HALOPERIDOL DECANOATE INJECTION SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

HALOPERIDOL (HALOPERIDOL DECANOATE)

Available from:

STRIDES PHARMA CANADA INC

ATC code:

N05AD01

INN (International Name):

HALOPERIDOL

Dosage:

100MG

Pharmaceutical form:

SOLUTION

Composition:

HALOPERIDOL (HALOPERIDOL DECANOATE) 100MG

Administration route:

INTRAMUSCULAR

Units in package:

1ML/5ML

Prescription type:

Prescription

Therapeutic area:

BUTYROPHENONES

Product summary:

Active ingredient group (AIG) number: 0101774008; AHFS:

Authorization status:

APPROVED

Authorization date:

2020-05-27

Summary of Product characteristics

PRODUCT MONOGRAPH
PR HALOPERIDOL DECANOATE INJECTION
(HALOPERIDOL DECANOATE INJECTION)
50 MG AND 100 MG HALOPERIDOL/ML
STERILE SOLUTION FOR INTRAMUSCULAR INJECTION
ANTIPSYCHOTIC AGENT
STRIDES PHARMA CANADA INC.
DATE OF REVISION:
1565, BOUL. LIONEL-BOULET
MAY 27, 2020
VARENNES, QUEBEC
CANADA J3X 1P7
SUBMISSION CONTROL NO.: 238030
1
PRODUCT MONOGRAPH
Pr
Haloperidol Decanoate Injection
(Haloperidol Decanoate Injection)
50 mg and 100 mg haloperidol/mL
THERAPEUTIC CLASSIFICATION
Antipsychotic Agent
ACTIONS AND CLINICAL PHARMACOLOGY
Haloperidol
decanoate,
an
ester
derivative
of
haloperidol
obtained
from
condensation
of
haloperidol with decanoic acid possesses the antipsychotic properties
of haloperidol. When it is
administered as an intramuscular (i.m.) depot in sesame oil, esterases
present in blood and
tissues hydrolyze 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 1 injection every 4 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.
PHARMACOKINETICS
The pharmacokinetics were studied in chronic psychotic patients
receiving monthly injections for
up to 2 years. The initial dose was based on the observ