Focalin (dexmethylphenidate) is a mild stimulant to the central nervous system. It affects chemicals in the brain that contribute to hyperactivity and impulse control.
Focalin is used to treat attention deficit hyperactivity disorder (ADHD).
Focalin may also be used for purposes not listed in this medication guide.
Important information
You should not use Focalin if you have glaucoma, tics or Tourette"s syndrome, or severe anxiety, tension, or agitation.
Do not use Focalin if you have taken an MAO inhibitor in the past 14 days, including isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.
Focalin 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.
Before taking this medicine
Do not use Focalin 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 Focalin if you are allergic to dexmethylphenidate or methylphenidate (Ritalin, Concerta), or if you have:
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glaucoma;
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a personal or family history of tics (muscle twitches) or Tourette"s syndrome; or
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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:
To make sure Focalin is safe for you, tell your doctor if you or anyone in your family has ever had:
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depression, mental illness, bipolar disorder, psychosis, or suicidal thoughts or actions;
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motor tics (muscle twitches) or Tourette"s syndrome;
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blood circulation problems in the hands or feet;
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seizures or epilepsy;
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an abnormal brain wave test (EEG); or
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a history of drug or alcohol addiction.
It is not known whether Focalin 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.
Focalin is not approved for use by anyone younger than 6 years old.
How should I take Focalin?
Using Focalin 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.
Focalin 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 Focalin 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 Focalin 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 Focalin, 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 Focalin 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.
Focalin dosing information
Usual Adult Dose of Focalin for Attention Deficit Disorder:
PATIENTS NEW TO METHYLPHENIDATE:
Immediate Release:
-Initial dose: 2.5 mg orally twice a day, at least 4 hours apart
-Maintenance dose: Dose may be adjusted in increments of 2.5 to 5 mg at weekly intervals.
-Maximum dose: 10 mg orally twice a day (20 mg/day)
Extended Release:
-Initial dose: 10 mg orally once a day in the morning
-Maintenance dose: Dose may be adjusted in increments of 10 mg at weekly intervals.
-Maximum dose: 40 mg orally once a day in the morning
PATIENTS CURRENTLY USING METHYLPHENIDATE:
Immediate Release:
-Initial dose: Half the total daily dose of racemic methylphenidate orally twice a day
-Maximum dose: 10 mg orally twice a day (20 mg/day)
Extended Release:
-Initial dose: Half the total daily dose of racemic methylphenidate orally once a day in the morning
-Maximum dose: 40 mg orally once a day in the morning
PATIENTS SWITCHING FROM IMMEDIATE RELEASE TO EXTENDED RELEASE:
-Continue same daily dosage orally once a day in the morning.
Comments:
-Dosage should be individualized according to the needs and responses of the patient.
-This drug should be used as part of a comprehensive treatment program that may include other measures (psychological, educational, social) such as counseling or other therapies.
Use: ADHD
Usual Pediatric Dose of Focalin for Attention Deficit Disorder:
PATIENTS NEW TO METHYLPHENIDATE (Age 6 years or older):
Immediate Release:
-Initial dose: 2.5 mg orally twice a day, at least 4 hours apart
-Maintenance dose: Dose may be adjusted in increments of 2.5 to 5 mg at weekly intervals.
-Maximum dose: 10 mg orally twice a day (20 mg/day)
Extended Release:
-Initial dose: 5 mg orally once a day in the morning
-Maintenance dose: Dose may be adjusted in increments of 5 mg at weekly intervals.
-Maximum dose: 30 mg orally once a day in the morning
PATIENTS CURRENTLY USING METHYLPHENIDATE (Age 6 years or older):
Immediate Release:
-Initial dose: Half the total daily dose of racemic methylphenidate orally twice a day
-Maximum dose: 10 mg orally twice a day (20 mg/day)
Extended Release:
-Initial dose: Half the total daily dose of racemic methylphenidate orally once a day in the morning
-Maximum dose: 30 mg orally once a day in the morning
PATIENTS SWITCHING FROM IMMEDIATE RELEASE TO EXTENDED RELEASE (Age 6 years or older):
-Continue same daily dosage orally once a day in the morning.
Comments:
-Dosage should be individualized according to the needs and responses of the patient.
-This drug should be used as part of a comprehensive treatment program that may include other measures (psychological, educational, social) such as counseling or other therapies.
Use: ADHD
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?
Avoid taking Focalin 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 side effects
Get emergency medical help if you have signs of an allergic reaction to Focalin: fever; hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Focalin can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.
Stop taking Focalin and call your doctor at once if you have:
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chest pain, trouble breathing, feeling like you might pass out;
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hallucinations (seeing or hearing things that are not real), new behavior problems, aggression, hostility, paranoia;
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a seizure (convulsions);
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numbness, pain, cold feeling, unexplained wounds, or skin color changes (pale, red, or blue appearance) in your fingers or toes;
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blurred vision or other visual changes;
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penis erection that is painful or lasts 4 hours or longer (rare); or
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unexplained muscle pain, tenderness, or weakness (especially if you also have fever, unusual tiredness, and dark colored urine).
Common Focalin side effects may include:
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loss of appetite;
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nausea, stomach pain; or
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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?
Tell your doctor about all your current medicines and any you start or stop using, especially:
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an antacid;
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an antidepressant;
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blood pressure medication;
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a blood thinner such as warfarin (Coumadin, Jantoven);
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a cold or allergy medicine that contains a decongestant such as pseudoephedrine or phenylephrine; or
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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.
