Ülke: Kanada
Dil: İngilizce
Kaynak: Health Canada
AMITRIPTYLINE HYDROCHLORIDE
PRO DOC LIMITEE
N06AA09
AMITRIPTYLINE
25MG
TABLET
AMITRIPTYLINE HYDROCHLORIDE 25MG
ORAL
100/1000
Prescription
TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS
Active ingredient group (AIG) number: 0101524002; AHFS:
MARKETED
1976-12-31
_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 ....................................................................................................................... 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 D Belgenin tamamını okuyun