Country: Canada
Language: English
Source: Health Canada
OXYBUTYNIN CHLORIDE
PURDUE PHARMA
G04BD04
OXYBUTYNIN
10MG
TABLET (EXTENDED-RELEASE)
OXYBUTYNIN CHLORIDE 10MG
ORAL
100
Prescription
Antimuscarinics
Active ingredient group (AIG) number: 0114692004; AHFS:
CANCELLED POST MARKET
2013-08-01
_ _ _ _ _Page 1 of 26_ PRODUCT MONOGRAPH Pr UROMAX ® Oxybutynin Chloride Controlled Release Tablets – 5, 10 and 15 mg Anticholinergic-Antispasmodic ATC: G04BD04 Purdue Pharma 575 Granite Court Pickering, ON L1W 3W8 DATE OF REVISION: October 16, 2013 SUBMISSION CONTROL NO: 167196 _ _ _ _ _Page 2 of 26_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................3 WARNINGS AND PRECAUTIONS ..................................................................................4 ADVERSE REACTIONS ....................................................................................................5 DRUG INTERACTIONS ....................................................................................................9 DOSAGE AND ADMINISTRATION ..............................................................................10 OVERDOSAGE ................................................................................................................10 ACTION AND CLINICAL PHARMACOLOGY ............................................................11 STORAGE AND STABILITY ..........................................................................................13 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................14 PART II: SCIENTIFIC INFORMATION ...............................................................................15 PHARMACEUTICAL INFORMATION ..........................................................................15 CLINICAL TRIALS ..........................................................................................................16 DETAILED PHARMACOLOGY ................................................. Read the complete document