PAROXETINE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PAROXETINE (PAROXETINE HYDROCHLORIDE ACETONE SOLVATE)

Available from:

SORRES PHARMA INC

ATC code:

N06AB05

INN (International Name):

PAROXETINE

Dosage:

20MG

Pharmaceutical form:

TABLET

Composition:

PAROXETINE (PAROXETINE HYDROCHLORIDE ACETONE SOLVATE) 20MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0123131002; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2014-06-20

Summary of Product characteristics

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
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_PAROXETINE Product Monograph _
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_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
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_PAROXETINE Product Monograph _
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_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