PHL-OXYBUTYNIN SYRUP

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

OXYBUTYNIN CHLORIDE

Предлага се от:

PHARMEL INC

АТС код:

G04BD04

INN (Международно Name):

OXYBUTYNIN

дозиране:

5MG

Лекарствена форма:

SYRUP

Композиция:

OXYBUTYNIN CHLORIDE 5MG

Начин на приложение:

ORAL

Броя в опаковка:

500ML

Вид предписание :

Prescription

Терапевтична област:

Antimuscarinics

Каталог на резюме:

Active ingredient group (AIG) number: 0114692002; AHFS:

Статус Оторизация:

CANCELLED POST MARKET

Дата Оторизация:

2004-12-06

Данни за продукта

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