Country: Canada
Language: English
Source: Health Canada
FLUCONAZOLE
DOMINION PHARMACAL
J02AC01
FLUCONAZOLE
50MG
TABLET
FLUCONAZOLE 50MG
ORAL
50/100
Prescription
AZOLES
Active ingredient group (AIG) number: 0122529001; AHFS:
APPROVED
2002-07-02
PRODUCT MONOGRAPH PR DOM-FLUCONAZOLE (Fluconazole) C Tablets 50 &100 mg C Capsules 150 mg ANTIFUNGAL AGENT DOMINION PHARMACAL DATE OF PREPARATION: 6111 Royalmount Ave., Suite 100 April 22, 2008 Montreal, Quebec H4P 2T4 CONTROL NO. 121426 Page 2 of 47 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ......................................................... 3 SUMMARY PRODUCT INFORMATION................................................................................. 3 INDICATIONS AND CLINICAL USE ...................................................................................... 3 CONTRAINDICATIONS ........................................................................................................... 4 WARNINGS AND PRECAUTIONS .......................................................................................... 4 ADVERSE REACTIONS............................................................................................................ 8 DRUG INTERACTIONS .......................................................................................................... 12 DOSAGE AND ADMINISTRATION ...................................................................................... 17 OVERDOSAGE ........................................................................................................................ 20 STORAGE AND STABILITY .................................................................................................. 22 DOSAGE FORMS, COMPOSITION AND PACKAGING ...................................................... 22 PART II: SCIENTIFIC INFORMATION ............................................................................... 23 PHARMACEUTICAL INFORMATION.................................................................................. 23 C LINICAL T RIALS ........................................................................................................................ 23 DETAILED PHARMACOLOGY .................................................................................... Read the complete document