MINT-CITALOPRAM TABLET

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

CITALOPRAM (CITALOPRAM HYDROBROMIDE)

Prieinama:

MINT PHARMACEUTICALS INC

ATC kodas:

N06AB04

INN (Tarptautinis Pavadinimas):

CITALOPRAM

Dozė:

20MG

Vaisto forma:

TABLET

Sudėtis:

CITALOPRAM (CITALOPRAM HYDROBROMIDE) 20MG

Vartojimo būdas:

ORAL

Vienetai pakuotėje:

30/100/500

Recepto tipas:

Prescription

Gydymo sritis:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Produkto santrauka:

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

Autorizacija statusas:

CANCELLED POST MARKET

Leidimo data:

2018-08-01

Prekės savybės

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