DALMANE CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

FLURAZEPAM HYDROCHLORIDE

Available from:

VALEANT CANADA LP / VALEANT CANADA S.E.C.

ATC code:

N05CD01

INN (International Name):

FLURAZEPAM

Dosage:

15MG

Pharmaceutical form:

CAPSULE

Composition:

FLURAZEPAM HYDROCHLORIDE 15MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Targeted (CDSA IV)

Therapeutic area:

BENZODIAZEPINES

Product summary:

Active ingredient group (AIG) number: 0108704002; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2016-07-08

Summary of Product characteristics

IMPORTANT: PLEASE READ
_ _
_Product Monograph - Dalmane_
_®_
_ Page 1 of 17_
PRODUCT MONOGRAPH
T\C
DALMANE
®
Flurazepam Hydrochloride
Capsules; 15 mg, 30 mg
Hypnotic
Valeant Canada limitée/Limited
4787 Levy Street
Montreal (Quebec) H4R 2P9
DATE OF REVISION:
JUNE 29, 2009
SUBMISSION CONTROL NO: 127818
®
REGISTERED TRADEMARK
Valeant Canada ltée/Ltd.
_ _
_Product Monograph - Dalmane_
_®_
_ _
_Page 2 of 17_
NAME OF DRUG
T\C
DALMANE
®
(flurazepam hydrochloride)
HYPNOTIC
ACTIONS AND CLINICAL PHARMACOLOGY
Dalmane
®
(flurazepam hydrochloride), a benzodiazepine derivative, is a hypnotic
agent which
does not appear to decrease dream time as measured by rapid eye
movements (REM). ‘Dalmane’
decreases sleep latency and number of awakenings for a consequent
increase in total sleep time.
The duration of hypnotic effect and the profile of unwanted effects
may be influenced by the
alpha (distribution) and beta (elimination) half-lives of the
administered drug and any active
metabolites formed. When half-lives are long, the drug or metabolite
may accumulate during
periods of nightly administration and be associated with impairments
of cognitive and motor
performance during waking hours. If half-lives are short, the drug and
metabolites will be cleared
before the next dose is ingested, and carry-over effects related to
sedation or CNS depression
should be minimal or absent. However, during nightly use and for an
extended period,
pharmacodynamic tolerance or adaptation to some effects of
benzodiazepine hypnotics may
develop. If the drug has a very short elimination half-life, it is
possible that a relative deficiency
(i.e., in relation to the receptor site) may occur at some point in
the interval between each night's
use. This sequence of events may account for two clinical findings
reported to occur after several
weeks of nightly use of rapidly eliminated benzodiazepine hypnotics:
1) increased wakefulness
during the last third of the night; and 2) the appearance of increased
daytime anxiety (see
WARNINGS).
Flurazepam is