METOPROLOL TARTRATE INJECTION USP SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

METOPROLOL TARTRATE

Available from:

JUNO PHARMACEUTICALS CORP.

ATC code:

C07AB02

INN (International Name):

METOPROLOL

Dosage:

1MG

Pharmaceutical form:

SOLUTION

Composition:

METOPROLOL TARTRATE 1MG

Administration route:

INTRAVENOUS

Units in package:

10X5ML

Prescription type:

Prescription

Therapeutic area:

BETA-ADRENERGIC BLOCKING AGENTS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2020-04-16

Summary of Product characteristics

_Metoprolol Tartrate Injection USP Page 1 of 38 _
PRODUCT MONOGRAPH PR
METOPROLOL TARTRATE INJECTION USP
(metoprolol tartrate)
5 mL vials (1 mg / mL)
Sterile Solution
β-Adrenergic Receptor Blocking Agent
Juno Pharmaceuticals Corp.
402-2233 Argentia Road
Mississauga, Ontario
L5N 2X7
Date of Revision:
July 05, 2023
M
Submission Control No: 271006
_Metoprolol Tartrate Injection USP 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
....................................................................................................
12
DOSAGE AND ADMINISTRATION
................................................................................
18
OVERDOSAGE
..................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
.............................................................. 21
STORAGE AND STABILITY
............................................................................................
24
SPECIAL HANDLING INSTRUCTIONS
.........................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................... 25
PART II: SCIENTIFIC INFORMATION
.................................................................................
26
PHARMACEUTICAL INFORMATION
....................................