PMS-TEMAZEPAM CAPSULE

Country: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

TEMAZEPAM

Доступно од:

PHARMASCIENCE INC

АТЦ код:

N05CD07

INN (Међународно име):

TEMAZEPAM

Дозирање:

15MG

Фармацеутски облик:

CAPSULE

Састав:

TEMAZEPAM 15MG

Пут администрације:

ORAL

Јединице у пакету:

100/500

Тип рецептора:

Targeted (CDSA IV)

Терапеутска област:

BENZODIAZEPINES

Резиме производа:

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

Статус ауторизације:

APPROVED

Датум одобрења:

2005-11-21

Карактеристике производа

PRODUCT MONOGRAPH
PMS-TEMAZEPAM
(Temazepam Capsules, USP)
15 mg & 30 mg
H
YPNOTIC
PHARMASCIENCE INC.
Date of Revision:
6111 Royalmount Ave, Suite #100
December 31, 2009
Montreal, Quebec
H4P 2T4
CONTROL NO: 133618
2
PRODUCT MONOGRAPH
PMS-TEMAZEPAM
(Temazepam Capsules, USP)
15 mg & 30 mg
THERAPEUTIC CLASSIFICATION
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
3
sleep latency at the higher dose. REM sleep was essentially unchanged
and slow wave sleep was
decreased.
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 (elimina