Brand Name(s):

Orap^®

IMPORTANT WARNING

Studies have shown that older adults with dementia (a brain disorder that affects the ability to remember, think clearly, communicate, and perform daily activities and that may cause changes in mood and personality) who take antipsychotics (medications for mental illness) such as pimozide have an increased chance of death during treatment.

Pimozide is not approved by the Food and Drug Administration (FDA) for the treatment of behavior problems in older adults with dementia. Talk to the doctor who prescribed this medication if you, a family member, or someone you care for has dementia and is taking pimozide. For more information, visit the FDA website:http://www.fda.gov/Drugs

WHY is this medicine prescribed?

Pimozide is used to control motor or verbal tics (an uncontrollable need to repeat certain movements or sounds) caused by Tourette's disorder (condition characterized by motor or verbal tics). Pimozide should only be used to treat people who cannot take other medications or who have taken other medications without good results. Pimozide should only be used to treat severe tics that stop the person from learning, working, or performing daily activities.

Pimozide is in a class of medications called conventional antipsychotics. It works by decreasing abnormal excitement in the brain.

HOW should this medicine be used?

Pimozide comes as a tablet to take by mouth. It is usually taken once a day at bedtime or two or more times a day. Take pimozide 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. Take pimozide exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor will probably start you on a low dose of pimozide and gradually increase your dose, not more than once every 2 or 3 days. Your doctor may decrease your dose once your condition is controlled. Be sure to tell your doctor how you are feeling during your treatment with pimozide.

Pimozide controls Tourette's disorder but does not cure it. It may take some time before you feel the full benefit of pimozide. Continue to take pimozide even if you feel well. Do not stop taking pimozide without talking to your doctor. If you suddenly stop taking pimozide, you may experience difficulty controlling your movements. Your doctor will probably decrease your dose gradually.

Are there OTHER USES for this medicine?

Pimozide is also used sometimes to treat schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions) and certain behavior, personality, movement, and psychiatric disorders in adults. Talk to your doctor about the possible risks of using this medication for your condition.

This medication may be prescribed for other uses; talk to your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before taking pimozide,

tell your doctor and pharmacist if you are allergic to pimozide, other medications for mental illness, or any other medications.
tell your doctor if you are taking any of the following medications: certain antibiotics including azithromycin (Zithromax, Z-Pak), clarithromycin (Biaxin), erythromycin (E.E.S., E-Mycin, Erythrocin), and moxifloxacin (Avelox); antifungals such as itraconazole (Sporanox) and ketoconazole (Nizoral); arsenic trioxide (Trisenox); dofetilide (Tikosyn); chlorpromazine; dolasetron (Anzemet); droperidol (Inapsine); HIV protease inhibitors such as indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), and ritonavir (Norvir, in Kaletra); medications for irregular heartbeat such as amiodarone (Cordarone), disopyramide (Norpace), procainamide, quinidine, and sotalol (Betapace); medications for mental illness and nausea; mefloquine (Lariam); nefazadone; pentamidine (Nebu-Pent); certain selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil, Pexeva), and sertraline (Zoloft); tacrolimus (Prograf); thioridazine; zileuton (Zyflo); and ziprasidone (Geodon). Your doctor may tell you not to take pimozide.
tell your doctor if you are taking medications that may cause tics, including amphetamines such as amphetamine (Adderall) and dextroamphetamine (Dexadrine, Dextrostat); pemoline (Cylert) (not available in the US); and methylphenidate (Concerta, Ritalin). Your doctor may tell you to stop taking your medication for a while before you start taking pimozide. This will let your doctor see if your tics were caused by the other medication and can be treated by stopping it.
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: antidepressants; cimetidine (Tagamet); diuretics ('water pills'); medications for anxiety, pain, and seizures; sedatives; sleeping pills; ticlopidine (Ticlid); and tranquilizers. Many other medications may interact with pimozide, so be sure to tell your doctor about all the medications you are taking, even those not listed here or on the lists above. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
tell your doctor if you have or have ever had long QT syndrome (condition that increases the risk of developing an irregular heartbeat that may cause loss of consciousness or sudden death); an irregular heartbeat; or low levels of potassium or magnesium in your blood. Also tell your doctor if you have severe diarrhea before your treatment or at any time during your treatment. Your doctor may tell you not to take pimozide.
tell your doctor if you have or have ever had breast cancer; Parkinson's disease (PD; a disorder of the nervous system that causes difficulties with movement, muscle control, and balance); glaucoma (condition in which increased pressure in the eye can lead to gradual loss of vision); problems with urination; trouble keeping your balance, an abnormal electroencephalogram (EEG; test that records electrical activity in the brain); seizures; or prostate, liver, or kidney disease. Also tell your doctor if you have ever had to stop taking a medication for mental illness due to severe side effects.
tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, or if you plan to become pregnant or are breast-feeding. If you become pregnant while taking pimozide, call your doctor. Pimozide may cause problems in newborns following delivery if it is taken during the last months of pregnancy.
if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking pimozide.
you should know that pimozide may make you drowsy and may affect your thinking and movements, especially at the beginning of your treatment. Do not drive a car or operate machinery until you know how this medication affects you.
you should know that pimozide may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
ask your doctor about the safe use of alcohol during your treatment with pimozide. Alcohol can make the side effects of pimozide worse.

What SPECIAL DIETARY instructions should I follow?

Do not eat grapefruit or drink grapefruit juice while you are taking this medication.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the 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.

What SIDE EFFECTS can this medicine cause?

What should I know about STORAGE and DISPOSAL of this medication?

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

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online athttps://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

blank facial expression
shuffling walk
unusual, slowed, or uncontrollable movements of any part of the body
restlessness
fast heartbeat
drowsiness
coma (loss of consciousness for a period of time)
difficulty breathing

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to pimozide.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

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.

AHFS^® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: July 15, 2017.