Pays: Canada
Langue: anglais
Source: Health Canada
LORAZEPAM
DOMINION PHARMACAL
N05BA06
LORAZEPAM
.5MG
TABLET
LORAZEPAM .5MG
ORAL
100/500/1000
Targeted (CDSA IV)
BENZODIAZEPINES
Active ingredient group (AIG) number: 0110731003; AHFS:
CANCELLED POST MARKET
2019-02-20
_Dom-LORAZEPAM Product Monograph _ _Page 1 of 27 _ PRODUCT MONOGRAPH DOM-LORAZEPAM Lorazepam Tablets, USP 0.5 mg, 1 mg and 2 mg Anxiolytic-Sedative DOMINION PHARMACAL 6111 Royalmount Ave., Suite 100 Montréal, Québec, Canada H4P 2T4 DATE OF REVISION: July 13, 2016 Submission Control No.: 195774 _Dom-LORAZEPAM Product Monograph _ _Page 2 of 27 _ PRODUCT MONOGRAPH Dom-LORAZEPAM Lorazepam Tablets, USP 0.5 mg, 1 mg and 2 mg THERAPEUTIC CLASSIFICATION Anxiolytic-Sedative ACTIONS AND CLINICAL PHARMACOLOGY Lorazepam is an active benzodiazepine with a depressant action on the central nervous system. It has anxiolytic and sedative properties which are of value in the symptomatic relief of pathologic anxiety in patients with anxiety disorders giving rise to significant functional disability but is not considered indicated in the management of trait anxiety. Lorazepam has also been shown to possess anticonvulsant activity. Lorazepam is rapidly absorbed after oral administration, with mean peak plasma concentrations of free lorazepam at 2 hours (range between 1-6 hours). Lorazepam is rapidly conjugated to a glucuronide which has no demonstrable psychopharmacological activity and is excreted mainly in the urine. Very small amounts of other metabolites and their conjugates have been isolated from urine and plasma. The serum half-life of lorazepam ranges between 12 to 15 hours, while that of the conjugate varied between 16 to 20 hours. Most of the drug (88%) is excreted in the urine, with 75% excreted as the glucuronide. At the clinically relevant concentrations, approximately 85% of lorazepam is bound to plasma proteins. Anterograde amnesia, a lack of recall of events during period of drug action, has been reported and appears to be dose-related. _Dom-LORAZEPAM Product Monograph _ _Page 3 of 27 _ A bioavailability study comparing two different formulations of lorazepam was performed. Pharmacokinetic and bioavailabilty data of Dom-LORAZEPAM were measured from volunteers in the fasting state after a single 4 mg (2 x 2 mg tablet Lire le document complet