INDERAL-LA CAPSULE (EXTENDED RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PROPRANOLOL HYDROCHLORIDE

Available from:

PFIZER CANADA ULC

ATC code:

C07AA05

INN (International Name):

PROPRANOLOL

Dosage:

60MG

Pharmaceutical form:

CAPSULE (EXTENDED RELEASE)

Composition:

PROPRANOLOL HYDROCHLORIDE 60MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

BETA-ADRENERGIC BLOCKING AGENTS

Product summary:

Active ingredient group (AIG) number: 0101831008; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2022-05-31

Summary of Product characteristics

_INDERAL-LA (propranolol hydrochloride) Product Monograph_
_ _
_Page 1 of 29_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
INDERAL
®
-LA
Propranolol Hydrochloride Extended-Release Capsules
Extended-Release Capsules, 60 mg, 80 mg, 120 mg and 160 mg, Oral
USP
Beta-Adrenergic Receptor Blocking Agent
Pfizer Canada ULC
Kirkland, Quebec H9J 2M5
Date of Initial Authorization:
SEP 21, 2010
Date of Revision:
June 16, 2021
Submission Control Number: 248972
®
Trademark AstraZeneca UK Limited
_ _
_INDERAL-LA (propranolol hydrochloride) Product Monograph _
_Page 2 of 29_
RECENT MAJOR LABEL CHANGES
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
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
..........................................................................................................
4
1.2
Geriatrics...........................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
4
DOSAGE AND
ADMINISTRATION.................................................................................
5
4.1
Dosing Considerations
.......................................................................................
5
4.2
Recommended Dose and Dosage
Adjustment..................................................... 5
4.4
Administration...................................................................................................
6
4.5
Missed Dose
.....