Description and Brand Names

Drug information provided by: IBM Micromedex

US Brand Name

  1. Aptensio XR
  2. Concerta
  3. Metadate ER
  4. Methylin
  5. Methylin ER
  6. QuilliChew ER
  7. Quillivant XR
  8. Ritalin
  9. Ritalin LA
  10. Ritalin-SR

Descriptions


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

Methylphenidate is also used to treat 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. 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 your doctor's prescription.

This product is available in the following dosage forms:

  • Tablet, Extended Release, Disintegrating
  • Capsule, Extended Release Biphasic 40/60
  • Capsule, Extended Release
  • Capsule, Extended Release Biphasic 30/70
  • Tablet, Chewable
  • Tablet, Extended Release
  • Solution
  • Capsule, Extended Release Biphasic 50/50
  • Tablet
  • Powder for Suspension, Extended Release
  • Tablet, Extended Release, 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 pediatric-specific problems that would limit the usefulness of methylphenidate in children 6 years of age and older (6 to 12 years of age for Ritalin LA®). 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 methylphenidate have not been performed in the geriatric population.

Pregnancy

Information about this methylphenidate-oral-route
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

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.

  • Furazolidone
  • Iproniazid
  • Isocarboxazid
  • Linezolid
  • Methylene Blue
  • Moclobemide
  • Nialamide
  • 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.

  • Amifampridine
  • Bupropion
  • Desflurane
  • Donepezil
  • Enflurane
  • Halothane
  • Iobenguane I 131
  • Isoflurane
  • Sevoflurane

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—Use with caution. Dependence may be more likely to develop.
  • Allergy to aspirin—Use with caution. Adhansia XR™ contains a yellow dye called tartrazine, which may cause severe allergic reactions in patients with this condition.
  • Asthma or
  • Bipolar disorder (manic-depressive illness), history of or
  • Depression, history of or
  • Hypertension (high blood pressure) or
  • Priapism (painful and prolonged erection of the penis) or
  • Psychosis (mental illness), history of or
  • Raynaud's phenomenon (blood vessel disease) or
  • Seizures, history of or
  • Tachycardia (rapid heart rate)—Use with caution. May make these conditions worse.
  • Coronary artery disease or
  • Heart attack, recent or
  • Heart disease (eg, cardiomyopathy) or
  • Heart failure or
  • Heart rhythm problems (eg, ventricular arrhythmia), history of or
  • Hyperthyroidism (overactive thyroid) or
  • Stroke, history of—Use with caution. May make side effects become worse.
  • Phenylketonuria—The chewable tablet contains aspartame, which can make this condition worse.

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 think this medicine is not working properly after you have taken it for several weeks, check with your doctor 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 PM, unless your doctor gives you a different time.

If you are taking the chewable tablet, drink at least 8 ounces of water or other liquid when you chew the tablet. Take it preferably 30 to 45 minutes before meals.

Shake the oral liquid gently just before using it. Use a marked measuring spoon, oral syringe, or medicine cup to measure the right dose. Take it preferably 30 to 45 minutes before meals.

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

  • The Concerta® extended release tablets, Adhansia XR™, Aptensio XR™, Metadate CD®, or 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 cannot swallow the Adhansia XR™ extended-release capsule whole, you may open it and sprinkle the medicine onto a tablespoon of applesauce or yogurt. Swallow this mixture without chewing, right away or within 10 minutes. Do not store this mixture for later use.
  • If you are unable to swallow the Aptensio XR™, Metadate CD®, or 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 should 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, Adhansia XR™ or Aptensio XR™ extended-release capsules, or Cotempla XR-ODT™ extended release disintegrating tablets with or without food.
  • If you are taking the Cotempla XR-ODT™ extended release disintegrating tablet, make sure your hands are dry before you handle it. Do not open the blister pack that contains the tablet until you are ready to take it. Remove the tablet from the blister pack by peeling back the foil, then taking the tablet out. Do not push the tablet through the foil. Place the tablet in your mouth. It should melt quickly. Do not crush or chew it.
  • If you are taking the Quillivant® XR extended-release suspension, shake the bottle well for at least 10 seconds before measuring each dose. Use only the oral dosing dispenser provided in the package to get the right dose. You may take it with or without food.
  • If you are taking the Quillichew ER™ tablets, you may cut the 20- and 30-milligram (mg) scored chewable tablets into two if needed.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

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 short-acting oral dosage forms (chewable tablets or solution):
      • Adults—Administer 2 or 3 times a day and take 30 to 45 minutes before meals. The average dose is 20 to 30 milligrams (mg) per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per day.
      • Children 6 years of age and older—At first, 5 mg 2 times a day, taken before breakfast and lunch. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per day.
      • Children younger than 6 years of age—Use and dose must be determined by the doctor.
    • For short-acting oral dosage form (tablets):
      • Adults—20 to 30 milligrams (mg) given in divided doses 2 or 3 times a day, taken 30 to 45 minutes before meals. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per day.
      • Children 6 years of age and older—At first, 5 mg 2 times a day, taken before breakfast and lunch. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per day.
      • Children younger than 6 years of age—Use and dose must be determined by the doctor.
    • For long-acting oral dosage form (extended-release capsules):
      • Patients who have not been treated with methylphenidate:
        • Adhansia XR™:
          • Adults and children 6 years of age and older—At first, 25 milligrams (mg) once a day, taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 100 mg per day for adults and 85 mg for children.
          • Children younger than 6 years of age—Use and dose must be determined by the doctor.
        • Aptensio XR™, Metadate CD®, Ritalin LA®:
          • Adults and children 6 years of age and older—At first, 10 to 20 milligrams (mg) once a day, taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per day.
          • Children younger than 6 years of age—Use and dose must be determined by the doctor.
      • Patients who are already taking methylphenidate:
        • Adults and children 6 to 12 years of age—10 to 60 milligrams (mg) once a day, taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per day.
        • Children younger than 6 years of age—Use and dose must be determined by the doctor.
    • For long-acting oral dosage form (extended-release suspension):
      • Adults and children 6 years of age and older—At first, 20 milligrams (mg) once a day, taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per day.
      • Children younger than 6 years of age—Use and dose must be determined by the doctor.
    • For long-acting oral dosage form (extended-release chewable tablets):
      • Adults and children 6 years of age and older—At first, 20 milligrams (mg) once a day, taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per day.
      • Children younger than 6 years of age—Use and dose must be determined by the doctor.
    • For long-acting oral dosage form (extended-release disintegrating tablets):
      • Adults and children 6 years of age and older—At first, 17.3 milligrams (mg) once a day, taken in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 51.8 mg per day.
      • Children younger than 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 adjust your dose as needed. However, the dose is usually not more than 72 mg per day.
        • Children 6 years of age and older—At first, 18 mg once a day in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 72 mg per day.
        • Children younger than 6 years of age—Use and dose must be determined by your doctor.
      • For patients already using Concerta®:
        • Adults and children 6 years of age and older—At first, 18 to 72 milligrams (mg) once a day in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 72 mg per day.
        • Children younger than 6 years of age—Use and dose must be determined by your doctor.
  • For narcolepsy:
    • For short-acting oral dosage forms (chewable tablets or solution):
      • Adults—Administer 2 or 3 times a day and take 30 to 45 minutes before meals. Average dose is 20 to 30 milligrams (mg) per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per day.
      • Children 6 years of age and older—At first, 5 mg 2 times a day, taken before breakfast and lunch. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per day.
      • Children younger than 6 years of age—Use and dose must be determined by the doctor.
    • For short-acting oral dosage form (tablets):
      • Adults—20 to 30 milligrams (mg) given in divided doses 2 or 3 times a day, taken 30 to 45 minutes before meals (breakfast and lunch). Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per day.
      • Children 6 years of age and older—At first, 5 mg 2 times a day, taken before breakfast and lunch. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 mg per day.
      • Children younger than 6 years of age—Use and dose must be determined by your 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 miss a dose of Adhansia XR™, 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.

For the extended-release suspension: Throw away any unused suspension 4 months after it is used for the first time.

Store the extended release disintegrating tablets in the reusable travel case after you remove it from the carton.

Mixed unused medicine with used coffee grounds or kitty litter, then place it in a sealable bag, empty can, or other container before throwing into the trash. Ask your pharmacist about the best way to dispose of medicine you do not use.

Precautions

It is very important that your doctor 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. Blood tests may be needed to check for unwanted effects.

You or your child will also need to have your blood pressure and heart rate measured before starting this medicine and while you are using it. If you notice any change in your blood pressure, call your doctor right away. If you have questions about this, talk to your doctor.

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

Methylphenidate may cause dizziness, drowsiness, or changes in vision. Do not drive or do anything else that could 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 or your child has chest pain, troubled breathing, fainting, or a fast, irregular heartbeat while using this medicine.

Tell your doctor right away if you or your family notice 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 feel, see, or hear things that are not there, or have any unusual thoughts, especially if they are new or getting worse quickly.

This medicine may cause slow growth and weight loss. If your child is using this medicine, the doctor will need to keep track of his height and weight to make sure that he is growing properly.

Methylphenidate may cause a condition called Raynaud's phenomenon. Check with your doctor right away if you or your child has tingling or pain in the fingers or toes when exposed to cold temperatures, paleness or a cold feeling in the fingertips and toes, or a skin color change in your fingers.

Make sure any doctor or dentist who treats you knows that you are using Metadate CD®, Ritalin®, Ritalin LA®, or Ritalin-SR®. You may need to stop using this medicine before you have surgery.

Avoid drinking alcohol while using Cotempla XR-ODT™ extended release disintegrating tablets, Adhansia XR™, Aptensio XR™, Metadate CD®, or Ritalin LA® extended-release capsules, or Quillichew ER™ extended-release chewable tablets.

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.

Adhansia XR™ contains a yellow dye called tartrazine, which may cause severe allergic reactions. Tell your doctor if you have any allergies (including an aspirin allergy).

If you have been using this medicine for a long time and you think you may have become mentally or physically dependent on it, check with your doctor right away. Some signs of dependence may include:

  • A strong desire or need to continue using the medicine.
  • A need to increase the dose to receive the same effects.
  • Withdrawal effects after stopping the medicine, such as irritability, anxiety, unusual tiredness or weakness, nightmares, trouble sleeping or oversleeping, increased appetite, agitation, or slowing of mental and physical activity.

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.

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

  1. Fast heartbeat

Less common

  1. Chest pain
  2. fever
  3. joint pain
  4. skin rash or hives

Rare

  1. Black, tarry stools
  2. blood in the urine or stools
  3. blurred vision or other changes in vision
  4. crusting, dryness, or flaking of the skin
  5. muscle cramps
  6. pinpoint red spots on the skin
  7. scaling, severe redness, soreness, or swelling of the skin
  8. seizures
  9. uncontrolled vocal outbursts or tics (uncontrolled and repeated body movements)
  10. unusual bleeding or bruising

Incidence not known

  1. Agitation
  2. arm, back or jaw pain
  3. bleeding gums
  4. bloody nose
  5. chest discomfort
  6. chest tightness or heaviness
  7. chills
  8. confusion
  9. cough
  10. dark urine
  11. diarrhea
  12. difficulty in speaking
  13. difficulty swallowing
  14. discouragement
  15. dizziness
  16. double vision
  17. drowsiness
  18. fainting
  19. fast, pounding, or irregular heartbeat or pulse
  20. feeling like surroundings are not real
  21. feeling sad or empty
  22. feeling that others are watching you or controlling your behavior
  23. feeling that others can hear your thoughts
  24. feeling, seeing, or hearing things that are not there
  25. headache
  26. heavier menstrual periods
  27. inability to move the arms, legs, or facial muscles
  28. inability to speak
  29. irritability
  30. itching skin
  31. large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
  32. loss of interest or pleasure
  33. mood swings
  34. muscle pain, stiffness, or spasms
  35. nausea
  36. nervousness
  37. numbness of the hands
  38. overactive reflexes
  39. painful or difficult urination
  40. pale skin
  41. paleness or cold feeling in the fingertips and toes
  42. poor coordination
  43. pounding in the ears
  44. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  45. red, irritated eyes
  46. red, swollen, or scaly skin
  47. redness, soreness, or itching skin
  48. restlessness
  49. right upper quadrant tenderness
  50. seeing, hearing, or feeling things that are not there
  51. seizures
  52. severe or sudden headache
  53. shivering
  54. slow speech
  55. slowed growth in children
  56. sore throat
  57. sores, ulcers, or white spots on the lips or in the mouth
  58. stuffy or runny nose
  59. sudden loss of coordination
  60. sudden slurring of speech
  61. sweating
  62. swollen glands
  63. talking or acting with excitement you cannot control
  64. tingling or pain in the fingers or toes when exposed to cold temperatures
  65. trembling or shaking
  66. tremor
  67. trouble concentrating
  68. trouble sleeping
  69. troubled breathing with exertion
  70. twitching, twisting, or uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
  71. unusual behavior
  72. unusual tiredness or weakness
  73. weight loss
  74. yellow skin or eyes

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

Symptoms of overdose

  1. Agitation
  2. anxiety
  3. bigger, dilated, or enlarged pupils of the eyes
  4. confusion as to time, place, or person
  5. dark urine
  6. diarrhea
  7. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  8. dry eyes, mouth, nose, or throat
  9. false or unusual sense of well-being
  10. fast, slow, irregular, pounding, or racing heartbeat or pulse
  11. holding false beliefs that cannot be changed by fact
  12. increased sensitivity of the eyes to light
  13. loss of consciousness
  14. muscle pain, stiffness, or twitching
  15. nervousness
  16. overactive reflexes
  17. pounding in the ears
  18. rapid, shallow breathing
  19. sweating
  20. tremors
  21. unusual excitement, nervousness, or restlessness

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

  1. Loss of appetite
  2. stomach pain

Less common

  1. Anger
  2. fear
  3. irritability
  4. scalp hair loss
  5. vomiting

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.