国: カナダ
言語: 英語
ソース: Health Canada
CITALOPRAM (CITALOPRAM HYDROBROMIDE)
TORRENT PHARMACEUTICALS LIMITED
N06AB04
CITALOPRAM
20MG
TABLET
CITALOPRAM (CITALOPRAM HYDROBROMIDE) 20MG
ORAL
30/100/500
Prescription
SELECTIVE-SEROTONIN REUPTAKE INHIBITORS
Active ingredient group (AIG) number: 0136243001; AHFS:
CANCELLED (UNRETURNED ANNUAL)
2021-12-20
_ _ _ _ _Page 1 of 49_ _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 _ _ _ _ _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……… 完全なドキュメントを読む