OLEPTRO TABLET (EXTENDED-RELEASE)

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

TRAZODONE HYDROCHLORIDE

Доступна з:

ANGELINI PHARMA INC

Код атс:

N06AX05

ІПН (Міжнародна Ім'я):

TRAZODONE

Дозування:

300MG

Фармацевтична форма:

TABLET (EXTENDED-RELEASE)

Склад:

TRAZODONE HYDROCHLORIDE 300MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

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

Тип рецепту:

Prescription

Терапевтична области:

SEROTONIN MODULATORS

Огляд продуктів:

Active ingredient group (AIG) number: 0115713006; AHFS:

Статус Авторизація:

APPROVED

Дата Авторизація:

2011-01-19

Характеристики продукта

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