Pimozide 1 mg/1
Pimozide · TABLET · Endo USA, Inc.
Pimozide is a tablet containing pimozide at 1 mg/1, taken oral. Manufactured by Endo USA, Inc..
Key Facts
- Brand Name
- Pimozide
- Generic Name
- Pimozide
- NDC Code (Product)
49884-347- Manufacturer
- Endo USA, Inc.
- Strength
- 1 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA204521
- Drug Class
- Typical Antipsychotic [EPC]
- Marketing Start
- 09/28/2015
Recall History
Aidapak Services, LLC
Labeling:Label Mixup; PIMOZIDE Tablet, 1 mg (1/2 of 2 mg) may be potentially mislabeled as METOPROLOL TARTRATE, Tablet, 12.5 mg (1/2 of 25 mg), NDC 63304057901, Pedigree: AD73525_52, EXP: 5/30/2014.
Aidapak Services, LLC
Labeling:Label Mixup; PIMOZIDE Tablet, 2 mg may be potentially mislabeled as DULoxetine HCl DR, Capsule, 20 mg, NDC 00002323560, Pedigree: AD30140_31, EXP: 5/7/2014.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS & USAGE Pimozide tablets are indicated for the suppression of motor and phonic tics in patients with Tourette’s Disorder who have failed to respond satisfactorily to standard treatment. Pimozide tablets are not intended as a treatment of first choice nor is it intended for the treatment of tics that are merely annoying or cosmetically troublesome. Pimozide tablets should be reserved for use in Tourette’s Disorder patients whose development and/or daily life function is severely compromised by the presence of motor and phonic tics. Evidence supporting approval of pimozide tablets for use in Tourette’s Disorder was obtained in two controlled clinical investigations which enrolled patients between the ages of 8 and 53 years. Most subjects in the two trials were 12 or older.
Dosage & Administration
DOSAGE & ADMINISTRATION General The suppression of tics by pimozide tablets requires a slow and gradual introduction of the drug. The patient’s dose should be carefully adjusted to a point where the suppression of tics and the relief afforded is balanced against the untoward side effects of the drug. An ECG should be done at baseline and periodically thereafter, especially during the period of dose adjustment (see WARNINGS and PRECAUTIONS - Laboratory Tests ). Periodic attempts should be made to reduce the dosage of pimozide tablets to see whether or not tics persist at the level and extent first identified. In attempts to reduce the dosage of pimozide tablets consideration should be given to the possibility that increases of tic intensity and frequency may represent a transient, withdrawal related phenomenon rather than a return of disease symptoms. Specifically, one to two weeks should be allowed to elapse before one concludes that an increase in tic manifestations is a function of the underlying disease syndrome rather than a response to drug withdrawal. A gradual withdrawal is recommended in any case. Children Reliable dose response data for the effects of pimozide tablets on t…
Warnings
WARNINGS The use of pimozide in the treatment of Tourette’s Disorder involves different risk/benefit considerations than when antipsychotic drugs are used to treat other conditions. Consequently, a decision to use pimozide should take into consideration the following (see also PRECAUTIONS - Information for Patients ). Tardive Dyskinesia A syndrome consisting of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of antipsychotic treatment, which patients are likely to develop the syndrome. Whether antipsychotic drug products differ in their potential to cause tardive dyskinesia is unknown. Both the risk of developing tardive dyskinesia and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient increase. However, the syndrome can develop, although much less commonly, after relatively brief treatment periods a…
Contraindications
CONTRAINDICATIONS Pimozide is contraindicated in the treatment of simple tics or tics other than those associated with Tourette’s Disorder. Pimozide should not be used in patients taking drugs that may, themselves, cause motor and phonic tics (e.g., pemoline, methylphenidate and amphetamines) until such patients have been withdrawn from these drugs to determine whether or not the drugs, rather than Tourette’s Disorder, are responsible for the tics. Because pimozide prolongs the QT interval of the electrocardiogram it is contraindicated in patients with congenital long QT syndrome, patients with a history of cardiac arrhythmias, patients taking other drugs which prolong the QT interval of the electrocardiogram or patients with known hypokalemia or hypomagnesemia (see also PRECAUTIONS - Drug Interactions ). Pimozide is contraindicated in patients with severe toxic central nervous system depression or comatose states from any cause. Pimozide is contraindicated in patients with hypersensitivity to it. As it is not known whether cross-sensitivity exists among the antipsychotics, pimozide should be used with appropriate caution in patients who have demonstrated hypersensitivity to other …
Drug Interactions
DRUG INTERACTIONS Because pimozide prolongs the QT interval of the electrocardiogram, an additive effect on QT interval would be anticipated if administered with other drugs, such as phenothiazines, tricyclic antidepressants or antiarrhythmic agents, which prolong the QT interval. Accordingly, pimozide should not be given with dofetilide, sotalol, quinidine, other Class Ia and III anti-arrhythmics, mesoridazine, thioridazine, chlorpromazine, droperidol, sparfloxacin, gatifloxacin, moxifloxacin, halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadyl acetate, dolasetron mesylate, probucol, tacrolimus, ziprasidone, or other drugs that have demonstrated QT prolongation as one of their pharmacodynamic effects. Also, the use of macrolide antibiotics in patients with prolonged QT intervals has been rarely associated with ventricular arrhythmias. Such concomitant administration should not be undertaken (see CONTRAINDICATIONS ). Since pimozide is partly metabolized via CYP 3A4, it should not be administered concomitantly with inhibitors of this metabolic system, such as azole antifungal agents and protease inhibitor drugs (see CONTRAINDICATIONS ). Pimozide and Celexa: In a co…
Adverse Reactions
ADVERSE REACTIONS General Extrapyramidal Reactions: Neuromuscular (extrapyramidal) reactions during the administration of pimozide have been reported frequently, often during the first few days of treatment. In most patients, these reactions involved Parkinson-like symptoms which, when first observed, were usually mild to moderately severe and usually reversible. Other types of neuromuscular reactions (motor restlessness, dystonia, akathisia, hyperreflexia, opisthotonos, oculogyric crises) have been reported far less frequently. Severe extrapyramidal reactions have been reported to occur at relatively low doses. Generally the occurrence and severity of most extrapyramidal symptoms are doserelated since they occur at relatively high doses and have been shown to disappear or become less severe when the dose is reduced. Administration of antiparkinson drugs such as benztropine mesylate or trihexyphenidyl hydrochloride may be required for control of such reactions. It should be noted that persistent extrapyramidal reactions have been reported and that the drug may have to be discontinued in such cases. Withdrawal Emergent Neurological Signs: Generally, patients receiving short term the…
Frequently Asked Questions
What is Pimozide used for?
Pimozide contains Pimozide. It is a tablet taken oral. Consult your doctor for specific uses.
Is Pimozide a controlled substance?
Pimozide is not classified as a controlled substance by the DEA.
What is the generic name for Pimozide?
The generic name for Pimozide is Pimozide. There are no other listed brand versions of Pimozide.
What is the NDC code for Pimozide 1 mg/1?
The NDC (National Drug Code) for Pimozide 1 mg/1 is 49884-347, listed by Endo USA, Inc..
Other Pimozide Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)