AMITRIPTYLINE-25 TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

AMITRIPTYLINE HYDROCHLORIDE

Dostępny od:

PRO DOC LIMITEE

Kod ATC:

N06AA09

INN (International Nazwa):

AMITRIPTYLINE

Dawkowanie:

25MG

Forma farmaceutyczna:

TABLET

Skład:

AMITRIPTYLINE HYDROCHLORIDE 25MG

Droga podania:

ORAL

Sztuk w opakowaniu:

100/1000

Typ recepty:

Prescription

Dziedzina terapeutyczna:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0101524002; AHFS:

Status autoryzacji:

MARKETED

Data autoryzacji:

1976-12-31

Charakterystyka produktu

_AMITRIPTYLINE (amitriptyline chlorhydrate) _
_Page 1 of 43 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR AMITRIPTYLINE - 10
PR AMITRIPTYLINE - 25
PR AMITRIPTYLINE - 50
Amitriptyline Hydrochloride Tablets
Tablets, 10 mg, 25 mg and 50 mg, Oral
USP
Antidepressant
PRO DOC LTÉE.
2925 boul. Industriel
Laval, Quebec
H7L 3W9
Submission Control Number: 283162
Date of Initial Authorization:
AUG
09,
2012
Date of Revision:
FEB
16, 2024
_AMITRIPTYLINE (amitriptyline chlorhydrate) _
_Page 2 of 43 _
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
02/2024
7 WARNINGS AND PRECAUTIONS
02/2024
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
02/2024
7 WARNINGS AND PRECAUTIONS, Neurologic
04/2023
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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
.............................................................................................................................
4
1.1
Pediatrics
.................................................................................................................................
4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
................................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
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5
4
DOSAGE AND ADMINISTRATION
................................................................................................
5
4.1
D