methylphenidate Oral, Transdermal

meth-il-FEN-i-date

Oral route(Tablet;Tablet, Extended Release;Tablet, Chewable;Solution)

Use cautiously in emotionally unstable patients, such as those with a history of drug dependence or alcoholism, due to abuse potential. Chronic abuse can lead to marked tolerance and psychic dependence with varying degrees of abnormal behavior including psychotic episodes. Careful supervision during drug withdrawal, since severe depression as well as the effects of chronic overactivity can be unmasked .

Commonly used brand name(s)

In the U.S.

• Concerta


• Metadate CD


• Metadate ER


• Methylin


• Methylin ER


• Ritalin


• Ritalin LA


• Ritalin-SR

Available Dosage Forms:

• Tablet, Extended Release


• Capsule, Extended Release


• Tablet, Chewable


• Solution


• Tablet

Therapeutic Class: CNS Stimulant

Chemical Class: Amphetamine Related

Uses For methylphenidate

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. Narcolepsy 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. methylphenidate is used as part of a total treatment program that also includes social, educational, and psychological treatment.

methylphenidate 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.

Before Using methylphenidate

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 methylphenidate, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to methylphenidate 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 pediatric-specific problems that would limit the usefulness of methylphenidate in children. Safety and efficacy have not been established in children younger than 6 years of age.

Geriatric

Appropriate studies on the relationship of age to the effects of Concerta® extended release tablets have not been performed in the geriatric population. However, no geriatric-specific problems have been documented to date.

No information is available on the relationship of age to the effects of Ritalin® and Ritalin LA® 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.

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.

Interactions with 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 methylphenidate, 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 methylphenidate 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.

• Brofaromine


• Clorgyline


• Furazolidone


• Iproniazid


• Isocarboxazid


• Lazabemide


• Linezolid


• Moclobemide


• Nialamide


• Pargyline


• Phenelzine


• Procarbazine


• Rasagiline


• Selegiline


• Toloxatone


• Tranylcypromine

Using methylphenidate 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

Interactions with Food/Tobacco/Alcohol

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 methylphenidate. 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), history of or


• Blood vessel problems or


• Coronary artery disease or


• Depression, history of or


• Heart attack, recent or


• Heart disease (e.g., cardiomyopathy) or


• Heart failure or


• Heart rhythm problems (e.g., ventricular arrhythmia), history of or


• Hypertension (high blood pressure) or


• Hyperthyroidism (overactive thyroid) or


• Psychosis (mental illness), history of or


• Seizures, history of or


• Stroke, history of or


• Tachycardia (rapid heart rate)—Use with caution. May make these conditions worse.

• Cystic fibrosis or


• Stomach or bowel problems (e.g., bowel blockage, Meckel's diverticulum, peritonitis, short gut syndrome) or


• Trouble with swallowing—Concerta® extended release tablets should not be given in patients with these conditions.

Proper Use of methylphenidate

Take methylphenidate 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 methylphenidate is not working properly after you have taken it for several weeks, check with your doctor first and do not increase the dose.

methylphenidate 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 or your child a different time.

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

• The Concerta® extended release tablets, Ritalin LA® capsules, and Ritalin SR® tablets are to be swallowed whole with water or other liquids. Do not break, open, crush, or chew them before swallowing.


• 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.


• If you are taking the Concerta® 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.


• You may take Concerta® extended release tablets with or without food.

Dosing

The dose of methylphenidate 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 methylphenidate. 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 short-acting oral dosage form (tablets):
    
    • Adults—5 to 20 milligrams (mg) two or three times a day, taken 30 to 45 minutes before meals.
    
    
    • Teenagers and children 6 years of age and older—At first, 5 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 long-acting oral dosage form (extended-release tablets):
    
    • For patients who have not been treated with Concerta®:
      
      • Adults—At first, 18 to 36 milligrams (mg) once a day in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 72 mg a day.
      
      
      • Teenagers and children 6 years of age and older—At first, 18 mg once a day in the morning. Your doctor may increase your dose as needed. However, the dose is usually not more than 72 mg a day.
      
      
      • Children up to 6 years of age—Use and dose must be determined by your doctor.
      
      
    
    
    • For patients already using Concerta®:
      
      • Adults, teenagers, and children 6 years of age and older—At first, 18 to 72 milligrams (mg) once a day in the morning, depending on your previous dose of methylphenidate. Your doctor may increase your dose as needed. However, the dose is usually not more than 72 mg a day.
      
      
      • Children up to 6 years of age—Use and dose must be determined by your doctor.
      
      
    
    
  
  
  • For long-acting oral dosage form (sustained-release tablets):
    
    • Adults, teenagers, and children 6 years of age and older—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 6 years of age and older—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 narcolepsy:
  
  • For short-acting oral dosage form (tablets):
    
    • Adults—5 to 20 milligrams (mg) two or three times a day, taken 30 to 45 minutes before meals.
    
    
    • Teenagers and children 6 years of age and older—At first, 5 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 your doctor.
    
    
  
  
  • For long-acting oral dosage form (sustained-release tablets):
    
    • Adults and teenagers and children 6 years of age and older—The dose must be determined by the doctor.
    
    
    • Children up to 6 years of age—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of methylphenidate, 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.

Storage

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

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 While Using methylphenidate

Your doctor should check you or your child's progress at regular visits to make sure methylphenidate is working properly and to decide if you or your child should continue to take 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 methylphenidate and while you or your child 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 or your child should not use methylphenidate 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 methylphenidate 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 or your child have chest pain, shortness of breath, or fainting while using methylphenidate.

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.

methylphenidate may cause slow growth. If your child is using methylphenidate, the doctor will need to keep track of your child's height and weight to make sure that your child is growing properly.

methylphenidate 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

Less common

• Chest pain


• fever


• joint pain


• skin rash or hives

Rare

• Black, tarry stools


• blood in the urine or stools


• blurred vision or other changes in vision


• convulsions


• crusting, dryness, or flaking of the skin


• muscle cramps


• pinpoint red spots on the skin


• scaling, severe redness, soreness, or swelling of the skin


• uncontrolled vocal outbursts or tics (uncontrolled and repeated body movements)


• unusual bleeding or bruising

Incidence not known

• 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 the 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 the 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 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

• Loss of appetite


• nervousness


• sleeplessness


• stuffy nose


• trouble with sleeping


• unable to sleep


• unusually warm skin

Less common

• Anger


• dizziness


• drowsiness


• fear


• headache


• irritability


• muscle aches


• nausea


• nervousness


• runny nose


• scalp hair loss


• stomach pain


• talking, feeling, and acting with excitement

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.

See also: methylphenidate Oral, Transdermal side effects (in more detail)

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