NTP-OXYBUTYNIN TABLET

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

OXYBUTYNIN CHLORIDE

可用日期:

TEVA CANADA LIMITED

ATC代码:

G04BD04

INN（国际名称）:

OXYBUTYNIN

剂量:

5MG

药物剂型:

TABLET

组成:

OXYBUTYNIN CHLORIDE 5MG

给药途径:

ORAL

每包单位数:

100/500

处方类型:

Prescription

治疗领域:

Antimuscarinics

產品總結:

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

授权状态:

CANCELLED PRE MARKET

授权日期:

2015-08-06

产品特点

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