HALCION TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

TRIAZOLAM

Διαθέσιμο από:

PFIZER CANADA ULC

Φαρμακολογική κατηγορία (ATC):

N05CD05

INN (Διεθνής Όνομα):

TRIAZOLAM

Δοσολογία:

0.25MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

TRIAZOLAM 0.25MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

10X7 TABLETS/BLISTER

Τρόπος διάθεσης:

Targeted (CDSA IV)

Θεραπευτική περιοχή:

BENZODIAZEPINES

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0112970002; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2007-05-29

Αρχείο Π.Χ.Π.

PRODUCT MONOGRAPH
HALCION
*
(triazolam tablets USP)
0.125 mg and 0.25 mg tablets
Hypnotic
Pfizer Canada Inc
Date of Preparation:
17,300 Trans-Canada Highway
September 17, 2003
Kirkland, Quebec H9J 2M5
Control No. 086680
* TM Pharmacia Enterprises S.A.
Pfizer Canada Inc, Licensee
© Pfizer Canada Inc 2003
PRODUCT MONOGRAPH
HALCION
*
2
0.125 mg and 0.25 mg tablets
THERAPEUTIC CLASSIFICATION
HYPNOTIC
ACTIONS
HALCION (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 tha