Daytrana

Daytrana is a prescription medication used to treat Attention-Deficit Hyperactivity Disorder (ADHD). Daytrana belongs to a group of drugs called central nervous system (CNS) stimulants, which works by changing the amount of natural substances in the brain to decrease impulsiveness and hyperactivity.

This medication comes as a patch and is applied to the hip area 2 hours before an effect is needed and should be removed 9 hours after application.

Common side effects of Daytrana include redness, small bumps, itching where you apply Daytrana patch.

Daytrana is a prescription medication used to treat attention-deficit hyperactivity disorder (ADHD).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Noven Therapeutics, Llc

Serious side effects have been reported with Daytrana. See “Daytrana Precautions” section.

Daytrana may cause serious side effects, including:

• seizures, mainly in patients with a history of seizures
• slowing of growth (weight and height)
• eyesight changes or blurred vision
• allergic skin rash (patch form) Stop using Daytrana patch and see your doctor right away if you have swelling or blisters at or around the application site. You may have a skin allergy to the patch. People who have skin allergies to Daytrana patch may develop an allergy to all medicines that contain methylphenidate, even those methylphenidate medicines that are taken by mouth.

The most common side effects of Daytrana include:

• poor appetite
• nausea
• vomiting
• stomach pain
• weight loss
• tics
• trouble sleeping
• mood swings
• dizziness
• redness, small bumps, itching where you apply Daytrana patch

This is not a complete list of Daytrana side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements. Daytrana and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking Daytrana.

Your doctor will decide whether Daytrana can be taken with other medicines.

Especially tell your doctor if you or your child takes:

• anti-depression medicines including MAOIs
• seizure medicines
• blood thinner medicines
• blood pressure medicines
• cold or allergy medicines that contain decongestants

Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist.

Do not start any new medicine while taking Daytrana without talking to your doctor first.

June 24, 2015 - The FDA issued a warning that permanent loss of skin color may occur with use of the Daytrana patch. This skin condition is known as chemical leukoderma. It causes the skin to lose color due to repeated exposure to specific chemical compounds. The condition is not physically harmful, but it is disfiguring. The areas of skin color loss described with the Daytrana patch ranged up to 8 inches in diameter. This condition is not thought to be reversible. Watch for new areas of lighter skin, especially under the drug patch, and immediately report these changes to your healthcare provider. Do not stop using the Daytrana patch without first talking to your healthcare provider. If you experience skin color changes, your healthcare provider will consider alternative treatments.

The following have been reported with use of Daytrana and other stimulant medicines.

• Heart-related problems:
  • sudden death in patients who have heart problems or heart defects
  • stroke and heart attack in adults
  • increased blood pressure and heart rate

Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems.

Your doctor should check you or your child carefully for heart problems before starting Daytrana.

Your doctor should check your or your child's blood pressure and heart rate regularly during treatment with Daytrana.

Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Daytrana.

• Mental (psychiatric) problems:
  • All Patients
    • new or worse behavior and thought problems
    • new or worse bipolar illness
    • new or worse aggressive behavior or hostility
  • Children and Teenagers
  • new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms

Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.

Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking Daytrana, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

Do not take Daytrana if you or your child:

• are very anxious, tense, or agitated
• have an eye problem called glaucoma
• have tics or Tourette’s syndrome, or a family history of Tourette's syndrome. Tics are hard to control repeated movements or sounds.
• are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI.
• are allergic to anything in Daytrana

Daytrana should not be used in children less than 6 years old because it has not been studied in this age group.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Daytrana, there are no specific foods that you must exclude from your diet when receiving Daytrana.

Before starting Daytrana, tell your or your child's doctor about all health conditions (or a family history of) including:

• heart problems, heart defects, high blood pressure
• mental problems including psychosis, mania, bipolar illness, or depression
• tics or Tourette's syndrome
• seizures or have had an abnormal brain wave test (EEG)
• skin problems such as eczema or psoriasis, or have skin reactions to soaps, lotions, make-up, or adhesives/glues (patch form)

Tell your doctor if you or your child is pregnant, planning to become pregnant, or breastfeeding.

Tell your doctor about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if Daytrana will harm your unborn baby.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Daytrana falls into category C. There are no adequate animal or human studies; or studies in animals have shown a harmful and undesired effect on the unborn baby, yet there are no adequate and well-controlled studies in pregnant women.

This medication may be given to a pregnant woman if her healthcare provider believes that its benefits to the pregnant woman outweigh any possible risks to her unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Daytrana is excreted in human breast milk or if it will harm your nursing baby.

Use Daytrana exactly as prescribed by your doctor. Follow the directions on your prescription label carefully

• Use Daytrana exactly as your doctor tells you to.
• Your doctor may change your dose if needed.
• Apply Daytrana to your hip 2 hours before an effect is needed.
• Do not wear Daytrana longer than 9 hours a day.
• Apply Daytrana to a different hip each day.
• Do not cut Daytrana patches.
• Parents or caregivers should apply and remove Daytrana for their child if the child is not responsible enough to do so
• Your doctor may stop Daytrana treatment to check your ADHD symptoms.
• Your doctor may do certain blood tests and check your heart and blood pressure while you use Daytrana.
• If you forget to apply a patch in the morning, you may apply the patch later in the day. You should remove your patch at the usual time of day to lower the chance of side effects later in the day.
• If you have loss of appetite or trouble sleeping in the evening, ask your doctor if you can take the patch off earlier in the day.
• Contact with water while bathing, swimming, or showering can make the patch not stick well or make it fall off. If your patch falls off, do not touch the sticky side of the patch with your fingers. You may apply a new patch to a different area on the same hip. If you have to replace a patch that has fallen off, the total wear time for the first and second patch should not be more than a total of 9 hours in 1 day. Do not reapply the same patch that fell off.
• If you wear Daytrana longer than 9 hours, or if you wear more than 1 patch at a time, you have used too much Daytrana. Remove all Daytrana patches and wash the application sites right away. Call your local poison control center or go to the nearest hospital emergency room right away if you have vomiting, agitation, shaking, confusion or mental changes, see things that are not there (hallucinations), sweating, redness in your face, headache, or heartbeat changes.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended starting dose for patients new to or converting from another formulation of methylphenidate is 10 mg.

Daytrana (methylphenidate) should be applied to the hip area (using alternating sites) 2 hours before an effect is needed and should be removed 9 hours after application. Daytrana may be removed earlier than 9 hours if a shorter duration of effect is desired or late day side effects appear.

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Keep this and all medicines out of the reach of children.

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

Tell your doctor if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs.

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.