LISINOPRIL TABLETS
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
18-08-2009
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Active ingredient:
LISINOPRIL (LISINOPRIL DIHYDRATE)
Available from:
RANBAXY PHARMACEUTICALS CANADA INC.
ATC code:
C09AA03
INN (International Name):
LISINOPRIL
Dosage:
20MG
Pharmaceutical form:
TABLET
Composition:
LISINOPRIL (LISINOPRIL DIHYDRATE) 20MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
ANGIOTENSIN-CONVERTING ENZYME INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0121550002; AHFS:
Authorization status:
APPROVED
Authorization date:
2009-08-20
Summary of Product characteristics
_ _
_Page 1 of 41_
PRODUCT MONOGRAPH
PR
LISINOPRIL TABLETS
(LISINOPRIL)
5 mg, 10 mg and 20 mg of lisinopril as lisinopril dihydrate
USP
Angiotensin Converting Enzyme Inhibitor
Ranbaxy Pharmaceuticals Canada Inc.
2680 Matheson Blvd East, Suite 200
Mississauga, Ontario
L4W 0A5
Date of Preparation:
August 17, 2009
Submission Control No: 131981
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_Page 2 of 41_
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.................................................................................................
10
DRUG INTERACTIONS
.................................................................................................
16
DOSAGE AND
ADMINISTRATION.............................................................................
18
OVERDOSAGE
...............................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 21
STORAGE AND
STABILITY.........................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 24
PART II: SCIENTIFIC INFORMATION
..............................................................................
25
PHARMACEUTICAL
INFORMATION.........................................................................
25
CLINICAL
TRIALS.........................................................................................................
26
DETAILED
PHARMACOLOGY
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