Clinical Results - Continuous Delivery
When worn for the recommended 9 hours, the Daytrana Patch provides continuous delivery of MPH for smooth blood levels throughout the day.
- When the patch is worn for the recommended 9 hours, ascending plasma concentration curve results from continuous delivery of MPH.7.8
- Delivers MPH for as long as the patch is worn. 2,7,8
- In an analog classroom study, shorter wear time (4 and 6 hours) produced significant improvement in behavior vs placebo at all time points measured (2 to 10 hours). After patch removal, effects gradually decreased toward predose scores.*†1
Lower limit of quantification (0.25ng/mL).
Study 201: Drug concentration from multiple-dose administration of Daytrana in a randomized, double-blind, placebo-controlled laboratory classroom study.
*As measured on the SKAMP Department scale.
†Study 304: Randomized, double-blind, placebo-controlled, analog classroom study of 128 subjects aged 6 to 12 years.
Physicians Report Control
INDICATION
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 Daytrana was established in controlled clinical studies: two 7-week trials in children and one 7-week trial in adolescents. 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.
Daytrana should not be used in patients who have an allergy to methylphenidate or other patch components; marked anxiety, tension, and agitation; glaucoma; motor tics or with a diagnosis or a family history of Tourette’s syndrome; seizures; are being treated (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 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 (ie, exertional chest pain, unexplained syncope) suggestive of cardiac disease while taking Daytrana 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.
Use with caution in patients with a history of psychosis, EEG abnormalities, bipolar disorder, and depression. New psychosis, mania, aggression, 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 have their treatment interrupted.
Use of Daytrana 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.
The most common adverse reactions associated with Daytrana (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 see Full Prescribing Information, including Boxed Warning regarding Drug Dependence.
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Daytrana® is a registered trademark of Shire Pharmaceuticals Ireland Limited.
DAY-00507 07/10
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