Orap

Orap is a prescription medication used to treat movement and speech tics in patients with Tourette's Syndrome who have not responded to other medications. Orap belongs to a class of drugs known as antipsychotics, which block the effects of a certain chemical in the brain known as dopamine.

This medication comes in tablet form and is taken by mouth once at bedtime or multiple times a day. It can be taken with or without food.

Common side effects include difficulty with movement, tingling sensations, dry mouth, and constipation. Orap can also cause visual disturbances and drowsiness. Do not drive or operate heavy machinery until you know how it affects you.
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Orap is a prescription medication used to treat severe movement and speech tics in patients with Tourette's Syndrome who have responded to other medications.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Teva CNS

Serious side effects have been reported with Orap.  See the “Drug Precautions” section.

Common side effects of Orap include:

• drowsiness
• difficulty with movement
• tingling sensations
• dry mouth
• behavioral changes

This is not a complete list of Orap side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.  Especially tell your doctor if you take: 

• azithromycin (Zithromax, Z-pak)
• clarithromycin (Biaxin)
• erythromycin (E.E.S., Erythrocin, E-mycin)
• moxifloxacin (Avelox)
• dofetilide (Tikosyn)
• amiodarone (Cordarone)
• sotalol (Betapace)
• citalopram (Celexa)
• escitalopram (Lexapro)
• sertraline (Zoloft)
• moxifloxacin (Avelox)
• tacrolimus (Prograf)
• ziprasidone (Geodon)
• indinavir (Crixivan)
• ritonavir (Norvir)
• chlorpromazine (Thorazine)
• droperidol (Inapsine)
• tricyclic antidepressants such as trimipramine (Surmontil), amitriptyline (Elavil), nortriptyline (Pamelor, Aventyl), protriptyline (Vivactil), and clomipramine (Anafranil)
• medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan (Vaprisol), delavirdine (Rescriptor), and nefazodone (Serzone)
• medications that block a protein in the body (CYP2D6) such as quinidine (Qualaquin), fluoxetine (Prozac,Sarafem), amitriptyline (Elavil, Amitril, Amitid), and paroxetine (Paxil)

This is not a complete list of Orap interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Orap including the following:

• Tardive dyskinesia. Tardive Dyskinesia (TD) is a serious, sometimes permanent side effect reported with Orap iand similar medications. TD includes uncontrollable movements of the face, tongue, and other parts of the body. The risk of developing TD and the chance that it will become permanent is thought to increase with the length of therapy and the overall dose taken by the patient. This condition can develop after a brief period of therapy at low doses, although this is much less common. There is no known treatment for TD, but it may go away partially or completely if therapy is stopped.
• Neuroleptic malignant syndrome. A possibly fatal condition with symptoms of muscle rigidity, altered mental status, and irregular heartbeat, or blood pressure problems. Call your doctor immediately if the person being treated develops symptoms such as high fever; stiff muscles; shaking; confusion; sweating; changes in pulse, heart rate, or blood pressure; or muscle pain and weakness. Treatment should be stopped if the person being treated has NMS.
• Leukopenia/neutropenia (a decrease in white blood cells). Your doctor may monitor your white blood cells, a type of cell that helps your body fight infection. Taking this medication may possibly lead to leukopenia/neutropenia.

Orap can cause drowsiness. Do not drive or operate heavy machinery until you know how Orap affects you.

Do not take Orap if you:

• are allergic to Orap or any of its ingredients
• have tics not associated with Tourette’s Disorder
• if you are taking itraconazole (Sporanox) or ketoconazole (Nizoral)
• If you are taking citalopram (Celexa), escitalopram (Lexapro), paroxetine (Paxil), or sertraline (Zoloft)
• if you are taking clarithromycin (Biaxin), erythromycin (EES, Ery-Tab), and azithromycin (Zithromax)
• if you are taking drugs known as protease inhibitors such as indinavir, nelfinavir, ritonavir, saquinavir, boceprevir, and telaprevir
• if you are taking zileuton (Zyflo) or fluvoxamine (Luvox)
• if you are taking drugs that block the protein CYP2D6. See the “Drug Interactions” section.
• have a condition known as congenital long QT syndrome
• have a history of arrhythmias
• have low blood potassium levels
• have low blood magnesium levels

Grapefruit and grapefruit juice may interact with Orap and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before taking Orap, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Orap or any of its ingredients
• are taking medications that may cause tics such as methylphenidate (Ritalin, Concerta), amphetamines (Adderall), or dextroamphetamine (Dexedrine)
• have ever had long QT syndrome (a potentially serious irregular heartbeat)
• have kidney or liver problems
• if any drug you have taken in the past has lowered your white blood cells (cells that help your body fight infection)
• if you are allergic to any other antipsychotic medications
• have a history of seizures
• are taking anti-seizure medication
• if you have already tried haloperidol (Haldol) to treat your Tourette's condition
• have other heart problems

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy.  Five categories- A,B,C,D and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy. 

Orap falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans, though. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Orap crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Orap.

Take Orap exactly as prescribed.

Orap comes in tablet form and is given by mouth once or twice a day, with or without food.

It is recommended that Orap be taken at bedtime if taken once a day.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose as the regular time. Do not take two doses of Orap at the same time.

The recommended dose of Orap for the treatment of speech and movement tics in patients with Tourette’s Syndrome is:

• Adults: starting dose of 1 to 2 mg a day by mouth in divided doses. It may be increased every other day up to 10 mg daily.
• Children (12 to 18 years old): starting dose of 0.05 mg/kg by mouth at bedtime. It may be increased every 3 days up to 10 mg per day.

If you take too much Orap, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Orap at controlled room temperature between 59˚and 86˚F.
• Keep in a tight, light resistant container.
• Keep this and all medications out of the reach of children.