Country: Canada
Language: English
Source: Health Canada
ISOTRETINOIN
SUN PHARMACEUTICAL INDUSTRIES LIMITED
D10BA01
ISOTRETINOIN
32MG
CAPSULE
ISOTRETINOIN 32MG
ORAL
15G/50G
Prescription
Active ingredient group (AIG) number: 0115751005; AHFS:
APPROVED
2023-06-22
_Absorica LD_ _®_ _ (isotretinoin) Product Monograph _ _Page 1 of 49_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR ABSORICA LD® Isotretinoin Capsules Micronized formulation Capsules, 8 mg, 16 mg, 24 mg, and 32 mg, Oral USP Retinoid for treatment of acne Sun Pharmaceutical Industries Limited Sun House, Plot 201 B/1 Western Express Highway, Goregaon (E) Mumbai - 400 063 Maharashtra, India Date of Initial Authorization: June 22, 2023 Imported and Distributed by: Sun Pharma Canada Inc. Brampton, ON L6T 1C1 Submission Control Number: 263460 Absorica LD and C-A-R-E are trademarks of Sun Pharma, or its affiliates and subsidiaries. © 2023 Sun Pharma, or its subsidiaries and affiliates. All rights reserved. _Absorica LD_ _®_ _ (isotretinoin) Product Monograph _ _Page 2 of 49_ 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 ................................................................................................. 5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 5 4 DOSAGE AND ADMINISTRATION................................................................................. 7 4.1 Dosing Considerations ....................................................................................... 7 4.2 Recommended Dose and Dosage Adjustment............................. Read the complete document