Clinical Results - All Day Control
When tested against a placebo, Daytrana delivered symptom control throughout the day and demonstrated significant improvement in behavior, from classroom to homework time.
- Daytrana delivered significant efficacy across the day and at home4
- Consistent with adverse events (AEs) commonly associated with the use of MPH, common AEs reported by patients who received Daytrana in 2 pivotal trials were decreased appetite, insomnia, nausea, vomiting, decreased weight, tics, affect lability, anorexia, and headache.2,6
Study 201: Randomized, double-blind, placebo-controlled analog classroom study of 93 subjects, aged 6 to 12 years, who met DSM-IV-TR®† criteria for a primary diagnosis of ADHD.4 The majority of subjects were categorized as moderately (55.9%) or markedly (34.4%) ill on the CGI-S.§ 5
* Swanson, Katkin, Agler, M-Flynn, and Pelham.
† Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision.
DSM-IV-TR® is a registered trademark of the American Psychiatric Association.
§Clinical Global Impressions—Severity of Illness.
Continuous Delivery
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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