OLEPTRO TABLET (EXTENDED-RELEASE)

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

TRAZODONE HYDROCHLORIDE

제공처:

ANGELINI PHARMA INC

ATC 코드:

N06AX05

INN (국제 이름):

TRAZODONE

복용량:

150MG

약제 형태:

TABLET (EXTENDED-RELEASE)

구성:

TRAZODONE HYDROCHLORIDE 150MG

관리 경로:

ORAL

패키지 단위:

4/7/10/11/30/90/500

처방전 유형:

Prescription

치료 영역:

SEROTONIN MODULATORS

제품 요약:

Active ingredient group (AIG) number: 0115713003; AHFS:

승인 상태:

APPROVED

승인 날짜:

2011-01-19

제품 특성 요약

OLEPTRO
™
(Trazodone Hydrochloride Extended-Release Caplets)
Page 1 of 37
PRODUCT MONOGRAPH
PR
OLEPTRO
™
Trazodone Hydrochloride Extended-Release Caplets
150 and 300 mg
Antidepressant
Angelini Pharma Inc.
8322 Helgerman Court
Gaithersburg, MD 20877
USA
Date of Preparation:
OCTOBER 7, 2014
SUBMISSION CONTROL NO: 177639
This Product Monograph is the exclusive property of Angelini Pharma
Inc. It may be not copied
in whole or in part without the written permission of Angelini Pharma
Inc.
OLEPTRO is a trademark of Angelini Pharma Inc.
© 2013 Angelini Pharma Inc.
OLEPTRO
™
(Trazodone Hydrochloride Extended-Release Caplets)
Page 2 of 37
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
..................................................................................................11
DRUG INTERACTIONS
..................................................................................................17
DOSAGE AND ADMINISTRATION
..............................................................................20
OVERDOSAGE
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................22
STORAGE AND STABILITY
..........................................................................................24
SPECIAL HANDLING INSTRUCTIONS
.......................................................................24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.....................