APO-MIRTAZAPINE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MIRTAZAPINE

Available from:

APOTEX INC

ATC code:

N06AX11

INN (International Name):

MIRTAZAPINE

Dosage:

45MG

Pharmaceutical form:

TABLET

Composition:

MIRTAZAPINE 45MG

Administration route:

ORAL

Units in package:

30

Prescription type:

Prescription

Therapeutic area:

MISCELLANEOUS ANTIDEPRESSANTS

Product summary:

Active ingredient group (AIG) number: 0143928003; AHFS:

Authorization status:

APPROVED

Authorization date:

2006-10-03

Summary of Product characteristics

_APO-MIRTAZAPINE (Mirtazapine Tablets) _
_ _
_Page 1 of 44 _
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-MIRTAZAPINE
Mirtazapine Tablets
15 mg, 30 mg and 45 mg
USP
Antidepressant
Apotex Inc.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
October 03, 2006
Date of Revision:
January 31, 2022
Submission Control Number: 257508
_APO-MIRTAZAPINE (Mirtazapine Tablets) _
_ _
_Page 2 of 44 _
_ _
RECENT MAJOR LABEL CHANGES
Warnings and Precautions, Skin (7)
01/2022
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................... 4
1
INDICATIONS
..................................................................................................................
4
1.1
PEDIATRICS
...................................................................................................................
4
1.2
GERIATRICS
...................................................................................................................
4
2
CONTRAINDICATIONS
.....................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
................................................................. 5
4
DOSAGE AND ADMINISTRATION
..................................................................................
5
4.1
DOSING CONSIDERATIONS
...........................................................................................
5
4.2
RECOMMENDED DOSE AND DOSAGE ADJUSTMENT
................................................... 5
4.3
ADMINISTRATION
.........................................................................................................
6
4.4
RECONSTITUTION
.........................................................................................................
6
4.5
MISSED DOSE
................................................................................................................
6
5
OVERDOSAGE
.....................................................