APO-AMLODIPINE-ATORVASTATIN TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

AMLODIPINE (AMLODIPINE BESYLATE); ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE)

Disponible depuis:

APOTEX INC

Code ATC:

C10BX03

DCI (Dénomination commune internationale):

ATORVASTATIN AND AMLODIPINE

Dosage:

10MG; 10MG

forme pharmaceutique:

TABLET

Composition:

AMLODIPINE (AMLODIPINE BESYLATE) 10MG; ATORVASTATIN (ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE) 10MG

Mode d'administration:

ORAL

Unités en paquet:

100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

HMG-COA REDUCTASE INHIBITORS

Descriptif du produit:

Active ingredient group (AIG) number: 0251555005; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2013-08-23

Résumé des caractéristiques du produit

_APO-AMLODIPINE-ATORVASTATIN (amlodipine besylate and atorvastatin
tablets) Page 1 of 83 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-AMLODIPINE-ATORVASTATIN
Amlodipine Besylate and Atorvastatin Calcium Tablets
Amlodipine Besylate and Atorvastatin (as atorvastatin calcium
propylene glycol solvate)
Tablets, 5/10 mg, 5/20 mg, 5/40 mg, 5/80 mg, 10/10 mg, 10/20 mg, 10/40
mg and 10/80 mg,
Oral
Apotex Standard
Anti-hypertensive/Anti-anginal Agent and Lipid Metabolism Regulator
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
AUG 23, 2013
Date of Revision:
MAY 19, 2023
Submission Control Number.: 270896
_APO-AMLODIPINE-ATORVASTATIN (amlodipine besylate and atorvastatin
tablets) Page 2 of 83 _
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
05/2023
7 WARNINGS AND PRECAUTIONS, Musculoskeletal
05/2023
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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................
4
1
INDICATIONS
...............................................................................................................
4
1.1
Pediatrics
...................................................................................................................
4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.1
Dosing Considerations
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