Methylphenidate (oral route)

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
Capsule, Extended Release
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.

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
Hydroxychloroquine
Imipramine
Insulin Aspart, Recombinant
Iobenguane I 131
Isoflurane
Landiolol
Lansoprazole
Lisdexamfetamine
Methoxyflurane
Nizatidine
Omeprazole
Pantoprazole
Paroxetine
Phenobarbital
Phenprocoumon
Phenytoin
Primidone
Rabeprazole
Ranitidine

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

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.
  - 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):
  - 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 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.

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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Brand Name

US Brand Name

Description

Before Using

Allergies

Pediatric

Geriatric

Breastfeeding

Drug Interactions

Other Interactions

Other Medical Problems

Proper Use

Dosing

Missed Dose

Storage

Precautions

Side Effects

More common

Less common

Rare

Incidence not known

Symptoms of overdose

More common

Less common

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