APO-AMLODIPINE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

AMLODIPINE (AMLODIPINE BESYLATE)

Available from:

APOTEX INC

ATC code:

C08CA01

INN (International Name):

AMLODIPINE

Dosage:

5MG

Pharmaceutical form:

TABLET

Composition:

AMLODIPINE (AMLODIPINE BESYLATE) 5MG

Administration route:

ORAL

Units in package:

100/500

Prescription type:

Prescription

Therapeutic area:

DIHYDROPYRIDINES

Product summary:

Active ingredient group (AIG) number: 0131437002; AHFS:

Authorization status:

APPROVED

Authorization date:

2009-07-09

Summary of Product characteristics

_APO-AMLODIPINE (amlodipine besylate tablets) _
_ _
_Page 1 of 40 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-AMLODIPINE
Amlodipine Besylate Tablets
Tablets, 5 mg and 10 mg amlodipine (as amlodipine besylate), Oral
USP
Antihypertensive-Antianginal Agent
Apotex Inc.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
JUL 09, 2009
Date of Revision:
SEP 1, 2023
Submission Control Number: 274841
_APO-AMLODIPINE (amlodipine besylate tablets) _
_ _
_ _
_ _
_ _
_ _
_Page 2 of 40_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
09/2023
4 DOSAGE AND ADMINISTRATION, 4.4 Administration
09/2023
4 DOSAGE AND ADMINISTRATION, 4.5 Missed Dose
09/2023
7 WARNINGS AND PRECAUTIONS, Cardiovascular
09/2023
7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male
Potential
09/2023
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
..................................................................................................
5
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.1
Dosing Considerations
.......................................................................................
5
4.2
Recommended Dose and Dosag