ESCITALOPRAM TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

ESCITALOPRAM (ESCITALOPRAM OXALATE)

Sẵn có từ:

JUBILANT GENERICS LIMITED

Mã ATC:

N06AB10

INN (Tên quốc tế):

ESCITALOPRAM

Liều dùng:

20MG

Dạng dược phẩm:

TABLET

Thành phần:

ESCITALOPRAM (ESCITALOPRAM OXALATE) 20MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

30/100

Loại thuốc theo toa:

Prescription

Khu trị liệu:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0150435004; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2017-07-12

Đặc tính sản phẩm

_PR_
_ESCITALOPRAM _
_Page 1 of 45 _
PRODUCT MONOGRAPH
PR
ESCITALOPRAM
ESCITALOPRAM TABLETS USP
10 mg and 20 mg as Escitalopram (as Escitalopram Oxalate)
ANTIDEPRESSANT / ANTIOBSESSIONAL
MANUFACTURER:
DATE OF PREPARATION:
Jubilant Generics Limited
July 07, 2017
1-A, Sector -16A, Noida,
India 201301
IMPORTER/DISTRIBUTOR:
JAMP Pharma Corporation
1310 rue Nobel, Boucherville,
QC, Canada J4B 5H3
SUBMISSION CONTROL NO: 200944
_PR_
_ESCITALOPRAM _
_Page 2 of 45 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
3
SUMMARY PRODUCT INFORMATION
3
INDICATIONS AND CLINICAL USE
3
CONTRAINDICATIONS
3
WARNINGS AND PRECAUTIONS
4
ADVERSE REACTIONS
10
DRUG INTERACTIONS
20
DOSAGE AND ADMINISTRATION
24
OVERDOSAGE
26
ACTION AND CLINICAL PHARMACOLOGY
27
STORAGE AND STABILITY
28
DOSAGE FORMS, COMPOSITION AND
PACKAGING
29
PART II: SCIENTIFIC INFORMATION
30
PHARMACEUTICAL INFORMATION
30
CLINICAL TRIALS
30
DETAILED PHARMACOLOGY
33
TOXICOLOGY
36
REFERENCES
40
PART III: CONSUMER INFORMATION
42
_PR_
_ESCITALOPRAM _
_Page 3 of 45 _
ESCITALOPRAM TABLETS USP
10 mg and 20 mg as escitalopram
PART I: HEALTH PROFESSIONAL INFORMATION
SUMMARY PRODUCT INFORMATION
ROUTE OF
ADMINISTRATION
DOSAGE FORM/ STRENGTH
NONMEDICINAL INGREDIENTS
Oral
Tablets 10 mg and 20 mg
Colloidal anhydrous silica, croscarmellose sodium,
hypromellose, magnesium stearate, microcrystalline
cellulose, polyethylene glycol 400, talc, titanium
dioxide.
INDICATIONS AND CLINICAL USE
ADULTS

Escitalopram
oxalate
is
indicated
for
the
symptomatic
relief
of
Major
Depressive
Disorder (MDD)

The efficacy of escitalopram oxalate in maintaining an antidepressant
response, in
patients with major depressive disorder who responded during an
8-week, acute-treatment
phase while taking escitalopram oxalate and were then observed for
relapse during a
period
of
up
to
36
weeks,
was
demonstrated
in
a
placebo-controlled
trial
(see
CLINICAL TRIALS).

Escitalopram oxalate is indicated for the symptomatic relief of
obsessive-compulsive
disorder (OCD). The obsessions and compulsions must be