Country: Canada
Language: English
Source: Health Canada
LEVOTHYROXINE SODIUM
ASPEN PHARMACARE CANADA INC.
H03AA01
LEVOTHYROXINE SODIUM
300MCG
TABLET
LEVOTHYROXINE SODIUM 300MCG
ORAL
100/500
Prescription
THYROID AGENTS
Active ingredient group (AIG) number: 0107794002; AHFS:
CANCELLED POST MARKET
2018-09-17
_ELTROXIN_ _®_ _ levothyroxine sodium _ _Page 1 of 30_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR ELTROXIN ® Levothyroxine sodium 50, 100, 150, 200 and 300 mcg Tablets BP Thyroid hormone ATC Code: H03AA01 Aspen Pharmacare Canada Inc. 111 Queen Street East, Suite 450 Toronto, Ontario, M5C 1S2 Date of Initial Approval: DEC 30, 1951 Date of Revision: FEB 8, 2018 Submission Control No: 209764 _ELTROXIN_ _®_ _ levothyroxine sodium _ _Page 2 of 30_ RECENT MAJOR LABEL CHANGES Indications, Pediatrics (1.1) 04/2017 Indications, Geriatrics (1.2) 04/2017 Contraindications (2) 04/2017 Dosage and Administration, Dosing Considerations (4.1) 04/2017 Dosage and Administration, Recommended Dose and Dosage Adjustment (4.2) 04/2017 Overdosage (5) 04/2017 Warnings and Precautions (7) 04/2017 Warnings and Precautions, Pregnant Women (7.1.1) 04/2017 Warnings and Precautions, Breast-feeding (7.1.2) 04/2017 Warnings and Precautions, Pediatrics (7.1.3) 04/2017 Warnings and Precautions, Geriatrics (7.1.4) 04/2017 Adverse Reactions, Adverse Reaction Overview (8.1) 04/2017 Drug Interactions, Overview (9.2) 04/2017 Drug Interactions, Drug-Drug Interactions (9.3) 04/2017 Drug Interactions, Drug-Food Interactions (9.4) 04/2017 Drug Interactions, Drug-Laboratory Interactions (9.6) 04/2017 Action and Clinical Pharmacology, Mechanism of Action (10.1) 04/2017 Action and Clinical Pharmacology, Pharmacokinetics (10.3) 04/2017 TABLE OF CONTENTS 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 ........................................................................ Read the complete document