What is DAYTRANA?
DAYTRANA contains a prescription central nervous system (brain) stimulant medicine used to treat ADHD
in children and adolescents 6 to 17 years old. Use of DAYTRANA may help increase attention and
decrease impulsive and hyperactive behavior. DAYTRANA is a patch that you apply to your skin on your
hip. DAYTRANA should be used as a part of a total treatment program for ADHD that may include
counseling or other therapies. It is not known if DAYTRANA is safe and effective in children less
than 6 years.
IMPORTANT SAFETY INFORMATION
IMPORTANT:
DAYTRANA is a federally 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.
DAYTRANA 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.
Serious side effects have been reported with DAYTRANA or other stimulant medicines
including:
Heart problems including:
sudden death in people with heart problems or heart defects
stroke and heart attack in adults
increased blood pressure and heart rate
Remove DAYTRANA and call the doctor right away if your child has
any signs of heart problems such as chest pain, shortness of breath, or fainting. Tell
the doctor if your child or a family member has any heart problems, heart defects, or increased
blood pressure and heart rate.
Mental (psychiatric) problems 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 your doctor right away if your child has any new or worsening
mental symptoms or problems while using DAYTRANA . Tell the doctor about any mental
problems your child or family members have experienced including suicide or depression, bipolar
illness, mania, or psychosis.
Circulation problems in fingers and toes: fingers or toes may feel numb, cool,
painful and/or may change color from pale to blue, to red.
Tell your doctor if you have or your child has numbness, pain, skin color change, or
sensitivity to temperature in your fingers or toes
Call your doctor right away if you have or your child has any signs of unexplained
wounds appearing on fingers or toes while using DAYTRANA
Tell your doctor if you, your child, or a family member has a history of vitiligo.
Be sure to tell the doctor if your child is pregnant or breast feeding.
Possible serious side effects of DAYTRANA include:
Seizures (this usually happens in children with a history of seizures)Painful and prolonged erections (priapism). Because of the potential for lasting damage, seek
medical help right away.
Slowing of growth (weight and height) . You should have your child’s height and
weight checked while using DAYTRANA.Loss of skin color (chemical leukoderma) . Call your doctor immediately if you
have changes in your skin color.Allergic skin rash. Stop using DAYTRANA and see your doctor right away if you have
swelling or blisters at or around the application site. Eyesight changes or blurred vision.
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 DAYTRANA 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.
The most common side effects seen while using 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 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 http://www.fda.gov/medwatch or call 1-800-FDA-1088 .
DAYTRANA® is a registered trademark of Noven Therapeutics, LLC.
