Special Alerts:
[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.
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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.
Pimozide should not be taken with other medicines that, may themselves, cause motor and phonic tics including
pemoline (Cylert);
methylphenidate (Ritalin, Concerta, Metadate, Methylin);
dexmethylphenidate (Focalin); and
amphetamines such as amphetamine, amphetamine-dextroamphetamine (Adderall), dextroamphetamine (Dexedrine, Dextrostat), and methamphetamine (Desoxyn).
Talk to your doctor before taking pimozide if you are taking any of the medicines listed above.
Tell your doctor if you are taking any medicines to treat a seizure disorder. Pimozide may increase the risk of having a seizure.
Pimozide may also increase the side effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, sedatives (medicines that treat insomnia), pain relievers, anxiety medicines, muscle relaxants, and any other drug that makes you feel sleepy or relaxed. Tell your doctor about all medicines that you are taking and do not take any medicine unless your doctor approves.
Drugs other than those listed here may also interact with pimozide. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.
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.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
