METOPROLOL TARTRATE INJECTION, USP SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

METOPROLOL TARTRATE

Available from:

STRIDES PHARMA CANADA INC

ATC code:

C07AB02

INN (International Name):

METOPROLOL

Dosage:

1MG

Pharmaceutical form:

SOLUTION

Composition:

METOPROLOL TARTRATE 1MG

Administration route:

INTRAVENOUS

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

BETA-ADRENERGIC BLOCKING AGENTS

Product summary:

Active ingredient group (AIG) number: 0111923004; AHFS:

Authorization status:

APPROVED

Authorization date:

2020-08-13

Summary of Product characteristics

_Page 1 of 37 _
PRODUCT MONOGRAPH
PR
METOPROLOL TARTRATE INJECTION, USP
1 mg/mL – 5 mL vial
STERILE SOLUTION FOR INTRAVENOUS INJECTION
ß-Adrenergic Receptor Blocking Agent
Strides Pharma Canada Inc.
1565, Boul. Lionel-Boulet
Varennes, Quebec
Canada, J3X 1P7
Date of Revision:
August 12, 2020
Submission Control No.: 241321
_Page 2 of 37 _
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
....................................................................................................
9
DRUG INTERACTIONS
..................................................................................................
11
DOSAGE AND ADMINISTRATION
..............................................................................
17
OVERDOSAGE
................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 20
STORAGE AND STABILITY
..........................................................................................
23
SPECIAL HANDLING INSTRUCTIONS
.......................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 24
PART II: SCIENTIFIC INFORMATION
...............................................................................
25
PHARMACEUTICAL INFORMATION
..........................................................................
25
DETAILED PHARMACOLOGY
....................