NORTRIPTYLINE CAPSULE

Country: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

NORTRIPTYLINE (NORTRIPTYLINE HYDROCHLORIDE)

Fáanlegur frá:

APOTEX INC

ATC númer:

N06AA10

INN (Alþjóðlegt nafn):

NORTRIPTYLINE

Skammtar:

10MG

Lyfjaform:

CAPSULE

Samsetning:

NORTRIPTYLINE (NORTRIPTYLINE HYDROCHLORIDE) 10MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

100

Gerð lyfseðils:

Prescription

Lækningarsvæði:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Vörulýsing:

Active ingredient group (AIG) number: 0102630002; AHFS:

Leyfisstaða:

APPROVED

Leyfisdagur:

2021-04-06

Vara einkenni

_NORTRIPTYLINE (_
_Nortriptyline Hydrochloride Capsules_
_) _
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_ Page 1 of 33_
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
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:
APR 01, 2021
Date of Revision:
APRIL 5, 2023
Submission Control Number: 269184
_NORTRIPTYLINE (_
_Nortriptyline Hydrochloride Capsules_
_) _
_ _
_ _
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_ Page 2 of 33_
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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
..................................................................................
5
4.1
DOSING CONSIDERATIONS
............................................................................................
5
4.2
RECOMMENDED DOSE AND DOSAGE ADJUSTMENT
....................................................... 5
4.4
ADMINISTRATION
..............................