CITALOPRAM TABLETS USP

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CITALOPRAM (CITALOPRAM HYDROBROMIDE)

Available from:

TORRENT PHARMACEUTICALS LIMITED

ATC code:

N06AB04

INN (International Name):

CITALOPRAM

Dosage:

20MG

Pharmaceutical form:

TABLET

Composition:

CITALOPRAM (CITALOPRAM HYDROBROMIDE) 20MG

Administration route:

ORAL

Units in package:

30/100/500

Prescription type:

Prescription

Therapeutic area:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Product summary:

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

Authorization status:

CANCELLED (UNRETURNED ANNUAL)

Authorization date:

2021-12-20

Summary of Product characteristics

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_Citalopram Tablets USP _
PRODUCT MONOGRAPH
Pr
Citalopram Tablets USP
10 mg, 20 mg and 40 mg citalopram (as citalopram hydrobromide)
Antidepressant
Torrent Pharmaceuticals Ltd.
Ahmedabad-Mehsana Highway
Taluka-Kadi, Dist. Mehsana
Indrad-382 721, Gujarat, India
Distributed by:
Torrent Pharma Canada Inc.
Woodbridge, ON, L4H 2K4
Date of Revision:
December 8, 2016
Submission Control No: 200395
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_Citalopram Tablets USP _
_Page 2 of 49_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION…………………………………
3
SUMMARY PRODUCT
INFORMATION………………………………………..
3
INDICATIONS AND CLINICAL
USE……………………………………………
3
CONTRAINDICATIONS………………………………………………………….
4
WAARNINGS AND
PRECAUSIONS…………………………………………….
4
ADVERSE
REACTIONS………………………………………………………….
12
DRUG
INTERACTIONS…………………………………………………………..
19
DOSAGE AND
ADMINISTRATION……………………………………………..
26
OVERDOSAGE……………………………………………………………………
28
ACTION AND CLINICAL
PHARMACOLOGY…………………………………
29
STORAGE AND
STABILITY…………………………………………………….
30
DOSAGE FORMS, COMPOSITION AND PACKING…………………………..
31
PART II: SCIENTIFIC
INFORMATION…………………………………………………
32
PHARMACEUTICAL
INFORMATION………………………………………….
32
CLINICAL
TRIALS……………………………………………………………….
33
DETAILED
PHARMACOLOGY………………………………………………….
34
TOXICOLOGY…………………………………………………………………….
37
REFERNCES……………………………………………………………………….
42
PART III: CONSUMER
INFORMATION………