PMS-FLUPHENAZINE DECANOATE INJ (BP) 25MG/ML LIQUID

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

FLUPHENAZINE DECANOATE

Available from:

PHARMASCIENCE INC

ATC code:

N05AB02

INN (International Name):

FLUPHENAZINE

Dosage:

25MG

Pharmaceutical form:

LIQUID

Composition:

FLUPHENAZINE DECANOATE 25MG

Administration route:

INTRAMUSCULAR

Units in package:

5ML

Prescription type:

Prescription

Therapeutic area:

PHENOTHIAZINES

Product summary:

Active ingredient group (AIG) number: 0110769001; AHFS:

Authorization status:

MARKETED

Authorization date:

1994-12-31

Summary of Product characteristics

_pms-FLUPHENAZINE DECANOATE Product Monograph _
_Page 1 of 31_
PRODUCT MONOGRAPH
Pr
PMS-FLUPHENAZINE DECANOATE
Fluphenazine Decanoate Injection, BP
25 mg/mL and 100 mg/mL
ANTIPSYCHOTIC
PHARMASCIENCE INC.
DATE OF REVISION:
6111 Royalmount Ave., Suite 100
November 14, 2013
Montréal, Québec
H4P 2T4
www.pharmascience.com
DATE OF REVISION:
September 18, 2014 CONTROL NO.:
170565
_pms-FLUPHENAZINE DECANOATE Product Monograph _
_Page 2 of 31_
PRODUCT MONOGRAPH
PMS-FLUPHENAZINE DECANOATE
Fluphenazine Decanoate Injection, BP
25 mg/mL and 100 mg/mL
THERAPEUTIC CLASSIFICATION
Antipsychotic
ACTION AND CLINICAL PHARMACOLOGY
The effects of pms-FLUPHENAZINE DECANOATE (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 the 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 a