Daytrana® (methylphenidate transdermal system)

The first patch for ADHD

Daytrana®, approved for marketing in the U.S. by the FDA in April 2006, is the first and only transdermal medication approved to treat the symptoms of Attention Deficit Hyperactivity Disorder (ADHD). It is approved for children aged 6 to 17 years with ADHD. Shire plc, the market leader in ADHD therapy, is the global licensee of Daytrana®. Daytrana® was developed and is manufactured by Noven and, effective October 1, 2010, the product will be marketed and sold by Noven Therapeutics, LLC.

Important Safety Information

IMPORTANT:
Daytrana is a controlled substance (CII) because it can be abused or lead to dependence. Keep Daytrana in a safe place to protect it from theft and prevent misuse or abuse. Selling or giving away Daytrana may harm others and is against the law.

Tell the prescribing doctor if your child has ever abused or been dependent on alcohol, prescription medicines or street drugs.

Daytrana should not be used if your child is very anxious, tense, or agitated; has an eye problem called glaucoma; has tics (repeated movements or sounds that cannot be controlled), a diagnosis or family history of seizures, a diagnosis or family history of Tourette’s syndrome; or had an abnormal brain wave test (EEG); is taking a monoamine oxidase inhibitor (MAOI) medicine or has discontinued an MAOI medicine in the last 2 weeks; is pregnant or breastfeeding; or is allergic to methylphenidate or any other ingredients of Daytrana.

Serious heart problems have been reported with Daytrana or other stimulant medicines including:

  • sudden death in people with heart problems or heart defects
  • stroke and heart attack in adults
  • increased blood pressure and heart rate

Tell the doctor if your child or a family member has any heart problems, heart defects, or increased blood pressure and heart rate. Remove the Daytrana patch and call the doctor right away if your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while using Daytrana.

Serious mental (psychiatric) problems have been reported with Daytrana or other stimulant medicines including:

  • new or worse aggressive behavior, hostility, anger or irritability
  • new or worse bipolar illness or mania (an extreme increase in activity or talking)
  • new or worse psychosis (hearing or seeing things that are not real, being suspicious, or distrustful, believing things that are not true)
  • other unusual or extreme changes in behavior or mood

Tell the doctor about any mental problems your child or family members have including suicide or depression, bipolar illness, mania, or psychosis. Call the doctor right away if your child has any new or worsening mental symptoms or problems while using Daytrana.

Serious side effects such as seizures (this usually happens in people with a history of seizures), slowing of growth (weight and height), eyesight changes or blurred vision have been reported with Daytrana. Allergic skin rash may occur. Stop using Daytrana and see the doctor right away if swelling, bumps, or blisters happen at or around where the patch is applied.

If the patch is worn longer than 9 hours in a day, or if more than 1 patch is worn at a time, too much Daytrana has been used. Your child should not use hair dryers, heating pads, electric blankets, heated water beds or other heat sources while wearing a Daytrana patch. This could cause too much medicine to pass into your child’s body and cause serious side effects.

Your child should have his or her height and weight checked often while taking Daytrana and your doctor may stop treatment if a problem is found during these check-ups.

Most common side effects seen with Daytrana include skin problems (redness, small bumps, itching) where the patch is applied, poor appetite, nausea, vomiting, stomach pain, weight loss, tics, trouble sleeping, mood swings, and dizziness.

Please see Full Prescribing Information and Medication Guide including Warning regarding abuse and dependence.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

For full prescribing information and additional product information, go to www.daytrana.com.



For patient, physician and pharmacist inquiries
regarding Daytrana®, please contact:

Shire US Inc.
725 Chesterbrook Blvd.
Wayne, PA 19087
Ph: 800-828-2088

 

Copyright © 2010 Noven Pharmaceuticals, Inc. All rights reserved.