Daytrana is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children (ages 6-12) and adolescents (ages 13-17). The efficacy of the Daytrana patch was established in controlled clinical studies: two 7-week trials in children and one 7-week trial in adolescents. Diagnosis of ADHD is based on complete patient history and evaluation, not just DSM-IV-TR® characteristics. Daytrana is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, and social).
Important Safety Information
WARNING: DRUG DEPENDENCE
Daytrana should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during 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.
Contraindications: The Daytrana patch should not be used by patients who have an allergy to methylphenidate, acrylic adhesive, or silicone adhesive (does not contain latex); marked anxiety, tension, and agitation; glaucoma; motor tics or with a diagnosis or a family history of Tourette's syndrome; are being treated (or within 14 days after treatment) with monoamine oxidase inhibitors (MAOIs).
Serious Cardiovascular Effects: 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. A careful patient history, including family history, and physical exam should be performed to assess the presence of cardiac disease. 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. Patients who develop symptoms (i.e., exertional chest pain, unexplained syncope) suggestive of cardiac disease while using or wearing the Daytrana patch should be promptly evaluated. Use with caution in patients whose underlying medical condition might be affected by increases in blood pressure or heart rate. Use cautiously with pressor agents. Hematologic monitoring is advised during prolonged treatment.
Psychiatric, Seizures, and Growth Suppression: Use with caution in patients with a history of psychosis, bipolar disorder, depression, seizures, or EEG abnormalities. New psychosis, mania, aggression, seizures, visual disturbances, and growth suppression have been associated with the use of stimulants. Growth should be monitored in children during treatment with stimulants, and patients who are not growing (gaining height or weight) as expected may need to suspend treatment with Daytrana.
Contact Sensitization: Use of the Daytrana patch may lead to contact sensitization. Erythema has been commonly reported and is not by itself an indication of sensitization. If contact sensitization is suspected (erythema with edema, papules and/or vesicles spread beyond the patch site and/or lack of improvement within 48 hours), treatment should be discontinued. Patients should avoid applying external heat to the Daytrana patch; application of heat can increase the extent and rate of absorption.
Most Common Adverse Events: The most common adverse reactions associated with the Daytrana patch (at least 5% and twice the rate of placebo-treated patients) in clinical trials were: children – decreased appetite, insomnia, nausea, vomiting, decreased weight, tics, affect lability, and anorexia; adolescents – decreased appetite, nausea, insomnia, decreased weight, dizziness, abdominal pain, and anorexia. In addition, the majority of subjects in these studies had minimal to definite skin erythema at the patch application site. Leaving the patch on for longer than the recommended 9 hours has resulted in an increased incidence of adverse events.
Please read Full Prescribing Information, including Medication Guide and Boxed Warning regarding Drug Dependence.