PMS-AMLODIPINE-ATORVASTATIN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
03-05-2019
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Active ingredient:
AMLODIPINE (AMLODIPINE BESYLATE); ATORVASTATIN (ATORVASTATIN CALCIUM)
Available from:
PHARMASCIENCE INC
ATC code:
C10BX03
INN (International Name):
ATORVASTATIN AND AMLODIPINE
Dosage:
10MG; 20MG
Pharmaceutical form:
TABLET
Composition:
AMLODIPINE (AMLODIPINE BESYLATE) 10MG; ATORVASTATIN (ATORVASTATIN CALCIUM) 20MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
HMG-COA REDUCTASE INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0251555006; AHFS:
Authorization status:
APPROVED
Authorization date:
2013-03-26
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
PMS-AMLODIPINE-ATORVASTATIN
Amlodipine besylate and Atorvastatin calcium Tablets
5 mg/10 mg, 5 mg/20 mg and 10 mg/10 mg, 10 mg/20 mg
Amlodipine, as Amlodipine besylate/Atorvastatin, as Atorvastatin
calcium
ANTI-HYPERTENSIVE/ANTI-ANGINAL AGENT AND LIPID METABOLISM REGULATOR
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
www.pharmascience.com
DATE OF REVISION:
May 3, 2019
Submission Control No: 226468
_pms-AMLODIPINE-ATORVASTATIN Product Monograph _
_Page 2 of 70_
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
.........................................................................................................
12
DRUG INTERACTIONS
.........................................................................................................
19
DOSAGE AND ADMINISTRATION
.....................................................................................
30
OVERDOSAGE
.......................................................................................................................
32
STORAGE AND STABILITY
.................................................................................................
39
SPECIAL HANDLING INSTRUCTIONS
..............................................................................
39
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 39
PART II: SCIENTIFIC INFORMATION
..........................................................................
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