Brand Name
US Brand Name
Aptensio XR
Concerta
Cotempla XR-ODT
Jornay PM
Metadate ER
Methylin
Methylin ER
QuilliChew ER
Quillivant XR
Ritalin
Ritalin LA
Ritalin-SR
Description
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 Biphasic 30/70
- Tablet, Chewable
- Capsule, Extended Release
- 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.
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.
- 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
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 use disorder, history of or
- Drug use disorder or dependence, history of—Use with caution. Dependence may be more likely to develop.
- Asthma or
- Bipolar disorder (manic-depressive illness), history of or
- Depression, history of or
- Eye or vision problems (eg, intraocular pressure, open angle glaucoma), 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
- Stomach or bowel problems (eg, blockage, narrowing), severe or
- Tachycardia (rapid heart rate)—Use with caution. May make these conditions worse.
- Heart attack, recent or
- Heart disease (eg, cardiomyopathy, coronary artery disease) or
- Heart failure or
- Heart rhythm problems (eg, ventricular arrhythmia), or a family 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 and cause mental or physical dependence.
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® or Relexxii® extended release tablets, 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 are unable to swallow the Aptensio XR™, Jornay PM®, 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® or Relexxii® 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® or Relexxii® extended release tablets, Aptensio XR™, or Jornay PM® extended-release capsules, or Cotempla XR-ODT™ extended release disintegrating tablets with or without food.
- If your child is 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 your child is 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 child's 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. If you are switching from other brands of this medicine, your doctor may tell you to stop using other methylphenidate products and adjust your dose of Quillivant® XR extended-release suspension.
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:
- Aptensio XR™:
- Adults and children 6 years of age and older—At first, 10 (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.
- Metadate CD®, Ritalin LA®:
- 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.
- Jornay PM®:
- Adults and children 6 years of age and older—At first, 20 milligrams (mg) once a day, taken in the evening. Your doctor may adjust your dose as needed. However, the dose is usually not more than 100 mg per day.
- Children younger than 6 years of age—Use and dose must be determined by the doctor.
- Aptensio XR™:
- 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.
- Patients who have not been treated with methylphenidate:
- 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):
- 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 methylphenidate:
- 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.
- Teenagers 13 to 17 years of age—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 6 to 12 years of age—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 54 mg per day.
- Children younger than 6 years of age—Use and dose must be determined by your doctor.
- For patients already using methylphenidate:
- 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 patients who have not been treated with methylphenidate:
- For short-acting oral dosage forms (chewable tablets or solution):
- 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.
- For short-acting oral dosage forms (chewable tablets or solution):
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.
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: Dispose of 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.
Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine 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
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.
This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.
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, trouble 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, including 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®, Relexxii®, Ritalin®, Ritalin LA®, or Ritalin-SR®. You may need to stop using this medicine before you have surgery.
Avoid drinking alcohol while using Concerta®, Cotempla XR-ODT™ extended release disintegrating tablets, Aptensio XR™, Metadate CD®, or Ritalin LA® extended-release capsules, Quillichew ER™ extended-release chewable tablets, or Quillivant® XR extended-release suspension.
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.
Symptoms of 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 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, including 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
- 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
- crusting, dryness, or flaking of the skin
- muscle cramps
- pinpoint red spots on the skin
- scaling, severe redness, soreness, or swelling of the skin
- seizures
- uncontrolled vocal outbursts or tics (uncontrolled and repeated body movements)
- unusual bleeding or bruising
Incidence not known
- Agitation
- arm, back or jaw pain
- bleeding gums
- bloody nose
- chest discomfort, tightness, or heaviness
- chills
- clenching, gnashing, or grinding teeth
- confusion
- cough
- dark urine
- decreased interest in sexual intercourse
- diarrhea
- difficulty with speaking
- difficulty with swallowing
- discouragement
- dizziness
- double vision
- drowsiness
- fainting
- fast, pounding, or irregular heartbeat or pulse
- feeling like surroundings are not real
- feeling sad or empty
- feeling that others are watching you or controlling your behavior
- feeling that others can hear your thoughts
- feeling, seeing, or hearing things that are not there
- headache
- heavier menstrual periods
- inability to have or keep an erection
- inability to move the arms, legs, or facial muscles
- inability to speak
- irritability
- itching skin
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
- loss in sexual ability, desire, drive, or performance
- loss of interest or pleasure
- mood swings
- muscle pain, stiffness, or spasms
- nausea
- nervousness
- numbness of the hands
- overactive reflexes
- painful or difficult urination
- pale skin
- paleness or cold feeling in the fingertips and toes
- poor coordination
- pounding in the ears
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red, irritated eyes
- red, swollen, or scaly skin
- redness, soreness, or itching skin
- restlessness
- right upper stomach tenderness
- seeing, hearing, or feeling things that are not there
- severe or sudden headache
- shivering
- slow speech
- slowed growth in children
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- stuffy or runny nose
- sudden loss of coordination
- sudden slurring of speech
- sweating
- swollen glands
- talking or acting with excitement you cannot control
- tingling or pain in the fingers or toes when exposed to cold temperatures
- trembling or shaking
- tremor
- trouble concentrating
- trouble sleeping
- trouble breathing
- twitching, twisting, or uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
- 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
- anxiety
- bigger, dilated, or enlarged pupils of the eyes
- blurred vision
- change in consciousness
- chest pain or discomfort
- confusion as to time, place, or person
- dark urine
- diarrhea
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- dry eyes, mouth, nose, or throat
- false or unusual sense of well-being
- fast, slow, irregular, pounding, or racing heartbeat or pulse
- fever
- headache
- holding false beliefs that cannot be changed by fact
- inability to speak
- increased sensitivity of the eyes to light
- loss of consciousness
- muscle pain, cramps, stiffness, or twitching
- nausea
- nervousness
- overactive reflexes
- pain or discomfort in the arms, jaw, back, or neck
- pale, clammy skin
- palpitations
- pounding in the ears
- rapid, shallow breathing
- seeing, hearing, or feeling things that are not there
- seizures
- shivering
- slurred speech
- sweating
- talking or acting with excitement you cannot control
- temporary blindness
- thirst
- trembling or shaking
- trouble breathing
- unusual excitement, nervousness, or restlessness
- 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
- Loss of appetite
- stomach pain
Less common
- Acid or sour stomach
- anger
- belching
- fear
- heartburn
- indigestion
- irritability
- scalp hair loss
- stomach discomfort or upset
- 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.
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