treatment. P
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