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Focalin

This page contains drug information on Focalin.

Generic Name: dexmethylphenidate (dex meh thill FEH nih date)

Brand Names: Focalin, Focalin XR

What is the most important information I should know about dexmethylphenidate?

 •  Use caution when driving, operating machinery, or performing other hazardous activities. Dexmethylphenidate may cause dizziness, drowsiness, or blurred vision or impair the ability to concentrate. If you experience dizziness, drowsiness, blurred vision, or impaired concentration, avoid these activities.

 •  Tell your healthcare provider if you have a history of alcohol or drug abuse or dependence. Chronic, abusive use of dexmethylphenidate can lead to dependence, psychological problems, and withdrawal symptoms upon discontinuation of the medication.

 What is dexmethylphenidate?

 •  Dexmethylphenidate is a mild stimulant to the central nervous system (brain and nerves). The exact way that dexmethylphenidate works is unknown.

 •  Dexmethylphenidate is used in the treatment of attention deficit hyperactivity disorder (ADHD).

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

 What should I discuss with my healthcare provider before taking dexmethylphenidate?

 •  Do not take dexmethylphenidate without first talking to your doctor if you

      · have taken a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days;

      · are allergic to methylphenidate (Ritalin, Methylin, Metadate, Concerta) or dexmethylphenidate;

      · have significant tension, agitation, or anxiety;

      · have glaucoma;

      · have motor tics (involuntary repetitive movements), Tourette's syndrome or a family history of Tourette's syndrome;

      · suffer from depression;

      · have a mental illness or psychotic condition such as schizophrenia;

      · have epilepsy or another seizure disorders;

      · have high blood pressure (hypertension);

      · have a history of alcohol or drug abuse; or

      · have an abnormal heart rate or rhythm.

 •  You may not be able to take dexmethylphenidate, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

 •  Tell your healthcare provider if you have a history of alcohol or drug abuse or dependence. Chronic, abusive use of dexmethylphenidate can lead to dependence, psychological problems, and withdrawal symptoms upon discontinuation of the medication.

 •  Dexmethylphenidate is in the FDA pregnancy category C. This means that it is not known whether dexmethylphenidate will harm an unborn baby. Do not take dexmethylphenidate without first talking to your doctor if you are pregnant or could become pregnant during treatment.

 •  It is not known whether dexmethylphenidate passes into breast milk. Do not take dexmethylphenidate without first talking to your doctor if you are breast-feeding a baby.

 •  Dexmethylphenidate is not approved for use by children younger than 6 years of age.  

How should I take dexmethylphenidate?

 •  Take dexmethylphenidate exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain the instructions to you.

 •  Dexmethylphenidate is usually taken twice a day. The second dose of dexmethylphenidate should be taken at least 4 hours after the first dose.

 •  Take each dose with a full glass (8 ounces) of water.

 •  Dexmethylphenidate can be taken with or without food.

 •  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. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

 •  Seek emergency medical attention.

 •  Symptoms of a dexmethylphenidate overdose include vomiting, agitation, tremors (shaking), muscle twitches, convulsions (may be followed by coma), exaggerated reflexes, confusion, hallucinations, sweating, headache, flushing, fast or irregular heartbeats, large pupils, delirium, and dryness of the mouth and eyes.

 What should I avoid while taking dexmethylphenidate?

 •  Use caution when driving, operating machinery, or performing other hazardous activities. Dexmethylphenidate may cause dizziness, drowsiness, or blurred vision or impair the ability to concentrate. If you experience dizziness, drowsiness, blurred vision, or impaired concentration, avoid these activities.

What are the possible side effects of dexmethylphenidate?

 •  If you experience any of the following serious side effects, stop taking dexmethylphenidate and seek emergency medical attention or contact your doctor immediately:

      · an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

      · irregular or fast heartbeats;

      · chest pains or very high blood pressure (blurred vision, severe headache, flushing);

      · blurred vision or other visual changes;

      · unusual behavior or confusion; or

      · twitching or tics (involuntary repetitive movements).

 •  Other, less serious side effects may be more likely to occur. Continue to take dexmethylphenidate and talk to your doctor if you experience

      · insomnia (sleeplessness);

      · nervousness;

      · drowsiness;

      · dizziness;

      · fever;

      · headache;

      · abdominal pain, nausea, or vomiting;

      · decreased appetite or weight loss; or

      · slower weight gain and/ or growth.

 •  Physical and/ or psychological dependence may occur with chronic, abusive use of dexmethylphenidate. Withdrawal symptoms may occur when dexmethylphenidate is stopped following abusive use.

 •  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 dexmethylphenidate?

 •  Do not take dexmethylphenidate if you have taken a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days.

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

      · warfarin (Coumadin);

      · phenytoin (Dilantin);

      · phenobarbital (Luminal, Solfoton);

      · primidone (Mysoline);

      · a tricyclic antidepressant such as nortriptyline (Pamelor), amitriptyline (Elavil, Endep), doxepin (Sinequan), desipramine (Norpramin), clomipramine (Anafranil), imipramine (Tofranil), and others;

      · a selective serotonin reuptake inhibitor such as citalopram (Celexa), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), or sertraline (Zoloft); or

      · clonidine (Catapres).

 •  You may not be able to take dexmethylphenidate, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.

 •  Drugs other than those listed here may also interact with dexmethylphenidate. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

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 •  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.

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Last modified: 12/08/04