OXYTROL PATCH

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

OXYBUTYNIN

Pieejams no:

ALLERGAN INC

ATĶ kods:

G04BD04

SNN (starptautisko nepatentēto nosaukumu):

OXYBUTYNIN

Deva:

3.9MG

Zāļu forma:

PATCH

Kompozīcija:

OXYBUTYNIN 3.9MG

Ievadīšanas:

TRANSDERMAL

Vienības iepakojumā:

8

Receptes veids:

Prescription

Ārstniecības joma:

Antimuscarinics

Produktu pārskats:

Active ingredient group (AIG) number: 0150161002; AHFS:

Autorizācija statuss:

CANCELLED POST MARKET

Autorizācija datums:

2022-11-01

Produkta apraksts

PRODUCT MONOGRAPH
Pr
OXYTROL
®
OXYBUTYNIN TRANSDERMAL SYSTEM
Continuous Delivery for Twice Weekly Dosing
36 mg oxybutynin (3.9 mg / day system)
Antispasmodic / anticholinergic agent for treatment of overactive
bladder
Allergan Inc.
500 – 85 Enterprise Blvd.
Markham, Ontario
L6G 0B5
www.allergan.ca
Date of Preparation:
March 16, 2018
Control #: 213636
Page 2 of 25
PRODUCT MONOGRAPH
Pr
OXYTROL
®
OXYBUTYNIN TRANSDERMAL SYSTEM
CONTINUOUS DELIVERY FOR TWICE WEEKLY DOSING
36 MG OXYBUTYNIN (3.9 MG / DAY SYSTEM)
THERAPEUTIC CLASSIFICATION
Antispasmodic / anticholinergic agent for treatment of overactive
bladder
ACTIONS AND CLINICAL PHARMACOLOGY
Oxybutynin acts as a competitive antagonist of acetylcholine at
postganglionic muscarinic
receptors, resulting in relaxation of bladder smooth muscle. In
patients with overactive bladder,
characterized by detrusor muscle instability or hyperreflexia,
cystometric studies have
demonstrated that oxybutynin increases maximum urinary bladder
capacity and increases the
volume to first detrusor contraction. Oxybutynin thus decreases
urinary urgency and the
frequency of both incontinence episodes and voluntary urination.
Oxybutynin is a racemic (50:50) mixture of R- and S-isomers.
Antimuscarinic activity resides
predominantly in the R-isomer. The R-isomer of oxybutynin shows
greater selectivity for the M
3
and M
1
muscarinic subtypes (predominant in bladder detrusor muscle and
parotid gland)
compared to the M
2
subtype (predominant in cardiac tissue). The active metabolite,
N-desethyloxybutynin, has pharmacological activity on the human
detrusor muscle that is similar
to that of oxybutynin in _in vitro_ studies.
OXYTROL (oxybutynin transdermal system) is designed to deliver
oxybutynin continuously and
consistently over a 3 to 4-day time interval after application to
intact skin. The OXYTROL
system has a skin contact surface area of 39 cm
2
and contains 36 mg of oxybutynin.
Oxybutynin is transported across intact skin and into the systemic
circulation by passive
diffusion across the st