Country: Canada
Language: English
Source: Health Canada
CITALOPRAM (CITALOPRAM HYDROBROMIDE)
CELLCHEM PHARMACEUTICALS INC.
N06AB04
CITALOPRAM
40MG
TABLET
CITALOPRAM (CITALOPRAM HYDROBROMIDE) 40MG
ORAL
30/100
Prescription
SELECTIVE-SEROTONIN REUPTAKE INHIBITORS
Active ingredient group (AIG) number: 0136243002; AHFS:
CANCELLED POST MARKET
2022-02-28
_CCP-CITALOPRAM _ Page 1 of 45 PRODUCT MONOGRAPH PR CCP-CITALOPRAM Citalopram Tablets, USP 20 mg and 40 mg tablets, citalopram (as citalopram hydrobromide) ANTIDEPRESSANT CellChem Pharmaceuticals Inc., Date of Revision: 30 Concourse Gate, Unit 1 APRIL 27, 2017 Ottawa, Ontario - K2E 7V7 Submission Control No: 201751 _CCP-CITALOPRAM _ Page 2 of 45 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ...................................................... 3 SUMMARY PRODUCT INFORMATION .................................................................... 3 INDICATIONS AND CLINICAL USE .......................................................................... 3 CONTRAINDICATIONS ............................................................................................... 3 WARNINGS AND PRECAUTIONS .............................................................................. 4 ADVERSE REACTIONS .............................................................................................. 11 DRUG INTERACTIONS .............................................................................................. 17 DOSAGE AND ADMINISTRATION .......................................................................... 24 OVERDOSAGE ............................................................................................................. 25 ACTION AND CLINICAL PHARMACOLOGY ........................................................ 26 STORAGE AND STABILITY ...................................................................................... 28 DOSAGE FORMS, COMPOSITION AND PACKAGING ......................................... 28 PART II: SCIENTIFIC INFORMATION ............................................................................ 29 PHARMACEUTICAL INFORMATION ...................................................................... 29 CLINICAL TRIALS ...................................................................................................... 30 DETAILED PHARMACOLOGY ................................................... Read the complete document