देश: कनाडा
भाषा: अंग्रेज़ी
स्रोत: Health Canada
OXYBUTYNIN CHLORIDE
PHARMASCIENCE INC
G04BD04
OXYBUTYNIN
5MG
SYRUP
OXYBUTYNIN CHLORIDE 5MG
ORAL
500ML
Prescription
Antimuscarinics
Active ingredient group (AIG) number: 0114692002; AHFS:
MARKETED
1996-09-04
PRODUCT MONOGRAPH PMS-OXYBUTYNIN (Oxybutynin Chloride Syrup and Tablets, USP ) 1 mg/mL Syrup 2.5mg & 5mg Tablets ANTICHOLINERGIC/ANTISPASMODIC AGENT Pharmascience Inc. 6111 Royalmount Avenue Suite #100 Date of Revision: Montreal, CANADA October 28, 2010 H4P 2T4 Submission Control No: 137911 2 PRODUCT MONOGRAPH NAME OF DRUG pms-OXYBUTYNIN (Oxybutynin Chloride Syrup and Tablets, USP) 1mg/mL Syrup, 2.5mg & 5mg Tablets THERAPUETIC CLASSIFICATION Anticholinergic / Antispasmodic Agent ACTION AND CLINICAL PHARMACOLOGY pms-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 3 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 approximately one hour after an oral dose and its duration 6 to 10 hours. A single blind, single dose, randomized, cross-over study was carried out to evaluate the rate and extent of absorption and bioequivalence between pms-O पूरा दस्तावेज़ पढ़ें