Pimozide
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Pimozide
(pi' moe zide)
(pi' moe zide)
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Orap
[Posted 06/16/2008] FDA notified healthcare professionals that both conventional and atypical antipsychotics are associated
with an increased risk of mortality in elderly patients treated for dementia-related psychosis. In April 2005, FDA notified
healthcare professionals that patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an
increased risk of death. Since issuing that notification, FDA has reviewed additional information that indicates the risk
is also associated with conventional antipsychotics. Antipsychotics are not indicated for the treatment of dementia-related
psychosis. The prescribing information for all antipsychotic drugs will now include the same information about this risk in
a BOXED WARNING and the WARNINGS section. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Antipsychotics, http://www.fda.gov/cder/drug/InfoSheets/HCP/antipsychotics_conventional.htm and http://www.fda.gov/bbs/topics/NEWS/2008/NEW01851.html.
Pimozide is used to control tics (unusual movements or sounds that the patient may be able to hold back for a short time but
cannot really control) caused by Tourette's disorder. Pimozide should only be used in patients who cannot take other medications
or who have taken other medications without good results. Pimozide should only be used to treat severe tics that stop the
patient from learning, working, or performing normal activities. Pimozide is in a class of medications called antipsychotics.
It works by decreasing abnormal excitement in the brain.
Pending revision, the material in this section should be considered in light of more recently available information in the
MedWatch notification at the beginning of this monograph.
Pimozide comes as a tablet to take by mouth. It is usually taken with or without food once a day at bedtime or twice a day.
To help you remember to take pimozide, take it around the same time every day. Follow the directions on your prescription
label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take pimozide exactly as directed.
Do not take more or less of it or take it more often than prescribed by your doctor.
Your doctor will probably start you on a low dose of pimozide and gradually increase your dose, not more than once every 2
or 3 days.
Pimozide controls Tourette's disorder but does not cure it. It may take some time before you feel the full benefit of pimozide.
Continue to take pimozide even if you feel well. Do not stop taking pimozide without talking to your doctor. You may experience
a serious reaction if you suddenly stop taking pimozide. Your doctor will probably decrease your dose gradually.
Pending revision, the material in this section should be considered in light of more recently available information in the
MedWatch notification at the beginning of this monograph.
Pimozide may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- sleepiness
- headache
- weakness
- dry mouth
- diarrhea
- constipation
- unusual hunger or thirst
- muscle tightness
- changes in posture
- difficulty falling or staying asleep
- nervousness
- changes in behavior
- changes in taste
- eyes sensitive to light
- changes in vision
- decreased sexual ability
- rash
Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor
immediately:
- unusual movements of your body or face that you cannot control
- high fever
- muscle stiffness
- confusion
- sweating
- fast heartbeat
- shuffling walk
- restlessness
- difficulty moving any part of your body
- difficulty speaking
At high doses, pimozide has caused tumors in mice. This does not necessarily mean that pimozide will also cause tumors in
humans. Pimozide may also cause other serious side effects. Talk to your doctor about the risks of taking this medication.
Pimozide may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA)
MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/index.html] or by phone [1-800-332-1088].
Pending revision, the material in this section should be considered in light of more recently available information in the
MedWatch notification at the beginning of this monograph.
Before taking pimozide,
- tell your doctor and pharmacist if you are allergic to pimozide, other medications for mental illness, or any other medications.
- do not take antibiotics such as azithromycin (Zithromax, Z-Pak), clarithromycin (Biaxin), dirithromycin (Dynabac), erythromycin (E.E.S., E-Mycin, Erythrocin), and troleandomycin (TAO); antifungals such as fluconazole (Diflucan), itraconazole (Sporanox), and ketoconazole (Nizoral); dofetilide (Tikosyn); chlorpromazine (Ormazine, Thorazine); cyclosporine (Neoral, Sandimmune); danazol (Danocrine); delavirdine (Rescriptor); diltiazem (Cardizem, Dilacor, Tiazac); dolasetron (Anzemet); fluoxetine (Prozac, Sarafem); fluvoxamine (Luvox); gatifloxacin (Tequin); HIV protease inhibitors such as indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Fortovase, Invirase), and ritonavir (Norvir); medication for irregular heartbeat such as amiodarone (Cordarone), disopyramide (Norpace), procainamide (Procanabid, Pronestyl), quinidine (Cardioquin, Quinaglute, Quinidex), and sotalol (Betapace); mefloquine (Lariam); mesoridazine (Serentil); metronidazole (Flagyl); moxifloxacin (Avelox); nefazadone (Serzone); oral contraceptives (birth control pills); pentamidine (Nebu-Pent); sertraline (Zoloft); sparfloxacin (Zagam); tacrolimus (Prograf); thioridazine (Mellaril); verapamil (Calan, Covera, Isoptin, Verelan); zafirlukast (Accolate); zileuton (Zyflo); and ziprasidone (Geodon) while taking pimozide.
- tell your doctor if you are taking medications that may cause tics, including amphetamines such as amphetamine (Adderall) and dextroamphetamine (Dexadrine, Dextrostat); pemoline (Cylert); and methyphenidate (Concerta, Ritalin). Your doctor may tell you to stop taking your medication for a while before you start taking pimozide. This will let your doctor see if your tics were caused by the other medication and can be treated by stopping it.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: antidepressants (mood elevators); diuretics ('water pills'); medications for anxiety, mental illness, pain, and seizures; sedatives; sleeping pills; and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have or have ever had breast cancer; an irregular heartbeat; Parkinson's disease; glaucoma; problems with urination; seizures; low levels of potassium or magnesium in your blood; and heart, prostate, liver, or kidney disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking pimozide, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking pimozide.
- you should know that pimozide may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
- remember that alcohol can add to the drowsiness caused by this medication.
- you should know that pimozide may make it harder for your body to cool down when it gets very hot. Tell your doctor if you plan to do vigorous exercise or be exposed to extreme heat.
Talk to your doctor about drinking grapefruit juice while taking this medicine.
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and
continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Pending revision, the material in this section should be considered in light of more recently available information in the
MedWatch notification at the beginning of this monograph.
Pimozide is also used sometimes to treat schizophrenia, and certain behavior, personality, movement, and psychiatric disorders
in adults. Pimozide should not be prescribed for other uses in children. Talk to your doctor about the possible risks of using
this medication for your condition.
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature
and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed.
Talk to your pharmacist about the proper disposal of your medication.
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing,
call local emergency services at 911.
Symptoms of overdose may include:
- difficulty moving body
- shuffling walk
- dizziness
- headache
- fainting
- blurred vision
- upset stomach
- coma
- difficulty breathing
Pending revision, the material in this section should be considered in light of more recently available information in the
MedWatch notification at the beginning of this monograph.
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response
to pimozide.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines
you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list
with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with
you in case of emergencies.
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