Pimozide works by changing the actions of chemicals in the brain.

Pimozide is used in people with Tourette's syndrome. Pimozide suppresses the physical (motor) and vocal (phonic) symptoms of tics when these symptoms interfere with daily life function.

Pimozide is not for use in treating motor tics that are not caused by Tourette's syndrome.

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

You should not use pimozide if you have long QT syndrome, low blood levels of potassium or magnesium, or if you take any medication that can cause tics (such as a stimulant or ADHD medication).

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can cause serious medical problems if you take them together with pimozide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Call your doctor if you are sick with vomiting or diarrhea. You may develop an electrolyte imbalance, which could cause heart rhythm problems while you are taking pimozide.

It may take several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve, or if they get worse.

Your doctor will need to check your progress on a regular basis. Your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).

Store at room temperature away from moisture, heat, and light.

Do not stop using pimozide suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using pimozide.

Usual Adult Dose for Tourette's Syndrome:

Initial dose: 1 to 2 mg orally per day in divided doses
Maintenance dose: Typically less than 0.2 mg/kg or 10 mg/day, whichever is less
Maximum dose: 10 mg/day

Comments:
-Use should be limited to patients with Tourette's Disorder whose development and/or daily life function is severely compromised by motor and phonic tics. This drug is not indicated for use as first-line therapy or in patients with tics that are merely annoying or cosmetically troublesome.
-Initial doses may be increased every other day if tolerated.
-Patients requiring doses greater than 4 mg/day should undergo CYP 450 2D6 genotyping.

Use: Suppression of motor and phonic tics in patients with Tourette's Disorder who have failed to respond to standard treatment

Usual Pediatric Dose for Tourette's Syndrome:

12 years and older:
-Initial dose: 0.05 mg/kg orally at bedtime
-Maximum dose: 0.2 mg/kg, not to exceed 10 mg/day

Comments:
-Use should be limited to patients with Tourette's Disorder whose development and/or daily life function is severely compromised by motor and phonic tics. This drug is not indicated for use as first-line therapy or in patients with tics that are merely annoying or cosmetically troublesome.
-Doses may be increased every 3 days to a maximum of 0.2 mg/kg.
-CYP450 2D6 genotyping should be performed in patients taking greater than 0.05 mg/kg/day.

Use: Suppression of motor and phonic tics in patients with Tourette's Disorder who have failed to respond to standard treatment

You should not use this medicine if you are allergic to pimozide or other antipsychotic medicines, or if:

• you have low levels of potassium or magnesium in your blood;

• you have long QT syndrome (in you or a family member); or

• you take medicines that can cause tics, such as a stimulant or ADHD medication (Adderalll, Ritalin, and others).

Some medicines can cause unwanted or dangerous effects when used with pimozide. Your doctor may change your treatment plan if you also use:

• ADHD medication;

• an antibiotic or antifungal medication;

• anti-psychotic medication;

• an antidepressant;

• antiviral medicines to treat hepatitis C or HIV;

• anti-malaria medication;

• heart rhythm medication;

• medicine to prevent or treat nausea and vomiting (such as Zofran);

• "triptan" migraine headache medicine (such as Imitrex or Maxalt); or

• opioid medication.

Tell your doctor if you have ever had:

• liver disease;

• kidney disease;

• seizures or epilepsy;

• heart problems, high blood pressure, or a heart attack;

• an enlarged prostate or urination problems; or

• glaucoma.

Taking pimozide during the last 3 months of pregnancy may cause problems in the newborn, such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles. However, you may have withdrawal symptoms or other problems if you stop taking your medicine during pregnancy. Do not stop taking pimozide without your doctor's advice.

You should not breast-feed while using pimozide.

Pimozide is not approved for use by anyone younger than 12 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include muscle stiffness, shallow breathing, or feeling light-headed.

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

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

Avoid driving or hazardous activity until you know how pimozide will affect you. Your reactions could be impaired.

Drinking alcohol can increase certain side effects of pimozide.

Grapefruit may interact with pimozide and lead to unwanted side effects. Avoid the use of grapefruit products.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

High doses or long-term use of pimozide can cause a serious movement disorder that may not be reversible. The longer you use pimozide, the more likely you are to develop this disorder, especially if you are an older adult.

Pimozide may cause serious side effects. Call your doctor at once if you have:

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);

• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);

• fever, chills, tiredness, mouth sores, skin sores;

• a seizure (convulsions); or

• severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Common side effects of pimozide may include:

• problems with speech or vision;

• drowsiness, trouble sleeping;

• feeling restless;

• tight muscles;

• constipation; or

• dry mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Pimozide can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Using pimozide with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Many drugs can affect pimozide, and some drugs should not be used at the same time. Tell your doctor about all your current medicines and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

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.