Country: Canada
Language: English
Source: Health Canada
LURASIDONE HYDROCHLORIDE
AURO PHARMA INC
N05AE05
LURASIDONE
120MG
TABLET
LURASIDONE HYDROCHLORIDE 120MG
ORAL
15G/50G
Prescription
Active ingredient group (AIG) number: 0153185003; AHFS:
APPROVED
2022-11-15
Page 1 of 67 PRODUCT MONOGRAPH PR AURO-LURASIDONE Lurasidone Hydrochloride Tablets 20 mg, 40 mg, 60 mg, 80 mg and 120 mg film-coated tablets HOUSE STANDARD Antipsychotic AURO PHARMA INC. 3700 Steeles Avenue West, Suite # 402 Woodbridge, Ontario, L4L 8K8, Canada Date of Preparation: March 17, 2021 Submission Control No: 204040 Page 2 of 67 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION......................................................3 SUMMARY PRODUCT INFORMATION .................................................................... 3 INDICATIONS AND CLINICAL USE ......................................................................... 3 CONTRAINDICATIONS ............................................................................................. 4 WARNINGS AND PRECAUTIONS ............................................................................. 5 ADVERSE REACTIONS............................................................................................ 17 DRUG INTERACTIONS ............................................................................................ 40 DOSAGE AND ADMINISTRATION ......................................................................... 42 OVERDOSAGE ......................................................................................................... 45 ACTION AND CLINICAL PHARMACOLOGY ......................................................... 46 STORAGE AND STABILITY .................................................................................... 48 SPECIAL HANDLING INSTRUCTIONS ................................................................... 48 DOSAGE FORMS, COMPOSITION AND PACKAGING ........................................... 48 PART II: SCIENTIFIC INFORMATION ...........................................................................49 PHARMACEUTICAL INFORMATION ..................................................................... 49 CLINICAL TRIALS ................................................................................................... 50 Read the complete document