Slideshows Images Quizzes

Focalin

Last reviewed on RxList: 1/20/2017
Focalin Patient Information Including Side Effects

Brand Names: Focalin, Focalin XR

Generic Name: dexmethylphenidate (Pronunciation: dex METH il FEN i date)

What is dexmethylphenidate (Focalin, Focalin XR)?

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 not listed in this medication guide.

What are the possible side effects of dexmethylphenidate (Focalin, Focalin XR)?

Get emergency medical help if you have any of these signs of an allergic reaction: fever; 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:

  • dangerously high blood pressure (severe headache, ringing in your ears, chest pain, numbness);
  • seizure (convulsions);
  • fast or uneven heart rate;
  • blurred vision or other visual changes;
  • unusual behavior, confusion; or
  • twitching or tics.

Less serious side effects may include:

  • sleep problems (insomnia);
  • loss of appetite;
  • upset stomach;
  • feeling restless, anxious, or jittery;
  • dry mouth, sore throat; or
  • headache.

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.

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

Do not use dexmethylphenidate if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Before using this medication, tell your doctor if you have severe depression, seizures or epilepsy, high blood pressure, heart disease, a heart rhythm disorder, congestive heart failure, if you have recently had a heart attack, or if you have a history of mental illness or drug/alcohol addiction.

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 for whom it was prescribed. Keep the medication in a secure place where others cannot get to it.

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.

Focalin Patient Information including How Should I Take

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

Do not use dexmethylphenidate if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

You should 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.

To make sure you can safely take dexmethylphenidate, tell your doctor if you have any of these other conditions:

  • 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.

FDA pregnancy category C. It is not known whether dexmethylphenidate will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

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 medicine to a child younger than 6 years old without medical advice.

Dexmethylphenidate may be habit forming and should be used only by the person for whom it was prescribed. Never share dexmethylphenidate with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

How should I take dexmethylphenidate (Focalin, Focalin XR)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

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

Take this medicine 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 right away without chewing. Do not save the mixture for later use. Discard the empty capsule.

Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

Store at room temperature away from moisture and heat.

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.

Focalin Patient Information including If I Miss a Dose

What happens if I miss a dose (Focalin, Focalin XR)?

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 (Focalin, Focalin XR)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms 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 dexmethylphenidate (Focalin, Focalin XR)?

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.

What other drugs will affect dexmethylphenidate (Focalin, Focalin XR)?

Tell your doctor about all other medicines you use, especially:

  • antacids;
  • blood pressure medications;
  • a blood thinner such as warfarin (Coumadin, Jantoven);
  • clonidine (Catapres);
  • seizure medications such as phenytoin (Dilantin), phenobarbital (Luminal, Solfoton), primidone (Mysoline); or
  • antidepressants such as amitriptyline (Elavil, Vanatrip, Limbitrol), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Sinequan, Silenor), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), or trimipramine (Surmontil).

This list is not complete and other drugs may interact with dexmethylphenidate. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

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.

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 1996-2013 Cerner Multum, Inc. Version: 5.03. Revision date: 6/13/2012.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

Healthwise

Health Solutions From Our Sponsors