LUPIN-PROPRANOLOL LA CAPSULE (EXTENDED RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PROPRANOLOL HYDROCHLORIDE

Available from:

LUPIN PHARMA CANADA LIMITED

ATC code:

C07AA05

INN (International Name):

PROPRANOLOL

Dosage:

120MG

Pharmaceutical form:

CAPSULE (EXTENDED RELEASE)

Composition:

PROPRANOLOL HYDROCHLORIDE 120MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

BETA-ADRENERGIC BLOCKING AGENTS

Product summary:

Active ingredient group (AIG) number: 0101831001; AHFS:

Authorization status:

APPROVED

Authorization date:

2019-08-30

Summary of Product characteristics

_Page 1 of 30 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
LUPIN-PROPRANOLOL 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
Lupin Pharma Canada Ltd.
1001 De Maisonneuve Est, Suite 304
Montréal, Quebec
H2L 4P9
Date of Initial Authorization:
AUG 28, 2019
Date of Revision:
JAN 14, 2022
Submission Control Number: 255723
_Page 2 of 30 _
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
.........................................................................................................
6
5
OVERDOSAGE
.....