CHLORPROMAZINE HCL INJ 25MG/ML USP LIQUID

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

CHLORPROMAZINE HYDROCHLORIDE

Commercializzato da:

MYLAN PHARMACEUTICALS ULC

Codice ATC:

N05AA01

INN (Nome Internazionale):

CHLORPROMAZINE

Dosaggio:

25MG

Forma farmaceutica:

LIQUID

Composizione:

CHLORPROMAZINE HYDROCHLORIDE 25MG

Via di somministrazione:

INTRAMUSCULAR

Confezione:

2ML

Tipo di ricetta:

Prescription

Area terapeutica:

PHENOTHIAZINES

Dettagli prodotto:

Active ingredient group (AIG) number: 0106168007; AHFS:

Stato dell'autorizzazione:

CANCELLED POST MARKET

Data dell'autorizzazione:

2015-11-03

Scheda tecnica

1 PRESCRIBING INFORMATION PR
CHLORPROMAZINE HCL INJ 25 MG/ML USP STERILE
Antipsychotic–Antiemetic
Bioniche Pharma (Canada) Ltd.
Date Revised: December 1, 2011
40 Holly Street, Suite 801
Toronto, Ontario
M4S 3CE
Date of Revision: November 25,2011
Control Number: 151022
2
CHLORPROMAZINE HCL INJ 25 MG/ML USP
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
Chlorpromazine HCL Inj 25mg/ml USP is used for the symptomatic
management of psychotic
disorders. The drug is also used for the prevention and treatment of
nausea and vomiting; for relief of
restlessness and apprehension before surgery and for the sympto