NTP-ALPRAZOLAM TABLET

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

ALPRAZOLAM

Fáanlegur frá:

TEVA CANADA LIMITED

ATC númer:

N05BA12

INN (Alþjóðlegt nafn):

ALPRAZOLAM

Skammtar:

0.25MG

Lyfjaform:

TABLET

Samsetning:

ALPRAZOLAM 0.25MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

100/500/1000

Gerð lyfseðils:

Targeted (CDSA IV)

Lækningarsvæði:

BENZODIAZEPINES

Vörulýsing:

Active ingredient group (AIG) number: 0115008001; AHFS:

Leyfisstaða:

CANCELLED PRE MARKET

Leyfisdagur:

2015-08-06

Vara einkenni

PRODUCT MONOGRAPH
Pr
NTP-ALPRAZOLAM
(Alprazolam)
0.25 mg and 0.5 mg Tablets
USP
Anxiolytic/Sedative
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
Submission Control No: 165698
Date of Preparation:
June 20, 2013
2
Pr
NTP-ALPRAZOLAM
(Alprazolam)
0.25 mg and 0.5 mg Tablets
USP
THERAPEUTIC CLASSIFICATION
Anxiolytic/Sedative
ACTION AND CLINICAL PHARMACOLOGY
NTP-ALPRAZOLAM (alprazolam) is a benzodiazepine with anxiolytic
properties.
In man, orally administered alprazolam is readily absorbed and reaches
peak plasma
concentrations within 1 to 2 hours. Alprazolam has a mean half-life of
6 to 20 hours after the
administration of a single dose. When multiple doses given 3 times
daily are administered, a
steady state is reached within 7 days. The primary route of excretion
for alprazolam and its
metabolites is urinary with approximately 80% recovery. Fecal
elimination accounts for about
7%. The primary metabolites, alpha-hydroxy-alprazolam and a
benzophenone derivative, are the
result of oxidation which is the main route degradation. Further
transformation of the alpha-
hydroxy metabolite yields demethylalprazolam. The metabolites,
demethylalprazolam and alpha-
hydroxy-alprazolam, are active and appear to have half-lives similar
to that of alprazolam;
however, these metabolites are present in the plasma at low levels.
Alprazolam is 80% protein-
bound.
In human sleep laboratory studies, alprazolam was shown to decrease
sleep latency and the
number of nocturnal awakenings and to increase the duration of sleep.
Stage 3, stage 4 and REM
sleep were all slightly reduced by alprazolam. A dose related increase
in REM latency was also
observed.
The administration of alprazolam 0.5 mg 3 limes daily for 14 days had
no effect on prothrombin
times or plasma warfarin levels in male volunteers given oral sodium
warfarin.
A single-dose two-way, crossover study was conducted in order to
compare the rate and extent of
absorption and bioequivalence of NTP-ALPRAZOLAM 0.5 mg tablets with
Xanax
®
0.5 mg
tablets. The pha