Dexmethylphenidate

IMPORTANT WARNING:

Dexmethylphenidate can be habit-forming.Do not take a larger dose, take it more often, take it for a longer time, or take it in a different way than prescribed by your doctor. If you take too much dexmethylphenidate, you may continue to feel a need to take large amounts of the medication, and you may experience unusual changes in your behavior. You or your caregiver should tell your doctor immediately, if you experience any of the following symptoms: fast, pounding, or irregular heartbeat; sweating; dilated pupils; abnormally excited mood; restlessness; difficulty falling sleeping or staying asleep; hostility; aggression; anxiety; loss of appetite; loss of coordination; uncontrollable movement of a part of the body; flushed skin; vomiting; stomach pain; or thinking about harming or killing oneself or others or planning or trying to do so. Also, tell your doctor if you drink or have ever drunk large amounts of alcohol, use or have ever used street drugs, or have overused prescription medications.

Do not stop taking dexmethylphenidate without talking to your doctor, especially if you have overused the medication. Your doctor will probably decrease your dose gradually and monitor you carefully during this time. You may develop severe depression if you suddenly stop taking dexmethylphenidate after overusing it. Your doctor may need to monitor you carefully after you stop taking dexmethylphenidate, even if you have not overused the medication, because your symptoms may worsen when treatment is stopped.

Do not sell, give away, or let anyone else take your medication. Selling or giving away dexmethylphenidate is against the law and may harm others. Store dexmethylphenidate in a safe place where no one else can take it accidentally or on purpose. Keep track of how many tablets or capsules are left so you will know if any are missing.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with dexmethylphenidate and each time you get more medication. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

IMPORTANT NOTICE:

On June 30, 2025, FDA issued a drug safety communication about a risk of weight loss in patients younger than 6 years of age taking extended-release stimulants for ADHD and will be revising the labeling for all these products to reflect this new safety information. Although extended-release stimulants are not approved for children younger than 6 years, health care professionals can prescribe them “off label” to treat ADHD. For additional information, see https://www.fda.gov/media/187347/download.

WHY is this medicine prescribed?

Dexmethylphenidate is used as part of a treatment program to control symptoms of attention deficit hyperactivity disorder (ADHD; more difficulty focusing, controlling actions, and remaining still or quiet than other people who are the same age) in adults and children.Dexmethylphenidate is in a class of medications called central nervous system (CNS) stimulants. It works by increasing the amounts of certain natural substances in the brain.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Dexmethylphenidate comes as a tablet and an extended-release (long-acting) capsule to take by mouth.The tablet is usually taken twice a day, at least 4 hours apart, with or without food. The extended-release capsule is usually taken once a day in the morning. It may be taken with or without food, but will start to work faster if it is taken without food. Take dexmethylphenidate at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.

Swallow the extended-release capsules whole; do not chew or crush them.If you are unable to swallow the extended-release capsule, you can carefully open the capsule and sprinkle the contents on a spoonful of applesauce.Swallow this mixture immediately, but do not chew it. Do not save this mixture to use at a later time.

Your doctor will probably start you on a low dose of dexmethylphenidate and gradually increase your dose, not more often than once a week.

Your condition should improve during your treatment. Call your doctor if your symptoms worsen at any time during your treatment or do not improve after 1 month.

Your doctor may tell you to stop taking dexmethylphenidate from time to time to see if the medication is still needed.Follow these directions carefully.

What SPECIAL PRECAUTIONS should I follow?

Before taking dexmethylphenidate,

• tell your doctor and pharmacist if you are allergic to dexmethylphenidate, methylphenidate (Concerta^®, Metadate^®, Methylin^®, Ritalin^®),or any other medications.

• tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan^®), linezolid (Zyvox^®), methylene blue, phenelzine (Nardil^®), selegiline (Eldepryl^®, Emsam^®, Zelapar^®), and tranylcypromine (Parnate^®).

• some medications should not be taken with dexmethylphenidate. Other medications may cause dosing changes or extra monitoring when taken with dexmethylphenidate. Make sure you have discussed any medications you are currently taking or plan to take before starting dexmethylphenidate with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking dexmethylphenidate, please get the advice of your doctor or pharmacist.

• tell your doctor if you or anyone in your family has or has ever had Tourette's syndrome (a condition characterized by the need to perform repeated motions or to repeat sounds or words),facial or motor tics (repeated uncontrollable movements),or verbal tics (repetition of sounds or words that is hard to control).Also tell your doctor if you have glaucoma,or feelings of anxiety, tension, or agitation.Your doctor will probably tell you not to take dexmethylphenidate.

• tell your doctor if anyone in your family has or has ever had an irregular heartbeat or has died suddenly.Also tell your doctor if you have recently had a heart attack and if you have or have ever had a heart defect, high blood pressure, an irregular heartbeat, heart or blood vessel disease, hardening of the arteries; or other heart problems. Your doctor will examine you to see if your heart and blood vessels are healthy.Your doctor will probably tell you not to take dexmethylphenidate if you have a heart condition or if there is a high risk that you may develop a heart condition.

• tell your doctor if you or anyone in your family has or has ever had depression, bipolar disorder (mood that changes from depressed to abnormally excited), mania (frenzied, abnormally excited mood), or has thought about or attempted suicide. Also tell your doctor if you have or have ever had circulation problems in your fingers or toes;depression;mental illness; seizures;an abnormal electroencephalogram (EEG; a test that measures electrical activity in the brain);or thyroid disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding.If you become pregnant while taking dexmethylphenidate, call your doctor.

• you should know that dexmethylphenidate should be used as part of a total treatment program for ADHD, which may include counseling and special education. Make sure to follow all of your doctor's and/or therapist's instructions.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Dexmethylphenidate may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• heartburn
• weight loss
• dry mouth
• dizziness
• drowsiness
• nervousness or jitteriness
• headache

Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• excessive tiredness
• slow or difficult speech
• dizziness
• weakness or numbness of an arm or leg
• changes in vision or blurred vision
• seizures
• believing things that are not true
• feeling unusually suspicious of others
• hallucinations (seeing things or hearing voices that do not exist)
• mood changes
• depression
• motor or verbal tics
• swelling of the face, throat, tongue, lips, or eyes
• rash
• hives
• itching
• purple blotches under the skin
• fever
• blistering or peeling skin
• joint pain
• frequent, painful erections
• erection that lasts longer than 4 hours
• numbness, pain, or sensitivity to temperature in the fingers or toes
• skin color change from pale to blue to red in the fingers or toes
• unexplained wounds on the fingers or toes

Dexmethylphenidate may cause sudden death in children and teenagers, especially children and teenagers with heart defects or serious heart problems.This medication also may cause sudden death, heart attack, or stroke in adults, especially adults with heart defects or serious heart problems. Call your doctor right away if you or your child has any signs of heart problems while taking this medication including: chest pain, shortness of breath, or fainting. Talk to your doctor about the risks of taking this medication.

Dexmethylphenidate may slow children's growth or weight gain.Your child's doctor will watch his or her growth carefully.Talk to your child's doctor if you have concerns about your child's growth or weight gain while he or she is taking this medication. Talk to your child's doctor about the risks of giving dexmethylphenidate to your child.

Dexmethylphenidate may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• vomiting
• agitation
• uncontrollable shaking of a part of the body
• muscle twitching
• seizures
• unconsciousness
• inappropriate happiness
• confusion
• hallucinations (seeing things or hearing voices that do not exist)
• sweating
• flushing
• headache
• fever
• rapid, pounding, or irregular heartbeat
• widening of pupils (black circles in the middle of the eyes)
• dry mouth

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to dexmethylphenidate.

This prescription is not refillable. Be sure to schedule appointments with your doctor on a regular basis so you do not run out of medication.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.