AVA-OXYBUTYNIN TABLET

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

OXYBUTYNIN CHLORIDE

Fáanlegur frá:

AVANSTRA INC

ATC númer:

G04BD04

INN (Alþjóðlegt nafn):

OXYBUTYNIN

Skammtar:

5MG

Lyfjaform:

TABLET

Samsetning:

OXYBUTYNIN CHLORIDE 5MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

100

Gerð lyfseðils:

Prescription

Lækningarsvæði:

Antimuscarinics

Vörulýsing:

Active ingredient group (AIG) number: 0114692001; AHFS:

Leyfisstaða:

CANCELLED POST MARKET

Leyfisdagur:

2014-08-21

Vara einkenni

PRODUCT MONOGRAPH
AVA-OXYBUTYNIN
(Oxybutynin Chloride)
Tablets, USP
ANTICHOLINERGIC / ANTISPASMODIC AGENT
AVANSTRA INC.
DATE OF PREPARATION:
10761 – 25th NE, Suite 110, Building “B”
February 17, 2011
Calgary, Alberta
T2C 3C2
Control # 144956
[1]
PRODUCT MONOGRAPH
AVA-OXYBUTYNIN
(Oxybutynin Chloride)
Tablets, USP
THERAPEUTIC CLASSIFICATION
Anticholinergic / Antispasmodic Agent
ACTION AND CLINICAL PHARTMACOLOGY
Oxybutynin chloride is a tertiary amine anticholinergic agent which
exerts anti-muscarinic as
well as direct antispasmodic action on smooth muscle. In vitro studies
have shown that its
anticholinergic effects are weaker than those of atropine, but that it
possesses greater
antispasmodic activity. No blocking effects occur at skeletal
neuromuscular junctions or in
autonomic ganglia (no antinicotinic effects).
In addition to its smooth muscle relaxing effects, oxybutynin chloride
exerts an analgesic and a
local anesthetic effect. In animal studies the central nervous system
and cardiovascular actions of
oxybutynin chloride were shown to be similar to, but weaker than,
those of atropine.
Oxybutynin chloride relaxes bladder smooth muscle. In patients with
uninhibited neurogenic and
reflex neurogenic bladder, cystometric studies have demonstrated that
oxybutynin chloride
increases bladder (vesical) capacity, diminishes the frequency of
uninhibited contractions of the
detrusor muscle, and delays the initial desire to void. Oxybutynin
chloride thus decreases
urgency and the frequency of both incontinent episodes and voluntary
urination. These effects
are more consistently improved in patients with uninhibited neurogenic
bladder.
Oxybutynin chloride is readily absorbed from the gastrointestinal
tract. The onset of action is
approximately one hour after an oral dose and its duration 6 to 10
hours.
[2]
Comparative Bioavailability
A two-way, single-dose, open-label, randomized crossover
bioavailability study in 18 normal
male volunteers was conducted to evaluate the relative bioavailability
of a 10 mg dose of AVA