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All about: Focalin XR

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

What is Focalin XR (dexmethylphenidate)?

Dexmethylphenidate is a mild stimulant to the central nervous system (brain and nerves).

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

Dexmethylphenidate may also be used for purposes other than those listed in this medication guide.

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

Do not use dexmethylphenidate if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take dexmethylphenidate before the MAO inhibitor has cleared from your body.

Before using this medication, tell your doctor if you are allergic to any drugs, or if you have severe depression or a history of mental illness, seizures or epilepsy, high blood pressure, a history of drug or alcohol addiction, congestive heart failure, or if you have recently had a heart attack.

Some stimulants have caused sudden death in children and adolescents with serious heart problems or congenital heart defects. Before taking dexmethylphenidate, tell your doctor if you have any type of heart problems.

Long-term use of dexmethylphenidate can slow a child's growth. Tell your doctor if the child using this medication is not growing or gaining weight properly.

Dexmethylphenidate may be habit-forming and should be used only by the person it was prescribed for. Dexmethylphenidate should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Keep track of how many pills have been used from each new bottle of this medicine. Dexmethylphenidate is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

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

Do not use dexmethylphenidate if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take dexmethylphenidate before the MAO inhibitor has cleared from your body. Do not take this medication if you are allergic to dexmethylphenidate or methylphenidate (Ritalin, Concerta), or if you have:
  • glaucoma;

  • motor tics (twitches);

  • a personal or family history of Tourette's syndrome; or

  • if you have significant tension, agitation, or anxiety.

Some stimulants have caused sudden death in children and adolescents with serious heart problems or congenital heart defects. Before taking dexmethylphenidate, tell your doctor if you have any type of heart problems.

Before using this medication, tell your doctor if you are allergic to any drugs, or if you have:

  • severe depression or a history of mental illness;

  • a history of drug or alcohol addiction;

  • seizures or epilepsy;

  • high blood pressure;

  • heart disease, heart rhythm problems, or congestive heart failure; or

  • if you have recently had a heart attack.

If you have any of these conditions, you may not be able to use dexmethylphenidate, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether dexmethylphenidate passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Long-term use of dexmethylphenidate can slow a child's growth. Tell your doctor if the child using this medication is not growing or gaining weight properly.

Do not give this medication to a child younger than 6 years old. Dexmethylphenidate may be habit-forming and should be used only by the person it was prescribed for. Dexmethylphenidate should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Keep track of how many pills have been used from each new bottle of this medicine. Dexmethylphenidate is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

How should I take Focalin XR (dexmethylphenidate)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Take each dose with a full glass of water.

This medication is usually taken in the morning before breakfast. You may take it with or without food.

You may open the dexmethylphenidate capsule and sprinkle the medicine into a spoonful of applesauce to make swallowing easier. Swallow this mixture right away without chewing. Do not save the mixture for later use. Discard the empty capsule.

To be sure this medication is helping your condition, your doctor will need to check your progress on a regular basis. Do not miss any scheduled visits to your doctor.

Store dexmethylphenidate at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, or if it is already evening, skip the missed dose and take the medicine the next morning. Taking this medicine late in the day can cause sleep problems. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of a dexmethylphenidate overdose may include dry mouth, sweating, headache, warmth or tingly feeling, vomiting, agitation, tremors, muscle twitches, confusion, hallucinations, fast or pounding heartbeats, large pupils, and seizure (convulsions).

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

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

Dexmethylphenidate can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Focalin XR (dexmethylphenidate) side effects

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

Stop using dexmethylphenidate and call your doctor at once if you have any of these serious side effects:

  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);

  • fast or uneven heart rate;

  • blurred vision or other visual changes;

  • unusual behavior, confusion; or

  • twitching or tics.

Continue using dexmethylphenidate and talk to your doctor if you have any of these less serious side effects:

  • sleep problems (insomnia);

  • loss of appetite;

  • upset stomach;

  • feeling restless, anxious, or jittery;

  • dry mouth, sore throat; or

  • headache.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Focalin XR (dexmethylphenidate)?

Before taking dexmethylphenidate, tell your doctor if you are using any of the following medicines:

  • antacids;

  • blood pressure medications;

  • a blood thinner such as warfarin (Coumadin);

  • clonidine (Catapres);

  • seizure medications such as phenytoin (Dilantin), phenobarbital (Luminal, Solfoton), primidone (Mysoline); or

  • antidepressants such as amitriptyline (Elavil, Etrafon), amoxapine (Ascendin), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), or trimipramine (Surmontil).

If you are using any of these drugs, you may not be able to use dexmethylphenidate, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect dexmethylphenidate. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist has information about dexmethylphenidate written for health professionals that you may read.

What does my medication look like?

Dexmethylphenidate is available with a prescription under the brand name Focalin. Other formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

  • Focalin 2.5 mg--D-shaped, blue tablets

  • Focalin 5 mg--D-shaped, yellow tablets

  • Focalin 10 mg--D-shaped, white tablets

  • 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.
  • 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 1996-2006 Cerner Multum, Inc. Version: 4.01. Revision Date: 9/8/06 12:50:31 PM.

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