METOPROLOL-L TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
31-03-2021
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Active ingredient:
METOPROLOL TARTRATE
Available from:
SIVEM PHARMACEUTICALS ULC
ATC code:
C07AB02
INN (International Name):
METOPROLOL
Dosage:
25MG
Pharmaceutical form:
TABLET
Composition:
METOPROLOL TARTRATE 25MG
Administration route:
ORAL
Units in package:
100/500
Prescription type:
Prescription
Therapeutic area:
BETA-ADRENERGIC BLOCKING AGENTS
Product summary:
Active ingredient group (AIG) number: 0111923005; AHFS:
Authorization status:
APPROVED
Authorization date:
2015-07-03
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
METOPROLOL-L
Metoprolol Tartrate Tablets, USP
25 mg, 50 mg and 100 mg
Β-ADRENERGIC RECEPTOR BLOCKING AGENT
Sivem Pharmaceuticals ULC
4705 Dobrin Street
Saint-Laurent, Quebec
H4R 2P7
www.sivem.ca DATE OF REVISION:
March 31, 2021
SUBMISSION CONTROL NO.: 249498
_METOPROLOL-L Product Monograph _
_Page 2 of 39_
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
..................................................................................................11
DRUG INTERACTIONS
..................................................................................................13
DOSAGE AND ADMINISTRATION
..............................................................................17
OVERDOSAGE
................................................................................................................20
ACTION AND CLINICAL PHARMACOLOGY
............................................................21
STORAGE AND STABILITY
..........................................................................................24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................24
PART II: SCIENTIFIC INFORMATION
...............................................................................26
PHARMACEUTICAL INFORMATION
..........................................................................26
DETAILED PHARMACOLOGY
.....................................................................................27
TOXICOLOGY
.....................................................
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