Country: Canada
Language: English
Source: Health Canada
VALPROIC ACID (DIVALPROEX SODIUM)
APOTEX INC
N03AG01
VALPROIC ACID
125MG
TABLET (DELAYED-RELEASE)
VALPROIC ACID (DIVALPROEX SODIUM) 125MG
ORAL
100
Prescription
MISCELLANEOUS ANTICONVULSANTS
Active ingredient group (AIG) number: 0112996004; AHFS:
APPROVED
2021-12-21
_APO-DIVALPROEX (Divalproex Sodium Delayed-Release Tablets) _ _ Page 1 of 79 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR APO-DIVALPROEX Divalproex Sodium Delayed-Release Tablets Delayed-Release Tablets, 125 mg, 250 mg and 500 mg valproic acid (as divalproex sodium), Oral Apotex Standard Antiepileptic Submission Control Number: 280469 APOTEX INC. 150 Signet Drive Toronto, Ontario M9L 1T9 Date of Initial Authorization: MAR 23, 1999 Date of Revision: NOV 17, 2023 _APO-DIVALPROEX (Divalproex Sodium Delayed-Release Tablets) _ _ Page 2 of 79 _ RECENT MAJOR LABEL CHANGES 2 CONTRAINDICATIONS 11/2023 3 SERIOUS WARNINGS AND PRECAUTIONS BOX, Hepatotoxicity 11/2023 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment 02/2023 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism: Hyperammonemia 11/2023 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism: Patients at Risk of Hypocarnitinemia 11/2023 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic: Serious or Fatal Hepatotoxicity 11/2023 7 WARNINGS AND PRECAUTIONS, Psychiatric: Behavioural Disorders 02/2023 7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male Potential 02/2023 7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women, Pregnancy Exposure Risk related to Valproate 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 .................................. Read the complete document