MYLAN-LOSARTAN HCTZ TABLET

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE

MAH:

MYLAN PHARMACEUTICALS ULC

ATC_code:

C09DA01

INN:

LOSARTAN AND DIURETICS

dosage:

100MG; 12.5MG

pharmaceutical_form:

TABLET

composition:

LOSARTAN POTASSIUM 100MG; HYDROCHLOROTHIAZIDE 12.5MG

administration_route:

ORAL

units_in_package:

30/100

prescription_type:

Prescription

therapeutic_area:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

leaflet_short:

Active ingredient group (AIG) number: 0233168003; AHFS:

authorization_status:

CANCELLED POST MARKET

authorization_date:

2018-05-10

SPC

________________________________________________________________________________________________________
MYLAN-LOSARTAN HCTZ
Page 1 of 42
PRODUCT MONOGRAPH
Pr
MYLAN-LOSARTAN HCTZ
losartan potassium and hydrochlorothiazide tablets
50 mg/12.5 mg, 100 mg/12.5 mg and 100 mg/25 mg
Manufacturer’s standard
Angiotensin II Receptor Antagonist and Diuretic
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Revision:
August 09, 2013
SUBMISSION CONTROL NUMBER: 166901
________________________________________________________________________________________________________
MYLAN-LOSARTAN HCTZ
Page 2 of 42
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
.............................................................................................
8
DRUG INTERACTIONS
...........................................................................................
11
DOSAGE AND ADMINISTRATION
......................................................................
16
OVERDOSAGE
..........................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
................................................... 18
STORAGE AND STABILITY
..................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................... 21
PART II: SCIENTIFIC INFORMATION
.............................................................. 23
PHARMACEUTICAL INFORMATION
................................................................. 2