AMLODIPINE BESYLATE TABLETS, 10MG

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

AMLODIPINE (AMLODIPINE BESYLATE)

Disponible desde:

DR. REDDY'S LABORATORIES INC

Código ATC:

C08CA01

Designación común internacional (DCI):

AMLODIPINE

Dosis:

10MG

formulario farmacéutico:

TABLET

Composición:

AMLODIPINE (AMLODIPINE BESYLATE) 10MG

Vía de administración:

ORAL

Unidades en paquete:

90/100/200/300/500

tipo de receta:

Prescription

Área terapéutica:

DIHYDROPYRIDINES

Resumen del producto:

Active ingredient group (AIG) number: 0131437001; AHFS:

Estado de Autorización:

CANCELLED PRE MARKET

Fecha de autorización:

2023-06-27

Ficha técnica

Page 1 of 33
PRODUCT MONOGRAPH
PR
AMLODIPINE BESYLATE TABLETS
5 mg and 10 mg amlodipine as amlodipine besylate
Antihypertensive-Antianginal
Agent
MANUFACTURED BY:
Date of Initial Approval:
DR. REDDY’S LABORATORIES INC.
December 14, 2009
107 College Road East, Princeton
New Jersey, 08540
Date of Revision:
USA
October 24, 2022
IMPORTED AND DISTRIBUTED BY:
DR. REDDY’S LABORATORIES CANADA INC.
5580 Explorer Drive, Suite 204
Mississauga, ON L4W 4Y1
Canada
SUBMISSION CONTROL NO: 264381
Page 2 of 33
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
..............................................................................................
6
DRUG INTERACTIONS
..............................................................................................
9
DOSAGE AND
ADMINISTRATION..........................................................................
14
OVERDOSAGE
..........................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
......................................................... 16
STORAGE AND
STABILITY.....................................................................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 19
PART II: SCIENTIFIC
INFORMATI ON ...........................................................................
20
PHARMACEUTICAL
INFORMATION
.......................................................................
20
DETAILED PHARMACOLOGY
.........................