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. Daytrana® was developed and is manufactured by Noven and, as of October 1, 2010, the product is marketed and sold by Noven Therapeutics, Noven's specialty pharmaceuticals unit.

The Daytrana patch contains a prescription central nervous system (brain) stimulant medicine used to treat ADHD in children 6 to 17 years old. Daytrana may help increase attention and decrease impulsive and hyperactive behavior. The Daytrana patch should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

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. 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.

The Daytrana patch should not be used if your child has been diagnosed as very anxious, tense, or agitated; has an eye problem called glaucoma; has tics (repeated movements or sounds that cannot be controlled); has a diagnosis or family history of Tourette's syndrome; is taking a monoamine oxidase inhibitor (MAOI) medicine or has discontinued an MAOI medicine in the last 2 weeks; or is allergic to methylphenidate, acrylic adhesive, or silicone adhesive (does not contain latex).

Serious heart problems have been reported with the Daytrana patch 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 the Daytrana patch 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 the Daytrana patch.

Be sure to tell the doctor if your child is pregnant or breast feeding.

Serious side effects such as seizures (this usually happens in children with a history of seizures), slowing of growth (weight and height), eyesight changes or blurred vision have been reported with the Daytrana patch. Your child should have their height, weight, and blood work checked while using the Daytrana patch and your doctor may stop treatment if a problem is found during these check-ups.

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 medicine has been applied. Avoid exposing the Daytrana patch to direct external heat sources such as hair dryers, heating pads, electric blankets, heated water beds, or other heat sources while wearing the patch. Heating the patch could cause too much medicine to pass into your child's body and cause serious side effects.

Most common side effects seen while using the Daytrana patch 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 read Medication Guide and Full Prescribing Information including the Boxed 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:

Daytrana® Information
11960 SW 144th Street
Miami, FL 33186
Tel: 877-567-7857

 

Copyright © 2012 Noven Pharmaceuticals, Inc. All rights reserved.