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Concerta (methylphenidate)

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Generic Name : methylphenidate
Pronounced : METH il FEN i date

What is methylphenidate?

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

Methylphenidate is used to treat attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD), and narcolepsy.

Methylphenidate may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about methylphenidate?

Do not use methylphenidate if you have used an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), rasagiline (Azilect), or selegiline (Eldepryl, Emsam) within the past 14 days. Serious, life-threatening side effects can occur if you use methylphenidate before the MAO inhibitor has cleared from your body. Do not use this medication if you are allergic to methylphenidate or if you have glaucoma, overactive thyroid, severe high blood pressure, tics or Tourette's syndrome, angina, heart failure, heart rhythm disorder, recent heart attack, a hereditary condition such as fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency, or severe anxiety, tension, or agitation. Methylphenidate may be habit-forming and should be used only by the person it was prescribed for. Methylphenidate should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

What should I discuss with my healthcare provider before taking methylphenidate?

Do not take methylphenidate if you have used an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), rasagiline (Azilect), or selegiline (Eldepryl, Emsam) within the past 14 days. Serious, life-threatening side effects can occur if you use methylphenidate before the MAO inhibitor has cleared from your body. Some stimulants have caused sudden death in children and adolescents with serious heart problems or congenital heart defects. Tell your doctor if you have a congenital heart defect. FDA pregnancy category C. It is not known whether methylphenidate is harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether methylphenidate passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give methylphenidate to a child younger than 6 years old without the advice of a doctor.

How should I take methylphenidate?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take this medication at least 30 minutes before a meal. The extended-release forms of methylphenidate (Ritalin-SR, Metadate ER, Metadate CD, Methylin ER, Concerta) can be taken with or without food. The chewable tablet must be chewed before you swallow it.

Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time. If you have trouble swallowing the extended-release capsule, you may open the capsule and sprinkle the medicine into a spoonful of applesauce to make swallowing easier. Swallow this mixture right away without chewing. Do not save the mixture for later use. Discard the empty capsule.

Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

To prevent sleep problems, take this medication early in the day, no later than 6:00 pm.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using methylphenidate. You may need to stop using the medicine the day of your surgery. Store methylphenidate at room temperature away from moisture and heat. Keep track of how many pills have been used from each new bottle of this medicine. Methylphenidate is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of methylphenidate can be fatal. Overdose can cause vomiting, agitation, tremors, muscle twitching, seizure (convulsions), confusion, hallucinations, sweating, fast or pounding heartbeat, blurred vision, dry mouth and nose, and fainting.

What should I avoid while taking methylphenidate?

Methylphenidate can cause side effects that may impair your vision or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

What are the possible side effects of methylphenidate?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking methylphenidate and call your doctor at once if you have any of these serious side effects:

fast, pounding, or uneven heartbeats;
feeling like you might pass out;
fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
aggression, restlessness, hallucinations, unusual behavior, or motor tics (muscle twitches);
easy bruising, purple spots on your skin; or
dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

stomach pain, nausea, vomiting, loss of appetite;
vision problems, dizziness, mild headache;
sweating, mild skin rash;
numbness, tingling, or cold feeling in your hands or feet;
nervous feeling, sleep problems (insomnia); or
weight loss.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect methylphenidate?

Before taking methylphenidate, tell your doctor if you are using any of the following drugs:

a blood thinner such as warfarin (Coumadin);
clonidine (Catapres);
dobutamine (Dobutrex), epinephrine (EpiPen), or isoproterenol (Isuprel);
phenylbutazonie (Azolid, Butazolidin);
cold/allergy medicine that contains phenylephrine (a decongestant);
potassium citrate (Urocit-K, Twin-K), sodium acetate, sodium bicarbonate (Alka-Seltzer), citric acid and potassium citrate (Cytra-K, Poly-Citra), or sodium citrate and citric acid (Bicitra, Oracit);
medications to treat high or low blood pressure;
stimulant medications or diet pills;
seizure medicine such as phenytoin (Dilantin), phenobarbital (Luminal), primidone (Mysoline); or
an antidepressant such as amitriptyline (Elavil, Etrafon), citalopram (Celexa), doxepin (Sinequan), fluoxetine (Prozac, Sarafem), imipramine (Janimine, Tofranil), nortriptyline (Pamelor) paroxetine (Paxil), sertraline (Zoloft), and others.

This list is not complete and there may be other drugs that can interact with methylphenidate. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about methylphenidate.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Multum version: 146.0 (Oct 22, 2009)

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