RATIO-TEMAZEPAM CAPSULE

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

TEMAZEPAM

Предлага се от:

RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED

АТС код:

N05CD07

INN (Международно Name):

TEMAZEPAM

дозиране:

15MG

Лекарствена форма:

CAPSULE

Композиция:

TEMAZEPAM 15MG

Начин на приложение:

ORAL

Броя в опаковка:

100/500

Вид предписание :

Targeted (CDSA IV)

Терапевтична област:

BENZODIAZEPINES

Каталог на резюме:

Active ingredient group (AIG) number: 0114415002; AHFS:

Статус Оторизация:

CANCELLED POST MARKET

Дата Оторизация:

2014-09-19

Данни за продукта

PRODUCT MONOGRAPH
RATIO-TEMAZEPAM
TEMAZEPAM
15 MG AND 30 MG CAPSULES, USP
HYPNOTIC
RATIOPHARM INC.
CANADA, J7J 1P3
D-1017
CONTROL #: 133554
DATE OF REVISION:
JANUARY 4, 2010
Page 2
PRODUCT MONOGRAPH
RATIO-TEMAZEPAM
TEMAZEPAM
15 MG AND 30 MG CAPSULES, USP
HYPNOTIC
ACTIONS AND CLINICAL PHARMACOLOGY
General:
Temazepam is a benzodiazepine with hypnotic properties.
Benzodiazepines act as depressants of the central nervous system
(CNS). It is
believed
that
benzodiazepines
enhance
or
facilitate
the
effects
of
the
inhibitory
neurotransmitter gamma-aminobutyric acid (GABA).
Benzodiazepines
act
as
agonists
at
the
benzodiazepine
receptors
sites.
The
benzodiazepine-GABA receptor-chloride ionophore complex functions
mainly in the
gating
of
the
chloride
channel.
Benzodiazepines
are
thought
to
produce
their
pharmacological effects by facilitating GABA-mediated transmission in
the CNS, which
reportedly increase the frequency of the chloride channel opening.
In sleep laboratory studies, the effect of temazepam 15 mg and 30 mg,
was compared
to placebo over a two week period. There was a linear dose-response
improvement in
total sleep time and sleep latency with significant drug-placebo
differences occurring for
total sleep time at both doses, and for sleep latency at the higher
dose. REM sleep was
essentially unchanged and slow wave sleep was decreased.
Page 3
Rebound insomnia:
A transient syndrome, known as "rebound insomnia", whereby the
symptoms that led to
treatment with a benzodiazepine recur in an enhanced form, may occur
on withdrawal
of hypnotic treatment. In the sleep laboratory studies, no measurable
effects on
daytime alertness or performance occurred following temazepam
treatment or during
the
withdrawal
period,
even
though
a
transient
sleep
disturbance
in
some
sleep
parameters was observed following the withdrawal of the higher doses.
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
activ