Misuse or abuse of dexmethylphenidate may result in serious (possibly fatal) heart and blood pressure problems.

Dexmethylphenidate may be habit-forming and should be used cautiously by people who have mental/mood disorders or a history of alcohol/drug abuse. Such patients may be more likely to increase their dose of this drug unnecessarily or take this medication too often. With prolonged use or abuse of this medication, drug dependence and abnormal behavior may occur. Withdrawal symptoms may occur after stopping the drug. Consult your doctor or pharmacist for more details. (See also How to Use section.)

Dexmethylphenidate is used to treat attention deficit hyperactivity disorder (ADHD) as part of a total treatment plan including psychological, educational, social, and other treatments.

It is thought to work by restoring the balance of certain natural substances (neurotransmitters) in the brain. This medication helps increase your ability to pay attention, stay focused on an activity, and control behavior problems. It may also help improve listening skills, help you to stop fidgeting, and allow you to organize your tasks better.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used for certain sleep disorders (e.g., narcolepsy). This medication should not be used to treat severe depression or tiredness or to hold off sleep in people who do not have a sleep disorder.

Read the Medication Guide provided by your pharmacist before you start using dexmethylphenidate and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Take this medication by mouth with or without food, usually twice daily or as directed by your doctor. Take the first dose as soon as you wake up in the morning and the second dose at least 4 hours later, or take as directed by your doctor. Taking this medication late in the day may cause trouble sleeping (insomnia).

The dosage is based on your medical condition and response to therapy. Your doctor may adjust your dose (e.g., weekly) to find the dose that is best for you. The total daily dose is usually 20 milligrams or less. Follow your doctor's instructions carefully.

Methylphenidate and dexmethylphenidate are different medications and do not provide the same amount of medicine. Do not switch between products unless your doctor tells you to.

Use this medication regularly and exactly as prescribed in order to get the most benefit from it. To help you remember, take it at the same times each day.

This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as depression, suicidal thoughts, or other mental/mood changes) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.

Though it is very unlikely to occur, this medication can also result in abnormal drug-seeking behavior (addiction/habit forming). Do not increase your dose, take it more frequently, or use it for a longer time than prescribed. Properly stop the medication when so directed. This will lessen the chances of becoming addicted.

Inform your doctor if your condition persists or worsens. Your doctor may recommend drug holidays when your medication is stopped temporarily so that behavior can be re-evaluated.

Trouble sleeping, nausea, stomach pain, headache, nervousness, loss of appetite, or weight loss may occur. If any of these effects persist or worsen, notify your doctor.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: high fever, uncontrolled muscle movements (e.g., stiffness, twitching, shaking), mental/mood/behavior changes (e.g., agitation, aggression, mood swings, depression, hallucinations, abnormal thoughts/behavior), outbursts of words/sounds, severe sweating, swelling of the ankles/feet, extreme tiredness, blurred vision.

Seek immediate medical attention if any of these rare but very serious side effects occur: shortness of breath, easy bleeding/bruising, fainting, sudden vision changes, chest/jaw/left arm pain, severe headache, fast/irregular/pounding heartbeat, signs of infection (fever, persistent sore throat), seizures, weakness, slurred speech, confusion.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking dexmethylphenidate, tell your doctor or pharmacist if you are allergic to it; or to methylphenidate; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe anxiety/tension, heart/blood vessel disease (e.g., irregular heartbeat/rhythm, coronary artery disease, angina, heart failure, cardiomyopathy), problems with heart structure (e.g., valve problems), history of heart attack or stroke, certain eye problem (glaucoma), personal or family history of uncontrolled muscle movements (motor tics, Tourette's syndrome), seizures, certain mental/mood conditions (e.g., agitation, psychosis).

Tell your doctor your medical history, especially of: family history of sudden death/irregular heartbeat/rhythm, history of alcohol/drug abuse, heart problems (e.g., recent heart attack, heart failure, abnormal heartbeat), high blood pressure, family/personal history of mental/mood disorders (e.g., bipolar disorder, depression, psychotic disorder, suicidal thoughts), history of seizure disorders, overactive thyroid (hyperthyroidism).

This drug may cause blurred vision. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

Before having surgery, tell your doctor or dentist that you are taking this medication.

Caution is advised when using this drug in children because it may affect weight, growth rate, and final height. The doctor may recommend temporarily stopping the medication from time to time to reduce this risk. Monitor your child's weight and height and consult your doctor or pharmacist for more details.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.

Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop or change the dosage of any medicine before checking with them first.

Avoid taking MAO inhibitors (e.g., furazolidone, linezolid, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, isocarboxazid, tranylcypromine) within 2 weeks before, during, or after treatment with this medication. Consult your doctor or pharmacist for additional information.

If you are currently taking any of these medications listed above, tell your doctor or pharmacist before starting this medication.

Before using this medication, tell your doctor of all prescription and nonprescription medications you may use, especially: "blood thinners" (e.g., warfarin), antidepressants (e.g., tricyclics such as amitriptyline/nortriptyline, SSRIs such as fluoxetine/paroxetine, venlafaxine), medication for high blood pressure (e.g., beta blockers, guanethidine), medications that increase blood pressure/decongestants (e.g., epinephrine, phenylephrine, pseudoephedrine), anti-seizure medicine (e.g., phenobarbital, phenytoin, primidone), other stimulant medications (e.g., amphetamines).

Also report the use of drugs which might increase seizure risk (decrease seizure threshold) when combined with dexmethylphenidate such as bupropion, isoniazid (INH), phenothiazines (e.g., thioridazine), theophylline, or tricyclic antidepressants (e.g., imipramine) among others. Consult your doctor or pharmacist for details.

Check the labels on all your medicines/herbal products (e.g., cough-and-cold products, diet aids) because they may contain ingredients that could increase your heart rate or blood pressure (e.g., pseudoephedrine, phenylpropanolamine, ephedra/ma huang). Ask your pharmacist about the safe use of these products.

Avoid drinking large amounts of beverages containing caffeine (e.g., coffee, tea, colas). Caffeine can increase the side effects of this medication.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: severe mental/mood changes, confusion, severe/persistent headache, irregular/pounding heartbeat, severe restlessness, fast breathing, flushing, sweating, and widened pupils.

Do not share this medication with others. It is against the law.

Laboratory and/or medical tests (e.g., blood pressure, blood counts) may be performed to monitor your progress or check for side effects.

If you miss a dose, take it as soon as you remember in the morning hours. If it is later in the day or near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2009 Copyright(c) 2009 First DataBank, Inc.