CHLORPROMAZINE HYDROCHLORIDE INJECTION SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

CHLORPROMAZINE (CHLORPROMAZINE HYDROCHLORIDE)

Dostopno od:

SANDOZ CANADA INCORPORATED

Koda artikla:

N05AA01

INN (mednarodno ime):

CHLORPROMAZINE

Odmerek:

25MG

Farmacevtska oblika:

SOLUTION

Sestava:

CHLORPROMAZINE (CHLORPROMAZINE HYDROCHLORIDE) 25MG

Pot uporabe:

INTRAMUSCULAR

Enote v paketu:

2ML

Tip zastaranja:

Prescription

Terapevtsko območje:

PHENOTHIAZINES

Povzetek izdelek:

Active ingredient group (AIG) number: 0106167006; AHFS:

Status dovoljenje:

CANCELLED POST MARKET

Datum dovoljenje:

2019-08-01

Lastnosti izdelka

_Chlorpromazine Hydrochloride Injection _
_ Page 1 of 14 _
PRESCRIBING INFORMATION
PR
CHLORPROMAZINE HYDROCHLORIDE INJECTION
25 MG BASE/ML
(27.9 MG CHLORPROMAZINE HYDROCHLORIDE/ML)
STERILE
Antipsychotic–Antiemetic
Sandoz Canada Inc.
145 Jules-Léger
Date of Revision: February 1, 2013
Boucherville, QC, Canada
J4B 7K8
Submission Control No: 160980
_Chlorpromazine Hydrochloride Injection _
_ Page 2 of 14 _
PR
CHLORPROMAZINE HYDROCHLORIDE INJECTION
25 MG BASE/ML
(27.9 MG CHLORPROMAZINE HYDROCHLORIDE/ML)
STERILE
THERAPEUTIC CLASSIFICATION
Antipsychotic–Antiemetic
PHARMACOLOGY
The principal pharmacologic effects of chlorpromazine are similar to
those of other propylamino
derivatives of phenothiazine. Chlorpromazine has strong
anticholinergic and sedative effects and
moderate extrapyramidal effects. Chlorpromazine has strong antiemetic
and adrenergic blocking
activity, and weak ganglionic blocking, antihistaminic and
antiserotonergic activity.
PHARMACOKINETICS
Chlorpromazine is rapidly absorbed from parenteral sites of injection.
Chlorpromazine is
extensively metabolized in the liver and is excreted in the urine and
bile in the form of numerous
active and inactive metabolites; there is evidence of enterohepatic
recycling. Owing to the first-
pass effect, plasma concentrations following oral administration are
much lower than those
following intramuscular administration. Moreover, there is very wide
intersubject variation in
plasma concentrations of chlorpromazine and its metabolites, and their
therapeutic effect.
Although the plasma half-life of chlorpromazine itself has been
reported to be only a few hours,
elimination of the metabolites may be very prolonged.
Chlorpromazine is very extensively bound to plasma proteins. It is
widely distributed in the body
and crosses the blood-brain barrier to achieve higher concentrations
in the brain than in the
plasma. Chlorpromazine and its metabolites also cross the placental
barrier and are excreted in
milk.
INDICATIONS AND CLINICAL USE
Chlorpromazine is used for the symptom