MYLAN-TRIAZOLAM TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

TRIAZOLAM

Tilgjengelig fra:

MYLAN PHARMACEUTICALS ULC

ATC-kode:

N05CD05

INN (International Name):

TRIAZOLAM

Dosering :

0.125MG

Legemiddelform:

TABLET

Sammensetning:

TRIAZOLAM 0.125MG

Administreringsrute:

ORAL

Enheter i pakken:

70

Resept typen:

Targeted (CDSA IV)

Terapeutisk område:

BENZODIAZEPINES

Produkt oppsummering:

Active ingredient group (AIG) number: 0112970001; AHFS:

Autorisasjon status:

CANCELLED POST MARKET

Autorisasjon dato:

2011-03-04

Preparatomtale

1
PRODUCT MONOGRAPH
MYLAN-TRIAZOLAM
triazolam USP
0.125 mg, 0.25 mg Tablets
USP
Hypnotic
Mylan Pharmaceuticals ULC
Date of Revision: March 4, 2010
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Submission Control Number: 134343
2
PRODUCT MONOGRAPH
NAME OF DRUG
MYLAN-TRIAZOLAM
(triazolam)
0.125 mg, 0.25 mg Tablets USP
THERAPEUTIC CLASSIFICATION
Hypnotic
ACTIONS
MYLAN-TRIAZOLAM (triazolam) is a benzodiazepine hypnotic with a very
short elimination
half- life (about 3 hours).
In sleep laboratory studies of one to 21 days duration, triazolam
significantly decreased sleep
latency, increased the duration of sleep and decreased the number of
nocturnal awakenings.
However, after two weeks of consecutive nightly administration, the
drug's effect on total wake
time was decreased, and the values recorded in the last third of the
night approached baseline
levels. On the first and/or second night after drug discontinuance
(first or second post-drug
night), total time asleep, and percentage of time spent sleeping
frequently were significantly
decreased, and sleep latency significantly increased when compared to
baseline (predrug)
nights. This effect is referred to as "REBOUND" INSOMNIA
.
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 metabolites
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 relatio