PHL-LOSARTAN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
27-01-2012
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Active ingredient:
LOSARTAN POTASSIUM
Available from:
PHARMEL INC
ATC code:
C09CA01
INN (International Name):
LOSARTAN
Dosage:
50MG
Pharmaceutical form:
TABLET
Composition:
LOSARTAN POTASSIUM 50MG
Administration route:
ORAL
Units in package:
30/100
Prescription type:
Prescription
Therapeutic area:
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Product summary:
Active ingredient group (AIG) number: 0127971003; AHFS:
Authorization status:
CANCELLED PRE MARKET
Authorization date:
2017-05-31
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
PHL-LOSARTAN
Losartan potassium tablets, USP
25, 50 and 100 mg
ANGIOTENSIN II RECEPTOR ANTAGONIST
PHARMEL INC.
DATE OF PREPARATION
6111 Royalmount Ave. Suite 100
January 27, 2012
Montréal, Québec
H4P 2T4
SUBMISSION CONTROL NO: 123553, 145007
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_phl-LOSARTAN Product Monograph _
_Page 2 of 39_
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..............................................................................12
OVERDOSAGE
................................................................................................................14
ACTION AND CLINICAL
PHARMACOLOGY............................................................14
STORAGE AND STABILITY
.........................................................................................17
DOSAGE FORMS, COMPOSITION AND
PACKAGING.............................................17
PART II: SCIENTIFIC
INFORMATION...............................................................................19
PHARMACEUTICAL INFORMATION
.........................................................................19
CLINICAL
TRIALS..........................................................................................................20
DETAILED
PHARMACOLOGY.....................................................
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