SANDOZ NITRAZEPAM TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

NITRAZEPAM

Disponibil de la:

SANDOZ CANADA INCORPORATED

Codul ATC:

N05CD02

INN (nume internaţional):

NITRAZEPAM

Dozare:

5MG

Forma farmaceutică:

TABLET

Compoziție:

NITRAZEPAM 5MG

Calea de administrare:

ORAL

Unități în pachet:

100/500

Tip de prescriptie medicala:

Targeted (CDSA IV)

Zonă Terapeutică:

BENZODIAZEPINES

Rezumat produs:

Active ingredient group (AIG) number: 0114345001; AHFS:

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2018-08-01

Caracteristicilor produsului

_Sandoz Nitrazepam_
Page 1 of 20
PRODUCT MONOGRAPH
T\C
SANDOZ NITRAZEPAM
(Nitrazepam BP)
5 mg and 10 mg Tablets
Hypnotic and Anticonvulsant
Sandoz Canada Inc.
145 Jules-Léger
Boucherville, QC, Canada
J4B 7K8
Date of Revision : August 5, 2011
Control # 148130
_Sandoz Nitrazepam_
Page 2 of 20
T\C
SANDOZ NITRAZEPAM
Nitrazepam BP
Tablets
Hypnotic and Anticonvulsant
ACTION AND CLINICAL PHARMACOLOGY
Nitrazepam is a benzodiazepine with hypnotic and anticonvulsant
properties.
In sleep laboratory studies nitrazepam decreased sleep latency,
increased total sleep time and
decreased awake time. There is delay in the onset, and decrease in the
duration of REM sleep.
Nitrazepam is reported to significantly decrease stage 1, 3 and 4
sleep and to increase stage 2.
Following discontinuation of the drug, REM sleep rebound has been
reported in some studies.
Nitrazepam has been shown to raise the seizure threshold.
GENERAL BENZODIAZEPINE CLINICAL PHARMACOLOGY
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 benzodia