Methylphenidate, Transdermal

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KEY POINTS

• This medicine is a patch put on the skin to treat attention deficit hyperactivity disorder (ADHD). Use it exactly as directed.
• Keep all appointments for checkups to see how this medicine affects you.
• This medicine may cause serious or life-threatening heart problems, or new or worsening mental or behavioral symptoms. It may cause other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: stimulant

Generic and brand names: methylphenidate, transdermal; Daytrana

What is this medicine used for?

This medicine is a patch put on the skin to treat attention deficit hyperactivity disorder (ADHD). It may be used along with therapy and education to treat this condition.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Do not take this medicine if you have:

• A history of anxiety, tension, or agitation
• Glaucoma
• Motor tics or Tourette's syndrome

Do not take this medicine if you have taken an MAO inhibitor within the past 14 days. You may have serious side effects. Talk with your healthcare provider about this.

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Circulation problems, such as Raynaud’s disease or peripheral vascular disease
• Epilepsy or other seizure disorder
• Heart disease or heart rhythm problems
• High blood pressure
• Mental health problems such as anxiety, bipolar disorder, depression, or schizophrenia
• Problems with alcohol or drug abuse
• Skin problems such as eczema, psoriasis, contact dermatitis, vitiligo, or reactions to soaps or other products used on your skin
• Thyroid problems

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Do not use the medicine for any other conditions without your healthcare provider's approval. Use it exactly as prescribed. Do not use more or less or use it longer than prescribed. Do not stop taking this medicine without your healthcare provider's approval.

Check with your healthcare provider before using this medicine in children under age 6.

Do not use a heating pad, electric blanket, hot tub, sauna, or other direct heat where you apply the patch. These may increase the amount of medicine released from the patch and could result in an overdose.

Just before you apply the patch, remove it from the sealed pouch. Do not store the patch outside of the sealed pouch.

The patch should be worn for about 9 hours each day. For example, if the patch is applied at 6 AM, it should be removed at 3 PM the same day. Apply the patch at the same time every day. Follow the instructions in the medicine package carefully for using the patch. Use the Dosing Chart included in the medicine package to write down when you apply the patch each morning and when you remove the patch. Do not cut the patch.

Bathing, swimming, or showering may loosen the patch or make it fall off. If a patch falls off, do not touch the sticky side of the patch with your fingers. Put a new patch on a different area of the same hip. If a new patch must be put on, remove it 9 hours after the first patch for that day was applied. Do not use bandages, tape, or other adhesives to hold the patch on the skin.

What if I miss a dose?

If you forget to apply a patch in the morning, you may do so later in the day. However, remove the patch at the usual time of day to reduce the chance of late day side effects. Do not wear a patch longer than 9 hours a day. Do not apply extra patches to make up for a missed dose. If you are not sure of what to do, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: vomiting, restlessness, tremors, muscle twitching, seizures, confusion, hallucinations, sweating, fast or pounding heartbeat, blurred vision, headache, fever, flushing, dry mouth or nose, fainting.

What should I watch out for?

This medicine may cause serious or life-threatening heart problems. Some stimulants have been linked to sudden death in children who have heart problems or heart defects. Some stimulants have also been linked to sudden death, stroke, and heart attacks in adults. Your healthcare provider will check you carefully for any heart problems before taking this medicine.

Your healthcare provider should check blood pressure and heart rate regularly during treatment with this medicine. Call your healthcare provider right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking this medicine.

This medicine can be habit-forming. If you use this medicine for a long time, you may become dependent on it. If you do not use this medicine correctly, it may not work as well. It may also cause abnormal behavior. Call your healthcare provider right away if you notice any new or worsening mental symptoms or problems while taking this medicine, especially:

• More outgoing or aggressive behavior than normal
• Hallucinations (seeing or hearing things that are not real)
• Psychosis (believing things that are not real)
• Paranoia (unusually suspicious)

This medicine is a controlled substance. It is illegal to give this medicine to anyone else.

Do not use this medicine for normal tiredness or as a stimulant. It can be habit-forming.

This medicine should be given by an adult when prescribed for a child. Do not give this medicine to a child under 6 years of age without your healthcare provider’s approval. When taken for a long time, this medicine may interfere with the growth of children. Talk to your healthcare provider about this.

You may need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

This medicine may cause blurred vision or dizziness. Do not allow your child to operate machinery unless he or she is fully alert and can see clearly.

This medicine may cause areas of the skin to permanently lose color. Contact your healthcare provider right away if you notice areas of lighter skin while using the patch. This medicine may irritate the skin or cause an allergic skin rash. Contact your provider if blistering, redness, or swelling in the area around the patch continues or gets worse 24 hours after the patch is removed.

Rarely, this medicine may cause problems with the blood vessels in your fingers or toes. Contact your healthcare provider right away if your fingers or toes feel numb, cool, painful, or change color from pale, to blue, to red, or if you have unexplained wounds or sores on your hands or feet while taking this medicine.

Rarely, this medicine may cause a painful erection of the penis that will not return to normal. If this happens, contact your healthcare provider or get medical care right away. It can lead to permanent erectile dysfunction if not treated.

This medicine may cause trouble sleeping. Wearing the patch for less than 9 hours per day may help. Talk with your provider about this.

I If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are using this medicine. The patch may need to be removed before certain tests or procedures such as MRIs.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat), seizures (may be followed by coma).

Serious (Report these to your healthcare provider right away.): Mood changes, sudden vision changes or blurred vision, chest pain, shortness of breath, fainting or severe dizziness, twitching, irregular or fast heartbeat, severe weakness and sweating, severe rash; numbness, pain, or skin color changes; new or worsening anxiety or severe nervousness; uncontrollable head, neck, mouth, arm or leg movements; unusual or ongoing muscle pain, tenderness, or weakness, especially if you also have a fever or unusual tiredness; hallucinations; unusual thoughts or behavior; severe redness, blisters, or swelling in the area around the patch.

Other: Mild skin redness or itching, loss of appetite, weight loss, nervousness, headache, stuffy nose, trouble sleeping, nausea, vomiting, stomach pain, dizziness, drowsiness.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• ACE inhibitors such as benazepril (Lotensin), captopril, enalapril (Vasotec), fosinopril, lisinopril (Prinivil, Zestril), quinapril (Accupril), and ramipril (Altace)
• Allergy, cold, or cough medicines that contain phenylephrine (Neo-Synephrine, Sudafed PE) or pseudoephedrine (Sudafed)
• Alpha blockers such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), silodosin (Rapaflo), tamsulosin (Flomax), and terazosin
• Angiotensin receptor blockers (ARBs) such as azilsartan (Edarbi), candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), telmisartan (Micardis), and valsartan (Diovan)
• Antidepressants such as amitriptyline, citalopram (Celexa), clomipramine, desipramine (Norpramin), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nortriptyline (Pamelor), and sertraline (Zoloft)
• Antipsychotic medicines such as chlorpromazine, haloperidol (Haldol), olanzapine (Zyprexa), risperidone (Risperdal), thioridazine, trifluoperazine, and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Atomoxetine (Strattera)
• Beta blockers such as acebutolol (Sectral), atenolol (Tenormin), bisoprolol (Zebeta), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), nebivolol (Bystolic), pindolol, and sotalol (Betapace, Sorine)
• Caffeine
• Calcium channel blockers such as amlodipine (Norvasc), amlodipine/atorvastatin (Caduet), diltiazem (Cardizem, Cartia, Tiazac), felodipine, isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), nisoldipine (Sular), and verapamil (Calan, Covera, Verelan)
• Clonidine (Catapres, Kapvay)
• Diuretics (water pills) such as amiloride, bumetanide, chlorothiazide (Diuril), furosemide (Lasix), hydrochlorothiazide (Microzide), spironolactone (Aldactone), torsemide (Demadex), and triamterene (Dyrenium)
• Doxepin (Silenor)
• Ephedrine
• Epinephrine (Adrenalin, Asthmanefrin, Auvi-Q, EpiPen)
• Linezolid (Zyvox)
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Medicines to treat breathing or lung problems such as albuterol (ProAir, Proventil, Ventolin), arformoterol (Brovana), levalbuterol (Xopenex), pirbuterol (Maxair), salmeterol (Serevent), and theophylline
• Midodrine
• Natural remedies such as ephedra, guarana, St. John's wort, and yohimbe
• Other stimulants and diet pills such as armodafinil (Nuvigil), benzphetamine (Regimex), dexmethylphenidate (Focalin), dextroamphetamine (Dexedrine), diethylpropion (Tenuate), lisdexamfetamine (Vyvanse), methamphetamine (Desoxyn), methylphenidate (Concerta, Daytrana, Metadate, Ritalin), modafinil (Provigil), phendimetrazine, and phentermine (Adipex-P, Suprenza)
• Parkinson’s disease medicines such as bromocriptine (Cycloset, Parlodel), levodopa/carbidopa (Duopa, Rytary, Sinemet), pramipexole (Mirapex), rasagiline (Azilect), and ropinirole (Requip)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Procarbazine (Matulane)
• Products that contain methylene blue (Hyophen, Prosed DS, Urophen, Uta)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Warfarin (Coumadin)

Do not drink alcohol while you are taking this medicine.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Do NOT refrigerate or freeze the patches. Keep the patches in pouches until ready to use. Protect from heat, high humidity, and bright light. Dispose of patches 2 months after you open the pouch. Carefully follow package instructions about how to dispose of this medicine.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.