Drug Notebook

FDA Alerts

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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pimozide
(PIM oh zide)

What is pimozide?
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.

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What is the price of this medication and similar alternatives?

This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Orap 1MG Tablets GATE60/$60.99 or 180/$171.97
Orap 2MG Tablets GATE60/$78.99 or 180/$225.95

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What are the possible side effects of pimozide?

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.

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How should I take pimozide?
Take pimozide exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you. Take each dose with a full glass of water. Never take more of this medication than is prescribed for you. Do not consume grapefruit or grapefruit juice during treatment with pimozide. Pimozide can interact with grapefruit products, and the interaction may have dangerous effects. Talk to your doctor before you stop taking this medication. It may be several weeks before you begin to feel better, and you may require continuous treatment for quite some time. A gradual reduction in dose may be recommended before stopping the medication.

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

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What happens if I miss a dose?
Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

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What other drugs will affect pimozide?
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);

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Can I take this if I am pregnant or trying to get pregnant or if I am breastfeeding?

Pimozide has been assigned to pregnancy category C by the FDA. Animal studies have revealed prolonged estrus cycles, decreased numbers of pregnancies, retarded development of fetuses, dose related maternal toxicity, mortality, decreased weight gain, and embryotoxicity including increased resorptions. There are no controlled data in human pregnancy. Pimozide should only be given during pregnancy when benefits outweigh risks.

There are no data on the excretion of pimozide into human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions due to pimozide in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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Who should NOT use this medication?

  • Simple tics or tics other than those associated with Tourette's syndrome.
  • Concurrent therapy with drugs that cause motor and vocal tics (e.g., amphetamines, methylphenidate, pemoline [no longer commercially available in the US]) until such drugs have been withdrawn to determine whether tics were caused by the drug rather than Tourette's syndrome.
  • Congenital long QT syndrome, history of cardiac arrhythmias, concomitant therapy with other drugs that prolong QT interval, or known hypokalemia or hypomagnesemia. (See Cardiovascular Effects under Cautions.)
  • Concomitant therapy with drugs that inhibit CYP3A4 or drugs that prolong the QT interval (e.g., azole antifungals, macrolide antibiotics, protease inhibitors, SSRIs [citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline], nefazodone, zileuton). (See Interactions.)
  • Severe toxic CNS depression or comatose states from any cause.
  • Hypersensitivity to pimozide; use caution in patients who have demonstrated hypersensitivity to other antipsychotic drugs.

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What does my medication look like?
Pimozide is available with a prescription under the brand name Orap. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you. Orap 1 mg--white, oval, scored tablets Orap 2 mg--white, oval, scored tablets

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What happens if I overdose?
Seek emergency medical attention. Symptoms of a pimozide overdose include dizziness, drowsiness, uncontrollable movements, coma, and death.

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What should I discuss with my healthcare provider before taking pimozide?
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);

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Can I stop taking the medication if I feel better?
As a general rule, you should always take your medications exactly as prescribed and do not change the dosage or stop taking the medication without first discussing it with your healthcare provider.

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I am on so many medications; do I have to take them all?
This is called polypharmacy—many different medications being used at the same time by one person. Sometimes, being on multiple medications is acceptable and appropriate but at other times it may be problematic. If you are receiving your medications from multiple physicians you need to ensure that they all know what medications you are taking. The best way to do this is to make a list of all the medications you are currently using, including all nutritional supplements, homeopathic remedies, vitamins and over-the-counter drugs (if possible, also include all the diseases you have been diagnosed with). Give a copy to every doctor who takes care of you so they have it on file, this way they can avoid duplicating medications and perhaps even try to consolidate some. After every doctor's visit remember to update the list accordingly. Also, as much as you possibly can, try to use the same pharmacy to fill all your prescriptions, this way any potential drug interactions can be caught and averted.

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Where can I get more information?
More Information

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