MINT-CITALOPRAM TABLET

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

CITALOPRAM (CITALOPRAM HYDROBROMIDE)

متاح من:

MINT PHARMACEUTICALS INC

ATC رمز:

N06AB04

INN (الاسم الدولي):

CITALOPRAM

جرعة:

20MG

الشكل الصيدلاني:

TABLET

تركيب:

CITALOPRAM (CITALOPRAM HYDROBROMIDE) 20MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

30/100/500

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

ملخص المنتج:

Active ingredient group (AIG) number: 0136243001; AHFS:

الوضع إذن:

CANCELLED POST MARKET

تاريخ الترخيص:

2018-08-01

خصائص المنتج

1
PRODUCT MONOGRAPH
PR
MINT-CITALOPRAM
CITALOPRAM TABLETS, USP
10 MG, 20 MG AND 40 MG CITALOPRAM (AS CITALOPRAM HYDROBROMIDE)
ANTIDEPRESSANT
MINT PHARMACEUTICALS INC.,
DATE OF REVISION:
1093 MEYERSIDE DRIVE, UNIT 1,
MAY 29, 2014
MISSISSAUGA, ONTARIO
L5T 1J6
CONTROL#: 173999
2
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
…………………………………………………
11
DRUG
INTERACTIONS…………………………………………………..
19
DOSAGE AND ADMINISTRATION…………………………………….
26
OVERDOSAGE……………………………………………………………
28
ACTION AND CLINICAL PHARMACOLOGY…………………………
29
STORAGE AND STABILITY
…………………………………………….
30
DOSAGE FORMS, COMPOSITION AND PACKAGING……………….
30
PART II: SCIENTIFIC INFORMATION………………………………
32
PHARMACEUTICAL INFORMATION………………………………….
32
CLINICAL
TRIALS……………………………………………………….
33
DETAILED PHARMACOLOGY………………………………………….
35
TOXICOLOGY…………………………………………………………….
38
REFERENCES……………………………………………………………..
42
PART III: CONSUMER INFORMATION ……………………………..
46
3
Pr
MINT-CITALOPRAM
Citalopram tablets, USP
10 mg, 20, and 40 mg citalopram (as citalopram hydrobromide)
PART I: HEALTH PROFESSIONAL INFORMATION
SUMMARY PRODUCT INFORMATION
INDICATIONS AND CLINICAL USE
Adults
MINT-CITALOPRAM (Citalopram hydrobromide) is indicated for
the symptomatic relief of depressive illness.
The relapse rate was signifi