NITRAZADON TABLET

দেশ: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

NITRAZEPAM

থেকে পাওয়া:

AA PHARMA INC

এটিসি কোড:

N05CD02

INN (আন্তর্জাতিক নাম):

NITRAZEPAM

ডোজ:

5MG

ফার্মাসিউটিকাল ফর্ম:

TABLET

রচনা:

NITRAZEPAM 5MG

প্রশাসন রুট:

ORAL

প্যাকেজ ইউনিট:

100

প্রেসক্রিপশন টাইপ:

Targeted (CDSA IV)

থেরাপিউটিক এলাকা:

BENZODIAZEPINES

পণ্য সারাংশ:

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

অনুমোদন অবস্থা:

CANCELLED POST MARKET

অনুমোদন তারিখ:

2014-06-25

পণ্য বৈশিষ্ট্য

_ _
_Product Monograph NITRAZADON _
_Page 1 of 20_
T\C
NITRAZADON
®
(nitrazepam)
5 mg and 10 mg Tablets
Hypnotic and Anticonvulsant
AA PHARMA INC.
Date of Preparation:
1165 Creditstone Road, Unit #1
June 23, 2014
Vaughan, Ontario
L4K 4N7
CONTROL NUMBER: 175173
_ _
_Product Monograph NITRAZADON _
_Page 2 of 20_
NAME OF DRUG
T\C
NITRAZADON
®
(nitrazepam)
TABLETS
HYPNOTIC AND ANTICONVULSANT
ACTIONS AND CLINICAL PHARMACOLOGY
NITRAZADON (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