HALOPERIDOL INJECTION SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

HALOPERIDOL

Available from:

JUNO PHARMACEUTICALS CORP.

ATC code:

N05AD01

INN (International Name):

HALOPERIDOL

Dosage:

5MG

Pharmaceutical form:

SOLUTION

Composition:

HALOPERIDOL 5MG

Administration route:

INTRAMUSCULAR

Units in package:

100

Prescription type:

Prescription

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2023-08-04

Summary of Product characteristics

- 1 -
PRODUCT MONOGRAPH
PR
HALOPERIDOL INJECTION
(Haloperidol)
5 MG/ML
Mfr. Std.
FOR INTRAMUSCULAR INJECTION ONLY. NOT FOR INTRAVENOUS USE.
ANTIPSYCHOTIC AGENT
Juno Pharmaceuticals Corp.
402 2233 Argentia Road
Mississauga, Ontario
L5N 2X7
Submission Control No.:
275660
Date
of
Preparation:
August
04, 2023
- 2 -
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.
- 3 -
CONTRAINDICATIONS
▪
Haloperidol Injection (intramuscular) is not to be used intravenously.
▪
Haloperidol
Injection (intramuscular) is contraindicated in comatose states and