HALOPERIDOL DECANOATE INJECTION LIQUID

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

HALOPERIDOL (HALOPERIDOL DECANOATE)

Available from:

HOSPIRA HEALTHCARE ULC

ATC code:

N05AD01

INN (International Name):

HALOPERIDOL

Dosage:

50MG

Pharmaceutical form:

LIQUID

Composition:

HALOPERIDOL (HALOPERIDOL DECANOATE) 50MG

Administration route:

INTRAMUSCULAR

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

BUTYROPHENONES

Product summary:

Active ingredient group (AIG) number: 0101774007; AHFS:

Authorization status:

CANCELLED PRE MARKET

Authorization date:

2019-06-21

Summary of Product characteristics

PRODUCT MONOGRAPH
HALOPERIDOL DECANOATE INJECTION
50 mg/mL, 100 mg/mL
FOR INTRAMUSCULAR INJECTION ONLY. NOT FOR INTRAVENOUS USE
Antipsychotic Agent
Hospira Healthcare Corporation
Date of Preparation: 27 March 2009
1111 Dr. Frederik Philips, Suite 600
Saint-Laurent, Quebec
H4M 2X6
Control number 124727
_PRODUCT MONOGRAPH – Haloperidol Decanoate Injection _
_Page 2 of 25 _
PRODUCT MONOGRAPH
Haloperidol Decanoate Injection 50 mg/mL, 100 mg/mL
THERAPEUTIC CLASSIFICATION
Antipsychotic Agent
ACTION AND CLINICAL PHARMACOLOGY
Haloperidol decanoate (intramuscular), an ester derivative of
haloperidol, possesses
the
antipsychotic
properties
of
haloperidol.
When
it
is
administered
as
an
intramuscular depot in sesame oil, esterases present in blood and
tissues hydrolyse
haloperidol decanoate to provide a slow release of the active
neuroleptic haloperidol
from the depot into the systemic circulation. The onset of action
occurs within a few
days after injection and the therapeutic effect continues for 2 to 4
weeks, although
adequate control is frequently maintained with one injection every
four weeks.
Careful
supervision
is
required
throughout
treatment
due
to
the
variations
in
individual patient response.
Haloperidol decanoate 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
decanoate has
not been entirely elucidated, but has been attributed to the
inhibition of the transport
mechanism of cerebral monoamines by haloperidol, particularly by
blocking the
impulse transmission in dopaminergic neurons.
The pharmacokinetics were studied in chronic psychotic patients
receiving monthly
injections for up to two years. The initial dose was based on the
observation that the
bioavailability of oral haloperidol is 60 to 70%, cor