MYLAN-OXYBUTYNIN TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

OXYBUTYNIN CHLORIDE

Commercializzato da:

MYLAN PHARMACEUTICALS ULC

Codice ATC:

G04BD04

INN (Nome Internazionale):

OXYBUTYNIN

Dosaggio:

5MG

Forma farmaceutica:

TABLET

Composizione:

OXYBUTYNIN CHLORIDE 5MG

Via di somministrazione:

ORAL

Confezione:

100

Tipo di ricetta:

Prescription

Area terapeutica:

Antimuscarinics

Dettagli prodotto:

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

Stato dell'autorizzazione:

CANCELLED POST MARKET

Data dell'autorizzazione:

2016-06-28

Scheda tecnica

PRODUCT MONOGRAPH
PR
MYLAN-OXYBUTYNIN
(Oxybutynin chloride tablets, USP)
5 MG
Anticholinergic - Antispasmodic agent
MYLAN PHARMACEUTICALS ULC
Date of Preparation:
85 Advance Road
September 2, 2009
Toronto, Ontario
M8Z 2S6
Control#: 132253
1
PRODUCT MONOGRAPH
PR
MYLAN-OXYBUTYNIN
(Oxybutynin chloride tablets, USP)
5 MG
THERAPEUTIC CLASSIFICATION
Anticholinergic/Antispasmodic Agent
ACTION AND CLINICAL PHARMACOLOGY
:
Pharmacology:
Oxybutynin chloride is a synthetic tertiary amine which exerts a
direct spasmolytic (papaverine-
like) action and an antimuscarinic (atropine-like) action on smooth
muscle. Oxybutynin does not
appear to exhibit antinicotinic effects (i.e., block acetylcholine
effects at skeletal myoneural
junctions or at autonomic ganglia).
The spasmolytic effect of the drug has been demonstrated on the
detrusor muscle of the bladder,
the small intestine, and the colon of various animals. Unlike
papaverine, however, oxybutynin
appears to have little or no effect on the smooth muscle of blood
vessels.
2
Cystometric studies in patients with uninhibited neurogenic and reflex
neurogenic bladders
indicate that oxybutynin chloride increases urinary bladder capacity,
diminishes the frequency of
uninhibited contractions of the detrusor muscle, and delays the
initial desire to void. These
effects were more evident in patients with uninhibited neurogenic
bladders than in those with
reflex neurogenic bladders.
In animal studies, the drug has shown moderate antihistaminic, some
local anesthetic, some mild
analgesic, and very low mydriatic and antisialagogue activity.
Pharmacokinetics:
Absorption:
Based on animal studies, oxybutynin chloride appears to be rapidly and
well absorbed from the
gastrointestinal tract following oral administration. In rats, studies
using radiolabeled drug
indicated that peak radioactivity occurred in plasma approximately 2
hours following oral
administration of the drug, and radioactivity was no longer detectable
in the plasma 72 hours
after administration. Plasma concentrations required for