MINT-CITALOPRAM TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

CITALOPRAM (CITALOPRAM HYDROBROMIDE)

זמין מ:

MINT PHARMACEUTICALS INC

קוד ATC:

N06AB04

INN (שם בינלאומי):

CITALOPRAM

כמות:

20MG

טופס פרצבטיות:

TABLET

הרכב:

CITALOPRAM (CITALOPRAM HYDROBROMIDE) 20MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

30/100/500

סוג מרשם:

Prescription

איזור תרפויטי:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

leaflet_short:

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

מצב אישור:

CANCELLED POST MARKET

תאריך אישור:

2018-08-01

מאפייני מוצר

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