Country: Canada
Language: English
Source: Health Canada
AMITRIPTYLINE HYDROCHLORIDE
PHARMASCIENCE INC
N06AA09
AMITRIPTYLINE
75MG
TABLET
AMITRIPTYLINE HYDROCHLORIDE 75MG
ORAL
100
Prescription
TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS
Active ingredient group (AIG) number: 0101524004; AHFS:
APPROVED
2014-02-07
_pms-AMITRIPTYLINE (amitriptyline hydrochloride) _ _Page 1 of 34 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR PMS-AMITRIPTYLINE Amitriptyline Hydrochloride Tablets Tablets, 10 mg, 25 mg, 50 mg, 75 mg and 100 mg, Oral USP Antidepressant PHARMASCIENCE INC. 6111 Royalmount Ave., Suite 100 Montréal, Canada H4P 2T4 www.pharmascience.com Submission Control Number: 267085 Date of Initial Authorization: December 11, 1998 Date of Revision: February 3, 2023 _pms-AMITRIPTYLINE (amitriptyline hydrochloride) _ _Page 2 of 34 _ RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS, Neurologic 02/2023 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 ................................... Read the complete document