Orap

DRUG DESCRIPTION

ORAP® (pimozide) is an orally active antipsychotic agent of the diphenyl-butylpiperidine series. The structural formula of pimozide, 1-[1-[4,4-bis(4-fluorophenyl) butyl]-4piperidinyl]-1,3-dihydro-2H-benzimidazole-2-one is:

ORAP® (Pimozide) Structural Formula Illustration

The solubility of pimozide in water is less than 0.01 mg/mL; it is slightly soluble in most organic solvents.

Each white ORAP tablet contains either 1 mg or 2 mg of pimozide and the following inactive ingredients: calcium stearate, microcrystalline cellulose, lactose anhydrous and corn starch.

What are the possible side effects of pimozide (Orap)?

Call your doctor immediately if you experience uncontrollable movements of the mouth, tongue, cheeks, jaw, arms, or legs; fever; muscle rigidity; sweating; irregular pulse; or fast or irregular heartbeats.

If you experience any of the following serious side effects, stop taking pimozide and seek emergency medical attention or notify your doctor immediately:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
  • seizures or convulsions;
  • fever;...

Read All Potential Side Effects and See Pictures of Orap »

What are the precautions when taking pimozide (Orap)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood problems (such as a low white blood cell count), a certain eye condition (glaucoma), dementia, depression, heart problems (such as slow/fast/irregular heartbeat, low blood pressure), slow movement of the gut/intestines (such as chronic constipation, blockage), kidney disease, liver disease, brain disorder/tumor/injury, drug/alcohol/substance abuse, breast cancer, Parkinson's disease, seizure disorder, a certain...

Read All Potential Precautions of Orap »


Orap Consumer (continued)

SIDE EFFECTS: Drowsiness, dizziness, dry mouth, blurred vision, tiredness, or weakness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

This drug may cause muscle/nervous system problems (extrapyramidal symptoms-EPS). Your doctor may prescribe another medication to decrease these side effects. Therefore, tell your doctor immediately if you notice any of the following side effects: stiff muscles, severe muscle spasms/cramping (such as twisting neck, arching back, eyes rolling up), restlessness/constant need to move, shaking (tremor), slow/shuffling walk, drooling/trouble swallowing, mask-like expression of the face.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Some people using this medication do not have serious side effects.

This medication may cause a condition known as tardive dyskinesia. In some cases, this condition may be permanent. Tell your doctor immediately if you develop any involuntary/repetitive muscle movements such as lip smacking/puckering, tongue thrusting, chewing, or finger/toe movements.

In rare cases, pimozide may increase your level of a certain chemical made by the body (prolactin). For females, this increase in prolactin may result in unwanted breast milk, missed/stopped periods, or difficulty becoming pregnant. For males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop any of these symptoms, tell your doctor immediately.

Tell your doctor immediately if any of these rare but very serious side effects occur: signs of infection (such as fever, persistent sore throat).

Seek immediate medical attention if any of these rare but very serious side effects occur: severe dizziness, fainting, fast/slow/irregular heartbeat, seizures.

This medication may rarely cause a serious condition called neuroleptic malignant syndrome (NMS). Seek immediate medical attention if you develop the following: fever, stiff muscles, sweating, fast/irregular heartbeat, sudden mental/mood changes (such as confusion, loss of consciousness), change in the amount of urine.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood problems (such as a low white blood cell count), a certain eye condition (glaucoma), dementia, depression, heart problems (such as slow/fast/irregular heartbeat, low blood pressure), slow movement of the gut/intestines (such as chronic constipation, blockage), kidney disease, liver disease, brain disorder/tumor/injury, drug/alcohol/substance abuse, breast cancer, Parkinson's disease, seizure disorder, a certain severe reaction to other antipsychotic-type medications (neuroleptic malignant syndrome-NMS), difficulty urinating (such as due to prostate problems).

This drug may make you dizzy or drowsy or cause vision changes. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Pimozide may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using pimozide, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using pimozide safely.

Before having surgery or imaging procedures (such as certain X-rays, CT scans) requiring the use of contrast dye (such as metrizamide), tell your doctor or dentist that you are using this medication and about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Do not stop taking this medication unless directed by your doctor. Babies born to mothers who have used this drug during the last 3 months of pregnancy may infrequently develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice any of these symptoms in your newborn anytime during their first month, tell the doctor right away.

It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.


Orap Patient Information Including Side Effects

Brand Names: Orap

Generic Name: pimozide (Pronunciation: PIM oh zide)

  • What is pimozide (Orap)?
  • What are the possible side effects of pimozide (Orap)?
  • What is the most important information I should know about pimozide (Orap)?
  • What should I discuss with my healthcare provider before taking pimozide (Orap)?
  • How should I take pimozide (Orap)?
  • What happens if I miss a dose (Orap)?
  • What happens if I overdose (Orap)?
  • What should I avoid while taking pimozide (Orap)?
  • What other drugs will affect pimozide (Orap)?
  • Where can I get more information?

What is pimozide (Orap)?

Pimozide is an antipsychotic medication. It works by changing the actions of chemicals in the brain.

Pimozide is used to suppress the motor and phonic tics associated with Tourette's disorder.

Pimozide may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of pimozide (Orap)?

Call your doctor immediately if you experience uncontrollable movements of the mouth, tongue, cheeks, jaw, arms, or legs; fever; muscle rigidity; sweating; irregular pulse; or fast or irregular heartbeats.

If you experience any of the following serious side effects, stop taking pimozide and seek emergency medical attention or notify your doctor immediately:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
  • seizures or convulsions;
  • fever; or
  • a very fast or an irregular heartbeat.

Other, less serious side effects may be more likely to occur. Continue to take pimozide and talk to your doctor if you experience

  • dizziness or drowsiness;
  • insomnia;
  • nausea or vomiting;
  • diarrhea or constipation;
  • dry mouth; or
  • blurred vision or sensitivity of the eyes to light.

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. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about pimozide (Orap)?

Do not take pimozide with any of the following medicines:

  • antibiotics including azithromycin (Zithromax), clarithromycin (Biaxin), erythromycin (Ery-Tab, E.E.S., E-Mycin, Eryc, PCE, and others), dirithromycin (Dynabac), and troleandomycin (TAO);
  • antifungal medicines including itraconazole (Sporanox) and ketoconazole (Nizoral);
  • protease inhibitors including amprenavir (Agenerase), ritonavir (Norvir), saquinavir (Fortovase, Invirase), indinavir (Crixivan), and nelfinavir (Viracept);
  • phenothiazines including chlorpromazine (Thorazine), fluphenazine (Prolixin), thioridazine (Mellaril), mesoridazine (Serentil), and trifluoperazine (Stelazine);
  • tricyclic antidepressants including amoxapine (Asendin), amitriptyline (Elavil, Endep), clomipramine (Anafranil), doxepin (Sinequan), desipramine (Norpramin), imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil);
  • medicines for irregular heartbeats, including quinidine (Cardioquin, Quinora, Quinaglute, Quinidex), procainamide (Pronestyl, Procan SR), disopyramide (Norpace), propafenone (Rythmol), flecainide (Tambocor), amiodarone (Cordarone), and sotalol (Betapace);
  • nefazodone (Serzone);
  • zileuton (Zyflo); or
  • sertraline (Zoloft).

A dangerous interaction, possibly resulting in irregular heartbeats and/or death may occur if pimozide is taken with any of the medicines listed above.

Do not consume grapefruit or grapefruit juice during treatment with pimozide. Pimozide can interact with grapefruit products, and the interaction may have dangerous effects.

Call your doctor immediately if you experience uncontrollable movements of the mouth, tongue, cheeks, jaw, arms, or legs; fever; muscle rigidity; sweating; irregular pulse; or fast or irregular heartbeats.

Use caution when driving, operating machinery, or performing other hazardous activities. Pimozide may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.

Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking pimozide.

Avoid becoming overheated in hot weather and during exercise. Pimozide increases the risk of heat stroke. Drink plenty of fluids to maintain hydration.

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