מדינה: קנדה
שפה: אנגלית
מקור: Health Canada
CHLORPROMAZINE HYDROCHLORIDE
MYLAN PHARMACEUTICALS ULC
N05AA01
CHLORPROMAZINE
25MG
LIQUID
CHLORPROMAZINE HYDROCHLORIDE 25MG
INTRAMUSCULAR
2ML
Prescription
PHENOTHIAZINES
Active ingredient group (AIG) number: 0106168007; AHFS:
CANCELLED POST MARKET
2015-11-03
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 קרא את המסמך השלם