CO TEMAZEPAM CAPSULES 15MG

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

TEMAZEPAM

זמין מ:

COBALT PHARMACEUTICALS COMPANY

קוד ATC:

N05CD07

INN (שם בינלאומי):

TEMAZEPAM

כמות:

15MG

טופס פרצבטיות:

CAPSULE

הרכב:

TEMAZEPAM 15MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

100

סוג מרשם:

Targeted (CDSA IV)

איזור תרפויטי:

BENZODIAZEPINES

leaflet_short:

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

מצב אישור:

CANCELLED POST MARKET

תאריך אישור:

2015-08-07

מאפייני מוצר

PRODUCT MONOGRAPH
_ _
_ _
_CO_ TEMAZEPAM
(TEMAZEPAM)
15 MG AND 30 MG CAPSULES
HYPNOTIC
Cobalt Pharmaceuticals Inc.
6500 Kitimat Road
Mississauga, ON
Canada, L5N 2B8
Date of Revision:
December 22, 2009
Submission Control No: 133482
2
PRODUCT MONOGRAPH
NAME OF DRUG
_ CO_ TEMAZEPAM
Capsules
(temazepam)
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 sleep latency at the higher dose. REM sleep was
essentially unchanged and slow
wave sleep was decreased.
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