Dexmethylphenidate (By mouth)

Introduction

Dexmethylphenidate (dex-meth-il-FEN-i-date)

Treats attention deficit hyperactivity disorder (ADHD).

Brand Name(s)

Focalin XR, Focalin

There may be other brand names for this medicine.

When This Medicine Should Not Be Used

You should not use this medicine if you or your child have had an allergic reaction to dexmethylphenidate. You should not use this medicine if you have glaucoma, or if you are anxious, tense, or agitated most of the time. You should not use this medicine if you have muscle tics or Tourette's syndrome, a condition that causes you to have muscle twitches or to makes sounds you are not able to control. Do not use this medicine if you have taken an MAO inhibitor (MAOI) such as Eldepryl®, Marplan®, Nardil®, or Parnate® within the past 14 days. This medicine should not be given to a child younger than 6 years of age unless your doctor tells you otherwise.

If you notice other side effects that you think are caused by this medicine, tell your doctor

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

How to Use This Medicine

Long Acting Capsule, Tablet

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.
• You may take this medicine with or without food.
• This medicine is usually given once daily. Because dexmethylphenidate can cause a loss of appetite, it is best to take the medicine after eating or just before your morning meal, unless your doctor tells you otherwise.
• Swallow the extended-release capsule whole. Do not crush, break, or chew it.
• If you cannot swallow the extended-release capsule, you may open it and pour the medicine into a small amount of soft food such as pudding, yogurt, or applesauce. Stir this mixture well and swallow it without chewing.
• Always take this medicine with a full glass of liquid (water, milk, or juice).
• This medicine is part of an ADHD treatment program that may also include counseling or special education. Carefully follow your doctor's instructions about all treatment measures.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using blood pressure medicines (such as atenolol, hydrochlorothiazide [HCTZ], lisinopril, metoprolol, quinapril, Accupril®, Cozaar®, Diovan®, Lotrel®, Norvasc®, Toprol®, or Zestril®), a blood thinner (such as warfarin, Coumadin®), or medicines to treat seizures (such as phenytoin, phenobarbital, primidone, Dilantin®, Luminal®, or Mysoline®). Tell your doctor if you use medicines for depression (such as amitriptyline, clomipramine, desipramine, imipramine, trazodone, Celexa®, Effexor®, Luvox®, Norpramin®, Paxil®, Prozac®, Serzone®, Vivactil®, or Zoloft®).
• Tell your doctor if you use cold or allergy medicines, or antacids or stomach acid reducers (such as Axid®, Prilosec®, Tagamet®, or Zantac®).

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant, planning to become pregnant, or breastfeeding, or if you or your child have kidney disease, liver disease, heart disease, heart failure, heart rhythm problems, high blood pressure, or recent heart attack. Your doctor should know if you or your child have epilepsy, a history of seizures, depression or mental illness (including bipolar disease, mania, or psychosis), or drug or alcohol problems. Also tell your doctor if you or anyone in your family has tried to commit suicide.
• This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.
• Check with your doctor right away if you or your child have blurred vision or changes in vision. This could be a sign of high blood pressure.
• This medicine may make you dizzy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.
• This medicine may cause slow growth. If your child is using this medicine, the doctor will need to keep track of your child's height and weight to make sure that your child is growing properly.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments. Your doctor will need to check your or your child's blood, heart, and blood pressure for any problems or unwanted effects that may be caused by this medicine.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision, or trouble seeing.
• Chest pain or shortness of breath.
• Fast, pounding, or uneven heartbeat.
• Lightheadedness, dizziness, or fainting.
• Mood or mental changes, confusion, or unusual behavior.
• Seeing, hearing, or feeling things that are not there.
• Seizures.
• Tremors or shaking.
• Uncontrollable muscle movements or twitching.
• Unusual bleeding, bruising, or weakness.
• Vomiting, agitation, confusion, sweating, or fever.

If you notice these less serious side effects, talk with your doctor:

• Dry mouth or nose, sore throat.
• Feeling restless, anxious, or nervous.
• Headache.
• Nausea, vomiting, loss of appetite, heartburn, or stomach pain or upset.
• Trouble with sleeping.