MODECATE CONCENTRATE LIQUID

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

FLUPHENAZINE DECANOATE

Available from:

BRISTOL-MYERS SQUIBB CANADA

ATC code:

N05AB02

INN (International Name):

FLUPHENAZINE

Dosage:

100MG

Pharmaceutical form:

LIQUID

Composition:

FLUPHENAZINE DECANOATE 100MG

Administration route:

INTRAMUSCULAR

Units in package:

1ML

Prescription type:

Prescription

Therapeutic area:

PHENOTHIAZINES

Product summary:

Active ingredient group (AIG) number: 0110769002; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2018-12-30

Summary of Product characteristics

PRODUCT MONOGRAPH
Pr
MODECATE
® CONCENTRATE
Fluphenazine Decanoate Injection, B.P.
100 mg/ml
Antipsychotic
Date of Preparation:
Bristol-Myers Squibb Canada
July 22, 1980
Montréal, Canada
Date of Revision: 8 AUGUST 2017
®
Registered trademark of Bristol-Myers Squibb Company used under
license by Bristol-Myers
Squibb Canada
CONTROL NO.: 200123
PRODUCT MONOGRAPH
MODECATE CONCENTRATE
Fluphenazine Decanoate Injection, B.P.
THERAPEUTIC CLASSIFICATION
ANTIPSYCHOTIC
ACTION AND CLINICAL PHARMACOLOGY
The effects of MODECATE CONCENTRATE (fluphenazine decanoate) are the
same as those of
fluphenazine
hydrochloride,
however,
the
slow
release
of
the
decanoate
derivative
of
fluphenazine from the site of injection results in a prolonged
duration of action. Once released in
the blood, fluphenazine decanoate is rapidly hydrolyzed by blood
esterases with no attenuation of
its antipsychotic action. The onset of action generally appears
between 24 to 72 hours after
injection, and the effects of the drug on psychotic symptoms become
significant within 48 to 96
hours. Amelioration of symptoms then continues for 1-8 weeks with an
average duration of 3-4
weeks. There is considerable variation in the individual response of
patients to this depot
fluphenazine and its use for maintenance therapy requires careful
supervision.
Like other phenothiazines, fluphenazine exerts activity at various
levels of the central nervous
system as well as on peripheral organ systems which accounts for its
antipsychotic action and
side effects common to this class of drugs. Indirect evidence
indicates that the antipsychotic
effects of phenothiazines are linked to their effect in blocking
dopamine and other catecholamine
receptor sites.
Fluphenazine differs from some phenothiazine derivatives in several
respects: it has less
potentiating effect on central nervous system depressants and
anesthetics than do some of the
phenothiazines and appears to be less sedating. While hypotension may
occur less frequently
than
with
other
phenothiazines,
appropriate
precaut