Methylphenidate (Oral Route, Transdermal Route)

Drug Information provided by: Micromedex

ARTICLE SECTIONS

US Brand Names

Concerta
Daytrana
Metadate CD
Metadate ER
Methylin

Methylin ER
Ritalin
Ritalin LA
Ritalin-SR

Description

Methylphenidate belongs to the group of medicines called central nervous system (CNS) stimulants. It is used to treat attention deficit hyperactivity disorder (ADHD) and narcolepsy, which is an uncontrollable desire for sleep or a sudden attack of deep sleep .

Methylphenidate works in the treatment of ADHD 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 .

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although not specifically included in product labeling, methylphenidate may be used in certain patients with the following condition:

Depressive disorder secondary to physical illness in patients who cannot take antidepressant medicines .

This product is available in the following dosage forms:

Patch, Extended Release
Tablet, Extended Release
Solution
Tablet
Capsule, Extended Release
Tablet, Chewable

Before Using

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.

Pediatric

Appropriate studies performed to date have not demonstrated pediatrics-specific problems that would limit the usefulness of methylphenidate in children. Safety and efficacy have not been established in children under 6 years of age .

Geriatric

No information is available on the relationship of age to the effects of methylphenidate in geriatric patients .

Pregnancy

	Pregnancy Category	Explanation
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.

Breastfeeding

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.

Drug Interactions

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.

Clorgyline
Iproniazid
Isocarboxazid
Lazabemide
Moclobemide
Nialamide
Pargyline
Phenelzine
Procarbazine
Selegiline
Toloxatone
Tranylcypromine

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. Discuss with your healthcare professional the use of your medicine with 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 (or history of) or
Drug abuse or dependence (or history of)—Dependence may be more likely to develop .

Blood vessel problems or
Depression, severe or
Heart disease or failure or
Heart rhythm problems or
Hypertension (high blood pressure) or
Hyperthyroidism (overactive thyroid) or
Psychosis (mental illness) or
Seizures, history of or
Tachycardia (rapid heart rate)—May make these conditions worse .

Skin problems (e.g., eczema, psoriasis)—Skin patch may cause skin irritation .

Proper Use

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may become habit-forming. If you or your child think this medicine is not working properly after you have taken it for several weeks, check with your doctor first and do not increase the dose .

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one .

To help prevent trouble with sleeping, take the last dose of the short-acting tablets before 6 p.m., unless your doctor gives you a different time .

If you or your child are taking the long-acting forms of this medicine:

The Ritalin LA® capsules and Ritalin SR® tablets are to be swallowed whole. Do not break, open, crush, or chew them before swallowing .
If you are taking the Concerta® brand of the extended-release tablets, you may sometimes notice what looks like a tablet in your stool. This is the empty tablet shell that is left after the medicine has been absorbed into your body .
If you or your child are unable to swallow the Ritalin LA® extended-release capsule whole, carefully open the capsule and sprinkle the small beads over a spoonful of applesauce. The mixture of drug and applesauce should be taken right away without chewing. The drug and applesauce mixture can not be stored for future use .

For patients using the transdermal system (skin patch):

Methylphenidate patches come with patient instructions. Read them carefully before using this medicine. Methylphenidate patches will work only if applied correctly.
Do not remove the patch from its sealed pouch until you are ready to put it on your skin. The patch may not work as well if it is unwrapped too soon.
Apply the patch 2 hours before the desired effect.
Do not try to trim or cut the patch to adjust the dose. Check with your doctor if you think the medicine is not working as it should.
Apply the patch to a clean, dry area of skin on your hip. Choose an area that is not very oily, has little or no hair, and is free of scars, cuts, burns, or any other skin irritation. A different place on either hip should be used each day. The patch should not be applied to the waistline or where tight clothing may rub it.
Press the patch firmly in place with the palm of your hand for about 10 seconds. Make sure there is good contact with your skin, especially around the edges of 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.
After removing a used patch, fold it in half with the sticky sides together. Place the folded, used patch in its protective pouch or in aluminum foil. Make sure to dispose of it where children and pets will not find it.

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 attention deficit hyperactivity disorder (ADHD):
- For the short-acting oral dosage form (tablets):
  - Adults and teenagers—5 to 20 milligrams (mg) two or three times a day, taken 30 to 45 minutes before meals .
  - Children 6 years of age and older—To start, 5 milligrams (mg) two times a day, taken before breakfast and lunch. If needed, your doctor may increase the dose once a week by 5 to 10 mg a day until symptoms improve or a maximum dose of 60 mg is reached .
  - Children up to 6 years of age—Use and dose must be determined by the doctor .
- For the long-acting oral dosage form (sustained-release tablets):
  - Adults, teenagers, and children over 6 years of age—The dose must be determined by the doctor .
  - Children up to 6 years of age—Use and dose must be determined by the doctor .
- For the long-acting oral dosage form (extended-release capsules):
  - Adults, teenagers, and children over 6 years of age—10 to 20 milligrams (mg) once a day, taken in the morning before breakfast. If needed, your doctor may increase the dose once a week by 10 mg a day as needed up to 60 mg a day .
  - Children up to 6 years of age—Use and dose must be determined by the doctor .
- For the transdermal (stick-on) skin patch:
  - Adults, teenagers, and children over 6 years of age—The dose must be determined by the doctor .
  - Children up to 6 years of age—Use and dose must be determined by the doctor .
For narcolepsy:
- For the short-acting oral dosage form (tablets):
  - Adults and teenagers—5 to 20 milligrams (mg) two or three times a day, taken 30 to 45 minutes before meals .
- For the long-acting oral dosage form (sustained-release tablets):
  - Adults and teenagers—The dose must be determined by the doctor .

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

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

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

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.

Precautions

Your doctor should check your or your child's progress at regular visits to make sure this medicine is working properly and to decide if you should continue to take it .

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

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

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 .

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, shortness of breath, or fainting while taking this medicine .

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 have hallucinations or any unusual thoughts, especially if they are new or getting worse quickly.

If you or your child are using the transdermal skin patch, and you have any swelling or blistering where the patch has been, call your doctor right away .

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 .

Side Effects

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

Fast heartbeat
Increased blood pressure

Less common

Chest pain
Fever
Joint pain
Skin rash or hives

Rare

Black, tarry stools
Blistering, burning, itching, peeling, skin rash, redness, or other signs of irritation at site of patch
Blood in urine or stools
Blurred vision or other changes in vision
Convulsions
Crusting, dryness, or flaking of skin
Muscle cramps
Pinpoint red spots on the skin
Scaling, severe redness, soreness, or swelling of the skin
Uncontrolled vocal outbursts and/or tics (uncontrolled and repeated body movements)
Unusual bleeding or bruising

Incidence unknown

Confusion
Cracks in the skin
Delusions (false beliefs)
Depersonalization (feeling like surroundings are not real)
Depression (severe)
Hallucinations (seeing, hearing, or feeling things that are not there)
Hives or welts
Loss of heat from the body
Mood changes
Numbness of hands
Painful or difficult urination
Pale skin
Red, irritated eyes
Red, swollen, or scaly skin
Severe or sudden headache
Shortness of breath
Sore throat
Sores, ulcers, or white spots on the lips or in the mouth
Sudden loss of coordination
Sudden slurring of speech
Swollen glands
Troubled breathing with exertion
Unusual behavior
Unusual tiredness or weakness
Weight loss
Yellow skin or eyes

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

Symptoms of overdose

Agitation
Confusion (severe)
Convulsions
Dryness of mouth or mucous membranes
False sense of well-being
Fast, pounding, or irregular heartbeat
Fever
Flushing
Hallucinations (seeing, hearing, or feeling things that are not there)
Headache (severe)
Increased blood pressure
Increased sweating
Large pupils
Muscle twitching
Overactive reflexes
Sweating
Trembling or shaking
Vomiting

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