DOM-PAROXETINE TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

PAROXETINE (PAROXETINE HYDROCHLORIDE ACETONE SOLVATE)

Предлага се от:

DOMINION PHARMACAL

АТС код:

N06AB05

INN (Международно Name):

PAROXETINE

дозиране:

30MG

Лекарствена форма:

TABLET

Композиция:

PAROXETINE (PAROXETINE HYDROCHLORIDE ACETONE SOLVATE) 30MG

Начин на приложение:

ORAL

Броя в опаковка:

100

Вид предписание :

Prescription

Терапевтична област:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Каталог на резюме:

Active ingredient group (AIG) number: 0123131001; AHFS:

Статус Оторизация:

APPROVED

Дата Оторизация:

2004-01-09

Данни за продукта

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_Dom-PAROXETINE Product Monograph _
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_Page 1 of 58 _
PRODUCT MONOGRAPH
Pr
DOM-PAROXETINE
Paroxetine Tablets, USP
10 mg, 20 mg, 30 mg and 40 mg
Paroxetine (as paroxetine hydrochloride)
Antidepressant – Antiobsessional – Antipanic – Anxiolytic Agent
–
Social Phobia (Social Anxiety Disorder) – Post-traumatic Stress
Disorder Therapy
DOMINION PHARMACAL
6111 Royalmount Ave., Suite 100
Montréal, Quebec
H4P 2T4
Date of Revision:
March 20, 2017
Submission Control No.: 202732
_ _
_Dom-PAROXETINE Product Monograph _
_ _
_Page 2 of 58 _
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
23
DOSAGE AND ADMINISTRATION
28
OVERDOSAGE
31
ACTION AND CLINICAL PHARMACOLOGY
32
STORAGE AND STABILITY
35
DOSAGE FORMS, COMPOSITION AND PACKAGING
35
PART II: SCIENTIFIC INFORMATION
37
PHARMACEUTICAL INFORMATION
37
CLINICAL TRIALS
39
DETAILED PHARMACOLOGY
45
TOXICOLOGY
46
REFERENCES
49
PART III: CONSUMER INFORMATION
54
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_Dom-PAROXETINE Product Monograph _
_ _
_Page 3 of 58 _
PR
DOM-PAROXETINE
Paroxetine Tablets
10 mg, 20 mg, 30 mg and 40 mg
Paroxetine (as paroxetine hydrochloride)
PART I: HEALTH PROFESSIONAL INFORMATION
SUMMARY PRODUCT INFORMATION
ROUTE OF
ADMINISTRATION
DOSAGE FORM /
STRENGTH
ALL NON-MEDICINAL INGREDIENTS
Oral
Tablet
10 mg, 20 mg,
30 mg and 40 mg
Colloidal silicon dioxide, croscarmellose sodium,
magnesium stearate, microcrystalline cellulose,
polyethylene glycol, titanium dioxide_._ In addition,
10 MG tablets also contain: D&C yellow #10 aluminum
lake, FD&C yellow #6/Sunset yellow FCF aluminum
lake, hypromellose, polydextrose, triacetin.
20 MG tablets also contain: D&C red #30 aluminum
lake, hypromellose, polydextrose, triacetin.
30 MG tablets also contain: FD&C blue #2/Indigo
carmine aluminum lake, hypromellose, polydextrose,
triacetin.
40 MG tablets also contain: D&C yellow #10 aluminum
lake, FD&C blue #2/Indigo carmine aluminum lake,
lecithin, poly