DOM-LORAZEPAM TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

LORAZEPAM

Available from:

DOMINION PHARMACAL

ATC code:

N05BA06

INN (International Name):

LORAZEPAM

Dosage:

.5MG

Pharmaceutical form:

TABLET

Composition:

LORAZEPAM .5MG

Administration route:

ORAL

Units in package:

100/500/1000

Prescription type:

Targeted (CDSA IV)

Therapeutic area:

BENZODIAZEPINES

Product summary:

Active ingredient group (AIG) number: 0110731003; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2019-02-20

Summary of Product characteristics

_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