PHL-OXYBUTYNIN TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

OXYBUTYNIN CHLORIDE

Disponible desde:

PHARMEL INC

Código ATC:

G04BD04

Designación común internacional (DCI):

OXYBUTYNIN

Dosis:

2.5MG

formulario farmacéutico:

TABLET

Composición:

OXYBUTYNIN CHLORIDE 2.5MG

Vía de administración:

ORAL

Unidades en paquete:

100

tipo de receta:

Prescription

Área terapéutica:

Antimuscarinics

Resumen del producto:

Active ingredient group (AIG) number: 0114692003; AHFS:

Estado de Autorización:

CANCELLED POST MARKET

Fecha de autorización:

2004-12-02

Ficha técnica

PRODUCT MONOGRAPH
PR
PHL-OXYBUTYNIN
(OXYBUTYNIN CHLORIDE TABLETS, USP )
2.5 & 5 MG
(OXYBUTYNIN CHLORIDE SYRUP, USP)
1 MG/ML
ANTICHOLINERGIC/ANTISPASMODIC AGENT
PHARMEL INC.
DATE OF PREPARATION:
8699, 8TH AVE
November 5, 2004
MONTRÉAL, QUÉBEC
H1Z 2X4
CONTROL NO.: 095059
DATE OF REVISION:
2
PRODUCT MONOGRAPH
Pr
phl-OXYBUTYNIN
(Oxybutynin Chloride Tablets, USP)
2.5 & 5mg Tablets
(Oxybutynin Chloride Syrup, USP)
1 mg/mL
THERAPEUTIC CLASSIFICATION
Anticholinergic / Antispasmodic Agent
ACTION AND CLINICAL PHARMACOLOGY
Oxybutynin Chloride is a tertiary amine anticholinergic agent which
exerts antimuscarinic 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 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 exerts
an analgesic and a local
anaesthetic effect. In animal studies the central nervous system and
cardiovascular actions of
oxybutynin were shown to be similar to but weaker than those of
atropine.
Oxybutynin relaxes bladder smooth muscle. In patients with uninhibited
neurogenic and reflex
neurogenic bladder, cystometric studies have demonstrated that
oxybutynin increases bladder
(vesical) capacity, diminishes the frequency of uninhibited
contractions of the detrusor muscle, and
delays the initial desire to void. Oxybutynin thus decreases urgency
and the frequency of both
incontinent episodes and voluntary urination. These effects are more
consistently improved in
3
patients with uninhibited neurogenic bladder.
Oxybutynin chloride is readily absorbed from the gastro-intestinal
tract. The onset of action is
approximately one hour after an oral dose and its duration 6 to 10
hours.
A single blind, single dose, randomized, cross-over study was carried
out to evaluate the rate and
extent of absorption and bioequivalence between phl-OXYBUTYNIN 5 m