PROCHLORPERAZINE MESYLATE INJ 5MG/ML LIQUID

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

PROCHLORPERAZINE (PROCHLORPERAZINE MESYLATE)

Disponible des:

SANDOZ CANADA INCORPORATED

Codi ATC:

N05AB04

Designació comuna internacional (DCI):

PROCHLORPERAZINE

Dosis:

5MG

formulario farmacéutico:

LIQUID

Composición:

PROCHLORPERAZINE (PROCHLORPERAZINE MESYLATE) 5MG

Vía de administración:

INTRAMUSCULAR

Unidades en paquete:

2ML

tipo de receta:

Prescription

Área terapéutica:

PHENOTHIAZINES

Resumen del producto:

Active ingredient group (AIG) number: 0106181002; AHFS:

Estat d'Autorització:

CANCELLED POST MARKET

Data d'autorització:

2017-08-01

Fitxa tècnica

_Prochlorperazine Mesylate Injection and Sandoz Prochlorperazine _
_Page 1 of 20 _
PRESCRIBING INFORMATION
PR
PROCHLORPERAZINE MESYLATE INJECTION
5 mg /mL prochlorperazine (as prochlorperazine mesylate)
Sandoz Standard
PR
SANDOZ PROCHLORPERAZINE
Prochlorperazine Suppository USP
10 mg prochlorperazine / suppository
Antipsychotic - Antiemetic
Sandoz Canada Inc.
145, Jules-Léger
Date of Revision: October 7, 2013
Boucherville, QC, Canada
J4B 7K8
Submission Control Number: 167673 and 167671
_Prochlorperazine Mesylate Injection and Sandoz Prochlorperazine _
_Page 2 of 20 _
PR
PROCHLORPERAZINE MESYLATE INJECTION
5 MG /ML PROCHLORPERAZINE (AS PROCHLORPERAZINE MESYLATE)
SANDOZ STANDARD
PR
SANDOZ PROCHLORPERAZINE
PROCHLORPERAZINE SUPPOSITORY USP
10 MG PROCHLORPERAZINE / SUPPOSITORY
THERAPEUTIC CLASSIFICATION
ANTIPSYCHOTIC – ANTIEMETIC
ACTION AND CLINICAL PHARMACOLOGY
Prochlorperazine is a piperazine phenothiazine derivative with
antipsychotic, antiemetic and
weak sedative activity.
Prochlorperazine has actions similar to those of other phenothiazine
derivatives but appears to
be less sedating and to have a weak propensity for causing hypotension
or potentiating the
effects of Central Nervous System (CNS) depressants and anesthetics.
However, it produces a
high incidence of extrapyramidal reactions.
Prochlorperazine is well absorbed from the gastrointestinal tract.
The onset of action is 60 minutes following rectal administration of
suppositories and 10 to
20 minutes after IM administration. Duration of action for all routes
is 3 to 4 hours.
Prochlorperazine distributes to most body tissues with high
concentrations being distributed
into the liver and spleen. Prochlorperazine enters the enterohepatic
circulation and is excreted
chiefly in the feces.
INDICATIONS AND CLINICAL USE
In the management of manifestations of psychotic disorders such as
agitation, confusion,
delusion, tension and anxiety.
Prochlorperazine is also effective in controlling nausea and vomiting
due to stimulation of the
chemoreceptor trigger zone (CTZ