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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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);
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.
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.
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 take pimozide without first talking to your doctor if you haveheart disease or other heart problems such as high blood pressure, a history of a heart attack, or irregular heartbeats;
seizures or epilepsy;
an enlarged prostate or difficulty urinating; or
You may not be able to take pimozide, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
Pimozide is in the FDA pregnancy category C. This means that it is not known whether pimozide will be harmful to an unborn baby. Do not take pimozide without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether pimozide passes into breast milk. Do not take pimozide without first talking to your doctor if you are breast-feeding a baby.![]() |
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