APO-NORTRIPTYLINE - CAP 25MG CAPSULE

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

NORTRIPTYLINE (NORTRIPTYLINE HYDROCHLORIDE)

Dostępny od:

APOTEX INC

Kod ATC:

N06AA10

INN (International Nazwa):

NORTRIPTYLINE

Dawkowanie:

25MG

Forma farmaceutyczna:

CAPSULE

Skład:

NORTRIPTYLINE (NORTRIPTYLINE HYDROCHLORIDE) 25MG

Droga podania:

ORAL

Sztuk w opakowaniu:

100/500

Typ recepty:

Prescription

Dziedzina terapeutyczna:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Podsumowanie produktu:

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

Status autoryzacji:

APPROVED

Data autoryzacji:

2021-12-02

Charakterystyka produktu

_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
...........