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
Important Safety Information
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. Patients should avoid applying external heat to the Daytrana patch. Erythema has been commonly reported. Contact sensitization may occur.
Daytrana should be given cautiously to patients with a history of drug dependence and alcoholism. Chronic abuse can lead to marked tolerance and psychological dependence. 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.
Common adverse events reported by patients who received Daytrana in clinical trials were decreased appetite, insomnia, nausea, vomiting, decreased weight, tics, affect lability, and anorexia, consistent with adverse events commonly associated with the use of methylphenidate.
©2008 Shire US Inc., Wayne, PA 19087-5367, (800) 828-2088. All rights reserved.
Daytrana® is a registered trademark of Shire Pharmaceuticals Ireland Limited.
DAY-00032 08/08
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