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ORAP® (Pimozide)
Tablets
GATE

151
187
DESCRIPTION
ORAP (pimozide) is an orally active antipsychotic agent of the diphenyl-butylpiperidine series. The structural formula of pimozide, 1-[1-[4,4-bis(4-fluorophenyl) butyl]-4-piperidinyl]-1,3-dihydro-2H-benzimidazole-2-one is:
The solubility of pimozide in water is less than 0.01 mg/mL; it is slightly soluble in most
organic solvents.
Each white ORAP tablet contains either 1 mg or 2 mg of pimozide and the following
inactive ingredients: calcium stearate, microcrystalline cellulose, lactose anhydrous and
corn starch.
CLINICAL PHARMACOLOGY
Pharmacodynamic Actions
ORAP (pimozide) is an orally active antipsychotic drug product which shares with other
antipsychotics the ability to blockade dopaminergic receptors on neurons in the central
nervous system. Although its exact mode of action has not been established, the ability
of pimozide to suppress motor and phonic tics in Tourette’s Disorder is thought to be a
function of its dopaminergic blocking activity. However, receptor blockade is often
accompanied by a series of secondary alterations in central dopamine metabolism and
function which may contribute to both pimozide’s therapeutic and untoward effects. In
addition, pimozide, in common with other antipsychotic drugs, has various effects on
other central nervous system receptor systems which are not fully characterized.
Metabolism and Pharmacokinetics
More than 50% of a dose of pimozide is absorbed after oral administration. Based on the
pharmacokinetic and metabolic profile, pimozide appears to undergo significant first pass
metabolism. Peak serum levels occur generally six to eight hours (range 4-12 hours)
after dosing.
Pimozide is extensively metabolized, primarily by N-dealkylation in the liver. This
metabolism is catalyzed mainly by the cytochrome P450 3A4 (CYP 3A4) enzymatic
system and to a lesser extent, by cytochrome P450 1A2 (CYP 1A2). Two major
metabolites have been identified, 1-(4-piperidyl)-2-benzimidazolinone and 4,4-bis(4-
fluorophenyl) butyric acid. The antipsychotic activity of these metabolites is
undetermined. The major route of elimination of pimozide and its metabolites is through
the kidney.
The mean serum elimination half-life of pimozide in schizophrenic patients was
approximately 55 hours. There was a 13-fold interindividual difference in the area under
the serum pimozide level-time curve and an equivalent degree of variation in peak serum
levels among patients studied. The significance of this is unclear since there are few
correlations between plasma levels and clinical findings.
Effects of food and disease upon the absorption, distribution, metabolism and elimination
of pimozide are not known. Effects of concomitant medication on pimozide metabolism
are described in the CONTRAINDICATIONS section.
INDICATIONS AND USAGE
ORAP (pimozide) is indicated for the suppression of motor and phonic tics in patients
with Tourette’s Disorder who have failed to respond satisfactorily to standard treatment.
ORAP is not intended as a treatment of first choice nor is it intended for the treatment of
tics that are merely annoying or cosmetically troublesome. ORAP 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 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.
CONTRAINDICATIONS
1. ORAP (pimozide) is contraindicated in the treatment of simple tics or tics other than
those associated with Tourette’s Disorder.
2. ORAP 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.
3. Because ORAP 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).

4. ORAP is contraindicated in patients with severe toxic central nervous system
depression or comatose states from any cause.
5. ORAP 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
antipsychotic drugs.
6. Ventricular arrhythmias have been rarely associated with the use of macrolide
antibiotics in patients with prolonged QT intervals, as might be produced by ORAP.
Specifically, two sudden deaths have been reported when clarithromycin was added to
ongoing pimozide therapy. Furthermore, some evidence suggests that pimozide is
metabolized partly by the enzyme system cytochrome P450 3A4 (CYP 3A4). Macrolide
antibiotics are inhibitors of CYP 3A4, and thus could potentially impede pimozide
metabolism. For these reasons, ORAP is contraindicated in patients receiving the
macrolide antibiotics clarithromycin, erythromycin, azithromycin, dirithromycin, and
troleandomycin.
7. Concomitant use in patients taking Celexa or Lexapro is contraindicated (see
Precautions - Drug InteractionsPimozide and Celexa).
Because azole antifungal agents are also inhibitors of the CYP 3A4 enzymes and thus
may likewise impair pimozide metabolism, ORAP is contraindicated in patients receiving
the azole antifungal agents itraconazole and ketoconazole.
Similarly, protease inhibitor drugs are also inhibitors of CYP 3A4, and thus ORAP is
contraindicated in patients receiving protease inhibitors such as ritonavir, saquinovir,
indinavir, and nelfinavir. (See PRECAUTIONS - Drug Interactions.)
Nefazodone is a potent inhibitor of CYP 3A4, and its concomitant use with ORAP is also
contraindicated.
Other drugs that are relatively less potent inhibitors of CYP 3A4 should also be avoided,
in view of the risks: e.g. zileuton, fluvoxamine.
Concomitant use of pimozide in patients taking sertraline is contraindicated (See
PRECAUTIONS - Drug Interactions).
WARNINGS
The use of ORAP (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 ORAP 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 at
low doses.
There is no known treatment for established cases of tardive dyskinesia, although the
syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn.
Antipsychotic treatment itself, however, may suppress (or partially suppress) the signs
and symptoms of the syndrome and thereby may possibly mask the underlying process.
The effect that symptomatic suppression has upon the long-term course of the syndrome
is unknown.
Given these considerations, antipsychotic drugs should be prescribed in a manner that is
most likely to minimize the occurrence of tardive dyskinesia. Chronic antipsychotic
treatment should generally be reserved for patients who suffer from a chronic illness that,
1) is known to respond to antipsychotic drugs, and, 2) for whom alternative, equally
effective, but potentially less harmful treatments are not available or appropriate. In
patients who do require chronic treatment, the smallest dose and the shortest duration of
treatment producing a satisfactory clinical response should be sought. The need for
continued treatment should be reassessed periodically.
If signs and symptoms of tardive dyskinesia appear in a patient on antipsychotics, drug
discontinuation should be considered. However, some patients may require treatment
despite the presence of the syndrome.
(For further information about the description of tardive dyskinesia and its clinical
detection, please refer to ADVERSE REACTIONS and PRECAUTIONS -
Information for Patients
.)
Neuroleptic Malignant Syndrome (NMS)
A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant
Syndrome (NMS) has been reported in association with antipsychotic drugs. Clinical
manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status (including
catatonic signs) and evidence of autonomic instability (irregular pulse or blood pressure,
tachycardia, diaphoresis, and cardiac dysrhythmias). Additional signs may include
elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis) and acute renal
failure.
The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a
diagnosis, it is important to identify cases where the clinical presentation includes both
serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or
inadequately treated extrapyramidal signs and symptoms (EPS). Other important
considerations in the differential diagnosis include central anticholinergic toxicity, heat
stroke, drug fever and primary central nervous system (CNS) pathology.
The management of NMS should include 1) immediate discontinuation of antipsychotic
drugs and other drugs not essential to concurrent therapy, 2) intensive symptomatic
treatment and medical monitoring, and 3) treatment of any concomitant serious medical
problems for which specific treatments are available. There is no general agreement
about specific pharmacological treatment regimens for uncomplicated NMS.
If a patient requires antipsychotic drug treatment after recovery from NMS, the potential
reintroduction of drug therapy should be carefully considered. The patient should be
carefully monitored, since recurrences of NMS have been reported.
Hyperpyrexia, not associated with the above symptom complex, has been reported with
other antipsychotic drugs.
Other
Sudden, unexpected deaths have occurred in experimental studies of conditions other
than Tourette’s Disorder. These deaths occurred while patients were receiving dosages
in the range of 1 mg per kg. One possible mechanism for such deaths is prolongation of
the QT interval predisposing patients to ventricular arrhythmia. An electrocardiogram
should be performed before ORAP treatment is initiated and periodically thereafter,
especially during the period of dose adjustment.
ORAP may have a tumorigenic potential. Based on studies conducted in mice, it is
known that pimozide can produce a dose-related increase in pituitary tumors. The full
significance of this finding is not known, but should be taken into consideration in the
physician’s and patient’s decisions to use this drug product. This finding should be given
special consideration when the patient is young and chronic use of pimozide is
anticipated (see PRECAUTIONS - Carcinogenesis, Mutagenesis,
Impairment of Fertility
).
PRECAUTIONS
General
ORAP (pimozide) may impair the mental and/or physical abilities required for the
performance of potentially hazardous tasks, such as driving a car or operating machinery,
especially during the first few days of therapy.
ORAP produces anticholinergic side effects and should be used with caution in
individuals whose conditions may be aggravated by anticholinergic activity.
ORAP should be administered cautiously to patients with impairment of liver or kidney
function, because it is metabolized by the liver and excreted by the kidneys.

Antipsychotics should be administered with caution to patients receiving anticonvulsant
medication, with a history of seizures, or with EEG abnormalities, because they may
lower the convulsive threshold. If indicated, adequate anticonvulsant therapy should be
maintained concomitantly.
Information for Patients
Treatment with ORAP exposes the patient to serious risks. A decision to use ORAP
chronically in Tourette’s Disorder is one that deserves full consideration by the patient
(or patient’s family) as well as by the treating physician. Because the goal of treatment is
symptomatic improvement, the patient’s view of the need for treatment and assessment of
response are critical in evaluating the impact of therapy and weighing its benefits against
the risks. Since the physician is the primary source of information about the use of a
drug in any disease, it is recommended that the following information be discussed with
patients and/or their families.
ORAP is intended only for use in patients with Tourette’s Disorder whose symptoms are
severe and who cannot tolerate, or who do not respond to HALDOL® (haloperidol).
Given the likelihood that a proportion of patients exposed chronically to antipsychotics
will develop tardive dyskinesia, it is advised that all patients in whom chronic use is
contemplated be given, if possible, full information about this risk. The decision to
inform patients and/or their guardians must obviously take into account the clinical
circumstances and the competency of the patient to understand the information provided.
There is limited information available on the use of ORAP in children under 12 years of
age.
The information available on ORAP from foreign marketing experience and from U.S.
clinical trials indicates that ORAP has a side effect profile similar to that of other
antipsychotic drugs. Patients should be informed that all types of side effects associated
with the use of antipsychotics may be associated with the use of ORAP.
In addition, sudden, unexpected deaths have occurred in patients taking high doses of
ORAP for conditions other than Tourette’s Disorder. These deaths may have been the
result of an effect of ORAP upon the heart. Therefore, patients should be instructed not
to exceed the prescribed dose of ORAP and they should realize the need for the initial
ECG and for follow-up ECGs during treatment.
Also, pimozide, at a dose about 15 times that given humans, caused an increase in the
number of benign tumors of the pituitary gland in female mice. It is not possible to say
how important this is. Similar tumors were not seen in rats given pimozide, nor at lower
doses in mice, which is reassuring. However, any such finding must be considered to
suggest a possible risk of long term use of the drug.
Because substances in grapefruit juice may inhibit the metabolism of pimozide by CYP
3A4, patients should be advised to avoid grapefruit juice.

Laboratory Tests
An ECG should be done at baseline and periodically thereafter throughout the period of
dose adjustment. Any indication of prolongation of QTc interval beyond an absolute
limit of 0.47 seconds (children) or 0.52 seconds (adults), or more than 25% above the
patient’s original baseline should be considered a basis for stopping further dose increase
(see CONTRAINDICATIONS) and considering a lower dose.
Since hypokalemia has been associated with ventricular arrhythmias, potassium
insufficiency, secondary to diuretics, diarrhea, or other cause, should be corrected before
ORAP therapy is initiated and normal potassium maintained during therapy.
Drug Interactions
Because ORAP 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).
Pimozide and Celexa – In a controlled study, a single dose of pimozide 2 mg co-
administered with racemic citalopram 40 mg given once daily for 11 days was associated
with a mean increase in QTc values of approximately 10 msec compared to pimozide
given alone. Racemic citalopram did not alter the mean AUC or C of pimozide. The
mechanism of this pharmacodynamic interaction is not known.
Since ORAP 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).
As CYP 1A2 may also contribute to the metabolism of ORAP, prescribers should be
aware of the theoretical potential for drug interactions with inhibitors of this enzymatic
system.
ORAP may be capable of potentiating CNS depressants, including analgesics, sedatives,
anxiolytics, and alcohol.
Rare case reports have suggested possible additive effects of pimozide and fluoxetine
leading to bradycardia.
Concomitant administration of pimozide and sertraline should be contraindicated (See
CONTRAINDICATIONS).

Interaction with Food
Patients should avoid grapefruit juice because it may inhibit the metabolism of pimozide
by CYP 3A4.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity studies were conducted in mice and rats. In mice, pimozide causes a
dose-related increase in pituitary and mammary tumors.
When mice were treated for up to 18 months with pimozide, pituitary gland changes
developed in females only. These changes were characterized as hyperplasia at doses
approximating the human dose and adenoma at doses about fifteen times the maximum
recommended human dose on a mg per kg basis. The mechanism for the induction of
pituitary tumors in mice is not known.
Mammary gland tumors in female mice were also increased, but these tumors are
expected in rodents treated with antipsychotic drugs which elevate prolactin levels.
Chronic administration of an antipsychotic also causes elevated prolactin levels in
humans. Tissue culture experiments indicate that approximately one-third of human
breast cancers are prolactin-dependent in vitro, a factor of potential importance if the
prescription of these drugs is contemplated in a patient with a previously detected breast
cancer. Although disturbances such as galactorrhea, amenorrhea, gynecomastia, and
impotence have been reported with antipsychotic drugs, the clinical significance of
elevated serum prolactin levels is unknown for most patients. Neither clinical studies nor
epidemiologic studies conducted to date have shown an association between chronic
administration of these drugs and mammary tumorigenesis. The available evidence,
however, is considered too limited to be conclusive at this time.
In a 24-month carcinogenicity study in rats, animals received up to 50 times the
maximum recommended human dose. No increased incidence of overall tumors or
tumors at any site was observed in either sex. Because of the limited number of animals
surviving this study, the meaning of these results is unclear.
Pimozide did not have mutagenic activity in the Ames test with four bacterial test strains,
in the mouse dominant lethal test or in the micronucleus test in rats.
Reproduction studies in animals were not adequate to assess all aspects of fertility.
Nevertheless, female rats administered pimozide had prolonged estrus cycles, an effect
also produced by other antipsychotic drugs.
Pregnancy
Category C. Reproduction studies performed in rats and rabbits at oral doses up to 8
times the maximum human dose did not reveal evidence of teratogenicity. In the rat,
however, this multiple of the human dose resulted in decreased pregnancies and in the
retarded development of fetuses. These effects are thought to be due to an inhibition or
delay in implantation which is also observed in rodents administered other antipsychotic
drugs. In the rabbit, maternal toxicity, mortality, decreased weight gain, and
embryotoxicity including increased resorptions were dose-related. Because animal
reproduction studies are not always predictive of human response, pimozide should be
given to a pregnant woman only if the potential benefits of treatment clearly outweigh the
potential risks.
Labor and Delivery
This drug has no recognized use in labor or delivery.
Nursing Mothers
It is not known whether pimozide is excreted in human milk. Because many drugs are
excreted in human milk and because of the potential for tumorigenicity and unknown
cardiovascular effects in the infant, a decision should be made whether to discontinue
nursing or to discontinue the drug, taking into account the importance of the drug to the
mother.

Pediatric Use
Although Tourette's Disorder most often has its onset between the ages of 2 and 15 years,
information on the use and efficacy of ORAP in patients less than 12 years of age is
limited. A 24-week open label study in 36 children between the ages of 2 and 12
demonstrated that pimozide has a similar safety profile in this age group as in older
patients and there were no safety findings that would preclude its use in this age group.
Because its use and safety have not been evaluated in other childhood disorders, ORAP is
not recommended for use in any condition other than Tourette’s Disorder.
ADVERSE REACTIONS
General
Extrapyramidal Reactions: Neuromuscular (extrapyramidal) reactions during the
administration of ORAP (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 dose-related 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 therapy experience no problems with abrupt discontinuation of antipsychotic drugs. However, some patients on maintenance treatment experience transient dyskinetic signs after abrupt withdrawal. In certain of these cases the dyskinetic movements are indistinguishable from the syndrome described below under “Tardive Dyskinesia” except
for duration. It is not known whether gradual withdrawal of antipsychotic drugs will
reduce the rate of occurrence of withdrawal emergent neurological signs, but until further
evidence becomes available, it seems reasonable to gradually withdraw use of ORAP.
Tardive Dyskinesia: ORAP may be associated with persistent dyskinesias. Tardive
dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic
movements, may appear in some patients on long-term therapy or may occur after drug
therapy has been discontinued. The risk appears to be greater in elderly patients on high-
dose therapy, especially females. The symptoms are persistent and in some patients
appear irreversible. The syndrome is characterized by rhythmical involuntary
movements of tongue, face, mouth or jaw (e.g., protrusion of tongue, puffing of cheeks,
puckering of mouth, chewing movements). Sometimes these may be accompanied by
involuntary movements of extremities and the trunk.
There is no known effective treatment for tardive dyskinesia; antiparkinson agents
usually do not alleviate the symptoms of this syndrome. It is suggested that all
antipsychotic agents be discontinued if these symptoms appear. Should it be necessary to
reinstitute treatment, or increase the dosage of the agent, or switch to a different
antipsychotic agent, this syndrome may be masked.
It has been reported that fine vermicular movement of the tongue may be an early sign of
tardive dyskinesia and if the medication is stopped at that time the syndrome may not
develop.
Electrocardiographic Changes: Electrocardiographic changes have been observed in
clinical trials of ORAP in Tourette’s Disorder and schizophrenia. These have included
prolongation of the QT interval, flattening, notching and inversion of the T wave and the
appearance of U waves. Sudden, unexpected deaths and grand mal seizure have occurred
at doses above 20 mg/day.
Neuroleptic Malignant Syndrome: Neuroleptic malignant syndrome (NMS) has been
reported with ORAP. (See WARNINGS for further information concerning NMS.)
Hyperpyrexia: Hyperpyrexia has been reported with other antipsychotic drugs.
Clinical Trials
The following adverse reaction tabulation was derived from 20 patients in a 6-week long
placebo-controlled clinical trial of ORAP in Tourette’s Disorder.

Body System/

Pimozide
Adverse Reaction

Body as a Whole
Headache 1

Gastrointestinal
Dry Mouth

Endocrine
Menstrual disorder

Musculoskeletal
Muscle cramps

CNS
Drowsiness 7

Psychiatric
Depression 2

Special Senses
Visual disturbance

Urogenital
Impotence 3
The following adverse event tabulation was derived from 36 children (age 2 to 12) in a
24-week open trial of ORAP in Tourette’s Disorder.
Body System/
Number of Patients
Adverse Reaction
Experiencing Each Event (%)
All Events
Drug-Related

Body as a Whole

Gastrointestinal

Musculoskeletal

Central Nervous System

Psychiatric

Special Senses

Cardiovascular

Because clinical investigational experience with ORAP in Tourette’s Disorder is limited,
uncommon adverse reactions may not have been detected. The physician should consider
that other adverse reactions associated with antipsychotics may occur.
Other Adverse Reactions
In addition to the adverse reactions listed above, those listed below have been reported in
U.S. clinical trials of ORAP in conditions other than Tourette’s Disorder.
Body as a Whole: Asthenia, chest pain, periorbital edema
Cardiovascular/Respiratory: Postural hypotension, hypotension, hypertension,
tachycardia, palpitations
Gastrointestinal: Increased salivation, nausea, vomiting, anorexia, GI distress
Endocrine: Loss of libido
Metabolic/Nutritional: Weight gain, weight loss
Central Nervous System: Dizziness, tremor, parkinsonism, fainting, dyskinesia
Psychiatric: Excitement
Skin: Rash, sweating, skin irritation
Special Senses: Blurred vision, cataracts
Urogenital: Nocturia, urinary frequency
Postmarketing Reports
The following experiences were described in spontaneous postmarketing reports. These
reports do not provide sufficient information to establish a clear causal relationship with
the use of ORAP.
Gastrointestinal: Gingival hyperplasia in one patient
Hematologic: Hemolytic anemia
Metabolic/Nutritional: Hyponatremia
Other: Seizure
OVERDOSAGE
In general, the signs and symptoms of overdosage with ORAP (pimozide) would be an
exaggeration of known pharmacologic effects and adverse reactions, the most prominent
of which would be: 1) electrocardiographic abnormalities, 2) severe extrapyramidal
reactions, 3) hypotension, 4) a comatose state with respiratory depression.
In the event of overdosage, gastric lavage, establishment of a patent airway and, if
necessary, mechanically-assisted respiration are advised. Electrocardiographic
monitoring should commence immediately and continue until the ECG parameters are
within the normal range. Hypotension and circulatory collapse may be counteracted by
use of intravenous fluids, plasma, or concentrated albumin, and vasopressor agents such
as metaraminol, phenylephrine and norepinephrine.
Epinephrine should not be used. In case of severe extrapyramidal reactions,
antiparkinson medication should be administered. Because of the long half-life of
pimozide, patients who take an overdose should be observed for at least 4 days. As with
all drugs, the physician should consider contacting a poison control center for additional
information on the treatment of overdose.
DOSAGE AND ADMINISTRATION
General
The suppression of tics by ORAP 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 ORAP to see
whether or not tics persist at the level and extent first identified. In attempts to reduce
the dosage of ORAP, 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 ORAP (pimozide) on tic manifestation in
Tourette’s Disorder patients below the age of twelve are not available.
Treatment should be initiated at a dose of 0.05 mg/kg preferably taken once at bedtime.
The dose may be increased every third day to a maximum of 0.2 mg/kg not to exceed 10
mg/day.
Adults
In general, treatment with ORAP should be initiated with a dose of 1 to 2 mg a day in
divided doses. The dose may be increased thereafter every other day. Most patients are
maintained at less than 0.2 mg/kg per day, or 10 mg/day, whichever is less. Doses
greater than 0.2 mg/kg/day or 10 mg/day are not recommended.
ANIMAL PHARMACOLOGY
A chronic study in dogs indicated that pimozide caused gingival hyperplasia when
administered for several months at about 5 times the maximum recommended human
dose. This condition was reversible after withdrawal.
HOW SUPPLIED
ORAP® (pimozide) 1 mg tablets are white, oval, scored tablets, debossed “ORAP 1”.
They are available in bottles of 100 (NDC 57844-151-01).
ORAP® (pimozide) 2 mg tablets are white, oval, scored tablets, debossed “LEMMON”
on one side and “ORAP 2” on the other. They are available in bottles of 100 (NDC
57844-187-01).
Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled
Room Temperature].
Dispense in a tight, light-resistant container as defined in the official compendium.
Pharmacist: Dispense in child-resistant container.
GATE PHARMACEUTICALS
TEVA PHARMACEUTICALS USA

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