দেশ: কানাডা
ভাষা: ইংরেজি
সূত্র: Health Canada
PAROXETINE (PAROXETINE HYDROCHLORIDE ACETONE SOLVATE)
SORRES PHARMA INC
N06AB05
PAROXETINE
10MG
TABLET
PAROXETINE (PAROXETINE HYDROCHLORIDE ACETONE SOLVATE) 10MG
ORAL
100
Prescription
SELECTIVE-SEROTONIN REUPTAKE INHIBITORS
Active ingredient group (AIG) number: 0123131003; AHFS:
CANCELLED POST MARKET
2014-06-20
PRODUCT MONOGRAPH PR PAROXETINE Paroxetine Hydrochloride Tablets, USP 10 mg, 20 mg, 30 mg and 40 mg Antidepressant – Antiobsessional – Antipanic – Anxiolytic Agent – Social Phobia (Social Anxiety Disorder) - Posttraumatic Stress Disorder Therapy SORRES PHARMA INC. 6111 Royalmount Ave., Suite 100 Montreal, Quebec H4P 2T4 Date of Preparation: June 10, 2011 Submission Control No. 137565, 147006 _ _ _PAROXETINE Product Monograph _ _ _ _Page 2 of 57 _ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION 3 SUMMARY PRODUCT INFORMATION 3 INDICATIONS AND CLINICAL USE 3 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5 ADVERSE REACTIONS 13 DRUG INTERACTIONS 23 DOSAGE AND ADMINISTRATION 28 OVERDOSAGE 31 ACTION AND CLINICAL PHARMACOLOGY 32 STORAGE AND STABILITY 34 DOSAGE FORMS, COMPOSITION AND PACKAGING 35 PART II: SCIENTIFIC INFORMATION 36 PHARMACEUTICAL INFORMATION 36 CLINICAL TRIALS 38 DETAILED PHARMACOLOGY 44 TOXICOLOGY 45 REFERENCES 48 PART III: CONSUMER INFORMATION 53 _ _ _PAROXETINE Product Monograph _ _ _ _Page 3 of 57 _ PR PAROXETINE Paroxetine Hydrochloride Tablets PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION ROUTE OF ADMINISTRATION DOSAGE FORM / STRENGTH CLINICALLY RELEVANT NONMEDICINAL INGREDIENTS Oral Tablet 10 mg, 20 mg, 30 mg and 40 mg _For a complete listing see Dosage Forms, _ _Composition and Packaging section._ INDICATIONS AND CLINICAL USE ADULTS DEPRESSION PAROXETINE (paroxetine hydrochloride) is indicated for symptomatic relief of Major Depressive Disorder (MDD). Clinical trials have provided evidence that continuation treatment with paroxetine hydrochloride in patients with moderate to moderately severe depressive disorder is effective for at least 6 months (see Clinical Trials, Depression). OBSESSIVE-COMPULSIVE DISORDER PAROXETINE is indicated for the symptomatic treatment of obsessive-compulsive disorder (OCD). The obsessions or compulsions must be experienced as intrusive, markedly distressing, time-consuming, or interfering significantly with the person’s social or সম্পূর্ণ নথি পড়ুন