PMS-OLMESARTAN-HCTZ TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

Tersedia dari:

PHARMASCIENCE INC

Kode ATC:

C09DA08

INN (Nama Internasional):

OLMESARTAN MEDOXOMIL AND DIURETICS

Dosis:

25MG; 40MG

Bentuk farmasi:

TABLET

Komposisi:

HYDROCHLOROTHIAZIDE 25MG; OLMESARTAN MEDOXOMIL 40MG

Rute administrasi :

ORAL

Unit dalam paket:

30/100/1000

Jenis Resep:

Prescription

Area terapi:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Ringkasan produk:

Active ingredient group (AIG) number: 0252502003; AHFS:

Status otorisasi:

CANCELLED PRE MARKET

Tanggal Otorisasi:

2019-02-07

Karakteristik produk

PRODUCT MONOGRAPH
Pr
PMS-OLMESARTAN-HCTZ
Olmesartan Medoxomil and Hydrochlorothiazide Tablets
20 mg/12.5 mg, 40 mg/12.5 mg, and 40 mg/25 mg
Angiotensin II AT
1
Receptor Blocker - Diuretic
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Quebec
H4P 2T4
www.pharmascience.com
DATE OF REVISION:
June 28, 2017
Submission Control No.: 205707, 200930
_ _
_pms-OLMESARTAN-HCTZ Product Monograph _
_Page 2 of 35_
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
....................................................................................................9
DRUG INTERACTIONS
..................................................................................................12
DOSAGE AND ADMINISTRATION
..............................................................................16
OVERDOSAGE
................................................................................................................18
ACTION AND CLINICAL PHARMACOLOGY
............................................................19
STORAGE AND STABILITY
..........................................................................................22
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................22
PART II: SCIENTIFIC INFORMATION
...............................................................................23
PHARMACEUTICAL INFORMATION
..........................................................................23
CLINICAL TRIALS
.....................................................................