TARO-ZOPICLONE TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

ZOPICLONE

Dostępny od:

SUN PHARMA CANADA INC

Kod ATC:

N05CF01

INN (International Nazwa):

ZOPICLONE

Dawkowanie:

5MG

Forma farmaceutyczna:

TABLET

Skład:

ZOPICLONE 5MG

Droga podania:

ORAL

Sztuk w opakowaniu:

250ML

Typ recepty:

Prescription

Dziedzina terapeutyczna:

MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0122562002; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2011-12-01

Charakterystyka produktu

Page 1 of 39
PRODUCT MONOGRAPH
Pr
TARO-ZOPICLONE
Zopiclone Tablets, House Standard
5 mg and 7.5 mg
Hypnotic and Sedative
Sun Pharma Canada Inc.
Date of Revision:
126 East Drive
June 26, 2020
Brampton, Ontario
L6T 1C1
Submission Control No.: 239547
Page 2 of 39
NAME OF DRUG
Pr
TARO-ZOPICLONE
Zopiclone Tablets, 5 mg and 7.5 mg
Hypnotic and Sedative
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS
Concomitant use of zopiclone and opioids may result in profound
sedation, respiratory
depression, coma, and death (see WARNINGS, Risks from concomitant use
of opioids and
benzodiazepines or other CNS depressants).
·
Reserve concomitant prescribing of these drugs for use in patients for
whom alternative
treatment options are inadequate.
·
Limit dosages and duration to the minimum required.
·
Follow patients for signs and symptoms of respiratory depression and
sedation.
ACTIONS, CLINICAL PHARMACOLOGY
Zopiclone, a cyclopyrrolone derivative, is a short-acting hypnotic
agent. Zopiclone is structurally
unrelated to existing hypnotics. However, the pharmacological profile
of zopiclone is similar to
that of the benzodiazepines.
Zopiclone pharmacological properties are: hypnotic, sedative,
anxiolytic, anti-convulsant, muscle-
relaxant. These effects are related to a specific agonist action at
central receptors belonging to the
GABA
A
macromolecular complex, modulating the opening of the chloride ion
channel.
In sleep laboratory studies of one to 21-day duration in man,
zopiclone reduced sleep latency,
increased the duration of sleep and decreased the number of nocturnal
awakenings. Zopiclone
delayed the onset of REM sleep but did not reduce consistently the
total duration of REM periods.
The duration of stage 1 sleep was shortened, and the time spent in
stage 2 sleep increased. In most
studies, stage 3 and 4 sleep tended to be increased, but no change and
actual decreases have also
been observed. The effect of zopiclone on stage 3 and 4 sleep differs
from that of the
benzodiazepines, which suppress slow wave sleep. The clinical