What is Focalin?
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.
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 this medicine is a drug of abuse. Tell your doctor if you have had problems with drug or alcohol abuse..
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), or if you have:
- a personal or family history of tics (muscle twitches) or Tourette’s syndrome; or
- severe anxiety, tension, or agitation (stimulant medicine can make these symptoms worse).
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, phenelzine, rasagiline, selegiline, tranylcypromine, and methylene blue injection.
Some medicines can interact with Focalin and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson’s disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.
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.
To make sure this medicine is safe for you, tell your doctor if you or anyone in your family has ever had:
- depression, mental illness, bipolar disorder, psychosis, or suicidal thoughts or actions;
- motor tics (muscle twitches) or Tourette’s syndrome;
- blood circulation problems in the hands or feet;
- seizures or epilepsy;
- an abnormal brain wave test (EEG); or
- a history of drug or alcohol addiction.
Taking Focalin during pregnancy can cause premature birth, low birth weight, or withdrawal symptoms in the newborn 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 nursing baby. Tell your doctor if you are breast-feeding.
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.
Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended.
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 Focalin 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. Selling or giving away this medicine is against the law.
You may take Focalin with or without food. Take the regular tablet twice daily, at least 4 hours apart. Take the extended-release Focalin XR capsule once daily in the morning.
Do not crush, chew, break, or open an extended-release capsule. Swallow the capsule whole.
To make swallowing easier, you may open the Focalin XR 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. You may also need frequent blood tests.
Store at room temperature away from moisture, heat, and light.
Keep track of your medicine. Dexmethylphenidate is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.
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 Focalin could be fatal.
Overdose symptoms may include restlessness, tremor, muscle twitches, rapid breathing, confusion, hallucinations, panic, muscle pain or weakness, and dark colored urine. These symptoms may be followed by depression and tiredness. Other overdose symptoms include nausea, vomiting, diarrhea, stomach pain, uneven heartbeats, feeling light-headed, fainting, seizure (convulsions), or coma.
What to avoid
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.
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 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;
- a seizure (convulsions);
- blurred vision or other visual changes; or
- penis erection that is painful or lasts 4 hours or longer (rare).
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.
Common Focalin side effects may include:
- loss of appetite;
- nausea, stomach pain; or
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 other drugs will affect Focalin?
Tell your doctor about all your current medicines and any you start or stop using, especially:
- an antidepressant, including MAO inhibitors (isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, tranylcypromine, or methylene blue injection), and SSRIs (citalopram, escitalopram, fluoxetine, paroxetine, sertraline, vilazodone) and others;
- blood pressure medication;
- other stimulant medications (methylphenidate or Ritalin, Concerta);
- a blood thinner such as warfarin (Coumadin, Jantoven);
- a cold or allergy medicine that contains a decongestant; or
- Parkinson’s medication;
- opioid medication (hydrocodone, morphine, oxycodone, others);
- migraine medication;
- nausea medicine; or
- seizure medicine.
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.
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