Dexmethylphenidate is a stimulant that is used to treat attention deficit hyperactivity disorder (ADHD).

Dexmethylphenidate may also be used for purposes not listed in this medication guide.

Stimulants have caused stroke, heart attack, and sudden death in people with high blood pressure, heart disease, or a heart defect.

Dexmethylphenidate may cause new or worsening psychosis (unusual thoughts or behavior), especially if you have a history of depression, mental illness, or bipolar disorder.

Call your doctor right away if you have: signs of heart problems--chest pain, feeling light-headed or short of breath; or signs of psychosis--paranoia, aggression, new thought or behavior problems, seeing or hearing things that are not real.

Dexmethylphenidate may be habit-forming. Tell your doctor if you have a history of drug or alcohol addiction. Keep the medication where others cannot get to it.

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.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Dexmethylphenidate may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication where others cannot get to it. Selling or giving away this medicine is against the law.

Dexmethylphenidate is usually taken twice per day, at least 4 hours apart.

You may take dexmethylphenidate with or without food. Take the regular tablet twice daily, at least 4 hours apart. Take the extended-release capsule once daily in the morning.

Swallow the extended-release capsule whole and do not crush, chew, break, or open it.

If you cannot swallow a capsule whole, open it and mix the medicine with applesauce. Swallow the mixture right away without chewing.

Your doctor will need to check your progress on a regular basis. Your heart and blood pressure may also need to be checked often.

Tell your doctor if you have a planned surgery.

Your treatment may also include counseling or other treatments.

Store tightly closed at room temperature, away from moisture, heat, and light. Keep your medicine in a place where no one can use it improperly.

You should not take dexmethylphenidate if you are allergic to dexmethylphenidate or methylphenidate (Ritalin, Concerta).

Stimulants have caused stroke, heart attack, and sudden death in certain people. Tell your doctor if you have:

• heart problems or a congenital heart defect;

• high blood pressure; or

• a family history of heart disease or sudden death.

Do not use dexmethylphenidate if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, and tranylcypromine.

Tell your doctor if you also use opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. An interaction with dexmethylphenidate could cause a serious condition called serotonin syndrome.

Tell your doctor if you or anyone in your family has ever had:

• depression, mental illness, bipolar disorder, psychosis, or suicidal thoughts or actions;

• blood circulation problems in the hands or feet; or

• alcoholism or drug addiction.

Becoming dependent on this medicine during pregnancy can cause premature birth or low birth weight. Tell your doctor if you are pregnant or plan to become pregnant. If you are pregnant, your name may be listed on a pregnancy registry to track the effects of dexmethylphenidate on the baby.

Ask a doctor if it is safe to breastfeed while using this medicine.

Not approved for use by anyone younger than 6 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of dexmethylphenidate could be fatal.

Overdose symptoms may include dry mouth, vomiting, agitation, tremor, muscle twitches, confusion, hallucinations, dilated pupils, muscle pain or weakness, fever, sweating, headache, pounding in your neck or ears, fast or pounding heartbeats, seizure (convulsions), or coma.

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).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: fever; hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Dexmethylphenidate may cause serious side effects. Call your doctor at once if you have:

• signs of heart problems--chest pain, trouble breathing, feeling like you might pass out;

• signs of psychosis--hallucinations (seeing or hearing things that are not real), new thought or behavior problems, aggression, hostility, paranoia;

• signs of circulation problems--numbness, pain, cold feeling, unexplained wounds, or skin color changes (pale, red, or blue appearance) in your fingers or toes; or

• penis erection that is painful or lasts 4 hours or longer.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Dexmethylphenidate can affect growth in children. Your child's height and weight may need to be checked often. Tell your doctor if your child is not growing at a normal rate.

Common side effects of dexmethylphenidate may include:

• loss of appetite;

• nausea, stomach pain; or

• fever.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• an antidepressant; or

• blood pressure medication.

This list is not complete. Other drugs may affect dexmethylphenidate, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

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.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.