LOSARTAN TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

LOSARTAN POTASSIUM

Available from:

RANBAXY PHARMACEUTICALS CANADA INC.

ATC code:

C09CA01

INN (International Name):

LOSARTAN

Dosage:

50MG

Pharmaceutical form:

TABLET

Composition:

LOSARTAN POTASSIUM 50MG

Administration route:

ORAL

Units in package:

10/30/500

Prescription type:

Prescription

Therapeutic area:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Product summary:

Active ingredient group (AIG) number: 0127971003; AHFS:

Authorization status:

APPROVED

Authorization date:

2013-08-21

Summary of Product characteristics

IMPORTANT: PLEASE READ
IMPORTANT: PLEASE READ
_LOSARTAN (Losartan Potassium Tablets) Product Monograph _
_ Page 1 of 38 _
PRODUCT MONOGRAPH
LOSARTAN
Losartan Potassium Tablets,
Manufacturer's Standard
25 mg, 50 mg and 100 mg
Angiotensin II Receptor Antagonist
Ranbaxy Pharmaceuticals Canada Inc.
Date of Preparation:
2680 Matheson Blvd. E., Suite 200
August 15, 2013
Mississauga, Ontario
L4W 0A5
SUBMISSION CONTROL NO: 166987
Trademark owned by Ranbaxy Laboratories Limited
IMPORTANT: PLEASE READ
IMPORTANT: PLEASE READ
_LOSARTAN (Losartan Potassium Tablets) Product Monograph _
_ Page 2 of 38 _
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
...........................................................................................................
7
DRUG INTERACTIONS
.........................................................................................................
10
DOSAGE AND ADMINISTRATION
.....................................................................................
11
OVERDOSAGE
.......................................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 13
STORAGE AND STABILITY
.................................................................................................
17
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 17
PART II: SCIENTIFIC INFORMATION
....