APO-NORTRIPTYLINE - CAP 25MG CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

NORTRIPTYLINE (NORTRIPTYLINE HYDROCHLORIDE)

Available from:

APOTEX INC

ATC code:

N06AA10

INN (International Name):

NORTRIPTYLINE

Dosage:

25MG

Pharmaceutical form:

CAPSULE

Composition:

NORTRIPTYLINE (NORTRIPTYLINE HYDROCHLORIDE) 25MG

Administration route:

ORAL

Units in package:

100/500

Prescription type:

Prescription

Therapeutic area:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0102630001; AHFS:

Authorization status:

APPROVED

Authorization date:

2021-12-02

Summary of Product characteristics

_APO-NORTRIPTYLINE (_
_Nortriptyline Hydrochloride Capsules) _
_Page 1 of 32_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-NORTRIPTYLINE
Nortriptyline Hydrochloride Capsules
Capsules, 10 mg and 25 mg, Oral
USP
Antidepressant
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
JUN 27, 1996
Date or Revision:
JUN 07, 2023
Submission Control Number: 275780
_APO-NORTRIPTYLINE (_
_Nortriptyline Hydrochloride Capsules) _
_Page 2 of 32_
RECENT MAJOR LABEL CHANGES
N/A
N/A
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
.....................................................................................................
2
TABLE OF CONTENTS
.......................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
...............................................................................
4
1
INDICATION
.......................................................................................................................................
4
1.1
Pediatrics
....................................................................................................................................
4
1.2
Geriatrics
....................................................................................................................................
4
2
CONTRAINDICATIONS
..............................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS
.................................................................................
4
4
DOSAGE AND ADMINISTRATION
..............................................................................................
4
4.1
Dosing Considerations
...............................................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
...........