HALOPERIDOL INJECTION SOLUTION

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

HALOPERIDOL

Beschikbaar vanaf:

OMEGA LABORATORIES LIMITED

ATC-code:

N05AD01

INN (Algemene Internationale Benaming):

HALOPERIDOL

Dosering:

5MG

farmaceutische vorm:

SOLUTION

Samenstelling:

HALOPERIDOL 5MG

Toedieningsweg:

INTRAMUSCULAR

Eenheden in pakket:

10X1ML

Prescription-type:

Prescription

Therapeutisch gebied:

BUTYROPHENONES

Product samenvatting:

Active ingredient group (AIG) number: 0101774001; AHFS:

Autorisatie-status:

APPROVED

Autorisatie datum:

2011-03-24

Productkenmerken

_HALOPERIDOL INJECTION (Haloperidol) _
_Page 1 of 22 _
PRODUCT MONOGRAPH
PR
HALOPERIDOL INJECTION
(Haloperidol)
5 MG / ML, 1 ML VIAL
Omega Standard
For intramuscular injection only. NOT FOR intravenous use.
Antipsychotic Agent
Omega Laboratories Limited
Date of Revision:
11 177 Hamon
Montreal, Canada
H3M 3E4
December 20, 2023
Submission Control Number: 277158
_HALOPERIDOL INJECTION (Haloperidol) _
_Page 2 of 22 _
PR
HALOPERIDOL INJECTION
5 MG / ML, 1 ML VIAL
THERAPEUTIC CLASSIFICATION
Antipsychotic Agent
ACTION AND CLINICAL PHARMACOLOGY
Haloperidol injection (intramuscular) 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 alpha-adrenolytic
properties. It may also exhibit hypothermic and anorexiant effects,
and potentiate the action of
barbiturates, general anesthetics, and other CNS depressant drugs.
As with other neuroleptics, the mechanism of action of haloperidol has
not been clearly
established, but it has been shown to be a dopamine receptor
antagonist.
Peak plasma levels of haloperidol occur within about twenty minutes
after intramuscular
administration. Protein binding is 90% or more. Haloperidol is
extensively metabolized by the
liver and the metabolites are subsequently excreted in the urine and
feces, _via_ the bile. The half-
life of elimination is 21 hours (range 13 to 35 hours).
INDICATIONS AND CLINICAL USE
Haloperidol Injection (intramuscular) is indicated for the rapid
control of the acute manifestations
of schizophrenia and manic states. It may also be of value in the
management of aggressive and
agitated behaviour in patients with chronic brain syndrome and mental
retardation and in the
symptomatic control of Gilles de la Tourette’s syndrome.
CONTRAINDICATIONS
•
Haloperidol injection (intramuscular) is not to be used