Methylphenidate (Transdermal route)
- Patch, Extended Release
Warnings:Transdermal route(Patch, Extended Release)
Give 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 drug withdrawal from abusive use since severe depression may occur .
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 total 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:
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.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of methylphenidate transdermal in the pediatric population. However, safety and efficacy have not been established in children younger than 6 years of age.
Appropriate studies on the relationship of age to the effects of methylphenidate transdermal have not been performed in geriatric patients.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
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.
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.
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.
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.
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.
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:
- Agitation, severe or
- Anxiety, severe or
- Glaucoma or
- Motor tics (repeated muscle movements) or
- Tension, severe or
- Tourette's syndrome, or family history of—Should not be used in patients with these conditions.
- 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, Raynaud's phenomenon) or
- Coronary artery disease or
- Depression, or a family history of or
- Heart attack, recent or
- Heart disease (eg, cardiomyopathy) or
- Heart failure or
- Heart rhythm problems (eg, ventricular arrhythmia), or a family history of or
- Hypertension (high blood pressure) or
- Priapism (painful or prolonged erection of the penis) or
- Psychosis (mental illness), history of or
- Seizures, history of or
- Stroke, history of or
- Tachycardia (increased heart rate)—Use with caution. May make these conditions worse.
- Skin problems (eg, eczema, psoriasis)—This medicine may cause skin irritation.
Proper Use of This Medicine:
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:
- Methylphenidate patches come with patient instructions. Read them carefully before using this medicine. It will work only if applied correctly.
- 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.
- Apply the patch after removing it from the protective pouch. Apply it 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 a clean, dry, intact skin area on your hip. Choose an area with little or no hair and free of scars, cuts, or irritation. A different place on either hip should be used each day. Avoid putting the patch on areas (eg, waistline) where it could be rubbed off by tight clothing.
- 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 apply any medicine, cream, or lotion on the skin at the application site before applying the patch.
- The patch should stay in place when you are showering, bathing, or swimming. Apply a new patch if one falls off. But, the total amount of time you wear a patch for that day should not be longer than the amount of time your doctor ordered for each day.
- Remove the patch about 9 hours after it was applied, or as directed by your doctor.
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 (ADHD):
- Adults, teenagers, and children 6 years of age and older—One patch applied on the hip 2 hours before the desired effect.
- Children younger than 6 years of age—Use and dose must be determined by the doctor.
- For attention deficit hyperactivity disorder (ADHD):
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.
Store the patches at room temperature in a closed container, away from heat, moisture, and direct light.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
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. Throw any used patch away so that children or pets cannot get to it. There is still enough medicine in a used patch to make a child or pet very sick. When throwing away a patch, fold it in half with the sticky sides together and flush it down the toilet, and then wash your hands thoroughly with soap and water. When you stop treatment with this medicine, take all of the leftover patches out of the pouches and flush them down the toilet. Do not flush the pouches or the protective liners down the toilet. Put them in a trash can with a cover. You will also need to throw away old patches after the expiration date has passed.
Precautions While Using This Medicine:
Your doctor should check you or your child's 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 or your child will also need to have your blood pressure measured before starting this medicine and while you are using it. If you notice any change to you or your child's recommended blood pressure, call your doctor right away. If you have questions about this, talk to your doctor.
You should not use this medicine if you or your child have 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 or your child have chest pain, trouble breathing, or fainting while using this medicine.
If you or your child have any redness, itching, swelling, or blistering where the patch has been, call your doctor right away.
Tell your doctor right away if you or your family notices any unusual changes in behavior, such as an increase in aggression, hostility, agitation, irritability, or suicidal thinking or behaviors. Also tell your doctor if you or your child have hallucinations or any unusual thoughts, especially if they are new or getting worse quickly.
This medicine may cause a condition called Raynaud's phenomenon. Check with your doctor right away if you or your child have tingling or pain in the fingers or toes when exposed to cold, paleness or cold feeling in fingertips and toes, or 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 to make sure that your child is growing properly.
If you or your child experience a prolonged or painful erection of the penis for more than 4 hours, check with your doctor right away.
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.
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:
- 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 or discomfort
- chest tightness or heaviness
- cough or hoarseness
- cracks in the skin
- fast, pounding, or irregular heartbeat or pulse
- flu-like symptoms
- heavier menstrual periods
- joint or muscle pain
- loss of heat from the body
- 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
- twitching, twisting, or uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
- unusual bleeding or bruising
- unusual tiredness or weakness
- difficulty with breathing
- high fever
- increased sweating
- loss of bladder control
- severe muscle stiffness
- 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
- troubled breathing with exertion
- Symptoms of overdose
- Confusion as to time, place, or person
- false or unusual sense of well-being
- holding false beliefs that cannot be changed by fact
- muscle twitching
- overactive reflexes
- unusual excitement, nervousness, or restlessness
- More common
- Abdominal or stomach pain
- decreased weight
- difficulty with moving
- hives or welts
- loss of appetite
- muscle pain or stiffness
- redness of the skin
- trouble sleeping
- 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
- halos around lights
- increased sensitivity of the eyes to light
- night blindness
- overbright appearance of lights
- thinning of the hair
- tunnel vision
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:
Get emergency help immediately if any of the following symptoms of overdose occur:
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:
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.
Last Updated: 11/4/2014