Land: Kanada
Sprache: Englisch
Quelle: Health Canada
PAROXETINE (PAROXETINE HYDROCHLORIDE, ISOPROPYL SOLVATE)
QD PHARMACEUTICALS ULC
N06AB05
PAROXETINE
20MG
TABLET
PAROXETINE (PAROXETINE HYDROCHLORIDE, ISOPROPYL SOLVATE) 20MG
ORAL
10/20/30/100/500
Prescription
SELECTIVE-SEROTONIN REUPTAKE INHIBITORS
Active ingredient group (AIG) number: 0123131002; AHFS:
CANCELLED POST MARKET
2015-08-21
_1_ PRODUCT MONOGRAPH PR Q-PAROXETINE Paroxetine Tablets, USP 10 mg, 20 mg and 30 mg Paroxetine (as paroxetine hydrochloride isopropyl solvate) Antidepressant – Antiobsessional – Antipanic – Anxiolytic Agent – Social Phobia (Social Anxiety Disorder) - Posttraumatic Stress Disorder Therapy QD Pharmaceuticals ULC Date of Revision: 85 Advance Road May 04, 2015 Etobicoke, Ontario M8Z 2S6 Submission Control No: 183548 _ _ _ _ _ _ _2_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ...................................................... 3 SUMMARY PRODUCT INFORMATION .............................................................................. 3 INDICATIONS AND CLINICAL USE .................................................................................... 3 CONTRAINDICATIONS .......................................................................................................... 5 WARNINGS AND PRECAUTIONS ........................................................................................ 6 ADVERSE REACTIONS ......................................................................................................... 14 DRUG INTERACTIONS ......................................................................................................... 24 DOSAGE AND ADMINISTRATION .................................................................................... 29 OVERDOSAGE .......................................................................................................................... 32 ACTION AND CLINICAL PHARMACOLOGY .................................................................. 33 STORAGE AND STABILITY ................................................................................................. 35 DOSAGE FORMS, COMPOSITION AND PACKAGING .................................................. 35 PART II: SCIENTIFIC INFORMATION .............................................................................. 37 PHARMACEUTICAL INFORMATION .......................................................... Lesen Sie das vollständige Dokument