DOM-PAROXETINE TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

PAROXETINE (PAROXETINE HYDROCHLORIDE)

Tersedia dari:

DOMINION PHARMACAL

Kode ATC:

N06AB05

INN (Nama Internasional):

PAROXETINE

Dosis:

40MG

Bentuk farmasi:

TABLET

Komposisi:

PAROXETINE (PAROXETINE HYDROCHLORIDE) 40MG

Rute administrasi :

ORAL

Unit dalam paket:

100

Jenis Resep:

Prescription

Area terapi:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Ringkasan produk:

Active ingredient group (AIG) number: 0123131007; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2009-12-04

Karakteristik produk

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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
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_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