PENDO-AMLODIPINE-ATORVASTATIN TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

AMLODIPINE (AMLODIPINE BESYLATE); ATORVASTATIN (ATORVASTATIN CALCIUM)

Tersedia dari:

PENDOPHARM DIVISION OF PHARMASCIENCE INC

Kode ATC:

C10BX03

INN (Nama Internasional):

ATORVASTATIN AND AMLODIPINE

Dosis:

5MG; 20MG

Bentuk farmasi:

TABLET

Komposisi:

AMLODIPINE (AMLODIPINE BESYLATE) 5MG; ATORVASTATIN (ATORVASTATIN CALCIUM) 20MG

Rute administrasi :

ORAL

Unit dalam paket:

100

Jenis Resep:

Prescription

Area terapi:

HMG-COA REDUCTASE INHIBITORS

Ringkasan produk:

Active ingredient group (AIG) number: 0251555002; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2014-08-05

Karakteristik produk

PRODUCT MONOGRAPH
PR
PENDO-AMLODIPINE-ATORVASTATIN
Amlodipine besylate and Atorvastatin calcium Tablets
5 mg/10 mg, 5 mg/20 mg and 10 mg/10 mg, 10 mg/20 mg
Amlodipine, as Amlodipine besylate/Atorvastatin, as Atorvastatin
calcium
Anti-hypertensive/Anti-anginal Agent and Lipid Metabolism Regulator
PENDOPHARM, division of Pharmascience Inc.
6111 Royalmount Ave., Suite 100
Montreal, Quebec
H4P 2T4
www.pendopharm.com
Date of Revision:
July 13, 2016
Submission Control No: 195771
_ _
_pendo-AMLODIPINE-ATORVASTATIN Product Monograph _
_Page 2 of 70_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
3
SUMMARY PRODUCT INFORMATION
..............................................................................
3
INDICATIONS AND CLINICAL USE
...................................................................................
3
CONTRAINDICATIONS
.........................................................................................................
3
WARNINGS AND PRECAUTIONS
.......................................................................................
4
ADVERSE REACTIONS
.......................................................................................................
12
DRUG INTERACTIONS
........................................................................................................
19
DOSAGE AND ADMINISTRATION
....................................................................................
28
OVERDOSAGE
......................................................................................................................
30
ACTION AND CLINICAL PHARMACOLOGY
.................................................................. 31
STORAGE AND STABILITY
...............................................................................................
38
SPECIAL HANDLING INSTRUCTIONS
.............................................................................
38
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................... 38
PART II: SCIENTIFIC INFORMATION
40
PHARMACEUTIC