Land: Canada
Taal: Engels
Bron: Health Canada
AMITRIPTYLINE HYDROCHLORIDE
JAMP PHARMA CORPORATION
N06AA09
AMITRIPTYLINE
10MG
TABLET
AMITRIPTYLINE HYDROCHLORIDE 10MG
ORAL
100/1000
Prescription
TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS
Active ingredient group (AIG) number: 0101524001; AHFS:
MARKETED
2015-01-12
_JAMP-Amitriptyline Tablets (Amitriptyline _ _Hydrochloride Tablets)_ _ _ _Page 1 of 32 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR JAMP-AMITRIPTYLINE TABLETS Amitriptyline Hydrochloride Tablets Tablets, 10 mg, 25 mg, 50 mg and 75 mg, Oral House Standard Antidepressant JAMP Pharma Corporation 1310, rue Nobel Boucherville, Quebec J4B 5H3, Canada Submission Control Number: 272470 Date of Initial Authorization: December 12, 2014 Date of Revision: March 10, 2023 _JAMP-Amitriptyline Tablets (Amitriptyline Hydrochloride Tablets)_ _ _ _ _ _Page 2 of 32 _ RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS, Neurologic 03/2023 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 ................ Lees het volledige document