MAR-FEBUXOSTAT TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
22-01-2020
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Active ingredient:
FEBUXOSTAT (FEBUXOSTAT HEMIHYDRATE)
Available from:
MARCAN PHARMACEUTICALS INC
ATC code:
M04AA03
INN (International Name):
FEBUXOSTAT
Dosage:
80MG
Pharmaceutical form:
TABLET
Composition:
FEBUXOSTAT (FEBUXOSTAT HEMIHYDRATE) 80MG
Administration route:
ORAL
Units in package:
30/100/1000
Prescription type:
Prescription
Therapeutic area:
ANTIGOUT AGENTS
Product summary:
Active ingredient group (AIG) number: 0152809001; AHFS:
Authorization status:
APPROVED
Authorization date:
2019-04-23
Summary of Product characteristics
Page 1 of 32
PRODUCT MONOGRAPH
PR
MAR-FEBUXOSTAT
Febuxostat Tablets
80 mg febuxostat (as febuxostat hemihydrate)
Preparations Inhibiting Uric Acid Production
Marcan Pharmaceuticals Inc.
2 Gurdwara Road, Suite #112,
Ottawa, ON, K2E 1A2
Date of Revision:
January 22, 2020
Control # 234069
Page 2 of 32
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT
INFORMATION
..............................................................................................................................
3
INDICATIONS AND CLINICAL USE
................................................................................
3
CONTRAINDICATIONS
.....................................................................................................
3
WARNINGS AND PRECAUTIONS
....................................................................................
3
ADVERSE REACTIONS
......................................................................................................
6
DRUG INTERACTIONS
....................................................................................................
10
DOSAGE AND ADMINISTRATION
................................................................................
12
ACTION AND CLINICAL PHARMACOLOGY
............................................................... 13
STORAGE AND STABILITY
............................................................................................
15
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................ 15
PART II: SCIENTIFIC INFORMATION
.................................................................................
16
PHARMACEUTICAL INFORMATION
............................................................................
16
CLINICAL TRIALS
............................................................................................................
18
DETAILED PHARMACOLOGY
.......................................................................................
24
TOXICOLOGY
..............................................
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