Country: Canada
Language: English
Source: Health Canada
LEVOTHYROXINE SODIUM
ASPEN PHARMACARE CANADA INC.
H03AA01
LEVOTHYROXINE SODIUM
150MCG
TABLET
LEVOTHYROXINE SODIUM 150MCG
ORAL
500
Prescription
THYROID AGENTS
Active ingredient group (AIG) number: 0107794004; AHFS:
APPROVED
2001-08-03
_ELTROXIN_ _®_ _ levothyroxine sodium _ _Page 1 of 36_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR ELTROXIN ® Levothyroxine sodium Tablets, 50 mcg, 100 mcg, 150 mcg and 200 mcg, Oral , BP Thyroid hormone ATC Code: H03AA01 Aspen Pharmacare Canada Inc. Unit 8-1155 North Service Road West, Oakville, Ontario, L6M 3E3 Date of Initial Authorization: Dec. 30, 1951 Date of Revision: July 28, 2023 Submission Control Number: 273170 _ELTROXIN_ _®_ _ levothyroxine sodium _ _Page 2 of 36_ RECENT MAJOR LABEL CHANGES 1 Indication 10/2021 1 Indications, 1.1 Pediatrics 10/2021 4 Dosage and Administration, 4.1 Dosing Considerations 10/2021 4 Dosage and Administration, 4.2 Recommended Dose and Dosage Adjustment 10/2021 4 Dosage and Administration, 4.4 Administration 10/2021 7 Warnings and Precautions 07/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed 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 Read the complete document