ISOPTIN SR TABLET (EXTENDED-RELEASE)

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

VERAPAMIL HYDROCHLORIDE

Доступна з:

BGP PHARMA ULC

Код атс:

C08DA01

ІПН (Міжнародна Ім'я):

VERAPAMIL

Дозування:

120MG

Фармацевтична форма:

TABLET (EXTENDED-RELEASE)

Склад:

VERAPAMIL HYDROCHLORIDE 120MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

100

Тип рецепту:

Prescription

Терапевтична области:

MISCELLANEOUS CALCIUM-CHANNEL BLOCKING AGENTS

Огляд продуктів:

Active ingredient group (AIG) number: 0113846001; AHFS:

Статус Авторизація:

APPROVED

Дата Авторизація:

2015-01-07

Характеристики продукта

_ISOPTIN®_
_ _
_SR (verapamil hydrochloride) Product Monograph_
_ _
_Page 1 of 42 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ISOPTIN®SR
verapamil hydrochloride sustained-release tablets
120 mg, 180 mg and 240 mg
Manufacturer’s Standard
_ _
Antihypertensive Agent
BGP Pharma ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Date of Initial Authorization:
December 18, 2014
Date of Revision:
December 7, 2021
Submission Control Number: 253349
_ _
_ISOPTIN®_
_ _
_SR (verapamil hydrochloride) Product Monograph_
_ _
_Page 2 of 42_
RECENT MAJOR LABEL CHANGES
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
October 2019
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL
CHANGES..............................................................................................2
TABLE OF CONTENTS
................................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................4
INDICATIONS
...........................................................................................................................4
1.1
Pediatrics
............................................................................................................4
1.2
Geriatrics.............................................................................................................4
CONTRAINDICATIONS
..............................................................................................................4
4
DOSAGE AND
ADMINISTRATION...................................................................................5
4.1
Dosing Considerations
.........................................................................................5
4.2
Recommended Dose and Dosage
Adjustment.......................................................6
4.4
Administration.......................................................................