TEVA-HALOPERIDOL TABLET

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Active ingredient:
HALOPERIDOL
Available from:
TEVA CANADA LIMITED
ATC code:
N05AD01
INN (International Name):
HALOPERIDOL
Dosage:
2MG
Pharmaceutical form:
TABLET
Composition:
HALOPERIDOL 2MG
Administration route:
ORAL
Units in package:
100/1000
Prescription type:
Prescription
Therapeutic area:
BUTYROPHENONES
Product summary:
Active ingredient group (AIG) number: 0101774004; AHFS: 28:16.08.08
Authorization status:
APPROVED
Authorization number:
00363669
Authorization date:
2016-09-12

PRODUCT MONOGRAPH

Pr

TEVA-HALOPERIDOL

Haloperidol Tablets

0.5, 1, 2, 5, 10 and 20 mg

Antipsychotic

Teva Canada Limited

Date of Revision:

30 Novopharm Court August 26, 2016

Toronto, Ontario

Canada M1B 2K9

www.tevacanada.com

Control No.: 196054

ACTION

Haloperidol is a butyrophenone derivative with antipsychotic properties that has been considered

particularly effective in the management of hyperactivity, agitation, and mania. Haloperidol is an

effective neuroleptic and also possesses antiemetic properties; it has a marked tendency to

provoke extrapyramidal effects and has relatively weak alphaadrenolytic properties. It may also

exhibit hypothermic and anorexiant effects and potentiates the reaction of barbiturates, general

anesthetics and other CNS depressant drugs.

As with other neuroleptics, the mechanism of action of haloperidol has not been entirely

elucidated, but has been attributed to the inhibition of the transport mechanism of cerebral

monoamines, particularly by blocking the impulse transmission in dopaminergic neurons.

Peak plasma levels of haloperidol occur within 2 to 6 hours of oral dosing and about 20 minutes

after intramuscular administration. The mean plasma (terminal elimination) half-life has been

determined at 20.7 ± 4.6 (SD) hours, and although excretion begins rapidly, only 24 to 60% of

ingested radioactive drug is excreted (mainly as metabolites in urine, some in feces) by the end

of the first week, and very small but detectable levels of radioactivity persist in the blood and are

excreted for several weeks after dosing. About 1% of the ingested dose is recovered unchanged

in the urine.

INDICATIONS AND CLINICAL USES

TEVA-HALOPERIDOL (haloperidol) is indicated in the management of manifestations of acute

and chronic psychosis, including schizophrenia and manic states. It may also be of value in the

management of aggressive and agitated behavior in patients with chronic brain syndrome and

mental retardation and in the symptomatic control of Gilles de la Tourette’s syndrome.

CONTRAINDICATIONS

TEVA-HALOPERIDOL (haloperidol) is contraindicated in comatose states and in the presence

of CNS depression due to alcohol or other depressant drugs. It is also contraindicated in patients

with significant depressive states, previous spastic diseases, and in Parkinson’s syndrome, except

in the case of dyskinesias due to levodopa treatment. It should not be used in patients shown to

be sensitive to the drug, nor in senile patients with pre-existing Parkinson-like symptoms.

Use in Children: Safety and effectiveness in young children have not been established; therefore,

haloperidol is contraindicated in this age group.

Use in Pregnancy: Safe use of haloperidol in pregnancy has not been established. It should,

therefore, not be used in women of child-bearing potential unless, in the opinion of the physician,

the expected benefits of the drug outweigh the potential hazard to the fetus.

WARNINGS AND PRECAUTIONS

TEVA-HALOPERIDOL (haloperidol) prolongs the hypnotic action of barbiturates and may

potentiate the effects of alcohol and other central nervous system depressant drugs, such as

anesthetics and narcotics; caution should therefore be exercised when it is used with agents of

this type and adjustments in its dosage may be required.

Haloperidol may lower the convulsive threshold and has been reported to trigger seizures in

previously controlled known epileptics. When instituting haloperidol therapy in these patients,

adequate anticonvulsant medication should be maintained concomitantly.

Elderly or debilitated patients receiving the drug should be carefully observed for any evidence

of oversedation which might lead to dehydration and reduced pulmonary ventilation and could

result in complications, such as terminal bronchopneumonia.

Although haloperidol is a relatively non-sedating neuroleptic, sedation may occur in some

patients. Therefore, physicians should be aware of this possibility and caution patients about the

danger of participating in activities requiring complete mental alertness, judgment and physical

coordination, such as driving and operating dangerous machinery.

Haloperidol has been reported to interfere with the anticoagulant properties of phenindione in an

isolated case, and the possibility should be kept in mind of a similar effect occurring when

haloperidol is used with other anticoagulants.

Administration to patients with severe cardiac involvement should be guarded, despite the fact

that haloperidol is well tolerated by patients with cardiac insufficiency and that it has been used

with favorable results to maintain the cardiovascular function of patients with excitive crises. In

very rare instances, it has been felt that haloperidol was contributory to the precipitation of

attacks in angina-prone patients. Moderate hypotension may occur with parenteral administration

or excessive oral doses of haloperidol; however, vertigo and syncope occur only rarely.

Haloperidol has lowered the level of cholesterol in the serum and liver of monkeys. An

accumulation of desmosterol has been observed in the serum of rats given repeated high doses

(10 mg/kg) of haloperidol. In man, mild transient decreases in serum cholesterol were reported in

preliminary studies. However, in a study involving a group of schizophrenic patients on extended

medication, significant lowering of serum cholesterol was not observed with haloperidol, and

there was no accumulation of desmosterol or 7-dehydrocholesterol. A significant lowering of

cholesterol together with an accumulation of another sterol (possibly 7-dehydrocholesterol) has

been reported in patients receiving a chemically related drug (trifluperidol), and skin and eye

changes (ichthyosis and cataracts) have occurred clinically with another butyrophenone

derivative. Skin and eye changes have not been observed in patients receiving haloperidol.

However, it is advisable that all patients receiving haloperidol for a prolonged period of time be

carefully observed for any changes in the skin and eyes. If such changes are seen, the drug

should be discontinued promptly.

Tardive dyskinesias are known to occur in patients on long-term antipsychotic therapy, including

haloperidol (see ADVERSE REACTIONS). This should be borne in mind when using

neuroleptics, and if possible, the dosage should be reduced or the drug discontinued when

manifestations of this syndrome are detected.

The antiemetic action of haloperidol may obscure signs of toxicity due to overdosage of other

drugs or mask the symptoms of some organic diseases, such as brain tumor or intestinal

obstructions.

If an antiparkinson agent is used concomitantly with haloperidol, both drugs should not be

discontinued simultaneously, since extrapyramidal symptoms may occur due to the slower

excretion rate of haloperidol.

Neuroleptic drugs elevate prolactin levels; the elevation persists during chronic administration.

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, the clinical

significance of elevated serum prolactin levels is unknown for most patients. An increase in

mammary neoplasms has been found in rodents after chronic administration of neuroleptic drugs.

Neither clinical studies nor epidemiologic studies conducted to date, however have shown an

association between chronic administration of these drugs and mammary tumorigenesis; the

available evidence is considered to be too limited to be conclusive at this time.

Neutropenia, granulocytopenia and agranulocytosis have been reported during antipsychotic use.

Therefore, it is recommended that patients have their complete blood count (CBC) tested prior to

starting TEVA-HALOPERIDOL and then periodically throughout treatment.

Withdrawal Emergent Neurological Signs: Abrupt withdrawal after short-term administration of

antipsychotic drugs does not generally pose problems. However, transient dyskinetic signs are

experienced by some patients on maintenance therapy after abrupt withdrawal. The signs are

very similar to those described under Tardive Dyskinesia, except for duration. Although it is not

known whether gradual withdrawal of antipsychotic drugs will decrease the incidence of

withdrawal emergent neurological signs, gradual withdrawal would appear to be advisable.

Endocrine and Metabolism:

Hyperglycemia:

Diabetic ketoacidosis (DKA) has occurred in patients with no reported history of hyperglycemia.

Patients should have baseline and periodic monitoring of blood glucose and body weight.

Hyperprolactinemia:

Long-standing hyperprolactinemia when associated with hypogonadism may lead to decreased

bone mineral density in both female and male subjects.

Genitourinary

Rare cases of priapism have been reported with antipsychotic use, such as haloperidol.

This adverse reaction, as with other psychotropic drugs, did not appear to be dose-dependent and

did not correlate with the duration of treatment.

Special Populations, Pregnant Women:

Non-Teratogenic Effects

Neonates exposed to antipsychotic drugs (including haloperidol) during the third trimester of

pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There

have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress

and feeding disorder in these neonates. These complications have varied in severity; while in

some cases symptoms have been self-limited, in other cases neonates have required intensive

care unit support and prolonged hospitalization.

TEVA-HALOPERIDOL should not be used during pregnancy unless the expected benefits to the

mother markedly outweigh the potential risks to the fetus.

Hematologic:

Venous Thromboembolism:

Venous thromboembolism (VTE), including fatal pulmonary embolism, has been reported with

antipsychotic drugs, including Haloperidol Decanoate, in case reports and/or observational

studies. When prescribing Haloperidol Decanoate all potential risk factors for VTE should be

identified and preventative measures undertaken.

ADVERSE REACTIONS

Neurological: Neuromuscular (extrapyramidal) effects such as Parkinson-like symptoms,

akathisia, dyskinesia, dystonia, hyper-reflexia, rigidity, opisthotonas and occasionally,

oculogyric crisis are the most frequently reported side effects associated with the administration

of haloperidol. Headache, vertigo and cerebral seizures have also been reported. The

extrapyramidal reactions are usually dose-related in occurrence and severity and as a rule, tend to

subside when the dose is reduced or the drug is temporarily discontinued. However, considerable

inter-patient variability exists and although some individuals may tolerate higher than average

doses of haloperidol, severe extrapyramidal reactions, necessitating discontinuation of the drug,

may occur at relatively low doses. Administration of an anti-Parkinson agent is usually, but not

always, effective in preventing or reversing neuromuscular reactions associated with haloperidol.

Tardive Dyskinesias: As with all antipsychotic agents, tardive dyskinesia may appear in some

patients on long-term therapy or may appear 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 to be irreversible. The syndrome is characterized by

rhythmical involuntary movements of the tongue, face, mouth or jaw (e.g. protrusion of tongue,

puffing of cheeks, puckering of mouth, chewing movements). Sometimes they may be

accompanied by involuntary movements of extremities.

There is no known effective treatment for tardive dyskinesia; anti-Parkinsonism 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, the syndrome may be

masked. The physician may be able to reduce the risk of this syndrome by minimizing the

unnecessary use of neuroleptic drugs and reducing the dose or discontinuing the drug if possible,

when manifestations of this syndrome are recognized particularly in patients over the age of 50.

It has been reported that fine vermicular movements of the tongue may be an early sign of the

syndrome and if the medication is stopped at that time the syndrome may not develop.

Behavioral: Insomnia, depressive reactions, and toxic confusional states are the more common

effects encountered. Drowsiness, lethargy, stupor and catalepsy, confusion, restlessness,

agitation, anxiety, euphoria, and exacerbation of psychotic symptoms, including hallucinations,

have also been reported.

Cardiovascular: Tachycardia and hypotension have occurred but severe orthostatic hypotension

has not been reported. However, should it occur, supportive measures, including intravenous

vasopressors such as norepinephrine may be required. EPINEPHRINE SHOULD NOT BE

USED, since haloperidol may block the vasoconstrictor effects of this drug.

Autonomic: Dry mouth, blurred vision, urinary retention and incontinence have been reported.

Allergic and Toxic: The overall incidence of significant hematologic changes in patients on

haloperidol has been low. Occasionally, there have been reports of mild and usually transient

leukopenia and leukocytosis, decreases in blood cell counts, anemia, and a tendency toward

lymphomonocytosis. Agranulocytosis has rarely been reported with the use of haloperidol, and

then only in associated with other medication. Impairment of liver function (jaundice or

hepatitis) has been reported rarely. One case of photosensitization is known and isolated cases of

idiosyncratic cutaneous involvement have been observed.

Endocrine: Lactation, breast engorgement, mastalgia, menstrual irregularities, gynecomastia,

impotence, increased libido and changes in blood sugar levels have been reported.

Gastrointestinal: Heartburn, nausea, vomiting, anorexia, weight loss, constipation, diarrhea and

hypersalivation have been reported.

Miscellaneous: Other untoward effects encountered include peripheral edema,

hypocholesterolemia, hyperpyrexia, alopecia, laryngospasm, bronchospasm and increased depth

of respiration, stasis pneumonia, and a syndrome characterized by perspiration, dehydration,

hyperthermia and a dazed state of mind (if this occurs the drug should be discontinued).

Patients should be advised of the risk of severe constipation during TEVA-HALOPERIDOL

treatment, and should tell their doctor if constipation occurs or worsens, as they may need

laxatives.

SYMPTOMS AND TREATMENT OF OVERDOSAGE:

For management of a suspected drug overdose, contact your regional Poison Control

Centre.

In general, the symptoms of overdosage would be an exaggeration of known pharmacologic

effects and adverse reactions, the most prominent of which would be 1) severe extrapyramidal

reactions, 2) hypotension, or 3) sedation. The patient would appear comatose with respiratory

depression and hypotension which could be severe enough to produce a shock-like state. The

extrapyramidal reaction would be manifested by muscular weakness or rigidity and a generalized

or localized tremor as demonstrated by the akinetic or agitans types, respectively.

Gastric lavage or induction of emesis should be carried out immediately followed by

administration of the universal antidote. Since there is no specific antidote, treatment is primarily

supportive. A patent airway must be established by use of an oropharyngeal airway or

endotracheal tube or in prolonged cases of coma, by tracheotomy. Respiratory depression may be

counteracted by artificial respiration and mechanical respirators. Hypotension and circulatory

collapse may be counteracted by use of intravenous fluids, plasma, or concentrated albumin, and

vasopressor agents such as norepinephrine. Epinephrine should not be used. In case of severe

extrapyramidal reactions, antiparkinson medication should be administered.

DOSAGE AND ADMINISTRATION

Initial dosage should be individualized through consideration of severity of symptoms, age,

weight, health, previous response to neuroleptic drugs and concomitant disease states. It is

important initially to increase dosage adequately until symptoms are controlled or side effects

requiring lowering the dosage or discontinuing the drug are encountered, when a satisfactory

therapeutic response is achieved, dosage should then be reduced gradually to the lowest effective

maintenance level.

Patients with previous adverse responses to other neuroleptic drugs, children and the elderly or

debilitated may require less haloperidol. The optimal response in such patients is best obtained if

therapy is initiated at a lower dosage level and titration is more gradual.

Initially, oral dosages of 1-2 mg, b.i.d. or t.i.d. are usually employed, followed by upward

adjustment as tolerated until the desired effect is achieved or limiting side effects appear.

Clinical experience has shown that it is seldom necessary to employ dosages greater than 4-6 mg

t.i.d. However, 30-40 mg daily may be required in severely disturbed patients who remain

inadequately controlled by lower doses and up to 100 mg daily has been used occasionally in

particularly resistant patients. Nevertheless, the safety of prolonged administration of the higher

doses has not been established. After a therapeutic response has been achieved, dosages should

be gradually adjusted downwards until a schedule providing adequate maintenance is reached.

Maintenance dosages are commonly in the range of 1-2 mg t.i.d. or q.i.d.

Children (6 years or over, and able to swallow the tablets)

and Elderly or Debilitated Patients:

Lower doses are recommended in these patients since they may be more sensitive to the drug.

Initial daily doses ranging from 0.5 to 1.5 mg (0.25* to 0.5 mg, 2 or 3 times a day) should be

employed. Upward adjustment of these doses should be made gradually maximum and

maintenance doses should be individualized and are generally lower in this type of patient.

*Please note that Teva does not hold a liquid dosage form to reach the 0.25mg dose, and the

0.5mg tablets cannot be split in halves.

AVAILABILITY

TEVA-HALOPERIDOL (haloperidol) tablets are supplied as:

0.5 mg: Small, white, round, flat-faced, bevel-edged, compressed tablets, engraved 0.5 between

vertical broken bisect on one side and novo on the reverse. Bottles of 100 tablets.

1.0 mg: Small, yellow coloured, round, flat-faced, bevel-edged, compressed tablets, engraved 1

between broken bisect on one side and stylized N on the reverse. Bottles of 100 tablets.

2.0 mg: Pink coloured, round, flat-faced, bevel-edged, compressed tablets, engraved 2 between

broken horizontal bisect on one side and stylized N on the reverse. Bottles of 100 tablets.

5.0 mg: Small, green coloured, round, flat with bevelled-edge, compressed tablets, engraved N

over 5 on one side and plain on the reverse. Bottles of 100 tablets.

10.0 mg: Small, aqua-marine coloured, round, flat with bevelled-edged, compressed tablets,

engraved 10 between broken vertical bisect on one side and stylized N on the reverse. Bottles of

100 tablets.

20.0 mg: Salmon coloured, round, flat with bevelled-edged, compressed tablets, engraved 20

between broken vertical bisect on one side and stylized N on the reverse. Bottles of 100 tablets.

PHARMACOLOGY

Haloperidol is an antipsychotic drug with the chemical name 4-[4-(p-chlorophenyl)-4-

hydroxypiperidino]-4,-fluorobutyrophenone. Its chemical structure is as follows:

Molecular Formula:

CIFNO

Molecular Weight: 375.87

The pharmacological profile of haloperidol in laboratory animals resembles that of the

phenothiazine antipsychotics. As with other neuroleptics, it reduces locomotor and exploratory

behaviour (ambulation and “emotional” defecation) in rats at low doses and induces cataleptic

immobility and palpebral ptosis at higher doses. Haloperidol is more potent than chlorpromazine

in abolishing the righting reflex in mice (milligram potency 2 times that of chlorpromazine). It

also depresses food consumption and weight increase in laboratory animals and has an

epileptogenic effect at subtoxic dose levels. Haloperidol suppresses the conditioned avoidance

response in the jumping box test (milligram potency 16 times that of chlorpromazine in rats). It

blocks amphetamine-induced activity in rats and apomorphine-induced emesis in dogs

(milligram potency 50 times that of chlorpromazine), but it is weaker than chlorpromazine in

prolonging barbiturate sleeping time. It has relatively weak adrenolytic properties. Equal doses

of haloperidol and chlorpromazine are required to produce significant hypotension in the cat and

hypothermia in the rat. In dogs and cats, it decreases the epinephrine-induced contractions of the

nictitating membrane, but is less effective against norepinephrine. It would appear from studies

in the rabbit that the decreased responsiveness of the reticular formation produced by the drug

may be more marked in the caudal portion of that area. Changes in the EEG activity produced by

haloperidol are similar to those seen with phenothiazine derivatives. In animals and in humans

haloperidol is rapidly absorbed following oral administration and peak plasma levels are reached

in 2 to 6 hours. Excretion begins promptly, but proceeds slowly and in isotope studies small

amounts of radioactivity are excreted or can be detected in the plasma several weeks after

ingestion of the drug. This may be related to a high degree of plasma protein binding which in

one study was observed to the extent of 92%.

TOXICOLOGY

TABLE 1: LD

(mg/kg by ROUTE OF ADMINISTRATION).

Species

i.v.

s.c.

oral

Mice

144 mg/kg

Rats

850 mg/kg

Hamsters

405 mg/kg

Rabbits

Dogs

90 mg/kg

During an 18 month evaluation in rats haloperidol was mixed with the animals normal daily diet

and consumed in amounts that averaged 33.0, 14.5, 6.5 and 3.5 mg/kg/day. None of these

amounts of haloperidol caused abnormalities as evidenced by repeated urinalyses, hematologic

studies (CBC and blood chemistries), and gross and/or microscopic observations. At the end of

the evaluation, however, mean body weights and food consumption were lower in the treated

animals than in the untreated controls. The lesser gain in body weight may be attributed to the

decreased food consumption; the latter was presumably caused by the drug's tranquilizing action.

Two safety evaluations of haloperidol were conducted in dogs. In one evaluation, 3 groups of 6

animals each received either 2.0, 0.5, or 0 mg/kg/day for 6 months; in the other evaluation, 4

groups of 8 animals each received either 12.0, 6.0, 2.0 or 0 mg/kg/day for 12 months.

No fatalities occurred in either evaluation and none of the dogs in the 6-month evaluation

exhibited any drug-related toxic effects (gross or microscopic). In the 12-month study, decreased

weight gain was observed in dogs at the mid- and high-dose levels and dogs on the highest dose

showed convulsions, tremors, and emesis. Transient breast engorgement and lactation occurred

in 6 to 12 female dogs between the 3rd and 8th weeks of the evaluation, but were not dose-

related. Liver toxicity was dose-related with hepatocellular changes seen in dogs on the two

highest doses and possibly at all dose levels.

SGPT changes (increase) were reversible since they returned to normal in animals studied for

one month after termination of dosing; liver sections from animals sacrificed at this time also

indicated that cellular changes had returned toward normal.

When haloperidol was administered to rats (0.6-3.0 mg/kg), rabbits (1.0 and 6.0 mg/kg) and dogs

(1.0-4.0 mg/kg), the offspring of each of these species did not exhibit a greater incidence of

teratologic effects than was observed in the respective control groups. In rats receiving amounts

of the drug (4.0 mg/kg) large enough to produce marked CNS depression, increased delivery

time was noted. Available data suggest that, in rats, large oral doses (1.9 mg/kg) may reduce

libido, and that larger i.v. doses (3.0 mg/kg) may decrease implantation. An increased incidence

of fetal resorptions was observed in rabbits receiving 6.0 mg/kg orally; however, at 1.0 mg/kg

orally this effect was not observed.

BIBLIOGRAPHY

PRE-CLINICAL

Cressman, W.A., Bianchine, J.R., Slotnick, V.B., Johnson, P.C. and Plostnieks, J. Plasma

Level Profile of Haloperidol in Man Following Intramuscular Administration. Europ. J.

Clin. Pharm. 7:99, 1974.

Forsman, A. and Ohman, R.: On the Pharmacokinetics of Haloperidol. Nord. Psyk.

Tidsskr. 28:441, 1974.

Di Mascio, A.: The Butyrophenones: An Overview of Their Pharmacologic and

Metabolic Properties. In: Di Mascio, A. and Shader, R.I. (eds): Butyrophenones in

Psychiatry. New York, Raven Press, 1972, pp. 11-23.

Snyder, S.H., Taylor K.M., Coyle, J.T. and Myerhoff, J.L.: The Role of Brain Dopamine

in Behavioral Regulation and the Actions of Psychotropic Drugs. Amer. J. Psychiat.

127(2):199, 1970.

Simpson, G.M., Cooper, T.B. and Braun, G.A.: Further Studies on the Effects of

Buturophenones on Cholesterol Synthesis in Humans. Curro Ther. Res. 9(8):413, 1967.

Janssen, P.A.J.: The Pharmacology of Haloperidol. Int J. Neuropsychiatry, Supple 1,

3:S10, 1967.

Dunlop, E.: Clinical Pharmacological Studies in Haloperidol. J. New Drugs, 6:243, 1966.

CLINICAL

Sellers, E.M. and Kalant, H.: Alcohol Intoxication and Withdrawal. New Engl. J. Med.

294(14):757, 1976.

Haloperidol in Psychiatry. The Medical Letter 17(3): Jan. 31, 1975.

Ban, T.A.: Haloperidol and the Butyrophenones. Psychosomatics 14(5):286, 1973.

Ayd, F.J.: Haloperidol: Fifteen Years of Clinical Experience. Dis. Nerv. Syst. 33(7):459,

1972.

Stotsky, B.A.: Haloperidol in the Treatment of Geriatric Patients. In: Di Mascio, A. and

Shader, R.I. (eds.): Butyrophenones in Psychiatry. New York, Raven Press, 1972, p. 71.

Shapiro, A.K., Shapiro, E., Wayne, H. and Clarkin, J.: Psychopathology of Gilles de la

Tourette's Syndrome. Amer J. Psychiatry, 129(3):427, Oct. 1972.

Klett, C.J. and Caffey, E.M.: Evaluating Long-Term Need for Antiparkinson Drugs by

Chronic Schizophrenics. Veterans Administration Cooperative Studies in Psychiatry.

Prepublication Report No. 87, May 1972.

Greenblatt, D.J., Shader, R.I. and Di Mascio, A.: Extrapyramidal Effects In: Shader, R.I.

and Di Mascio, A. (eds.): Psychotropic Drug Side Effects. Baltimore, The Williams &

Wilkins Co. 1970, pp. 92-106.

Ucer, E. and Kreger, K.C.: A Double-blind Study Comparing Haloperidol with

Thioridazine in Emotionally Disturbed Mentally Retarded Children. Curro Ther. Res.

11(5):278, 1969.

Le Vann, L.J.: Haloperidol in the Treatment of Behavioral Disorders in Children and

Adolescents Can. Psy. Ass. J. 14(2):217, 1969.

Burk, H.W. and Menolascino, F.J.: Haloperidol in Emotionally Disturbed Mentally

Retarded Individuals. Amer. J. Psychiat. 124:1589, 1968.

Connell, P.H., Corbett, J.A.’ Horne, J.D. and Mathews, A.M.: Drug Treatment of

Adolescent Tiqueurs. Brit. J. Psychiat. 113:375, 1967.

Crane, G.E.: A Review of Clinical Literature on Haloperidol. Int. J. Neuropsychiatry,

Supple 1, 3:S111, 1967.

Simpson, G.M.: Prospective Clinical Applications of Haloperidol. Int. J.

Neuropsychiatry, 3:533, 1967.

Goldstein, B.J.: Haloperidol in Controlling the Symptoms of Acute Psychoses. Part 1. A

Preliminary Investigation. Curro Ther. Res. 8:232, 1966.

Goldstein, B.J. and Clyde, D.J.: Haloperidol in Controlling the Symptoms of Acute

Psychoses Part 2: A Double-Blind Evaluation of Haloperidol and Trifluoperazine. Curr.

Ther. Res. 8:236, 1966.

Rogers, W.J.B.: Use of Haloperidol in Children’s Psychiatric Disorders. Clin. Trials UJ.

2:162, May 1965.

Holstein, A.P. and Chen, C.H.: Haloperidol - A Preliminary Clinical Study. Amer. J.

Psychiat. 122:462, 1965.

Chapel, J.L., Brown, N. and Jenkins R.L.: Tourette’s Disease: Symptomatic Relief with

Haloperidol. Amer. J. Psychiat. 121:608, 1964.

Pratt, J. Bishop, M. and Gallant, D.: Comparison of Haloperidol in the Psychiatric

Disorders of Old Age. Amer. J. Psychiat. 120(12):1190, 1964.

Sugerman, A.A. Williams, B.H. and Adlerstein, A.M.: Haloperidol in the Psychiatric

Disorders of Old Age. Amer. J. Psychiat. 120(12):1190, 1964.

Haward, L.R.: Differential Inter-Drug Analysis - A Preliminary Study, Brit. J. Psychiat.

110:514, July 1964.

Lawson, J.I.M. and McGowan, S.W.: Haloperidol in Obstetrics, A Clinical Trial in 350

Women in Labor. Lancet 1:1205, 1962.

HALDOL Product Monograph, McNeil Pharmaceutical (Canada) Ltd. Date of revision:

November 28, 1983.

Apo-Haloperidol Tablets Product Monograph, Apotex Inc., Canada. Date of revision:

January 28, 2013, Control No. 160968.

IMPORTANT: PLEASE READ

PART III: CONSUMER INFORMATION

Pr

TEVA-HALOPERIDOL

Haloperidol Tablets USP

This leaflet is part III of a three-part "Product

Monograph" published when TEVA-HALOPERIDOL

was approved for sale in Canada and is designed

specifically for Consumers. This leaflet is a summary

and will not tell you everything about TEVA-

HALOPERIDOL. Contact your doctor or pharmacist if

you have any questions about the drug.

ABOUT THIS MEDICATION

What the medication is used for:

This medication is used for the management of

manifestations of chronic schizophrenia.

What it does:

TEVA-HALOPERIDOL

is an antipsychotic medication

which affects chemicals in the brain that allow

communication between nerve cells (neurotransmitters).

These chemicals are called dopamine and serotonin.

Exactly how TEVA-HALOPERIDOL works is unknown.

However, it seems to readjust the balance of dopamine and

serotonin.

When it should not be used:

You should not use TEVA-HALOPERIDOL

if you have:

An allergy to haloperidol, to any of its

ingredients or to phenothiazines

A medical condition known as

pheochromocytoma (a tumor of the adrenal

gland)

A severe heart or blood vessel disorder

Severe kidney problems

Had brain damage

Liver disease

A blood cell disorder such as anemia, low white

blood cell counts, or low platelets

Drowsiness, slow breathing, weak pulse

Decreased alertness caused by taking certain

medications or drinking alcohol

You are going to receive anesthesia in the spine

or for a region (such as an arm, leg or the lower

part of your body)

What the medicinal ingredient is:

Haloperidol

What the nonmedicinal ingredients are:

The TEVA-HALOPERIDOL

tablets contain sodium starch

glycolate, dibasic calcium phosphate (dehydrates),

microcrystalline cellulose, sodium lauryl sulfate, colloidal

silicon dioxide and magnesium stearate.

Additionally the 1 mg, 2 mg, 5 mg, 10 mg and 20 mg

tablets contain as follows:

1 mg:

FD&C Yellow #6

aluminum lake and

D&C Yellow #10

aluminum lake

2 mg:

FD&C Red #3 lake

5 mg:

FD&C Yellow #6

aluminum lake,

D&C

Yellow #10

aluminum lake and

FD & C Blue

aluminum lake

10 mg:

FD & C Blue #1

aluminum lake

D&C Yellow #10

aluminum lake

20 mg:

FD&C Yellow #6

aluminum lake,

FD&C Red #3 lake

FD & C Blue #1

aluminum lake

What dosage forms it comes in:

TEVA-HALOPERIDOL

is available in 0.5 mg, 1 mg, 2

mg, 5 mg, 10 mg and 20 mg tablets.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

Studies with various medicines of the group to which TEVA-

HALOPERIDOL

belongs, when used in the elderly patients with

dementia, have been associated with an increased rate of death.

TEVA-HALOPERIDOL

is not indicated in elderly patients with

dementia.

BEFORE you use TEVA-HALOPERIDOL

talk to your

doctor or pharmacist if:

You have heart disease, glaucoma or prostatic

hypertrophy

You are addicted to alcohol. You should not take

TEVA-HALOPERIDOL

if you are under the

effects of alcohol.

You are pregnant. TEVA-HALOPERIDOL

should not be used during pregnancy unless your

doctor considers the benefits to you markedly

outweigh the potential risks to the fetus

You are taking barbiturates, painkillers, narcotics

or, antihistamines or other drugs that make you

drowsy.

You have any allergies to this drug or its

ingredients

You have or ever had a blackout or seizure

You are breast feeding.

You have risk factors for developing blood clots

such as: a family history of blood clots, age over

65, smoking, obesity, recent major surgery (such

as hip or knee replacement), immobility due to

air travel or other reason, or take oral

contraceptives (“The Pill”).

IMPORTANT: PLEASE READ

TEVA-HALOPERIDOL

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. You should be cautious when performing

potentially hazardous tasks.

Effects on Newborns:

In some cases babies born to a mother taking TEVA-

HALOPERIDOL

during pregnancy have experienced

symptoms that are severe and require the newborn to be

hospitalized. Sometimes, the symptoms may resolve on

their own. Be prepared to seek immediate emergency

medical attention for your newborn if they have difficulty

breathing, are overly sleepy, have muscle stiffness, or

floppy muscles (like a rag doll), are shaking, or are having

difficulty feeding.

People who take TEVA-HALOPERIDOL

are cautioned:

Against exposure to extreme heat

That drugs such as TEVA-HALOPERIDOL

increase the toxicity of certain types of

insecticides ("organophosphorous" insecticides)

including insecticides for agriculture (farming),

treating animals (flea and tick control) and for

treating pests around the house and garden. Be

cautious if you must use these products while

taking TEVA-HALOPERIDOL.

INTERACTIONS WITH THIS MEDICATION

TEVA-HALOPERIDOL

can add to the effects of alcohol.

You should avoid consuming alcoholic beverages while on

TEVA-HALOPERIDOL

therapy.

Tell your doctor about all your prescription and over-the-

counter medications, vitamins, minerals, herbal products

(such as St. John’s Wort), and drugs prescribed by other

doctors. Do not start a new medication without telling your

doctor.

Before using TEVA-HALOPERIDOL, tell your doctor if

you regularly use other medicines that make you sleepy

(such as cold or allergy medicine, narcotic pain medicine,

sleeping pills, muscle relaxants, and medicine for seizures,

depression, or anxiety). You should not take TEVA-

HALOPERIDOL

if you have drowsiness caused by other

medications.

Drugs that may interact with TEVA-HALOPERIDOL

include:

anti-anxiety agents, antidepressants, muscle relaxants, anti-

seizure medicine, high blood pressure medicine,

cabergoline, metrizamide, guanethidine, guanadrel,

grepafloxacin, sparfloxacin, lithium, cisapride, atropine-

like drugs, narcotic pain relievers (e.g., codeine), drugs

used to aid sleep, drowsiness-causing antihistamines (e.g.,

diphenhydramine), other drugs that may make you drowsy.

Many cough-and-cold products contain ingredients that

may add a drowsiness effect. Before using cough-and-cold

medications, ask your doctor or pharmacist about the safe

use of those products. Do not start or stop any medicine

without doctor or pharmacist approval.

This list is not complete and there may be other drugs that

can interact with TEVA-HALOPERIDOL.

PROPER USE OF THIS MEDICATION

Take this medication by mouth exactly as prescribed.

During the first few days your doctor may gradually

increase your dose to allow your body to adjust to the

medication. Do not take this more often or increase your

dose without consulting your doctor. Your condition will

not improve any faster but the risk of serious side effects

will be increased. Do not stop taking this drug suddenly

without your doctor's approval.

Your doctor will decide which dose is best for you.

Usual dose:

Dose is individualized based on the severity of your

symptoms, your age, weight, health, other diseases you

may have, and previous response to drugs similar to

haloperidol.

The initial dose is 1-2 mg twice or three times a day.

Some patients may require doses of 4-6 mg three times a

day. For some patients doses as high as 30-40 mg a day

have been used.

Rarely doses of 100 mg per day have been used.

The maintenance dose is commonly in the range of 1-2 mg

three to four times a day.

Lower doses are recommended for children and elderly or

debilitated patients as they may be more sensitive to the

drug.

Overdose:

In case of drug overdose, contact a health care

practitioner, hospital emergency department or regional

Poison Control Centre immediately, even if there are no

symptoms.

Overdose symptoms may include agitation, and confusion,

drowsiness, dizziness, muscle stiffness or twitching,

increased salivation, trouble swallowing, weakness, loss of

balance or coordination, and fainting.

Missed Dose:

Take the missed dose as soon as you remember. If it is

almost time for your next dose, wait until then to take the

medicine and skip the missed dose. Do not double your

dose to make up the missed dose.

IMPORTANT: PLEASE READ

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like other medications, TEVA-HALOPERIDOL

cause some side effects. These side effects may be minor

and temporary. However, some may be serious and need

medical attention.

Side effects may include: sweating, urinary incontinence,

dizziness, drowsiness, dry mouth, nasal congestion, nausea

and vomiting, headache, menstrual changes, change in

libido, swelling of the breasts and milk production in both

men and women, weight changes and blurred vision.

If any of these affects you severely, tell your doctor.

Your doctor should check your body weight before starting

TEVA-HALOPERIDOL

and continue to monitor it for as

long as you are being treated.

Your doctor should take blood tests before starting TEVA-

HALOPERIDOL. They will monitor blood sugar, and the

number of infection fighting white blood cells. Your doctor

should continue to monitor your blood for as long as you

are being treated.

If you have high levels of prolactin (measured with a blood

test) and a condition called hypogonadism, you may be at

increased risk of breaking a bone due to osteoporosis. This

occurs in both men and women.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN

AND WHAT TO DO ABOUT THEM

Symptom / effect

Talk with your

doctor or

pharmacist

Stop taking

drug and

seek

immediate

emergency

medical

attention

Only if

severe

In all

cases

Unknown

Allergic

Reaction: rash,

hives, swelling

of the face, lips,

tongue or

throat, difficulty

swallowing or

breathing

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN

AND WHAT TO DO ABOUT THEM

Symptom / effect

Talk with your

doctor or

pharmacist

Stop taking

drug and

seek

immediate

emergency

medical

attention

Only if

severe

In all

cases

Neuroleptic

Malignant

Syndrome: any

group of

symptoms

which may

include high

fever, sweating,

stiff muscles,

fast heartbeat,

fast breathing

and feeling

confused,

drowsy or

agitated

Extrapyramida

l Symptoms:

muscle

stiffness, body

spasms, upward

eye rolling,

exaggeration of

reflexes,

drooling,

difficulty

moving how

and when you

want.

Fast or irregular

heartbeat

Seizures or fits

Long-lasting

(greater than 4

hours in

duration) and

painful erection

of penis

Tardive

Dyskinesia:

uncontrollable

movements or

twitches of the

body, face, eyes

or tongue,

stretching the

neck and body

IMPORTANT: PLEASE READ

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN

AND WHAT TO DO ABOUT THEM

Symptom / effect

Talk with your

doctor or

pharmacist

Stop taking

drug and

seek

immediate

emergency

medical

attention

Only if

severe

In all

cases

Low Blood

Pressure:

feeling of

lightheadedness

or fainting

especially when

getting up from

a lying or sitting

position

High Blood

Pressure:

headaches,

vision disorders,

nausea and

vomiting

Decreased

sweating

Jaundice:

yellow colour to

skin and eyes,

dark urine

Respiratory

Infection:

fever, flu-like

symptoms,

coughing,

difficult or fast

breathing

New or

worsening

constipation

Akathisia: a

feeling of

restlessness,

inability to

remain

motionless

Vision

Changes:

blurred vision,

glaucoma or

other eye

disorder

Increased

Blood Sugar:

frequent

urination, thirst

and hunger

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN

AND WHAT TO DO ABOUT THEM

Symptom / effect

Talk with your

doctor or

pharmacist

Stop taking

drug and

seek

immediate

emergency

medical

attention

Only if

severe

In all

cases

Uncom

Blood clots:

swelling

pain and

redness in an

arm or leg

that can be

warm to

touch. You

may develop

sudden chest

pain,

difficulty

breathing

and heart

palpitations

This is not a complete list of side effects. For any

unexpected effects while taking TEVA-HALOPERIDOL,

contact your doctor or pharmacist.

HOW TO STORE IT

Store at controlled room temperature (15º-30ºC).

Keep this and all medications out of the reach and sight of

children.

IMPORTANT: PLEASE READ

Reporting Side Effects

You can help improve the safe use of health products

for Canadians by reporting serious and unexpected

side effects to Health Canada. Your report may help

to identify new side effects and change the product

safety information.

3 ways to report:

Online at MedEffect (http://hc-sc.gc.ca/dhp-

mps/medeff/index-eng.php);

By calling 1-866-234-2345 (toll-free);

By completing a Consumer Side Effect

Reporting Form and sending it by:

- Fax to 1-866-678-6789 (toll-free), or

- Mail to: Canada Vigilance Program

Health Canada

Postal Locator 0701E

Ottawa, ON

K1A 0K9

Postage paid labels and the Consumer Side Effect

Reporting Form are available at MedEffect (http://hc-

sc.gc.ca/dhp-mps/medeff/index-eng.php).

NOTE: Contact your health professional if you need

information about how to manage your side effects.

The Canada Vigilance Program does not provide

medical advice.

MORE INFORMATION

This document plus the full product monograph,

prepared for health professionals can be found by

contacting Teva Canada Limited at:

Phone: 1-800-268-4127 ext. 3;

Email: druginfo@tevacanada.com; or

Fax: 1-416-335-4472

Reporting Side Effects to Teva Canada Limited:

Phone: 1-800-268-4127 ext. 3;

Email: PhV@tevacanada.com; or

Fax: 1-416-335-4472

This leaflet was prepared by:

Teva Canada Limited

30 Novopharm Court

Toronto, Ontario

M1B 2K9

Canada

www.tevacanada.com

Last revised: August 26, 2016

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