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Focalin XR

Pronunciation

Generic Name: dexmethylphenidate (dex METH il FEN i date)
Brand Name: Focalin, Focalin XR

What is Focalin XR (dexmethylphenidate)?

Dexmethylphenidate is a mild stimulant to the central nervous system. It affects chemicals in the brain that contribute to hyperactivity and impulse control.

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

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

What is the most important information I should know about Focalin XR (dexmethylphenidate)?

You should not use dexmethylphenidate if you have glaucoma, tics or Tourette's syndrome, or severe anxiety, tension, or agitation.

Do not use dexmethylphenidate if you have taken an MAO inhibitor in the past 14 days, including isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

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Dexmethylphenidate may be habit forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction.

Using this medicine improperly can cause death or serious side effects on the heart.

What should I discuss with my healthcare provider before taking Focalin XR (dexmethylphenidate)?

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

You should not take this medicine if you are allergic to dexmethylphenidate or methylphenidate (Ritalin, Concerta), or if you have:

  • glaucoma;

  • a personal or family history of tics (muscle twitches) or Tourette's syndrome; or

  • severe anxiety, tension, or agitation (stimulant medicine can make these symptoms worse).

Some stimulants have caused 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.

To make sure this medicine is safe for you, tell your doctor if you or anyone in your family has ever had:

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

  • motor tics (muscle twitches) or Tourette's syndrome;

  • blood circulation problems in the hands or feet;

  • seizures or epilepsy;

  • an abnormal brain wave test (EEG); or

  • a history of drug or alcohol addiction.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether dexmethylphenidate passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Dexmethylphenidate is not approved for use by anyone younger than 6 years old.

How should I take Focalin XR (dexmethylphenidate)?

Using this medicine improperly can cause death or serious side effects on the heart.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Dexmethylphenidate may be habit forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

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.

Do not crush, chew, break, or open an extended-release capsule. Swallow it whole.

To make swallowing easier, you may open the dexmethylphenidate capsule and sprinkle the medicine into a spoonful of applesauce. Swallow right away without chewing. Do not save the mixture for later use.

While using dexmethylphenidate, your doctor will need to check your progress at regular visits. Your heart rate, blood pressure, height and weight may also need to be checked often.

Store at room temperature away from moisture, heat, and light.

Keep track of the amount of medicine used from each new bottle. Dexmethylphenidate is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

Take the missed dose as soon as you remember, but not late in the day or you could have trouble sleeping. Skip the missed dose if it is almost evening. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

What should I avoid while taking Focalin XR (dexmethylphenidate)?

Avoid taking dexmethylphenidate in the evening because it may cause sleep problems (insomnia).

This medication may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Focalin XR (dexmethylphenidate) side effects

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 can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Stop taking dexmethylphenidate and call your doctor at once if you have:

  • chest pain, trouble breathing, feeling like you might pass out;

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

  • a seizure (convulsions);

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

  • blurred vision or other visual changes;

  • penis erection that is painful or lasts 4 hours or longer (rare); or

  • unexplained muscle pain, tenderness, or weakness (especially if you also have fever, unusual tiredness, and dark colored urine).

Common side effects 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.

See also: Side effects (in more detail)

What other drugs will affect Focalin XR (dexmethylphenidate)?

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • an antacid;

  • an antidepressant;

  • blood pressure medication;

  • a blood thinner such as warfarin (Coumadin, Jantoven);

  • a cold or allergy medicine that contains a decongestant such as pseudoephedrine or phenylephrine; or

  • seizure medication.

This list is not complete. Other drugs may interact with dexmethylphenidate, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your pharmacist can provide more information about dexmethylphenidate.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 9.01. Revision Date: 2015-06-10, 10:50:49 AM.

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