Focalin is a mild stimulant to the central nervous system. It affects chemicals in the brain that contribute to hyperactivity and impulse control.

Focalin is a prescription medicine used to treat attention deficit hyperactivity disorder (ADHD).

Focalin should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

Do not use Focalin if you have used a MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, tranylcypromine, or methylene blue injection.

You should not use Focalin if you have glaucoma, tics or Tourette's syndrome, or severe anxiety, tension, or agitation.

Focalin may be habit-forming, and dexmethylphenidate is a drug of abuse. Tell your doctor if you have had problems with drug or alcohol abuse. Keep the medication where others cannot get to it.

Stimulants such as Focalin have caused stroke, heart attack, and sudden death in people with high blood pressure, heart disease, or a heart defect.

Focalin may cause new or worsening psychosis (unusual thoughts or behavior), especially if you have a history of depression, mental illness, or bipolar disorder.

Focalin may cause blood circulation problems that can cause numbness, pain, or discoloration in your fingers or toes.

Call your doctor right away if you have: signs of heart problems--chest pain, feeling light-headed or short of breath; signs of psychosis - paranoia, aggression, new behavior problems, seeing or hearing things that are not real; signs of circulation problems - unexplained wounds on your fingers or toes.

Before taking this medicine

You should not take Focalin if you are allergic to dexmethylphenidate or methylphenidate (Ritalin, Concerta).

Stimulants have caused stroke, heart attack, and sudden death in certain people. Tell your doctor if you have:

• heart problems or a congenital heart defect;

• high blood pressure; or

• a family history of heart disease or sudden death.

Do not use Focalin if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, and tranylcypromine.

Tell your doctor if you also use stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. An interaction with Focalin could cause a serious condition called serotonin syndrome.

Tell your doctor if you or anyone in your family has ever had:

• depression, mental illness, bipolar disorder, psychosis, or suicidal thoughts or actions;

• blood circulation problems in the hands or feet; or

• alcoholism or drug addiction.

Becoming dependent on Focalin during pregnancy can cause premature birth or low birth weight. Tell your doctor if you are pregnant or plan to become pregnant. If you are pregnant, your name may be listed on a pregnancy registry to track the effects of dexmethylphenidate on the baby.

Ask a doctor if it is safe to breastfeed while using this medicine.

Focalin is not approved for use by anyone younger than 6 years old.

Take Focalin exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Dexmethylphenidate may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication where others cannot get to it. Selling or giving away Focalin is against the law.

Focalin is usually taken twice per day, at least 4 hours apart.

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.

Swallow the extended-release capsule whole and do not crush, chew, break, or open it.

If you cannot swallow a capsule whole, open it and mix the medicine with applesauce. Swallow the mixture right away without chewing.

Your doctor will need to check your progress on a regular basis. Your heart and blood pressure may also need to be checked often.

Tell your doctor if you have a planned surgery.

Your treatment may also include counseling or other treatments.

Store tightly closed at room temperature, away from moisture, heat, and light. Keep your medicine in a place where no one can use it improperly.

Usual Adult Dose of Focalin for Attention Deficit Disorder:

Immediate-Release:
For patients NEW to methylphenidate or on stimulants other than methylphenidate:
-Initial dose: 2.5 mg orally twice a day, at least 4 hours apart
For patients CURRENTLY on methylphenidate:
-Initial dose: One-half the total daily dose of methylphenidate; divide dose and administer orally twice a day at least 4 hours apart
Adjust dose in increments of 2.5 to 5 mg weekly according to needs and responses
Maximum dose: 20 mg/day (10 mg twice a day)

Extended Release (XR):
For patients NEW to this drug or methylphenidate, or on stimulants other than methylphenidate:
-Initial dose: 10 mg orally once a day
For patients CURRENTLY on methylphenidate:
-Initial dose: One-half of the total daily dose of methylphenidate orally once a day
For patients CURRENTLY on dexmethylphenidate immediate-release (IR):
-Initial dose: Same dexmethylphenidate IR daily dose orally once a day
Adjust dose weekly in 10 mg increments according to the needs and responses
-Maximum dose: 40 mg/day.

Usual Pediatric Dose of Focalin for Attention Deficit Disorder:

Age 6 years or older:

Immediate-Release:
For patients NEW to methylphenidate or on stimulants other than methylphenidate:
-Initial dose: 2.5 mg orally twice a day, at least 4 hours apart
For patients CURRENTLY on methylphenidate:
-Initial dose: One-half the total daily dose of methylphenidate; divide dose and administer orally twice a day at least 4 hours apart
Adjust dose in increments of 2.5 to 5 mg weekly according to needs and responses
Maximum dose: 20 mg/day

Extended Release (XR):
For patients NEW to this drug or methylphenidate, or on stimulants other than methylphenidate:
-Initial dose: 5 mg orally once a day
For patients CURRENTLY on methylphenidate:
-Initial dose: One-half of the total daily dose of methylphenidate orally once a day
For patients CURRENTLY on dexmethylphenidate immediate-release (IR):
-Initial dose: Same dexmethylphenidate IR daily dose orally once a day
Adjust dose weekly in 5 mg increments according to the needs and responses
-Maximum dose: 30 mg/day

Comments:
-The dose should be individualized according to the needs and response of the patient.
-The immediate-release tablets should be taken twice a day at least 4 hours apart (with or without food); the extended-release capsules should be taken once a day in the morning (with or without food); if necessary, the capsule may be opened and sprinkled onto applesauce (see Administration Advice).
-If paradoxical aggravation of symptoms or other adverse reactions occur, dose reduction or discontinuation may be necessary.
-If improvement is not observed after 1-month of optimal dosing, this drug should be discontinued.

Use: For the treatment of attention deficit hyperactivity disorder (ADHD).

You should not take Focalin if you are allergic to dexmethylphenidate or methylphenidate (Ritalin, Concerta).

Stimulants have caused stroke, heart attack, and sudden death in certain people. Tell your doctor if you have:

• heart problems or a congenital heart defect;

• high blood pressure; or

• a family history of heart disease or sudden death.

Do not use Focalin if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, and tranylcypromine.

Tell your doctor if you also use stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. An interaction with Focalin could cause a serious condition called serotonin syndrome.

Tell your doctor if you or anyone in your family has ever had:

• depression, mental illness, bipolar disorder, psychosis, or suicidal thoughts or actions;

• blood circulation problems in the hands or feet; or

• alcoholism or drug addiction.

Becoming dependent on Focalin during pregnancy can cause premature birth or low birth weight. Tell your doctor if you are pregnant or plan to become pregnant. If you are pregnant, your name may be listed on a pregnancy registry to track the effects of dexmethylphenidate on the baby.

Ask a doctor if it is safe to breastfeed while using this medicine.

Focalin is not approved for use by anyone younger than 6 years old.

Take Focalin as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of dexmethylphenidate could be fatal.

Overdose symptoms may include dry mouth, vomiting, agitation, tremor, muscle twitches, confusion, hallucinations, dilated pupils, muscle pain or weakness, fever, sweating, headache, pounding in your neck or ears, fast or pounding heartbeats, seizure (convulsions), or coma.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

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.

Call your doctor at once if you have:

• signs of heart problems - chest pain, trouble breathing, feeling like you might pass out;

• signs of psychosis - hallucinations (seeing or hearing things that are not real), new thought or behavior problems, aggression, hostility, paranoia;

• signs of circulation problems - numbness, pain, cold feeling, unexplained wounds, or skin color changes (pale, red, or blue appearance) in your fingers or toes; or

• penis erection that is painful or lasts 4 hours or longer.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Dexmethylphenidate can affect growth in children. Your child's height and weight may need to be checked often. Tell your doctor if your child is not growing at a normal rate.

Common Focalin side effects may include:

• loss of appetite;

• nausea, stomach pain; or

• 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.

Tell your doctor about all your other medicines, especially:

• an antidepressant; or

• blood pressure 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 drug interactions are listed here.