Pronunciation:

meth-il-FEN-i-date

Brand Names:

• Daytrana

Dosage Forms:

• Patch, Extended Release

Warnings:

Warning: Abuse, Misuse, and AddictionMethylphenidate has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including methylphenidate, can result in overdose and death, and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing methylphenidate, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout methylphenidate treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction .

Classifications:

Therapeutic—

CNS Stimulant

Chemical—

Amphetamine Related

Uses of This Medicine:

Methylphenidate transdermal is used to treat attention deficit hyperactivity disorder (ADHD). It belongs to the group of medicines called central nervous system (CNS) stimulants.

Methylphenidate transdermal works by increasing attention and decreasing restlessness in children and adults who are overactive, cannot concentrate for very long, or are easily distracted and impulsive. This medicine is used as part of a treatment program that also includes social, educational, and psychological treatment.

This medicine is available only with a doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of methylphenidate transdermal in children younger than 6 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies on the relationship of age to the effects of methylphenidate transdermal have not been performed in geriatric patients.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Isocarboxazid
• Linezolid
• Methylene Blue
• Ozanimod
• Phenelzine
• Procarbazine
• Rasagiline
• Safinamide
• Selegiline
• Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acenocoumarol
• Amifampridine
• Amphetamine
• Bupropion
• Cimetidine
• Citalopram
• Clomipramine
• Desflurane
• Desipramine
• Dexlansoprazole
• Dextroamphetamine
• Donepezil
• Ebrotidine
• Enflurane
• Escitalopram
• Esomeprazole
• Famotidine
• Fluoxetine
• Fluvoxamine
• Fosphenytoin
• Halothane
• Imipramine
• Iobenguane I 131
• Isoflurane
• Lansoprazole
• Lisdexamfetamine
• Methoxyflurane
• Nizatidine
• Omeprazole
• Pantoprazole
• Paroxetine
• Phenobarbital
• Phenprocoumon
• Phenytoin
• Primidone
• Rabeprazole
• Ranitidine
• Ranitidine Bismuth Citrate
• Risperidone
• Roxatidine
• Sertraline
• Sevoflurane
• Vilazodone
• Vortioxetine
• Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Carbamazepine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse, history of or
• Drug abuse or dependence, history of—Dependence may be more likely to develop.

• Bipolar disorder (manic-depressive illness), or a family history of or
• Blood vessel problems (eg, peripheral vasculopathy) or
• Hypertension (high blood pressure) or
• Priapism (painful or prolonged erection of the penis) or
• Psychosis (mental illness), history of or
• Raynaud phenomenon or
• Seizures, history of or
• Tachycardia (increased heart rate)—Use with caution. May make these conditions worse.

• Depression, or a family history of or
• Eye or vision problems (eg, angle closure glaucoma, intraocular pressure) or
• Heart attack, recent or
• Heart or blood vessel disease (eg, cardiomyopathy, coronary artery disease) or
• Heart failure or
• Heart rhythm problems (eg, ventricular arrhythmia), or a family history of or
• Stroke, history of or
• Tourette syndrome, or family history of or
• Vitiligo (skin disease), or family history of—Use with caution. May make side effects become worse.

Proper Use of This Medicine:

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

To use the skin patch:

• Wash your hands with soap and water before and after applying a patch. Do not touch your eyes until after you have washed your hands.
• Remove the patch from the protective pouch and apply it to the skin 2 hours before the desired effect.
• Do not cut it into smaller pieces and do not touch the sticky surface of the patch.
• Apply the patch to clean, dry skin on your hip. Choose an area with little or no hair that is free of scars, cuts, or irritation. Avoid putting the patch where it could be rubbed off by tight clothing (eg, waistline).
• A different place on either hip should be used each day.
• Press the patch firmly in place with the palm of your hand for about 30 seconds. Make sure there is good contact with your skin, especially around the edges of the patch.
• Do not place any medicine, cream, or lotion on the skin at the application site before applying the patch.
• Do not use tape, coverings, or adhesives with the patch.
• The patch should stay in place when you are showering, bathing, or swimming, but it may not stick as well after being exposed to water.
• If the patch falls off or is not sticking to the skin, apply a new one. The total amount of time you wear a patch each day, even if a second one is used, should not be longer than the amount of time your doctor ordered.
• Remove the patch 9 hours after it was applied or sooner if directed by your doctor.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For transdermal dosage form (skin patch):
  • For attention deficit hyperactivity disorder:
    • Children and adolescents 6 to 17 years—One patch applied to the hip 2 hours before the desired effect.
    • Children younger than 6 years—Use is not recommended.

Missed dose—

If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Store the patches at room temperature in a closed container, away from heat, moisture, and direct light.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Do not store unopened or unused patches in the refrigerator or freezer. Make sure you store the medicine in a safe and secure place to prevent others from getting it. Get rid of used patches as directed so that children or pets cannot get to them. There is still enough medicine in a used patch to make a child or pet very sick.

To dispose of this medicine, fold the patch in half with the sticky side inside. Wash your hands thoroughly with soap and water. If the patch has not been used, take it out of the pouch and remove the liner that covers the sticky side of the patch before folding it in half. Do not flush the pouch or the protective liner down the toilet. Put them in a trash can with a cover. Drop off any unused folded patches at a drug take-back location right away. If you do not have a drug take-back location near you, flush any folded patches down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm

Precautions While Using This Medicine:

Your doctor should check your progress at regular visits to make sure this medicine is working properly and to decide if you should continue to use it. Blood tests may be needed to check for unwanted effects.

You will need to have your blood pressure measured before starting this medicine and while you are using it. If you notice any change to your recommended blood pressure, call your doctor right away.

Do not use this medicine if you used a medicine for depression called an MAO inhibitor (MAOI), such as Eldepryl®, Marplan®, Nardil®, or Parnate®, within the past 14 days.

Methylphenidate may cause serious heart or blood vessel problems. This may be more likely in patients who have a family history of heart disease. Check with your doctor right away if you have chest pain, trouble breathing, or fainting while using this medicine.

If you have any redness, itching, swelling, or blistering where the patch has been, call your doctor right away.

Tell your doctor right away if you notice any unusual changes in behavior, such as an increase in aggression, hostility, agitation, irritability, or suicidal thinking or behaviors. Check with your doctor if you have hallucinations or any unusual thoughts, especially if they are new or getting worse quickly.

This medicine may cause a condition called Raynaud phenomenon. Check with your doctor right away if you have tingling or pain in the fingers or toes when exposed to cold, paleness or a cold feeling in the fingertips and toes, or a skin color change of your fingers while using this medicine.

This medicine may cause slow growth. If your child is using this medicine, the doctor will need to keep track of your child's height and weight.

Symptoms of an overdose include: agitation, blurred vision, change in consciousness, chest pain or discomfort, confusion, dark urine, diarrhea, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, fast, pounding, or irregular heartbeat or pulse, fever, headache, inability to speak, loss of consciousness, muscle cramps, spasms, pain, or stiffness, nausea, nervousness, overactive reflexes, pain or discomfort in the arms, jaw, back, or neck, pale, clammy skin, palpitations, pounding in the ears, seeing, hearing, or feeling things that are not there, seizures, shivering, slow or fast heartbeat, slurred speech, sweating, talking or acting with excitement you cannot control, temporary blindness, thirst, trembling or shaking, trouble breathing, unusual tiredness or weakness, vomiting, or weakness in the arm or leg on one side of the body, sudden and severe. Call your doctor right away if you notice these symptoms.

If you have a prolonged or painful erection of the penis for more than 4 hours, check with your doctor right away.

Using this medicine may cause loss of skin color where the patch is applied or on other areas of the skin. This usually occurs more often if you have a personal or family history of vitiligo. Call your doctor right away if you notice changes in skin color while using this medicine.

Methylphenidate may cause dizziness, drowsiness, or changes in vision. Do not drive a car, ride a bicycle, operate machinery, or do other things that might be dangerous until you know how this medicine affects you.

Avoid putting this medicine near external sources of direct heat, such as hair dyers, heating pads, electric blankets, heated water beds, or hot tubs.

Check with your doctor immediately if blurred vision, change in vision, eye pain, or loss of vision occurs during or after treatment. Your doctor may want you or your child to have your eyes checked by an ophthalmologist (eye doctor).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements, and medicine for appetite control, asthma, colds, cough, hayfever, or sinus problems.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Aggressive and violent behavior

arm, back, or jaw pain

black, tarry stools

blistering, peeling, or loosening of the skin

blood in the urine

bloody nose

chest pain, discomfort, heaviness, or tightness

chills

cold

confusion

cough or hoarseness

cracks in the skin

crying

depersonalization

diarrhea

dizziness

dysphoria

euphoria

fainting

fast, pounding, or irregular heartbeat or pulse

fever

flu-like symptoms

heavier menstrual periods

joint or muscle pain

loss of heat from the body

nausea

nervousness

paranoia

pinpoint red spots on the skin

quick to react or overreact emotionally

rapidly changing moods

red, irritated eyes

red, swollen skin

scaly skin

seeing, hearing, or feeling things that are not there

severe or sudden headache

skin rash or itching

sore throat

sores, ulcers, or white spots in the mouth or on the lips

sudden loss of coordination

sudden slurring of speech

sweating

twitching, twisting, or uncontrolled repetitive movements of the tongue, lips, face, arms, or legs

unusual bleeding or bruising

unusual tiredness or weakness

Rare

Difficulty with breathing

high fever

increased sweating

loss of bladder control

seizures

severe muscle stiffness

tiredness

uncontrolled vocal outbursts or tics (uncontrolled repeated body movements)

unusually pale skin

Incidence not known

Blistering, burning, crusting, dryness, or flaking of the skin

chest pain

difficulty with swallowing

hives, itching, scaling, severe redness, soreness, or swelling of the skin

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

painful or difficult urination

pale skin

paleness or cold feeling in the fingertips and toes

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

swollen glands

tingling or pain in the fingers or toes when exposed to cold

trouble breathing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Agitation

blurred vision

change in consciousness

chest pain or discomfort

confusion

dark urine

diarrhea

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fast, slow, or irregular heartbeat

fever

headache

inability to speak

loss of consciousness

muscle cramps, spasms, pain, or stiffness

nausea

nervousness

overactive reflexes

pain or discomfort in the arms, jaw, back, or neck

pale, clammy skin

palpitations

pounding in the ears

seeing, hearing, or feeling things that are not there

seizures

shivering

slow or fast heartbeat

slurred speech

sweating

talking or acting with excitement you cannot control

temporary blindness

thirst

tremor

trouble breathing

unusual tiredness or weakness

vomiting

weakness in the arm or leg on one side of the body, sudden and severe

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Decreased weight

difficulty with moving

drowsiness

headache

loss of appetite

muscle pain or stiffness

redness of the skin

stomach pain

trouble sleeping

vomiting

Less common

Decreased appetite

stuffy or runny nose

weight loss

Incidence not known

Bigger, dilated, or enlarged pupils (black part of the eye)

bleeding, bruising, burning, itching, redness, skin rash, swelling, or soreness at the application site

blurred or loss of vision

disturbed color perception

double vision

hair loss or thinning of the hair

halos around lights

increased sensitivity of the eyes to light

night blindness

overbright appearance of lights

tunnel vision

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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