PHL-LORAZEPAM TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

LORAZEPAM

Disponible depuis:

PHARMEL INC

Code ATC:

N05BA06

DCI (Dénomination commune internationale):

LORAZEPAM

Dosage:

1MG

forme pharmaceutique:

TABLET

Composition:

LORAZEPAM 1MG

Mode d'administration:

ORAL

Unités en paquet:

100/1000

Type d'ordonnance:

Targeted (CDSA IV)

Domaine thérapeutique:

BENZODIAZEPINES

Descriptif du produit:

Active ingredient group (AIG) number: 0110731001; AHFS:

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2007-07-30

Résumé des caractéristiques du produit

_phl-LORAZEPAM Product Monograph _
_Page 1 of 27 _
PRODUCT MONOGRAPH
PHL-LORAZEPAM
Lorazepam Tablets, USP
0.5 mg, 1 mg and 2 mg
Anxiolytic-Sedative
PHARMEL INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec, Canada
H4P 2T4
DATE OF REVISION:
July 13, 2016
Submission Control No.: 195775
_phl-LORAZEPAM Product Monograph _
_Page 2 of 27 _
PRODUCT MONOGRAPH
phl-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.
_phl-LORAZEPAM Product Monograph _
_Page 3 of 27 _
A bioavailability study comparing two different formulations of
lorazepam was performed.
Pharmacokinetic and bioavailabilty data of phl-LORAZEPAM were measured
from volunteers in
the
fasting
state
after
a
single
4 mg
(2
x
2 mg
tablets)
dos