RIVA-OXYBUTYNIN TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

OXYBUTYNIN CHLORIDE

Boleh didapati daripada:

LABORATOIRE RIVA INC.

Kod ATC:

G04BD04

INN (Nama Antarabangsa):

OXYBUTYNIN

Dos:

5MG

Borang farmaseutikal:

TABLET

Komposisi:

OXYBUTYNIN CHLORIDE 5MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

100\500

Jenis preskripsi:

Prescription

Kawasan terapeutik:

Antimuscarinics

Ringkasan produk:

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

Status kebenaran:

APPROVED

Tarikh kebenaran:

2007-09-14

Ciri produk

PRODUCT MONOGRAPH
PR
RIVA-OXYBUTYNIN
Oxybutynin Chloride Tablets
5 mg
ANTICHOLINERGIC/ANTISPASMODIC AGENT
LABORATOIRE RIVA INC.
660 Industriel Blvd.
Blainville, Quebec, Canada.
J7C 3V4
www.labriva.com
Date of Revision:
February 1, 2016
Submission Control No: 191358
_Product Monograph – RIVA-OXYBUTYNIN _
_Page 2 of 15_
PRODUCT MONOGRAPH
Pr
RIVA-OXYBUTYNIN
Oxybutynin Chloride Tablets
5 mg
THERAPEUTIC CLASSIFICATION
Anticholinergic / Antispasmodic Agent
ACTION AND CLINICAL PHARMACOLOGY
RIVA-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 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
_Product Monograph – RIVA-OXYBUTYNIN _
_Page 3 of 15_
approximately one hour after an oral dose and its duration 6 to 10
hours.
The results of the present investigation show that no statistical
difference could be detected for all the
pharmacokinetic p