Pimozide

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

Pimozide is used for people with Tourette's syndrome. Pimozide reduces the physical (motor) and vocal (phonic) symptoms of tics when these symptoms disrupt daily life.

Pimozide is not for treating motor tics that are not due to Tourette's syndrome.

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

Follow all instructions on your prescription label and read all medication guides or instruction sheets. Your doctor may change your dose from time to time. 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 lead to heart rhythm problems while taking pimozide.

It may take several weeks before you notice an improvement in your symptoms. Continue using the medication as directed and inform your doctor if your symptoms do not improve or if they worsen.

Your doctor will need to monitor your progress regularly. Your heart function may need to be checked with an electrocardiograph or ECG (sometimes referred to as an EKG).

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

Do not stop using pimozide suddenly, as this could lead to unpleasant withdrawal symptoms. Ask your doctor how to safely discontinue pimozide.

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.

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 yourself or a family member); or
• you take medicines that can cause tics, such as a stimulant or ADHD medication (Adderall, 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.

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.

Usual Adult Dose for Tourette's Syndrome:

Initial dose: 1 to 2 mg orally per day in divided dosesMaintenance dose: Typically less than 0.2 mg/kg or 10 mg/day, whichever is lessMaximum dose: 10 mg/dayComments:-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/dayComments:-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

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

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.

Pimozide can lead to a serious heart issue. Your risk may increase if you are also taking certain other medicines for infections, asthma, heart issues, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Taking pimozide with other medications that cause drowsiness can make this effect worse. Check with your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Many medications can influence how pimozide works, and some should not be taken at the same time. Inform your doctor about all your current medications and any new ones you start or stop taking. This includes prescription and over-the-counter medications, vitamins, and herbal products. Not all potential interactions are mentioned here.