Generic Name: pimozide (PIM-oh-zide)
Brand Name: Orap
Orap is used for:
Treating severe muscle tics and speech tics in patients with Tourette syndrome when other medicines have not worked.
Orap is an antipsychotic agent. It works by blocking the action of dopamine, a naturally occurring chemical in the brain.
Do NOT use Orap if:
- you are allergic to any ingredient in Orap
- you are treating simple tics or tics other than those associated with Tourette syndrome (eg, tics that may be caused by certain medicines, such as amphetamines, methylphenidate, or pemoline)
- you have congenital long QT syndrome, low blood potassium or magnesium levels, severe drowsiness, or a history of irregular heartbeat
- you are taking aprepitant, astemizole, azole antifungals (eg, itraconazole, ketoconazole, voriconazole), cisapride, crizotinib, delavirdine, dronedarone, droperidol, efavirenz, a macrolide antibiotic (eg, azithromycin, clarithromycin, erythromycin), metoclopramide, nefazodone, nilotinib, a protease inhibitor (eg, boceprevir, ritonavir, saquinavir), quinidine, certain quinolone antibiotics (eg, moxifloxacin), selective serotonin reuptake inhibitors (SSRIs) (eg, citalopram, sertraline, paroxetine), a streptogramin (eg, quinupristin), telithromycin, terfenadine, toremifene, vandetanib, zileuton, or any other medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat
Contact your doctor or health care provider right away if any of these apply to you.
Before using Orap:
Some medical conditions may interact with Orap. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines (including other antipsychotic medicines), foods, or other substances
- if you have a history of low white blood cell levels, blood electrolyte problems (eg, low blood magnesium, low blood potassium), seizures, an abnormal electroencephalogram (EEG), neuroleptic malignant syndrome (NMS), alcohol abuse, or depression
- if you have heart problems or if a member of your family has a history of irregular heartbeat or other heart problems
- if you have a history of liver or kidney problems, a bowel blockage, an enlarged prostate, or glaucoma
- if you have severe diarrhea, difficulty urinating, or high or low blood pressure
- if you have had high blood prolactin levels or a history of certain types of cancer (eg, breast, pancreas, pituitary, brain), or if you are at risk of breast cancer
- if you have been very ill, have had very poor nutrition, or will be exposed to very high temperatures
- if you are taking medicine to treat seizures
Some MEDICINES MAY INTERACT with Orap. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Antiarrhythmics (eg, amiodarone, dofetilide, quinidine, sotalol), arsenic, astemizole, azole antifungal agents (eg, itraconazole, ketoconazole, voriconazole), bepridil, chloroquine, cisapride, domperidone, dronedarone, droperidol, halofantrine, haloperidol, iloperidone, lithium, macrolide antibiotics (eg, azithromycin, clarithromycin, erythromycin), maprotiline, methadone, nilotinib, paliperidone, pentamidine, phenothiazines (eg, chlorpromazine), quetiapine, certain quinolone antibiotics (eg, moxifloxacin), romidepsin, serotonin receptor antagonist antiemetics (eg, dolasetron), streptogramins (eg, quinupristin), SSRIs (eg, citalopram, sertraline, paroxetine), tacrolimus, telithromycin, terfenadine, tetrabenazine, toremifene, tricyclic antidepressants (eg, amitriptyline), tyrosine kinase inhibitors (eg, dasatinib), vandetanib, ziprasidone, or any other medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval) because irregular heartbeat (eg, QT prolongation) or heart attack may occur. Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat
- Abiraterone, aprepitant, crizotinib, delavirdine, diuretics (eg, furosemide, hydrochlorothiazide), efavirenz, imatinib, nefazodone, protease inhibitors (eg, boceprevir, ritonavir, saquinavir), quinolone antibiotics (eg, ciprofloxacin), or zileuton because they may increase the risk of Orap's side effects
- Tamoxifen because its effectiveness may be decreased by Orap
- Metoclopramide because the risk of its side effects may be increased by Orap
This may not be a complete list of all interactions that may occur. Ask your health care provider if Orap may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Orap:
Use Orap as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Orap by mouth with or without food.
- Do not eat grapefruit or drink grapefruit juice while you use Orap.
- If you miss a dose of Orap, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Orap.
Important safety information:
- Orap may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Orap with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Orap may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
- Do not drink alcohol while you are using Orap.
- Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Orap; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Do not become overheated in hot weather or while you are being active; heatstroke may occur.
- Do NOT take more than the recommended dose without checking with your doctor.
- Tell your doctor or dentist that you take Orap before you receive any medical or dental care, emergency care, or surgery.
- Neuroleptic malignant syndrome (NMS) is a possibly fatal syndrome that can be caused by Orap. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.
- Some patients who take Orap may develop muscle movements that they cannot control. This is more likely to happen in elderly patients, especially women. The chance that this will happen or that it will become permanent is greater in those who take Orap in higher doses or for a long time. Muscle problems may also occur after short-term treatment with low doses. Tell your doctor at once if you have muscle problems with your arms; legs; or your tongue, face, mouth, or jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements) while taking Orap.
- Orap may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
- Orap may increase the amount of a certain hormone (prolactin) in your blood. Symptoms may include enlarged breasts, missed menstrual period, decreased sexual ability, or nipple discharge. Contact your doctor right away if you experience any of these symptoms.
- Lab tests, including complete blood cell counts, blood potassium and magnesium levels, or electrocardiograms (ECGs), may be performed while you use Orap. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Orap with caution in the ELDERLY; they may be more sensitive to its effects, especially uncontrolled muscle movements.
- Orap should be used with extreme caution in CHILDREN younger than 12 years; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Orap while you are pregnant. Using Orap during the third trimester may result in uncontrolled muscle movements or withdrawal symptoms in the newborn. Discuss any questions or concerns with your doctor. It is not known if this medicine is found in breast milk. Do not breast-feed while taking Orap.
If you suddenly stop taking Orap, you may experience WITHDRAWAL symptoms, including involuntary movements of tongue, face, mouth, or jaw (eg, protrusion of tongue, puffing of cheeks, puckering of mouth, chewing movements) or involuntary movements of the arms and legs.
Possible side effects of Orap:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Constipation; drowsiness; dry mouth; restlessness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; chest pain; confusion; decreased sexual desire or ability; difficulty urinating; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; inability to move the eyes or unusual eye movements; mental or mood changes (eg, abnormal thinking, depression); muscle stiffness; rigid muscles; seizures; severe or persistent dizziness, headache, or light-headedness; severe restlessness or trouble sitting still; trouble walking, speaking, or swallowing; twitching or twisting movements; uncontrolled muscle spasms or unusual body movements (eg, of the arms, legs, tongue, jaw, cheeks, neck; lip smacking or puckering; puffing of the cheeks; tremors); trouble sleeping.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include coma; difficulty breathing; fainting; irregular heartbeat; severe dizziness or drowsiness; uncontrolled muscle movements (eg, twitching of the face or tongue; loss of balance; uncontrolled movements of arms or legs); trouble speaking or swallowing.Proper storage of Orap:
Store Orap at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Keep Orap out of the reach of children and away from pets.
- If you have any questions about Orap, please talk with your doctor, pharmacist, or other health care provider.
- Orap is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Orap or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Orap. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Orap. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Orap.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.