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Pimozide Full Prescribing Information

Brand Name: Orap
Generic Name: Pimozide

Orap, Pimozide is for treatment of tics caused by Tourette's Syndrome, management of chronic psychosis in schizophrenia patients (in Europe). Usage, dosage, side effects of Orap.

Contents:

Description
Pharmacology
Indications and Usage
Contraindications
Warnings
Precautions
Drug Interactions
Adverse Reactions
Overdose
Dosage
Supplied

Description

Pimozide (Orap) helps to lessen the muscle and speech tics that are caused by Tourette's syndrome. Pimozide can also treat conditions that may cause you to hear or see things that others do not.

Pharmacology

An antipsychotic, Pimozide (Orap) posesses neuroleptic properties that have been found to be useful in the management of chronic schizophrenic patients. It is relatively non-sedating and can be administered in a single daily dose.

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Indications and Usage

The management of the manifestations of chronic schizophrenia in which the main manifestations do not include excitement, agitation or hyperactivity. Pimozide has relatively little sedative action and can be used as a once daily medication.

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Contraindications

Pimozide is not indicated in the management of patients with mania or acute schizophrenia.

 

CNS depression, comatose states, liver disorders, renal insufficiency, blood dyscrasias, and in individuals who have previously displayed hypersensitivity to the drug. It should not be used in depressive disorders or Parkinson's syndrome.

Contraindicated in patients with congenital long QT syndrome, patients with a history of cardiac arrhythmias, or patients taking other drugs which prolong the QT interval of the ECG.

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Warnings

Visit your prescriber or health care professional for regular checks on your progress. It may be several weeks before you see the full effects of pimozide. Do not suddenly stop taking pimozide. You may need to gradually reduce the dose. Only stop taking pimozide on your prescriber's advice.

You may get dizzy or drowsy. Do not drive, use machinery, or do anything that needs mental alertness until you know how pimozide affects you. Alcohol can increase dizziness and drowsiness. Avoid alcoholic drinks.

Do not drink grapefruit juice products while taking pimozide. An ingredient in grapefruit juice can increase the chance of developing serious heart problems from pimozide.

If you are going to have surgery tell your prescriber or health care professional that you are taking pimozide.

Pregnancy and Lactation:
The safety of use of pimozide in pregnancy and lactation has not been established. Therefore, it should not be administered to nursing mothers or to women of child-bearing potential, particularly during the first trimester of pregnancy, unless, in the opinion of the physician, the expected benefits of the drug to the patient outweigh the potential risk to the fetus or child.

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Precautions

Clinical trials with pimozide (orap) indicate that it is not effective in, and therefore should not be used in the management of, manifestations of chronic schizophrenia in which the main symptoms include agitation, excitement and anxiety.

Sudden, unexpected deaths have occurred with pimozide, mainly at doses above 20 mg/day. ECG changes have been reported in association with the use of pimozide.

Jaundice of the cholestatic type of hepatitis or liver damage have been reported with other antipsychotics; therefore, administer pimozide with caution to patients with liver disease.

Tardive Dyskinesia:
Tardive dyskinesia is known to occur in patients treated with antipsychotic drugs and other drugs with substantial antipsychotic activity. Although the dyskinetic syndrome may remit partially or completely if the medication is withdrawn, it is irreversible in some patients. At the present time there is uncertainty as to whether antipsychotic drugs differ in their potential to cause tardive dyskinesia.

Since there is a significant prevalence of this syndrome associated with the use of antipsychotic drugs, and since there is no known effective treatment, chronic use of these drugs should generally be restricted to patients for whom antipsychotics are known to be effective and for whom there is no alternative therapy available with better risk acceptability. If manifestations of tardive dyskinesia are detected during the use of a neuroleptic, the drug should be discontinued.

The risk of a patient developing tardive dyskinesia and of the syndrome becoming irreversible appear to increase with the duration of treatment and the total amount of drugs administered, although, in some instances, tardive dyskinesia may develop after relatively short periods of treatment at low doses. The risk of developing tardive dyskinesia may, therefore, be minimized by reducing the dose of the antipsychotic drug used and its duration of administration, consistent with the effective management of the patient's condition. Continued use of antipsychotics should be periodically reassessed.

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Drug Interactions

BEFORE USING THIS MEDICINE: INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. Also tell your prescriber or health care professional if you are a frequent user of grapefruit juice, drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

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Adverse Reactions

Side effects that you should report to your prescriber or health care professional as soon as possible:

Rare or uncommon: Side effects that you should report to your prescriber or health care professional as soon as possible:

  • change in emotion or behavior such as feeling depressed, angry, or anxious
  • change in vision - difficulty breathing
  • difficulty swallowing
  • fast or irregular heartbeat (palpitations)
  • fever - inability to control muscle movements in the face, hands, arms, or legs
  • increased thirst
  • loss of balance or difficulty walking
  • menstrual changes
  • rash - seizures
  • stiff muscles or jaw
  • seizures
  • sexual difficulties
  • skin rash
  • spasms of the face, tongue, or mouth
  • uncontrollable tongue or mouth movements

More common:

  • dizziness or lightheadedness
  • restlessness or need to keep moving
  • tremors or trembling

Other Side Effects:

The following additional adverse reactions have been reported:

  • changes in sexual desire
  • constipation
  • difficulty sleeping
  • difficulty urinating
  • excessive watering or drooling of mouth
  • headache -nausea or vomiting
  • trouble in controlling urine
  • weight gain More Common
  • dizziness; especially on standing from a sitting or lying position
  • drowsiness
  • dry mouth
  • weight loss.

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Overdose

Signs and Symptoms

In general, the signs and symptoms of overdosage with pimozide would be an exaggeration of known pharmacologic effects and adverse reactions, the most prominent of which would be: ECG abnormalities, severe extrapyramidal reactions, hypotension, and a comatose state with respiratory depression. The risk of cardiac arrhythmias should be considered.

Treatment

Establish and maintain an airway to ensure adequate ventilation and oxygenation. Gastric lavage should be considered. Cardiac and vital sign monitoring are recommended, along with general symptomatic and supportive measures. Because of the long half-life of pimozide, patients who take an overdose should be observed for at least 4 days.

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Dosage

HOW TO USE THIS MEDICINE:

DO NOT EXCEED THE RECOMMENDED DOSE or take this medicine for longer than prescribed.

Do not drink alcoholic beverages or grapefruit juice products while taking pimozide, orap.

  • Follow the directions for using this medicine provided by your doctor.
  • Orap, Pimozide should be administered once daily, in the morning with or without food. Follow the directions on the prescription label.
  • Store this medicine at room temperature, away from heat and light.
  • If you miss a dose of this medicine, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take double or extra doses. Follow your prescriber or health care professional's advice on missed doses.
  • Do not stop taking this medicine without first checking with your doctor.

Adults: The initial recommended dose in patients with chronic schizophrenia for whom pimozide might be indicated is: 2 to 4 mg once daily, with weekly increments of 2 to 4 mg until a satisfactory level of therapeutic effect is attained or excessive adverse effects occur. Average maintenance dose: 6 mg daily; usual range is 2 to 12 mg/day. Daily doses above 20 mg are not recommended.

Additional Information:: Do not share this medicine with others for whom it was not prescribed. Do not use this medicine for other health conditions. Keep this medicine out of the reach of children.

IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out.

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How Supplied

Each round, hard, uncoated tablet, scored on one side and imprinted "McNEIL" on the other, contains: Pimozide 2 mg (white), 4 mg (green), or 10 mg (peach). Also contains tartrazine (4 mg). Energy: 2 mg: 1.784 kJ (0.424 kcal); 4 mg: 1.750 kJ (0.415 kcal); 10 mg: 6.208 kJ (1.474 kcal). Sodium: <1 mmol (<1 mg)/tablet. Bottles of 100.

All tablets also contain lactose and are gluten-free and sodium metabisulfite-free. Store in well-closed containers.


The information in this monograph is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects. This information is generalized and is not intended as specific medical advice. If you have questions about the medicines you are taking or would like more information, check with your doctor, pharmacist, or nurse. Last updated 3/03.

Copyright © 2007 Healthyplace Inc. All rights reserved.

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back to: Psychiatric Medications Pharmacology Homepage

Last Updated: 09 April 2017
Reviewed by Harry Croft, MD

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