TEVA-HALOPERIDOL TABLET

Country: Canada

Language: English

Source: Health Canada

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:

Authorization status:

APPROVED

Authorization date:

2016-09-12

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
TEVA-HALOPERIDOL
Haloperidol Tablets
USP
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
2
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.
CONTRAINDIC