OLEPTRO TABLET (EXTENDED-RELEASE)

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

TRAZODONE HYDROCHLORIDE

Tillgänglig från:

ANGELINI PHARMA INC

ATC-kod:

N06AX05

INN (International namn):

TRAZODONE

Dos:

150MG

Läkemedelsform:

TABLET (EXTENDED-RELEASE)

Sammansättning:

TRAZODONE HYDROCHLORIDE 150MG

Administreringssätt:

ORAL

Enheter i paketet:

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

Receptbelagda typ:

Prescription

Terapiområde:

SEROTONIN MODULATORS

Produktsammanfattning:

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

Bemyndigande status:

APPROVED

Tillstånd datum:

2011-01-19

Produktens egenskaper

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
.....................