PENDO-METOPROLOL-L TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
06-10-2016
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Active ingredient:
METOPROLOL TARTRATE
Available from:
PENDOPHARM DIVISION OF PHARMASCIENCE INC
ATC code:
C07AB02
INN (International Name):
METOPROLOL
Dosage:
50MG
Pharmaceutical form:
TABLET
Composition:
METOPROLOL TARTRATE 50MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
BETA-ADRENERGIC BLOCKING AGENTS
Product summary:
Active ingredient group (AIG) number: 0111923002; AHFS:
Authorization status:
APPROVED
Authorization date:
2014-08-01
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
PENDO-METOPROLOL-L
Metoprolol Tartrate Tablets, USP
25 mg and 50 mg
Β-ADRENERGIC RECEPTOR BLOCKING AGENT
PENDOPHARM, DIVISION OF/DE PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Canada
H4P 2T4
DATE OF REVISION:
September 28, 2016
www.pendopharm.com
SUBMISSION CONTROL NO: 197898
_pendo-METOPROLOL-L Product Monograph _
_Page 2 of 38_
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..................................................................................................
10
DRUG INTERACTIONS
..................................................................................................
13
DOSAGE AND ADMINISTRATION
..............................................................................
17
OVERDOSAGE
................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 20
STORAGE AND STABILITY
..........................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 24
PART II: SCIENTIFIC INFORMATION
...............................................................................
25
PHARMACEUTICAL
INFORMATION..........................................................................
25
DETAILED PHARMACOLOGY
.....................................................................................
26
TOXICOLOGY
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