1 What is Orap?

Brand: Orap

Generic: Pimozide

Orap is an antipsychotic drug used for the treatment of symptoms of Tourette's syndrome. This drug is used only for patients with severe symptoms who cannot take or have not been helped by other drugs.

This drug works in the central nervous system to help control the vocal outbursts and uncontrolled, repeated movements of the body that may interfere with the patient's normal life.

This drug will only reduce the number and severity of tics. This drug requires a prescription.

2 What to Know Before Using

Your doctor will inform you of what you need to know before using Orap. Inform your healthcare provider for any allergic reactions to these drugs or any other drugs, foods, dyes, preservatives, or animals.

Carefully read the label of non-prescription drugs for any possible allergic reaction or contraindications. Studies in children 12 years of age and older have not demonstrated any pediatric-specific problems that would limit the utility of pimozide.

However, safety and efficacy have not been established in children younger than 12 years of age. Data on the correlation of age to the effects of pimozide in geriatric patients are still unavailable. Adverse effects have been reported in animal studies but studies in pregnant women or animals are still inadequate.

Infant risk is still undetermined when using this drug during breastfeeding. Discuss with your healthcare professional about the potential risks and benefits of taking this drug while breastfeeding.

Drugs should not be taken together to prevent any interactions but in necessary cases inquire your healthcare provider regarding the adjustments in dosage or any other necessary precautions to prevent any unwanted side effects.

Inform your healthcare professional if you are taking any other drugs such as:

  • Phenothiazines
  • Tricyclic antidepressants
  • Antiarrhythmic agents
  • Macrolide antibiotics
  • Azole antifungal agents
  • Protease inhibitor drugs
  • Analgesics
  • Sedatives
  • Anxiolytics
  • and Alcohol

Intake of specific food or using alcohol or tobacco with this drug is associated with an increased risk of certain side effects. Your healthcare professional can give you special instructions about the use of food, alcohol, or tobacco.

Inform your healthcare provider for any other medical problems such as:

  • Blood or bone marrow problems
  • Breast cancer
  • Heart disease
  • Intestinal or bowel problems
  • Leukopenia
  • Neutropenia
  • Narrow-angle glaucoma
  • Pituitary gland problems
  • Seizures
  • Urinary tract problems
  • Central nervous system depression
  • Heart rhythm problems
  • Hypokalemia
  • Hypomagnesemia
  • Tics other than those caused by Tourette's syndrome
  • Kidney disease or liver disease

3 Proper Usage

Proper usage of Orap requires strict adherence to your doctor’s orders. To prevent any side effects, take this drug exactly as directed on the label or as prescribed by your healthcare professional.

Eating grapefruit or drinking grapefruit juice is not recommended while you are taking this drug, as grapefruit may alter the absorption of this drug. It is recommended to take this drug at bedtime.

The dose of this drug will be variable for different patients. The directions on the label or the prescription by your healthcare professional should be followed. The dosage of this drug you take depends on the medical problem for which you are using this drug.

Adults with Tourette's syndrome are initially given 1 to 2 milligrams per day, taken in divided doses. Your healthcare professional may increase your dose every other day if necessary. The dose must not exceed 10 mg per day.

The dose in children 12 years of age and older is based on body weight and must be determined by your healthcare professional. The starting dose is usually 0.05 milligram per kilogram of body weight per day. Your healthcare professional may increase your dose after 3 days if necessary. The dose must not exceed 10 mg per day.

Use and dose in children younger than 12 years of age must be determined by the healthcare professional. A missed dose should be taken as soon as possible. However, skip the missed dose and go back to your regular dosing schedule if it is almost time for your next dose.

Store the drug in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children. Dispose any outdated or expired drugs and ask your healthcare professional for the proper disposal of the drugs.

4 Precautions to Take

Before using Orap, there are some precautions you must take. Regular visits should be made to your healthcare provider to track your progress and to monitor the effectiveness of the drug.

Unwanted effects can be screened using blood tests. Your heart rhythm will be monitored while you are using this drug.

This drug is contraindicated for use with:

  • Arsenic trioxide (TrisenoxВ®)
  • Cisapride (PropulsidВ®)
  • Dolasetron mesylate (AnzemetВ®)
  • Droperidol (DridolВ®
  • InapsineВ®)
  • Levomethadyl acetate (OrlaamВ®)
  • Methylphenidate (RitalinВ®)
  • Pemoline (CylertВ®)
  • Pentamidine (NebupentВ®)
  • probucol
  • Tacrolimus (PrografВ®)
  • Zileuton (ZyfloВ®)
  • Amphetamines (such as DesoxynВ®, DexedrineВ®)
  • Drug for heart rhythm problems (such as amiodarone, disopyramide, dofetilide, procainamide, quinidine, sotalol, BetapaceВ®
  • CardioquinВ®
  • CordaroneВ®
  • NorpaceВ®
  • ProcanbidВ®
  • QuinagluteВ®
  • or TikosynВ®)
  • Drug for depression (such as amitriptyline, citalopram, escitalopram, fluoxetine, fluvoxamine, nefazodone, nortriptyline, paroxetine, sertraline, CelexaВ®, ElavilВ®, Lexaproв„ў, LuvoxВ®, PamelorВ®, PaxilВ®, ProzacВ®, SarafemВ®, SerzoneВ®, VivactilВ®, or ZoloftВ®)
  • Certain antibiotics (such as azithromycin, clarithromycin, dirithromycin, erythromycin, gatifloxacin, itraconazole, ketoconazole, levofloxacin, moxifloxacin, sparfloxacin, troleandomycin, AveloxВ®, BiaxinВ®, Ery-tabВ®, LevaquinВ®, NizoralВ®, SporanoxВ®, TaoВ®, TequinВ®, ZagamВ®, or ZithromaxВ®)
  • Drug to treat HIV infection (such as indinavir, nelfinavir, ritonavir, saquinavir, CrixivanВ®, FortovaseВ®, InviraseВ®, NorvirВ®, or ViraceptВ®)
  • Drug to treat malaria (such as halofantrine, mefloquine, HalfanВ®, or LariamВ®)
  • or drug to treat mental illness (such as chlorpromazine, loxapine, mesoridazine, molindone, perphenazine, prochlorperazine, quetiapine, thioridazine, thiothixene, ziprasidone, CompazineВ®, GeodonВ®, MellarilВ®, SerentilВ®, or SeroquelВ® to prevent any risk of more serious side effects

Contact your healthcare professional immediately if you have any symptoms of heart rhythm problems such as:

  • Fast, pounding or uneven heartbeats.

Check with your healthcare professional immediately if you have symptoms of Tardive dyskinesia such as:

  • lip smacking or puckering
  • puffing of the cheeks
  • rapid or worm-like movements of the tongue
  • uncontrolled chewing movements
  • uncontrolled movements of the arms and legs

Check with your healthcare professional immediately if you have symptoms of Neuroleptic malignant syndrome such as:

  • convulsions
  • the difficulty with breathing
  • a fast heartbeat
  • high fever
  • high or low blood pressure
  • increased sweating
  • loss of bladder control
  • severe muscle stiffness
  • unusually pale skin
  • tiredness

Check with your healthcare professional if you notice any signs of infection such as:

Check with your healthcare professional before you suddenly stop taking this drug. Your healthcare professional may slowly taper the amount you are taking before stopping completely to give your body time to adjust and help to avoid worsening of your medical condition.

This drug will potentiate the effects of alcohol and other CNS depressants such as:

  • Antihistamines or drug for hay fever
  • other allergies or colds
  • sedatives, tranquilizers or sleeping drug
  • prescription pain drug or narcotics
  • a drug for seizures or barbiturates
  • muscle relaxants or anesthetics, including some dental anesthetics

Check with your healthcare professional before taking any of the above whiles you are using this drug. This drug may cause some people to become dizzy, drowsy, or less alert or to have blurred vision or muscle stiffness, especially as the amount of drug is increased.

You may feel drowsy or less alert when you wake up even if you take this drug at bedtime. Be careful in taking this drug before you drive, use machines, or do anything else that could be dangerous if you are not alert, not able to see well, or if you do not have good muscle control.

Dizziness, lightheadedness, or fainting may occur when you get up from a sitting or lying position. Getting up slowly may help. If the problem continues or gets worse, check with your healthcare professional.

Inform the health care professional or dentist in charge that you are using this drug before having any kind of surgery, dental treatment, or emergency treatment.

Taking this drug together with drugs that are used during surgery or dental or emergency treatment may increase the CNS depressant effects. Pimozide may cause dryness of the mouth.

It is recommended to use sugarless gum or candy, melt bits of ice in your mouth, or use a saliva substitute for temporary relief of mouth dryness.

Check with your health care professional or dentist if your mouth dryness persists for more than 2 weeks, since this may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Consult with your healthcare professional before taking any other prescription or nonprescription drugs, and herbal or vitamin supplements.

5 Potential Side Effects

As with many medications, there are several potential side effects associated with Orap. Side effects may vary for each individual and prompt medical attention should be given if they occur.

Seek advice from your healthcare professional immediately if you experience any unusual symptoms such as:

  • Difficulty with speaking
  • Dizziness or fainting
  • Fast or irregular heartbeat
  • Lack of facial expression
  • Loss of balance control
  • Mood or behavior changes
  • Restlessness or need to keep moving
  • Shuffling walk
  • Slowed movements
  • Stiffness of the arms and legs
  • Swelling or soreness of the breasts
  • Trembling and shaking of the fingers and hands
  • Unusual secretion of milk
  • Difficulty with swallowing
  • Inability to move the eyes
  • Increased blinking or spasms of the eyelid
  • Lip smacking or puckering
  • Menstrual changes
  • Muscle spasms, especially of the face, neck, or back puffing of the cheeks
  • Rapid or worm-like movements of the tongue
  • Skin rash and itching
  • A sore throat and fever
  • Swelling of the face
  • Uncontrolled chewing movements
  • Uncontrolled movements of the neck, trunk, arms, or legs, including twisting movements
  • Unusual bleeding or bruising
  • Unusual facial expressions or body positions
  • Yellow eyes or skin
  • Convulsions
  • Difficult or unusually fast breathing
  • Fast heartbeat or irregular pulse
  • Fever high or low blood pressure
  • Increased sweating
  • Loss of bladder control
  • Muscle stiffness
  • Or symptoms of overdose such as coma, dizziness, muscle trembling, jerking, or stiffness
  • Troubled breathing, or uncontrolled movements

Some side effects may occur that usually do not need medical attention. As your body adjusts to the medicine, the side effects will slowly disappear. Ask your healthcare professional about ways to prevent or reduce some of these side effects.

If any of the following side effects persists or are inconvenient, or if you notice any other effects, or if you have any questions about them, consult with your health care professional. Report any side effects to the FDA hotline at 1-800-FDA-1088.

6 Related Clinical Trials