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 methylphenidate or pemoline)
• you are taking medicines that may cause a certain type of irregular heartbeat (prolonged QT interval) such as certain heart medicines (eg, quinidine)
• you are taking astemizole, cisapride, delavirdine, dofetilide, fluvoxamine, nefazodone, a ketolide antibiotic (eg, telithromycin), a macrolide antibiotic (eg, erythromycin), an azole antifungal (eg, itraconazole), an HIV protease inhibitor (eg, ritonavir), sertraline, terfenadine, or zileuton
• you have congenital long QT syndrome, an irregular heartbeat or history of irregular heartbeat, low blood potassium or magnesium levels, or severe nervous system depression
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, foods, or other substances
• if you have breast cancer, a blockage of your bowel, an enlarged prostate, or tardive dyskinesia
• a history of liver or kidney problems, seizures, electroencephalogram (EEG) abnormalities, glaucoma, low blood potassium or magnesium levels, or unusual growths or tumors in the brain (eg, pituitary tumors)
Some MEDICINES MAY INTERACT with Orap . Tell your health care provider if you are taking any other medicines, especially any of the following:
• Aprepitant, delavirdine, haloperidol, HIV protease inhibitors (eg, ritonavir), imatinib, nefazodone, quinolone antibiotics (eg, ciprofloxacin), or zileuton because the side effects of Orap may be increased
• Azole antifungal agents (eg, itraconazole ), amiodarone, arsenic, astemizole, cisapride, dofetilide, droperidol, fluvoxamine, halofantrine, IA and IC antiarrhythmics (eg, quinidine), ketolide antibiotics (eg, telithromycin), macrolide antibiotics (eg, erythromycin), phenothiazines (eg, chlorpromazine), serotonin receptor antagonist antiemetics (eg, dolasetron), sertraline, streptogramins (eg, quinupristin), terfenadine, tricyclic antidepressants (eg, amitriptyline), or ziprasidone because irregular heartbeat (eg, QT prolongation) or heart attack may occur
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.
• Orap may be taken with or without food.
• Avoid eating grapefruit or drinking grapefruit juice while taking 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 or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Orap . Using Orap alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Avoid drinking alcohol or taking other medicines that cause drowsiness (eg, sedatives, tranquilizers) while taking Orap . Orap will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
• Do not become overheated in hot weather or during exercise or other activities. Heatstroke may occur.
• Neuroleptic malignant syndrome (NMS) is a potentially deadly syndrome associated with Orap . Symptoms may include increased body heat; rigid muscles; altered mental abilities, including lack of response to your surroundings; fast or irregular heartbeat; or sweating. Contact your doctor at once if any of these symptoms occur.
• Involuntary and uncontrollable movements may develop in patients taking Orap . Occurrence is highest among the elderly, especially women. The risk of developing these involuntary movements and the likelihood they will become permanent are increased with long-term use and with high doses. However it is possible to develop these symptoms after short-term treatment at low doses. Contact your health care provider at once if any of the following occur: involuntary movements of tongue, face, mouth, or jaw (eg, protrusion of tongue, puffing of cheeks, puckering of mouth, chewing movements), sometimes accompanied by involuntary movements of the arms and legs.
• LAB TESTS, including heart function tests and blood potassium and magnesium levels, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Use Orap with extreme caution in CHILDREN younger than 12 years of age. Safety and effectiveness in this age group have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Orap , discuss with your doctor the benefits and risks of using Orap during pregnancy. It is unknown if Orap is excreted 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:
Constipation; drowsiness; dry mouth.
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); decreased sexual function; fever; involuntary movements of the tongue, mouth, face, or jaw; irregular heartbeat; muscle stiffness or spasm; trouble sleeping; unusual body movements; vision changes.
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.
Proper storage of Orap :
Store Orap at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Keep Orap out of the reach of children and away from pets.