STEMETIL SUPPOSITORY

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

PROCHLORPERAZINE

Tilgjengelig fra:

SANOFI-AVENTIS CANADA INC

ATC-kode:

N05AB04

INN (International Name):

PROCHLORPERAZINE

Dosering :

10MG

Legemiddelform:

SUPPOSITORY

Sammensetning:

PROCHLORPERAZINE 10MG

Administreringsrute:

RECTAL

Enheter i pakken:

10

Resept typen:

Prescription

Terapeutisk område:

PHENOTHIAZINES

Produkt oppsummering:

Active ingredient group (AIG) number: 0106181001; AHFS:

Autorisasjon status:

CANCELLED POST MARKET

Autorisasjon dato:

2006-07-28

Preparatomtale

Page 1 of 19
PRODUCT MONOGRAPH
STEMETIL
®
PROCHLORPERAZINE MESYLATE INJECTION
10 MG/2 ML_ _PROCHLORPERAZINE AS PROCHLORPERAZINE MESYLATE
PROCHLORPERAZINE SUPPOSITORIES
10 MG
ANTIPSYCHOTIC - ANTIEMETIC
sanofi-aventis Canada Inc.
Revision Date:
2150 St. Elzear Blvd. West
October 13, 2006
Laval, Quebec H7L 4A8
Submission Control No.: 107337
s-a version 3.0 dated
Page 2 of 19
PRODUCT MONOGRAPH
NAME OF DRUG
STEMETIL
PROCHLORPERAZINE MESYLATE INJECTION _ _
PROCHLORPERAZINE SUPPOSITORIES
_ _
THERAPEUTIC CLASSIFICATION
Antipsychotic - Antiemetic
ACTION
Stemetil
(prochlorperazine)
is
a
piperazine
phenothiazine
derivative
with
antipsychotic,
antiemetic and weak sedative activity.
Stemetil 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
CNS depressants and anesthetics. However, it produces a high incidence
of extrapyramidal
reactions.
INDICATIONS
Stemetil (prochlorperazine) is indicated in the management of
manifestations of psychotic
disorders such as agitation, confusion, delusion, tension and anxiety.
It is also effective in controlling nausea and vomiting due to
stimulation of the chemoreceptor
trigger zone.
In selected patients, Stemetil may be of value for the relief of
excessive anxiety, accompanied by
severe tension and agitation, associated with psychoneurotic or
somatic conditions.
Page 3 of 19
CONTRAINDICATIONS
Stemetil (prochlorperazine) should not be administered in the presence
of circulatory collapse,
altered states of consciousness or comatose states, particularly when
these are due to intoxication
with
central depressant drugs (alcohol, hypnotics,
narcotics, etc.). It is contraindicated in
severely
depressed
patients,
in
the
presence
of
blood
dyscrasias,
liver
disease,
renal
insufficiency, pheochromocytoma, or in patients with severe
cardiovascular disorders or a
history of hypersensitivity to phenothiazine derivatives.
As
with
other
phenothiazines,
Stemetil
is
contraindicate