PMS-OXYBUTYNIN TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

OXYBUTYNIN CHLORIDE

Disponible depuis:

PHARMASCIENCE INC

Code ATC:

G04BD04

DCI (Dénomination commune internationale):

OXYBUTYNIN

Dosage:

5MG

forme pharmaceutique:

TABLET

Composition:

OXYBUTYNIN CHLORIDE 5MG

Mode d'administration:

ORAL

Unités en paquet:

100/500

Type d'ordonnance:

Prescription

Domaine thérapeutique:

Antimuscarinics

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

1999-08-06

Résumé des caractéristiques du produit

PRODUCT MONOGRAPH
PMS-OXYBUTYNIN
(Oxybutynin Chloride Syrup and Tablets, USP )
1 mg/mL Syrup
2.5mg & 5mg Tablets
ANTICHOLINERGIC/ANTISPASMODIC AGENT
Pharmascience Inc.
6111 Royalmount Avenue
Suite #100
Date of Revision:
Montreal, CANADA
October 28, 2010
H4P 2T4
Submission Control No: 137911
2
PRODUCT MONOGRAPH
NAME OF DRUG
pms-OXYBUTYNIN
(Oxybutynin Chloride Syrup and Tablets, USP)
1mg/mL Syrup, 2.5mg & 5mg Tablets
THERAPUETIC CLASSIFICATION
Anticholinergic / Antispasmodic Agent
ACTION AND CLINICAL PHARMACOLOGY
pms-OXYBUTYNIN (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
anesthetic 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
3
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 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 pms-O