Focalin

Uses

What is Focalin® (dexmethylphenidate) used for?

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 used to treat attention deficit hyperactivity disorder (ADHD).

Focalin® may also be used for purposes not listed in this medication guide.

How should I take Focalin® (dexmethylphenidate)?

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.

Dexmethylphenidate 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.

How do I store Focalin® (dexmethylphenidate)?

Focalin® is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Focalin® in the bathroom or the freezer. There may be different brands of Focalin® that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Focalin® down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Focalin® (dexmethylphenidate)?

Before using this drug, tell your doctor if:

• You are pregnant or breastfeeding. This is because, while you are expecting or feeding a baby, you should only take medicines on the recommendation of a doctor.
• You are taking any other medicines. This includes any medicines you are taking which are available to buy without a prescription, such as herbal and complementary medicines.
• You have allergy with any of active or inactive ingredients of Focalin® or other medications.
• You have any other illnesses, disorders, or medical conditions.

You should not take Focalin® if you have:

• Glaucoma
• A personal or family history of tics (muscle twitches) or Tourette’s syndrome
• 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, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Some medicines can interact with dexmethylphenidate 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
• 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)
• A history of drug or alcohol addiction

Is it safe during pregnancy or breastfeeding?

There are no adequate studies in women for determining risk when using Focalin® during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Focalin®. Focalin® is pregnancy risk category C, according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

• A=No risk
• B=No risk in some studies
• C=There may be some risk
• D=Positive evidence of risk
• X=Contraindicated
• N=Unknown

Side effects

What side effects can occur from Focalin® (dexmethylphenidate)?

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
• 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 side effects may include:

• Loss of appetite
• Nausea, stomach pain
• Fever

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Focalin® (dexmethylphenidate)?

Focalin® may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs, and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Products that may interact with this drug are:

• An antidepressant
• Blood pressure medication
• A blood thinner such as warfarin (Coumadin, Jantoven)
• A cold or allergy medicine that contains a decongestant
• Seizure medicine

Does food or alcohol interact with Focalin® (dexmethylphenidate)?

Focalin® may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Focalin® (dexmethylphenidate)?

Focalin® may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using Focalin® (dexmethylphenidate).

What is the dose of Focalin® (dexmethylphenidate) for an adult?

Focalin® is administered twice daily, at least 4 hours apart. Focalin® may be administered with or without food.

Dosage should be individualized according to the needs and responses of the patient.

What is the dose of Focalin® (dexmethylphenidate) for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Focalin® (dexmethylphenidate) available?

Focalin® is available in the following dosage forms and strengths:

• Tablet: dexmethylphenidate hydrochloride 2.5mg

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Focalin®, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.