Country: Canada
Language: English
Source: Health Canada
LEVOTHYROXINE SODIUM
IBSA INSTITUT BIOCHIMIQUE SA
H03AA01
LEVOTHYROXINE SODIUM
175MCG
CAPSULE
LEVOTHYROXINE SODIUM 175MCG
ORAL
100
Prescription
THYROID AGENTS
Active ingredient group (AIG) number: 0107794009; AHFS:
APPROVED
2021-06-21
_TIROCAP™ (levothyroxine sodium capsules) _ _Page 1 of 32_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR TIROCAP™ Levothyroxine Sodium capsule Capsules,13 mcg, 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg and 200 mcg, oral Thyroid Hormone ATC Code: H03AA01 Institut Biochimique SA (IBSA) Via del Piano 266 CH-6915 Pambio-Noranco, Switzerland Imported by: Progress Therapeutics Inc. 14-320 Harry Walker Parkway North Newmarket ON Canada, L3Y 7B4 Date of Initial Authorization: November 25, 2020 Date of Revision: June 17, 2021 Submission Control No: 248553 _ _ _TIROCAP™ (levothyroxine sodium capsules) _ _Page 2 of 32_ TABLE OF CONTENTS 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 4.3 Administration................................................................................................... 9 4.4 Missed Dose..................................................................................................... 9 5 OVER Read the complete document