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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.
You should not take this medication if you are allergic to dexmethylphenidate or methylphenidate (Ritalin, Concerta), or if you have:
- 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 need a dose adjustment or special tests to safely take dexmethylphenidate.
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 shared with 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.
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.
Seek emergency medical attention if you think you have used too much of this medicine.
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).
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.
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.
Less serious side effects may include:
- sleep problems (insomnia);
- loss of appetite;
- upset stomach;
- feeling restless, anxious, or jittery;
- dry mouth, sore throat; or
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Before taking dexmethylphenidate, tell your doctor if you are using any of the following medicines:
- 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).
This list is not complete and there may be other drugs that can interact with 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.
Focalin, Focalin XR, and dexmethylphenidate
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Copyright 1996-2004 Cerner Multum, Inc. Version 2.05. Revision date 8/23/04