ATORVASTATIN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
08-12-2014
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Active ingredient:
ATORVASTATIN (ATORVASTATIN CALCIUM)
Available from:
RANBAXY PHARMACEUTICALS CANADA INC.
ATC code:
C10AA05
INN (International Name):
ATORVASTATIN
Dosage:
10MG
Pharmaceutical form:
TABLET
Composition:
ATORVASTATIN (ATORVASTATIN CALCIUM) 10MG
Administration route:
ORAL
Units in package:
90/500
Prescription type:
Prescription
Therapeutic area:
HMG-COA REDUCTASE INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0133055001; AHFS:
Authorization status:
APPROVED
Authorization date:
2014-12-19
Summary of Product characteristics
_ _
_ATORVASTATIN (Atorvastatin Calcium Tablets) Product Monograph _
_Page 1 of 50_
PRODUCT MONOGRAPH
ATORVASTATIN
(ATORVASTATIN CALCIUM TABLETS)
10 MG, 20 MG, 40 MG AND 80 MG ATORVASTATIN
LIPID METABOLISM REGULATOR
Ranbaxy Pharmaceuticals Canada Inc.
2680 Matheson Blvd. East, Suite 200
Mississauga, ON
L4W 0A5
Date of Preparation:
December 8, 2014
Submission Control No: 179960
_ _
_ATORVASTATIN (Atorvastatin Calcium Tablets) Product Monograph _
_Page 2 of 50_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................5
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
..................................................................................................10
DRUG INTERACTIONS
..................................................................................................13
DOSAGE AND ADMINISTRATION
..............................................................................18
OVERDOSAGE
................................................................................................................19
ACTION AND CLINICAL PHARMACOLOGY
............................................................19
STORAGE AND STABILITY
..........................................................................................23
SPECIAL HANDLING INSTRUCTIONS
.......................................................................23
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................23
PART II: SCIENTIFIC INFORMATION
...............................................................................24
PHARMACEUTICAL INFORMATION
.............
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