Land: Kanada
Språk: engelska
Källa: Health Canada
AMITRIPTYLINE HYDROCHLORIDE
JAMP PHARMA CORPORATION
N06AA09
AMITRIPTYLINE
50MG
TABLET
AMITRIPTYLINE HYDROCHLORIDE 50MG
ORAL
100
Prescription
TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS
Active ingredient group (AIG) number: 0101524003; AHFS:
APPROVED
2016-09-14
_JAMP-Amitriptyline_ _ _ _(Amitriptyline Hydrochloride Tablets)_ Page 1 of 34 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr JAMP-AMITRIPTYLINE Amitriptyline Hydrochloride Tablets Tablets, 10 mg, 25 mg, 50 mg and 75 mg, Oral USP Antidepressant JAMP Pharma Corporation 1310 rue Nobel Boucherville, Quebec J4B 5H3, Canada Date of Initial Authorization: September 14, 2016 Date of Revision: February 7, 2023 Submission Control Number: 267331 _JAMP-Amitriptyline_ _ _ _(Amitriptyline Hydrochloride Tablets)_ 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 ....................................................... 6 4.4 Administration ............................. Läs hela dokumentet