NORTRIPTYLINE CAPSULE

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

NORTRIPTYLINE (NORTRIPTYLINE HYDROCHLORIDE)

Boleh didapati daripada:

APOTEX INC

Kod ATC:

N06AA10

INN (Nama Antarabangsa):

NORTRIPTYLINE

Dos:

10MG

Borang farmaseutikal:

CAPSULE

Komposisi:

NORTRIPTYLINE (NORTRIPTYLINE HYDROCHLORIDE) 10MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

100

Jenis preskripsi:

Prescription

Kawasan terapeutik:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Ringkasan produk:

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

Status kebenaran:

APPROVED

Tarikh kebenaran:

2021-04-06

Ciri produk

_NORTRIPTYLINE (_
_Nortriptyline Hydrochloride Capsules_
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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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RECENT MAJOR LABEL CHANGES
N/A
N/A
TABLE OF CONTENTS
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SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED._ _
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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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
..............................