MINT-CITALOPRAM TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

CITALOPRAM (CITALOPRAM HYDROBROMIDE)

Saatavilla:

MINT PHARMACEUTICALS INC

ATC-koodi:

N06AB04

INN (Kansainvälinen yleisnimi):

CITALOPRAM

Annos:

10MG

Lääkemuoto:

TABLET

Koostumus:

CITALOPRAM (CITALOPRAM HYDROBROMIDE) 10MG

Antoreitti:

ORAL

Kpl paketissa:

100

Prescription tyyppi:

Prescription

Terapeuttinen alue:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0136243003; AHFS:

Valtuutuksen tilan:

CANCELLED POST MARKET

Valtuutus päivämäärä:

2018-08-01

Valmisteyhteenveto

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