Patient FAQ
Below you’ll find a list of commonly asked questions about Daytrana.
- Q. What happens if I leave the Daytrana patch on for more than 9 hours?
- A. It’s recommended that the patch be applied to the hip area 2 hours before an effect is needed and be worn for 9 hours; its effects continue for several hours more after it's removed. If the child wears it beyond 9 hours, he or she may experience increased side effects such as difficulty sleeping or lack of appetite. If these side effects or others become bothersome, please contact your child's doctor.
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- Q. Why must the Daytrana patch be applied to the hip?
- A. If applied elsewhere, the medication in the patch may be absorbed differently. This has not been adequately tested in clinical studies.
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- Q. What happens if I accidentally put the Daytrana patch on the same hip two days in a row?
- A. Placing the Daytrana patch on the same hip for two days in a row may increase the risk of skin irritation where the patch was applied. It is recommended that you alternate the hip on which the patch is worn every day to reduce the potential for irritation. You should also put the patch in a different place on the child’s hip each time.
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- Q. What is the active ingredient in Daytrana?
- A. The active ingredient in Daytrana is methylphenidate. Doctors have been using methylphenidate in pills to treat ADHD for over 50 years. What makes Daytrana different is its delivery method (transdermal patch technology) and dosage form. Because of this, some of the benefits and risks of Daytrana are different than those associated with oral forms of methylphenidate.
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- Q. What happens if the Daytrana patch gets wet while my child is wearing it?
- A. Exposure to water during bathing, swimming, or showering may affect patch adhesion. When properly applied, the Daytrana patch is designed to stay on and keep delivering medicine. If the patch falls off, discard the old patch and a new patch can be applied to a different area of the same hip. If a new patch is applied, the total wear time for that day should remain 9 hours. Do not use tape, bandages, or other household adhesives to reapply the patch that no longer adheres.
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- Q. If I take the Daytrana patch off of my child early one day, can I reuse it on another day?
- A. No. Anytime you take off the Daytrana patch, you should dispose of it properly (see Daytrana Application, Removal, and Disposal Instructions).
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- Q. What happens if I accidentally touch the sticky part, or get some adhesive on my hands?
- A. If you touch the sticky part with your fingers, wash your hands immediately after application to avoid absorbing the medication.
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- Q. What if my child is pregnant?
- A. If your child is pregnant or sexually active tell the doctor before using Daytrana. If your child takes methylphenidate, it may be in her breast milk. Be sure to tell the doctor if your child is nursing a baby.
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- Q. What happens if I accidentally cut the patch when removing it from the protective pouch?
- A. If you cut or damage the patch when removing it from the protective pouch, do not use it. Throw away the damaged patch and use a new one.
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- Q. Is skin redness common?
- A. Because Daytrana is a patch that sticks to the skin, you and your child may notice mild skin redness or itching. This is common when using Daytrana and in most cases, skin irritation disappears within 24 hours.
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- Q. How can I reduce skin redness?
- A. To minimize potential skin side effects, use Daytrana as prescribed by your child’s doctor.
- Alternate the hip on which the patch is applied every day.
- Always remove the patch gently from your child’s skin.
- If needed, use an oil-based product such as petroleum jelly to remove patch adhesive residue from skin.
- Showers or baths are best taken in the evening using mild soaps, followed by the use of moisturizers. Do not use moisturizer before applying the patch in the morning.
IMPORTANT: Before you apply a new Daytrana patch, skin must be clean and dry, with NO powder, oil, lotion, cuts, or irritation. Do not wash with soap or apply creams or lotions immediately before applying patch.
If redness is accompanied by a more intense skin reaction that does not significantly improve within 48 hours or spreads beyond the patch site, discontinue use and contact your physician.
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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.
©2010 Shire US Inc., Wayne, PA 19087, (800) 828-2088. All rights reserved.
Daytrana® is a registered trademark of Shire Pharmaceuticals Ireland Limited.
DAY-00507 07/10
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