HALOPERIDOL LA LIQUID

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

HALOPERIDOL (HALOPERIDOL DECANOATE)

Available from:

SANDOZ CANADA INCORPORATED

ATC code:

N05AD01

INN (International Name):

HALOPERIDOL

Dosage:

50MG

Pharmaceutical form:

LIQUID

Composition:

HALOPERIDOL (HALOPERIDOL DECANOATE) 50MG

Administration route:

INTRAMUSCULAR

Units in package:

1 X 5ML

Prescription type:

Prescription

Therapeutic area:

BUTYROPHENONES

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2005-08-05

Summary of Product characteristics

_Haloperidol LA _
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_Page 1 of 29 _
PRODUCT MONOGRAPH
PR
HALOPERIDOL LA
(HALOPERIDOL DECANOATE INJECTION)
STERILE
50 mg haloperidol/mL
100 mg haloperidol/mL
For intramuscular injection only. NOT FOR intravenous use.
Antipsychotic Agent
Sandoz Canada Inc.
Date of Revision: November 13, 2013
145 Jules-Léger
Boucherville, QC, Canada
J4B 7K8
SUBMISSION CONTROL NO: 167547
_Haloperidol LA _
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_Page 2 of 29 _
HALOPERIDOL LA
Haloperidol Decanoate Injection
Sterile
50 mg/mL haloperidol
100 mg/mL haloperidol
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
IM 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 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 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 2 years. The initial dose was based on the
observation that the
bioavailability of oral halo