Focalin (Dexmethylphenidate HCl)

Dexmethylphenidate (dex meth ill fen' i date) Focalin® Focalin® XR Dexmethylphenidate can be habit-forming.Do not take a larger dose, take it more often, take it for a longer time, or take it in a different way than prescribed by your doctor. If you take too much dexmethylphenidate, you may find that the medication no longer controls your symptoms, you may feel a need to take large amounts of the medication, and you may experience unusual changes in your behavior Tell your doctor if you drink or have ever drunk large amounts of alcohol, use or have ever used street drugs, or have overused prescription medications. Do not stop taking dexmethylphenidate without talking to your doctor, especially if you have overused the medication. Your doctor will probably decrease your dose gradually and monitor you carefully during this time. You may develop severe depression if you suddenly stop taking dexmethylphenidate after overusing it. Your doctor may need to monitor you carefully after you stop taking dexmethylphenidate, even if you have not overused the medication, because your symptoms may worsen when treatment is stopped. Do not sell, give away, or let anyone else take your medication. Selling or giving away dexmethylphenidate is against the law and may harm others. Store dexmethylphenidate in a safe place where no one else can take it accidentally or on purpose. Keep track of how many tablets or capsules are left so you will know if any are missing. Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with dexmethylphenidate and each time you get more medication. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Dexmethylphenidate is used as part of a treatment program to control symptoms of attention deficit hyperactivity disorder (ADHD; more difficulty focusing, controlling actions, and remaining still or quiet than other people who are the same age) in adults and children. Dexmethylphenidate is in a class of medications called central nervous system (CNS) stimulants. It works by increasing the amounts of certain natural substances in the brain.

Dexmethylphenidate comes as a tablet and an extended-release (long-acting) capsule to take by mouth. The tablet is usually taken twice a day, at least 4 hours apart, with or without food. The extended-release capsule is usually taken once a day in the morning. It may be taken with or without food, but will start to work faster if it is taken without food . Take dexmethylphenidate at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Swallow the extended-release capsules whole; do not chew or crush them. If you are unable to swallow the extended-release capsule, you can carefully open the capsule and sprinkle the contents on a spoonful of applesauce. Swallow this mixture immediately, but do not chew it. Do not save this mixture to use at a later time. Your doctor will probably start you on a low dose of dexmethylphenidate and gradually increase your dose, not more often than once a week. Your condition should improve during your treatment. Call your doctor if your symptoms worsen at any time during your treatment or do not improve after 1 month. Your doctor may tell you to stop taking dexmethylphenidate from time to time to see if the medication is still needed. Follow these directions carefully.

Before taking dexmethylphenidate, tell your doctor and pharmacist if you are allergic to dexmethylphenidate, methylphenidate (Concerta, Metadate, Methylin, Ritalin), or any other medications. tell your doctor if you are taking monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate), or if you have stopped taking them during the past 14 days. Your doctor will probably tell you not to take dexmethylphenidate until at least 14 days have passed since you last took an MAO inhibitor. tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven); antidepressants (mood elevators) such as amitriptyline (Elavil), amoxapine, clomipramine (Anafranil), desipramine (Norpramin), doxepin (Silenor), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil); decongestants (cough and cold medications); guanabenz; guanfacine; medications for high blood pressure; medications for seizures such as phenobarbital phenytoin (Dilantin), and primidone (Mysoline); methyldopa; selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), and sertraline (Zoloft); and venlafaxine (Effexor). If you are taking the extended-release capsules, also tell your doctor if you are taking antacids, or other medications for heartburn or ulcers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. tell your doctor if you or anyone in your family has or has ever had Tourette's syndrome (a condition characterized by the need to perform repeated motions or to repeat sounds or words), facial or motor tics (repeated uncontrollable movements), or verbal tics (repetition of sounds or words that is hard to control). Also tell your doctor if you have glaucoma, or feelings of anxiety, tension, or agitation. Your doctor will probably tell you not to take dexmethylphenidate. tell your doctor if anyone in your family has or has ever had an irregular heartbeat or has died suddenly. Also tell your doctor if you have recently had a heart attack and if you have or have ever had a heart defect, high blood pressure, an irregular heartbeat, heart or blood vessel disease, hardening of the arteries; or other heart problems. Your doctor will examine you to see if your heart and blood vessels are healthy. Your doctor will probably tell you not to take dexmethylphenidate if you have a heart condition or if there is a high risk that you may develop a heart condition. tell your doctor if you or anyone in your family has or has ever had depression, bipolar disorder (mood that changes from depressed to abnormally excited), mania (frenzied, abnormally excited mood), or has thought about or attempted suicide. Also tell your doctor if you have or have ever had circulation problems in your fingers or toes; depression; mental illness; seizures; an abnormal electroencephalogram (EEG; a test that measures electrical activity in the brain); or thyroid disease. tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking dexmethylphenidate, call your doctor. you should know that dexmethylphenidate should be used as part of a total treatment program for ADHD, which may include counseling and special education. Make sure to follow all of your doctor's and/or therapist's instructions.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Dexmethylphenidate may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away: stomach pain loss of appetite nausea vomiting heartburn weight loss dry mouth difficulty falling asleep or staying asleep dizziness drowsiness nervousness or jitteriness headache Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately: fast, pounding, or irregular heartbeat chest pain shortness of breath excessive tiredness slow or difficult speech dizziness or faintness weakness or numbness of an arm or leg changes in vision or blurred vision seizures believing things that are not true feeling unusually suspicious of others aggressive behavior hallucinations (seeing things or hearing voices that do not exist) mood changes depression motor tics or verbal tics swelling of the face, throat, tongue, lips, or eyes rash hives itching purple blotches under the skin fever blistering or peeling skin joint pain frequent, painful erections erection that lasts longer than 4 hours numbness, pain, or sensitivity to temperature in the fingers or toes skin color change from pale to blue to red in the fingers or toes unexplained wounds on the fingers or toes Dexmethylphenidate may cause sudden death in children and teenagers, especially children and teenagers with heart defects or serious heart problems. This medication also may cause sudden death, heart attack, or stroke in adults, especially adults with heart defects or serious heart problems. Talk to your doctor about the risks of taking this medication. Dexmethylphenidate may slow children's growth or weight gain. Your child's doctor will watch his or her growth carefully. Talk to your child's doctor if you have concerns about your child's growth or weight gain while he or she is taking this medication. Talk to your child's doctor about the risks of giving dexmethylphenidate to your child. Dexmethylphenidate may cause other side effects. Call your doctor if you have any unusual problems while taking this medication. If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program. It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to dexmethylphenidate. This prescription is not refillable. Be sure to schedule appointments with your doctor on a regular basis so you do not run out of medication. It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.