Orap

Orap changes how chemicals in the brain work.

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

Orap is not for treating motor tics that are not related to Tourette's syndrome.

Orap may also be used for other reasons not mentioned in this medication guide.

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 Orap.

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 Orap suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using Orap.

You should not use Orap 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 that you start or stop using. Many drugs can cause serious medical problems if you take them together with Orap.

You should not use this medicine if you are allergic to Orap 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 (Adderall, Ritalin, and others).

Some medicines can cause unwanted or dangerous effects when used with Orap. 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 Orap 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 this medicine without your doctor's advice.

You should not breast-feed while using Orap.

Orap 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 Orap, the more likely you are to develop this disorder, especially if you are an older adult.

Orap 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 Orap 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.

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 doing dangerous activities until you know how Orap will affect you. Your reactions could be impaired.

Drinking alcohol can increase certain side effects of pimozide.

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

Orap 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 Orap 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 Orap, 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.