NTP-OXYBUTYNIN TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

OXYBUTYNIN CHLORIDE

Tilgjengelig fra:

TEVA CANADA LIMITED

ATC-kode:

G04BD04

INN (International Name):

OXYBUTYNIN

Dosering :

5MG

Legemiddelform:

TABLET

Sammensetning:

OXYBUTYNIN CHLORIDE 5MG

Administreringsrute:

ORAL

Enheter i pakken:

100/500

Resept typen:

Prescription

Terapeutisk område:

Antimuscarinics

Produkt oppsummering:

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

Autorisasjon status:

CANCELLED PRE MARKET

Autorisasjon dato:

2015-08-06

Preparatomtale

1
PRODUCT MONOGRAPH
NTP–OXYBUTYNIN
(oxybutynin chloride)
Tablets
USP
Anticholinergic/Antispasmodic Agent
Teva Canada Limited
Date of Preparation:
30 Novopharm Court
June 21, 2013
Toronto, Ontario
Canada, M1B 2K9
Submission Control No: 165702
2
PRODUCT MONOGRAPH
NTP–OXYBUTYNIN
(oxybutynin chloride)
Tablets
USP
PHARMACOLOGICAL CLASSIFICATION
Anticholinergic/Antispasmodic Agent
ACTION AND CLINICAL PHARMACOLOGICAL
NTP–OXYBUTYNIN (oxybutynin chloride) is a tertiary amine
anticholinergic agent which exerts
antimuscarinic in addition to direct antispasmodic action on smooth
muscle. Studies _in vitro _ have shown
that its anticholinergic effects are weaker than those of atropine,
however, it possesses greater
antispasmodic activity. No blocking effects occur at either skeletal
neuromuscular junctions or in
autonomic ganglia (no antinicotinic effects).
Oxybutynin chloride exerts an analgesic and a local anesthetic effect
in addition to its smooth muscle
relaxing effects. Studies conducted in animals revealed that the
central nervous system and
cardiovascular actions of oxybutynin were similar to but weaker than
those of atropine.
Bladder smooth muscle is relaxed by oxybutynin chloride. Cystometric
studies in patients with
uninhibited neurogenic and reflex neurogenic bladder have demonstrated
that oxybutynin chloride
increases bladder (vesical) capacity, diminishes the frequency of
uninhibited contractions of the detrusor
muscle, and delays the initial desire to void. Therefore, urgency and
the frequency of both incontinent
episodes and voluntary urination are decreased by oxybutynin chloride.
In patients with uninhibited
neurogenic bladder, these effects are more consistently improved.
3
Oxybutynin chloride is readily absorbed from the gastrointestinal
tract. The onset of action is
approximately one hour after an oral dose and its duration 6 to 10
hours.
A single-dose, fasting comparative bioavailability study was performed
on two 5 mg oxybutynin chloride
products, NTP-OXYBUTYNIN 5 mg tablets and Ditropan
®
5 mg ta