Nazione: Canada
Lingua: inglese
Fonte: Health Canada
OXYBUTYNIN CHLORIDE
PHARMEL INC
G04BD04
OXYBUTYNIN
5MG
SYRUP
OXYBUTYNIN CHLORIDE 5MG
ORAL
500ML
Prescription
Antimuscarinics
Active ingredient group (AIG) number: 0114692002; AHFS:
CANCELLED POST MARKET
2004-12-06
PRODUCT MONOGRAPH PR PHL-OXYBUTYNIN (OXYBUTYNIN CHLORIDE TABLETS, USP ) 2.5 & 5 MG (OXYBUTYNIN CHLORIDE SYRUP, USP) 1 MG/ML ANTICHOLINERGIC/ANTISPASMODIC AGENT PHARMEL INC. DATE OF PREPARATION: 8699, 8TH AVE November 5, 2004 MONTRÉAL, QUÉBEC H1Z 2X4 CONTROL NO.: 095059 DATE OF REVISION: 2 PRODUCT MONOGRAPH Pr phl-OXYBUTYNIN (Oxybutynin Chloride Tablets, USP) 2.5 & 5mg Tablets (Oxybutynin Chloride Syrup, USP) 1 mg/mL THERAPEUTIC CLASSIFICATION Anticholinergic / Antispasmodic Agent ACTION AND CLINICAL PHARMACOLOGY 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 anaesthetic 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 both incontinent episodes and voluntary urination. These effects are more consistently improved in 3 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 phl-OXYBUTYNIN 5 m Leggi il documento completo