País: Canadá
Língua: inglês
Origem: Health Canada
CHLORPROMAZINE (CHLORPROMAZINE HYDROCHLORIDE)
SANDOZ CANADA INCORPORATED
N05AA01
CHLORPROMAZINE
25MG
SOLUTION
CHLORPROMAZINE (CHLORPROMAZINE HYDROCHLORIDE) 25MG
INTRAMUSCULAR
2ML
Prescription
PHENOTHIAZINES
Active ingredient group (AIG) number: 0106167006; AHFS:
CANCELLED POST MARKET
2019-08-01
_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 Leia o documento completo