AMITRIPTYLINE HYDROCHLORIDE TABLETS USP

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

AMITRIPTYLINE HYDROCHLORIDE

Διαθέσιμο από:

STRIDES PHARMA CANADA INC

Φαρμακολογική κατηγορία (ATC):

N06AA09

INN (Διεθνής Όνομα):

AMITRIPTYLINE

Δοσολογία:

25MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

AMITRIPTYLINE HYDROCHLORIDE 25MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

100

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2019-03-05

Αρχείο Π.Χ.Π.

Page 1 of 34
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AMITRIPTYLINE HYDROCHLORIDE TABLETS USP
Amitriptyline hydrochloride tablets
Tablets, 10 mg, 25 mg, 50 mg and 75 mg, Oral
USP
Antidepressant
Strides Pharma Canada Inc.
1565, Boul. Lionel-Boulet,
Varennes, QC J3X 1P7
Canada
Date of Initial Authorization:
March 5, 2019
Date of Revision:
April 12, 2023
Submission Control Number: 269974
Page 2 of 34
RECENT MAJOR LABEL CHANGES
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
...............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................
4
1
INDICATIONS
...............................................................................................................
4
1.1
Pediatrics
...................................................................................................................
4
1.2
Geriatrics
....................................................................................................................
4
2
CONTRAINDICATIONS
..................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
................................................................... 5
4
DOSAGE AND ADMINISTRATION
..................................................................................
5
4.1
Dosing Considerations
...............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
.......................................................... 5
4.4
Administration
.......................................................................................